National Hiv Testing Services: Policy: A Long and Healthy Life For All South Africans

HIV TESTING SERVICES: POLICY, 2016
NATIONAL HIV
TESTING SERVICES:
POLICY
2016
Prepared by the national Department of Health
A long and Healthy Life for All South Africans

NATIONAL HIV
TESTING SERVICES:
POLICY 2016
i
TABLE OF CONTENTS
LIST OF TABLES................................................................................................................................................. vi
LIST OF FIGURES..............................................................................................................................................vii
ACKNOWLEDGEMENTS.................................................................................................................................viii
FOREWORD......................................................................................................................................................... x
ABBREVIATIONS AND ACRONYMS...............................................................................................................xii
DEFINITION OF TERMS....................................................................................................................................xv
1 INTRODUCTION......................................................................................................................................... 1
1.1 Background.......................................................................................................................................... 1
1.2 Rationale for an HTS Policy.............................................................................................................. 1
1.3 Goals and objectives.......................................................................................................................... 2
1.4 Target audience................................................................................................................................... 2
1.5 Guiding principles................................................................................................................................ 2
1.5.1 A rights-based approach........................................................................................................... 2
1.5.2 The 5Cs....................................................................................................................................... 3
1.5.3 HTS continuum of care.............................................................................................................. 3
2 ETHICAL AND LEGAL CONSIDERATIONS........................................................................................... 4
2.1 Human rights and rights to access................................................................................................... 4
2.1.1 Promoting equality for vulnerable groups............................................................................... 4
2.1.2 Promoting the best interests of children.................................................................................. 4
2.1.3 Availability of HTS services....................................................................................................... 5
2.1.4 Duty and responsibility of all healthcare personnel............................................................... 5
2.1.5 Challenging discrimination........................................................................................................ 5
2.1.6 Quality of HTS services............................................................................................................. 5
2.1.7 Effective partnerships................................................................................................................ 5
2.1.8 Effective communication........................................................................................................... 5
2.1.9 Strengthening service selivery and integrating services....................................................... 6
2.1.10 Using scientific evidence........................................................................................................... 6
2.1.11 Leadership role of government................................................................................................. 6
2.2 Right to dignity and non-discrimination............................................................................................ 6
2.2.1 Right to privacy and confidentiality.......................................................................................... 6
2.2.2 Right to refuse HIV testing........................................................................................................ 6
2.3 Informed consent................................................................................................................................ 7
2.3.1 Requirements of informed consent.......................................................................................... 7
2.3.2 Capacity to consent.................................................................................................................... 7
2.4 The Children’s Act............................................................................................................................... 8
3 NORMS AND STANDARDS.................................................................................................................... 10
3.1 OPERATIONAL REQUIREMENTS FOR FACILITY-BASED HCT SERVICES........................ 10
3.1.1 Requirements for facility-based HTS service....................................................................... 10
3.1.2 Infrastructure requirements for HTS sites............................................................................. 10
3.1.3 Personnel requirements.......................................................................................................... 10
3.1.4 Waste management................................................................................................................. 10
3.2 Operational requirements for community-based HTS services.................................................. 11
3.2.1 Facility safety and security...................................................................................................... 11
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4 SERVICE DELIVERY APPROACHES................................................................................................... 13

4.1 HTS: Approaches and settings........................................................................................................ 13
4.2 HTS in health facilities...................................................................................................................... 14
4.2.1 Provider-initiated counselling and testing (PICT)................................................................ 14
4.2.2 Client-initiated counselling and testing (CICT)..................................................................... 14
4.3 HTS approaches used in the community setting.......................................................................... 15
4.3.1 Stand-alone HTS...................................................................................................................... 15
4.3.2 Home-based HTS..................................................................................................................... 15
4.3.3 Mobile and outreach HTS....................................................................................................... 16
4.3.4 HTS in the workplace............................................................................................................... 16
4.3.5 HTS in schools and tertiary institutions................................................................................. 16
4.4 Self-testing......................................................................................................................................... 17
4.5 HTS in clinical trial/research settings............................................................................................. 17
5 PRIORITY POPULATIONS..................................................................................................................... 18
5.1 Infants and children.......................................................................................................................... 18
5.2 Adolescents and young women...................................................................................................... 18
5.3 Pregnant women............................................................................................................................... 19
5.4 Couples and partners....................................................................................................................... 19
5.5 Men..................................................................................................................................................... 20
5.6 Healthcare providers and workers exposed to HIV...................................................................... 20
5.7 Survivors of sexual assault.............................................................................................................. 20
5.8 Prisoners............................................................................................................................................ 20
5.9 Migrant and mobile populations...................................................................................................... 20
5.10 Populations abusing alcohol and other drugs........................................................................... 21
5.11 Key populations............................................................................................................................. 21
5.11.1 Men who have sex with men (MSM)..................................................................................... 22
5.11.2 Sex workers............................................................................................................................... 22
5.11.3 People injecting/using drugs (PWID/PWUD)........................................................................ 22
5.11.4 Transgender.............................................................................................................................. 23
6 PRE-TEST SERVICES............................................................................................................................ 23
6.1 Demand creation............................................................................................................................... 23
6.2 Confidentiality.................................................................................................................................... 23
6.3 Pre-test information........................................................................................................................... 23
6.4 Intensified tuberculosis case finding............................................................................................... 23
6.5 Sexually transmitted infections and non-communicable diseases............................................. 24
6.6 The pre-test information session.................................................................................................... 26
6.6.1 Pregnant or post-partum women............................................................................................ 26
6.6.2 HIV testing services in couples.............................................................................................. 26
7 HIV TESTING PROCESS........................................................................................................................ 27
7.1 HIV testing algorithm........................................................................................................................ 27
7.2 Managing and documenting HIV results........................................................................................ 29
7.3 Issuing written confirmation of HIV test results............................................................................. 30
8 POST-TEST SERVICES.......................................................................................................................... 31
8.1 Post-test services for people testing HIV-negative....................................................................... 31
8.2 Services for people with discrepant test results........................................................................... 31
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8.2.1 Re-testing during the window period..................................................................................... 31

8.3 Services for people testing HIV-positive........................................................................................ 33
8.3.1 HIV disclosure........................................................................................................................... 34
9 LINKAGES TO CARE............................................................................................................................... 35
9.1. Integration of oral PrEP across various entry points............................................................ 36
10 QUALITY ASSURANCE AND IMPROVEMENT................................................................................... 38
10.1 Quality assurance for HIV testing............................................................................................... 38
10.2 Quality management system....................................................................................................... 38
10.3 Regulation of HIV diagnostics..................................................................................................... 40
10.3.1 Pre- and post-marketing surveillance of diagnostics........................................................... 40
10.4 Quality control (QC)...................................................................................................................... 40
10.5 External quality assessment and proficiency testing............................................................... 41
10.5.1 Supportive supervision, site assessment and observed practice...................................... 42
10.5.2 Mentorship and observations of counselling sessions........................................................ 43
11 MONITORING AND EVALUATION........................................................................................................ 44
11.1 Documenting, monitoring and evaluation.................................................................................. 44
11.1.1 Quality assurance indicators in HTS register....................................................................... 44
11.2 Data management........................................................................................................................ 44
11.3 Roles and responsibilities for information flow......................................................................... 45
11.4 Monitoring and evaluation framework and objectives............................................................. 45
11.5 HTS programmes: Essential and strategic indicators............................................................. 46
11.6 Data quality assurance................................................................................................................ 48
12 SUPPLY CHAIN MANAGEMENT........................................................................................................... 49
12.1 Forecasting.................................................................................................................................... 49
12.2 Procurement of rapid test kits..................................................................................................... 49
12.3 Storage of HIV test supplies........................................................................................................ 49
12.4 Distribution..................................................................................................................................... 49
12.5 Stockouts....................................................................................................................................... 49
12.6 Human resources......................................................................................................................... 49
12.7 HTS training requirements.......................................................................................................... 50
12.7.1 Qualifications of HTS providers.............................................................................................. 50
12.7.2 Certification and recertification............................................................................................... 50
13 CONCLUSION........................................................................................................................................... 51
14 REFERENCES.......................................................................................................................................... 52
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TABLE OF TABLES
Table 1. Recommended frequency of testing................................................................................................. 32

Table 2. Testing under different circumstances.............................................................................................. 32
Table 3. Recommended HTS indicators.......................................................................................................... 46
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TABLE OF FIGURES
Figure 1. HTS continuum of care....................................................................................................................... 3

Figure 2. Service delivery platforms................................................................................................................ 14
Figure 3. HIV/TB screening algorithm to increase TB case finding in HTS............................................... 25
Figure 4. Different linkages related to HTS..................................................................................................... 35
Figure 5. Twelve elements of a quality management system...................................................................... 39
Figure 7. The proficiency testing cycle............................................................................................................ 42
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TABLE OF FIGURES
The HIV Testing Services Policy, 2016 is the product of great collaboration among the South African
government, civil society and non-governmental organisations as well as international agencies. Wide
consultation and partnership in the development of these revised guidelines will go a long way to ensure the
success of the rollout and uptake of the guidance included in the document.
The national Department of Health extends special thanks to all the individuals for providing support and
technical expertise towards the content and finalisation of this document.
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FOREWORD
Responding to HIV and AIDS is one of the most important tasks in
South Africa, which is why the prevention of new HIV infections and
treatment and care of HIV-infected people are one of the South African
government’s top priorities.
Recent new South African and international guidelines and

recommendations prompted the review of South Africa’s HIV Counselling
and Testing (HCT) guidelines, which resulted in this newly revised
document, the South African National HIV Testing Services: Policy,
2016. The National Strategic Plan for HIV, STIs and TB 2012-2016 (NSP)
guides this response, while the Health Sector HIV Prevention Strategy
and Guidelines, 2014 -2016, which focuses on the implementation of
combination prevention, contributes to the operationalisation of the
NSP. The policy is also aligned with the National Development Plan,
2030 and the ambitious 90-90-90 targets expounded by UNAIDS.
The NSP outlines four strategic objectives that shape the HIV, STI and TB responses in South Africa. These
include:
• addressing the social and structural drivers of HIV, STI and TB infections
• preventing new HIV, STI and TB infections through combination interventions
• sustaining the health and wellness of people through improved access to high quality treatment, care
and support services
• protecting the human rights of and improving access to justice for people living with HIV
Over a period of five years, the NSP aims to reach the following goals:
• reduce new HIV infections by at least 50 per cent using combination prevention approaches
• initiate at least 80 per cent of eligible patients on antiretroviral treatment, ensuring that 70 per cent of
patients are still alive and on treatment five years after initiation
• reduce the number of new TB infections and deaths from TB by 50 per cent
• ensure an enabling and accessible legal framework that protects and promotes the rights of those
living with HIV
• reduce stigma and discrimination related to HIV and TB by at least 50 per cent
Knowing one’s HIV status is critical to the achievement of these prevention and treatment goals, making HIV
testing services (HTS) the gateway to a complete continuum of care. A comprehensive approach, known
as HTS is central to every single HIV intervention and among all target populations, and requires close
collaboration with other health services. Through linkages with care, treatment and support programmes,
HTS is an effective package of services that diminishes the impact of the HIV epidemic in our country. The
South African Government has embarked on a deliberate effort to scale up and strengthen the quality of
HTS at all public health facilities and non-health sites offering this service, and over the years, testing and
counselling has improved and has progressively become more available and acceptable to our people.
The national Department of Health acknowledges international trends and recommendations as described in
the revised World Health Organization’s (WHO) guidelines. All forms of HTS adhere to the 5Cs: Confidentiality,
Counselling, Consent, Correct results and Connection, or linkage to care, with all based within a human rights
context. In addition to the 5Cs, however, the department accentuates the use of a variety of approaches to
HTS that will reduce the number of missed opportunities. These include provider-initiated counselling and
testing, couple counselling and testing, home-to-home and infant and children counselling and testing in
alignment to the revised WHO guidelines.
Effective combination prevention interventions require strengthened biomedical interventions like the familiar
prevention of mother-to-child transmission or medical male circumcision. It also demands that we engage
fully with changing the attitudes, beliefs, cultural practices and other barriers that thwart individual, couple,
family, and community access to HTS and other prevention interventions. We recognise that prevention
remains the cornerstone of our entire response to this epidemic. The programme seeks to ensure that people
who test HIV-negative are encouraged and motivated to maintain their negative status, and those who test
positive are supported in living long, healthy lives through positive health-seeking behaviour and the provision
of appropriate services.
viii
The national HTS Programme will continue to provide an integrated service at all levels of the public health
service delivery system. We encourage and support formal collaboration among public, private and non-
governmental sectors.
The revision of our national HTS policy is important to keep abreast of international guidance and
recommendations. More importantly, I am confident that the implementation of these revised guidelines will
be important in achieving epidemic control in South Africa. I strongly urge all HTS service providers to do all
that is necessary to adhere to the recommendations outlined herein.
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ABBREVIATIONS AND ACRONYMS

