Preventing Hiv Infection in High-Risk Adolescents Using Preexposure Prophylaxis (Prep)

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Practice Brief

Preventing HIV Infection in High-Risk


Adolescents Using Preexposure
Prophylaxis (PrEP)
Christopher W. Blackwell, PhD, ARNP, ANP-BC, AGACNP-BC, CNE, FAANP*

Key words: adolescent men who have sex with men of PrEP in combination with risk-reduction behaviors
(AMSM), bisexual, HIV, homosexual, PrEP could reduce HIV infection significantly (Baeten
et al., 2012; Blackwell, 2014; Grant et al., 2010).
Preexposure prophylaxis (PrEP) has emerged as a Data from the Preexposure Prophylaxis Initiative
major tool in the prevention of HIV infection. Appro- and the tenofovir disoproxil fumarate and
priate use of once-daily emtricitabine 200 mg and te- emtricitabine studies showed that HIV infection was
nofovir disoproxil fumarate 300 mg (TruvadaÒ; reduced by 90% when patients appropriately
Gilead, Foster City, CA) in combination with safer adhered to PrEP and were also provided with a
sex activities significantly reduces the risk of HIV prevention program including providing condoms,
infection. Trials initially supported efficacy of PrEP screening for HIV each month, and educating about
in adults, prompting its approval for adult use by reducing risk (Centers for Disease Control and
the U.S. Food and Drug Administration (FDA) in Prevention [CDC], 2012; 2013).
July 2012 (Gilead, 2018). Due to growing data sug- Other studies have also supported PrEP as an
gesting PrEP as beneficial in preventing HIV in effective tool in the prevention of HIV in special
high-risk adolescents, the FDA approved it for pre- high-risk populations. For example, while the tenofo-
vention of HIV in this patient population in May vir disoproxil fumarate and emtricitabine; Partners
2018 (Gilead, 2018; Smart 1 Strong, 2018). The PrEP; Preexposure Prophylaxis Trial for HIV Preven-
purpose of this article is to discuss the use of PrEP tion among African Woman; Phase 2 Trial of Preex-
to prevent HIV infection in high-risk adolescents. posure Prophylaxis with Tenofovir Among Women in
Topics covered include a review of the data sup- Ghana, Cameroon, and Nigeria; and Vaginal and Oral
porting PrEP as effective in adults and adolescents, Interventions to Control the Epidemic trials all sup-
reaching the decision to initiate PrEP in adolescents, ported the efficacy of the regimen among heterosex-
sexual history-taking considerations, and initiating ual men and women, the Preexposure Prophylaxis
and monitoring PrEP in this group of vulnerable Initiative and U.S. Men Who Have Sex with Men
individuals. Safety Trials focused on the effectiveness of PrEP
in men who have sex with men (MSM; U.S. Public
Health Service, 2014). In addition, the Bangkok
Support for PrEP in Adults in Clinical Trials
Christopher W. Blackwell, PhD, ARNP, ANP-BC,
The FDA approved the once-daily use of Tru-
AGACNP-BC, CNE, FAANP, is an Associate Professor
vadaÒ to prevent HIV in high-risk adults in July and the Program Director, Adult-Gerontology Acute Care
2012 (U.S. Department of Health and Human Nurse Practitioner Programs, Department of Nursing
Services, 2012). Known as preexposure prophylaxis Practice, College of Nursing, University of Central Flor-
(PrEP), efficacy of the regimen was supported by ida, Orlando, Florida, USA. (*Correspondence to:
several clinical trials that suggested appropriate use Christopher.blackwell@ucf.edu).

JOURNAL OF THE ASSOCIATION OF NURSES IN AIDS CARE, Vol. -, No. -, -/- 2018, 1-5
https://doi.org/10.1016/j.jana.2018.06.001
Copyright Ó 2018 Association of Nurses in AIDS Care
2 JANAC Vol. -, No. -, -/- 2018

