NATIONAL GUIDELINES FOR

COMPREHENSIVE HIV PREVENTION, CARE

AND TREATMENT

FEDERAL MINSTRY OF HEALTH

JUNE, 2014

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Forward

Antiretroviral treatment began in 2003 and free ART was launched in Ethiopia in 2005. An estimated
769,500 Ethiopians are currently living with HIV, out of who542600 require antiretroviral treatment
(ART) and 367 000 are currently taking ARV.

Recognizing the need for antiretroviral treatment, the Government of Ethiopia (GOE) issued the first
antiretroviral (ARV) guidelines in 2003, which were revised in 2005 and 2008 to facilitate a rapid
scale up of ART. With continued care and treatment updates the Federal Ministry of Health revised
the national guideline in order to scale up and improve the quality of service at all levels of care and
treatment.

Expansion and strengthening ART care and treatment activities at regional, zonal, woreda and kebele
levels through targeted social mobilization and active community participation are expected to create
an enabling environment to prevent and control spread of the epidemic. The process of task shifting:
training of nurses and community health agents in prevention, treatment, care and support activities
will further strengthen community linkages and ensure availability of standard minimum packages of
HIV/AIDS services at primary health care level. Currently there are 938 health facilities providing
HIV care and treatment service.

This revised 4th edition of guidelines for use of OI and ARV drugs in adult and children is based on
recent national and global evidence and experience and is intended as a clear guide for rational and
safe use of OI and antiretroviral drugs. The Federal Ministry of Health believes that these guidelines,
along with other national implementation guidelines, will be instrumental in accelerating and scaling
up ART uptake.

Kebede Worku, MD,MPH

State Minister

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Contents
Forward.................................................................................................................................................................................. i

Acknowledgement.................................................................................................................................................................. v

Acronyms and Abbreviations................................................................................................................................................vii

CHAPTER ONE: - INTRODUCTION....................................................................................................................................1

1.1. Background and context.......................................................................................................................................1

1.2. Rationale for the consolidated guideline....................................................................................................................2

1.2.1. Objectives of the guideline..................................................................................................................................2

1.2.2. Target Audience..................................................................................................................................................2

1.2.3. Guiding principles...............................................................................................................................................3

CHAPTER TWO - HIV DIAGNOSIS AND PREVENTION....................................................................................................5

2.1. HIV Testing and counseling (HTC) services...............................................................................................................5

2.1.1. Guiding Principles..............................................................................................................................................5

2.1.2. Service Delivery Models......................................................................................................................................6

2.1.3. Procedures of HTC service delivery............................................................................................................8

2.1.4. Retesting....................................................................................................................................................11

Repeat testing..............................................................................................................................................................11

Referral and linkage:..................................................................................................................................................12

2.2. HIV testing and counseling in specific populations............................................................................................12

2.3. Quality Management..........................................................................................................................................16

2.4. Policy, Ethical & Legal considerations for HIV Testing and Counseling...........................................................17

2.5. Post Exposure management including Prophylaxis............................................................................................20

2.5.1. Management of occupational exposure to HIV:................................................................................................20

2.5.2. Prevention of the transmission of the Human Immunodeficiency Virus (HIV) after sexual assault:..........24

2.6. Combination Prevention.....................................................................................................................................26

2.7. Care of HIV exposed infants....................................................................................................................................30

2.8. Linking people diagnosed with HIV infection.....................................................................................................35

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CHAPTER THREE: - CARE AND TREATMENT of PEOPLE WITH HIV INFECTION.....................................................37

3.1. General care packages for PLHIV.....................................................................................................................37

3.2. Pre-ART care package....................................................................................................................................... 38

3.3. Preparing people living with HIV for ART.........................................................................................................38

3.4. When to Start ART..............................................................................................................................................39

3.5. What ART regimen to start with (first-line ART)................................................................................................41

3.6. Monitoring response to ART and the diagnosis of treatment failure...................................................................48

3.6.1. What to expect in the first months of ART..................................................................................................48

3.6.2. CD4 recovery.............................................................................................................................................48

3.6.3. Immune reconstitution inflammatory syndrome (IRIS)..............................................................................48

3.6.4. Clinical and Laboratory monitoring before and after initiating ART........................................................50

3.6.5. Monitoring for drug toxicities and substitutions for ARV..........................................................................56

3.7. Monitoring the response to ART and the diagnosis of treatment failure.............................................................64

3.8. What ART regimen to switch to (second-line ART).............................................................................................67

3.8.1. Second-line ART for children (including adolescents)...............................................................................68

CHAPTER FOUR:-PREVENTION, SCREENING AND MANAGEMENT OF COMMON CO-INFECTIONS....................70

4.1. Co-trimoxazole preventive therapy (CPT ).........................................................................................................70

4.2. Management of Opportunistic Diseases of the respiratory system.....................................................................73

4.2.1. Tuberculosis...............................................................................................................................................73

4.2.2. Bacterial pneumonia.................................................................................................................................85

4.2.3. Pneumocystis Pneumonia..........................................................................................................................86

4.2.4. Lymphoid Interstitial Pneumonitis (LIP)....................................................................................................87

4.3. Management of Gastrointestinal Opportunistic Diseases...................................................................................88

4.3.1. Dysphagia and odynophagia.....................................................................................................................88

4.3.2. Diarrhoea..................................................................................................................................................89

4.3.3. Peri-anal problems....................................................................................................................................91

4.4. Management of Opportunistic Diseases of the Nervous System.........................................................................92

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 4.4.1. Toxoplasma gondii Encephalitis................................................................................................................93

4.4.2. Cryptococcal infection...............................................................................................................................95

4.4.3. Peripheral Neuropathies............................................................................................................................97

4.5. Cutaneous manifestations...................................................................................................................................99

4.5.1. Etiological Classification of Skin Disorders in HIV Disease.....................................................................99

4.5.3. Pruritic Papular Eruption...............................................................................................................................101

4.6. Visceral Leishmaniasis.....................................................................................................................................102

4.7. Screening for co-morbidities............................................................................................................................102

CHAPTER FIVE:- Guidance on operations and service delivery......................................................................................103

5.1. Adherence to ART...................................................................................................................................................103

5.2. Disclosure...............................................................................................................................................................106

5.2.1. Planning for Disclosure..................................................................................................................................110

5.2.2. Disclosure in adults.........................................................................................................................................113

5.3. Retention across the continuum of care..................................................................................................................115

5.4. Service delivery...................................................................................................................................................... 120

5.5. Laboratory and diagnostic services........................................................................................................................122

5.6. Pharmaceuticals Supply Management System........................................................................................................125

CHAPTER SIX: - GUIDANCE FOR PROGRAMME MANAGERS...................................................................................129

6.1 Guiding principles...................................................................................................................................................129

6.2. National and local HIV epidemiology....................................................................................................................132

6.3. Program performance and response analysis.........................................................................................................132

6.4. Key parameters for decision-making......................................................................................................................133

6.5. Roles and responsibility..........................................................................................................................................136

6.6. Coordination mechanisms......................................................................................................................................137

CHAPTER SEVEN: - MONITORING & EVALUATION...................................................................................................137

7.1. Monitoring the implementation of the New recommendation...........................................................................139

7.2. Key Indicators..................................................................................................................................................140

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 7.3. Data Reporting, Data Flow and Quality Assurance.........................................................................................140

7.2.1. Data Quality Assurance (DQA)...............................................................................................................141

7.3. Supportive Supervision and Review Meetings..................................................................................................141

7.3.1. Supportive Supervision............................................................................................................................141

7.3.2. Review Meetings......................................................................................................................................142

7.4. Other monitoring considerations......................................................................................................................142

Annexes..............................................................................................................................................................................144

Annex 1: Growth Curves...............................................................................................................................................144

Annex 2: Dosage of antiretroviral drugs for adults and adolescents.............................................................................154

Annex 3: Dosage of antiretroviral drugs in children.....................................................................................................155

Annex 4: Pediatric ARV Drug Formulations, Side Effects and Special considerations in Children..............................158

Annex 5 Grading of toxicity in adults and adolescents..................................................................................................163

Annex 6- Grading of adverse events in children............................................................................................................165

Annex 7Laboratory Grading of Adverse Events in Adults and adolescents (ACTG)......................................................168

Annex 8-Grading toxicities in children by selected laboratory findings........................................................................169

Annex 8: Pediatric TB screening tool.........................................................................................................................171

Annex 9: Adult TB screening tool...............................................................................................................................172

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Acknowledgement
The Ministry of Health expresses its appreciation for the institutions participated in the development
of this consolidated HIV prevention care and treatment guideline and extends special thanks for
supporting the workshop for revision of the guideline and training materials.The printing of the
guidelines has been funded by ICAP Ethiopia and WHO country offices.

The ministry also recognizes the following experts for their contribution in the development of the
Guideline

Name Organization
Dr FrehiwotNigatu FMOH
Dr MizanKiros FMOH
MrsSebleMamo FMOH
Dr FethiaKeder FMOH
MrTekalignMoges FMOH
Dr ZelalemTadesse FMOH/ICAP-E
Dr Eshetu Gezehagn ICAP-E
Dr Solomon Amsalu ICAP-E
Dr AberaRefisa ICAP-E
Dr YigeremuAbebe CHAI
Dr GetchewFeleke ITECH
Dr TsegazeabKahsu MSH/ENAT-CS
Dr Fahmi Mohammed WHO
Dr GhionTirsite WHO
Dr AschalewEndale WHO
MrMasreshaAssefa PFSA

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Acronyms and Abbreviations
3TC Lamivudine

ABC Abacavir

AFB Acid fast bacilli

AIDS Acquired Immune Deficiency Syndrome

ANC Antenatal Care

ARV Antiretroviral

ART Antiretroviral Therapy

AZT/ZDV Zidovudine

CBC Complete Blood Count

CD4 cells Type of T-lymphocyte, white blood cells

CMV Cytomegalovirus

CPT Cotrimoxazole Preventive Therapy

DBS Dried Blood Spot

d4T Stavudine

ddI Didanosine

DHS Demographic and Health Survey

DNA Deoxyribonucleic acid

DOTS Directly Observed Therapy Short Course

EFV Efavirenz, also abbreviated as EFZ

FBOs Faith-based organizations

FDC Fixed dose combination

FHAPCO Federal HIV/AIDS Prevention and Control Office

FMOH Federal Ministry of Health

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HAART Highly active antiretroviral therapy

HANS HIV/AIDS Nurse Specialist training

training

HBV Hepatitis B Virus

HCV Hepatitis C Virus

HIV Human Immunodeficiency Virus

IDV Indinavir

IP Infection Prevention

IPT INH Preventive Therapy

IRIS or IRS Immune Reconstitution Inflammatory Syndrome also called Immune

Reconstitution Syndrome (IRS)

I-TECH International Training and Education Center on HIV/AIDS

LFT Liver Function Test

LPV Lopinavir

MTCT Mother-To-Child Transmission (of HIV)

MD Medical Doctor

NFV Nelfinavir

NGO Non-governmental Organization

NNRTI Non-nucleoside reverse transcriptase inhibitor

NRTI Nucleoside Analogue Reverse Transcriptase Inhibitor

NVP Neverapin

OIs Opportunistic Infections

PCR Polymerase chain reaction

PEP Post-exposure prophylaxis

PI Protease Inhibitor
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PITC Provider Initiative Testing and Counselling

PLHIV People living with HIV

PMTCT Prevention of mother-to-child transmission (of HIV)

RNA Ribonucleic acid

RTV, r Ritonavir

PI/r Ritonavir boosted Protease Inhibitor

RFT Renal function test

RT Reverse transcriptase

STI Sexually Transmitted Illnesses

TB Tuberculosis

TLC Total Lymphocyte Count

U/A Urine analysis

UNAIDS The Joint United Nations Program on HIV/AIDS

UP Universal Precautions

WHO World Health Organization

ZDV Zidovudine (also abbreviated as AZT)

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CHAPTER ONE: -INTRODUCTION

1.1. Background and context

The first evidence of HIV epidemic in Ethiopia was detected in 1984. Since then, AIDS has claimed
the lives of millions and has left behind hundreds of thousands of orphans. The government of
Ethiopia took several steps in preventing further disease spread, and in increasing accessibility to HIV
care, treatment and support for persons living with HIV.

According to single point HIV related estimates and projections for Ethiopia 2014 the national HIV
prevalence is 1.14%.The recent 2011 EDHS shown that the urban prevalence is 4.2% which is seven
times higher than that of the rural (0.6%). The 2011 EDHS also shows that the HIV prevalence varies
from region to region ranging from 0.9% in SNNPR to 6.5% in Gambela. Furthermore, the HIV
related estimates and projections indicate that the 2013 HIV prevalence in regions ranges from 0.8%
to 5.8%.
Currently there are 367000 adults and 23400 children under the age of 15 are taking ARV. Based on
the 2014estimatethe 2014ART need is 542 121for adults and 178500 for children under 15 years of
age.

Free ARV service was launched in January 2005 and public hospitals start providing free ARVs in
March 2005.ART service is available in 913 Health facilities of which 765 are Health centers. On
the basis of the 2010-2014 strategic plan ART coverage for adults (age 15+) has reached 76% but the
coverage remains low (23.5%) for children (age <15) living with HIV. The national human resources
development strategy focuses on training and upgrading of frontline, low and mid level health
workers that will staff primary health facilities. In line with this, appropriate HIV care and ART
training, strong follow-up and effective clinical mentorship should continue to ensure the consistent
application of the treatment guidelines and maintain the quality of HIV care and ART services at all
levels.Since the National ART treatment guideline was last published in 2007, new information as
well as evidence-based best practices have become available to make HIV treatment more effective
and accessible, creating a need to revise the existing guidelines. Hence, this guideline is developed
taking into consideration the current recommendations released by WHO in its 2013 revised guidance
for national programs.

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 1.2. Rationale for the consolidated guideline
The consolidated guidelines offer the following anticipated benefits
 Guidance on using ARV drugs is presented within the context of the continuum of HIV-
related prevention, treatment and care. In addition to providing recommendations on the
clinical use of ARV drugs for treatment, the guidelines address other major aspects of HIV-
related care.
 The guidelines address the use of ARV drugs for all age groups and populations.
Previously separate WHO guidelines on using ART among adults and adolescents have been
combined with those for children and for PMTCT, harmonizing ARV regimens and treatment
approaches to the extent possible across age groups and populations.
 New and existing guidance is harmonized. Consolidation has allowed for new
recommendations to be harmonized with relevant, existing WHO guidance.
 Consolidation promotes the consistency of approaches and linkage between settings.
Consolidated recommendations help to facilitate linkage and promote consistency of
approaches across the various settings in which ARV drugs and related services may be
provided, including specialized HIV care, primary care, community-based care, maternal and
child health services, TB services and services for people who use drugs.
 Up/dates will be more timely and comprehensive. Consolidated guidelines enable key
clinical, operational and programmatic implications of new science and emerging practice in
the use of ARV drugs to be comprehensively reviewed every two years across populations,
age groups and settings.

1.2.1. Objectives of the guideline

This new version aims

 to provide updated, evidence-based clinical recommendations outlining a public health
approach to providing ARV drugs for HIV treatment and prevention in the context of the
continuum of HIV care in the comprehensive HIV/AIDS service delivery setting
 to provide guidance on key operational and service delivery issues that need to be addressed to
increase access to HIV services, strengthen the continuum of HIV care and further integrate
the provision of ARV drugs into health systems; andto serve as a reference material for health
service providers and program managers

1.2.2. Target Audience

The guideline is intended to be used by

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  Health care workers (physicians, health officers, nurses, pharmacy personnel, laboratory
technicians and case managers) providing care to people infected and affected with HIV
 HIV/AIDS program managers,health planners and researchers
 Organizations involved in antiretroviral drug procurement, supply management, and ART
service delivery.
 Community based organizations and Faith based organizations working on HIV/AIDs
programs

1.2.3. Guiding principles

Public health approach

The public health approach seeks to ensure the widest possible access to high-quality services at the
population level, based on simplified and standardized approaches, and to strike a balance between
implementing the best-proven standard of care and what is feasible on a large scale in resource-
limited settings.

Strengthening health systems through innovation and learning

HIV services are already being integrated at lower-level health facilities in many settings with a high
burden of HIV infection, while services for PMTCT are increasingly becoming core elements of
maternal and child health services. As people receiving ART begin to age and HIV infection becomes
a chronic, manageable condition, improving the integration of HIV services with care for non-
communicable diseases will also become more important.

Increasing the effectiveness and efficiency of program

HIV program through a strategic approach to using ARV drugs that involves: giving priority to
providing ARV drugs to people living with HIV who are eligible for treatment and most in need;
exploring opportunities to enhance the impact of ARV drugs on HIV prevention by starting treatment
earlier in certain populations; increasing the effectiveness and reach of ARV program across the
continuum of care through a strategic mix of quality-assured HIV testing approaches, improving
adherence and retention, innovative service delivery, integrating ART in a wider range of settings and
strengthening links between services; and engaging in both short- and longer-term efforts to optimize
and harmonize drug regimens and increase their affordability and to develop and implement simpler
and more affordable point-of-care diagnostics and laboratory services.

Promoting human rights and health equity

Access to HIV prevention, treatment, care and support should be recognized as fundamental to
realizing the universal right to health, and these guidelines should be implemented based on core
human rights and ethical principles.

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Implementation based on local context

Implementation of the recommendations in these guidelines should be informed by local context,

including HIV epidemiology, availability of resources, the organization and capacity of the health
system and anticipated cost-effectiveness.

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CHAPTER TWO -HIV DIAGNOSIS AND PREVENTION

2.1. HIV Testing and counseling (HTC) services

HIV testing is the critical first step in identifying and linking PLHIV to the treatment cascade and it
also provide an important opportunity to reinforce HIV prevention among the negatives.

Ensuring service quality is the area which should not be compromised in HIV testing and counseling
services provided by different models. National Guidelines, standard operating procedures, protocols
and other necessary job aides must followedand the HTC service must be regularly supervised.

One of the main objectives in HIV testing and counseling is to identify and link HIV positive persons
to care and treatment servicesand HIV negative people to prevention services. Referral and linkage of
clients must get necessary attentions to maximize the number of identified HIV infected persons that
are linked to available care and treatment services in the country.

2.1.1. Guiding Principles

All forms of HIV testing and counseling should be voluntary and adhere to the five C’s: consent,
confidentiality, counseling, correct test results and connections to care, treatment and
prevention services.

 People receiving HIV testing and counseling must give informed consent (verbal consent is
sufficient and written consent is not required) to be tested and counseled. They should be
informed of the process for HIV testing and counseling and their right to decline testing.

 HIV testing and counseling services are confidential, meaning that what the HIV testing and
counseling provider and the person discuss will not be disclosed to anyone else without the
expressed consent of the person being tested. Although confidentiality should be respected, it
should not be allowed to reinforce secrecy, Stigma or shame. Counselors should rise, among
other issues, whom else the person may wish to inform and how they would like this to be
done. Shared confidentialitywith partner or family members and trusted others and with health
care providers is often highly beneficial.
 HIV testing and counseling services must be accompanied by appropriate and high-quality
pre-test information and posttest counseling.
 HIV testing and counseling providers should strive to provide high-quality testing services.

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  Connections to prevention care and treatment services should include the provision of
effective referral to appropriate follow-up services as indicated, including long-termprevention
and treatment support.

2.1.2. Service Delivery Models

There are two major HIV testing and counseling service delivery models and under these models
there are different service delivery approaches.
These are health facility based HIV testing and counseling model and community based HIV
testing and counseling model
A. Health Facility Based Model of HIV Testing and Counseling
Currently both VCT and PITC are the approaches being implemented in health facilities to deal with
HIV testing and counseling services. Generally the HIV testing and counseling approaches in health
facilities are
1. Client initiated HIV testing and counseling (VCT) which can be stand alone or other health
services integrated
2. Provider initiated HIV testing and counseling (PITC) which is provided by opt-out approach at
clinical service points for eligible patients who come to the facility for other medical reasons
 All health facilities both public and private, shouldprovide HIV testing and counseling
services to their clients by using both VCT and PITC approaches
 All health facilities with VCT services must provide couple counseling and testing
services
 All health facilities should provide PITC for their eligible clients at outpatient, inpatient,
labor and delivery , Ante-natal Care, Post natal Care, EPI, Family Planning and TB Clinic
departments by using national algorithms

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The eligible clients for routine HIV testing and counseling by using PITC approach are
1. All pregnant women with unknown HIV status and their partners
2. All laboring mothers with unknown HIV status and their partners
3. All postpartum mothers with unknown HIV status and their partners
4. All patients at TB clinics with unknown HIV status
5. All STI patients with unknown HIV status and their partners
6. All family members of index cases
7. All under five children visiting HF
8. Children Orphaned by AIDS and vulnerable children
9. All family planning clients with unknown HIV status and their partners
10. All key populations and adolescent/youth clients (15-24 years),
11. Clients coming with clinical signs and symptoms of HIV/AIDS visiting health facilities at
OPD and Wards
12. Discordant couples

On public health grounds, mandatory and compulsory HIV testingand counseling are forbidden in
Ethiopia. Therefore health facilities and healthcare providers must refrain themselves from testing and
counseling individuals without their will and consents. Mandatory testing is allowed in Ethiopia only
for screening purposes of blood and blood components for transfusion, in cases of organ
transplantation and by order of court case.
B. Community Based Model of HIV Testing and Counseling
Community based model is one approach of addressing eligible clients who don’t appear at health
facilities for HIV testing and counseling for different reasons. This model builds public trust and also
mitigates issues related to stigma and discrimination.HTCrelieve clients from transportation and other
expenses. It has also importance to identify HIV positive earlier than facility based approach as well
as reaching populations that services provided at community level can break existing barriers to HIV
testing and counseling. In Ethiopia community based model of HIV testing and counseling is
recommended at the following settings:
 Home-based testing targeting specific sub-population group
 Outreach HIV testing and counseling services. Targeting specific geographic areas with high
HIV prevalence (hot-spots).While planning outreach HTC, effective linkage of the identified
HIV infected clients is very critical.
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  Work place HTC is recommended with high number of eligible persons for HIV testing and
counseling. Some of the eligible work places where community based model of HIV testing
and counseling services are:
 Big farms with huge number of regular and temporary workers
 Big construction sites (roads, dams for irrigation hydro-electric etc.)
 Big factories and mining sites
Mixed service delivery models will be used especially in cases of mobile populations and Mega
project sites.

2.1.3. Procedures of HTC service delivery

Figure-2.1 HIV counseling and testing protocol with workflow.

A user-friendly site guide for VCT, quick reference manual, SOPs for HTC, counseling protocol and
HIV testing algorithm should be available at all health facilities providing HTC service. Same day
results should be respected at all times irrespective of the type of delivery model.VCT and PITC
service providers should follow the national HTC protocol, cue-card and job-aids while providing
HTC services.
a. Client registration
At VCT sites clients will be registered using unique identifiers (code numbers) however at PITC sites
provider can use the patient’s medical registration number (MRN).
b. Pre-test Information
Pre-test information should be provided by VCT counselor using the cue-card. Couples should be
encouraged to receive results together
Pre-test information for PITC can be provided in the form of individual or group information sessions.
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The relevant information that should be provided includes:
 The reasons why HIV testing and counseling is being recommended.
 The clinical and prevention benefits of individual and couple testing
 The available services in the case of either -negative or -positive test result, including availability
of ART.
 The confidentiality of result other than heath care providers directly involved in providing services
to the patient
 The right to decline the offered test and declining an HIV test will not affect the patient's access to
other medical services
• The right of the client to ask the health care provider any concern or questions.
c. Informed consent
Informed consent should always be given as a verbal consent as individual or couple privately. For
pediatric age group(less than 15 years of age) the parents or guardian of the child need to consent
verbally. Mature minors (13-15 year age) can give verbal consent by themselves.

Unconscious or patient who is not in status of self-consent should not be tested for HIV unless the
clinician determines it necessary to establish diagnosis and make treatment decisions. The most senior
clinician or counselor in the institution should be consulted before testing such patient. The patient’s
next of kin should be counseled and supported before HIV testing is carried out and afterwards to
understand the results and cope with the impact. Consent of kin should be obtained during counseling
and service provider should act accordingly.
d. HIV Testing
To improve the quality of service delivery and the acceptability and uptake of HTC, for many
settingsrapid diagnostic tests (RDTs) should be used. These testing strategies have been developed
assuming that all HIV assays used have a sensitivity of at least 99% and a specificity of at least 98%,
resulting in an overall positive predictive value of 99%.
The HIV testing must be done using national accepted RDTs following nationalHIV testing algorism.

e. Providing HIV test results

Test results should be declared in person (not by telephone, e mail or letter). HCT sites should not
provide written HIV test results to clients to avoid misuse of results. Clients requesting or requiring
referral to other facility should be referred to the appropriate institution including pertinent
information.

f. Post-test counseling
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All clients undergoing HIV testing should be provided with post-test counseling in person
(as individual or couple): The form of the post-test counseling session depends on the test result; For
positives, sessions will focus on meaning of HIV positive result, coping with the test result,
importance of medical care and treatment, disclosure and partner testing, prevention messages and
positive living referral for care and treatment.
The post-test counseling session for negatives should include meaning of test result, prevention
message (risk-reduction plan to remain negative) and importance of partner testing.
In situations where the counselor does not perform the test, results should be sent to the requesting
counselor/service provider, and not disclosed to clients. All sites providing HCT services -VCT or
PITC- should ensure counselors follow the standardized protocol to provide post-test counseling.

g. Disclosure of HIV test results to other people:

All clients, positive or negative, should be empowered to inform their sexual partner/s of their test
result. When HIV-positive clients are reluctant or fearful to disclose their results, the counselor should
provide additional counseling to help the client to disclose the test result and bring the partner for
testing. If a client fails to disclose after repeated documented counseling sessions (2-3 within two
weeks) and the counselor feels that the partner is at risk of infection, he/she should consult the
supervisor or immediate management staff for further action including revealing the result.

Disclosing HIV status to children is a process. Counselors should be encouraged to answer

children’s questions truthfully from early age. Information should be given in a way a child can
understand at a pace s/he can cope with according to their cognitive and emotional maturity.

h. Follow-up counseling
After counseling a client on test results, counselors should take opportunity to review or share
information that may not have been absorbed. Emphasis should be placed on prevention of further
transmission, referrals to other services, involvement of partners and family members, coping
mechanisms and identifying available support services and resources.

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 2.1.4. Retesting
There is a need to reduce unnecessary re-testing among persons who have previously been testedand
learnt their results. Most people do not require re-testing to validate an HIV-negative result. However,
it is important to accurately identify persons who do require re-testing. Such persons include those
whose initial test results were indeterminate, those who tested negative but are at ongoing risk for
acquiring HIV (e.g. due to high-risk behaviors) and those who may be in the early stages of infection
and have not yet developed a sufficient level of antibodies that can be detected by serological testing
(‘window period’).
Repeat testing– refers to a situation where additional testing is performed for an individualimmediately
following a first test during the same testing visit due to inconclusive or discordanttest results; the
same assays are used and, where possible, the same specimen.
Re-testing – refers to a situation where additional testing is performed for an individual after adefined
period of time for explicit reasons, such as a specific incident of possible HIV exposurewithin the past
three months, or ongoing risk of HIV exposure such as sharing injecting equipment.Re-testing is
always performed on a new specimen and may or may not use the sameassays (tests) as the one at the
initial test visit.
Recommendations for re-testing

General Recommendation:
Re-testing is warranted in all epidemic types:
1. If an individual has previous or ongoing risk for HIV infection (i.e. sex workers, having a
high-risk or known HIV positive partner; having clinical indications for re-testing such as
newly acquired sexually transmitted infections [STI])
OR
2. If an individual can identify a specific incident of HIV exposure in the three months prior to
HIV testing (i.e. history of occupational exposure, unprotected sex with a known HIV-positive
person).

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Re-testing is recommended for persons who:
1. Occupational exposure or sexually assaulted client who started PEP, retest at
6 weeks, 3 months and 6 months
2. Pregnant women, who have tested HIV negative in the first /second trimester of pregnancy;
retest during third trimester or labor or postpartum
3. Have an STI: after 3months
4. Have continuing or ongoing risk of acquiring HIV (MARPs); every 12 months but for female
sex workers consider retesting every six month
5. Have specific incidents of known HIV exposure within the past three months,after3months
6. Discordant Couple, retest after 6-12month

Referral and linkage:Clientswith HIV positive result should be referred to relevant facility, or
community services for prevention or treatment services based or linked with relevant clinic for
follow-up and support.

2.2. HIV testing and counseling in specific populations

a. Couples
Couple:Two persons in an ongoing sexual relationship; each of these persons is referredto as a
“partner” in the relationship.
Studies in several countries have shown that couples HIV testing and counseling is acceptable,
feasible and effective. It can identify sero-concordant couples who can be linked to prevention, care
and treatment services. Services should be offered to married and cohabiting couples, premarital
couples, polygamous unions and any other partnerships. As with all HIV testing and counseling
approaches, couples HIV testing and counseling should be voluntary. Health providers must be aware
of the potential for intimate partner–based violence and should support individuals when they do not
want to test with their partners. Couples HIV testing and counseling can be offered at VCT,PMTCT
and ART sites.