AIDS Acquired immune deficiency syndrome
ANC Antenatal care
ART Antiretroviral therapy
ARV Antiretroviral (drugs)
AYWG Adolescents, young women and girls
CBO Community-based organisation
CDC United States Centers for Disease Control and Prevention
CICT Client-initiated counselling and testing
DHIS District Health Information System
DHS District health system
DNA Deoxyribonucleic acid
ELISA Enzyme-linked immunosorbent assay
EC Enzyme chemiluminescent assay
EPI Expanded programme on immunisation
EQA External quality assessment
FBO Faith-based organisation
FSW Female sex workers
FTM Female to male
HBHTS Home-based HIV testing service
HCT HIV counselling and testing
HIV Human immunodeficiency virus
HIVST HIV self-testing
HPCSA Health Professions Council of South Africa
HTA High transmission area
HTS HIV testing service
IDU Injection drug user
IEC Information, education and communication
M and E Monitoring and evaluation
MSM Men who have sex with men
MTF Male to female
NASBA Nucleic acid sequence-based amplification
NCD Non-communicable disease
NDOH national Department of Health
NGO Non-governmental organisation
NAT Nucleic acid testing
OI Opportunistic infection
OVC Orphans and vulnerable children
PCR Polymerase chain reaction
PEP Post-exposure prophylaxis
PICT Provider-initiated counselling and testing
PLWHA People living with HIV and AIDS
x
PMTCT Prevention of mother-to-child transmission

PrEP Pre-exposure prophylaxis
PWID People who inject drugs
PWUD People who use drugs
QA Quality assurance
QC Quality control
QI Quality improvement
QMS Quality management system
RDT Rapid diagnostic test
RNA Ribonucleic acid
SANAC South African National AIDS Council
SAPC South African Pharmacy Council
SBCC Social and behaviour change communication
SOP Standard operating procedure
SRH Sexual and reproductive health
STI Sexually transmitted infection
TB Tuberculosis
TNA Total nucleic acid
T and T Test and treat
UAT Unlinked anonymous testing
UNAIDS Joint United Nations Programme on HIV/AIDS
UNICEF United Nations Children’s Fund
USAID United States Agency for International Development
VCT Voluntary counselling and testing
VMMC Voluntary medical male circumcision
WB Western blot
WHO World Health Organization
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Active referral A referral where the person performing an HIV test makes an appointment for the client or accompanies the cli-
ent to an appointment, including an appointment for co-located services, and enrolment into HIV clinical care.
Acute infection The period in which an individual becomes HIV-infected and before HIV antibodies can be detected by a
serological assay.
Concentrated A defined sub-population (e.g., men who have sex with men, transgender people, sex workers and people
epidemic who use drugs) where HIV has spread rapidly compared to the general population, due to active networks with
high-risk behaviours within the sub-population.
Couple HTS When two or more partners are counselled, tested and receive their results together, resulting in mutual
disclosure of HIV status.
Discrepant test results When one HIV test result in an individual is reactive and the other test result using a different HIV assay in the
same individual is non-reactive.
Early infant diagnosis Testing infants to determine their HIV status, given that HIV can be acquired in utero (during pregnancy),
peri-partum (during delivery), post-partum (through breastfeeding) or via parental exposure.
Eclipse period The period between HIV infection and detection of virological markers, such as HIV RNA/DNA or HIV antigen.
HIV status Result from one or more assay. It refers to reports of HIV-positive, HIV-negative or HIV-inconclusive.
Inconclusive HIV test The first reactive test results are not confirmed by additional testing using subsequent HIV assays.
result
HIV-inconclusive The HIV status of an individual in whom the test results cannot lead to a definitive diagnosis (i.e. no clear HIV
status status, neither positive or negative can be assigned).
Index testing A focused approach to HIV testing in which the household and family members (including children) of people
diagnosed with HIV are offered HIV testing services; also referred to as index case HIV testing.
Indicator condition- A focused approach to test people more likely to be infected with HIV and who are identified through indicator
guided HIV testing conditions, such as sexually transmitted infections, lymphoma, cervical or anal neoplasia, herpes zoster, TB
and hepatitis B or C. These conditions occur more frequently in HIV-infected people than in uninfected people,
either because they share a common mode of transmission with HIV or their occurrence is facilitated by
immunosuppression associated with HIV infection.
Key populations Refer to defined groups who, due to higher-risk sexual and/or drug behaviours, have an increased risk for HIV
irrespective of the epidemic type or local context. These are men who have sex with men, people who inject
drugs, people in correctional services and other closed settings, sex workers and transgender people.
Nucleic acid testing Also referred to as molecular technology, for example, polymerase chain reaction (PCR) or nucleic acid
(NAT) sequence—based amplification (NASBA). This type of testing can detect small quantities of ribonucleic acid
(RNA), deoxyribonucleic acid (DNA) or total nucleic acid (TNA), qualitatively and quantitatively.
Partner testing This is when one person is tested and is then encouraged to bring in their partner for testing. The partner is
then tested separately. Partner testing may occur with or without disclosure.
Pre exposure The use of ARV drugs by HIV uninfected people before the potential exposure to block the acquisition of HIV.
prophylaxis (PrEP)
Quality assurance A part of quality management focused on providing confidence that quality requirements will be fulfilled.
(QA)
Quality control (QC) A mechanism which, when used with or as part of a test system (assay), monitors the analytical performance
of that test system (assay). It may monitor the entire test system (assay) or only one aspect of it.
Quality improvement Part of quality management focused on increasing the ability to fulfil quality requirements.
(QI)
Quality management A system to direct and control an organisation with regards to quality.
system (QMS)
Repeat HIV testing Refers to a situation where additional HIV testing is performed immediately after the initial test results, within
the same testing visit, using the same assays and, where possible, the same specimen.
Retesting for HIV In certain situations, individuals should be retested after a defined period of time to rule out errors and sero-
conversion. These include:
• HIV-negative people with recent or ongoing risk of exposure
• HIV-inconclusive status
• HIV-positive people before antiretroviral treatment (ART) initiation
Self-testing (HIVST) A process where a person wants to know his or her HIV status collects a specimen, performs a test and
interprets the result by him- or herself, often in private. Reactive test results must be followed by additional
HTS.
Serodiscordant couple A couple in which one partner is HIV-positive and the other is HIV-negative.
Unconfirmed HIV test Refers to an HIV-positive test result without a confirmatory test.
results
Verified People diagnosed HIV-positive are retested before initiating ART and their HIV diagnosis is verified before
initiating care or treatment.
Window period The period between HIV infection and the detection of HIV-1/2 antibodies using serological assays, this signals
the end of the seroconversion period.
xii
1. INTRODUCTION
1.1 Background
HIV represents the primary burden of disease in South Africa, with an estimated national prevalence of 12.2
per cent in 2012. The HIV annual incidence among individuals aged 15 to 49 years is estimated at 1.9 per
cent, and 2.3 per cent among youth aged 15 to 24 years.
The country has a generalised and maturing HIV epidemic, with the highest number of people (6.4 million)
living with HIV in the world. The prevalence of HIV in South Africa remains high. This can be attributed to the
rapid scale-up and success of the antiretroviral treatment (ART) programme. It is estimated that approximately
three million people are on ART, making it the largest programme in the
world.
HIV counselling and testing (HCT) is now referred to as HIV testing
services (HTS) to embrace the full range of services that should be
provided together with HIV testing. These services include:
• counselling (pre‐test information and post-test counselling)

• linkage to appropriate HIV prevention, treatment and care services and other clinical and support
services
• coordination with laboratory services to support quality assurance and the delivery of correct results.
The South African Government has embarked on a deliberate effort to scale up HTS and strengthen its
quality at all health facilities and non-health sites. With increasing availability of quality HTS and its uptake in
all public health facilities in South Africa, the proportion of people who have had an HIV test and are aware
of their status has increased from 50 per cent in 2008 to 66.5 per cent in 2014. In addition, 92.3 per cent
of South Africans are aware of HTS services and 66.2 per cent had actually utilised them in the past year,
according to 2014 data.
The goals of the National Strategic Plan on HIV, STIs and TB, 2012-2016 (NSP) include the reduction of new
HIV infections by at least 50 per cent using combination prevention approaches and initiation of at least 80
per cent of eligible patients on ART, with 70 per cent retained on treatment. Knowledge of HIV status is critical
to achieve prevention and treatment goals and HTS is the key entry point to a comprehensive continuum of
HIV care.
1.2 Rationale for an HTS Policy

There is a global initiative to accelerate universal access to HIV prevention, treatment, care and support
services for people living with HIV and AIDS (PLWHA). The main entry point for the HIV continuum of care
is through HTS, which has become increasingly available. South Africa has more than 4 000 public health
facilities offering provider-initiated counselling and testing (PICT) and client-initiated counselling and testing
(CICT). In addition, HTS is also available through non-medical sites and the private sector.
South Africa has adopted UNAIDS’ 90–90–90 strategy, which calls for 90 per cent of all people living with HIV
to be diagnosed, 90 per cent of eligible people with diagnosed HIV to receive ART and 90 per cent of those
on ART to have a suppressed viral load by 2020.
This policy guideline provides a framework for all HTS modalities that should be implemented in the country.
A variety of HTS modalities should be utilised to reach targeted populations in different settings.
1.3 Goals and objectives

The overarching HTS goal is to identify people living with HIV timeously through the provision of quality testing
services for all --including adults, children, couples and families -- and effectively link them to appropriate
prevention, care treatment and support services.
The main objectives of this document are to provide guidance to the healthcare worker that will ensure:
• consistent provision of high quality HTS
• appropriate use of HTS modalities to reach different populations
• strengthened linkages to prevention, care and treatment services
• strengthened quality assurance and the delivery of accurate results
1
1.4 Target audience

This document is intended for clinical and non-clinical HTS service providers. National, provincial and district
health facility managers and healthcare providers in private and public health facilities need to comply with
these guidelines. HTS providers engaged by community- and faith-based organisations (CBOs/FBOs), non-
governmental organisations (NGOs), the private sector, educational institutions and any other HTS service
providers should also adhere to these guidelines.
1.5 Guiding principles
1.5.1 A rights-based approach

A human rights-based approach that prioritises universal health coverage, gender equality and health-related
rights such as accessibility, availability, acceptability and quality of services is essential for the success of
an HTS programme. The national HTS Programme will benefit the tested individuals and simultaneously
improve health outcomes at the population level. It will also ensure access to appropriate, quality services
that are linked to prevention, treatment, care and support services for those who need these services. HIV
testing for diagnosis must always be voluntary, consent must be informed through pre-test information, and
testing must be linked to prevention, treatment, care and support services to maximise individual and public
health benefits.
1.5.2 The 5Cs
The 5Cs are the foundation of effective HTS. Consent, Confidentiality, Counselling, Correct test results and
Connection are the 5Cs and are described below.
Consent: People who receive testing must consent to be tested and counselled. Clients or patients must
be informed of the process for HTS and of their right to decline testing.
Confidentiality: Discussions between the HTS provider and the client

should not be disclosed to anyone without the expressed consent of
the person being tested. Shared confidentiality with a partner or family
members or trusted others must be encouraged.
Counselling: Pre-test information can be done in a group setting, but
a private setting must be provided for individuals who have questions
that they do not wish to share with others. HIV testing must be followed
by appropriate high quality post-test counselling.
Correct: Quality assurance (QA) mechanisms are essential to ensure that people receive a correct diagnosis.
Connection: Linkage to prevention, treatment and care services and effective and appropriate follow-up
should be provided.
1.5.3 HTS continuum of care
HTS providers shall ensure that clients are not lost in the HTS cascade. The continuum of care is depicted
in Figure 1.
Figure 1. HTS continuum of care
2
2 ETHICAL
2 ETHICAL AND
AND LEGAL CONSIDERATIONS
CONSIDERATIONS
2.1 Human rights and rights to access

