Preexposure prophylaxis (PrEP) was first approved by the FDA in 2012, but only for use among adults. An indication was added in 2018 for its use among adolescents.
Combination preexposure prophylaxis (PrEP) of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) was first approved by the FDA in 2012, but only for use among adults. Knowing that at-risk adolescents could also benefit from the preventive therapy, the FDA expanded the indication in 2018 to include those in this age category who weigh at least 77 lb. This was followed in 2019 by approval of tenofovir alafenamide (TAF)/FTC for use as PrEP in adults and adolescents—excepting individuals whose risk for HIV comes from receptive vaginal sex because of little evidence on its effectiveness among cisgender women.
According to the latest Morbidity and Mortality Weekly Report (MMWR) from the CDC, promoting the use of PrEP among adolescents must be undertaken with caution. Not because there could be pushback, but because certain additional considerations are necessary due to the younger ages and because HIV-positive adolescents are at greater risk for medication nonadherence and viral rebound. The top considerations include PrEP safety data, legal issues (eg, consent, confidentiality), therapeutic partnership, clinical visit approach for prevention services, and medication initiation, adherence, and persistence.
“Current evidence indicates that many adolescents are not aware of PrEP, and many do not know how they could access PrEP if needed,” the MMWR report states. “Clinicians should be prepared to address and support medication adherence as a routine part of prescribing PrEP.”
The Top Considerations
To start, healthcare providers need to make adolescents aware of PrEP safety data. TDF/FTC is proven safe, but trials among adults have resulted in such adverse effects as headache, fatigue, decreased bone mass, and abdominal pain. All are possible in adolescents; however, the younger group also faces the possibility of mild bone toxicity, skin hyperpigmentation, and anemia. TAF/FTC as PrEP safety, efficacy, and adherence data are not available because clinical trials have not evaluated those measures among adolescents. The FDA approval stems from the DISCOVER adult trial.
The top legal issues focus on consent, status as a legal minor, and confidentiality. Although the exact legal framework is different from state to state, minors can autonomously request PrEP in all states. “All states have statutes, regulations, or both that explicitly allow certain minors to consent to STI diagnosis and treatment,” the report notes. However, this does not mean confidentiality carries throughout the care process. Twenty-three states have mandatory reporting requirements to parents or guardians when minors access PrEP care.
The therapeutic partnership centers on allowing for adolescent autonomy, but involving parents or guardians as needed, because one of the biggest challenges in discussing PrEP with adolescents is reconciling their wish to be independent but knowing their parents or guardians may not be ready for that—especially when study results show that the more involved parents are, the less likely their adolescent children are to engage in risky behavior. On the flip side of this is that time alone equates to receipt of more sexual health services. Effective counseling is key, and for this, the US Preventive Services Task Force recommends presenting several options: one-on-one talks, videos, written materials, or telephone support.
Most important in the clinical visit approach for prevention services is tailoring these visits to adolescents to make it easiest for them to open up. Getting a medical history that also covers social and sexual history best helps “at identifying adolescents’ health needs and providing individualized recommendations and counseling.” Additional suggestions include healthcare providers speaking with adolescents alone, in cases where their parents are present; using the HE2ADS3 approach, which asks about home, education or employment, eating, peer-related activities, drugs, sexuality, suicide or depression, and safety; or utilizing the 5 Ps method that involves questions about partners, practices, STI protection, past history of STIs, and pregnancy prevention.
The best way for healthcare providers to assist with PrEP medication initiation, adherence, and persistence is to address potential barriers, especially those related to cost. For this, the MMWR report recommends screening for sociodemographic and behavioral influences (eg, housing, drug use, mental health issues) because it allows healthcare providers to suggest more targeted resources. Other ideas include enhanced counseling, feedback, text message reminders, more flexible clinic hours, and adherence buddies.
“PrEP is a safe and effective intervention to reduce the risk for HIV acquisition,” the report concludes. “Adolescents should be screened for behaviors that put them at risk for acquiring HIV. In adolescents for whom PrEP is indicated, PrEP can be offered as part of a comprehensive approach tailored to their specific needs.”
Tanner MR, Miele P, Carter W, et al. Preexposure prophylaxis for prevention of HIV acquisition among adolescents: clinical considerations, 2020. MMWR Recomm Rep. 2020;69(3):1-12. doi: 10.15585/mmwr.rr6903a1.