Support to encourage the testing of the partners of people living with HIV is also an efficient and
effective way of identifying additional people living with HIV, who then can benefit from treatment.
Offering family counseling and testing to couples where one or both are living with HIV can identify
children, adolescents and other household members who have not previously been diagnosed.
12
Recommendations
 Couples and partners should be offered HIV testing at all HIV testing points with support for
mutual disclosure

b. Pregnant and postpartum women

Provider-initiated testing and counselling for pregnant women and linkage to prevention and care are
needed to promote the mother’s health and prevent new pediatric infections.
Recommendations
 Provider-initiated testing and counseling is recommended for women as a routine component
of the package of care in all antenatal, childbirth, postpartum and pediatric care settings.
 Re-testing is recommended in the third trimester, or during labor or shortly after delivery,
because of the high risk of acquiring HIV infection during pregnancy.
c. Infants and children
Mortality is very high among untreated infants infected with HIV in the first year of life, making early
HIV testing, prompt return of results and rapid initiation of treatment essential. Final diagnosis (or
definitive diagnosis) at the end of the risk period for mother to-child transmission (breastfeeding
period) should be ensured. For children 18 months of age and older (who are not being breastfed or
who stopped breastfeeding at least six weeks earlier), standard HIV serological tests such as rapid
diagnostic tests can be used to reliably determine HIV infection status.

Recommendations
It is strongly recommended that:
 HIV testing and counseling should be offered to all under five children visiting health facilities

 All HIV-exposed infants must have HIV virological testing at six weeks of age or at the
earliest opportunity thereafter.
 For infants with an initial positive virological test result, it is strongly recommended that ART
be started without delay and, at the same time, a second specimen be collected to confirm the
initial positive virological test result.
 Children 18 months of age or older with suspected HIV infection or HIV exposure, have HIV
serological testing performed according to the standard diagnostic HIV serological testing
algorithm used in adults
13
 HIV-exposed infant
(Infant born to HIV-infected mother or HIV
antibody positive infant <18 months of age)

DNA PCR at 6 weeks or at earliest opportunity after age 6 weeks

Start Co-trimoxazole prophylaxis
ARV prophylaxis as per the national PMTCT guideline

Positive Negative

HIV Infected Continue follow up per national guideline;

Take DBS to repeat viral test continue Co-trimoxazole, ARV per national
and refer/start ART in the PMTCT guideline
mean time1

If Infant gets sick If infant remains well

Repeat DNA PCR Continue follow up; continue co-trimoxazole
continue co-trimoxazole Rapid test at > 12 months of age or at least six
weeks after complete cessation of breastfeeding

Positive Negative

Initiate ART HIV infection unlikely Positive Negative *

Look for other causes repeat DNA PCR Not HIV infected
Rapid test at ≥12 months of
age or > 6 weeks after
complete cessation of
Follow- up in
breastfeeding
routine
child health
service

Positive Negative

* The child should not have been on

breast feeding at least for 6 weeks
before declaring HIV negative
Initiate ART Follow- up until HIV is
excluded

NB: If the first test is positive and the confirmatory virological test is negative, a third test will be needed to resolve the
discordance between the two earlier virological tests (WHO recommendations on the diagnosis of HIV infection in infants
and children,2010).

Figure 2.2 Algorithm for testing of HIV Exposed Infants <18 months

14
Adolescents

Adolescents are often underserved and given insufficient priority in many HIV programs, with poor
access to and uptake of HIV testing and counseling and linkage to prevention and care. Adolescents
with HIV include those surviving perinatal infection and those newly acquiring infection as they
become sexually active or are exposed through sexual assault, and blood transfusions. In generalized
epidemic settings, many vertically infected infants are not diagnosed through program for PMTCT
and would benefit from earlier HIV diagnosis and treatment. In many settings, adolescent girls and
adolescents from key populations are also vulnerable to HIV infection and would benefit from access
to acceptable and effective HIV services, including HIV testing and counseling. Mature minors and
adolescents above 15 years can access HTC service by giving self-consent.

Recommendations

 HIV testing and counseling with other prevention services and linkage to treatment and care is
recommended for all adolescents and youth age 15-24 years
 Adolescents be counseled about the potential benefits and risks of disclosure of their HIV
status and empowered and supported to determine if, when, how and to whom to disclose

Most at Risk Populations

HIV testing and counseling has been provided to key populations since HIV tests were first
developed. Both existing and new recommendations for HIV testing and counseling for these most-at-
risk and vulnerable groups should emphasize consent and confidentiality as well as ensuring that HIV
testing and counseling is part of a comprehensive prevention, care and treatment program. Populations
most at risk and vulnerable to HIV infections include but are not limited to: sex workers, mobile
workers, in-school youth, uniformed services and inmates.

Recommendations

 HIV testing and counseling with other prevention services and linkage to treatment and care
Should be accessible to MARPS at health facilities and community service model

15
 2.3. Quality Management
Quality HTC can be defined as accessible HTC services that meet the need of clients and providers, in
an equitable and acceptable manner, within the resources available and in line with national
guidelines.

Quality Assurance

Quality assurance (QA) for HIV testing and counseling refers to periodic assessments of factors that
affect the quality of HCT services: issues that need to be addressed while assessing for QA:
 Have the counselors/service provider received basic HTC training packages approved by
FMOH?
 Is there enough physical space to provide HCT that ensures privacy of the clients and point
of care testing?
 Are basic supplies and provider support tools available to provide HCT services?
 Is the service accessible and affordable to the clients?
 Are clients satisfied with the services?
 Are counseling and testing sessions conducted according to nationally approved protocols?
HTC services should be supervised by well-trained program supervisors on regular basis to ensure
HTC service qualities. The roles and responsibilities of the supervisors are:
• To determine if counselors/service providers received standard trainings and refresher courses
• To monitor how well counselors/service providers follow the counseling and testing protocol
• To monitor whether clients feel that their confidentiality is protected and satisfied with the services
they are provided
• To make sure that HIV test results are given in person during the post-test counseling session.
Quality control (QC) is a procedure or set of procedures intended to ensure that a performed service
adheres to a defined set of quality criteria or meets the requirements of the client.
Quality control of HIV testing
Only test kits validated by the Ethiopian Public Health Institute should be used by counseling and
testing sites. Training and supervision of laboratory staff, accurate testing materials that are well
stored and have not expired, and good maintenance of laboratory records are essential to quality HIV
testing. Quality can be controlled and ensured by looking at:
• How consistently the national testing protocol is followed
• How valid the testing algorithm is in terms of specificity and sensitivity
16
• Is the laboratory operating procedures are observed
• Is infection prevention practice is in place
Note: 10% of negative and 30% of positive samples must be sent to the regional laboratory for
external quality control at sites which perform more than 500 tests per month. For others, combined
on-site evaluations with proficiency testing will be conducted once or twice a year.
In addition, trained laboratory technicians may regularly retest samples tested by counselors and other
lab technicians as an internal quality control. Sites failing the proficiency tests need to receive
additional technical supervision and support.
Supervision and Quality Assurance: for testing standards and bio- safety;

 proficiency testing
 quality control testing in central laboratory
 Standardized laboratory log book
 Technical support on the quality of HCT service

2.4. Policy, Ethical & Legal considerations for HIV Testing and Counseling
POLICY AND LEGAL Framework
The following policy, legal and ethical statements reflect existing Ethiopian HIV/AIDSpolicy.
General HTC services
Policy objectives:
To promote and provide standard HCT services to individuals, couples, and communitygroups of all
ages regardless of gender, and especially to vulnerable and high-risk groups.
Policy Statements
 HCT services shall be integrated into existing health and social welfare services and promoted
in all settings: government, non-governmental, private sector, cooperatives, workplace, faith
based organizations etc
 HCT services shall be strengthened through effective networking, consultation
andcollaboration among stakeholders
 HCT services shall be standardized nationwide and shall be authorized, supervised, supported
and regulated by appropriate government health authorities
 Informed consent for testing shall be obtained in all cases, except in mandatory testing
 Adequate pre-test information, pre and post-test counseling shall be offered to all clients

17
  Test results, positive or negative, shall be declared to clients in person and must be provided
with post-test counseling
 No results will be provided in certificate form, however referral will be offered to access post-
test services (prevention, care, treatment and support)
 Clients’ confidentiality will be maintained at all times. Results can be shared with other
persons only at clients’ request or agreement, and with those involved in clinical management
of clients. Clients can be referred on if required or upon request.
 Mandatory HIV testing is a violation of human rights, only permissible in exceptional cases by
order of a court of law. Mandatory testing will be done on all voluntary blood, tissue and
organ donors, who shall be informed about HIV testing and given opportunity to learn their
test results.
 Provider-initiated testing and counseling (PITC) shall be promoted to all eligible person as
part of standardclinical management and care in all health facilities
Couples

Policy Statements
 Couples shall be encouraged to be counseled, tested and receive results together.
Partnernotification shall be encouraged in cases where one partner receives the results alone
 The privacy and autonomy of the couple and individual must be respected. Informeddecisions
shall be encouraged among discordant couples to protect negatives and support positives
 Pre-engagement, premarital, and preconception counselling and testing will be promoted.

Women

Policy Statements
 Women shall be routinely offered HCT during pregnancy,labour, post natal and at FP with the
right to refuse testing.

18
Children and youth

Policy Statements
 HIV testing for children under the age of 15 shall only be done with the knowledge and
consent of parents or guardians, and the testing must be done for the benefit of the child.
However children aged 13-15, who are married, pregnant, commercial sex workers, street
children, heads of families, or sexually active are regarded as “mature minors” who can
consent to HIV testing.
 Persons 15 years and above are considered mature enough to give informed consent for
themselves
 In some special cases, such as child adoption, a counselor may refuse a testing request when
not in the best interest of the child
 Children who have been sexually abused and put at risk of HIV infection shall receive
counseling, be encouraged to test for HIV and helped to access appropriate services
 The result of HIV testing is the property of the child tested and shall not be disclosed to
third parties unless clearly in the best interest of the child
 Youth-friendly counseling and testing services shall bemade widely available for youth
population.
Physically disabled and mental impaired individuals
People with physical disabilities and mental impairment require special care when
providingcounselling and testing services, particularly regarding communication.

Policy Statements

 HCT service shall accommodate the special needs of people with visual and hearing impairments
by adopting appropriate media of communication
 Individuals under the immediate influence of alcohol or addictive drugs (substance use) shall not
be offered HIV testing due to a mental inability to provide informed consent
 HCT for a mentally impaired individual requires the knowledge and consent of his/her guardian,
and should be for the benefit of the individual or patient.

19
Ethics in Counseling

Policy Statements

 All service providers shall abide by the rules, regulations and protocols contained in this document
and other related national guidelines
 All service providers shall observe the ethical requirements of confidentiality, informedconsent,
proper counseling, anonymity and privacy.
 Shared confidentiality shall be promoted as an avenue to demystify and de-stigmatize HIV/AIDS

2.5. Post Exposure management including Prophylaxis

2.5.1. Management of occupational exposure to HIV:

 Health care workers and support staff have a low but measurable risk of HIV infection after
accidental exposure to infected blood or body fluid
 Compliance with infection prevention recommendations is the mainstay in prevention of
occupational HIV infection. The priorities therefore must be to train health personnel in
infection prevention and provide them with necessary materials and protective equipment
 Risk of HIV infection after a needle stick or cut exposure to HIV-infected blood is estimated
to be 0.3% (3 in 1000). Stated another way, 99.7% of needle stick/cut exposures do not lead to
infection. The risk of HIV infection after exposure of mucous membranes to HIV-infected
blood is estimated to be 0.1% (1 in 1000).However, risk could vary depending on severity of
injury and viral load in the source patient.
 Antiretroviral treatment immediately after exposure to HIV can reduce risk of infection by
about 80%.
Set up for post exposure management in health facilities
 Regular prevention education for employees (health workers, cleaners and other staff involved
in institutional care for PLWHA.
 Ensure availability of control mechanisms for effective observation of Standard Precaution.
 Establish system for post exposure management to ensure urgent attention for victims who
have sustained accidental blood exposure

20
Minimum package for PEP sites
1. Assign one trained physician / HO / nurse as PEP focal person for the facility.
2. The contact address of the facility PEP focal person and the facility ART nurse or any other
second person assigned to coordinated PEP activity in the facility should be posted in all
Outpatient and inpatient departments within the heath facility
3. PEP starter packs including ARV drugs should be made available in designated sites inside the
heath facility which may be accessible to all staff, 24 hours and 7 days a week.
4. Provider support tool algorithmfordetermination of the severity of exposure (Exposure Code)
and PEP register should be available in the facility
Assessment of exposure risk:

Low-risk exposure:
 Exposure to small volume of blood or blood contaminated fluids
 Following injury with a solid needle
 Asymptomatic source patient
High-risk exposure:
 Exposure to a large volume of blood or potentially infectious fluids
 Exposure to blood or potentially infectious fluids from a patient with clinicalAIDS or acute
HIV infection
 Injury with a hollow needle
 Needle used in source patient artery or vein
 Visible blood on device
 Deep and extensive injury
Table 2.1Interpretation of exposure code (Severity of Exposure)
Exposure Code Type of exposure
1 EC 1 Is a minor mucocutanous exposure to small volume of blood for short period
( Few Seconds to minutes )
2 EC 2 Is a Major mucocutanous exposure to large volume of blood for longer duration
( Several minutes ) or
Mild Percutaneous exposure ( with Solid needle or superficial scratch or injury)

3 EC 3 Severe Percutaneous exposure (Large bore hollow needle , Deep puncture ,Visible blood
on devise , Needle used in patient artery/vein )

21
 Table 2.2- Interpretation of the HIV status of the source patient
HIV Source The HIV Status and Severity of the illness in the source patients
code ( SC)

1 HIV SC 1 The Source patient is HIV Positive but is asymptomatic and has reasonably
good immune status

2 HIV SC 2 The Source patient is HIV Positive and is symptomatic , may have AIDS or
has other evidence of advanced illness ( Low CD4 or High viral load )

3 HIV SC The HIV status of the source patients is unknown ( either the patient has
unknown refused HIV testing or died or discharged before HIV testing ) or The source
patient is unknown ( e/g Unlabeled blood sample in a laboratory )

Recommendation of PEP based on Risk assessment

Table 2.3. Recommended HIV post exposure prophylaxis for percutaneous injuries and Mucous membrane or
non-intact skin exposure
Exposure code

Status code EC 1 EC 2 EC 3

SC 1 basic 2 drug PEP basic 2 drug PEP expanded 3 drug PEP

SC 2 basic 2 drug PEP expanded 3 drug PEP expanded 3 drug PEP

SC unknown No PEP is warranted. No PEP is warranted Generally no PEP is warranted

consider basic 2-drugs PEP for source with HIV risk factors

HIV negative No PEP warranted No PEP warranted No PEP warranted

22
Table 2.4 Recommended drugs and administration guide.

ARV drug regimen Dose Frequency Duration

2-Drug Regimen:

Tenofovir (TDF) + TDF 300mg Once daily 28 days

Lamivudine(3TC)
3TC 300mg
or

Zidovudine (AZT) + Lamivudine

AZT 300mg 12 hourly 28days
(3TC)
3TC 150mg

3-Drug Regimen:

Triple FDC Triple FDC(TDF Once daily

300mg, 3TC
300mg,EFV600mg)
Tenofovir (TDF) / Zidovudine
(AZT) + Lamivudine (3TC) +
Efavirenz(EFV) AZT 300mg
12hourly 28 days
Or 3TC 150mg

EFV 600mg(daily)

Lopinavir/ritonavir (LPV/r)
LPV/r400mg/100mg
12hourly
Or
ATV/r300mg/100mg Once daily
Atazanavir/ritonavir(ATV/r)

23
Timing of initiation of prophylaxis:
To be effective, post-exposure prophylaxis should commence as soon as possible (within 1-2 hours).
The maximum delay for initiation of treatment which would prevent infection is not known in
humans. Don’t consider PEP beyond 72 hours post exposure. Prophylaxis is to be given for 28 days.
Testing and monitoring after occupational exposure:
• Testing source: rapid test is done after counseling and consent has been secured.If the
source patient is negative there is no need of further assessment of the exposed health
care worker. If the result is positive the health care worker needs to be tested
• Testing of health care worker: HIV serology should be performed immediately after
exposure. If result is positive there is no need for PEP, but if negative you should
administer PEP as soon as possible as outlined above and then repeat serology at 6
weeks, 3 months, and 6 months
Remember to initiate PEP immediately after exposure until test result confirms the HIV status of the
victim. Stop PEP if the health worker is positive for HIV antibodies
 Following HIV exposure there is a need for psychosocial support

2.5.2. Prevention of the transmission of the Human Immunodeficiency Virus (HIV) after
sexual assault:
1. All women 15 years and older presenting to a health facility after potential exposure to HIV
during sexual assault should be counseled by the examining health care worker about the
potential risk of HIV infection.
2. Parents/guardian of traumatized children should be counseled and informed on the risk of HIV
infection after sexual assault.
3. The following points should be covered in the counseling:
a) The exact risk of transmission is not known, but it exists
b) It is important to know the victim’s HIV status prior to any antiretroviral treatment
c) It is the patient’s choice to have immediate HIV testing or, if s/he prefers, this can be
delayed until 72 hours post examination visit (management guidelines on sexual
assault provides for a 3-day starter pack for those who prefer not to test immediately,
or those that are not ready to receive results immediately).However, encourage the
patient to be tested.

24
 d) PEP is not recommended after 72 hrs following sexual assault. Patients should be
counseled about risk of infection and the possibility of transmitting infection during
sero-conversion. They should be instructed to return at 6 weeks and 3 months post
sexual assault for voluntary counseling and HIV testing.
4. It is strongly recommended that the implementation of post-rape prophylaxis should be carefully
monitored and evaluated for:

• Psychosocial and legal support

• Screening for conventional STIs and follow up management
• Drug side effects
• Sero-conversion

PEP is not recommended

a) If victim presents more than 72 hours after exposure

b) Following condom leak or tear

Recommended regimen

AZT Or TDF+3TC+EFV for 28 days.

Alternatively, Kaletra OR Boosted Atazanavir can substitute EFV.

Follow-up of client Exposed to HIV

Post exposure Testing
 A client who are taking PEP should be followed in the adult ART clinic
Monitoring and Management of PEP Toxicity
 Exposed client s should be reassessed within 3-5 days for medication tolerability and toxicity.
If further details about the source become available, a risk assessment re-evaluation may also
be appropriate.
 Clients taking PEP should be monitored for drug toxicity by testing at baseline and again 2
weeks after starting PEP. The scope of testing should be based on medical conditions in the
exposed person and the toxicity of drugs included in the PEP regimen.
25
  Minimally, lab monitoring for toxicity should include a complete blood count and liver
function tests.
 If toxicity is noted, modification of the regimen should be considered.

2.6. Combination Prevention

HIV prevention approach based solely on one element does not work and can hinder the AIDS
response. There is no single magic bullet for HIV prevention. However, a growing number of
interventions have shown promise in partially protecting against HIV transmission and acquisition
that includes knowledge of sero-status, behavioral risk reduction, condoms, male circumcision,
treatment of curable sexually transmitted infections, and use of antiretroviral medications by both
HIV-infected and uninfected persons. We need to use a mix of behavioral, biomedical and structural
HIV prevention actions and tactics which suit with our country’s actual epidemic. HIV prevention
strategies that combine partially effective interventions should be scaled up and evaluated.

Combination HIV prevention is likely to be most effective when different points in the “transmission
cycle” are impeded; combining strategies to reduces infectiousness of HIV-positive persons with
strategies that reduce HIV susceptibility in the uninfected person. Most early HIV prevention policies
focused heavily on HIV- negative, at-risk persons (e.g. using behavior change communication
campaigns). However, sero-negative persons represent a very large pool to target for high coverage.
Strategies to reduce the infectiousness of HIV positive individuals by reducing secondary HIV
transmission should be part of the prevention policy. Theoretically, if high proportions of people
living with HIV/AIDS (PLHA) learned their HIV sero-status and adopt interventions such as ART
coupled with behavioral risk reduction, this could have a significant impact on HIV transmission.

Core Programmatic Components

Combination approach to prevent includes three types of mutually reinforcing interventions:

1. Biomedical interventions are those that directly influence the biological system through
which the virus infects a new host, such as Male and female condoms and Voluntary
medical male circumcision. Male condoms reduce heterosexual transmission by at least 80%,
if used consistently and correctly. Voluntary medical male circumcision reduces acquisition of
infection and the risk of acquisition for men by up to 66% and offers a significant lifelong
protection

26
 2. Behavioral interventions include a range of sexual behavior change communication
programs that use various communication channels(e.g. mass media, community level and
inter personal) to disseminate behavioral messages designed to encourage people to reduce
behaviors that increase risk of transmission.
3. Structural interventions address the critical social, legal, political, and environmental
enablers that contribute to the spread of HIV including legal and policy reform, measures to
reduce stigma and discrimination, the promotion of gender equality and prevention of gender-
based violence, economic empowerment, access to schooling and supportive interventions
designed to enhance referrals, adherence, retention and community mobilization.

Recommendation
Behavioral interventions
 Peer education
 Outreach activities
 Condom distribution
 Risk reduction Counseling
 Life skills training
 Behavioral change communication(BCC) Materials distribution
 Promotion of health care seeking behaviors through existing services
 Strengthen community based HIV prevention interventions to address the general population
through
o scale-up of quality Community Conversation (CC) and integrate with existing
community structures
o Develop and disseminate HIV prevention messages using print and electronic media.
 Strengthen workplace HIV prevention interventions.
o Strengthen workplace HIV mainstreaming
 Strengthen school based HIV prevention interventions.
o Conduct peer education programs in schools, higher education institutes and
Technical andVocational education and training (TVET).
o Conduct life-skill education in schools, higher education institutes and TVET.
o Conduct school based CC in high schools, higher education institutes and TVET.
27
 o Integrate HIV/AIDS into school curriculum.
o Train teachers on management of school HIV/AIDS programs.
o Develop and disseminate targeted BCC message in schools, higher education
institutes andTVET.
o Strengthen youth leadership development programs.
o Develop an HIV intervention strategy for school and higher education.
o Strengthen anti-AIDS clubs in schools, and higher education institutes and TVETs.
o Ensure active participation/ membership of students in anti-AIDS clubs of schools in
highereducation institutes and TVET.
 Scale-up comprehensive prevention interventions addressing key populations.
 Strengthen out-of-school youth HIV prevention programs.
 Intensify HIV prevention in development schemes including new business opportunity
locations.
o Target business opportunity locations, industries and private development schemes.
o Integrate HIV prevention in the project proposals of development schemes.
o Develop and disseminate targeted HIV/AIDS messages.
o Conduct peer education.
o Referral and linkages with health facilities for VCT, STI and ART services.
o Ensure HIV prevention among development schemes/projects areas communities.
 Scale-up HIV prevention among population groups with special needs.
o Integrate BCC interventions in youth centers for people with disability.
o Develop and disseminate BCC materials for people with special needs.

Biomedical interventions

 Ensure access and enhance uptake of HIV counseling and testing services to eligible patients
 Ensure access and enhance uptake of PMTCT services
o Strengthen the integration of PMTCT with MNCH in all health facilities.
o Mobilize the community to be actively involved in PMTCT.
o Promote PIHCT for all pregnant women attending ANC and delivery services.

28
 o Ensure male involvement in PMTCT service.
o Promote PMTCT by the health development armies.
o Provide education to households on PMTCT by health development armies.
o Expand PMTCT services.
o Provide PMTCT training for service providers to people with disability.
o Involve private health facilities to provide PMTCT services.

 Increase availability and utilization of STI services

STI services need to be revitalized in all health facilities through implementation of syndromic
casemanagement.
o Create strong leadership for STI programs.
o Expand STI services to all health facilities.
o Intensify health education to improve treatment seeking behavior and utilization
of STI services.
o Promote partner notification during STI case detection.
o Ensure availability of drugs and reagents in all public health facilities.
o Train heath care workers on syndromic STI case diagnosis and management.
o Provide STI training for service providers to provide user-friendly services to
people with disability.
 Friendly health services
 Increase supply, distribution and utilization of male and female condoms
o Ensure adequate supplies of condoms.
o Conduct targeted condom distribution, particularly to MARPs.
 Ensure infection prevention and safe blood supplies in Health system
 Avail post exposure prophylaxis (PEP) treatment
 Accelerate male circumcision in areas needed
 Intensifying positive prevention
Structural Interventions

 Community mobilization and awareness through Health development army

 Access to health services
29
 Address socio-cultural factors
o Address harmful traditional practices that fuel HIV/AIDS.
 Address stigma discrimination
 Reduce economic vulnerability
o Provide IGA support to vulnerable women.
 Legal & Policy Environment (Legal support system and partnership)
 Promote gender equality and prevention of gender-based violence
 Supportive interventions designed to enhance referrals, adherence, retention and community
mobilization

2.7. Care of HIV exposed infants

Introduction

Infants born to HIV positive pregnant women by definition are HIV exposed and these
infants can be infected with HIV during pregnancy, labor or after birth through breast
feeding. All HIV exposed infants (infected and non-infected) will test antibody positive
during the first few months of life. While the child with HIV infection can often be identified
during the first months of life, HIV infection often cannot be excluded until after 1 year of
age particularly in breast feeding babies.
Pediatric HIV disease can progress very rapidly and may require treatment before a
positive diagnosis can be confirmed. HIV infected infants are susceptible to many
opportunistic infections including PCP, TB and other bacterial infections that are associated
with high rates of mortality. In the provision of care for these children, we use the national
HIV exposed follow-up card.

30
Components of clinical care for the HIV exposed infant

1. History:
2. Physical examination:
3. Growth assessment:
 Growth is the most sensitive clinical indicator of HIV infection in infants and
young children.
 Children with HIV infection are at high risk for poor growth
 Growth should be monitored closely for all HIV exposed and infected infants

4. Developmental assessment: Use developmental check list to assess growth

and development

5. Infant feeding: Nutrition and feeding history should be assessed regularly.

6. Immunization: All HIV exposed infants should be immunized according to EPI recommendations

Table 2.3: Immunization schedule for HIV exposed infants.

Immunization schedule for Infants and children recommended by the WHO

Expanded Program on Immunization
Vaccine Age

Birth 6 Wks 10 Wks 14Wks 9 months

BCG X
Oral Polio X X X X
DPT-HepB-Hib X X X
Pneumococcal X X X
vaccine (PCV)
Rota X X
Measles X
Infants with symptomatic HIV should not receive BCG vaccine

7. ARV prophylaxis:

 NVP should be given to all babies born to HIV infected mothers

o Give NVP syrup to the baby once daily for the first six weeks of life
o For HIV exposed infants identified after birth (through infant or maternal

31
 HIV antibody testing)
 Infant on breastfeeding:
 Initiate ART for the mother
 Provide NVP syrup for the infant for 6 week (consider extending it for
12weeks if mother is diagnosed during labor or immediate postpartum)
 Collect specimen for DNA PCR testing at 6 weeks of age

 Infant not breast feeding

 Initiate ART for the mother based on eligibility criteria
 If the infant is brought within 72 hours of birth provide Nevirapine
prophylaxis otherwise there is no need to provide NVP syrup for the
infant
 Collect specimen for DNA PCR testing at 6 weeks of age

Table 2.4 – Dosage of NVP syrup for different age groups

Infant age NVP daily dosing Dose in ml

Birth to 6 weeks
 Birth weight 2000-2499 g 10mg once daily 1ml
 Birth weight >2500 g 15 mg once daily 1.5ml
Age 6 weeks to 6 months 20 mg once daily 2ml

Age 6 months to 9 months 30 mg once daily 3ml

Age > 9 months 40 mg once daily 4ml

 NVP concentration is 50mg/ml.

 Dose listed in the table is given once daily
 Follow the manufacturer’s instruction for the duration of use following opening. The bottle
should be labeled with the date on which it was 1st opened.
 Low birth weight infants (<2000mg) should receive mg/kg dosing, suggested dose is 2 mg/kg
once daily.
 NVP infant dose: The oral syringe should not be placed directly in to the bottle. Infant dose
should be measured by pouring a small amount of NVP syrup into a cup, and then draw the
actual dose with oral syringe. Discard the leftover suspension in the cup.
32
  Dosing beyond 6 weeks of age in special situations in which prolonged dosing of up to 12
weeks should be considered (such as the mother having had limited ART and not being likely
to be virally suppressed; the infant is identified as HIV exposed after birth and is
breastfeeding).

8. Co-trimoxazole preventive therapy (CPT)

Using pediatric co-trimoxazole in ALL HIV EXPOSED INFANTS significantly reduces

the rate of PCP and other bacterial infections and in turn reduces infant morbidity and
mortality rates. Start co-trimoxazole to all HIV exposed infants from 6weeks of age. CPT
for HIV exposed infants should be continued until the child is confirmed not to have
HIV infection using antibody test after 18 months of age.

9. TB risk assessment
At each visit the infant should be evaluated for Tuberculosis. We need to ask for
household exposure with an adult who has tuberculosis and symptoms suggestive of the disease
and chest radiograph (CXR) if clinically indicated

10. Determination and evaluation of infection status

One of the goals of follow up of HIV exposed infants is to identify and treat HIV infected
ones early. All HIV exposed infants should have virologic testing at 6 weeks of age or at
earliest opportunity thereafter.