A human rights-based approach to HTS ensures that the essential elements of the programme are aimed
towards realisation of rights and that those rights are used as standards. HTS must be offered in a way that
is consistent with the rights described in the Constitution of South Africa, 1996 (Act 108 of 1996); the National
Health Act, 2003 (Act 61 of 2003); and the Children’s Act, 2005 (Act 38 of 2005). It must be ethical and be
conducted within a supportive environment.
Access within the HTS policy must be understood in its broad sense to cover aspects of availability,
convenience, quality, affordability and acceptability to all those who need the service. All essential commodities
in HTS facilities, including rapid test kits, condoms and information, should be made available, affordable and
accessible. Even if resources are available, people may not have access if these resources are not located in
sufficient proximity to the people who need them. Access may be low if there is a lack of adequately trained
personnel to provide quality services. HIV positive individuals should receive appropriate counseling and
assistance linking to prevention, care and treatment services.
2.1.1 Promoting equality for vulnerable groups

The vulnerable position of women, girls, children, key populations and persons living with disabilities, with
respect to HIV and AIDS and its social impact is recognised. Their access to HTS services has to be addressed
by the policy and service providers should ensure that services are accessible to them.
2.1.2 Promoting the best interests of children
The impact of HIV on the rights of children is considerable. Respect for the best interests of the child dictates
that children’s rights and needs must be at the forefront of all interventions for HIV prevention, treatment and
support.The following principles should guide any interactions with children:
• provision of relevant, appropriate and accessible information on the prevention, treatment and care
of HIV during the counselling process in the language that the child is able to understand
• ensuring full participation by the child in any decision-making and consent process regarding HIV
testing and due consideration given to the views of the child
• HIV testing only when it is in the best interest of the child
• providing post-test access to treatment, care and support
• ensuring confidentiality regarding HIV test results and support with disclosure of HIV status
(Children’s Act 2005 as amended, Criminal Law (sexual offences and related matters)
Amendment Act, 2007 (Act 32 of 2007)
The South African National HTS Policy is aligned with the Joint United Nations Program on HIV and
AIDS (UNAIDS) and World Health Organization (WHO) Policy Statement on HIV testing, that: ‘ The
conditions under which people undergo HIV testing must be anchored in a human rights approach
which protects their human rights and pays due respect to ethical principles’.
2.1.3 Availability of HTS services

HTS should be made available in all public health facilities, private healthcare facilities and NGOs who have
been approved to offer HTS.
2.1.4 Duty and responsibility of all healthcare personnel
It is the duty and responsibility of all healthcare workers and health auxillary workers to inform people about
the risks of HIV so that people can make informed decisions about getting an HIV test. Healthcare workers
shall offer HIV testing to all patients in order to identify HIV positive men, their partners, HIV-exposed and
HIV-positive infants, children and youth so that they can access HIV care. Practiced within a human and child
rights framework, this critical intervention should prolong life and optimise maternal and child survival (NDoH
PMTCT Guidelines 2008).
3
2.1.5 Challenging discrimination

Discrimination against people with HIV undermines human dignity and hinders an effective response to
HIV and AIDS. The national HTS Programme should help reduce discrimination by creating knowledge and
competence about HIV in communities.
2.1.6 Quality of HTS services
All HTS services (counselling, testing and testing kits) shall be subject to quality assurance according to
defined national standards and should be monitored and evaluated. Lay counsellors should be trained to
provide quality HTS services according to the national policy framework.
2.1.7 Effective partnerships
All government departments, the private sector, partners, stakeholders and civil society shall be involved in
the HIV and AIDS response.
2.1.8 Effective communication
Clear and ongoing communication (with appropriate messages) between government and all civil society
stakeholders is necessary for the achievement of the aims of the policy. Effective communication also helps
to inform those affected and infected with HIV as to what they need to do, what is available and of any new
developments with regards to the policies around testing and treatment.
2.1.9 Strengthening service selivery and integrating services
Strengthening health and social systems within a multisectoral approach, including the organisational capacity
of NGOs, FBOs and CBOs, and ensuring integration between services, is central to effective implementation
of the policy.
2.1.10 Using scientific evidence
The interventions outlined in the HTS policy shall, wherever possible, be evidence-based.
2.1.11 Leadership role of government
The effective implementation of the HTS Policy Guidelines and the attainment of its goals depend on
government leadership in resource allocation, policy development and effective coordination of the programme
and interventions.
Three important human rights are described below.
2.2 Right to dignity and non discrimination

Every person has inherent dignity and the right to have their dignity respected and protected. No actions
should be taken against any individuals solely on the basis of their HIV status, as this will constitute stigma
and discrimination.
2.2.1 Right to privacy and confidentiality
All personal information concerning a client, his or her health
status, treatment or stay in a health establishment must be
kept confidential, unless ordered by the court of law or done
so for the advancement of the client’s care and treatment
after following the necessary procedure.
2.2.2 Right to refuse HIV testing
Clients have the right to refuse HIV testing, without

compromising their access to standard healthcare. There
shall be no mandatory HIV testing and all testing shall remain
voluntary with informed consent, even when the services are
initiated by the service provider. The only exception is in cases
of sexual assault where the survivor requests the status of
the perpetrator (Criminal Law; Sexual Offences and Related
Matters) Amendment Act No. 32 of 2007 (Government
gazette 31957, 6 March 2009).
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2.3 Informed consent

Informed consent refers to a person being given relevant and appropriate information about an HIV test, and
based on that information, given an opportunity to either accept or refuse to do the HIV test. Informed consent
should always be in written form and signed by only the client or proxy and the healthcare provider to avoid
unintended disclosure of results.
2.3.1 Requirements of informed consent
The information that clients and patients require in order to give their informed consent may vary based on
the service delivery approach and setting, but should generally include information about:
• benefits and implications of knowing one’s status and reasons for recommending HTS
• client’s right to withdraw consent at any stage of the process
• availability of follow-up treatment; care and support; and prevention services
• importance of disclosure and partner/family testing and availability of couple HTS
• HTS process and procedures
2.3.2 Capacity to consent
Any person aged 12 years and older, and/or with sufficient maturity and mental capacity to understand the
benefits, risks, social and other implications of HIV testing, may give consent for HTS in South Africa.
Potential clients or patients should:
• understand why they are being tested
• understand and report on the consequences of a negative or positive test result
• report how they are likely to respond to either result
If the patient/client is assessed as being incapable of giving informed voluntary consent, then proxy consent
may be sought. This is consent given by someone else who is acting in the best interests of the patient/client
(e.g., a senior clinician in charge of the case). If the patient regains capacity results must be disclosed. If the
patient/client has irreversible neurocognitive impairment, results can be shared with the carer.
HIV testing must always be voluntary and free from coercion. In some cases HIV testing can be prescribed
by a court of law. Consent shall be conducted in a language understood by the client, and in child-friendly
versions, as applicable. Consent shall be verbal and written.
Informed consent should always be documented in the following settings and populations:
Infants and children: HIV testing services should be offered to the guardians or parents as applicable, and
they should provide written informed consent. Where appropriate, children may also provide consent.
Couples: Informed consent should be given by individuals who are willing to be tested as a couple.
Research settings: Informed consent within clinical trials and other research settings should
always be written and documented as stipulated by the national Department of Health’s
Guidelines for Good Practice in Conduct of Clinical Trials with Human Participants 2006.
Illiteracy or inability to write: If the client cannot write, or has a disability that hinders his or her ability to
write, the right-hand thumbprint can be used instead of the signature, if the client wishes to take up the HIV
test and give signed consent.
Inability to make a decision: According to the National Health Act, if a client is unable to give informed
consent, for example, in the case of unconsciousness/incapacitation or cognitive disability, and if the test
is clinically indicated, such consent can be given by a person authorised to give such consent, in terms of
any law or court order. In the case of adults, the spouse, next-of-kin (parent, grandparent, an adult child or a
sibling of the person), clinician or clinical manager, in the specific order listed, can give informed consent. In
the case of children, refer to Section 9.1. of this policy.
Any client or patient who does not give consent for HTS should still be provided with the best possible care
and should not be denied other health services. Client(s) or patient(s) declining an HIV test should be offered
assistance to access HTS in the future, and their decision to decline should be noted in their medical record
so that a discussion of HTS can be reinitiated at subsequent visits to the health facility.
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2.4 The Children’s Act

The Children’s Act, Section 130, stipulates when and how a child may be tested for HIV. The Act has clearly
distinguished HIV testing from other forms of medical treatment and has enforced conditions for HTS among
children.
A. Children may only be tested for HIV in two circumstances:

· if testing is in their best interest and lawful consent has been given for the test
· if the test is needed to establish the child’s HIV status in cases where a healthcare worker, caregiver,
parent or another person may have contracted HIV from the child’s body fluids.
This provision protects children against discriminatory or arbitrary HIV testing.
B. Consent for HIV testing for children may be given:

· by a child if he or she is older than 12 years
· by a child younger than 12 years if he or she has “sufficient maturity”
· by a parent, caregiver or the provincial head of the Department of Social Development if the child is
younger than 12 years and is not sufficiently mature.
This section of the Act ensures that a wide range of people may assist a child by consenting for HIV
testing on the child’s behalf. It facilitates HTS for orphans and vulnerable children.
C. Counselling during HIV testing among children:

· HIV testing must be accompanied by a correct pre-information session and post-test counselling done
by an appropriately trained person.
This provision ensures that children and their caregivers make appropriate choices regarding HIV testing.
D. No person may disclose a child’s HIV status without consent
Consent for the disclosure of HIV status can be given by the child if he or she is older than 12 years, or is
sufficiently mature. If the child does not have the capacity to give consent to the disclosure, consent can be
given by a range of people, including a parent or caregiver.
This provision aims to ensure that a child’s right to confidentiality is protected.
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3 NORMS AND STANDARDS

3 NORMS AND STANDARDS
3.1 OPERATIONAL REQUIREMENTS FOR FACILITY-BASED HCT SERVICES
3.1.1 Requirements for facility-based HTS service
HTS should be recommended for all patients attending health facilities, regardless of whether they show
signs or symptoms of HIV infection. Operational requirements for facility-based services include the
following:
• guiding documents or standard operating procedures (SOPs) that detail all elements of the HTS
process shall be available at every point where HTS is conducted
• staff shall be trained in the use of these SOPs
• guiding documents shall be updated as the need arises
• facilities must display signs or posters that inform clients about the availability and location of the
service
• facilities must have relevant HIV and AIDS information, education and communication (IEC)
materials in languages used by the facility’s catchment population, including people with a disability.
Where possible, this information shall be available in braille and other relevant formats
• facilities must facilitate access to other HIV and AIDS preventative services and, where appropriate,
facilitate linkage of clients to treatment, care and support services
• facilities must be accessible and convenient to all segments of the population, men, women and
children, citizens, and foreigners alike, including people with disabilities and other marginalised and
hard-to-reach populations
• facilities where children are tested should be child-friendly and ensure that children’s rights are
protected
3.1.2 Infrastructure requirements for HTS sites
Proposed counselling and testing space should have the following:
• waiting area that is well ventilated
• a room or designated area that has:
o adequate lighting, access to clean water
o adequate privacy to ensure confidentiality
o adequate storage space for supplies
3.1.3 Personnel requirements
• All healthcare personnel shall be trained on HIV testing services.
• Trained human resources are critical to the provision of high-quality HTS.
3.1.4 Waste management
Facility-based HTS providers must have necessary supplies where HTS is conducted to properly dispose
of waste. This includes having a sharps container for sharps (e.g. lancets) and a biohazard (red) bag for
other clinical waste (e.g. used gloves, cotton wool, etc.). Each HTS site has to follow the infection control
and prevention policy. For SOPs refer to the National Guidelines for Assuring the Accuracy and Reliability
of HIV Rapid Testing, NDOH, 2009.
3.2 Operational requirements for community-based HTS services

