December 1st marks the 35th year of commemorating World AIDS Day, an annual, global event to honor those we have lost to HIV and rally towards a day when HIV is no longer a public health threat. In line with the spirit of the day, this year’s theme, “Remember and Commit,” compels us to only reflect on the breakthroughs by scientists, industry, patients, and advocates that have transformed a once fatal disease into a treatable chronic condition. This year’s theme also challenges us to think about how we can take more collective responsibility towards a more equitable world of HIV prevention and care
For a clinical research network like the Adolescent Medicine Trials Network for HIV Interventions (ATN) that is specifically dedicated to addressing HIV among adolescents and young adults (AYA) ages 13-24 since 2001, we have a variety of accomplishments to remember and challenges to commit to across multiple fronts:
- Continuing to innovate HIV treatment to improve HIV care outcomes (e.g. viral suppression);
- finding ways to use technology to make learning about HIV and sexual health more accessible;
- and refining interventions to address the needs and concerns of trans and non-binary youth.
One of our most salient topics for today’s World AIDS Day commemoration is the development, approval, and continued improvement of pre-exposure prophylaxis (PrEP) for HIV prevention among adolescents and young adults (AYA) in the U.S.
Background on providing PrEP for Adolescents
PrEP is a medication that when taken as prescribed prevents the transmission of HIV, offering individuals a unique and effective tool to use in conjunction with other safer sex practices. The first medication approved for daily oral PrEP was Truvada, an antiretroviral medication initially prescribed for the treatment of HIV. At first, prescription of Truvada as PrEP was limited to adults who were behaviorally likely to acquire HIV (e.g. condomless sex, injection drug use).
It wasn’t until 2018 that PrEP was approved for an important population with a disproportionately high rate of HIV diagnosis: adolescents. While doctors in the US could prescribe approved drugs as they deemed appropriate and had been providing PrEP off-label for teens in some cases, the approval represented a significant milestone for improved HIV prevention. The approval of PrEP for adolescents not only increased the availability and affordability of PrEP by making it easier to obtain insurance coverage, but also allowed prescribers to feel confident in the safety and tolerability of PrEP for sexually active youth.
One of the key factors for the approval of PrEP for adolescents was the emergence of clinical trial data demonstrating that PrEP was as effective and safe among adolescents and young adults as among adults. Studies like ATN 113 PrEPare demonstrated that adolescents also did well on PrEP with a key distinction: they might need more frequent monitoring and support to ensure appropriate medication adherence.
About the study ATN 113 PrEPare
Building off of ATN 110, a previous study for young adults ages 18 to 22, ATN 113 assessed the safety and acceptance of Truvada PrEP among young sexual minority men (YSMM) ages 15 to 17 in six US cities. Participants received once-daily Truvada with HIV prevention counseling and adherence support over the course of 12 months. The first three follow-up visits were a month apart and extended to every three months after that. To see how well participants were sticking to their PrEP regimen, medication levels were measured using dried blood spot sampling.
Here are some of the key findings of ATN 110
- Three study participants acquired HIV during the study, twice the rate seen among young adults in ATN 110.
- Side effects were minor and similar to those seen in adults taking Truvada. One of the main medications in Truvada can sometimes cause kidney toxicity and bone loss. Observed bone loss usually stabilized after a year and began to recover after stopping the drug.
- Adherence was good within the first 3 months of the study; 55-60% of participants had protective medication levels, indicating they were dosing at least 4 times a week.
- However, adherence steeply dropped off at the 3-month mark; only 28-31% of participants had protective medication levels for the remainder of the study. The main reasons for missing a dose included being away from home (31%), too busy (27%) forgetting (25%), and changing routines (18%). Participants who indicated concern about being seen as having HIV or having sex with other men were also more likely to struggle with adherence.
Overall, ATN 113 managed to assuage concerns about how safe it would be to prescribe PrEP to adolescents, yet it brought attention to something that might not surprise providers, researchers, and other individuals familiar with development psychology: adolescents struggled to take a daily oral medication in the long run.
Adolescence is an exciting time for development that also comes with specific health-related needs. Adolescents are unique in that their prefrontal cortex (controls cause/effect, self-regulation) is still developing until their mid-twenties and might need more support with executive function, decision-making, and processing information. At the same time, adolescents also have many strengths because of their developing brains, such as having an increased capacity for learning, desire for social interaction, and testing out newfound independence.
For this reason, ATN 113 underscores the importance of investing in developmentally appropriate strategies to support how adolescents take PrEP. For example, this might mean having “enhanced” medical appointments with more opportunities to learn and talk about PrEP with a provider or counselor. Another strategy might be using mobile technology with a variety of tools to support adolescents’ daily needs, such as medication trackers, educational resources about PrEP and sexual health, and peer-to-peer coaching.
Jumping to Today
According to recent CDC data on HIV among adolescents and young adults (AYA), there has been significant progress in decreasing HIV diagnoses in adolescents. Between 2017 and 2021, there was a 34% decrease in new diagnoses among people aged 13 to 24, mostly gay and bisexual cisgender men. The number of PrEP prescriptions among 16 to 24 year olds who could benefit from PrEP also increased from 8 to 20% in this same period.
Nonetheless, there are still a number of challenges that remain for addressing disparities for HIV prevention among f AYA. When it comes to the decrease in HIV diagnoses, white AYA saw a larger decrease (45%) than Black AYA (27%). Similar racial disparities are seen when it comes to PrEP prescriptions. 78% of white people eligible for PrEP were prescribed it in 2021 compared to their Latine (21%) or Black (11%) counterparts. Other examples of key issues are related to disparities in geographic access to PrEP services, insurance coverage, or safe and affirming medical environments. Deeply entrenched social determinants of health (e.g. quality of public transportation, accessibility of healthcare services, and serophobia) cause and exacerbate many of these disparities and their outcomes.
As amazing as the advent of PrEP was for the HIV prevention landscape, it is still important to remind ourselves that we have a long way to go to meet federal Ending the HIV Epidemic goals for PrEP uptake and adherence. For the ATN, this means continuing to invest in developing and refining a variety of biological, behavioral, and technological interventions to support AYA looking to start and stay on PrEP.
Still more broadly, Sybil Hosek, the principal investigator of ATN 113 and foundational leader within the ATN, put it best when she presented ATN 113 results in 2016: “Young people may need more time, and we need to give it to them. If they want PrEP, we need to help them make it work.”