11. Current assessment and plan

At each visit based on the findings on history, physical examination (that includes growth and
development) and/or laboratory investigations, we need to have the assessment of the infant and
we should plan our next steps in their management and follow-up.

Follow up visits and schedule

Follow up of HIV exposed infant is recommended to be done monthly for the first six months
of life then every 3 months until infection status is determined. See table below for details of
follow up schedule and the care components that should be evaluated at each visit.

33
 Table 2.5: Follow up visit schedule for HIV exposed infants
Age in At 6 wk 10 14 wk 5 m 6m 9m 12 m 15 m 18 m
weeks/months birth wk
History x x x x x x x x x x

Physical exam x x x x x x x x x x

Growth x x x x x x x x x x
Assessme
Developmen
nt x x x x x x x x x x
tal
assessment
Infant Feeding x x x x x x x x x x
counseling
Determination of D Do DNA PCR if the test is not Perform rapid
HIV status N done at 6 weeks** antibody test at
A least 6 weeks
P Repeat DNA PCR if infant is sick or
the first DNA PCR test is positive a f t e r cessation of
C
breastfeeding
R
Co-trimoxazole x Continue until HIV is excluded and infant is no longer at risk
Preventive from breastfeeding
Therapy
TB Risk
At each visit
Assessment

Immunizations x x x x x
Adherence x x x x x x x x x x
*counseling
This is the minimum; children should be seen more frequently if clinically indicated.

** If the infant is between 9-12 months, first do Antibody test and if positive do DBS for DNA

34
2.8. Linking people diagnosed with HIV infection
It is critical for people living with HIV to enroll in care as early as possible. This enables both
early assessment of their eligibility for ART and timely initiation of ART as well as access to
interventions to prevent the further transmission of HIV, prevent other infections and co-
morbidities and thereby to minimize loss to follow-up.

Good practices for linkage to care from HTC sites

The following are recommended good practices to improve linkage of HIV positive person to
care and treatment services after the person is found positive at all HTC service sites

Implement standardized service delivery system that will improve referral and linkage
between HCT and HIV chronic care through the following recommended priority
interventions:
 Prepare SOP for inter and intra- facilities service outlets referral linkage system
 Establish site level support groups to improve escorting and feedback practices for
intra-facility referral
 Mapping and establishing network between available HCT, chronic care, and other
support services in the area

Standardize documentation, reporting system and feedback practice the Priority

Interventions are
 Harmonize site level HCT and chronic care registers, reporting formats, referral
and feedback formats (in line with HMIS)
 Ensure the availability and sustainability of recording and reporting formats
 Ensure a referral and linkage feedback mechanism in health facilitate

Ensure standardization of HCT guidelines and training materials on referral and linkages
issues, the priority interventions are:
 Ensure utilization of both VCT and PITC implementation manuals with referral
and linkage issues

35
Improve the involvement of Health Extension Workers (HEW), PLHIVs inawareness
creation activities as to improve referral and linkages through Priorities interventions
 Support HEWs in their day to day IEC/BCC activities in relation to HIV
 Establish and strengthen PLHIV associations and support groups to be involved on
the facilitation of referral and linkage through escorting and other mechanisms

Reduce stigma and discrimination through community involvement the Priority

interventions
 Develop IEC/BCC material focusing on stigma and discrimination
 Advocate gender inequality that predisposes to stigma and discrimination
 Increase media utilization focusing on stigma and discrimination
 Take a visible leadership role in community activities to address stigma and
discrimination through contextual available values and norms of the community
 Identify and analyze the root cause of stigma and discrimination
 Involve PLHIV to reduce stigma and discrimination and to be part of prevention
and care services.

Promote health seeking behavior and encourage HIV positive people for service utilization
through Priority interventions
 Educate clients on benefits of chronic care and other misconception
 Involve local officials, political leaders, community and Faith based organization
leaders to advocate the advantage of standard referral and linkage
 Involve HEWs and other sectors such as agricultural extension workers, education
workers, youth associations, women’s associations, PLHIV and etc. are aware of
the problem of referral and linkage and collaborate to resolve it

36
CHAPTER THREE: - CARE AND TREATMENT of PEOPLE WITH HIV INFECTION

It is critical for people living with HIV to enroll in care as early as possible. This enables both
early assessment of their eligibility for ART and timely initiation of ART as well as access to
interventions to prevent the further transmission of HIV, prevent other infections and co-
morbidities.

3.1. General care packages for PLHIV

Not all people living with HIV are eligible for ART and, of those eligible, not all will be able to
access ART immediately. Enrolment in care provides an opportunity for close clinical and
laboratory monitoring and early assessment of eligibility for ART and timely initiation, and aims
to minimize loss to follow-up. Many care interventions are relevant across the full continuum of
care, including HIV-exposed individuals and people living with HIV before initiation and during
ART.
Key elements at enrolment into chronic HIV care
1. Complete assessment(history taking , complete physical examination and relevant lab
tests)
2. Screening and management of opportunistic infection and co-morbidities
3. WHO clinical staging
4. Pregnancy status , family planning and contraception
5. Support for disclosure and partner notification
6. Risk reduction, counseling and combination HIV prevention approaches
7. Screening for and managing mental health problems and substance use
8. Adherence and psychosocial counseling and support
9. Nutritional assessment and counseling
10. Screening for STIs
11. Prevention of and screening Cervical cancer
12. Management of pain and symptoms

37
 3.2. Pre-ART care package
If patient is not eligible for ART he/she should be seen every three months regularly. During
every visit the patient needs to be evaluated according to the key elements of care mentioned
above. Patients in pre-ART care should receive intensive education and linked to social support
networks with proactive follow up. Clients failing to show up in the clinic on their schedule
should be traced.

3.3. Preparing people living with HIV for ART

Before people start ART, it is important to have a detailed discussion with them about their
willingness and readiness to initiate ART, the ARV regimen, dosage and scheduling, the likely
benefits and possible adverse effects and the required follow-up and monitoring visits. For
children with HIV, this conversation should directly involve the parent/legal guardian and include
discussion about disclosing their HIV status. Initiation of ART should consider nutritional status,
any co-morbidities and potentially interacting medications for possible contraindications or dose
adjustment.
The choice to accept or decline ART ultimately lies with the individual person or his or her
caretaker, and if they choose to defer initiation, ART can be offered again at subsequent visits. If
there is mental health, substance use or other problems that are major barriers to adherence,
appropriate support should be provided, and readiness to initiate ART should be reassessed at
regular intervals. A wide range of patient information materials as well as community and peer
support can help the person’s readiness and decision to start therapy. People starting treatment
and care givers should understand that the first ART regimen offers the best opportunity for
effective virological suppression and immune recovery, and that successful ART requires them to
take the medications exactly as prescribed. They should be advised that many adverse effects are
temporary or may be treated, or that substitutions can often be made for problematic ARV drugs.
People receiving ART and care givers should also be asked regularly about any other medications
that are taken, including herbal remedies and nutritional supplements.
People receiving ART should understand that; while the ARV drugs reduce the risk of HIV
transmission, they cannot be relied on to prevent other people from acquiring infection. They
should be given advice on safer sex (including condom use) and avoidance of other high-risk
activities, such as sharing of injecting equipment, to prevent transmitting HIV to other people.
38
 Requirements for initiation of ART
1. HIV positive test result with written documentation
2. Start only patients with medical eligibility for ART
3. Ensure readiness of patient for ARV therapy

3.4. When to Start ART

When to start ART in adults and adolescents
Early treatment initiation is associated with clinical and HIV prevention benefits, improving
survival and reducing the incidence of HIV infection at the community level. ART should be
provided to all eligible people with a confirmed HIV diagnosis.
3.4.1. When to start ART in pregnant and breastfeeding women
ARV drugs are used for pregnant and breastfeeding women with HIV primarily for the mother’s
health and to prevent the exposed child from becoming infected. All pregnant and breastfeeding
women with HIV should initiate lifelong triple ARVs (ART), which should be maintained at for
the duration of mother-to-child transmission risk as well as then after(Option B+). Infants should
be put on NVP prophylaxis for 4-6 weeks and exclusive breast feeding for the first six months

Table3.1Summary of recommendations on when to start ART in adults, adolescents, pregnant and

breastfeeding women.
a. HIV infection with CD4 count ≤500 cells/mm3 should
be started on HAART irrespective of WHO clinical
stage.
All Adults and
b. HIV infection and WHO clinical stage 3 and 4 should be
adolescents
started on HAART irrespective of CD4 cell count.

c. HIV infection and active TB disease should be started

on HAART irrespective of CD4 cell count.
d. All HIV positive pregnant and breast feeding women
irrespective of CD4 count.

e. Provide ART to all HIV infected partners of sero-

discordant couple regardless of CD4 cell count (to
reduce the risk of HIV transmission to the negative

39
partner).

40
Table 3.2: Summary of recommendations on when to start ART in pregnant and breastfeeding
women and prophylaxis for their infants

PMTCT program Pregnant and breast feeding HIV exposed infant

women with HIV prophylaxis
Use lifelong ART for all pregnant Initiate lifelong ART 6 weeks of infant
and breastfeeding women Regardless of WHO clinical prophylaxis with
(“Option B+”) stage or CD4 cell count once-daily NVP

When to start ART in discordant couple

It has been shown that viral load is the greatest risk factor for HIV transmission and lowering the
viral load is critical to interrupt transmission and preventing morbidity and mortality. Studies
showed that the risk of transmission is near zero when the viral load is very well controlled. Data
from observational and ecological studies confirmed that when ART is given to the infected
partner at a higher CD4 count the risk of transmission is decreased by 96% when compared with
those who started ART at CD4+ counts <350cells/mm3.

When to start ART in children

Infants and young children have an exceptionally high risk of poor outcomes from HIV infection.
Up to 52% and 75% of children die before the age of two and five years respectively in the
absence of any intervention. By five years of age, the risk of mortality and disease progression in
the absence of treatment falls to rates similar to those of young adults.
Diagnosing and retaining children exposed to HIV and children infected with HIV in care also
presents unique challenges because of their dependence on a caregiver. Loss to follow-up has
been particularly high along the continuum of care, with retention especially challenging for
children who are in HIV care but not yet eligible for ART. Where access to immunological
testing is limited, the burden of pediatric HIV disease is high and pediatric ART coverage is low,
simplifying the eligibility criteria for initiating ART may significantly improve the overall health
outcomes for children with HIV.
ART is recommended for HIV infected all children less than 15 years regardless of CD4 count
and WHO clinical stage.Treating all children younger than fifteen years of age is expected to

41
simplify pediatric treatment and facilitate a significant expansion of ART coverage for young
children. Note that late diagnosis is still occurring, and a large proportion of the children
identified as infected with HIV would already be eligible for ART based on previous
recommendations.
Children <15 years All children with HIV infection regardless of CD4 count and
WHO clinical stage.

3.5. What ART regimen to start with (first-line ART)

Using simplified, less toxic and more convenient regimens as fixed-dose combinations is
recommended for first-line ART. Once-daily regimens comprising NRTI backbone (TDF + 3TC)
and one NNRTI (EFV) are maintained as the preferred choices in adults, adolescents and children
older than ten years. For children younger than three years a PI-based regimen is the preferred
approach (Table 3.3).

Table 3.3:- Summary of first-line ART regimens for adults, adolescents, pregnant and
breastfeeding women and children

Population Preferred first Line Alternative First Line

regimens regimensb

Adults (including pregnant AZT + 3TC + EFV

and breastfeeding women AZT + 3TC + NVP
and adults TDF + 3TC + NVP
with TB co-infection))
TDF + 3TC + EFV(FDC)
Adolescents (10 to 19 years) AZT + 3TC + EFV
≥35 kg AZT + 3TC + NVP
TDF + 3TC + NVP
ABC + 3TC + EFV
Children 3 years to less than AZT/ABC + 3TC + EFV ABC + 3TC + NVP
10years and adolescents <35 AZT + 3TC + NVP
kg TDF + 3TC + EFV
TDF + 3TC + NVP
42
Children <3 years ABC or ABC + 3TC + NVP
AZT + 3TC + LPV/r AZT + 3TC + NVP
b
ABC,d4T or boosted PIs (ATV/r, LPV/r) can be used in special circumstances.

ART for TB/HIV co-infected adults

Timing of ART for adults: Antituberculosis treatment and Co-trimoxazole (CPT) should be
initiated first, followed by ART as soon as possible within the first 8 weeks of treatment.The
HIV-positive TB patients with profound immunosuppression such as CD4 counts less than 50
cells/mm3 should receive ART immediately within the first two weeks of initiating TB treatment
Preferred regimen for TB/HIV co-infected patients TDF +3TC+EFV

ARV for HIV/HBV co-infection

When the co-infected patient is eligible based on the HIV eligibility criteria the regimen should
contain TDF+3TC+EFV

First-line ART for pregnant and breastfeeding women and ARV drugs for their infants
A once-daily fixed-dose combination of TDF + 3TC + EFV is recommended as first-line ART in
pregnant and breastfeeding women, including pregnant women in the first trimester of pregnancy
and women of childbearing age. Infants of mothers who are receiving ART and are breastfeeding
should receive six weeks of infant prophylaxis with daily NVP. If infants are receiving
replacement feeding, they should be given six weeks of infant prophylaxis with daily NVP. Infant
prophylaxis should begin at birth or when HIV exposure is recognized postpartum.

Table 3.4Summary of maternal and infant ARV prophylaxis for different clinical scenarios.

Scenario Maternal ARV Infant ARV Durationof infant

prophylaxisa prophylaxisb ARV prophylaxis

Mother diagnosed Initiate maternal NVP 6 weeks

with HIV during ART
pregnancy c,d

43
Mother diagnosed Initiate maternal NVP 6weeks; consider
withHIV during ART extending this to
labour 12 weeks
orimmediately
postpartumand
plans to breastfeed
Mother diagnosed Refer mother for NVP 6 weeks
with HIV during HIV care and
labour or evaluation
immediately for treatment
postpartum
and plans
replacement
feeding
Infant identified as Initiate maternal NVP Perform infant PCR early
HIVexposed after ART infant diagnosis test and
birth(through then immediately
infant or maternal initiate 6 weeks of
HIV antibody NVP – strongly consider
testing) and extending this to 12
is breastfeeding weeks
Infant identified as Refer mother for No drug Do HIV PCR test
HIVexposed after HIV care and in accordance
birth(through evaluation with national
infant or maternal for treatment recommendations on
HIV antibody early infant diagnosis;
testing) and is no infant ARV
not breastfeeding prophylaxis; initiate
treatment if the infant is
infected
Mother receiving Determine an NVP Until 6 weeks
ART but interrupts
44
ART regimen alternative ART after maternal
while regimen or ART is restarted or
breastfeeding solution;counsel until 1 week after
(suchas toxicity, regarding breastfeeding has
stock-outs or continuing ART ended
refusal to continue) without
interruption
a. Ideally, obtain the mother’s CD4 cell count at the time of initiating or soon after initiating ART
b. If infant NVP causes toxicity or NVP is not available, 3TC can be substituted.
c. If the mother is using replacement feeding, infant AZT can be substituted for infant NVP; if there is
documented maternal viral suppression near delivery for a mother receiving ART and using replacement
feeding, four weeks of infant ARV prophylaxis may be considered.
d. If it is known that the mother has initiated ART less than 4 weeks before delivery, consider extending infant
NVP for infants who are breastfeeding to 12 weeks.

First-line ART for children

Treatment recommendations for children should be easy to implement at all levels of the health
system, including the primary care level, and by all ART service providers, rather than pediatric
specialists alone.

Infants and children younger than 3 years

Optimizing first-line ART in children younger than three years is critical to achieving effective
and rapid control of viral replication in the context of high viral load and rapid infant growth.
Considerations that may require alternative therapeutic approaches include the limited availability
of drugs in appropriate formulations, the long-term toxicities of ARV drugs, difficulty with
adherence and the possibility of pre-existing viral resistance because of ARV drug exposure for
PMTCT.

For infants and children infected with HIV younger than three years, the NRTI backbone for an
ART regimen should be ABC or AZT + 3TC. A LPV/r-based regimen should be used as first-line
ART for all children infected with HIV younger than three years (36 months) of age, regardless of
NNRTI exposure. If LPV/r is not feasible, treatment should be initiated with a NVP-based

45
regimen. For infants and children infected with HIV younger than three years, ABC + 3TC +
AZT is recommended as an option for children who develop TB while on an ART regimen
containing NVP or LPV/r. Once TB therapy has been completed, this regimen should be stopped
and the initial regimen should be restarted. (See table 3.5).

Children 3 years and older (including adolescents)

For children infected with HIV three years and older (including adolescents), EFV is the preferred
NNRTI for first-line treatment and NVP is the alternative. For children infected with HIV three
years to less than 10 years old (or adolescents less than 35 kg), the NRTI backbone for an ART
regimen should be one of the following, in preferential order ABC + 3TC OR AZT or TDF +
3TC and for adolescents infected with HIV (10 to 19 years old) weighing 35 kg or more, the
NRTI backbone for an ART regimen should align with that of adults and be one of the following,
in preferential order TDF + 3TC OR AZT + 3TC OR ABC + 3TC. At or above 35 kg, the dose
of TDF in adult dual and triple fixed-dose combinations and the dose of EFV in adult triple fixed-
dose combinations are acceptable for use in adolescents (Table3.3).

TB Co-treatment in children with HIV

TB is one of the most common opportunistic infections affecting children with HIV. Selecting
regimens that are compatible with TB therapy is therefore essential. Interactions between
rifampicin and LPV/r or NVP mean that co-treatment in children under three years is challenging,
but recent evidences in children has generated preliminary evidence on the efficacy of triple
nucleoside therapy which, despite limited data in the context of TB co-treatment, offers a suitable
option for children who require TB treatment while already receiving ART. The recommended
regimens for children diagnosed with TB and starting ART are consistent with the
previousrecommendations (Table 3.5). ART should be started as soon as tolerated within 8 weeks
of initiating anti-TB.

Table 3.5 Summary of recommended ART regimens for children who need TB treatment
Recommended regimens for children and adolescents initiating ART while on TB
treatmenta.b
Younger than 3 years Two NRTIs + NVP, ensuring that dose is 200
46
 mg/m2
or
Triple NRTI (AZT + 3TC + ABC) c

3 years and older Two NRTIs + EFV

or
Triple NRTI (AZT + 3TC + ABC) c

Recommended regimen for children and infants initiating TB treatment while receiving
ART
Child on standard Younger than Continue NVP, ensuring that dose is 200
NNRTI-based 3 years mg/m2
regimen Or Triple NRTI (AZT + 3TC + ABC)c
(two NRTIs + 3 years If the child is receiving EFV, continue the
EFV and older same regimen
or NVP) If the child is receiving NVP, substitute with
EFV
or
Triple NRTI (AZT + 3TC + ABC)c

Child on Younger than Triple NRTI (AZT + 3TC + ABC) c

standard PI based 3 years or
regimen Substitute NVP for LPV/r, ensuring that dose
(two NRTIs + is 200 mg/m2
LPV/r) 3 years If the child has no history of failure of an
and older NNRTI-based
regimen:
Substitute with EFVd
or
Triple NRTI (AZT + 3TC + ABC)c
or
If the child has a history of failure of an
NNRTI-basedregimen:

47
 Triple NRTI (AZT + 3TC + ABC)c
Consider consultation with experts for
constructing a second line regimen
a. Ensure optimal dosing of rifampicin based on new dosing guidelines
b. Substitute ARV drugs based on an age-appropriate ART regimen in line with nationally recommended first-
line ART.
c. Triple NRTI is only recommended for the duration of TB treatment; an age-appropriate PI- or NNRTI-based
regimen should be restarted when rifampicin-based therapy ends. Triple NRTI should also be considered as
the preferred regimen for children older than 3 years with a history of failure on a NNRTI-based regimen.
d. Substitution with EFV should be considered as the preferred option, and EFV could be maintained after TB
treatment ends to enable simplification and harmonization with the ARV drug regimens used for older
children.

48
 3.6. Monitoring response to ART and the diagnosis of treatment failure

3.6.1. What to expect in the first months of ART

Although taking ART is a lifelong commitment, the first six months of therapy are especially
important. Clinical and immunological improvement and virological suppression are expected
when individuals adhere to ART, but opportunistic infections and/or immune reconstitution
inflammatory syndrome (IRIS) may develop, as well as early adverse drug reactions, such as drug
hypersensitivity, especially in the first three months of ART. ART significantly decreases
mortality overall, but death rates are also highest in the first three months of ART. These
complications are commonest when the people starting ART already have advanced HIV disease
with severe immunodeficiency and existing co-infections and/or co-morbidities, severely low
hemoglobin, low body mass index and very low CD4 counts or are severely malnourished.

3.6.2. CD4 recovery

In most adults and children, CD4 cell counts rise when ART is initiated and immune recovery
starts. Generally, this increase occurs during the first year of treatment, and then continues to rise
further during the second year. However, severe immune-suppression may persist in some
individuals who do not experience a significant rise in CD4 cell count with treatment, especially
those with a very low CD4 cell count when initiating ART. Failure to achieve some CD4
recovery should alert the health care provider to potential adherence problems or primary non-
response to ART, and consideration should be given to continue prophylaxis for opportunistic
infections such as co-trimoxazole preventive therapy.

3.6.3. Immune reconstitution inflammatory syndrome (IRIS)

IRIS is a spectrum of clinical signs and symptoms thought to be associated with immune recovery
brought about by a response to ART. It is a widely recognized phenomenon that occurs among
10–30% of the people initiating ART, usually within the first 4–8 weeks after initiating therapy. It
may present in two different ways: paradoxical IRIS, when an opportunistic infection or tumor
diagnosed before ART initially responds to treatment but then deteriorates after ART starts; or
unmasking IRIS, in which initiating ART triggers disease that is not clinically apparent before

49
ART. It should be considered only when the presentation cannot be explained by a new infection,
expected course of a known infection or drug toxicity.
The clinical spectrum is diverse, and IRIS has been reported for many different infections, tumors
and non-infectious conditions. The most serious and life-threatening forms of paradoxical IRIS
are for TB, cryptococcosis, Kaposi’s sarcoma and hepatitis. BCG vaccine–associated IRIS
(localized and systemic) may occur in infants infected with HIV in settings where BCG
immunization is routine. A low CD4+ cell count (<50 cells/mm3) at ART initiation, disseminated
opportunistic infections or tumors and a shorter duration of therapy for opportunistic infections
before ART starts are the main risk factors. IRIS is generally self-limiting, and interruption of
ART is rarely indicated, but people may need to be reassured in the face of protracted symptoms
to prevent discontinuation of or poor adherence to ART.
Most or all of the following features should be present in order to make the diagnosis:
- A low pretreatment CD4 count (often less than 100 cells/µL) One important exception to
this general rule is tuberculosis. IRIS secondary to preexisting M. tuberculosis infection
may occur in individuals with CD4 counts >200.
- A positive virologic and immunological response to ART.
- The absence of evidence of drug-resistant infection, bacterial super infection, drug allergy
or other adverse drug reactions, patient noncompliance, or reduced drug levels due to
drug-drug interactions or malabsorption after appropriate evaluation for the clinical
presentation.
- The presence of clinical manifestations consistent with an inflammatory condition
- A temporal association between HAART initiation and the onset of clinical features of
illness- usually within the first 6 months

Management of IRIS
The most important steps to reduce the development of IRIS include: earlier HIV diagnosis and
initiation of ART before a decline to below 200 CD4 cells/mm3; improved screening for
opportunistic infections before ART, especially TB and Cryptococcus; and optimal management
of opportunistic infections before initiating ART. Timing of ART in people with opportunistic
infections requires balancing a greater risk of IRIS after early initiation against continuing high
mortality if ART is delayed. .
 Patients should generally be treated for the underlying opportunistic infection as soon as
possible
 Continuation of ART when IRIS occurs

50
Role of anti-inflammatory agents: Anti-inflammatory agents may be particularly helpful in the
setting of obstructive mass lesions (e.g. expanding cervical lymph node). Use of anti-
inflammatory agents, particularly corticosteroids, must be weighed against potential risks and side
effects. When we choose to treat with corticosteroids, initiate therapy with prednisone at a dose of
1 mg/kg/day (maximal dose 60 to 80 mg).A rapid taper over a 10 to 14 day period. IRIS in closed
spaces (e.g. CNS OIs) should be managed promptly or referred to appropriate center to avert
significant morbidity and mortality.

IRIS is not indicative of treatment failure or drug side effect. It is a transient phenomenon and is
not a reason to stop ART or change regimen. The OIs should be treated using standard guidelines
and in critically sick patients short course of corticosteroid might be indicated to control severe
symptoms

3.6.4. Clinical and Laboratory monitoring before and after initiating ART
Standardized clinical assessment of patients and, when available immunological, are mandatory at
baseline to decide on initiation of antiretroviral therapy. Patients who do not qualify for this have
a follow up protocol that monitors disease progression and starts antiretroviral therapy before life-
threatening immunodeficiency sets in. Patients qualifying for antiretroviral therapy are thoroughly
evaluated at baseline and for the rest of their lives to monitor toxicity, intolerance, response or
failure to treatment. Before ART initiation and thereafter patient readiness and adherence to
therapy are always assessed and necessary support provided. Opportunistic infections including
TB, IRIS, and co morbidities are always looked for and managed. Such standardized procedures
ensure HIV- infected persons a reasonable quality of care.

51
 Table 3.6: Procedure of Baseline Assessment and Follow up
Baseline assessment, week 0
Objectives Activities Decision
Assess patient  Check HIV test document or  Develop impression on
eligibility request test treatment readiness
 Adherence counseling and  Start CPT if clinically
ensure readiness indicated
 For transfer-ins check referral  Treat OI
form  Determine eligibility
 Register, fill intake format  Refer if necessary
 Clinical assessment: Hx of any  Continue ART for
HIV related illnesses in the transfer-ins
past, OIs, co-morbidities,  Give appointment of 1
pregnancy, past and current week
medication
 Stage with WHO staging
 Counselling and education:
determine treatment readiness,
social background, disclosure,
 Lab assessment1: CD4, (if
available CBC, ALT,
creatinine). If TB suspect
sputum smear. Pregnancy and
other tests as necessary.
2ndVisit, 1 week after baseline visit
To decide on  Review clinical and lab  Decide eligibility
Initiation data  Non-eligible patients come
 Adherence every 3/12
counsellingand ensure  Start CPT or IPT (as
1
For those eligible without CD4 count ART initiation should not be delayed for the CD4 test, however do the test at
earliest opportunity for monitoring purpose.
52
 readiness indicated)
 Drug counseling and  Treat OI including TB
education  Manage any drug toxicity
 Encourage disclosure and and intolerance
discuss with family for  Determine treatment
support readiness
 Decide on regimen and
initiate ART
 Provide education on drug
adverse reactions
 Appointment to return after
2 weeks
3rd visit, 2 weeks after initiation
To determine  Clinical assessment  Decide escalation of
toxicity/  Assess and support nevirapine
intolerance, adherence  Manage toxicity as
adherence, and  Provide counseling indicated
IRIS support  Treat OI if diagnosed
 Lab tests if necessary  Give appointment to return
in 2 weeks
4th visit 4 weeks after initiation
Same as third visit  Same as 3rd visit  Refill ART and other drugs
 Hg if patient is on ZDV as necessary for one month
 Assess and support  Treatment of OI
adherence Manage toxicity and
intolerance
 Refer if necessary
 Appointment to return after
4 weeks
5th visit 8 weeks after initiation
Same as 4th visit Same as 4th visit  Refill ART and other drugs
53
 as necessary for 1 month
 Treatment of OI
 Manage toxicity and
intolerance
 Refer if necessary
 Appointment to return after
4 weeks
6th visit 12 weeks after initiation
Same as 5th visit Same as 5th visit  Refill ART and other drugs
as necessary for 1 month
 Treatment of OI
 Manage toxicity and
intolerance
 Refer if necessary
 Appointment to return after
4 weeks
7thvisit 16weeks after initiation
Same as 6thvisit Same as 6thvisit  Refill ART and other drugs
as necessary for 2 months
 Treatment of OI
 Manage toxicity and
intolerance
 Refer if necessary
 Appointment to return after
8 weeks
 8th visit 24 weeks after initiation
Same as 7thvisit Same as 7thvisit  Determine CD4
 Determine Viral load
 Refill ART and other drugs
as necessary for 3 months

54
  Treatment of OI
 Manage toxicity and
intolerance
 Refer if necessary
 Appointment to return after
12 weeks

NB:

 After the 24th week of initiation of antiretroviral therapy patients are scheduled to return
every twelve weeks. At each visit antiretroviral drugs and CPT for three months are given,
counseling of positive living, safe sexual practice, adherence assessment and support are
done. Lab tests including ALT are requested when indicated. CD4 is repeated every 6/12.
 Patients should be encouraged to come at any time if they have concerns. Clients may be
seen out of the above schedule whenever necessary.
 At every visit conduct screening for TB

Table 3.7summarizes recommended laboratory tests for HIV screening and monitoring, as well as
approaches to screen for co-infections and non-communicable diseases.