Tenofovir Study emphasized PrEP as an effective tool the United States (CDC, 2018). Because 81% of these
to prevent HIV infection in injecting drug users (U.S. diagnoses occurred in AMSM, these adolescents
Public Health Service, 2014). were identified as being especially affected (CDC,
2018). AMSM have a number of factors that place
them at higher risk for HIV infection, including
Support for PrEP in Adolescents in Clinical high numbers of sexual partners, condomless sex,
Trials and use of alcohol/drugs during sex (Goodreau
et al., 2018). Just 4% of infections resulted from het-
Very few inquiries have been devoted to evaluating erosexual contact, and even fewer (3%) were from
the efficacy of PrEP in the adolescent patient popula- male-to-male sexual contact in combination with
tion. A review by Hosek and colleagues (2016) of the intravenous drug use or intravenous drug use alone
small number of studies being conducted across the (1%; CDC, 2018). Among infected AMSM, 54%
United States and South Africa indicated likelihood were African American; Hispanic/Latino AMSM
that PrEP would make a positive impact on popula- made up 25% of these diagnoses, while White
tion HIV incidence in adolescents. Goodreau and col- AMSM accounted for 16% (CDC, 2018). Between
leagues (2018) echoed similar assumptions. In their 2011 and 2015, rates of infection remained stable in
modeled study, these scholars found ‘‘PrEP can African American and White AMSM, but rose by
have a large impact on HIV incidence among adoles- 19% among young Hispanic/Latino AMSM while
cent sexual minority males in the United States, espe- dropping 25% in young women (CDC, 2018).
cially in settings with high prevalence’’ (Goodreau The May 2018 expanded indication for PrEP by
et al., 2018, p. 312). A major component of the study the FDA to include adolescents was largely devoid
used in the modeling procedure by Goodreau and col- of specific guidelines about which adolescents the cli-
leagues (2018) was the Adolescent Medicine Trials nicians should consider as appropriate for PrEP ther-
Network (ATN) 113 trial. The results of this trial apy, with Gilead (2018) distinctly indicating PrEP for
prompted the May 2018 FDA expansion of approval at-risk adolescents in their press release regarding the
for PrEP to include adolescents (Gilead, 2018; new expanded indication. Modeling research by
Rosenberg, 2018). Goodreau and colleagues (2018) predicted the effi-
ATN 113 focused on 78 uninfected individuals cacy of PrEP, specifically in AMSM, which was
with an average age of 16.5 years. Thirty-three appropriate given the most recent incidence data on
percent of participants were mixed race, 29% were HIV infections provided by the CDC (2018). The re-
Black, 21% were Latino, 14% were White, and 3% searchers recommended targeting 16- to 18-year-old
were Asian or Pacific Islander (Smart 1 Strong, AMSM (Goodreau et al., 2018), which would include
2016). Participants consisted of adolescent MSM the FDA-approved ages of 15 to 17 years for PrEP.
(AMSM) who were at higher risk for sexually trans- Other risk factors identified as appropriate for initia-
mitted diseases (STDs). Most participants disclosed tion of PrEP in adults (Blackwell, 2014) that might be
they had engaged in unprotected anal intercourse dur- applicable to adolescents include being the unin-
ing the study; and 15.4% were diagnosed and treated fected partner of a person living with HIV, having
for STDs during the 48-week trial (Smart 1 Strong, multiple sex partners regardless of sexual orientation,
2016). At the study’s conclusion, three had contracted participation in sex work, use of illicit substances,
HIV, yielding a 6.41% HIV infection rate per year and failure to use condoms consistently during sex.
(Smart 1 Strong, 2016). State regulations related to consent for preventa-
tive services and treatment in these persons is an
important factor to consider when choosing to initiate
Reaching the Decision to Initiate PrEP in PrEP in non-adult populations (Culp & Caucci,
Adolescents 2013). Clinicians should research their state regula-
tions that stipulate how minors are defined and
In 2016, individuals between the ages of 13 and what consents they are able to legally provide. Culp
24 years made up 21% of all new HIV diagnoses in and Caucci (2013) specifically focused on issues
Blackwell / Preventing HIV Infection in High-Risk Adolescents Using PrEP 3

related to consent when initiating PrEP in adolescents confirm a creatinine clearance of at least 60 mL/
in their study. Unfortunately, their work yielded little min using the Cockgroft-Gault formula, assess status
direction for clinicians and suggested more research of care in partners with HIV (providing necessary
is needed to determine the legality of providing referral as needed), screen for hepatitis B virus
PrEP to minors without parental consent throughout (HBV) and initiate appropriate treatment (as needed),
the country. document a patient weight of at least 35 kg, and
screen for and treat any STDs. In addition, females
must have a documented negative urine pregnancy
Sexual History Taking: Implications in test and acknowledge understanding that there are
Adolescents few data assessing the risk of using PrEP during preg-
nancy. Females who are breastfeeding should not be
Obtaining a sexual health history from an adoles- prescribed PrEP (Blackwell, 2014; Gilead, 2018).
cent is vital. Data have demonstrated improved The PrEP regimen consists of one daily emtricita-
screening and clinical outcomes in adolescents who bine 200 mg and tenofovir disoproxil fumarate
were asked about sexual history by their providers 300 mg (TruvadaÒ) tablet taken with or without
(Goyal, McCutcheon, Hayes, & Mollen, 2011; food. In addition to this prescription, clinicians
Ouelette, Wingelear, Peterson, Emery, & Jones, need to ensure proper education about consistent
2018). In addition, surveys have indicated that 45% use of condoms during every sexual encounter.
of 15- to 19-year-olds have had vaginal sex with an Providing condoms directly to patients has also
opposite sex partner, while 2.5% of males in this been found to be beneficial (CDC 2012; 2013). It is
age category have had anal or oral sex with other paramount that adolescents understand that PrEP
males and 11% of females in this age range have does not exclude the importance of consistent
had sexual activities with other females (Marcell & condom use and provides no protection against
Burstein, 2017). Unfortunately, research has shown other STDs (Gilead, 2018).
a great amount of inconsistency by clinicians in ob- An important distinction between follow-up in
taining a sexual history during adolescent health adults compared to adolescents relates to frequency.
care encounters (Goyal et al., 2011; Riese, Tarr, While it is recommended that adults follow up with
Baird, & Alverson, 2018; Sargant, Smallwood, & their providers every 3 months while on PrEP
Finlay, 2014). (Blackwell, 2014), adolescents may need more
All 50 states allow minors to consent for screening frequent follow-up (Gilead, 2018; Rosenberg, 2018;
of STDs (Marcell & Burstein, 2017), and the Amer- Smart 1 Strong, 2016; 2018). This is because a
ican Academy of Pediatrics recommends that clini- major finding from the ATN 113 study was poor
cians provide ‘‘confidential time during health adherence by adolescents, particularly as the time
maintenance visits to discuss sexuality, sexual health between follow-up visits increased. As reported by
promotion, and risk reduction’’ (Marcell & Burstein, Smart 1 Strong (2016):
2017, p. 2). Clinicians should make no assumptions Overall, adherence dropped considerably once
about any adolescent’s sexual history. Adolescents the study switched from monthly to quarterly
should be asked directly about sexual activities with clinic visits. At weeks 4, 8, 12, 24, 36, and 48,
men, women, or both; frequency of condom use dur- the proportion of the participants who took at
ing oral, vaginal, and anal sexual activities; use of least four tablets of Truvada per week according
alcohol or drugs during sex; and history of sex to dried blood spot testing was a respective
work (Blackwell, 2014; Goyal et al., 2011). 60%, 52.4%, 55%, 31.5%, 22.7%, and
28.21%. Previous research has found that taking
Initiating and Monitoring PrEP Truvada four or more times per week confers
maximum protection against HIV. ({ 9)
Before initiating PrEP therapy, clinicians need to Thus, monthly visits by adolescents on PrEP may
document a negative HIV antibody screening test, be indicated (Smart 1 Strong, 2016). The safety
4 JANAC Vol. -, No. -, -/- 2018