Community-based approaches must adhere to national policies and guidelines for HTS as outlined in this
document and accompanying resources. Operational requirements for community-based services demand
advance preparation and strong collaboration with local healthcare workers, community leaders, and other
key stakeholders to gain access to the community including:
• SOPs that detail all elements of the HTS process shall be available at every point where HTS is
conducted
• staff shall be trained in the use of these SOPs
• SOPs shall be updated as the need arises
• appropriate signage and mobilisation that inform communities about availability and location of the
service
• service points must be accessible and convenient to all segments of the population, men, women and
children, citizens, and foreigners alike, including people with disabilities and other marginalised and
hard-to-reach populations
• service points where children are tested should be child-friendly and ensure that children’s rights are
protected
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3.2.1 Facility safety and security

Adequate safety and security measures for staff and equipment in HTS services must be ensured. Each site
or set-up where HTS is performed must have an appropriate physical space for testing. Appropriateness of
the physical space includes the storage of test kits and quality control (QC) samples and other supplies used
for testing. Facility for the transportation of test kits and internal quality control/proficiency testing (IQC/PT)
samples must be appropriated to meet the requirements for their storage. Facility appropriateness should
include:
• adequate and levelled surface for performing tests, that can be cleaned
• assurance that environmental factors e.g. temperature, degree of humidity do not affect test kits
integrity and test performance
• a cooling system where temperatures exceed expected ranges
• hand washing facility
Testing sites should implement all safety measures to ensure safety of all workers that may come into contact
with biohazard materials including safety of the clients attending the sites. Personnel should always adhere
to universal safety rules when testing.
Procedures for handling biohazards should include:

• instructions on use of gloves, protective clothing, hand washing, handling of sharp objects, and
management of blood spillages
• visible basic safety instructions posted in the testing room
• display of general instructions such as “no eating, drinking, or smoking”
• availability of procedures for safe disposal of contaminated waste at the site
• procedures for workers to follow when an accidental exposure to biohazard material occurs
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4 SERVICE
4 SERVICE DELIVERY
DELIVERY APPROACHES
APPROACHES
4.1 HTS: Approaches and settings

HTS can be provided in both facility- and community-based settings. PICT refers to counselling and testing
that is routinely offered in a health facility. It includes providing pre-test information and obtaining consent,
with the option for individuals to decline testing.
Community-based HTS includes a number of approaches: Mobile outreach campaigns, events, workplace
testing, home-based testing, testing in educational settings and places of worship. Working in the community
increases early diagnosis by reaching first-time testers and people who seldom use clinical services. Men,
adolescents and key populations, for example, visit public health facilities less frequently than women and
particularly mothers.
A strategic mix of facility- and community-based settings and approaches facilitates the early diagnosis of
HIV-positive people. PICT and CICT are two testing models that can be incorporated in both settings. HTS
programmes should actively link HIV-positive people to prevention, treatment, care and support services.
HIV-negative people should not be lost; risk reduction counselling should be provided, and they should be
linked to prevention services. This strategic mix of settings and modalities will maximise yield, efficiency,
cost-effectiveness and equity. Finally, the strategic mix should support timely and complete linkage to care.
Figure 2. Service delivery platforms
4.2 HTS in health facilities

4.2.1 Provider-initiated counselling and testing (PICT)
Provider-initiated HIV counselling and testing (PICT) is routinely offered by healthcare providers to persons
attending healthcare facilities as a standard component of medical care. PICT should be offered to all persons
attending clinical services in both the public and private sector. Healthcare providers should recommend HTS
to all patients in a health facility, regardless of whether they show signs or symptoms of HIV infection. This
allows the healthcare provider to make medical decisions that would not be possible without knowledge of the
patient’s HIV status. Additionally, PICT contributes to increased rates of HIV testing and early identification of
HIV-infected persons, who may not otherwise know their HIV status.
PICT models can either be provider-delivered whereby the provider offers and conducts testing or provider-
referred whereby the provider recommends testing and refers patient for HIV testing within the facility (i.e.
onsite HTS). The patient flow may be adapted to ensure integration of HTS into routine services.
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4.2.2 Client-initiated counselling and testing (CICT)

Client-initiated counselling and testing (also referred to as voluntary counselling and testing [VCT]) refers
to when HTS is provided within healthcare facilities for clients who present specifically for these services.
Clients may voluntarily decide to learn their HIV status as an individual, couple or family.
4.3 HTS approaches used in the community setting

The focus of HTS in community-based settings is for properly trained healthcare providers to reach out to
communities outside of the health facility to increase access to and to normalise HTS for targeted geographic
locations and populations. Examples of community-based modalities are described below.
4.3.1 Stand-alone HTS
Stand-alone HTS sites are located within the community, with the sole primary function of providing HTS
services to individuals, couples, or families within the community. These are not attached to a health facility.
4.3.2 Home-based HTS
Home-based HIV testing services (HBHTS) is testing service offered in clients’ homes by a trained healthcare
worker. It is provided in two ways:
• Door-to door: Refers to an approach to home-based testing that aims for high coverage of services
within a specific community or geographic location.
• Index patient model: Refers to HTS providers visiting homes of people diagnosed with HIV or TB and
offering testing to their sexual partner/s and other family members, including children. HTS providers
must carry all necessary HTS supplies and equipment with them, and adhere to the standards and
quality assurance systems outlined in these guidelines.
Home-based HTS requires advance preparation and engagement with local leaders to gain access to the
community and peoples’ homes. Because the testing environment is less controlled in the home, particular
attention should be paid to biosafety and waste precautions, appropriate lighting, temperature of the test
kits and supplies, ensuring confidentiality, and maintaining high quality services under sometimes harsh
conditions.
Home-based HTS services may be combined with mobile or outreach sites to increase the reach of services.
 Benefits of HBHCT: There are many benefits to providing home-based HTS. These benefits include
increased acceptability of HIV testing; reduction in stigma and discrimination; facilitated disclosure
and support within families and couples; facilitate linkage to care; increased knowledge of HIV status
especially in hard to reach populations; early identification of HIV infected individuals including
children; systematic coverage of communities; greater buy-in and involvement of community leaders
in HIV issues; improved accessibility of HTS; reduced HIV infection rate through high HTS uptake;
removal of structural, logistic and social barriers to HTS; and timely access to treatment, support and
care.
 Target population of HBHCT: HBHCT targets families in their homes with a specific focus on
reaching men, women, children, couples including persons in polygamous marriages in line with the
national HCT targets. Pre-sexual, engaged, married, cohabiting, and reuniting couples, as well as
casual, short-term, and long-term couples, and same-sex and heterosexual couples.
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 Services offered in HBHCT: Services offered in HBHCT shall be offered in accordance to the
basic package of HTS service as described in this policy. This package includes HIV information
education; HIV counselling (incl. symptomatic screening of STIs and TB, FP); HIV testing; active
referrals to HIV treatment, care and support services (including referrals to FP, immunization,
PMTCT, TB, STI); and follow-up on linkage to care.
 Considerations for HBHCT: The following considerations shall be taken into account when
implementing HBHCT: Culture, religion, age, gender dynamics; violence in the home; alcohol and
other substance abuse, sexual abuse, key populations at higher risk of exposure; confidentiality and
privacy; child headed homes; family members with special needs (e.g. mental incapacitation); and
availability of referral services
4.3.3 Mobile and outreach HTS
Mobile and outreach HTS are provided through vans or tents within the community to increase access to
hard-to-reach populations such as rural communities, men, mobile populations, or key populations.
4.3.4 HTS in the workplace
HTS may also be offered in schools, higher education institutions and workplaces, including public and
private settings.
Many workplaces offer HTS services as part of routine, comprehensive workplace HIV programmes. These
services are often extended to immediate family members or dependents of the employee. HTS services
may also be introduced into a workplace on an ad hoc basis, for example, during an annual family day event.
Workplace HTS may be provided on site through a workplace clinic or in coordination with a nearby HTS
centre. HTS providers may visit the workplace and offer HTS services there, either in an office, a mobile
clinic, or in portable tents. Alternatively, a workplace may offer education about HTS and refer employees to
a nearby HTS site to receive services. As with any HTS model or approach, workplace HTS providers must
adhere to the standard operating procedures (SOPs) of the national Department of Health as outlined in this
document and accompanying resources.
4.3.5 HTS in schools and tertiary institutions
School-based testing provides easy access to HTS for sexually active youth. Testing, however, should only
be offered to learners who are at least 12 years old. School-based settings may be targeted as part of a
national HTS campaign.
Higher education-based HTS will be offered continually to all young people attending higher education
institutions, as well as to the staff at these institutions. As this is a high risk group, HTS providers should
ensure that as many young people as possible are voluntarily tested. All young people who test negative
should be screened for PrEP. Outreach services should target higher education institutions and all HIV testing
conducted in these settings shall be reported to the local health facilities.
4.4 Self-testing
HIV self-testing (HIVST) is a process in which an individual who wants to know his or her HIV status collects
a specimen, performs a test and interprets the result by him or herself, often in private. HIVST is a pre-
screening test and does not provide a definitive diagnosis. A reactive self-test result must always be followed
by additional testing following the national testing algorithm by a trained provider or counsellor.
HIVST provides people with an opportunity to test discretely and conveniently and may increase uptake of
HIV testing among people not reached by other HIV services. The South African Pharmacy Council (SAPC)
has approved over-the-counter distribution and use of HIV self-tests. All healthcare providers should support
clients who have self-tested and provide them with counselling as needed after confirmation of diagnosis.
4.5 HTS in clinical trial/research settings
Clients participating in clinical vaccine trials/research settings should be referred back to their research site
for appropriate testing to avoid misdiagnosis and be linked to care.
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5 PRIORITY
5 PRIORITYPOPULATIONS
POPULATIONS
5.1 Infants and children
The HIV-related mortality rate is very high in the first year of life for untreated HIV-infected infants, and it
peaks within three to four months of age. With an effective PMTCT programme, the yield of HIV-positive
children is likely to shift outside of PMTCT services.
Programmes should prioritise strategies which yield a positivity rate that is higher than the estimated HIV
prevalence among children. It is therefore important to integrate HIV testing into other child health programmes
and to develop a systematic process to identify and prioritise high-yield testing among infants and children.
HTS for children and infants must encompass:
• early infant diagnosis (EID) for all HIV-exposed infants

• testing all infants and children presenting with indicator conditions, such as failure to thrive, oral
candidiasis, skin conditions, chronic cough, etc.
• offering HTS to all medical admissions to wards
• testing all children receiving TB and malnutrition treatment
• testing all children of adults and siblings who are receiving HIV services
• testing all children accessing services for orphans and vulnerable children (OVC), especially if a
parent has died
5.2 Adolescents and young women
Adolescence is a period of high risk for HIV infection, with adolescent girls generally at higher risk than males
in their age group. By far the highest rate of new HIV infections occurs among adolescents, young women
and girls (AYWG). According to published studies, the incidence of HIV in the population group between 15
and 24 years of age has increased and this can be attributed to several factors such as decreased condom
use, increased concurrent multiple partners, low risk perceptions and age disparate relationships (Human
Sciences Research Council (HSRC) 2014). The WHO joint review report for HIV, TB, and PMTCT identified
increased teenage pregnancy and low integration between TB and HIV.
Groups of adolescents who need to be considered are:

• adolescents infected vertically, and who have not been diagnosed
• adolescents acquiring HIV horizontally, through early sex
• adolescents from key populations
There should be routine testing of adolescents and adequate support for disclosure of HIV status to the
adolescents and for support of disclosure to family members or significant others.
Prevention interventions for girls and young women aged between 15 and 24 years must become the highest
priority among health authorities and services at every level. Girls and young women include in- and out-of-
school youth and are part of the broader community. Emphasis must be put on those in informal settlements.
HIV prevention among girls and young women demands special and innovative attention in terms of national
social and behaviour change communication (SBCC) strategies.
5.3 Pregnant women