Management Recommended Desirable (if feasible)

HIV diagnosis  HIV serology  HBV (HBsAg) serologya

 Screening for sexually
transmitted infections
 Assessment for major
non-communicable
chronic diseases and co-
morbidities b
Follow-up before  CD4 cell count

55
ART every 6 months

ART initiation  CD4 cell count  Urine dipsticks for

Hemoglobin test glycosuria and estimated
for AZTc
glomerular filtration rate
(eGFR) and serum
creatinine for TDFd
 Alanine amino-transferase
for NVPe

Receiving ART  CD4 cell count  Urine dipstick for

(every 6 months) glycosuria and serum
 HIV viral load at 6 creatinine for TDF
months and then
every 12 months
Treatment failure CD4 cell count  HBV (HBsAg) serology
HIV viral load (before switching ART
regimen if this testing was
not done or if the result
was negative at baseline)
a. If feasible, HBsAg testing should be performed to identify people with HIV and HBV coinfection and who
therefore should initiate TDF-containing ART.
b. Consider assessing the presence of chronic conditions that can influence ART management such as
hypertension and other cardiovascular diseases, diabetes and TB.
c. Among children and adults with a high risk of adverse events associated with AZT (low CD4 or low BMI).
d. Among people with a high risk of adverse events associated with TDF: underlying renal disease, older age
group, low BMI, diabetes, hypertension and concomitant use of a boosted PI or potential nephrotoxic drugs.
e. Among people with a high risk of adverse events associated with NVP, such as being ART-naive, women
with HIV with a CD4 count >250 cells/mm3 and HCV co-infection. However, liver enzymes have low
predictive value for monitoring NVP toxicity.

56
 3.6.5. Monitoring for drug toxicities and substitutions for ARV
Guiding principles
 Establish whether the adverse event is due to ARV drugs, other drugs, or clinical illness.
 Try to identify the responsible ARV drug.
 Assess the severity using ACTG (AIDS Clinical Trial Group) grading system
Major types of ARV toxicities
The major causes of drug discontinuation in the first 3-6 months after initiating ART are due to
drug toxicities; therefore, they must be closely monitored. They occur from few weeks to months.
The most frequent drug adverse reactions include:
 Toxicities of NRRTIs (NVP and EFV) occur in the first few weeks, and may be life-
threatening
 ABC hypersensitivity reaction starting from first week following initiation
 Anaemia and neutropenia due to ZDV occur in the first 3 months

The clinical manifestations due to hypersensitivity reactions (ABC and NVP) may be confused
with IRIS. Intolerance to certain drugs, in particular ZDV induced gastrointestinal problems, are
important barriers to adherence unless appropriate measures are taken.
Table 3.8Types of toxicities associated with first and second line ARV drugs

ARV Major types of toxicity Risk factors Suggested

Drug management
ABC Hypersensitivity reaction Presence of HLA-B*5701 If ABC is being
Gene used in first-line
ART, substitute
with TDF or
AZT

If ABC is being
used in second
line
ART, substitute
with TDF
ATV/ Electrocardiographic Pre-existing conduction
r abnormalities (PR interval disease LPV/r.
prolongation) Concomitant use of other
drugs that may prolong
the
PR interval
57
 Indirect hyperbiliru-binaemia Underlying hepatic
(clinical jaundice) disease
HBV and HCV
coinfection
Concomitant use of
hepatotoxic drugs
Nephrolithiasis and risk of Risk factors unknown
prematurity
AZT Anaemia, neutropaenia, Baseline anaemia or If AZT is being
myopathy, neutropaenia used in first-
lipoatrophyorlipodystrophy CD4 count ≤200 lineART,
cells/mm3 substitute with
Lactic acidosis or BMI >25 (or body weight TDF or ABC
severehepatomegalywithsteato >75 kg) If AZT is being
sis Prolonged exposure to used in second-
nucleoside analogues lineART consult
specialist
LPV/ Electrocardiographic People with pre-existing If LPV/r is used
r abnormalities (PR andQT conduction system disease in first-line ART
interval prolongation,torsades Concomitant use of other for
de pointes) drugs that may prolong children, use an
the age-
PR interval appropriateNNR
QT interval prolongation Congenital long QT TI (NVP for
syndrome children younger
Hypokalemia than 3 years and
Concomitant use of drugs EFV for children
that may prolong the QT 3 years and
interval older). ATVcan
Hepatotoxicity Underlying hepatic be used for
disease children
HBV and HCV co- olderthan 6 years
infection If LPV/r is used
Concomitant use of in second-line
hepatotoxic drug ART
Pancreatitis Advanced HIV disease for adults, use
ATV/r. Ifboosted
PIs are
contraindicated
and the person
has failed
ontreatment with
NNRTI in first-
lineART consult
specialist
Risk of prematurity, Risk factors unknown
lipoatrophy or
58
 metabolicsyndrome,
dyslipidemia or
severe diarrhoea

NVP Hepatotoxicity Underlying hepatic EFV. If the

diseaseHBV and HCV person cannot
Co-infection tolerate
Concomitant use of either NNRTI,
hepatotoxic drugs use boosted PI
Baseline CD4 >250
cells/mm3 inWomen
Baseline CD4 >400
cells/mm3 for men
First month of therapy (if
lead-in dose is not used)
Severe skin rash and Risk factors unknown Use boosted PIs
hypersensitivity reaction
(Stevens-Johnson syndrome)

d4T Peripheral neuropathy, Older ageCD4 count ≤200 If d4T is being

lipoatrophy or lipodystrophy cells/mm3 used in first-
Concomitant use of lineART,
isoniazidorddI substitute with
Lactic acidosis or severe BMI >25 (or body weight TDF or AZTor
hepatomegaly with >75 kg) ABC
steatosis, acute pancreatitis Prolonged exposure to If d4T is being
nucleoside analogues used in second-
line
ART (after TDF
or ABC are
usedin first-line
ART), substitute
with AZT
EFV Persistent central nervous Depression or other NVP. If the
system toxicity (such mentaldisorder (previous person cannot
as abnormal dreams, or atbaseline) tolerate
depression or mental Daytime dosing either NNRTI,
confusion)2 use boosted PIs

Hepatotoxicity Underlyinghepaticdisease
–HBV and HCV co-
infection
Concomitant use of
hepatotoxic drug
Convulsions History of seizure

2
Most CNS side effects will improve within 2-4 weeks after initiation
59
 Hypersensitivity Risk factors unknown Use boosted PI
reaction,Stevens-Johnson
syndrome
Potential risk of neural
tubebirth defects
(very low risk in humans)
Male gynaecomastia

TDF TDF Tubularrenaldysfunction, Underlying renal disease If TDF is being

Fanconi syndrome Older ageBMI<18.5 (or used in first-line
body weight<50 kg) ART, substitute
Untreated diabetes with
mellitus AZT or ABC
Untreated hypertension If TDF is being
Concomitant use of used in second-
nephrotoxic drugs or a line
boosted PI ART (after d4T
+ AZT use in
first-line
ART), substitute
with ABC
Decreases in bone mineral History of
density osteomalaciaandpathologi
cal fracture
Risk factors for
osteoporosisor bone loss
Lactic acidosis or Prolonged exposure to
severehepatomegalywithsteato nucleoside analogues
sis Obesity

Exacerbation of hepatitis B Discontinuation of TDF Use alternative

(hepatic flares) dueto toxicity drug for hepatitis
B treatment
consult specialist

Monitoring TDF toxicity

It is advisable for high-risk people (those who are older or have underlying renal disease, long-
term diabetes or uncontrolled hypertension concomitant with boosted PIs or nephrotoxic drugs) to
detect and limit further progression of renal impairment. A significant uncertainty remains around
60
how best to monitor TDF-related bone toxicity among children however it is recommended to
monitor growth in children taking TDF containing regimen.

Clinical recommendations
• Laboratory monitoring is not mandatory to initiate treatment with TDF.
• Routine blood pressure monitoring may be used to assess for hypertension.
• Urine dipsticks may be used to detect glycosuria or severe TDF nephrotoxicity in
individuals without diabetes using TDF-containing regimens.
• If the creatinine test is routinely available, use the estimated glomerular filtration rate a at
baseline before initiating TDF regimens.
• Do not initiate TDF when the estimated glomerular filtration rate is <50 ml/min, or in
long-term diabetes, uncontrolled hypertension and renal failure.
• Monitor growth in children using TDF.

Toxicity monitoring for other ARV drugs

AZT
AZT is associated with a risk of hematological toxicity, and measuring hemoglobin is
recommended before initiating ART and monthly at least for the next three months. People with
HIV with severe anemia at baseline (hemoglobin <7.0 g/dl) should avoid AZT as first-line
therapy.

NVP
The laboratory measurement of liver enzymes has very low predictive value for NVP-containing
regimens. However, monitoring hepatic enzymes is recommended, especially for women with
HIV who have CD4 cell counts >250 cells/mm3 and men who have CD4 cell counts >400
cells/mm3 and individuals with HIV who are co-infected with HBV or HCV.

EFV
The main type of toxicity of EFV is central nervous system side effects, which typically resolve
after a few weeks. However, in some cases, they can persist for months or not resolve at all.
Drug substitutions for ARV drug toxicity
61
Drug regimen or single agent substitutions may be required for drug toxicity and to avoid drug
interactions.
Clinical considerations
- Delaying substitutions or switches when there are severe adverse drug effects may cause
harm and may affect adherence, leading to drug resistance and treatment failure.
- When drug interruptions are required, it is important to consider the various half-lives of
ARV drugs. For example, when a NNRTI needs to be discontinued, a staggered approach
should be used by prolonging the use of the NRTI backbone for two weeks except life
threatening conditions (grade 4conditions) where you have to discontinue all ARV
drugs(See Annex for details).

Strategies for managing adverse drug reactions:

Step 1 Establish whether the problem is due to antiretroviral drugs, other medications, OIs, non-
HIV related problems or clinical condition.
Step 2 Try to identify the responsible ARV drug.
Step 3 Assess the degree/severity of the Adverse Event using the ACTG/PACTG adverse events
grading system
Step 4 Manage the adverse event according to severity and also decide whether to substitute
or discontinue ARV drug common adverse events clinical grading system in adults and
adolescents (ACTG)
Drug interactions
Providers should be aware of all drugs that people with HIV are taking when ART is initiated and
new drugs that are added during treatment maintenance.

62
 Table 3.10 Key ARV drug interactions and suggested management
ARV drugs Key Mechanism Suggested management
interactions
NVP Rifampicin Substitute NVP with EFV

Itraconazole Decrease concentration of Use an alternative antifungal agent

and anti-fungals to sub (for example
therapeutic level
ketoconazole fluconazole)

EFV Amodiaquine Use an alternative antimalarial

agent

Methadone Adjust the methadone dose as

appropriate

Estrogen-based Use alternative or additional

hormonal contraceptive methods

contraception

Astemizole and Use an alternative anti-histamine

terfenadine agent

Boosted Rifampicin Substitute rifampicin with

rifabutin
PI (ATV/r,
Adjust the PI dose or substitute
LPV/r)
with three NRTIs (for
children)

Lovastatin and Increase concentration Use an alternative dyslipidaemia

simvastatin agent (for example pravastatin)

63
Estrogen-based Use alternative or additional
hormonal contraceptive methods

contraception

Methadone and Adjust methadone and

buprenorphine doses as
buprenorphine
appropriate

Astemizole and Use alternative antihistamine agent

terfenadine

64
 3.7. Monitoring the response to ART and the diagnosis of treatment failure

Monitoring individuals receiving ART is important to ensure successful treatment, identify

adherence problems and determine whether and which ART regimens should be switched in case
of treatment failure. The value of viral load testing as a more sensitive and early indicator of
treatment failure is increasingly recognized. Viral load testing should be done after 6 months of
initiating ART and every 12 months then after in order to detect treatment failure proactively.
Viral load testing should be used aside from the routine testing whenever there is clinical or
immunologic suspicion of treatment failure.
Table 3.11 Definitions of clinical, immunological and virological failure for the decision to
switch ART regimens
Failure Definition Remark
Clinical Adults and adolescents The condition must
failure New or recurrent clinical event be differentiated from
indicating severe immunodeficiency immune
(WHO clinical stage 4 condition reconstitution
and certain WHO clinical stage 3 inflammatory
conditions (pulmonary TB and syndrome occurring
severe bacterial infections) may also after initiating ART.
indicate treatment failure) after 6
months of effective treatment
Children
New or recurrent clinical event
indicating advanced or severe
immunodefiency (WHO clinical
stage 3 and 4 clinical condition
with exception of TB) after 6
months of effective treatment
Immunologic Adults and adolescents Without concomitant
failure CD4 count falls to the baseline (or or recent infection to
below) or cause a transient

65
 Persistent CD4 levels below 100 decline in the CD4
cells/mm3 cell count.
Children Current WHO clinical
Younger than 5 years and immunological
Persistent CD4 levels criteria have low
below 200 cells/mm3 or <10% sensitivity and
Older than 5 years positive predictive
Persistent CD4 levels below 100 value for identifying
cells/mm3 individuals with
virological failure.

Virologic Viral load above 1000 copies/ ml An individual must be

failure taking ART for at
least 6 months before
it can be determined
that a regimen has
failed. VL testing
should not be done
when there is an acute
infection/fever. See
guidance above.

66
 Algorithm fordiagnosis of clinical/immunologic treatment failure

a
Routine clinical and
Laboratory Assessment

Clinical/Immunologic suspicion
of treatment failure

Intensive adherence support

And
Opportunistic infection treatment

Reassess after 3 months for clinical T-

stage and/or immunologic
evaluation

No Improvement Improvement seen

Do Viral load testing

Viral load >1000copies/ml Viral load <1000copies/ml

Switch to 2nd line regimen Continue 1st line regimen

67
 Algorithm fordiagnosis of virologic treatment failure

Routine Virologic monitoring

Viral load
>1000copies/ml

Intensive adherence support

Do Viral load testing after 3

months

Viral load <1000copies/ml

Viral load >1000copies/ml

Switch to 2nd line regimen Continue 1st line regimen

Figure 12.2 Algorithm for diagnosis and management ofa) clinical and immunologic b) virologic treatment failure

68
 3.8. What ART regimen to switch to (second-line ART)
Using a boosted PI + two NRTI combinations is recommended as the preferred strategy for
second-line ART for adults, adolescents and also for children when NNRTI-containing regimens
were used in first-line ART. In children using a PI-based regimen for first-line ART, switching to
NNRTI or maintaining the PI regimen is recommended according with age.
Second-line ART for adults and adolescents

It is recommended that second-line adult regimens include a boosted-PI plus two NRTIs
(determined by the drug used in first-line therapy).
Guidance for Changing ARV Regimens for treatment failure
 Assess adherence and address barriers
 Drug interactions
 Don’t add one drug to a failing regimen
 Consider resistance & cross resistance
 Quality of life in end stage disease
 Get advice from experienced clinicians
 At least 2 new drugs
 Preferably 1 new drug class
 Premature changing in ARV can limit future options

Table 3.12 Summary of preferred second-line ART regimens for adults and adolescents
Target population Preferred Second line regimen

If AZT was used in first-line TDF + 3TC + LPV/r or ATV/r

Adults and adolescents (≥10 ART
years)a If TDF was used in first line AZT + 3TC + LPV/r or ATV/r
ART
HIV and TB co-infection If rifabutin is available Standard PI-containing
regimens asrecommended for
adults and adolescents
If rifabutin is not available Same NRTI backbones as
69
 recommended for adults and
adolescents plus double-dose
LPV/r(that is, LPV/r 800
mg/200 mg twice daily) or
standard LPV dose with an
adjusted dose of RTV (that is,
LPV/r 400 mg/400 mg twice
daily)
HIV and HBV co-infection AZT + TDF + 3TC + (ATV/r or LPV/r)

a. Adult clients taking ABC and ddI can be shifted to TDF and 3TC.
b. For pregnant women same regimens recommended as for adults and adolescents

3.8.1. Second-line ART for children (including adolescents)

Recommending potent and effective second-line regimens for infants and children is especially
difficult because of the current lack of experience in resource-limited settings and the limited
formulations available. This highlights the importance of choosing potent and effective first-line
regimens and ensuring their durability and effectiveness by optimizing adherence.
For children starting first-line ART with an NNRTI-based regimen, PI-based regimens remain the
recommended choice for second-line therapy. LPV/r is the preferred boosted PI option, but
ATV/r may be considered if more appropriate formulations become available. After failure of a
first-line LPV/r-based regimen, children younger than 3 years should remain on their first-line
regimen, and measures to improve adherence should be undertaken. After failure of a first-line
LPV/r-based regimen, children 3 years or older should switch to a second-line regimen containing
an NNRTI plus two NRTIs; EFV is the preferred NNRTI.
After failure of a first-line regimen of ABC or TDF + 3TC, the preferred NRTI backbone option
for second-line ART is AZT + 3TC and failure of a first-line regimen is containing AZT or d4T +
3TC, the preferred NRTI backbone option for second-line ART is ABC or TDF + 3TC.

70
Table 3.13 Summary of recommended first- and second-line ART regimens for children
(including adolescents)

Children First line regimen Second line regimen

Younger than ABC + 3TC + LPV/r
No changea
LPV/r-based first- 3 years AZT + 3TC + LPV/r
line ABC + 3TC + LPV/r AZT + 3TC + EFV
3 years and
regimen ABC or TDFb + 3TC +
Older AZT + 3TC + LPV/r
EFV
ABC + 3TC + EFV (or
NVP)
NNRTI-based first- b
AZT + 3TC + LPV/rc
TDF + 3TC + EFV (or
line All ages
NVP)
regimen
AZT + 3TC + EFV (or ABC or TDF + 3TC+
NVP) LPV/rc
a. No change is recommended unless in the presence of advanced clinical disease
progression or lack of adherence specifically because of poor palatability of LPV/r. In this
case, switching to a second-line NVP-based regimen should be considered.
b. TDF may only be given to children >2 years.
c. ATV/r can be used as an alternative to LPV/r in children older than 6 years.

71
CHAPTER FOUR:-PREVENTION, SCREENING AND MANAGEMENT OF COMMON CO-
INFECTIONS

Although initiation of ART is at a higher CD4 count of <500cells/mm3, most patients present for
care and treatment at late clinical stages, therefore screening and management of OI is still
critical. Opportunistic infections are the predominant causes of morbidity and mortality among
HIV-infected patients. Main areas affected are the nervous, gastro-intestinal and respiratory
systems, and the skin. The level of immunity determines the occurrence and type of opportunistic
infections. In general milder infections, such as herpes zoster and other skin infections, occur
early whereas serious life- threatening infections such as CNS toxoplasmosis and cryptococcal
meningitis occur later with severe immune-suppression. Some life-threatening infections, such as
pneumonia and TB, may occur early as well as later. When TB occurs later it is atypical, more
disseminated and more extra pulmonary.
General strategies to prevent opportunistic infections are:
- Reduction of exposure
- Chemoprophylaxis(primary/secondary)
- Immunization and
- starting HAART

4.1. Co-trimoxazole preventive therapy (CPT )

Co-trimoxazole preventive therapy (CPT) should be implemented as an integral
component of a package of HIV-related services. Existing recommendations cover
initiation of CPTamong adults, adolescents, pregnant women and children for prevention
of Pneumocystispneumonia, toxoplasmosis, bacterial infections&diarrhoea caused by
Isospora belli or Cyclospora species, as well as benefits for malariaprophylaxis.

72
 Table 4.1 CPT Indication for primary prophylaxis
Age Criteria for initiation Criteria for Monitoring approach
discontinuation*
In all, starting at 4– Until the risk of HIV Clinical at 3-monthly
HIVexposed transmission ends or HIV
6 weeks after birth Intervals
Infants infection is excluded
irrespective of CD4
level

<1year In all Until 5 years of age

regardless of CD4% or
clinical symptomsor
never

1-5 years WHO clinical Never stop

stages 2, 3 and 4
regardless of CD4
% or Any WHO
stage and CD4
<25%

≥5 years, Any WHO stage Never or when CD4

including and CD4 count ≥350 cells/mm3
Adults <350 cells/mm3d after 6 months of ART

Or WHO 3 or 4

irrespective of CD4

level

*Discontinue also if the person has Stevens-Johnson syndrome, severe liver disease, severe
anaemia, severe pancytopaenia or negative HIV status. Contraindications to co-trimoxazole

73
preventive therapy: severe allergy to sulfa drugs; severe liver disease, severe renal disease and
glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Table 4.2 Dosage of Co-trimoxazole for adults, Adolescents, children & infants
Age(weight ) Suspicion (240 Single strength Double strength
mg /5ml co- tab (480 mg of tab (960 mg of
trimoxazole ) Co-trimoxazole ) Co –
trimoxazole )
Up to 6month 2.5ml/day 1/2tab /day -
(5KG )

6 months to 5 yr 5ml /day 1/2 tab/day -

(5-15 Kg)

6-14 yr (15-30 10ml/day 1 tab/day ½ tab/day

KG)

>14 yrs (>30 KG ) 2tab/day 1 tab/day

Table 4.3 Adverse Effects of CPT & management

Toxicity Clinical description Recommendation
Grade 1 Erythema ,pruritis Prescribe Anti-histamine and
continue CPT & close Follow-up

Grade 2 Diffuse Prescribe Anti-histamine and

maculopapularrash,dry continue CPT & close Follow-up
desquamation

Grade 3 Vesiculation,minor mucosal STOP CPT, manage and re-

ulceration introduce after 2 weeks with
observation (desensitize)

Grade 4 Exfoliative dermatitis STOP CPT NEVER RESTART

CO-TRIMOXAZOL
Steven-Johnson syndrome or
erythema multiforme ,moist

74
 desquamation

4.2. Management of Opportunistic Diseases of the respiratory system

4.2.1. Tuberculosis
TB is the most frequent life-threatening opportunistic infection and a leading cause of death
among HIV infected people. TB increases HIV replication through the process of immune
activation leading to increased viral load. This results in more rapid progression of HIV disease.
On the other hand, HIV increases susceptibility to be infected with M.tuberculosis, the risk of
progression to TB disease and the incidence and prevalence of TB. The life time risk of HIV
positive individuals who develop TB is 20-37 times greater than HIV negative individuals. Thus,
it is essential for both TB and HIV control programs to synergize their joint efforts and intensify
the implementation of TB/HIV collaborative activities to mitigate the dual burden of TB/HIV in
populations at risk or affected by both diseases.
The rationale for the integration is that Tuberculosis and HIV Prevention and Control programs
share mutual challenge of high impact of TB on HIV and vise versa. Therefore, two programs
must collaborate to provide better service for the co-infected patients.

Nationally Recommended TB/HIV Collaborative Activities

A. Strengthen the Mechanisms for integrated TB and HIV services delivery
 Strengthen the coordination mechanism for integrated TB/HIV services at all levels;
 Conduct surveillance to determine HIV burden among TB patients and TB burden among
HIV patients;
 Carry out joint TB/HIV planning for integrated TB and HIV services delivery;
 Conduct monitoring and evaluation of collaborative TB/HIV activities.
B. Reduce the burden of TB in HIV infected people and initiate early antiretroviral therapy (The
three I’s i.e. Intensive case finding, INHPreventive Therapy and Infection control)
 Intensify TB case finding and ensure quality TB treatment;
 Initiate TB prevention with earlier initiation of ART and Isoniazid preventive therapy
(IPT);
 Ensure Tuberculosis infection control in healthcare and congregate settings.
C. Reduce the burden of HIV in patients with presumptive and diagnosed TB.
 Provide HIV testing and counseling to presumptive and confirmed TB patients;
 Provide HIV prevention services for presumptive and confirmed TB patients;
75
 Provide co-trimoxazole preventive therapy for HIV positive TB patients;
 Ensure HIV/AIDS prevention, treatment and care for HIV positive TB patients;
 Provide antiretroviral therapy for HIV positive TB patients.
Table 4.4 Timing of ART for adults and children with TB
Patients with Tuberculosis found to be HIV positive HIV positive patients taking ART
diagnosed with TB

 ART should be started in all TB patients,  Start anti-TB

including those with drug-resistant  Modify ART regimen to
TB,irrespective of the CD4 count. avoid drug-drug
 Antituberculosis treatment should be interaction
initiated first, followed by ART as soon as  Evaluate for treatment
possible within the first 8 weeks of failure
treatment. The HIV-positive TB patients
with profound immune-suppression (such as
CD4 counts less than 50 cells/mm3) should
receive ART immediately within the first
two weeks of initiating TB treatment
 ART should be started in any child with
active TB disease as soon as
possiblewithin eight weeks following the
initiation of anti-tuberculosis treatment
irrespective of the CD4 count and clinical
stage.
 Efavirenz should be used as the preferred
drug in patients starting ART while on
Anti-tuberculosis treatment

The 3Is intervention

I. Intensify TB case finding and ensure quality TB treatment

76
Tuberculosis case finding should be intensified in all HIV testing and counselingservices
for HIV positive clients by using a set of simple questions for earlyidentification of
presumptive TB cases. HIV positive clients coming through HCT services should be
informed about the advantages of being screened for TB. Once informed about the risk of
developing active TB, they should undergo screening for it. Adults and adolescents living
with HIV should be screened for TB with clinical algorithm, those who report any one of
the symptoms of current cough, fever, weight loss or night sweats may have active TB and
should be evaluated for TB and other diseases.

77
 Adolescents and adults with HIVa

Screen for TB with any of the

following symptoms: b
Current cough
Fever
Weight loss
Night Sweats

Assess contraindications to IPTc Investigate for TB and other

diseasesd
Yes No Other diagnosis Not TB TB

Give Follow up Treat

Give Defer
appropriate and for TB
IPT IPT
treatment and consider IPT
consider IPT

Screen for TB regularly at each encounter with a health worker or visit to a health facility
a
Every adult and adolescent should be evaluated for eligibility to receive ART. Infection control measures should be
given priority to reduce M.TB transmission in all settings that provide care
b
Chest radiography can be done if available but is not required to classify people into TB and non-TB groups. In
settings with high HIV prevalence and high TB prevalence among PLHIV (such as exceeding 10%), strong
consideration must be given to adding other sensitive investigations.
c
Contraindications include: active hepatitis(acute or chronic), regular and heavy acohol consumption and symptom of
requirement for initiating IPT
d
Investigations for TB should be performed in accordance with existing national guideline.
Figure 4.1 Algorithm for TB screening among adults and adolescents living with HIV in
HIV-prevalent and resource-constrained settings
78
Children living with HIV who have any of the symptoms of poor weight gain,fever, current cough
or contact history with TB case may have active TB and should be evaluated for TB and other
conditions. If the evaluation shows no TB, children should be offered IPT regardless of their age.

Child over 12 months of age and living with HIV

Screen for TB with any one of the following symptoms:

Poor weight gaina
Fever
Current cough
Contact history with TB patient

No Yes

Assess for contraindications Refer/Work up for TBc

to IPTb

Active TB diagnosed?
No Yes

Y No
Give Defer
IPT IPT

Treat for Treat for common

Tubercul Childhood diseases
osis

Child improved?

Yes No

Give IPT Consult for

further workup
Workup

Screen for TB Every Visit

a.Poor weight gain is defined as (1) reported weight loss or very low weight (weight for age less than –3 z-score), (2) underweight
(weight for age less than –2 z-score), (3) confirmed weight loss (>5%) since the last visit or (4) growth curve flattening.
b. Contraindications include: active hepatitis (acute or chronic) and symptoms of peripheral neuropathy
c. Investigations for TB must be performed in accordance with existing national guidelines.

Figure 4.2: Algorithm for TB screening and IPT for children more than one year old and
living with HIV-FMOH
79
 Infant with history of household contact with TB case

No Yes

Well Symptomatic/Unwell Infant

Not Eligible for IPT

Refer/Work up for TBb

Assess for contraindications to IPTa

Active TB diagnosed?

No Yes
Yes
No
Give IPT Defer IPT

Treat for Treat for commonChildhood diseases

Tuberculosis

Infant improved?

Yes N

Give IPT Consult for further workup

Workup

Screen for TB Every Visit

a. Contraindications include: active hepatitis (acute or chronic) and symptoms of peripheral neuropathy
b. Investigations for TB must be performed in accordance with existing national guidelines

Figure 4.3: Algorithm for TB Screening and IPT for Infants Less than One Year Old and
Living with HIV.

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Diagnosis of TB in HIV infected people
Diagnosis of TB is challenging in HIV positive individuals, especially when the stage of the
disease is advanced. Standard TB diagnostic approaches and clinical algorithms should be
followed to guide the diagnosis of TB in PLHIV.

Clinical assessment:thorough clinical evaluation of the patient, including exclusion of other OIs,
should be done. For patients with respiratory symptoms in whom tuberculosis is less likely and
who are treated empirically for bacterial pneumonia or pneumocystis pneumonia (PCP), clinical
response should not automatically exclude the diagnosis of tuberculosis. Acute bacterial
pneumonia of PCP may occur in patients with underlying tuberculosis and patients should
therefore be reevaluated for tuberculosis, particularly if respiratory symptoms persist after
treatment.

XPert MTB/RIF Test (GeneXpert Test): The GeneXpert MTB/RIF system is a fully automated
nested real time PCR system, which detects MTB complex DNA in sputum and other sample
types (i.e pleural, lymph node aspirate or tissue, CSF, gastric fluid and tissue other than lymph
node). It simultaneously identifies mutations in the rpoB gene, which are associated with
rifampicin resistance. The assay detects M.TB and rifampicin resistance; conferring mutations
using three specific primers and five unique molecular probes. It provides results less than 2
hours and has minimal bio-safety requirements and training.