profile of TruvadaÒ for adolescents is similar to that influence on the overall national incidence of HIV
of adults, with headache, abdominal pain, and weight infection in the near future.
loss being the most frequently reported adverse
events (Gilead, 2018). Bone mineral density loss, a
far less frequently reported adverse event, occurred Disclosures
in four patients enrolled in the ATN 113 study
(Gilead, 2018). The author reports no real or perceived vested in-
Patients should be screened for HIVevery 3 months terests that relate to this article that could be
and PrEP should be immediately discontinued if a pa- construed as a conflict of interest.
tient tests positive for HIV (Gilead, 2018). Finally,
exacerbations of HBV infections have been found
in patients infected with HBV after discontinuation References
of PrEP. Thus, patients with HBV will need close
monitoring of liver function assays for several Baeten J. M., Donnell D., Ndase P., Mugo N. R., Campbell J. D.,
months after discontinuing therapy (Gilead, 2018). Wangisi J., . Celum C. (2012). Antiretroviral prophylaxis
Other information about prescribing TruvadaÒ, for HIV-1 prevention among heterosexual men and women.
including boxed warnings, other warnings and pre- New England Journal of Medicine, 367(5), 399-410. https://
doi.org/10.1056/NEJMoa1108524
cautions and adverse events, information on preg- Blackwell C. W. (2014). Preexposure prophylaxis: An emerging
nancy and lactation, and dosage and administration clinical approach to preventing HIV in high-risk adults.
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Healthcare, 39(9), 50-53. https://doi.org/10.1097/01.NPR.
0000452976.92052.fa
Summary and Conclusion Centers for Disease Control and Prevention (CDC). (2012).
Interim guidance for clinicians considering the use of preex-
posure prophylaxis for the prevention of HIV infection in het-
The expanded indication for the use of PrEP in ad- erosexually active adults. Retrieved from https://www.cdc.
olescents is very recent. Therefore, there are no lon- gov/mmwr/preview/mmwrhtml/mm6131a2.htm
gitudinal studies that address the long-term impacts Centers for Disease Control and Prevention (CDC). (2013). CDC
of the use of PrEP in this patient population. None- fact sheet: PrEP: A new Tool for HIV prevention. Retrieved
from http://www.cdc.gov/hiv/prep/pdf/PrEPfactsheet.pdf
theless, advanced practice nurses, physicians, and Centers for Disease Control and Prevention (CDC). (2018). HIV
physician assistants who have the opportunity to pre- among youth. Retrieved from https://www.cdc.gov/hiv/group/
scribe PrEP for adolescents in their clinical practices age/youth/index.html
should be intimately familiar with the regimen. Data Culp L., Caucci L. (2013). State adolescent consent laws and im-
suggest that PrEP is effective and probably cost- plications for HIV pre-exposure prophylaxis. American Jour-
nal of Preventative Medicine, 44(1/2), 119-124. https://doi.
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But clinicians must consider other issues, as dis- Gilead. (2018). US Food and Drug Administration approves
cussed in this article, that are unique to the use of expanded indication for Truvada (emitricitabine and
PrEP in this patient population. These practice points tenofivir disoproxil fumurate) for reducing the risk of
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