Providing HTS early in pregnancy enables pregnant women to benefit from all the relevant prevention
interventions. For those who test HIV-positive this includes treatment and care, which will reduce the risk of
HIV transmission to their infants.
The package of care for pregnant women with HIV should include systematic screening for TB and STIs, and
referral and treatment as necessary. The presence of undetected TB among HIV-positive pregnant women
doubles the rate of vertical HIV transmission. Pregnant women testing HIV-positive must be linked to ART for
PMTCT and HIV services. All pregnant women should retest for HIV at the time of the diagnosis of pregnancy,
every visit during pregnancy, at delivery, and every three months during breastfeeding.
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5.4 Couples and partners

For the purpose of these guidelines, a “couple” is defined as two or more persons in an ongoing sexual
relationship or who plan to start such a relationship and therefore wish to test together for HIV and or mutually
disclose their test results. The term includes both heterosexual couples as well as same sex couples as
recognised by the Constitution of South Africa.
Testing the partners of people with HIV is an efficient and effective way of identifying additional people
with HIV, who can benefit from treatment. Couples and partner HTS can be conducted in various settings,
including ANC and community-based TB services. Those receiving ART services should be encouraged to
bring their partners to be tested.
Couples HIV counselling and testing (CHCT) has been shown to increase uptake of interventions to prevent
mother-to-child HIV transmission, to improve infant outcomes, and to improve uptake of and adherence to
HIV treatment services. CHCT services are especially important for identifying HIV serodiscordant couples,
where one member is HIV-infected and the other is not. Providing ongoing services to serodiscordant
couples can prevent HIV transmission to the negative partner. CHCT occurs when two or more partners are
counselled, tested and receive their test results together.
Another strategy for increasing knowledge of HIV status and disclosure among partners is partner testing.
This is when one partner has already been tested, and the other partner is then tested separately. This would
be a common scenario in antenatal settings, where women are routinely offered HTS and then encouraged
to bring in their partner for partner testing. Partner testing may occur with or without disclosure. Whenever
appropriate, feasible, and safe, mutual disclosure of HIV test results under the guidance of a counsellor
should be encouraged and facilitated. In this document partner testing with mutual disclosure is considered
a form of CHCT. Programmes that particularly serve key populations should provide and encourage partner
testing.
5.5 Men
Fewer men than women report ever testing for HIV and consequently, men are more likely to start ART at
later stages of HIV infection and thus experience higher morbidity and mortality after initiating treatment.
Greater emphasis on reaching men with HTS is required in many high prevalence settings. Men are less
likely than women to use clinical health services, making community-based approaches to reaching men,
such as home-based and mobile HTS helpful.
5.6 Healthcare providers and workers exposed to HIV

In the case of healthcare workers and providers who are accidentally exposed to HIV through a needle stick
injury (occupational exposure), it is important to establish the HIV status of the worker following exposure. If
the healthcare worker or provider is HIV-negative, post-exposure prophylaxis (PEP) should be administered
within 24 to 72 hours of exposure in order to minimise the risk of seroconverting to HIV. Such exposure should
be reported to the employer as per guidelines. If a client is not ready to test after pre-test counselling, they
should be started on PEP with a three-day starter pack.
5.7 Survivors of sexual assault

Survivors of sexual assault require an empathetic approach by healthcare professionals. The routine offer
of HIV testing is recommended as part of the comprehensive clinical management offered to sexual assault
survivors. Survivors who test HIV-negative and present within 72 hours of the assault should be offered post-
exposure prophylaxis in accordance with the South African National Guidelines for Antiretroviral Therapy. In
addition, screening and management of STIs and possible pregnancy should be considered. All processes
should follow relevant legislation (Criminal Law (sexual offences and related matters) Amendment Act).
5.8 Prisoners
Although there is little data on HIV prevalence rates among prisoners, HIV transmission is occurring among
prison populations in South Africa. HTS services should, therefore, be offered to prisoners to help prevent
the spread of HIV and to make sure that all HIV-positive prisoners are provided access to ART services. No
prisoner should be forced or coerced into having an HIV test. Instead, prisoners should be routinely offered
HTS services at the time they enter and leave a detention facility according to the procedures outlined in
Section 4 of this document.
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5.9 Migrant and mobile populations
Mobile populations such as truck drivers, farm workers, miners, and migrant workers are at high risk for
acquiring and transmitting HIV. In addition, refugees and migrants are vulnerable to HIV infection due to
their economic and social insecurity. To reach these populations with HTS services, the following should be
considered:
• provide outreach/mobile HTS services to migrant and refugee populations as they are unlikely to seek
healthcare at a health facility
• offer HTS and other prevention programs at convenient locations such as truck stops, harbours and
workplaces to reach mobile populations
• address cultural issues by providing culturally specific education videos about HIV/AIDS and other
STIs in the refugees’ local language
• refer all sexual assault survivors to appropriate services as described in Section 5.7 of this document
5.10 Populations abusing alcohol and other drugs

Both alcohol and drugs increase risk taking behaviours and have been associated with increased rates of HIV
transmission. Populations who abuse alcohol and other drugs often suffer worse health problems than the
general population but due to stigmatisation, these populations often have difficulty accessing quality health
services.To ensure that these populations have access to HTS services, HIV testing should be provided as a
standard part of medical care for all patients attending specialised health facilities for substance abuse (e.g.
drop-in centres, needle/syringe programmes, opioid substitution therapy (OST) programmes, alcohol/drug
dependence treatment services).
Implementation must include measures to prevent compulsory testing and unauthorised disclosure of HIV
status. Staff at these services should also receive training to enable them to enquire sensitively about risk
behaviours and to recognise the early symptoms of HIV-related disease. Provision of appropriate peer support
at such services can enhance access and ensure that individuals newly diagnosed with HIV are linked to
HIV care. In addition, involving members of this population in the development of HIV testing and counselling
protocols will help to ensure that the most appropriate and acceptable practices are followed.
5.11 Key populations

HIV testing services should be routinely offered to all key populations in the community, in designated high
transmission areas (HTAs), in closed settings such as correctional facilities and clinical settings. Community-
based HIV testing services for key populations with linkage to prevention, treatment and care service is
recommended in addition to PICT.
Several other populations need to be targeted for HTS services given their high risk of acquiring or transmitting
HIV. The term ‘key populations’ or ‘key populations at higher risk of HIV exposure’ refers to those most likely
to be exposed to HIV or to transmit it – their engagement is critical to a successful HIV response i.e. they are
key to the epidemic and key to the response. In all countries, key populations include people living with HIV.
In most settings, men who have sex with men, transgender persons, people who inject drugs, sex workers
and their clients, and seronegative partners in serodiscordant couples are at higher risk of HIV exposure than
other people.
Key populations in South Africa include men who have sex with men (MSM), female sex workers (FSW), long
distance truck drivers, injection drug users (IDUs) and prisoners. 9.2 per cent and 19.8 per cent respectively
of new HIV infections are related to MSM and sex work. Improving access to and uptake of HTS among key
population gay men and other MSM require a holistic approach.
5.11.1 Men who have sex with men (MSM)
Although there is a common assumption that all MSM are gay, with similar values, lifestyle and dress, MSM
is in reality a very broad term to describe a widely diverse group of men. The common thread is that these
men have sex with men. Not all MSM see themselves as homosexual, many may be married, have children
and have sex with women.
HIV prevalence rates among MSM are much higher than men in the general population of South Africa. While
there is no law against homosexuality in South Africa, many MSM face social stigma and, as a result, may be
reluctant to seek HTS services.
14
Promotion of condom and compatible water-based lubrication use should be the emphasis for anal penetrative
sex. MSM needs to be educated about the benefits of using appropriate water-based lubrication and if
possible such lubrication should be made available. The use of female condoms has become increasingly
popular among MSM for anal intercourse, it is important to demonstrate the use of female condoms for MSM.
5.11.2 Sex workers
The term ‘sex worker’ is intended to be non-judgmental and focuses on the working conditions under which
sexual services are sold. Sex workers include consenting female, male, and transgender adults and young
people over the age of 18 who receive money or goods in exchange for sexual services, either regularly
or occasionally. HTS for female sex workers is important because female sex workers across developing
countries are not aware of their HIV status and are less likely to get tested as they lack the knowledge about
HIV/AIDS, HTS services available to them, and the fear of being seen accessing HIV services, which can
result in the loss of clients. Further, sex work is illegal in most African countries and FSWs live in fear of being
criminalised and are vulnerable to physical abuse and rape from their clients as well as authority.
Condom use plays a big role in the sex work industry as its determines the amount of payment and/or
number of clients SWs will have access to if they have sex with or without a condom. SWs who have sex with
occasional and regular type of clients are less likely to use condoms. In some cases clients can demand to
have sex without a condom however, the SW can refuse to have sex unless with a condom.
5.11.3 People injecting/using drugs (PWID/PWUD)
Injecting drug users are one of the most vulnerable populations as they are at higher risk of dying from both
acute and chronic diseases mostly relating to abuse of drugs and infection from HIV and other blood-borne
diseases transmitted through sharing of needles and syringes (Mathers B. M. et al, 2012). People who inject
drugs are the fastest growing epidemic of HIV across the globe.
5.11.4 Transgender
The transgender population are described as people that do not follow traditional gender norms and are
commonly referred to as male-to-female (MTF) and female-to-male (FTM) to describe their gender identity.
Transgendered people may include transgenderists, drag queens, cross-dressers, intersex persons
and transsexuals. There is evidence to suggest the HIV prevalence rate of the transgender population is
significantly higher than those among other key populations.
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6 PRE-TEST SERVICES
6 PRE-TEST-SERVICES
Several pre-test activities should take place before testing in all settings and to all target populations.
6.1 Demand creation
General promotion and awareness campaigns for HTS must include children and the hard-to-reach
populations. The national HTS Programme must focus on promoting HTS to populations where HIV testing
rates remain suboptimal. Key populations and adolescents are two hard-to-reach populations in South Africa,
and campaigns should be targeted to reach these populations with carefully tailored messages. Existing
technological options such as MomConnect and Be-Wise must be used to encourage individuals to test for
HIV.
6.2 Confidentiality
Confidentiality applies to HIV test results, reports of HIV status and to any personal information about an
individual. This includes information about sexual behaviour and the use of illegal drugs. HTS providers
should be careful not to inadvertently reveal a client’s test results or HIV status to others in the waiting room
of a public health facility, or any other testing venue. HIV-positive individuals must be counselled in the same
room as the other clients. Lack of confidentiality discourages people from using HTS.
6.3 Pre-test information

HIV test results are available within minutes of doing the test and the client receives post-test counselling on
the same day. Intensive and lengthy pre-test counselling is no longer needed and individual risk assessment
and counselling during the pre-test information session is no longer recommended. Provision of pre-test
information through individual or group information sessions is adequate, although this must be presented in
an age-appropriate way.
6.4 Intensified tuberculosis case finding
Tuberculosis (TB) is the most common presenting illness among people living with HIV. Early detection, prompt
linkage to TB treatment along with ART can prevent unnecessary deaths. HTS should include screening for
TB to improve intensified TB case finding.
6.5 Sexually transmitted infections and non-communicable diseases
Sexually transmitted infections (STIs) and non-communicable diseases (NCDs) such as diabetes, and
hypertension contribute to South Africa’s quadruple burden of disease. All clients must be screened for STIs
and NCDs using existing screening tools. Results must be documented in the relevant register.
HTS must integrate screening for TB symptoms, STIs and NCDs into the pre-test information session at
health facilities and in community settings.
Figure 3. HIV/TB screening algorithm to increase TB case finding in HTS
16
In public health facilities and other high volume HTS settings, pre-test information and education sessions
may be conducted in a group rather than individually. In settings with low HTS volumes individual pre-test
counselling sessions may be conducted. Information sessions and print materials should be available in the
local language to all clients considering taking the HIV test.
6.6 The pre-test information session

The pre-test information session to an individual or to a group must include clear information on:
• the benefits of HIV testing
• the meaning of an HIV-positive and an HIV-negative diagnosis
• services - including ART provision - that are available should the client test positive
• the potential for incorrect results if a person who is already on ART is tested
• a brief description of prevention options and encouragement of partner testing
• the confidentiality of the test result and any other information shared by the client
• the right to refuse to be tested and that declining testing will not affect the client’s access to HIV
services or general medical care
• potential risks of testing, particularly in instances where there are legal implications for those who
test positive and for those whose sexual or other behaviour is stigmatised
6.6.1 Pregnant or post-partum women
Pregnant or post-partum women require additional pre-test information including:

• the potential risk of transmitting HIV to the infant
• counselling on infant feeding practices
• how to reduce mother-to-child transmission, including the use of ART to benefit the mother and
prevent HIV transmission to the infant
• benefits of early HIV diagnosis for mothers and infants
• benefits of partner testing
6.6.2 HIV testing services in couples
Encouraging couples to test together and to mutually disclose their HIV status allows couples to make joint,
informed decisions about HIV prevention and reproductive issues, such as contraception and conception.
Studies have consistently shown that couples who test together are more likely to adopt HIV prevention
strategies than individuals who test alone. In addition, CHCT is an important gateway for linking all couples
to appropriate prevention, care, and treatment services based on the couple’s serostatus.
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7 HIVTESTING
7 HIV TESTING PROCESS
PROCESS
7.1 HIV testing algorithm
HIV testing in South Africa should be conducted using two HIV testing technologies, a rapid HIV test for
children older than 18 months and adults, while polymerase chain reaction (PCR) should be used for children
younger than 18 months to avoid misdiagnosis.
When implementing HIV rapid testing, a serial testing algorithm should be followed (See Figure 7.1.1). This
means that one rapid test is run as a screening test and if reactive, a different rapid test is then run to confirm
the result of the screening test. If the screening test is non-reactive a negative result should be reported but
the possibility of recent exposure must be considered (window period). The selection of rapid test kits used
in the testing algorithm should be guided by the National Reference Laboratory and approved by the national
Department of Health.
In case of discrepant (discordant) test results where the first results is reactive and the second negative,
the rapid testing algorithm should be repeated immediately. If the repeat results are both non-reactive, a
negative result is reported, if the results are both positive, a positive result must be reported. In case of repeat
discrepant results, whole blood for an enzyme-linked immunosorbent/chemiluminescent assay (ELISA/EC)
must be collected for the reflex laboratory testing. The laboratory will conduct a serial testing algorithm using
fourth generation (ELISA/EC) testing (See figure 7.1.2). If the initial ELISA/EC testing is non-reactive, a
negative result must be reported. If both ELISA/EC results are reactive, a positive result must be reported.
In case of discrepant ELISA/EC results that are not resolved by further testing (i.e. HIV inconclusive results
and HIV inconclusive status) the patient/client must be asked to return to the facility for a repeat HIV rapid
testing after six weeks.
7.1.1. National HIV testing algorithm
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7.1.2 Reflex HIV laboratory testing to resolve discrepant HIV rapid testing
7.2 Managing and documenting HIV results
Key information should be collected for each HTS encounter in all models and settings. This data will allow
the health provider to monitor service delivery in a standardised manner and allow for useful analysis of
data. Section 11 describes the standard data collection tools that should be used when HTS is provided.
Completion of these data collection tools is key to monitoring performance and identifying trends in service
delivery.
7.3 Issuing written confirmation of HIV test results

Patients or clients may request written results which can be issued irrespective of their HIV status. All
written results should clearly include the patient/client’s name, the date of the HIV test, test result, signature,
designation of the issuing provider and the facility stamp. All written results should be issued by the nurse.
Clients/patients who test HIV-negative should be told that written results are a documentation of the results
at that specific point in time and are not a substitute for consistent periodic testing.
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8 POST-TEST SERVICES
8 POST-TEST-SERVICES
All clients, regardless of the outcome of the HIV test, should be offered and should receive post-test counselling
based on their test result. All results must be communicated clearly.
8.1 Post-test services for people testing HIV-negative

Those testing HIV-negative should receive health information about their test results. The health information
should include risk reduction counselling and recommendations on uptake of preventive behaviours including
consistent condom use. The post-test counselling session should focus on keeping the individual negative.
Active linkage to appropriate services is strongly recommended. In sero-discordant relationships, counselling
for those who test HIV-negative should include education on methods and behaviours to prevent HIV
acquisition and the provision of male or female condoms, lubricants and guidance on their use.
8.2 Services for people with discrepant test results

An HIV-inconclusive/indeterminate result means that the first reactive test results were not confirmed by
subsequent testing using an HIV rapid test (screening test was reactive and confirmatory test was non-
reactive). Clients with an HIV-inconclusive status should be told that a definitive diagnosis cannot be provided
that day and that immediate referral to HIV care or ART initiation is not appropriate. Whole blood should be
drawn and sent to the laboratory for ELISA testing as a tie breaker. Clients should be given a clear plan for
follow-up testing.
All clients with an HIV-inconclusive result should be encouraged to return within seven days for their ELISA
results to confirm their diagnosis.
8.2.1 Re-testing during the window period
The window period should be considered for HIV-negative clients who report recent or ongoing risk of exposure.
For most people who test negative additional retesting to rule out the window period is not necessary. Re-
testing for window period should be done after six weeks from the possible date of exposure.
Table 1. Recommended frequency of testing
Circumstance When to re-test Future re-testing
Known positive partner At six weeks post exposure Annually or more based on exposure
Unknown HIV status of partner At six weeks post exposure Annually or more based on exposure
Sex worker At six weeks post exposure Every three months depending on exposure
MSM and transgender people At six weeks post exposure Every three months depending on exposure
Post sexual violence and rape At six weeks and 12 weeks per relevant Annually or more based on exposure
guidelines
Occupational exposure At six weeks and 12 weeks per guidelines Annually or more based on exposure
Presenting with clinical conditions (e.g. STI) At six weeks Annually or more based on exposure
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Table 2. Testing under different circumstances
Who When
Pregnant women At confirmation of pregnancy, and follow appropriate programme guidelines for testing frequency. Ask about last date
of test at every visit and test appropriately throughout pregnancy and at labour or immediately after delivery as per
programme guidelines.
Breastfeeding women (to Every three months throughout breastfeeding. Follow appropriate guidelines for testing frequency but ask about last
detect HIV sero-conver- date of test at every visit.
sion)
HIV exposed babies At birth, at expanded programme on immunisation (EPI) visit according to the relevant guidelines and at 18 months.
Follow guidelines for frequency
Adolescents and young Every six to 12 months if sexually active or more frequently based on exposure
adults
If exposed to HIV (adults ) Immediately, after six weeks for window period, annually or more based on exposure
Key populations At six weeks, every three months
Clients on PrEP At one month, every three months
8.3 Services for people testing HIV-positive
People who test HIV-positive should receive health information about their test results. It is essential to ensure
that the HIV status test results are correct. All post-test counselling should be client-centred and responsive
to and tailored to the unique situation of each individual or couple. Health workers, professional counsellors,
social workers and trained lay providers can provide relevant counselling.
The post-test counselling information must include:

• an explanation of the test results and diagnosis
• clear information on ART and its benefits
• where and how to obtain ART
o make an active referral for a specific time and date
• how to prevent transmission of HIV and viral suppression condoms and lubricants and guidance on
their use
• how to encourage and offer HIV testing to sexual partners, children and other family members of the
client. This can be done individually, through couples testing, index testing or partner notification
However, the shock of learning one’s positive status may make it difficult for the client to absorb a lot of
information at one time. The counsellor should provide the necessary emotional support by:
• giving the client time to consider the results
• helping the client cope with emotions arising from the diagnosis of HIV infection
• discussing immediate concerns and help the client decide who in her or his social network may be
available to provide immediate support
• discussing barriers to linkage to care, same-day enrolment and ART eligibility assessment and
arrange for any follow-up of clients
• discussing possible disclosure of the result and the risks and benefits of disclosure
• assessing the risk of intimate partner violence and discussing possible steps to ensure the physical
safety of the client, particularly women, who are diagnosed HIV-positive
• assessing the risk of suicide, depression and other mental health consequences of a diagnosis of
HIV infection and providing additional appropriate referrals for prevention, counselling and support
• encouraging and allowing the client to ask additional questions
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8.3.1 HIV disclosure
Deciding about disclosure is a serious issue for a person who has been diagnosed with HIV. Three acceptable
types of disclosure are discussed below:
Disclosure to a sexual partner, family member or friend: When people learn their HIV-positive status,
they may need time to absorb and accept the diagnosis before they are ready to share it with another person
and as such, they do require ongoing counselling for disclosure. Disclosure does benefit sexual partners,
but the social context of an individual must be taken into consideration. For example, HTS providers and
counsellors should assess the risk of intimate partner violence and make appropriate referrals if necessary.
Disclosure of HIV in children: Disclosure of HIV status in children is not a single event, but rather a
process, involving ongoing discussions about the disease as the child matures cognitively, emotionally, and
sexually. Whenever possible, disclosure should occur when a child is clinically and emotionally stable and
the caregiver is ready. Although the process should not be rushed, disclosure should happen before the child
enters adolescence. The timing will depend on the caregiver’s acknowledgment of the disease and readiness
to disclose, the child’s cognitive skills and emotional maturity and an ability to maintain confidentiality.
Disclosure among children may be beneficial to the child, as it may:

• provide developmentally appropriate and truthful explanations of the disease and help the child
understand the illness
• validate the child’s concerns and clarify misconceptions
• increase the child’s willingness to adhere to ART, and consequently improve his or her social functioning
and school performance by decreasing stress
Shared confidentiality or disclosure by a health worker to other health workers involved in the client’s care
is a third type of disclosure. Clients and patients who test positive must be informed that their diagnosis may
be shared with other healthcare providers to ensure appropriate medical care from the different healthcare
workers. Such disclosure should respect their basic right to privacy and confidentiality of all medical information.
Disclosure by a health worker to employers, the police or other legal authorities is unlawful and
unethical unless the client has given a written consent for his or her HIV status to be disclosed.
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9 LINKAGES TO CARE
8 POST-TEST-SERVICES
Linkage or connection to HIV care is defined as a process of actions and activities that support people
testing for HIV and people diagnosed with HIV to engage with prevention, treatment and care services as
appropriate for their HIV status. For people living with HIV, it refers to the period beginning with HIV diagnosis
and ending with enrolment in care or treatment and other health services. It is the responsibility of all HTS
providers to ensure that clients and patients are connected to appropriate care. HIV testing alone is of limited
value unless it is linked with other services.
These services include:
• treatment, care, support and management of the disease
• sexual and reproductive health (i.e. contraception, PMTCT, cervical cancer screening, anal cancer
screening for men and STI screening)
• testing for partners and families: This includes partner notification and index case testing
• HIV prevention, including dissemination and education on the use of condoms and lubricants, and
voluntary medical male circumcision (VMMC)
other clinical and supportive services
While it is important to increase the number of clients tested for HIV, a shift is needed in the national HTS
Programme to focus on the outcome achieved through HIV tests. Those who are HIV-negative should be
assisted in reducing their risky behaviour and those who are HIV-positive must be successfully linked into
the continuum of HIV care.
9.1. Integration of oral PrEP across various entry points
Pre-exposure prophylaxis of HIV infection is defined by the WHO as the use of antiretroviral drugs by HIV-
negative people, before potential exposure to HIV, to block the acquisition of HIV infection. It is an evidence
based HIV risk-reduction intervention and an additional prevention choice for people at substantial risk of
HIV infection. PrEP should be offered to all people at substantial risk of acquiring HIV. Substantial risk of
HIV infection is defined by the WHO as a population group with an HIV incidence greater than three per 100
person–years in the absence of PrEP. South Africa will use a phased approach in the implementation of PrEP,
and has committed to offer PrEP to all sex workers, both male and female, in the initial phase.
PrEP should not displace or undermine the use of other effective and well-established HIV combination
prevention interventions. It must be promoted as an additional prevention choice among people for whom it
is suitable and their communities, in conjunction with other appropriate prevention methods.
PrEP can be integrated into a variety of practice settings, including HTS. Eligibility for PrEP requires an
HIV negative status and a very high risk for HIV infection. It is therefore important that HIV testing services
are available to clients in settings where the client population is at increased behavioural or clinical risk for
acquiring or transmitting HIV infection, including those at ongoing substantial risk of HIV infection.
Post-test counselling should include screening for eligibility for PrEP and discussions on the benefits of PrEP
Those that are found to be eligible should be linked to appropriate services for initiation of PrEP
A baseline rapid HIV test is required to confirm a negative HIV status. It is important to note that some
individuals requesting PrEP are likely to be at ongoing or substantive risk for HIV and might always fall into a
window period during HIV testing.
PrEP clients who test HIV-positive
HIV-positive prior to initiation of PrEP: All patients that are eligible for PrEP, who test HIV positive, are
eligible for ART initiation regardless of CD4 count. They must be linked to HIV care, treatment, and support.
Where possible, their partners should be encouraged to test for HIV.
HIV-positive after initiation of PrEP: HIV sero-conversion after initiating PrEP can occur, and may be due
to non-adherence or being in the window period at the time of PrEP initiation. As soon as an HIV-positive test
has been confirmed, the patient becomes eligible for ART initiation and must be referred and linked to HIV
care and treatment.
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PrEP and test and treat (T and T) will be integrated into all the entry points of the public health system such as
primary healthcare (PHC) clinics; HIV testing services (HTS); antenatal care (ANC); sexual and reproductive
health (SRH) services, contraception and fertility services, voluntary male medical circumcision (VMMC)
services, STI and TB screening, etc.) This will mitigate against stigmatisation when trying to obtain HTS and
PrEP services.
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10 QUALITYASSURANCE
10 QUALITY ASSURANCE AND
AND IMPROVEMENT
IMPROVEMENT
Quality assurance (QA) and quality improvement (QI) encompasses the entire process of HTS. Coordination
with laboratory services for QA and delivery of accurate HIV test results is a priority and a core component
of the 5Cs for HTS.
10.1 Quality assurance for HIV testing