Xpert MTB/RIF test (GeneXpert Test) is recommended as an initial diagnostic test for all
presumptive TB cases (individuals with TB symptoms) among HIV infected people.

AFB microscopy: AFB Microscopy is indicated for HIV infected presumptive TB cases when
access to XPERT MTB/RIF test is limited.

Chest radiography: Chest X-ray plays a significant role in shortening delays in diagnosisof TB
in PLHIV. It can also be an important entry point to diagnose non-tubercular chestdiseases, which
are common among HIV positives.

Sputum culture: sputum culture is the gold standard for the diagnosis of tuberculosis in general.
Inpatients with XPertnegative results, sputum culture may be indicated as part of thediagnostic
procedure for people living with HIV if clinical suspicion persists.

Diagnosis of extra-pulmonary tuberculosis in HIV positive

Extra-pulmonary tuberculosis is more HIV-related than pulmonary tuberculosis. Theaccurate

diagnosis of extra-pulmonary tuberculosis is complex and difficult, particularly inperipheral
health facilities with limited diagnostic capacity. Therefore, it is important forhealthcare workers
to have high-index of suspicion and critically evaluate throughclinicalalgorithms. For other sites,
do organ specificinvestigations.
81
 Note:

 Xpert MTB/RIF test is recommended as initial diagnostic test for CSF in patients presumed to
have TB meningitis.
 One sputum sample for the facility which have Xpert test and two sample for sample referring
facilities

Fig 4.4 National TB and MDR TB diagnostic algorithm at health facility level

Antibiotic trial: Antibiotic trial has a role to treat concomitant bacterial infection PLHIVwith
cough or serious illness. However, antibiotic trial is not helpful in the diagnosis of TBin HIV
positives.

82
Table 4.5 Extra pulmonary TB diagnostic approaches in HIV positive patients.

Type of TB Evidences Strongly Suggestive of EPTB Investigations and

recommendations

Lymph Node 2Cm or more in size, Asymmetrical/localized; Painless LN Aspirate for AFB has 85% yield,
TB swelling; Firm/fluctuated; Cervical location; patient if not possible to do FNAC of LN,
with weight loss, night sweats, fever start anti-TB.

Pleural Unilateral effusion; Aspirate of fluid is clear and straw Start anti-TB as soon as possible.
effusion colored and clots on standing in a tube without anti-
coagulants or pleural fluid analysis shows protein
>30g/L &>50% lymphocytes; Patients with weight
loss, night sweats, fever, or evidence of TB elsewhere

Tuberculosis Patients with weight loss, night sweats, fever; Admit patient, start anti-TB with
Meningitis Cerebrospinal fluid clear with high protein, low glucose steroids as soon as possible. Start
and lymphocytes; Cryptococal antigen (or Indian Ink treatment for cryptococcal meningitis
and fungal culture) negative in CSF based on clinical or lab evidences.

Evidence of TB elsewhere Note: GeneXpert test has to be

conducted on CSF specimen as an
initial diagnostic test as much as
possible.

Pericardial Heamodynamically significant pericardial effusion, CXR, Echocardiogram or chest

Effusion often with pleural effusions, Lung fields clear and intra- ultrasound; pericardiocentesis, and
thoracic lymphadenopathy. pericardial biopsy; routine TB
Workup.
Usually patients with weight loss, night sweats, fever.
Start anti-TB as soon as possible
N.B. 90% of Pericardial Effusions in HIV positive
patients in high-TB burden areas is due to TB.

Disseminated Patients with weight loss, night sweats, fever and Start anti-TB treatment (add
TB cough; Abnormal CXR (which can include military antibiotics if critically ill)
pattern); Large spleen/liver, Anemia

TB of the Pain over localized area, Children/adolescents –often Spinal imaging (e.g. X-Ray, MRI);
Spine thoracic vertebrae. FNA of vertebral lesions and /or
paraspinous abscesses when feasible.
Adults frequently lumbar vertebrae.

83
II. Initiate TB prevention with Isoniazid Preventive Therapy Isoniazid Preventive Therapy (IPT)
is the use of Isoniazid to sterilize latent TB infection. Thus, isoniazid is given to individuals with
latent infection with Mycobacterium tuberculosis in order to prevent reactivation to active
disease. Screening for exclusion of active TB in HIV infected persons is the single most
important step that should precede the decision to initiate IPT.
So far, evidences strongly favor the benefit of IPT in eligible individuals. Studies haveshown that
providing IPT to people living with HIV does not increase the risk ofdeveloping INH-resistant
TB. Therefore, concerns regarding the development of INHresistance should not be a barrier to
providing IPT.

The dose of INH is 300mg/day for adults and 10mg/kg for children. The duration ofIPT is for six
months. It is also desirable to provide vitamin B6 (25mg/day) to preventINH-induced peripheral
neuropathy.

Table 4.5 INH dosage for children and adolescents

Weight Ranges for Number of 100 mg tablets of INH to be Dose given

Children (kg) administered per dose (mg)

<5 ½ tablet 50

5.1-9.9 1 tablet 100

10-13.9 1 ½ tablet or ½ adult tablet 150

14 -19.9 2 tablets 200

20 -24.9 2 ½ tablets 250

>25 3 tablets or one adult tablet 300

Contraindications of IPT

 Individuals with any one or more of the following conditions should not receive IPT.

 Symptoms compatible with tuberculosis even if the diagnosis isn’t yet confirmed.

 Active hepatitis (chronic or acute)

84
  Regular and heavy alcohol consumptions

 Prior allergy or intolerance to isoniazid

 Symptoms of peripheral neuropathy

NB: - Past history of TB and current pregnancy should not be contraindications for starting of
IPT.
Follow-up of Patients on IPT

Patients should be given one-month supply of Isoniazid and assessed at each follow-up
visit to:
o Evaluate adherence to treatment and to educate client.
o Evaluate for drug toxicity.
o Evaluate for signs and symptoms of active tuberculosis or other OIs.
o Stop IPT if active TB is diagnosed and to immediately start anti-TB.

III. Infection control

People living with HIV are at high risk of acquiring TB in health care facilities and congregate
settings. Each health care facility should have a TB infection control plan for the facility that
includes administrative, environmental and personal protection measures to reduce the
transmission of TB in health care and congregate settings and surveillance of TB disease among
workers .Health care workers with HIV should be provided with ART and IPT if they are eligible.

Summary of recommendations for key actions for infection control

Administrative (facility-level infection control committee and protocols)

 A triage system to identify people suspected of having TB

 Separate people with suspected or confirmed TB
 Cough etiquette and respiratory hygiene

Health workers and care providers

 Surveillance and information
 Package of care for HIV-positive workers (ART and ionized preventive therapy)
 Protective equipment (particulate respirator masks that meet or exceed N95 standards)

85
  Relocation for health care workers living with HIV to a lower-risk area
Environmental
 Ventilation (mechanical)
 Ventilation (natural)
Personal
 Spend as much time as possible outside
 Cough etiquette
 Sleep alone while smear-positive
 Avoid congregate settings and public transport while smear-positive
Multidrug-resistant TB and HIV
Multidrug-resistant TB (MDR-TB) is defined as TB that is resistant to at least ionized and
rifampicin. Patients with both HIV and MDR-TB face complicated clinical management, fewer
treatment options and poor treatment outcomes.

Outbreaks of MDR-TB among people with HIV have been documented in hospital and other
settings, especially in Eastern Europe and in southern African countries with a high HIV
prevalence. People with HIV with suspected drug-resistant TB should be tested using Xpert
MTB/RIF where possible, since this test is more sensitive for detecting TB among people with
HIV and rapidly detects rifampicin resistance, thus greatly shortening the time to diagnose and
treat MDR-TB.

The burden of MDR-TB can be reduced by strengthening HIV prevention, improving infection
control and improving collaboration between HIV and TB control activities, with special attention
to the groups at the highest risk of MDR-TB and HIV infection, such as people who inject drugs
and those exposed in congregate settings.

86
 4.2.2. Bacterial pneumonia
This can occur in immune-competent individuals but In HIV-infected patients, particularly those
infected with S. pneumonia; incidence of bacteremia accompanying pneumonia is increased
compared with that in individuals who are not HIV infected. Bacterial pneumonia occurs during
the whole spectrum of HIV disease, but tends to be more severe and recurrent as the CD4 counts
drops significantly; in addition pneumonia can concomitantly present with sinusitis and/or
bacteremia. If not treated promptly, extra pulmonary complications like empyema, meningitis,
pericarditis, hepatitis and arthritis can follow. Streptococcus pneumonia and
Hemophylusinfluenzae are the most common etiologies of community acquired pneumonia.

Clinical Manifestation

Typically the patient presents with sudden onset of cough, sputum production, chest pain, fever
and/or shortness of breath.

Diagnosis:

The clinical suspicion is based on a history of acute symptoms presented over days to a few
weeks and/or abnormal physical signs of systemic infection and consolidation in the affected
lung/s. Radiologic imaging can assist in confirming the diagnosis of pneumonia.

Treatment:

Amoxicillin is the drug of choice for community-acquired bacterial pneumonia. Start with 500mg
tid for ten days in adults. In children amoxicillin syrup with a dose of 40mg/kg for seven days is
the recommended approach. In patients with penicillin allergy use erythromycin 500mg qid for
the same duration. Follow up is necessary to document resolution of initial symptoms or to
monitor complications. Moreover, the patient has to be staged to determine eligibility for ART.
When the patient has presented with clinical evidence of severe pneumonia, which includes
tachypnea (RR>30/minute), old age (>70 years), cyanosis, hypotension, systolic blood pressure
<80mm Hg, multi-lobar involvement and altered mental status in adults, and chest in-drawing,
grunting and presence of danger signs in children, admit for parentral antibiotic treatment and
supportive therapy or refer the patient if admission is impossible.

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 4.2.3. Pneumocystis Pneumonia
Pneumocystis pneumonia is caused by Pneumocystis jiroveci formerly known as pneumocystis
carini pneumonia (PCP), a ubiquitous organism that is classified as a fungus but also shares
biologic characteristics with protozoa. It commonly occurs when patients have significant
immune suppression (CD4<200cells/mm3 or CD4 percentage < 14%).

Clinical manifestation

Typical clinical presentations are characterized by insidious onset of low grade fever, dry cough,
and dyspnea exacerbated by exertion. Physical examination of ten reveals fever, tachypnea,
tachycardia and scattered rales in the lungs but examination of the lungs can appear normal in
some patients. In children highest incidence is seen between 2-6 months of age and is
characterized by abrupt onset of fever, tachypnea, dyspnea and cyanosis.

Diagnosis:

Presumptive diagnosis of PCP is based on clinical judgement and typical chest X-ray findings
revealing a perihilar interstitial infiltration with tendency to spread outwards. Note that the chest
X-ray can be normal in 20% of patients. Definitive diagnosis of PCP is based on demonstration of
the organism from an induced sputum sample using special stains like Giemsa or methylamine
silver stains, but these tests are not routinely done in Ethiopia. .

Treatment:

Use Trimethoprim 15-25 mg/Kg, three or four times daily for 21 days. Close monitoring is
necessary during the initial five days of treatment and if patient grows sicker, administration of
oxygen is useful. In severely ill patients with marked respiratory distress and extensive chest X-
ray findings, prednisolone has to be given simultaneously; 80mg for the first five days, 40 mg
until 11 days and 20 mg until completion of intensive co-trimoxazole therapy. For severe cases of
PCP in children provide prednisolone 2mg/kg per day for the first 7 - 10 days followed by a
tapering regimen for the next 10 - 14 days. Toxicity of co-trimoxazole, like skin rash, bone
marrow suppression, hepatitis and renal failure can be troublesome in some patients with
advanced HIV disease and requires close monitoring.

88
Secondary prophylaxis after completion of the course of treatment with co-trimoxazole should be
started (refer Table 4.2).

Alternative regimens for mild to moderate cases of PCP include:

1. Clindamycin 600 mg qid plus primaquine 15 mg bid

or

2. Clindamycin 600 mg qid plus dapsone 100 mg daily.

Consider spontaneous pneumothorax in patients with sudden deterioration in clinical condition.

4.2.4. Lymphoid Interstitial Pneumonitis (LIP)

Epidemiology: LIP is one of the most common chronic lower respiratory conditions occurring in
up to 25% of children with HIV/AIDS.

Clinical manifestations: Range from asymptomatic disease with isolated radiographic findings
to bullous lung disease with pulmonary insufficiency. Symptomatic children present with
insidious onset of tachypnea, cough, and mild to moderate hypoxemia with normal auscultatory
findings or minimal rales or wheezing. Progressive disease is accompanied by digital clubbing
and symptomatic hypoxemia. Associated physical findings include generalized lymphadenopathy,
hepatosplenomegaly and parotid enlargement.

Diagnosis: Usually based on clinical exam findings. Diffuse bilateral reticulonodular infiltrate on
X-ray with mediastinal lymphadenopathy. It is important to exclude tuberculosis and other
infectious etiology.

Treatment: Provide symptomatic treatment (hydration, oxygen). Use antibiotics if there is a

superimposed bacterial infection. Bronchodilators may be helpful in mild to moderate disease.
Corticosteroids are usually reserved for children with significant hypoxemia and symptoms of
pulmonary insufficiency. Give predinisolone 1 – 2 mg/kg/24 hrs for 6 – 8 weeks and then taper as
tolerated.

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 4.3. Management of Gastrointestinal Opportunistic Diseases

The GI OI diseases commonly manifest with diarrhoea, nausea and vomiting, dysphagia and
odynophagia among others. There are a number of opportunistic and pathogenic organisms
causing GI disease in patients infected with HIV most common ones being isospora belli,
cryptosporidium, shigella and salmonella, CMV etc. A scenario of multiple concurrent GI
infections is fairly common. The general principle of managing GI opportunistic infections is
identifying and treating the specific offending agent providing supportive care to monitor
situations such as fluid loss. A number of drugs can cause adverse effects that present with
clinical manifestations referable to GIS which are similar to OIs of the GI, posing challenges in
differential diagnosis.

4.3.1. Dysphagia and odynophagia

Dysphagia (difficulty in swallowing) and odynophagia (painful swallowing) are symptoms of
esophagitis occurring at advanced stages of AIDS. They are usually caused by candida, HSV,
CMV, and aphthous ulcers. As well as a sign of severe immunodeficiency, esophagitis also
seriously impairs the patient’s nutritional status. Therefore prompt diagnosis and treatment are
mandatory to avert nutritional complications and inability to swallow prescribed medications.
Children present with reluctance to eat, excessive salivation, or crying while feeding. If thrush is
associated with dysphagia, odynophagia, and/or retrosternal pain, consider oesophageal
candidiasis but this can also occur in the absence of oral thrush. Thrush or oropharyngeal candida
is characterized by white, painless, plaque-like lesions on the buccal surface and/or tongue.

Diagnosis: is frequently made on clinical grounds, but when facilities are available upper GI
endoscopy with or without biopsy or contrast imaging may be done.

Treatment: Dysphagia and/or odynophagia are treated as oesophageal candida on clinical

grounds, in particular when oropharyngeal candida is present. Patients are empirically treated
with Fluconazole in presumptive oesophageal candida. If the response is unsatisfactory they are
referred or investigated if facilities are available, to rule out other causes.

Drug of choice: Fluconazole 200 mg(3mg/k/day in children) PO daily for 14 days

90
 Alternatively, ketoconazole 200 mg(3-6mg/kg/day daily in children) twice
daily for 4 weeks.
Risk of recurrence after completing treatment may be high. If the patient is on ART, s/he should
be investigated for treatment failure. Take necessary precautions regarding drug interactions
especially with ketoconazole. Patients may need hospital admission for supportive care till the
oesophageal symptoms improve and necessary long term treatments are started. If diagnosis
suggests HSV eosophagitis use acyclovir 400mg po five times for 14 to 21 days.

4.3.2. Diarrhoea

Diarrhoea is defined as passing more than four loose or watery stools/day. It may be acute or
chronic, persistent or intermittent. Diarrhoea is among the most frequent symptoms of HIV
disease. Delay in treatment can result in fluid loss and hemodynamic instability. Chronic
diarrhoea may also lead to nutritional deficiencies and wasting. Diarrhoea is caused by
opportunistic or pathogenic organisms, such as viruses (including HIV), bacteria, protozoa, fungi,
helminthic, non-infectious causes and drugs. (Diarrhoea occurs as an adverse reaction to a
number of drugs).

Check the duration, volume, frequency, consistency of stools as well as any history of abdominal
pain, tenesmus, nausea, vomiting, and presence of constitutional symptoms such as fever.
Thorough physical examination is necessary to find out the state of hydration and the status of
HIV disease.

Laboratory evaluation: Stool microscopy including modified acid fast stain

Stool culture when indicated (optional)

Management:

The most important first step is correction of fluid loss. Depending on the severity of dehydration,
ORS or IV fluid therapy can be given. Patients with severe dehydration are admitted for
intravenous fluid administration. In children zinc 20mg per day for 10-14 days(10mg per day for
infants under 6months of age) should be added.

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If specific enteric pathogen is identified or strongly suspected on clinical grounds, it should be
treated accordingly.

Table 4.6: Treatment of specific enteric pathogens

Agent CD4 Symptom Diagnosis Rx

E. hystolytica any bloody stool, Stool Metronidazole

colitis microscopy

Giardia any Watery diarrhoea Stool Metronidazole

microscopy
Cryptosporidium <150 Watery diarrhoea Modified AFB ART

Isospora belli <100 Watery diarrhoea Modified AFB TMP-SMX

Microsporidium < 50 Watery diarrhoea Giemsa stain Albendazole

CMV <50 Watery/bloody Tissue biopsy Ganciclovir

diarrhoea, colitis

Patients with bloody diarrhoea but repeatedly negative stool results: empirical treatment with
ciprofloxacin or norfloxacin (co-trimoxazole in children) can be given, especially when patient
has constitutional symptoms such as fever.

Symptomatic treatment: In adults use anti-diarrhoeal agents Loperamide 4mg stat then 2mg
after each bowel motion or Diphenoxylate 5mg QID. Necessary caution should be taken to avoid
anti-diarrhoeal agents in bacterial or parasitic infectious colitis or enteritis, since toxic mega colon
may occur.

Patients with chronic diarrhoea develop nutritional deficiencies of variable severity; therefore
proper nutritional assessment and support are helpful.

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 4.3.3. Peri-anal problems
A number of chronic or acute peri-anal problems commonly occur in patients with HIV disease,
particularly in advanced stages of immunodeficiency. These include recurrent peri-anal abscesses,
chronic peri-anal fistula, peri-anal herpes (severe, persistent and extensive), and peri-anal warts
(sometimes large with obstructive problems). Patients with peri-anal problems frequently go to
local healers and receive different kinds of local therapy that usually complicate the situation.

Treatment of peri-anal abscess in adolescents and adults: It is not difficult to make the clinical
diagnosis of peri-anal abscess. All patients with acute or chronic peri-anal condition must be
thoroughly evaluated and per rectum done routinely. Peri-anal abscess may extend depending on
the immunological status of the patient; therefore early treatment is mandatory to avoid this and
more serious morbidity. If patients require surgical incision, it should be done promptly on first
visit, or referral made if the surgery is unavailable. Otherwise, broad spectrum antibiotics such as
amoxacillin-clavulanic acid (augmentin) alternatively amoxacillin or ampicillin must be
administered in sufficient dose for at least 10 days. Palliative care including Sithz baths and
analgesics are also important.

Peri-anal and/or genital herpes:

Latent or active infection with HSV I and II are common in the general population, and is usually
mild in immune-competent persons. Severe cutaneous disease or visceral involvement is usually
restricted to patients with advanced immunosuppression with a CD4 count <100 cell/mm3

The lesions become extensive, persistent, severe and sometimes bleeding. Unless thorough
evaluation with regular inspection of genital and peri-anal areas is done, patients very often don’t
complain about genital lesions. The response to Acycovir is gratifying if it is done in sufficient
dose (400mg 4 to 5 X/d) and sufficient duration (10 days to 2 weeks in moderately severe or
severe cases). There is risk of recurrence with severe immunodeficiency. In such cases repeat
treatment and put patient on chronic HIV care including ART. Herpetic oro-labial infection is
treated the same way as ano-genital herpes.

93
The treatment of anal and genital warts is particularly frustrating when they are large. Unlike
other opportunistic infections the response to ART is not satisfactory. Patients who have very
well responded immunologically with ART continue to suffer from the warts. Depending on the
size, cauterization, podophyllin treatment and surgical debulking, etc may be tried. Patients
should be referred to where these services are available.
Cervical cancer screening is an important test to prevent significant morbidity and mortality
associated with HPV in women.

4.4. Management of Opportunistic Diseases of the Nervous System

Neurological manifestations of HIV can occur at any time from viral acquisition to the late stages
of AIDS; they are varied and may affect any part of the nervous system including the brain, spinal
cord, autonomous nervous system and the peripheral nerves. HIV affects the nervous system in
70-80% of infected patients. The effect may be due to direct effect of the virus, opportunistic
infections and/or malignancies. For certain neurological manifestations a single aetiology is
responsible while in others it is due to multiple causes.

Most life-threatening neurological complications of HIV occur during the severe

immunodeficiency state and specific aetiological diagnosis in the Ethiopian setting is often a
major challenge. Thus, this unit attempts to guide the management of common opportunistic
infections and other treatable conditions in the nervous system.

Neurological complications in HIV patients may be due to:

- HIV(HIV encephalopathy)
- OIs(Toxoplasmosis, crypotococcalmeningits
- Neurosyphilis
- Malignancies (primary CNS lymphoma)and
- Drugs(e.g. EFV,d drugs, etc)

94
Diagnosis of neurological disorders in HIV in our setting depends on the history and standard
neurological examinations. In view of this, health care providers must be able to perform a
physical examination to detect neurological abnormalities. There can be single or multiple
abnormal neurological findings in the same patient necessitating holistic neurological evaluation.
Thus the examination should include assessment of:

• Mental status comprising cognitive function, orientation and memory.

• Cranial nerves
• Motor function including DTR
• Sensation

4.4.1. Toxoplasma gondii Encephalitis

Toxoplasmic encephalitis (TE) is caused by the protozoan Toxoplasma gondii. Disease appears to
occur almost exclusively because of reactivation of latent tissue cysts. Primary infection
occasionally is associated with acute cerebral or disseminated disease. Sero-prevalence varies
substantially in different communities; in Ethiopia, general prevalence is about 80%.

Clinical Manifestations
Among patients with AIDS, the most common clinical presentation of T. gondii infection is focal
encephalitis with headache, confusion, or motor weakness and fever. Patients may also present
with non-focal manifestations, including only non-specific headache and psychiatric symptoms.
Focal neurological abnormalities may be present on physical examination, and in the absence of
treatment, disease progression results in seizures, stupor, and coma.

Diagnosis
HIV-infected patients with TE are almost uniformly seropositive for anti-toxoplasma
immunoglobulin G (IgG) antibodies. The absence of IgG antibody makes a diagnosis of
toxoplasmosis unlikely but not impossible. Anti-toxoplasma immunoglobulin M (IgM) antibodies
usually are absent. Quantitative antibody titres are not useful for diagnosis. Definitive diagnosis
of CNS toxoplasmosis requires a compatible clinical syndrome; identification of one or more
mass lesions by CT, MRI, or other radiographic testing; and detection of the organism in a

95
clinical sample. In the absence of imaging support, empirical treatment is justified when patients
present with focal neurological findings and the CD4 count is < 200 cells μL. Failure to respond
to conventional therapy, based on presumptive clinical diagnosis within a week or two of
initiation of therapy, suggests the diagnosis to be unlikely.With empirical treatment for
toxoplasmosis, nearly 90% of patients will demonstrate clinical improvement within days of
starting therapy. Radiological evidence of improvement is usual after 14 days of treatment.

Treatment
1st line regimen in the Ethiopian context is:
Trimethoprim/sulfamethoxazole 80/400, oral, 4 tablets 12 hourly for 28 days, followed by 2
tablets 12 hourly for 3 months in adults.
In children 10mg of trimethoprim + 50mg of sulfamethoxazole/kg per dose every 12 hours for 28
days followed by maintenance therapy at 50%reduced dosage for three months.

Secondary prophylaxis: use co-trimoxazole 960mg daily for adults andin children refer to Table
4.3

Alternative regimen
I. Sulfadiazine, 1-2 gmp.o.q 6h for six weeks or 3 weeks after resolution of lesion
S/E: crystal urea, rash
C/I: severe liver, renal and hematological disorders; known hypersensitivity to Sulfonamides
Dosage/form: 500 mg tablets,
PLUS
Pyrimethamine
Loading dose of 200 mg once, followed by:
Pyrimethamine 50-75 mg/day
S/E: rash, fever and bone marrow depression (neutropenia and thrombocytopenia)
C/I: folate deficiency
Dosage/form: 25 mg tablets
PLUS
Folinic acid (Leucovorin): 10-20 mg/d
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 S/E: allergy
Dosage/form: 5 and 10 mg tablets

OR

II. Pyrimethamine and Folinic Acid (Leucovorin): (standard dose)

PLUS
Clindamycin: 600 mg q 6 hrs
S/E: toxicities include fever, rash, nausea and diarrhoea (including pseudomembranous colitis or
diarrhoea related to Clostridium difficile toxin)

Adjunctive corticosteroids should be used for patients with radiographic evidence of midline
shift, signs of critically elevated intracranial pressure or clinical deterioration within the first 48
hours of therapy. Dexamethasone (4 mg every six hours(0.15mg/kg/dose every 6 hours for
children)) is usually chosen and is generally tapered over several days and discontinued as soon
as possible.
Anticonvulsants should be administered to patients with a history of seizures, but should not be
given routinely for prophylaxis to all patients with the presumed diagnosis of TE. Careful
attention needs to be paid to any potential drug interactions.

4.4.2. Cryptococcal infection

Cryptococcal meningitis is one of the most important opportunistic infections and a major
Contributor to high mortality before and after ART is initiated. Most HIV-associated cryptococcal
infections are caused by Cryptococcus neoformans, in HIV-infected patients, cryptococcosis
commonly presents as a subacute meningitis or meningoencephalitis with fever, malaise, and
headache. Classic meningeal symptoms and signs, such as neck stiffness and photophobia, occur
in only one-quarter to one-third of patients. Some patients experience encephalopathic symptoms,
such as lethargy, altered mentation, personality changes, and memory loss that are usually a result

97
of increased intracranial pressure, thought to result from impaired cerebrospinal fluid (CSF)
absorption, or yeast infection of the brain.

98
Diagnosis
LP and CSF analysis:
- The opening pressure may be markedly elevated.
- CSF analysis
Protein= 30-150 mg/dl
WBC =0-100 /mm3 (monocyte)
Culture =positive 95-100%
Indian ink =positive 60-80%
Cryptococcal Ag > 95 % sensitive and specific
If it is not possible or contraindicated to do LP, serum cryptococcal antigen can be used for
diagnosis.
Management
Requires hospitalization and evaluation by physician
Phases of management:
1. Induction phase (2 weeks)
Option A. High dose fluconazole- Fluconazole 600 mg twice daily alone (In children 12mg/kg in
two divided doses):

Option B. Amphotericin B + fluconazole:

Amphotericin 0.7-1 mg/kg/day + fluconazole 800 mg/day
2. Consolidation phase (8 weeks)
Option A. Fluconazole 800 mg/day (In children 12mg/kg/day)
Option B.
Fluconazole 400-800 mg/day
Maintenance treatment (or secondary prophylaxis)- Fluconazole 200 mg daily (in children
6mg/kg/day)

Additional Points about Cryptococcal Meningitis

1. Management of elevated Intracranial pressure (ICP):
Management of increased ICP is critical as >90% of deaths in the first two weeks and 40% of
deaths in weeks 3-10 are due to increased ICP. Failure to manage elevated ICP is the most

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common and most dangerous mistake in management (Since the ICP is non-communicating
hydrocephalus there is no risk of CSF tapping within the recommended volume).
- Daily serial LP should be done to control increased ICP by drawing 20-30 ml of CSF
based on patient’s clinical response. Signs of ICP include headache, altered mental status,
meningismus and changing in hearing or vision should be closely monitored, if possible
opening pressure should be measured.

- There is no role for acetazolamide, mannitol, or corticosteroids to reduce intracranial

pressure.
2. Discontinuation of maintenance treatment (secondary prophylaxis)
When patients are stable and adherent to ART and anti-fungal maintenance treatment for at least
one year and have a CD4 cell count of greater than or equal to 200 cells/mm3 (two measurements
six months apart).
3. Timing of ART initiation
• Immediate ART initiation is not recommended in HIV-infected patients with
cryptococcal meningitis due to the high risk of IRIS, which may be life-threatening.
• ART initiation should be deferred until there is evidence of a sustained clinical response
to anti-fungal therapy, and
• After 2-4 weeks of induction and consolidation treatment with amphotericin B-containing
regimens combined with fluconazole, or
• After 4-6 weeks of induction and consolidation treatment with high-dose oral fluconazole
regimen

Poor prognostic signs

- Extra CNS manifestation(especially pulmonary)
- Altered mental status
- Low CSF WBC cell count less than 20cells/µL
- High CSF cryptococcal antigen titer

4.4.3. Peripheral Neuropathies

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Peripheral neuropathies are among the most common causes of painful legs in HIV infection;
they arise as a complication of HIV infection itself, of drug therapy, or of other metabolic or
organ dysfunction or nutritional deficiencies.
Distal symmetrical sensory polyneuropathy is the most common presentation but mono-
neuropathies can also occur. The neuropathies associated with HIV can be classified as:

 Primary, HIV-associated
 Secondary causes related to medications(ddI,d4T,INH), OIs or organ dysfunctions

Diagnosis: Peripheral neuropathy diagnosis in HIV-infected patients is based on the clinical

picture presenting with pain, tingling sensations, paresthesia or numbness. Physical examination
can reveal depressed or absent ankle reflex, decreased sensitivity to different modalities of
sensation and in severe cases, difficulty in walking. The feet and sometimes the hands are
involved in symmetrical distribution. The diagnosis can be supported by electro diagnostic studies
including electromyography (EMG) and nerve conduction studies (NCS) when available. Blood
tests are frequently obtained to exclude other causes of neuropathy. In most instances, however,
diagnosis is almost always clinical.

Treatment
• Avoid the offending agent if identified
• Substitute or switch drugs such as d4T/DDI when the neuropathy is severe
• Remove other drugs associated with peripheral neuropathy
• Supplement vitamin intake for all patients including concomitant administration of
pyridoxine with INH.
• Adjuvants for pain management(such as Amitriptlin, carbamazepin) indicated for patients
with pain and paresthesias.

Monitoring of events
• Recognize presence of peripheral neuropathy
• Asses severity at each clinical visit
• Avoid drugs causing neuropathy

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 4.5. Cutaneous manifestations

The skin is an organ frequently affected by OIs; early manifestations of HIV infections frequently
occur in the skin. Different kinds of OIs, such as herpes zoster, and other viral, fungal and
bacterial infections occur in the skin. Manifestations of adverse drug reactions and non-infectious
conditions alsooccur in the skin. Some skin reactions to drugs such as Nevirapine may be life-
threatening. In most instances diagnoses of skin disorders with HIV disease are made on clinical
grounds. Most skin disorders in HIV disease can be cured or ameliorated, but a few fail to
improve even with good general clinical and immunological responses to ART.
Pruritis is the most common dermatologic symptom in HIV infected patients. It can be localized
indicating primary skin lesion, or generalized that may or may not indicate primary skin lesions.
In many patients pruritus may be severe and not amenable to available therapy. The most
common skin conditions associated with pruritis in patients with AIDS include the following:
1. Excessive dryness of the skin ( Xerosis cutis)
2. Eczemas like seborrheic dermatitis or contact dermatitis
3. Folliculitis that may include infections by Staphylococcus aureas or hypersensitivity to insects
4. Drug eruptions
5. Scabies
6. Intertrigo (Candida, tinea, herpes simplex)
In most patients, diagnosis can be established by examining the lesions. However, as immune
deficiency advances it may be usefulto use investigationssuch as biopsy to diagnose specific
dermatosis or use staining and culture to diagnose specific infections.

4.5.1. Etiological Classification of Skin Disorders in HIV Disease

Skin disorders in HIV infected patientscanoccur due to infections, neoplasm, and hypersensitivity
to foreign agents including drugs, or to unknown causes. Nevertheless, infections are commonly
seenin clinical practice; refer to the following table:

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 *
In children
20mg/kg/dose
4x daily

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 *If patient has ophthalmic involvement refer to ophthalmic specialist.

4.5.3. Pruritic Papular Eruption

Pruritic papular eruption is common among HIV infected patients causing substantial morbidity
in sub-Saharan Africa. Its prevalence ranges from12-46% and it is uncommon in HIV negative
patients (PPVof 82-87%, and may play role in diagnosing HIV). The pathogenesis isunknown but
it may be related to hypersensitivity to arthropod bites. In extreme form, eosinophilia and
eosinophilicinfiltrates of the skinare present. Severity of rashoften correlates with CD4 count.
The clinical manifestation is intensely pruritic, discrete, firm papules with variable stages of
development and predilection for extremities, though they can involve trunk and face. Excoriation
results in pigmentation, scarring and nodules. Treat with topical steroid and oral antihistamines;
however it is often refractory to treatment and hence short course prednisolone may be used.
HAART is often effective.

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 4.6. Visceral Leishmaniasis
Visceral leishmaniasis (VL) is a systemic parasitic illness, transmitted primarily by the
phlebotomine sand fly from animal or human reservoirs. Visceral Leishmaniasis is endemic in
Ethiopia, with patchy distribution in the southern and north-western lowlands. The causative
parasite is L. Donovani. VL has emerged as a major OI associated with HIV. In HIV patients, VL
represents reactivation of latent infection with Leishmania parasite.
Clinical features: The cardinal signs of VL in patients with HIV infection are unexplained fever,
splenomegaly and pancytopenia (anaemia, leucopenia and thrombocytopenia). Presentation may
not be typical. The bone marrow is packed with parasites but two-thirds of cases have no
detectable anti Leishmanial antibodies. CD4+ cell count in co-infected patients is usually
<300cells/ml.
Diagnosis:
Parasitological diagnosis: Isolation of the organism from material taken from reticuloendothelial
tissue and examined withGiemsa, Wright’s orLeishmanial stain.
Immunological diagnosis
• Antibody detection
• Leishmanial test is negative
Treatment: Ambisome40mg/kg, require longer treatment and more liable to relapse.
Treatment of relapsed patients: These are patients who are slower to respond and have a higher
chance of further relapse and of becoming unresponsive to anti-monial drugs.
Treatment- same as above.

4.7. Screening for co-morbidities

People living with HIV have got increased risk of non AIDs defining chronic diseases such as
diabetes mellitus, cardiovascular illnesses, malignancies, chronic liver disease and chronic renal
disease. With the advent of ART people are living longer, hence they are at risk for age related
diseases. Therefore, screening of PLHIV for these co-morbidities during every visit is a critical
component of the care and treatment package.

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CHAPTER FIVE:-Guidance on operations and service delivery

Barriers to addherence

Adherence to ART Interventions to optimize adherence to ART

monitoring adherence
Operations and service

Ways to begin the process

Disclosure Assessing readiness for disclosure

delivery

Good practices for retention across the continuum

of care
Retention across the continum
Good practices in providing chronic care

Integrating and linking services

ART in ANC/MCH settings

Service Delivery
ART in TB/HIV settings

Human Resource Decentralizing HIV treatment and care

Supply chain managment

5.1. Adherence to ART

Barriers to adherence

WHO defines treatment adherence as “the extent to which a person’s behaviour – taking
medications, following a diet and/or executing lifestyle changes – corresponds with agreed
recommendations from a health care provider” For ART, a high level of sustained adherence is
necessary to suppress viral replication and improve immunological and clinical outcomes;
decrease the risk of developing ARV drug resistance; and reduce the risk of transmitting HIV.
Multiple factors related to health care delivery systems, the medication and the person taking
ARV drugs may affect adherence to ART.
Individual factors:-may include forgetting doses; being away from home; changes in daily
routines; depression or other illness; a lack of interest or desire to take the medicines; and
substance or alcohol use.
Medication-related factors:-may include adverse events; the complexity of dosing regimens; the
pill burden; and dietary restrictions.

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Health system factors: -may include requiring people with HIV to visit health services
frequently to receive care and obtain refills; travelling long distances to reach health services; and
bearing the direct and indirect costs of care.
Lack of clear information or instruction on medication, limited knowledge on the course of HIV
infection and treatment and adverse effects can all be barriers to adherence to ART. Interventions
to optimize adherence to ART out-of-pocket payments at the point of care, using fixed-dose
combination regimens for ART and strengthening drug supply management systems to reliably
forecast, procure, and deliver ARV drugs and prevent stock-outs.
Efforts to support Programme-level interventions for improving adherence to ART include:
avoiding imposing and maximize adherence should begin before ART is initiated. Developing an
adherence plan and education are important first steps. Initial patient education should cover basic
information about HIV, the ARV drugs themselves, expected adverse effects, preparing for
treatment and adherence to ART. Adherence preparation should not delay treatment initiation,
when prompt action is necessary.

Patient education and counseling and peer support

Patient education and counseling are essential both when ART is initiated and throughout the
Course of treatment. Informing and encouraging people receiving ART and their families and
Peers are essential components of chronic HIV care Substance use and mental health
interventions Studies indicate that improving well-being by treating depression and managing
substance use disorders improves HIV treatment outcomes.

Nutritional support
Nutrition assessment, care and support are essential components of HIV care. HIV programmes
should ensure that existing national policies on nutritional support are observed when it is
necessary and feasible to maximize adherence to ART and achieve optimal health outcomes in
food-insecure settings.

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Reminder and engagement tools
New recommendation mobile phone text messages could be considered as a reminder tool for
promoting adherence to ART as part of a package of adherence interventions other patient
reminder. Other patient reminder tools include alarms, phone calls, diaries and calendars and are
used to send brief reminders about the timing of ARV drugs, drug dosage and appointments.

Monitoring adherence to ART in routine Program and care settings

Objective monitoring of adherence to ARV drugs is necessary for effective and efficient
treatment planning and ongoing support. Each facility visit brings opportunity for assessing and
supporting treatment adherence. Effectively monitoring adherence requires a combination of
approaches based on human and financial resource capacity, acceptability to people living with
HIV and to health workers and the local context.

Viral load monitoring

These guidelines recommend viral load monitoring to diagnose and confirm treatment response
and failure. Although treatment failure is often caused by lapses in adherence to ART, it may also
result from other factors (such as drug stock-outs, drug interactions or malabsorption). However,
viral load monitoring does not provide an opportunity for care providers to monitor non-
adherence in real time and prevent progression to treatment failure. Viral load monitoring
must therefore be combined with other approaches to monitoring adherence.

Pharmacy refill records

Pharmacy refill records provide information on when people living with HIV pick up their ARV
drugs. When people obtain pharmacy refills at irregular intervals, this may indicate non-
adherence to ART; however, in many routine care settings, people may pick up their medications
when receiving care irrespective of their adherence level. This behavior could lead health care
providers to overestimate adherence by solely using pharmacy refill records. In many settings,
pharmacy refill records are already a part of national monitoring and evaluation frameworks and
can also provide additional information on adherence to ART when used in combination with
other tools.

Self-report
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Asking people living with HIV or their caregivers how many doses of medication they have
missed since the last visit (or within a specified number of days in the past) can help to estimate
non-adherence. However, although this method is commonly used, people may not remember
missed doses accurately or may not report missed doses because they want to be perceived as
being adherent and to avoid criticism. Counselling on the importance of remembering and/or
documenting ARV drug doses and an environment that promotes and enables honest reporting of
non-adherence are critical components of monitoring adherence to ART in routine care settings.

Pill counts
Counting the remaining pills in bottles may help to assess adherence. Pill counts usually take
place at routine health care visits. However, some people may throw away tablets prior to health
care visits, leading to overestimated adherence. Although unannounced visits at people’s homes
could lead to more accurate estimates, this approach poses financial, logistical and ethical
challenges. Counting pills also requires health care personnel to invest significant time and may
not be feasible in routine care settings

5.2. Disclosure
Pediatric disclosure is an ongoing process and in the best of circumstances may be difficult.
Adults struggle with the question of whether, when or how to tell children that they have HIV,
often agonizing over how to find the right words. All families are unique and there are no set
rules regarding when and how to disclose to children.
Children react to HIV disclosure in different ways and it is not uncommon for relatives to
disagree about disclosing HIV-related information to children. Even amongst the HIV/care team
there may be disagreement on the best approach. Disclosure has to be individualized taking into
consideration the particular child, parent/s, family, household and community.

Advantages of Disclosure

 For the child

 May feel relief at learning the cause of his/her illness
 May help to stop self-blaming as cause of the sickness.
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  May feel more in control
 May have greater open involvement in medical care decisions
 Avoid situation of accidental disclosure (e.g., child overhears caregiver discussing)
 May decrease disruptive behaviors
 May improve adherence to medication
 May improve social functioning and school performance
 May be more willing to access health education, social support, peer support
 Communicates respect for the child and build trust

 For the care giver

 Relieves the stress and anxiety that accompanies secrecy and deception
 Opportunity to develop trusting relationship and more open communication with
child
 Improved cooperation from a child
 Sharing positive messages with their child will lead to caregiver feeling less
helpless and hopeless
 Allow easier access to other services, care and support
Disadvantage of non-disclosure

 Child blames him/herself

 Maintains false understanding of illness including the belief that they are being
cured
 Parents may use forceful means to ensure child takes medication
 Child’s imagination creates unnecessary worry
 Becomes sexually active without knowing status
 No access to support
 Child may find out his /her status inadvertently/traumatic way
 Child may not trust caregiver in future

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Barriers to Disclosure
 Fear that the infected child will inappropriately disclose his/her HIV status,
especially in families in which the diagnosis remains closely guarded
 Fear of stigma, rejection, and loss of support by the family/community
 Desire to protect the child from worrying about his/her future
 The possibility that the burden of learning of his/her HIV status will lead to
depression or other mental health issues
 Feelings of guilt and shame may prevent HIV-infected caregivers from disclosing
their own infection to their child

Ways to Begin the Process

HIV disclosure is not a topic that comes naturally for family discussion, especially when children
are involved. The best way for child to learn about his/her HIV status is through age-appropriate
information shared by a loving and trusted caretaker. Disclosure to children should never happen
casually, inadvertently or in the heat of anger or conflict. A child’s maturity and cognitive
capacity varies and is not only dependent on age. It is important to tailor the discussion to the
child’s cognitive level and to the child’s personal and individual situation. It is important to assess
readiness of the entire family for disclosure and address potential barriers to disclosure (Table 12-
1). It is also important to discuss benefits of disclosure which have both short and long term
impact on the family.
Disclosure can:

 Help create a sense of closeness in the family

 Help reduce feelings of anxiety and isolation on the part of the parents/ caregiver
 Relieve the burden of living with the secret of being HIV-positive
 Help build social support networks
 Reduce the anxiety children experience when they suspect something is wrong; they will
now have information to make better sense of the situation
 May improve adherence in a non-adherent child
Table5.1 Assessing Readiness for Disclosure
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 The child

 Is the child symptomatic?Taking medications?

 How old is the child?
 Is the child living with a sick parent or family member?
 Is the child asking questions about HIV?
 Does the child appear distressed, anxious or worried?
 Is the child sexually active and at risk of contracting or spreading HIV?
The parent or caregiver

 Has the parent or caregiver been tested for HIV?

 Is the parent or caregiver infected? Symptomatic? Taking medication?
 Is the adult ill? Is s/he in need of help from children in the household?
 Is the infected adult an important attachment figure for the child?
The family or household

 Are there any adults in the household with HIV infection? Who is aware?
 Are other children in the household HIV-infected? Who is aware?
 How many family members are taking HIV-related medications?
 Is the family unit cohesive, or characterized by separations and/or conflict?

The community

 Are testing and treatment generally available in the community?

 Are there people in the community who are open about their own HIV
status? Does the child know anyone in the community who is open about
his/her HIV status?
 How strong is the stigma surrounding HIV in the community?
 Are there risks to the family (isolation, discrimination) if inadvertent
disclosure occurs?
 Are there resources within the community for children – a youth group
and/or trusted adults they can talk to?
Source: Columbia Pediatric Clinical Manual 2005

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 5.2.1. Planning for Disclosure
 Disclosure is not an event or a one-off conversation. It is a PROCESS that takes time and
constant communication in an age-appropriate manner. It is important to prepare
adequately for disclosure. This involves preparation, education, planning and follow-up
(Table 12-2). Once the decision has been made to disclose to the child it is important to
understand that the topic will have to be visited over and over again. It is important to give
a clear message and listen actively; take cues from the child and avoid lecturing; the
emphasis should be on asking directly and indirectly and listening. The following
examples can serve as a guide:
 Pre-schooler (4-6 years old): Younger children if symptomatic generally want to know
what will happen to them. They do not need to know their diagnosis but the illness must
be discussed with them. Young children may feel responsible for the parent’s illness or
just pretend nothing is happening. It is important to give reassurance and take cues from
younger children.
 School aged children (7-13 years): Some may have difficulty coping with disclosure
information leading to changes in behavior (acting out in school, i.e. fights, low grades,
absenteeism, anger, crying fits, or no expression of emotion). Others may have concerns
that other children in the school or community will make fun of them. Encourage them to
ask questions; do not be disappointed if they do not react in the manner you expected.
 Adolescents (14 years and older): Adolescents should know of their HIV status. They
must be fully informed in order to appreciate consequences for many aspects of their
health, including sexual behavior and treatment decisions. Be supportive and non-
judgmental. This is addressed in the adult care and treatment guidelines.

Stage 1 This is for children around the age of six. If they are symptomatic they want to know
what will happen to them. They do not need to be informed of their diagnosis but the illness must
be discussed with them.
Start providing partial disclosure; communicate with the child as follows:
• You are taking medicines to keep you healthy
• You have body soldiers that keep you healthy

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 • Your medicines increase the number of body soldiers and keep them strong so you can
stay healthy
• As long as your body soldiers are strong and you have many, you can do what you want to
do in life.
• You need to take your medicines in the morning and evening, when your (mother . . .)
gives them to you.

Stage 2 Once stage 1 understood, or if the child is school age (7-13years) move on to Stage two
and then to Stage three.

• Your body soldiers became weak because something was attacking them (“a germ”)
• If you take your medicines every day you keep the “germ” asleep so it can’t attack your
body soldiers
• Body soldiers can then increase in number and stay strong to keep you healthy
• If you don’t take your medicines the “germ” could wake up and start attacking your
soldiers
• May consider asking the child if he/she would like to know how many body soldiers they
have
o Check the file carefully first
 If CD4 trend is up, show child that their own “body soldier” numbers are
going up because they have taken their medicines
 If CD4 trend not up, re-enforce previous messages (while looking into
possible causes)
• Build on the story, introducing the concept of resistance
o If you forget your medicine and the “germ” wakes up too often, he can become
“tricky”; then your medicines may not work to keep him asleep

Make sure the child and caregiver are ready for disclosure. Some may have difficulty coping with
disclosure information leading to changes in behavior (acting out in school, i.e. fights, low grades,
truancy, anger, crying fits, and no expression of emotion). Others may have concerns that other
children in the school or community will make fun of them. Encourage them to ask questions; do
not be disappointed if they do not react in the manner you expected.

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115
Stage 3
• Introducing the words HIV and CD4
o Only proceed if child and caregiver are ready
o Anticipate how the child might react
• In presence of caregiver,
o As usual, ask child why taking medicines; congratulate for what he/she has learned
o Ask child if he/she wants to know the other names for the soldiers and the bad guy
 “germ” is a virus called HIV
 “body soldiers” are called CD4 cells
• Ask child what he/she has heard about HIV and correct any misconceptions
• Choose words that avoid assigning blame, e.g. if child asks where he/she got HIV,
o “some children are born with the virus / HIV, and we think that is what happened
to you”
o NOT“your mother gave it to you”
• Put new information back in the context of what the child has already learned
o “as long as you keep taking your medicines well, keep the germ asleep and the
soldiers strong, you can do everything you want to do in life”
• Continue to check understanding at each visit
N.B Full disclosure can be provided to most children over 10 years.

Each steps of disclosure should be documented on the patient’s chart.

Adolescents 14 years and older

Adolescents should know of their HIV status. They should be fully informed in order for them to
appreciate consequences for many aspects of their health, including sexual behavior and treatment
decisions. Be supportive and non-judgmental.

Post –disclosure assessments

Disclosure is a process that does not end with telling an HIV-infected child the name of their
illness or diagnosis. After the HIV diagnosis has been disclosed to the infected child, follow-up

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visits are needed to monitor the child and family’s understanding of the illness and their
emotional and psychological adjustment.

Once the diagnosis has been explained to a child, it needs to be reinforced or regularly discussed
as the child develops because many children will not have understood the full implications of the
disease or diagnosis at the time of disclosure. For example, preadolescent children can cognitively
understand the concepts about the virus but may be less likely to think of the future implications,
such as transmission risks and safe sexual practices. As the child ages and matures, he/she will
slowly understand and integrate the implications of the diagnosis into his/her life. Children’s
perception of self, health, illness, and death evolve as they mature through different
developmental stages.

Some children who learn of their HIV status may experience guilt and shame and may isolate
themselves as a result of the stigma and secrecy surrounding the disease. Changes in behavior and
school functioning may occur in these children and may be symptoms of depression. Patients and
families who have a difficult adjustment to HIV disclosure without progress over time should be
referred for mental health services and additional support. In young adolescents it will be
important to discuss about modes of HIV transmission, sexuality and reproductive health.

5.2.2. Disclosure in adults

Among other priorities, testing and counsellingprogrammes emphasize the importance of people
with HIV disclosing their HIV status, particularly to sexual partners. Informing the sexual
partners of an individual’s HIV infection is not only an effective means of halting the
transmission of HIV, but informing partners allows access to care and support as well as further
prevention efforts among the client’s partners and family.

Two main processes for informing partners of an individual’s HIV infection are disclosure and
partner notification. Disclosure, or beneficial disclosure as it is often known, refers to actions by
individuals themselves to notify their partners of their HIV serostatus. UNAIDS and WHO
strongly recommend beneficial disclosure, when appropriate, as this process is voluntary,

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respectful of the autonomy and dignity of the affected individuals and mindful of maintaining
confidentiality. Providers of testing and counseling prefer that individuals use beneficial
disclosure to inform those who need to know that they are infected. For the individual, his or her
sexual partners, and family, beneficial disclosure allows for greater openness about HIV in
communities and meets ethical imperatives. To encourage beneficial disclosure, it is needed to
establish safe social and legal environments in which more people are willing and able to get
tested for HIV and are empowered and encouraged to change their behavior according to the
results. This can be done by expanding access to counseling and testing services; providing
incentives to get tested in the form of greater access to community care, treatment and support;
and removing disincentives to testing and disclosure by protecting people from stigma and
discrimination and removing legal barriers.

Disclosure can be difficult as people may be afraid of the consequences: for example, the threat of
rejection and violence by partners and family or discrimination in the community and workplace.
In some cases, people may have limited knowledge of their partners and how to locate them, or
may not know the identity of their partners or where they can be located. Although evidence of
effectiveness of partner notification is limited in resource-limited settings, UNAIDS advises that
partner notification—or ethical partner counseling—be based on the informed consent of the
source client, and maintain the confidentiality of the source client, and where possible, protect
individuals from physical abuse, discrimination and stigma that may result from partner
notification. Ideally, partners of infected individuals should be encouraged to seek HIV testing
and counseling, as this is a critical prevention and treatment tool in the control of HIV.

How to discuss disclosure in adults

 Ask the patient if he/she has disclosed his/her HIV test result or is willing to disclose the
result to anyone.
 Discuss concerns about disclosure to partner, children, other family and friends.
 Assess readiness to disclose HIV status and to whom.
 Assess social support and needs (refer to support groups).
 Provide skills for disclosure (rehearsal can help).
 Help the patient make a plan for disclosure if now is not the time.

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  Encourage attendance of the partner to consider testing and explore barriers. As couples
may have different HIV status, partner testing is important.
 Reassure the patient that you will keep the result confidential and that disclosure is
voluntary.

If the patient does not want to disclose the result:

 Reassure that the results will remain confidential.

 Explore the difficulties and barriers to disclosure. Address fears and lack of skills (help
provide skills).
 Continue to motivate the client.
 Advise the client not to harm others.
 Offer to assist in disclosure (for example, talk with spouse).
 Offer another appointment and more help as needed (such as peer counselors ortrained
counselors).

For women, discuss benefits and possible disadvantages of disclosure of a positive result and
involving and testing male partners. Men are generally the decision makers in most families and
communities. Involving them will have greater impact on:

 Increasing acceptance of condom use, practicing safer sex and making appropriate
reproductive choices.
 Helping to decrease the risk of suspicion and violence.
 Helping to increase support to their partners.
 Motivating to get tested.

Disadvantages of involving and testing the partner: danger of blame, possible violence,
abandonment. Health worker should assess the risk of violence or suicide and discuss possible
steps to ensure the physical safety of patients. Health worker should try to counsel the couple
together, when possible.

5.3. Retention across the continuum of care

Retaining people living with HIV across the continuum of care is essential for optimal health
outcomes. Among those who do not have immediate indications for ART, care visits provide
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opportunities for screening, prevention and treatment of other conditions and comorbid illnesses,
including providing co-trimoxazole prophylaxis, PMTCT, isoniazid preventive therapy and
regular screening for TB and clinical and laboratory monitoring to allow timely initiation of ART
once the indications arise.
For people who are eligible for ART at the time they test HIV-positive, rapid linkage to care is
critical; delays of days or weeks with people already being ill with TB or other opportunistic
infections increases the risk of mortality . For people living with HIV who are receiving
treatment, uninterrupted ART and continual monitoring are essential for sustained viral
suppression and optimal treatment outcomes.
Retaining people living with HIV in care especially people who are not yet eligible for ART and
those who are eligible but have not yet initiated treatment poses a great challenge. People who
discontinue care especially those who are not eligible for ART at initial assessment – frequently
return to care only after they become ill with advanced HIV disease, when early mortality after
initiating ART is significant.Multiple factors relating to the health care delivery systems and
patients could facilitate or hinder retention in HIV care
Good practices for retention across the continuum of care
Optimizing retention in HIV care requires interventions at multiple levels of the health care
system. Given the broad array of challenges and heterogeneity of barriers across settings, no
single approach is likely to work for everyone in all settings. Improving the understanding of
barriers and innovative strategies to address them are important priorities in implementation
research and public health.
Related transport costs and loss of income while seeking care serve as disincentives when health
facilities are located far from the person’s home. Bringing services closer to communities, where
feasible, reduces the indirect costs of care for the people living with HIV and their families and
improves retention.
Waiting times at the facility during consultation are frequently high, especially in settings with a
high burden of HIV infection. Reorganizing services, such as systems for appointment, triage,
separating clinical consultation visits from visits to pick up medicine, integrating and linking
services and family-focused care may reduce waiting times at the health facility.
Many people living with HIV who are not yet eligible for ART may not attend clinic
appointments and may not return to care until they are symptomatic. Regularly following up these

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individuals is important to ensure continual monitoring and timely initiation of ART. Key
populations generally experience more barriers to accessing health services.
Interventions harnessing social support have emerged as a promising approach to counteract the
structural, economic, service delivery and psychosocial constraints that affect retention in care.

Table 5.2Summarizes the factors related to the health system and people receiving ART
influencing retention and adherence and potential interventions.
Factors related to the Possible interventions
health system
High direct and indirect costsof receiving care  ART and related diagnostics and
services free of charge at the point of
care

 Decentralize ART where feasible

 Scheduled facility visits

 Reduce waiting time at the facility
level:
 Appointment system
 Separate clinical consultation visits
from appointments for picking up
medicines
 Link, integrate and coordinate care
Stock-outs of ARV drugs  Optimize pharmaceutical supply
management systems to forecast,
procure and deliver ARV drugs.
 Use fixed-dose combinations to
simplify forecasting and supply
management systems
Lack of a system for monitoring retention in  Implement systems for patient
care monitoring across the continuum of
care, including cohort analysis and

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 patient tracking systems
Lack of a system for transferring people across  Interlinked patient monitoring system
across services for HIV, TB, maternal
different points of care
and child health and PMTCT; system
for transitioning from pediatric to
adolescent and adult services and from
maternal and child health and TB
services to chronic HIV care
Pill burden and complex ARV drug regimens  Use fixed-dose combinations to reduce
the pill burden and simplify the
regimens
Lack of accurate information for patients and  Engage and integrate community health
their families and peer support workers, volunteers and people living
with HIV in peer support, patient
education and counseling, and
community-level support
Adherence support  Task shifting for involving community
health workers
 Linking with community-level
interventions and resources such as
peer adherence support
 Using known effect reminder methods
(such as text messaging)
 Peer support also provides
opportunities for in-person reminders

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Poor relationship between patient and care  Train health workers on how to: reduce
provider stigma; improve treatment preparedness,
adherence and retention; provide adherence
support and care for key populations; and
provide simplified approaches foreducating
patients and their families
Lack of time for educating people in HIV  Task shifting and sharing among clinic team
care members
 People living with HIV as patient experts
and peer supporters
 A team approach to care
Adverse drug effects  Preparedness and knowledge of how and
when to self-manage adverse effects and
when to return to the clinic
Forgetfulness, life stress, stigma and  Using text messaging to keep patients
discrimination engaged
 Peer and family support
 Link to community support group
Comorbidity, substance and alcohol use  Manage HIV with mental health disorders,
disorders and mental health disorders alcohol and other substance use disorders
and link with community and social support
Patient knowledge and beliefs related to  Integrate the education of patients and their
HIV infection, its course and treatment families andcounseling, broader community
literacy and education and community
engagement

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 5.4. Service delivery

Good practices in providing chronic care

Most of the time health services are organized primarily to provide episodic acute care.As HIV
begins to become a manageable chronic condition, program managers and care providers need to
consider how current health delivery systems can be reorganized to provide chronic care.
Once people are diagnosed and enrolled in chronic care, follow-up visits should be scheduled and
planned. Waiting until people present with symptoms or preventable complications is costly and
inefficient. People living with HIV require care that anticipates their needs at different stages of
the care continuum. Compared with the acute care model, planned chronic care models provide
opportunities for prevention, early identification of issues and timely intervention.
Chronic care requires broad support for people living with HIV from their communities and
health care teams to stay in care, adhere to treatment and cope with stigma. People living with
HIV and their families need to be informed about HIV infection and the anticipated side effects of
medicines and supported to adhere to treatment. Health care teams play an important role in
linking people living with HIV with community-level interventions, resources and support.
Integrating and linking services
Chronic care requires integrating and linking related services to ensure comprehensive and
consistent patient management over time, including providing related services in single settings,
systems to share information and effective referrals across settings and providers.
Integrating and linking services are likely to reduce missed opportunities for initiating ART,
enhance long-term adherence support and optimize patient retention in care. Programs for HIV,
sexual and reproductive health, maternal and child health and TB need to collaborate to
successfully implement ART and related services at different levels of the health system.