Quality assurance (QA) is the confidence that quality requirements will be fulfilled. Continuous quality
improvement (CQI) focuses on increasing the ability to fulfil quality requirements. Every effort must be made
to ensure that service delivery is of the highest quality. QA for HIV testing refers to those strategies employed
by HTS that ensure that the final HIV test results are correct. The availability of rapid HIV diagnostic tests
with high performance characteristics alone does not guarantee accurate test results. Errors can occur at
multiple points along the diagnostic continuum. The following elements are key for assuring quality of HIV
testing results:
• a national HTS Policy
• QMS for all HIV testing in all settings
• regulation of selection and pre- and -post-market surveillance for in-vitro diagnostics
• validated national testing algorithms (with back-up options)
• training and supportive supervision for HTS providers
• consistent adequate stock of test kits and consumables
• SOPs for HTS
Service providers must be trained on how to keep HTS records (e.g. standardised registers) and have an
understanding of the importance of independent quality control (IQC) and proficiency testing (PT) programmes.
There must be effective site supervisory visits with informed corrective actions.
10.2 Quality management system
A quality management system (QMS) is a system that directs and controls the programme with regard to
quality. A QMS can be implemented to varying degrees, but the basic principles still apply to any service
providing HIV testing results. Any site conducting HIV testing should implement a QMS that incorporates the
12 elements shown in Figure 5.
Figure 5. Twelve elements of a quality management system
There are multiple points along the diagnostic continuum that can contribute to incorrect test results, including
poor quality HIV assay tests, improper storage of test kits, not following SOPs or poor documentation. Using
routine monitoring data to support facility efforts in monitoring, improving and evaluating quality, the six key
stages of assuring and improving quality illustrated in Figure 6 should be followed.
25
Figure 6. Quality assurance cycle: A continuous quality assurance and improvement process
10.3 Regulation of HIV diagnostics
The WHO Prequalification of In Vitro Diagnostics promotes and facilitates access to safe, appropriate and
affordable diagnostics of good quality. WHO systematically reviews the quality, safety and performance of
diagnostics that are available in markets in resource-limited settings. South Africa highly recommends the
use of WHO prequalified HIV rapid test kits or products eligible for procurement under donor arrangements
that have been verified by the reference laboratory.
10.3.1 Pre- and post-marketing surveillance of diagnostics
Post-marketing surveillance for HIV tests is a critical process for monitoring the quality of test kits that
are procured and used within South Africa. Once a product is placed on the market, its quality, safety and
performance must be monitored to ensure that it continues to meet the set standards. All rapid test kits
utilised in testing sites must be subjected to both pre- and post-market surveillance.
10.4 Quality control (QC)
Quality control refers to processes and activities that ensure that testing procedures are performed correctly,
that environmental conditions are suitable and that the assay works as expected. QC will detect, evaluate and
correct errors before test results are reported as the HIV status. It is a multi-step process with checkpoints
throughout the testing process. QC should be implemented at all HTS sites and records should be kept
accordingly. It is recommended that routine use be made of an independent quality control (IQC) serum
to assess the test devices prior to testing clients. The frequency and conditions of the use of the IQC are
described in detail in the QA guidelines and training materials.
10.5 External quality assessment and proficiency testing
External quality assessment, including proficiency testing (PT) refers to inter-facility comparison to determine
if the HIV testing service can provide the correct test status. PT involves testing of unknown samples at
regular interval by the testing sites. The PT cycle is shown in Figure 7.
26
Every six months each HTS site should receive a panel of blood specimens, known as a proficiency panel,
from the national reference laboratory. HTS service providers should perform HIV testing on the samples on
a rotational basis and they should record the test results on a standard form. The test results are returned to
the PT provider and are checked for accuracy. All sites should receive the results of their proficiency panel
testing. Any errors or mistakes are reported back to the site, so that corrections can be made. Facilities that
do not pass this test need to receive technical support from the national, regional, referral lab or implementing
partner supporting that site.
Figure 7. The proficiency testing cycle
10.5.1 Supportive supervision, site assessment and observed practice

Provincial supervisors should support healthcare managers and HTS providers at the district level. Ideally
a provincial and district supervisor, regional quality assurance officers, trained supervisors or designated
laboratory staff from the reference lab or implementation partner supporting the site should conduct quarterly
visits. A standardised checklist should be used to assess compliance with QA requirements and feedback
provided. Any recommended corrective action from a site/supervisory visit should be closed within a
recommended time.
Quality assurance for HIV Counselling
While standard protocols for rapid testing provide the appropriate information for the testing component of
HTS, the counselling skills have the greatest impact on the client’s HTS experience. It is therefore important to
have systems that ensure the quality of counselling. Such approaches are important for ensuring that human
rights are respected and the client’s needs are met. High quality counselling is defined as non-judgemental,
accessible and client-centred. Counselling should increase the knowledge of HIV prevention, benefits of
early treatment for HIV-positive individuals and help clients to focus on achievable steps to reduce their risk.
The following are the national SOPs for QA of counselling that must be followed by all service providers:
• all counsellors must meet the National Minimum Standards for Counselling to ensure that quality
counselling is conducted
• QA (i.e. supervision, observations of actual counselling sessions, regular training and feedback to
counsellors) of counselling must be performed at least on a quarterly basis. These strategies are
important in ensuring that quality counselling and testing is provided.
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10.5.2 Mentorship and observations of counselling sessions
Given the burden of the HIV epidemic in South Africa, healthcare workers and HTS counsellors may face
increased stress and burnout that sometimes compromise the quality of HIV counselling. Counselling support
supervision is important for preventing burnout of individual HTS providers and maintaining high level
communication between providers and clients or patients.
Quality improvement tools for counselling include:

• counsellor self-assessments
• supervision and mentoring
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11 MONITORINGAND
11 MONITORING AND EVALUATION
EVALUATION
11.1 Documenting, monitoring and evaluation
Monitoring and evaluation (M and E) is a necessary component of the implementation and management of
the HTS programme, ensuring that the resources going into a programme are utilised, services are accessed,
activities occur in an efficient and guided manner and the expected results are achieved. Routinely monitoring
HTS programmes ensures that service quality is improved and the maximum health benefit for the population
is obtained.
Monitoring is the routine tracking of service and programme performance using input, process and outcome
information that is collected on a regular and ongoing basis. This process makes use of HTS programme
tools such as registers, regular reporting systems and templates (e.g. the District Health Information System
(DHIS), as well as health facility support visits, client surveys and to some extent, population-based surveys).
Evaluation is the periodic assessment of results that can be attributed to programme activities. It uses
advanced data analysis and indicators that are not collected through routine information systems. It also
assesses whether the programme is effective in achieving its objectives.
11.1.1 Quality assurance indicators in HTS register
QA indicators in the HTS register are used for recording the specific results of each individual HIV test kit
used, and allows for easier monitoring of the lot number, type, and number of test kits used. They help HTS
providers to address test kit problems, such as expired test kits or inconclusive results. Every HTS provider
should complete the HTS register immediately following the performance of a HIV rapid test with clients or
patients. This register should be checked on a quarterly basis by HTS site supervisors.
11.2 Data management
Data management is essential for the effective management and improvement of HTS. Client data should be
used to monitor HTS at each site, in each district and region, and at national level. All HTS providers will use
a standardised HTS register as a data collection tool. Data collection will take place at the site or outreach
setting where clients/patients are seen (point of service) and data entry will be done at the district level. Data
will be collated at every level for analysis and reporting.
At each level, the collected data will be analysed and interpreted to help improve the service and for planning
and decision-making. Each district and provincial health information office should have a well-defined data
management protocol and data flow protocol from different peripheral service points, including those in the
private sector, to a central point.
Only healthcare workers, HTS counsellors and data capturers/information officers permanently designated to
work with health information, at all levels (facility, district, provincial, and national), should have access to data
for verification and quality checks (completeness, correctness and accuracy). The confidentiality of clients’
records should be maintained at all times.
11.3 Roles and responsibilities for information flow
All required data should flow from the HTS service points to and from the district, provincial and national
health offices. Compliance with the data flow policy and the data user agreement must be maintained at
each level. All HTS sites, including government and mission hospitals and health centres, NGOs, PLWHA
organisations, and private and commercial sites offering HTS must follow these procedures.
Data is collected routinely at the following levels:
Service points: All HTS record-keeping forms and registers will be completed at the service points by the
29
healthcare workers and HTS counsellors, consolidated by the facility data capturers and signed off by the
facility or programme manager. Periodic reports will be completed at the service points and transmitted to the
appropriate health districts.
District office: Data collected from the service points and NGOs or private facilities within districts will be
collated, captured on the District Health Information System (DHIS) database and reported to the respective
provincial office. This will be done monthly by the district health information officers and the district HTS
coordinator.
Provincial office: The provincial health information officer and HTS coordinator will compile all district data
and report to the national Department of Health.
National Department of Health: Final compilation of national HTS service data will occur at the national
office. Some indicators will be reported to the South African National AIDS Council (SANAC) monitoring and
evaluation unit by the monitoring and evaluation and HTS manager in the HIV and AIDS and STIs cluster in
the national Department of Health. The flow of information will ensure that feedback is provided at each level.
11.4 Monitoring and evaluation framework and objectives

The “input-output-outcome-impact” framework is used in most monitoring and evaluation environments.
These stages represent the flow of interventions over time and are intended to capture the relationship
starting with input and ending with impact. For an HTS programme to achieve its goals, inputs (policies,
budget, staff, HIV test kits), must result in outputs (HIV test kit stocks and supply systems, new or improved
HTS services and appropriate ratios of trained staff).
These outputs are often the result of specific processes, such as training sessions for staff and campaigns
aimed at promoting the uptake of HIV testing. If these outputs are well designed and reach the target
populations, the programme is likely to have positive short-term effects or outcomes, such as an increased
number of people from the target population testing for HIV. These positive short-term outcomes should lead
to changes in the longer-term impact of HTS programmes, possibly reflected in fewer new cases of HIV
infection in a target population.
11.5 HTS programmes: Essential and strategic indicators

HTS programmes should continually monitor the minimum set of indicators established by the national HTS
Programme. These indicators, which include antenatal care (ANC), TB, opportunistic infections (OI), STI,
post-exposure prophylaxis (PEP) in primary healthcare clinics and community/home-based HTS programmes
should be monitored at every service delivery point offering HTS. Indicators measuring referral to appropriate
services (e.g. TB screening, STI treatment, ART, VMMC) should be collected. Table 3 shows the set of
indicators that are recommended for the purpose of reporting on the implementation of the HTS programme
and policy.
Table 3. Recommended HTS indicators
Type of indi- Frequency of