Delivering ART in antenatal care and maternal and child health settings
ART should be initiated and maintained in all pregnant and postpartum women and in infants at
maternal and child health care settings, with linkage and referral to ongoing HIV care and ART,
where appropriate

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Delivering ART in TB treatment settings and TB treatment in HIV care settings
ART should be initiated for an individual living with HIV in TB treatment settings, with linkage
to ongoing HIV care and ART.

Decentralizing HIV treatment and care

Although rapidly scaling up HIV programs has significantly improved access to ART and
increased the health and survival of people living with HIV, it also poses significant challenges to
health systems. Decentralizing ART to primary care settings will ease the burden of routine
management on other parts of the health system and will improve equity by promoting access to
ART in rural areas. Decentralizing HIV care and treatment could reduce the workload for health
care personnel, thereby reducing waiting times for people with HIV and people receiving care at
hospitals for other conditions and bring HIV services closer to people’s homes.

Human resources
Building human resource capacity
Within the past decade, in the context of the rapid scaling up of HIV care and treatment, in-
service training has assumed a key role in rapidly upgrading the competencies of health workers.
All health workers, including community health workers, need to be regularly trained, mentored
and supervised to ensure high-quality care and the implementation of updated national
recommendations. Given the rapidly evolving knowledge on HIV care and treatment, the country
needs to consider a system for supporting health workers’ continuing education, including clinical
mentoring and regular supportive supervision. The use of new technologies such as computer-
based self-learning, distance education, online courses and phone-based consultation may
supplement classroom in-service training and support the efficient use of health workers’ time
and other resources. It is, however, equally important to fully embrace and strengthen HIV care
and treatment in existing pre-service courses leading to health workers graduating and being
certified in various disciplines. Health workers also need to be equipped to manage HIV as a
chronic condition, and to work in a team and need to be familiar with the national guidelines and
care protocol.

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Task shifting for HIV treatment and care
Reorganizing, integrating and decentralizing HIV treatment and care will require re-examining
the roles and tasks of teams of health care providers involved in delivering chronic HIV care.
Task shifting involves the rational redistribution of tasks among health workforce teams. With
this approach, specific tasks are reassigned, where appropriate, from highly qualified health
workers to health workers with shorter training and fewer complementary qualifications to more
efficiently and effectively use the available human resources. Task shifting should be
implemented alongside other strategies designed to increase the total numbers and capacity of all
types of health workers.

The quality of care in task shifting should be ensured by (a) providing training,
mentoring,supervision and support for nurses, non-physician clinicians and community health
workers;(b)stating clear indications for patient referral; (c) implementing referral systems and
(d)implementing monitoring and evaluation systems.

5.5. Laboratory and diagnostic services

The consolidated national HIV guidelines support an increased access to HIV care and treatment,
which will also require increased access to laboratory and diagnostic services. To ensure that
laboratory services are accurate and reliable, relevant quality assurance systems need to be
developed and strengthened. This guidance to strengthen laboratory and diagnostic services
emphasizes the importance of leadership and governance, high-quality laboratory services,
expanding testing services and developing the health workforce:
 to strengthen and expand laboratory and diagnostic services;
 to support a dedicated specimen referral system;
 to increase access to HIV viral load testing;
 to support the expansion of diagnostic services to include testing at the point of care;
 to train and certify health workers who perform the testing; and

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  to ensure high-quality diagnostics and plans for implementation, including quality
assurance.

1. Strengthening and expanding laboratory and diagnostic services

The following areas are important to strengthen the network of laboratory and diagnostic services
for implementing the national guidelines:
 expanding and strengthening current laboratory networks with efficient sample referral
mechanisms to support and monitor the decentralization and integration of laboratory
services or to provide access to laboratory tests which are available at limited number of
sites (e.g. HIV viral load testing, DNA PCR, CD4 count etc.)
 standardizing testing methods to streamline procurement, quality assurance and training;
 incorporating new testing approaches and systems into national laboratory strategic plans
and policies;
 evaluating diagnostics for their performance and operational characteristics to validate
testing algorithms (with back-up options) before introduction;
 carrying out strategic planning for properly placing and harmonizing testing platforms to
ensure appropriate use and cost–effectiveness;
 allocating appropriate resources to ensure the availability of testing services, including
human and financial resources.

2. Supporting a dedicated specimen referral system

Laboratory referral systems and procedures for collecting and processing specimens need to be
strengthened to increase access to viral load testing and other testing (for example, CD4 and early
infant diagnosis). Providing for and strengthening a dedicated, efficient, safe and cost-effective
specimen referral system requires reliable specimen transport with adequate conditions for whole
blood, plasma and dried blood spot specimens and rapidly and dependably reporting test results
back to the referring site with linkage to care. Rapidly reporting results is essential for timely
care.

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3. Increasing access to HIV viral load testing
The guidelines call for diagnosing and confirming treatment failure with viral load testing. This
will require strengthening the existing laboratory services and phased expansion of monitoring
services into peripheral facilities andcan include:
 strengthening and leveraging existing CD4 and early infant diagnosis networks;
 ensuring that laboratories have adequate infrastructure, technical testing expertise and
quality assurance and quality improvement programmes;
 ensuring an appropriate mix of high-volume centralized laboratory testing and testing at
the point of care for facilities in remote locations; and
 The use of dried blood spots as a tool to increase access to viral load testing.

4. Expanding diagnostic services to point-of-care settings

Decentralizing laboratory and diagnostic services requires that all aspects of testing be inplace
before implementing services, including:
 using only high-quality, evaluated and reliable diagnostic tests;
 supervising and monitoring point-of-care testing for quality and reliability;
 implementing a strategy for managing supply chain and equipment service; and
 Establishing data management systems for timely identification of quality issues and
regional and national data reporting.
5. Implementing comprehensive quality management systems
Developing a comprehensive quality management system including external quality assessment
(EQA) and quality control is essential. The quality management system should:
 be implemented within the laboratory network and all remote testing sites;
 be incorporated into the routine testing procedures and monitored;
 ensure that testing sites undertake quality control, as appropriate;
 ensure that testing sites are enrolled in an external quality assessment scheme
(proficiency testing program);
 ensure the use of standard operating procedures for all processes, including specimen
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 collection and processing, test methods, interpreting results and reporting;
 ensure the use of standardized logbooks or electronic data management and reporting,
including identifying errors and potential misclassification; and
 ensure that equipment and facilities are maintained, both preventive and corrective.

6. Providing guidance for developing health workers’ capacity, including staff training and
certification

There should be guidelines for the qualification of personnel who will perform the laboratory
tests. The guidelines should include training requirements for specific tests and the process for
certification and re-certification. All health workers assigned to perform point-of-care testing
must be trained and proficient on the testing procedure, specimen collection and quality assurance
before implementing these services.

5.6. Pharmaceuticals Supply Management System

The provision of complete health care necessitates the availability of safe, effective and
affordable drugs and related supplies of the required quality, in adequate quantity at all times.

The Integrated Pharmaceutical Logistics System (IPLS) integrates the management of essential
pharmaceuticals including the following pharmaceuticals that were used to be managed vertically:
HIV/AIDS, Malaria, TB and Leprosy, EPI, MCH and purchased essential drugs. It is the primary
mechanism through which health facilities obtain essential and vital pharmaceuticals. Products
included on the National pharmaceuticals procurement List (NPPL) are supplied and managed
through the IPLS.

PFSA is responsible for the selection, quantification, procurement planning, procurement,

storage, distribution, inventory management and rational drugs use of the pharmaceuticals and
delivery health products to health facilities.

1. Selection of ARV Drugs and Related Supplies:

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The National List of Drugs for Ethiopia describes the antiretroviral drugs and related supplies for
use in Ethiopia. This list will be updated as required. Forms containing information about strength
and dosage of individual drugs will also be made available.

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2. Quantification:

National quantification of pharmaceuticals need for the Ethiopian Antiretroviral Treatment

program will be conducted by PFSA in collaboration with stakeholders such as HAPCO, FMOH,
RHBs and development partners. Different orders of ARVs and related commodities will be
managed according to the quantities estimated in the quantification exercise. However, due to
various changes in the program regarding regimen proportions , dynamic ARV preparations, and
changes in the guidelines, it is found that it will be necessary to conduct the national level
quantification review exercise every year to update the previous quantification exercise
assumptions and results so that the forecast meets the current demands of the program.

3. Procurement:

All antiretroviral drugs and related products for use in the public or private sector should be
procured at affordable prices, with assured quality and adequate shelf life, from a reliable supply.
This will enable organizations and institutions supporting ART to determine the minimum safety
stock of ARVs they need in order to prevent stock-outs.
ARVs and related commodities are procured and distributed by PFSA. It follows the national and
international procurement regulation. It is a competitive approach through international bidding
or tender system on an annual basis and technical evaluation of bidders that it selects supplies and
awards contracts. Purchase orders are given to awarded bidders to deliver the products in a
staggered approach so as to avoid expiry and reduce expenses of storage.

4. Storage and Distribution:

Proper storage of ARVs, including refrigeration, is critical to maintain the quality of the drugs
and related supplies. Adequate space and facilities for proper handling must be ensured at various
levels.

Pharmaceuticals and health products distribution will follow the existing delivery system and it
extends from the central level to the Facility. PFSA will be the main system that will be used to
deliver the products to its Hubs; subsequently the hubs distribute the commodities to districts and
health facilities.

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Pharmaceuticals are ordered every two months by hospitals and health centres from the
Pharmaceutical Fund and Supply Agency (PFSA) and delivered by PFSA to these facilities.
Health posts report to health centres monthly and collect pharmaceuticals from those health
centres.

5. Inventory Control:

The Pharmaceutical Logistics Information Tracking System (PLITS) and PFSA MIS system are
electronic systems that collect data on the consumption at the facility level and the inventory at
the facility and PFSA warehouses. PLITS summarizes the consumption and the inventory data to
give regional and national picture about the status of the pharmaceuticals at the different levels.
This information along with the assumptions set during the yearly forecasting exercises are used
for decision on the quantities to procure and timing of procurement.

NB. PFSA is responsible for collecting, validating, analyzing, and utilizing the information to
ensure an uninterrupted supply of health products through electronic report that coming every two
months.

6. Rational use of medicines:

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Patients must receive the prescribed doze of medications appropriate to their clinical needs for an
adequate period of time free of charge.

Rational use of drugs implies promotion of rational prescribing, ensuring good dispensing
practice and encouraging appropriate drug use by the patient and the community at large. This
should be part and parcel of programmatic activities at each and every level and the
implementation is the responsibility of all stakeholders, including PFSA, FMOH, HAPCO and
other partners.

7. Quality Assurance:

Mechanisms must be put in place to assure the quality of drugs entering the country through pre-
procurement certification and post-marketing surveillance. Appropriate quality assurance
mechanisms for ARVs should be developed and implemented by FMHACA. Quality standards
should also define storage conditions at wholesale and facility stores. The national laboratory
must have the capacity to assure the quality of ARV drugs. Quality assurance of drugs and
supplies will be maintained using simple visual methods: a First-In-First-Out (FIFO) system will
be used to avoid expiration and ensure fresh supplies at all levels.

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CHAPTER SIX: -GUIDANCE FOR PROGRAMME MANAGERS

Policy development and review is a dynamic process. Policies change according to the lessons
learnt during the implementation of the program as well as evidence and knowledge change over
time at national, regional and global level. Policies set early in the development of a program may
negatively affect implementation and need to be revised. Policies, therefore, need to be able to
respond to these changes. Program managers should be cognizant of changes and challenges
affecting the development and implementation of HIV/AIDS policies. These include political
commitment, financial implications, administrative reforms, community participation (PLHIV
input) and basic legislation.
The key benefits to the global and country HIV response have been that policies have enabled
governments, communities, organizations and individuals to break the silence on issues
previously deemed taboo. These include matters related to sexual behavior, injecting drug use,
socio-cultural attitudes towards diseases, stigma associated with gender, poverty, ethnicity and
religious beliefs, entitlement to services and human rights that are discussed in an open manner.

6.1 Guiding principles

i. An effective response to HIV/AIDS requires ownership and active involvement of the
community and all other sectors
ii. Strong leadership commitment at all levels is essential for sustainable and effective response to
the HIV/AIDS epidemic
iii. Establishment of partnership by the government to enhance enabling environment (for the
strengthening of the partnership through nurturing local and international initiatives and
relationships)
iv. A multi-sectoral approach that includes partnership, consultations and coordination with all
stakeholders in the design, implementation, review, monitoring and evaluation of the national
response to HIV/AIDS.
v. Gender sensitivity must be considered as a corner stone to guarantee the success of HIV/AIDS
response with greater and sustained positive impact;

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vi. Public health approaches in HIV prevention, treatment, care and support services through
innovative, evidence based, cost effective and high impact interventions.
vii. Promotion and Protection of Human Rights shall be based on the principles of fundamental
human rights, social justice and equity guaranteed by the constitution of the country, including
avoidance of stigma and discrimination and addressing criminalization of HIV-related
behaviors;
viii. As key stakeholders in the fight against HIV/AIDS, Greater Involvement of People living
with HIV (PLHIV), at all levels and areas of the intervention is crucial for an effective
response;
ix. Best Use of Resources: efficiency, transparency and accountability in and for proper allocation
and effective utilization of resources are essential in the national response to HIV/AIDS
epidemic at all levels;
x. The HIV/AIDS programs are designed and implemented in order to ensure equitable and
universal access;
xi. Ensuring Sustainability is a cross-cutting and impassable agenda to be put on the forefront of
the HIV prevention, treatment, care and support programs design and their implementation;
xii. Ensuring that HIV/AIDS program activities are integrated (testing and counseling; access to
ART; access to PMTCT services; access to condoms; availability of STI services for youth and
most at risk populations; HIV/AIDS and the workplace (employment); blood safety; etc.) and
are linked to other pre-existing services.
As the HIV/AIDS policy framework was being developed, the Ministry of Health coordinated a
process of strategic planning and program development in Ethiopia's nine regions and two city
administrations. This process involved national and regional governmental institutions, the major
regional sector NGOs and religious organizations, and other key stakeholders. The framework
focuses on reducing the transmission of HIV and associated morbidity and mortality, and its
impact on individuals, families, and society at large. The strategy is built on four issues:

1. Multi-sectoralism,

2. Participation,

3. Leadership, and

4. Efficient management (including adequate monitoring and evaluation).

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 The strategy highlights the following priority areas for action: -

1. Intensifying HIV Prevention.

2. HIV Prevention Programs.

3. Reducing vulnerability of young people, women, orphan and vulnerable children and
others to HIV.

4. Increasing the availability and accessibility of basic facility based HIV Services, and
utilization of preventive services.

5. Increase access and quality of chronic care and treatment.

6. Strengthen Care and support to mitigate the impact of HIV/AIDS.

7. Strengthen generation and use of strategic information.

Most HIV/AIDS programs will have HIV strategic Information officers who will be responsible
for the technical aspects. For a manager, it is important to note that the key end-product of a
functional HIV strategic information system is the availability of adequate and quality data which
can be used for policy, program management and clinical care. To achieve this, a manager should
ensure that:
i. The key components of HIV strategic information systems including its coordination structures
and resources are in place.
ii. HIV data and information are adequately used at all levels to guide decision making processes,
priority setting, choice of interventions and future directions as well as understanding the
status of the HIV epidemic and response in the context of ‘Know Your Epidemic’ and ‘Know
Your Response’.
iii. Clear policies for data collection, storage, retrieval, sharing and confidentiality are articulated
and are in line with national health information policies and acts.
iv. Resources are mobilized for strengthening HIV strategic information.
National HIV program managers play a unique role in managing the process for adapting and
implementing the HIV guideline recommendations in their respective countries. First, convening
a broad, inclusive and transparent consultative process can help to define what program changes
are relevant and necessary, such as revising national protocols, guidelines and regulations.
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Second, in parallel, it is necessary to secure the financial resources and political support required
to implement the proposed changes. Third, systems are required to ensure broad accountability
for implementation from all partners at all levels and adequately document performance to inform
programming decisions and maintain political support. Lastly, implementation and operations
research should be supported so that innovative approaches can be assessed and taken to scale.
Human rights and ethical principles should guide the revision of national treatment policies to
ensure that they are equitable and meet the specific needs of all beneficiaries.
As HIV programs mature and increasingly focus on the challenges of long-term prevention,
treatment, care and support, national responses need to be considered within the broader health
and development contexts. The sustainability and effectiveness of HIV programs can be greatly
enhanced by creating and strengthening linkages with other health and non-health programs.

6.2. National and local HIV epidemiology

An epidemiological analysis should describe the prevalence levels among the general population
and in specific key populations, the rate at which HIV infection is acquired and among whom,
including infants, young children, pregnant women and sero discordant couples. Both prevalence
and incidence measurements should aim to identify populations at higher risk for HIV infection,
including in generalized epidemic settings, and adequate population size estimates for these
populations should be available so that results can be interpreted appropriately. Data on the
prevalence and incidence of key co-infections (such as TB and hepatitis B and C) and other co-
morbidities should also be gathered to inform decision-making.

6.3. Program performance and response analysis

Determining whether current ARV programs are adequate to address the needs that have been
identified requires understanding who is currently accessing these services. Programs should
assess present ARV coverage levels among the general population as well as key populations, the
disease stage at which they access care, how well these groups are retained in care and treatment,
the ARV regimens used and the impact of ART on viral load suppression, morbidity and
mortality. Disaggregated data for various groups enable assessment of ARV needs and
establishment of priorities for delivering services.

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Data on adherence, retention and viral load suppression are key to assess the quality of the
services provided. Surveillance of transmitted and acquired HIV drug resistance can also be
instrumental in informing decisions on optimal regimen choices.
Whenever possible, indicators of impact, such as changes in HIV-related incidence, prevalence,
morbidity and mortality, should also be reviewed.
Socioeconomic, policy and legal context
A review of epidemiological and programmatic data is incomplete without a deeper
understanding of what drives HIV vulnerability and how various political, social, economic and
legal factors affect the ability and willingness of various groups – such as men, women,
adolescents, sex workers, and people who inject drugs – to seek and access health services.
Stigma, discrimination, poverty, gender inequality, education and migration status are key
elements that should be taken into account to inform effective HIV programming.

6.4. Key parameters for decision-making

1. Ethics, equity and human rights
Multiple legal, social and normative obstacles have resulted in inequitable access to HIV
treatment and care. Global and national commitments require providing HIV treatment and
prevention to everyone in need, following the human rights principles of non-discrimination,
accountability and participation. National HIV strategies should be planned and implemented
from the outset with the ultimate goal of delivering the full package of services and interventions
recommended in these guidelines as soon as possible.
Key ethical principles of fairness, equity and urgency should also be observed in the process of
reviewing and adapting guidelines. The design of effective and equitable policies implies that
strategies should focus comprehensively on addressing barriers to access testing, prevention and
treatment services, particularly those faced by key populations.
2. Impact and cost–effectiveness
Realizing positive impact for a population is an important goal of public health programs and
policies. Examples of the impact of HIV programs include reduced HIV incidence, prevalence,
morbidity and mortality and improved quality of life. Impact is often a result of a complex set of
factors and a combination of diverse inputs and activities or processes, and it is often not
attributable to a single intervention or program.

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Cost–effectiveness analysis is one of several economic evaluation tools used to measure the value
of delivering particular services. Economic evaluation measures the costs and consequences of
alternative programs, which are then compared to assess how the greatest health benefits can be
generated. In cost–effectiveness analysis, impact is often measured using indicators related to a
change in health status, such as disability-adjusted life-years (DALYs) gained, which includes the
estimated number of deaths and infections averted. As the experience of scaling up ART in low-
and middle-income countries demonstrates, the cost–effectiveness of health interventions also
changes over time, as costs fall because of gains in scale, improvements in technology or the
design of more efficient delivery systems.
During the development of these guidelines, a consortium of research groups independently
developed and then compared mathematical models to assess the epidemiological and clinical
impact as well as cost–effectiveness ratios of various interventions, notably those related to
earlier initiation of ART.
Although evaluating cost–effectiveness and health impact may be useful in systematically
comparing various program interventions, they should be considered in the light of the ethical,
equity and human rights implications associated with different courses of action, especially in
settings in which not all eligible individuals currently have access to ART.
Investments in critical enabler programs (such as integrated treatment and rights literacy
programs, legal services, stigma and discrimination reduction programs, training for health care
workers and law enforcement) can play a role in overcoming barriers to accessing treatment and
other HIV-related services and keeping people connected to care. As such, these programs can
contribute to overall cost–effectiveness, in addition to achieving other important objectives, such
as reducing discrimination.
Opportunities and risks
The recommendations in these guidelines have the potential to further reduce HIV-related
mortality, improve the quality of life, reduce the number of people acquiring HIV infection and
enhance treatment effectiveness. The benefits accrued from implementing them are likely to
considerably outweigh the upfront investment needed and have the potential to fundamentally
change the course of the epidemic. Nevertheless, domestic factors (such as budget cuts, theft of
ARV drugs, and attrition of trained health workers and emergence of drug resistance) and
external contingencies (such as withdrawal of external financial support, political instability and
natural disasters) could negatively affect their implementation. It is essential to design strategies
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to mitigate such events so that continued service delivery can be assured, especially for those
most in need.
Implementations

In concentrated epidemic settings with low ART coverage, it is critical to identify opportunities to
expand access to HIV treatment and care, including testing and counseling, to most-at-risk
populations, such as men who have sex with men, transgender people, sex workers, people who
inject drugs and prisoners. This requires addressing any structural barriers that may prevent these
populations from seeking and accessing care. Integrating HIV services into drug dependence
treatment and harm reduction services and TB clinics can be a highly effective approach to
reaching these populations. In these settings, given the relatively limited number of pregnant
women living with HIV, phasing out option A for PMTCT and providing ART during pregnancy
and breastfeeding to reduce the risk of mother-to-child transmission of HIV (option B) are highly
effective and relatively low-cost strategies.
Identifying individuals with CD4 counts between 350 and 500 cells/mm3 provides an important
opportunity to link them into care and initiate ART early. Other strategies to improve the overall
levels of access to and uptake of ART include decentralizing HIV services to the primary health
care level and integrating HIV services with TB and antenatal care and maternal and child health
services, and offering pregnant and breastfeeding women living with HIV the option of receiving
lifelong ART, based on national program decisions. In addition, as in concentrated epidemics, it
important to identify and reach key populations and those with poor access to clinical and
community-based services. These may include sex workers, people who inject drugs, men who
have sex with men, transgender people or other groups such as adolescent girls, migrants and
other mobile populations, older women and certain high-risk occupational groups.
As coverage of ART increases and programs mature, expanding access to second-line regimens
increasingly becomes a programmatic priority. Scaling up viral load monitoring will be important
to adequately identify treatment failure and to avoid switching unnecessarily to second-line
regimens. Viral load monitoring is also likely to play a central monitoring role in places in which
ART is being broadly expanded to reduce HIV incidence.
As people initiate treatment earlier and stay on it for longer, monitoring the quality of service
delivery and strengthening service linkages to improve retention throughout the cascade of care
are essential to optimize treatment outcomes and long-term program performance.

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 6.5. Roles and responsibility
As the response to HIV involves a wide diversity of actors, coordination at various levels of
thesystem becomes important to ensure coherence and cohesion of efforts. HIV
programmemanagers should ensure effective coordination (a) with other health programmes, (b)
betweenthe HIV activities in the health sector and those in other sectors, and (c) for the
implementationof the HIV activities in the health sector, between the different levels of the health
system
(National, regional and district).

Ministry of Health

Some of the functions of the Ministry of Health are to provide policy guidance,
regulation,ensuring accountability for health, health intelligence and building partnership across
all healthactors. The Ministry of Health should also ensure that public health services are of
quality andare equitable. The Ministry of Health must play these critical roles in the health sector
responseto HIV, also, and in particular, when it is not a major provider of health services. The
AIDSProgramme of the Ministry of Health should provide technical leadership and coordination
ofthe health sector response to HIV. The AIDS Programme Manager should serve as a
leader,manager, facilitator and innovator and should liaise regularly with other health
programmesandother health and HIV actors.
Decentralization levels
For effective implementation and follow up, national strategic plans must be linked and cascaded
to the regional Zonal/Woreda level. RHB and zonal/Woreda Health Offices are mandated to
manage and coordinate the operation of primary health care services at the respective levels. They
are responsible for planning, financing, monitoring and evaluating of all HIV/AIDS programs and
service deliveries in the region and zonal/Woreda.

Partners
The roles and responsibilities of local and international partners include:
 Technical and financial support for implementation of the newly adopted interventions
 Participate in the national and regional HIV program coordination mechanisms
 Support the joint planning, monitoring and evaluation of the different program areas

141
 6.6. Coordination mechanisms
HIV/AIDS control and prevention office(HAPCO)
This is the primary mechanism for multi-sectoral coordination. It ideally includes representation
from key actors in the national response to HIV including various government ministries, regional
president’s nongovernmental organizations, and people living with HIV, faith-based
organizations, and private sector and development partners.
Coordination in the Health Sector
High level coordination mechanisms such as the Health Sector Joint Steering Committee, which
involves the heads of the Regional Health Bureaus, oversee the different programs in the health
sector. The committee is chaired by senior officials in the Ministry of Health and provides general
guidance to the health sector. Technical level coordination between health programs might occur
through technical advisory/working groups.
Donor Coordination Mechanisms
Some funding agencies, such as the Global Fund to fight AIDS, TB and Malaria, The President’s
Emergency Plan for AIDS Relief (PEPFAR) and other donors might have own types of
mechanisms for coordinating their in-country efforts however, the health sector is involved and
often a key member of these coordinating mechanisms and should always work to ensure
consistency and harmonization.

Stewardship and advocacy for the AIDS response in other sectors:

The health sector is often in a position to provide the evidence necessary to leverage action for
HIV in other sectors. The Ministry of Health has a crucial role in using its stewardship and
advocacy power to ensure that HIV issues are addressed in all policies. This includes engaging
ministries of education, social development, gender, transport etc.

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CHAPTER SEVEN: - MONITORING & EVALUATION

Monitoring & evaluation

Effective HIV prevention, care and treatment require proper and standardized recording and
reporting system. Recording and reporting is used to systematically monitor and evaluate progress
of patient/s and treatment outcome as well as the overall program performance. Monitoring and
evaluation is done at different levels of the health system where epidemiological and operational
indicators for monitoring of the HIV prevention, care and treatment are compiled, calculated and
analyzed.
The reporting of HIV prevention, care and treatment activities is integrated into the Health
Management Information System (HMIS) and all forms and registers are standardized in line with
HMIS throughout the country. Health facilities are the primary sources of data. Any information
concerning PLHIV should completely and correctly be recorded. Registers and reporting forms
should be kept neatly and maintained properly.

The expansion of HIV prevention care and treatment must be accompanied by effective M&E and
operational research to guide implementation and to see that efficiency, effectiveness, quality of
care and acceptability are established and maintained.

This national consolidated guide on monitoring and evaluation of HIV in the health sector that
brings together the various elements of monitoring and evaluation systems for HIV programmes.
The guide will consolidate and align existing monitoring and evaluation approaches in relevant
programmatic areas (such as HIV testing and counselling, ART, PMTCT and HIV drug
resistance)

143
 7.1. Monitoring the implementation of the New recommendation

Summary of the Implication for monitoring

new
recommendation
area

HIV testing and Monitor the uptake of community-based HIV testing strategies and
testing
Counseling
services for adolescents, including systems for linkages to care

When to start Monitor the number and percentage of different populations (such as
adults, adolescents, children and pregnant and breastfeeding women) who
ART
have initiated ART based on the new eligibility criteria

Review the monitoring system to assess what disaggregation is needed

forwhat purpose (such as CD4 counts ≤200 cells/mm3 to routinely
monitor late diagnosis or CD4 counts ≤350 cells/mm3 and 350–500
cells/mm3 to periodically assess the distribution of CD4 when ART is
initiated) and how to best collect the relevant data, and age disaggregation
of children (such as <2 years and <5 years)

WhichARTregiment Monitor the first- and second-line ART regimens people are
o start receivingMonitor the phasing out and/or introduction of specific drugs
(such as d4Tand TDF)

Monitoring tools may need to be adjusted to reflect new regimen options

Response to ART Monitor the percentage of people receiving ART who had a viral load test

and diagnosing and received the results

treatment failure Monitor the reasons for switching ART regimen

144
 7.2. Key Indicators
List the key indicators based on the revised HMIS

1. Number of individuals Tested and counseled for HIV and who received their test
results:- is the Number of individuals who have been tested for HIV and who received
their test results

2. Number of PLHIV newly enrolled in Pre-ART care:- is the Number of adults and
children with HIV infection newly enrolled and receiving pre-ART care

3. HIV positive persons receiving co-trimoxazole prophylaxis:- is the percentage of

adults and children enrolled in HIV care and eligible for co-trimoxazole (CTX)
prophylaxis (according to national guidelines) who are currently receiving CTX
prophylaxis

4. Number of PLHIV ever started on ART:- is the Cumulative number of adults and
children with advanced HIV infection started on antiretroviral therapy

5. Number of adults and children receiving antiretroviral therapy (ART)

(CURRENT):- is the Number of adults and children with HIV infection receiving
antiretroviral therapy

6. Number of adults and children with HIV infection newly started on ART:- is the
Number of adults and children with HIV infection newly started on antiretroviral therapy
during the reporting period

7. Survival on ART:- is the Percent of adults and children with HIV known to be alive and
on treatment 12 months after initiation of antiretroviral therapy (survival at 12 months)

7.3. Data Reporting, Data Flow and Quality Assurance

Routine HIV HMIS data are assembled and reported on a quarterly and annual basis. Facilities
aggregate and review their data monthly and report to their respective facility and administrative
office quarterly. The administrative office aggregates the data it receives, adds its own
administrative figures, and monitors its own performance based on these reports and self-
generated data. It then forwards the HMIS report to the next level. Annual reports include
additional data that are not collected quarterly. These reports follow the same line and principles
of desegregation as the quarterly reports. Data aggregation methodology is maintained throughout

145
the reporting chain so that it is possible to disaggregate data by facility type and ownership even
at the federal level. HMIS Data flow from the facilities to the federal level is depicted below.
Council of Ministers International Bodies
Other Ministries FMOH WHO, UN, GF, etc
Development Partners

Specialized and Generalized Hospitals report to the appropriate

Regional Council Regional Health Bureau

Zonal Health Department

Woreda Council Woreda Health Office Primary Hospital (GO, NGO, private, etc)

Health Centre/Clinic

Kebele Council Health Post

7.2.1. Data Quality Assurance (DQA)

Data Quality Check is one of the components of the M&E system. Once data are collected, the
data are checked for any inaccuracies and obvious errors at every level. The data quality
assurance is done at two levels: facility level and administrative level (district health offices). At
facility level, such a mechanism is the Lot Quality Assurance Sampling (LQAS) methodology
which is done on monthly basis. In this procedure randomly selected data elements from the
monthly reports are checked against the register or source of the report. The findings are then
compared to a standard Data Accuracy Table. The same procedure is done at district health
offices on quarterly basis before the data are sent to the next higher reporting unit. Hence, in
HMIS all reports are quality checked at every level, from the healthcare institution to the federal
level.

7.3. Supportive Supervision and Review Meetings

7.3.1. Supportive Supervision

146
Supervision aims at ensuring and improving quality, effectiveness and efficiency of services
provided; it should also enhance competence and satisfaction of the staff at all levels. Supervision
consists of observation, discussion, support and guidance. Since it is an essential tool in the
management of staff and facilities, it should be done on a regular basis. The overall aim of
supervision is the promotion of continuous improvement in the performance of the staff.

Supervisions at all levels are conducted in an integrated manner using standardized checklist
clearly identified in the Integrated Supportive Supervision guideline. It is done from every
administrative level to the respective office and health facility. The ISS guideline shows the
actual process of implementation, team composition and checklist.

Besides ISSs, in-depth TB Program-Specific supervisions using standardized TBL and TB/HIV
supportive supervision tool can also be conducted whenever critical gaps that require intensive
technical approach are identified during the ISS.

7.3.2. Review Meetings

Review meetings organized at various levels create a very good opportunity to review the status
of program implementation, achievements and challenges and come up with workable solutions
for the problems and challenges encountered. They are key elements for program management.
Furthermore, review meetings are forums for exchange of ideas and experiences among the health
professionals and program coordinators. In these meetings, program coordinators from the next
lower levels will present activity reports of their respective area, including major achievements
and challenges or constraints encountered during the period under review.

Integrated review meeting is conducted on regular bases at every level. In this manner, activities
taking place at all levels will then be brought forward to the respective review meeting sessions
where TBL and TB/HIV program performance is reviewed as part of the overall review meeting.

7.4. Other monitoring considerations

Programmes are increasingly moving beyond coverage indicators to focus on critical outcomes,
such as viral load suppression and immune reconstitution, and on the broader impact of HIV
treatment, including HIV-related mortality and HIV incidence. However, programmes also need
to measure potential unintended outcomes, such as HIV drug resistance and ARV-related

147
toxicities. Periodic evaluations and implementation research are also central to reviewing
programmes.

H IV drug resistance

The use of early warning indicators to help identify deficits in program performance that favor the
emergence of HIV drug resistance

Evaluation, including impact and program performance, and implementation research

Routine monitoring should be complemented by systematic evaluations and program reviews to

assess the performance and effects of HIV programmes, either comprehensively or with respect to
specific priority areas. Social science and implementation research are important to assess
perceptions and values of service recipients and communities along with barriers, facilitators and
experiences in delivering and receiving services.Impact indicators, such as incidence, morbidity
and mortality, are often difficult to measure.

Mathematical modeling is often undertaken to project various scenarios for program planning and
evaluating impact. Ensuring the availability of robust data is especially important when
estimating the prevention impact of ARV drugs at the population level, as multiple sources of
information and uncertainty come into play. Specific data collection efforts and models for
particular contexts may provide more accurate estimates.

148
Annexes
Annex 1: Growth Curves

149
150
151
152
153
154
155
156
157
158
Annex 2: Dosage of antiretroviral drugs for adults and adolescents

159
Annex 3: Dosage of antiretroviral drugs in children

160
 Strength of Number of tablets or ml by weight band (AM + PM) Strength of Number of tablets by
Drug Paediatric Children 6 weeks of age and above Adult Tab Weight band (AM + PM)
Tab (mg) 3-5.9 Kg 6-9.9 kg AM 10-13.9 kg AM 14-19.9 kg 20-24.9 kg (mg) 25-29.9 kg AM 30-34.9 kg AM
d4T/3TC or6/30 Liquid AM
1 ++1 PM + 2+PM1 +
2+ PM
2 AM
3 ++2 PM AM
3 ++3 PM 30/150 +
1+PM1 +
1+PM1
12/60 0.5 + 0.5 1 + 0.5 1+1 1.5 + 1 2+1
d4T/3TC/NVP 6/30/50 1+1 2+1 2+2 3+2 3+3 30/150/200 1 + 1 1+1
12/60/100 0.5 + 0.5 1 + 0.5 1+1 1.5 + 1 2+1
AZT/3TC 60/30 1+1 2+1 2+2 3+2 3+3 300/150 1+1 1+1
AZT/3TC/NVP 60/30/50 1 + 1 2+1 2+2 3+2 3+3 300/150/2001 + 1 1+1
EFZ 50, 200 n/r n/r 200 once daily 200 & 50 200 & 2 x 50 50, 200, 600 200 & 3 x 50 2 x 200 once
NVP 10 mg/ml 5ml + 5ml 8ml + 8ml 10ml + 10ml once /d once /d once /d daily
200 (adult) 1 + 0.5 1 + 0.5 200 1+1 1+1
AZT 10 mg/ml 6ml + 6ml 9ml + 9ml 12ml + 12ml
300 (adult) 0.5 + 0.5 1 + 0.5 300 1+1 1+1
d4T 1 mg/ml 6 ml + 6ml 9ml + 9ml 15ml + 15ml
3TC 10 mg/ml 3ml + 3ml 4ml + 4ml 5 ml + 5ml
150 (adult) .5 + .5 .5 + .5 1 + .5 150 1+1 1+1
ABC 20 mg/ml 3ml +3ml 4ml + 4ml 6ml + 6ml
60 1+1 2+1 2+2 3+2 3+3
300 (adult) 0.5 + 0.5 1 + 0.5 300 1+1 1+1
ABC/3TC 60/30 1+1 2+1 2+2 3+2 3+3 600/300 1 once daily 1 once daily
Lop/r 80/20 1ml + 1ml 2ml + 1ml 2ml + 2ml 3ml + 2ml 3ml + 3ml
100/25
mg/ml n/r n/r 2+1 2+2 3+2
200/50 n/r n/r n/r 1+1 1+1 200/50 2+1 2+2
ddI 25 chewable 2 x 25 +
(adult) 2 x 25 + 125 EC once 200 EC once 250 EC once 250 EC 1 once daily 1 once daily
tablet;

161
Note: A 1:1 ratio
125,of Lopinavir
200, 2 xand
25 Ritonavir
2 xis
25required when
daily Lop/r is co-administered
daily with enzyme-inducing drugs such as rifampicin; n/r
daily
= not recommended
250 EC

162
Annex 4: Pediatric ARV Drug Formulations, Side Effects and Special considerations in Children

Drug / Formulation Comments Side Effects

Nucleoside reverse transcriptase
Lamivudine (3TC) Can be given with food. Store solution at room temperature Common: head ache, nausea, abdominal
(use within one month of opening). pain.
Oral solution 10mg/ml
Tablet can be mixed with small amount of water and taken Less common: pancreatitis, neutropenia,
Tablet: 150mg
immediately. increased LFTs.
Side effects are rare.
Stavudine (d4T) Keep liquid refrigerated. Common: head ache, and GI intolerance.
Oral solution 1mg/ml Stable for 30 days. Less common: peripheral neuropathy,
Capsules: 15mg Capsules can be opened and mixed with small amount of lipoatrophy.
food or water. Life threatening: lactic acidosis with
20mg, 30mg, 40mg
severe hepatomegaly and steatosis.
DO NOT USE WITH AZT.
Zidovudine (AZT or Can be given with food. Syrup is light sensitive, store in a Common: neutropenia, anemia,
ZDV) glass jar. granulocyptopenia, macrocytosis, and head
Oral solution 10mg/ml Capsule can be opened and contents dispersed or tablet ache.
crushed and combined with food or small amount of water. Less common: myositis, myopathy,
Tablet: 300mg
mitochondrial disease.
Large volume of syrup not well tolerated in older children.
Capsule:300mg
DO NOT USE WITH d4T.

Non-nucleoside reverse transcriptase

Efavirenz (EFV) Only for children > 3 yrs. Common: skin rash, somnolence,
insomnia, abnormal dreams, confusion,

163
 Syrup: 30mg/ml Syrup requires higher dose than capsules. hallucinations.
Capsule:50mg, 100mg, Can be given with food (but avoid high fat foods). Less common: increased LFTs.
200mg Capsule can be opened and added to food: to avoid peppery
taste mix with sweet food or jam
Best given at night time to avoid CNS effects.
Nevirapine (NVP) Store at room temperature. Common: skin rash, head ache, nausea,
diarrhea.
Oral solution 10mg/ml Can be given with food.
Tablet: 200mg Tablets can be divided and combined with small amount of Less common: increased LFTs.
water or food and immediately administered. Life threatening: Steven Johnsons syndrome,
Patients should be warned of rash. Do not escalate dose if TEN, fatal hepatitis.
rash occurs.
For SJS and TEN discontinue drug and do not
rechallenge.
Multiple drug interactions.
Nucleoside reverse transcriptase

Abacavir (ABC) Can be given with food. Common: head ache, GI upset and rash.

Oral solution 20mg/ml Tablet can be mixed with small amount of water and taken Less common: lactic acidosis, hepatomegaly
immediately. with steatosis.
Tablet: 300mg
Instruct patient on how to recognize and respond to Life threatening: potentially fatal
potentially fatal hypersentivity reaction. hypersensitivity reaction (fatigue, rash, N/V,
sore throat, joint and muscle pain, cough, and
Patients should not interrupt therapy without consulting
dyspnea).
their healthcare provider.

164
 DO NOTrechallenge after hypersensitivity reaction.

Didanosine If tablets are dispersed in water, at least 2 tablets of Common: diarrhea, abdominal pain, N/V.
appropriate strength should be dissolved to ensure adequate
(ddI) Less common: increased LFTs, lactic acidosis
buffer.
with hepatomegaly and steatosis, peripheral
Powder for oral
Keep suspension refrigerated, shake well, stable for 30 days. neuropathy, hyperuricemia.
solution: reconstituted
10ml/ml Enteric formulation may be better tolerated. Life threatening: pancreatitis which is rare in
children.
Chewable tablets: 25mg,
50mg, 100mg, 150mg

Enteric coated capsules:

200mg, 250mg, 400mg

Lamivudine (3TC) Can be given with food. Store solution at room temperature Common: head ache, nausea, abdominal pain.
(use within one month of opening).
Oral solution 10mg/ml Less common: pancreatitis, neutropenia,
Tablet can be mixed with small amount of water and taken increased LFTs.
Tablet: 150mg
immediately.

Side effects are rare.

Stavudine (d4T) Keep liquid refrigerated. Common: head ache, and GI intolerance.

Oral solution 1mg/ml Stable for 30 days. Less common: peripheral neuropathy,
lipoatrophy.
Capsules: 15mg Capsules can be opened and mixed with small amount of

165
20mg, 30mg, 40mg food or water. Life threatening: lactic acidosis with severe
hepatomegaly and steatosis.
DO NOT USE WITH AZT.

Zidovudine (AZT or Can be given with food. Syrup is light sensitive, store in a Common: neutropenia, anemia,
ZDV) glass jar. granulocyptopenia, macrocytosis, and head
Oral solution 10mg/ml Capsule can be opened and contents dispersed or tablet ache.
crushed and combined with food or small amount of water. Less common: myositis, myopathy,
Tablet: 300mg
mitochondrial disease.
Large volume of syrup not well tolerated in older children.
Capsule:300mg
DO NOT USE WITH d4T.

Non-nucleoside reverse transcriptase

Efavirenz (EFV) Only for children > 3 yrs. Common: skin rash, somnolence, insomnia,
abnormal dreams, confusion, hallucinations.
Syrup: 30mg/ml Syrup requires higher dose than capsules.
Less common: increased LFTs.
Capsule:50mg, 100mg, Can be given with food (but avoid high fat foods).
200mg Capsule can be opened and added to food: to avoid peppery
taste mix with sweet food or jam
Best given at night time to avoid CNS effects.
Nevirapine (NVP) Store at room temperature. Common: skin rash, head ache, nausea,
diarrhea.
Oral solution 10mg/ml Can be given with food.
Tablet: 200mg Tablets can be divided and combined with small amount of Less common: increased LFTs.
water or food and immediately administered. Life threatening: Steven Johnsons syndrome,
Patients should be warned of rash. Do not escalate dose if TEN, fatal hepatitis.
rash occurs.
For SJS and TEN discontinue drug and do not
rechallenge.

166
 Multiple drug interactions.
Protease Inhibitors
Lopinavir /ritonavir (LPV/r)
Preferable to store capsules and liquid in a Common: diarrhea, head ache, nausea,
Oral solution 80mg/ml LPV refrigerator. vomiting,, increase in blood lipids
plus 20mg/ml r Can be stored at room temp 250C for 2 months Less common: pancreatitis, diabetes,
hyperglycemia, hepatic toxicity, fat
capsules:133.3mg LPV plus Should be taken with food.
redistribution.
33.3mg r Capsules should not be opened or crushed, swallow
whole.
Liquid has low volume but bitter taste.
Tablets require no cold chain; can be used in
children on full adult dose.
Nelfinavir (NFV) Take with food. Common: diarrhea, nausea, vomiting, head
ache
Powder for oral suspension Store at room temperature.
(mix with liquid): Less common: asthenia, abdominal pain, rash,
Crushed tablet preferred even for infants.
200 mg per level teaspoon lipodystrophy.
Drug interactions less than with RTV/PI
(50mg per1.25 ml scoop)
Tablet:250mg
Ritonavir Take with food to increase absorption and reduce GI Common: N/V, diarrhea, headache, abdominal
side effects. pain, anorexia
(RTV)
Oral solution must be refrigerated. Less Common: circumoralparaesthesia,
Suspension: 80mg/ml
increased LFTs, lipodystrophy, elevated
Can be kept at room temperature (250C) if used
Capsule: 100mg cholesterol and triglycerides, hyperglycemia.
within 30 days.
Bitter taste, coat mouth with peanut butter or
chocolate milk.

167
If given with ddI there should be 2 hours between
taking each drug.

168
Annex 5 Grading of toxicity in adults and adolescents

169
Item Grade 1 Grade 2 Grade 3 Grade 4
Mild toxicity Moderate Severe Severelife-
toxicity toxicity* threatening
toxicity
Grade Grade Grade Grade
I(mild) 2(moder 3(Severe 4(Severe Life
ate ) threatening)
Peripheral  Transient  Modera  Marked  Life-
neuropathy or mild te limitatio threatenin
discomfort, limitatio n in g, extreme
no n of activity, limitation
limitation activity, some in of
of activity some assistanc activity,
 no medical assistan e usually significant
interventio ce required assistance
n/treatment might , medical required,
required be intervent significant
needed ion/thera medical
 Non- py interventio
narcotic required n/ therapy
analgesi , required,
a hospitali hospitaliza
require zation tion/
d possible hospice
 severe care
discomfo  Incapacita
rt and/or ting or not
severe responsive
impairm to narcotic
ent analgesia
(decreas  Sensory
e or loss loss
of involves
sensatio limbs and
n up to trunk
knees or
wrists)
narcotic
analgesi
a
required
Cutaneous/Rash/ Erythema, Diffuse, Vesiculation Erythema
Dermatitis** pruritus maculopapul or moist multiforme or
ar rash or dry desquamatio suspected
desquamation n or Stevens-
ulceration* Johnson
syndrome or
Toxic
Epidermal
Necrolysis
(TEN)
Management Continue ARV substitute Stop ARV and
170
Provide careful clinical responsible consult
monitoring drug experienced
Consider change of a single physician
drug if condition worsens
 Annex 6- Grading of adverse events in children

Parameter Grade 1 Grade 2 Grade 3 Grade 4

Mild Moderate Severe Severe Life-
threatening
Diarrhoea
≥1 year of Transient or Persistent Grossly bloody Life-threatening
age intermittent episodes of diarrhoea or consequences
episodes of unformed to increase of ≥7 (e.g. hypotensive
unformed watery stools or stools per day or shock).
stools OR increase of IV fluid
increase of ≤3 4-6 stools over replacement
<1 year of stools over baseline per day. indicated.
age baseline per Liquid stools
day. Liquid stools Liquid stools resulting in
with increased with moderate severe
Liquid stools number of stools dehydration. dehydration with
(more or mild aggressive
unformed than dehydration. rehydration
usual) but indicated or
usual in hypotensive
number. shock.
Transient Persistent Persistent Persistent nausea
(<24 hours) nausea resulting nausea resulting with no or
Nausea or intermittent in decreased in minimal oral minimal oral
nausea with oral intake for intake for >48 intake resulting in
no or minimal 24-48 hours. hours or dehydration with
interference aggressive aggressive
with oral rehydration rehydration
intake. indicated (e.g. indicated.
IV fluids).
Transient or Persistent
intermittent Frequent vomiting Life threatening
Vomiting vomiting with episodes of resulting in consequences
no or minimal vomiting with no orthostatic (e.g. hypotensive
interference or mild hypotension or shock).
with oral dehydration. aggressive
intake. rehydration
indicated (e.g.
IV fluids).
Acute Localized Localized Generalized Acute anaphylaxis
systemic urticaria urticaria with urticaria or or life-
allergic (wheals) medical angiooedema threatening

171
Parameter Grade 1 Grade 2 Grade 3 Grade 4
Mild Moderate Severe Severe Life-
threatening
reaction lasting a few intervention with medical bronchospasm or
hours. indicated or intervention laryngeal
mild indicated or oedema.
angiooedema. symptomatic
mild
bronchospasm.
Symptomatic Symptomatic and Life-threatening
and hospitalization consequences
Pancreatitis NA
hospitalization not indicated (e.g. Circulatory
not indicated (other than failure,
(other than emergency haemorrhage,
emergency treatment). sepsis).
treatment).
Diffuse macular, Extensive or
maculopapular, generalized
or morbilliform bullous lesions or
Diffuse macular, rash with Stevens-Johnson
maculopapular, vesicles or syndrome or
Rash Localized
or morbilliform limited number ulceration of
macular rash
rash or target of bullae or mucous
lesions. superficial membrane
ulcerations of involving two or
mucous more distinct
membrane mucosal sites or
limited to one Toxic Epidermal
site. Necrolysis.
Alteration in Alteration Alteration Alteration
personality- causing no or causing greater causing inability Behaviour
behaviour or minimal than minimal to perform usual potentially
mood interference interference with social and harmful to self or
with usual usual social and functional others or with
social and functional activities and life-threatening
functional activities. intervention consequences.
activities indicated.
Mild lethargy or Onset of
somnolence confusion,
Changes
causing no or causing greater memory
Altered than minimal impairment, Onset of delirium,
minimal
Mental interference with lethargy, or obtundation, or
interference
Status coma.

172
Parameter Grade 1 Grade 2 Grade 3 Grade 4
Mild Moderate Severe Severe Life-
threatening
with usual usual social and somnolence
social and functional causing inability
functional activities. to perform usual
activities social and
functional
activities.
Source: Antiretroviral therapy of HIV infection in infants and children in resource-
limited settings. WHO 2006

173
 Annex 7Laboratory Grading of Adverse Events in Adults and adolescents (ACTG)
Laboratory Test Abnormalities
Item Grade 1 toxicity Grade 2 Grade 3 toxicity Grade 4 toxicity
toxicity
Haemoglobin 8.0-9.4 g/dL 7.0-7.9 g/dL 6.5-6.9 g/dL <6.5 g/dL
Absolute Neutrophil 1,000-1,500 750-990 mm3 500-749 mm3 <500 mm3
Count mm3
Platelets -75,0000- 50,000-74,999 20,0000-49,999 <20,000
99,000 mm3
ALT 1.25-2.5 X upper 2.5-5 X upper 5.0-10 X upper 10 X upper normal
normal limit normal limit normal limit limit
Bilirubin 1-1.5XULN 1.5-2.5 X ULN 2.5-5 x upper >5 x upper limits of
limits of normal normal
Amylase/lipase 1-1.5XULN 1.5-2 X ULN 2-5 x upper limits >5x upper limits of
of normal normal
Triglycerides * 200-399mg/dL 400-750 751-1200mg/dL >1200mg/dL
mg/dL
Cholesterol * 1.0 –1.3 X 1.3-1.6 X 1.6-2.0 X Upper 2.0 X Upper normal
Upper normal Upper normal normal limit limit
limit limit
MANAGEMENT Continue ARV substitute Stop ARV and consult
Repeat test 2 weeks after initial responsible drug experience physician
test and reassess
Lipid imbalances could be managed with diet,
exercise and pharmacologically with the use of
fibrates.
ALWAYS SEEK EXPERT ADVICE IN CASE OF
DOUBT
Grade 1 (Mild reaction): are bothersome but do not require changes in therapy
Grade 2 (Moderate reaction): consider continuation of ART as long as feasible. If the
patient does not improve in symptomatic therapy, consider single-drug substitution.
Grade 3 (Severe reaction): Substitute offending drug without stopping ART. Closely
monitor using laboratory and clinical parameters.
Grade 4 (Severe life-threatening reaction): Immediately discontinue all ARV drugs,
manage the medical event with symptomatic and supportive therapy, and reintroduce
ARV drugs using a modified regimen (i.e. with an ARV substitution for the offending
drug) when the patient is stabilised. Life-threatening toxicity includes severe hepatitis,
pancreatitis, lactic acidosis or Steven-Johnson syndrome.

174
 Annex 8-Grading toxicities in children by selected laboratory findings

Parameter Grade 1 Grade 2 Grade 3 Grade 4

Mild Moderate Severe Severe Life
threatening
Haemoglobin 8.5 – 10.0 7.5 –<8.5 6.5 – <7.5 <6.5
(g/dL)
ANC (mm3 ) 750 – <1,000 500 – 749 250 – 500 <250

Platelets (mm3 ) 100,000 – 50,000– 25,000 – <25,000 or bleeding

<125,000 <100,000 <50,000
ALT (SGPT) 1.25 – 2.5 x 2.6 – 5.0 x 5.1 – 10.0 x ULN >10.0 x ULN
ULN ULN
AST (SGOT) 1.25 – 2.5 x 2.6 – 5.0 x 5.1 – 10.0 x ULN >10.0 x ULN
ULN ULN
Bilirubin (>2 1.1 – 1.5 x 1.6 – 2.5 x 2.6 – 5.0 x ULN >5.0 x ULN
weeks of age) ULN ULN
Lipase 1.1 – 1.5 x 1.6 – 3.0 x 3.1 – 5.0 x ULN >5.0 x ULN
ULN ULN
Pancreatic 1.1 – 1.5 x 1.6 – 2.0 x 2.1 – 5.0 x ULN >5.0 x ULN
amylase ULN ULN
Cholesterol
(fasting, <18 170 – <200 200 – 300 >300 NA
years old)
mg/dL

Glucose, 116 – <161 161 – <251 251 – 500 >500

serum,
Nonfasting
(mg/dL)

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Glucose, 110 – <126 126 – <251 251 – 500 >500
serum, high:
Fasting
(mg/dL)
Increased lactate Increased lactate with
ULN 2.0 x ULN with pH <7.3 pH <7.3 with life
<2.0 x
without life threatening
without without
Lactate threatening consequences (e.g.
acidosis acidosis
consequences or neurological findings,
related condition coma) or related
present condition present
Triglycerides: NA 500 – <751 751 – 1,200 >1,200
Fasting
(mg/dL)
Source: Antiretroviral therapy of HIV infection in infants and children in resource-limited
settings. WHO 2006

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 Annex 8: Pediatric TB screening tool
Follow Up Visit
Date: Date: Date: Date: Date: Date:
Children TB screening questions
Current cough __/__/ __/ __/__/ __/ __/__/ __/__/
Fever
Poor weight gain*
Close Contact history with TB pt.
*poor wt gain = reported wt loss, very low wt (<-3 Z-score), or underwt (< -2 Z-score), or confirmed wt loss (>
5%) since the last visit, or growth curve flattening
Evaluation for positive TB screening
Bacteriology: date ordered
Gastric
date result received
Aspirate/Induced
result (+, -ve, Not Done)
sputum/ Sputum
for AFB
Radiology: CxR,date ordered
etc.
date received
result (Suggestive, inconclusive,
other dx, Not Done)
Other: FNA, etc date ordered
date received
result (+, -ve, Not Done)
TB diagnosis date: / / Circle type of TB: PTB :- smear pos, smear neg, EPTB TB Rx start date / /

Is the child eligible for IPT? Yes___ No____ If no, reason If yes, start IPT and use the chart below

Contraindications for IPT: Active TB, active hepatitis, allergy to INH, peripheral neuropathy
TB SymptomsHepatitis SxNeurologic Sx Adherence
Date INH
[cough, fever,[abdpain, nausea, [numbness, (≥95% =good;
collected
failure to gain wt vomiting, tingling, 85-94%= FairRem ark
Rash (yes, no)
or wt loss] (yes,abnormal LFT]paresthesia](yes, <85%=Poor)
no) (yes, no) no)
___/____/__
___/___/___
___/___/___
___/___/___
___/___/___
___/___/___
Outcome of IPT (Write Date): Completed __/___/____ Defaulted__/___ /______Died_______/___/____/
Interrupted for any reason______/________/______
Key: If there are symptoms suggesting TB during follow up, stop INH and work up for TB
If there are symptoms suggesting hepatitis, hold INH. Can resume when liver function normalizes

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If there are neurologic symptoms, continue INH and give pyridoxine 50mg daily. NB this side effect is rare if
the child is already on pyridoxine skin rash is very rare, if occurs and is extensive, discontinue INH, and
give anti histamine

Annex 9: Adult TB screening tool

Follow Up Visit
Date: Date: Date: Date: Date: Date:
Children TB screening questions
1. Current cough __/__/ __/ __/__/ __/ __/__/ __/__/
2. Fever
3. Weight lose
4. Night seats
Evaluate for TB if "yes" to anyone of the above (positive TB screening)

Bacteriology: Done = yes/no

Sputum for AFB
(+/- induced) result (+, -ve, unknown )

Radiology: CxR,Done = yes/no

etc.
Result (Suggestive, inconclusive,
other dx, Not Done)
FNA, culture,Done = yes/no
ultrasound etc
If done result
TB diagnosed Yes (write type of TB)/No
Is patient eligible
Yes/No
for IPT
Contraindications for IPT: Active TB, active hepatitis, allergy to INH, peripheral neuropathy

IPT start date __________________________________

TB SymptomsHepatotoxicity Neurologic Sx Adherence

Date INH
[cough, fever, wt[abdpain, nausea, [numbness, (≥95% =good;
collected
loss) (yes, no) vomiting, tingling, 85-94%= FairRemark
Rash (yes, no)
abnormal LFT]paresthesia](yes, <85%=Poor)
(yes, no) no)
___/____/__
___/___/___
___/___/___
___/___/___
___/___/___
___/___/___
Outcome of IPT (Write Date): Completed __/___/____ Defaulted__/___ /______Died_______/___/____/

Patient stopped______/________/______ Stopped ______/________/______ Transferred out

___/___/__________________________________

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