No Indicator Measurement tool Levels of disaggregation
cator collection
1. Number of public health facilities offering Input DHIS Quarterly Province, district and facility
HTS
2. Number of non-health facilities providing Input Programme Quarterly Province and district
HTS monitoring and DHIS
3. Number of campaigns aimed at promoting Process Programme Quarterly Province and district
HTS monitoring
4. Number of trained lay counsellors on Process Programme Quarterly Province, district and facility
stipend monitoring and DHIS
5. Number of clients receiving pre-test Output Programme Monthly Province, district, facility,
information gender and pregnancy status
monitoring and DHIS among females
6. Number of clients tested for HIV Output DHIS Monthly Province, district, facility,
gender and pregnancy status
among females
7. Number of clients screened for TB Process Programme Monthly Province, district and facility
monitoring or DHIS
8. Proportion of HIV-negative men referred Process Programme Monthly Province, district and facility
for MMC monitoring or DHIS
30
9. Proportion of HIV-positive clients referred Process Programme Quarterly Province, district and facility
for CD4 testing monitoring or DHIS
10. Number of HIV-positive clients receiving Output Programme Monthly Province, district and facility
CD4 results monitoring or DHIS
11. Proportion of new TB patients tested for Output DHIS Monthly Province, district and facility
HIV
12. Proportion of new STI patients tested for Output Programme Monthly Province and district
HIV monitoring or DHIS
13. Proportion of new pregnant women tested Output DHIS Monthly Province, district and facility
for HIV
14. Percentage of facilities where the HTS Outcome Programme Quarterly Province, district and facility
policy guidelines are available monitoring
15. Proportion of individuals who have been Outcome Population-based Periodically Province, district and facility
tested for HIV in the previous year and surveys (BSS or
have received results DHS)
16. Proportion of newly diagnosed HIV- Process Programme Monthly Province, district and facility
positive (people newly enrolled in and monitoring
receiving care)
A data collection tool should be available with a minimum set of data elements, which reflect policy goals
and objectives. Indicators should be dynamic and should be revised periodically depending on availability of
information and changing circumstances or technologies.
The minimum set of data elements must include the following:
• age
• gender
• location
Indicator relatedness: Programme monitoring activities (in-year monitoring) and periodic outcome and
impact activities should be closely linked. Indicators that are logically connected (i.e. inputs, outputs and
outcomes) should be used.
Reporting requirements: For reporting, all facilities and community programmes providing HTS services
will be required to comply with agreed reporting standards and schedules as well as to comply with the data
flow policy outlined in Figure 11.
Figure 8. Information flow within the HTS Programme
31
11.6 Data quality assurance
To assure the quality of the data that is reported, the district, regional and national level DHIS officers should
select sites to be visited for data verification every quarter. A data verification tool should be developed to
assist in this process.
32
12 SUPPLYCHAIN
12 SUPPLY CHAINMANAGEMENT
MANAGEMENT
Procurement processes and procedures should be rigorous enough to minimise stockouts of rapid test kits
and other testing commodities. This is essential for ensuring the quality of HTS.
12.1 Forecasting
Accurate forecasting is necessary to ensure adequate and ongoing supply of HIV test kits and other
consumables. Forecasting for HIV rapid test kits should be based on the programme’s capacity to provide
HIV testing.
The province and district authority should ensure proper adherence to inventory management protocols,
including maintenance of quality records, timely reporting, accurate forecasting and adequate supply of tests
and other essential commodities, in order to prevent the disruption of HTS service provision.
12.2 Procurement of rapid test kits

Rapid HIV test kits procured through the national tender shall be used in the public health sector and in other
sectors where testing is undertaken.
12.3 Storage of HIV test supplies

Rapid test kit quality assurance standards must be followed. Refer to the Guidelines for Assuring the Accuracy
and Reliability of HIV Rapid Testing: Applying a Quality System Approach, national Department of Health,
2009.
12.4 Distribution
Distribution of test kits shall follow quality assurance standards.
12.5 Stockouts
To avoid stockouts, proper forecasting shall be done.
12.6 Human resources

HTS sites should have adequate human resources including trained professional health workers, HIV and
AIDS counsellors or community health workers and other support staff to provide the required services.
Service providers should ensure a safe working environment for all healthcare staff.
HTS must be carried out by trained healthcare providers, community health workers or counsellors, working
under the supervision of a suitably trained professional health worker. Counsellor training should be
conducted according to the National Minimum Standards for Counselling and Testing. HTS counsellors shall
have appropriate training on counselling of children.
A counsellor working in facilities should counsel a minimum of five clients a day, while a minimum of ten
clients should be reached per day when doing outreach.
12.7 HTS training requirements

The HTS training curricula must be standardised and aligned to the national Department of Health HTS
curricula. HTS training shall be made available to all persons providing HTS in healthcare facilities, stand-
alone, mobile/outreach, home-based or workplace HTS settings.
12.7.1 Qualifications of HTS providers
HTS providers should at a very minimum, have the following qualifications:
• matric or equivalent
• national Department of Health-aligned HTS training. HTS training provides skills development on
counselling, rapid testing and quality assurance. The rapid test training must include a competency
component to ensure providers are proficient at conducting rapid tests.
33
12.7.2 Certification and recertification
Certification: Persons completing nationally approved HTS curricula will receive competency certificates
upon completion of the course by recognised training institutions.
It is the responsibility of healthcare workers to register with the Health Professions Council of South Africa
(HPCSA) and present their HTS training certificates for licensing purposes. Workers who are not engaged in
public healthcare are not required to register with the council at this time, but should be prepared to do so, as
this requirement may change in the future.
Refresher training: Periodic refresher training is necessary to ensure that HTS providers have the most
accurate up-to-date information and that they are able to deliver high-quality HTS.
Persons conducting HTS should receive refresher training every 24 months and be recertified as HTS
providers. Persons who have not conducted HTS for more than 12 months are required to be recertified
before they begin practicing HTS again. Persons who have not provided HTS for more than 24 months are
required to be retrained and issued with a new certificate of competency.
34
13 CONCLUSION
13 CONCLUSION
The aim of the National HIV Testing Services: Policy and Guideline, 2016 is to provide a national framework to
direct the provision of HTS to children, youth and adults in the public and private sectors in South Africa. The
main purpose of these policy guidelines are to ensure better quality and greater consistency of the delivery of
the many elements of counselling and testing. For these guidelines to take root and to have meaning in the
lives of clients who access and ultimately use HTS services, all service providers, programme planners and
policy makers must commit and adhere to the spirit and intention underlying these policy guidelines. We need
not only collective commitment, but also consistent implementation of the policy if we are to achieve greater
quality and improved standardisation of HTS across the country.
35
14 REFERENCES
14 REFERENCES
1. Kenya. Ministry of Public Health and Sanitation. National AIDS and STI Control Programme (NASCOP).
National Guidelines for HIV Testing and Counselling in Kenya Nairobi NASCOP 2008. Available from:
http://www.who.int/hiv/topics/vct/policy/KenyaGuidelines_Final2009.pdf.
2. Namibia. Ministry of Health and Social Services. National Guidelines for HIV Counselling and Testing
in the Republic of Namibia. Windhoek: Ministry of Health and Social Services 2010. Available from:
www.aidsspace.org/getDownload.php?id=1973.
3. Shisana O., Rehle, T., Simbayi L.C., Zuma, K., Jooste, S., Zungu N., Labadarios, D.,Onoya, D. et
al, 2014South African National HIV Prevalence, Incidence and Behaviour Survey, 2012. Cape Town
HSRC Press; 2014 Available from: http://www.hsrc.ac.za/en/research-data/view/6871.
4. South Africa. National Department of Health. Guidelines for Assuring the Accuracy and Reliability
of HIV Rapid Testing: Applying a Quality System Approach. Pretoria: National Department of
Health 2009. Available from: http://policyresearch.limpopo.gov.za/bitstream/handle/123456789/897/
Guidelines%20for%20assuring%20the%20accuracy%20and%20reliability%20of%20HIV%20
rapid%20testing,.pdf?sequence=1.
5. South Africa. National Department of Health. Guidelines for Good Practice in the Conduct of Clinical
Trials with Human Participants in South Africa Tshwane South Africa. National Department of Health.
; 2006 January 2013. Available from: www.kznhealth.gov.za/research/guideline1.pdf.
6. South Africa. National Department of Health, 2014. National Consolidated Guidelines for the
Prevention of Mother-to-Child Transmission of HIV (PMTCT) and the Management of HIV in Children,
Adolescents and Adults, 2014. Available from: http://www.sahivsoc.org/upload/documents/HIV%20
guidelines%20_Jan%202015.pdf
7. Uganda. Ministry of Health. Uganda National Policy Guidelines for HIV Counselling and Testing
Kampala: Ministry of Health 2005. Available from: http://www.who.int/hiv/pub/guidelines/uganda_art.
pdf.
8. UNAIDS. UBRAF thematic report: reducing sexual transmission. Geneva UNAIDS; 2014. Available
from: https://results.unaids.org/sites/default/files/documents/A1_Reducing_sexual_transmission_
Oct2014_final.pdf.
9. UNHCR, WHO, UNAIDS. Policy Statement on HIV Testing and Counselling for Refugees and other
persons of concern to UNHCR. Geneva United Nations High Commissioner for Refugees; 2014.
Available from: http://www.unhcr.org/53a816729.pdf.
10. World Health Organization. Consolidated Guidelines on HIV Testing Services. Geneva WHO; 2015.
Available from: http://www.who.int/hiv/pub/guidelines/hiv-testing-services/en/.
11. World Health Organization. Module 4: HIV Testing Strategies and Algorithms; 2005. Available from:
http://www.who.int/diagnostics_laboratory/documents/guidance/pm_module4.pdf.
36
37
National Department of Health
Civitas Building
Cnr Thabo Sehume and Struben Streets
Pretoria
0001
Switchboard: 012 395 8000
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HIV TESTING SERVICES: POLICY, 2016

Prepared by the national Department of Health

A long and Healthy Life for All South Africans

4 SERVICE DELIVERY APPROACHES................................................................................................... 13

8.2.1 Re-testing during the window period..................................................................................... 31

Table 1. Recommended frequency of testing................................................................................................. 32

Figure 1. HTS continuum of care....................................................................................................................... 3

Recent new South African and international guidelines and

ABBREVIATIONS AND ACRONYMS

PMTCT Prevention of mother-to-child transmission

• counselling (pre‐test information and post-test counselling)

1.2 Rationale for an HTS Policy

1.3 Goals and objectives

1.4 Target audience

1.5 Guiding principles

1.5.1 A rights-based approach

1.5.2 The 5Cs

Confidentiality: Discussions between the HTS provider and the client

1.5.3 HTS continuum of care

Figure 1. HTS continuum of care

2.1 Human rights and rights to access

2.1.1 Promoting equality for vulnerable groups

2.1.3 Availability of HTS services

2.1.5 Challenging discrimination

2.2 Right to dignity and non discrimination

2.2.2 Right to refuse HIV testing

Clients have the right to refuse HIV testing, without

2.3 Informed consent

2.4 The Children’s Act

A. Children may only be tested for HIV in two circumstances:

This provision protects children against discriminatory or arbitrary HIV testing.

B. Consent for HIV testing for children may be given:

· by a child younger than 12 years if he or she has “sufficient maturity”

C. Counselling during HIV testing among children:

D. No person may disclose a child’s HIV status without consent

This provision aims to ensure that a child’s right to confidentiality is protected.

3 NORMS AND STANDARDS

3.2 Operational requirements for community-based HTS services

3.2.1 Facility safety and security

Procedures for handling biohazards should include:

4.1 HTS: Approaches and settings

Figure 2. Service delivery platforms

4.2 HTS in health facilities

4.2.2 Client-initiated counselling and testing (CICT)

4.3 HTS approaches used in the community setting

4.3.2 Home-based HTS

4.5 HTS in clinical trial/research settings

5.1 Infants and children

• early infant diagnosis (EID) for all HIV-exposed infants

5.2 Adolescents and young women

Groups of adolescents who need to be considered are:

5.3 Pregnant women

5.4 Couples and partners

5.6 Healthcare providers and workers exposed to HIV

5.7 Survivors of sexual assault

5.9 Migrant and mobile populations

5.10 Populations abusing alcohol and other drugs

5.11 Key populations

6.3 Pre-test information