An HIV Preexposure Prophylaxis Demonstration Project and Safety Study for Young MSM

Abstract

Background Young men who have sex with men (YMSM) are a key population for implementation of PrEP interventions. This open-label study examined adherence to PrEP and assessed sexual behavior among a diverse sample of YMSM in 12 U.S. cities. Methods Eligible participants were 18–22 year old HIV-uninfected MSM who reported HIV transmission risk behavior in the past 6 months. Participants were provided daily TDF/FTC (Truvada®). Study visits occurred at baseline, monthly through week 12, then quarterly through week 48. Dried blood spots (DBS) were serially collected for the quantification of tenofovir diphosphate (TFV-DP). Results Between March-September 2013, 2186 individuals were approached and 400 were found to be preliminarily eligible. Of those 400, 277 were scheduled for an in-person screening visit and 200 were enrolled (mean age=20.2; 54.5% Black, 26.5% Latino). Diagnoses of sexually transmitted infections (STIs), including urethral and rectal chlamydial/gonococcal infection and syphilis, at baseline was 22% and remained high across visits. At week 4, 56% of participants had TFV-DP levels consistent with ≥4 pills/week. By week 48, 34% of participants had TFV-DP levels consistent with ≥4 pills/week, with a noticeable drop-off occurring at Week 24. Four HIV seroconversions occurred on study (3.29/100 person-years). Condomless sex was reported by >80% of participants and condomless anal sex with last partner was associated with higher TFV-DP levels. Conclusions Acceptability of PrEP was high and most participants achieved protective drug levels during monthly visits. As visit frequency decreased, so did adherence. YMSM in the US may need PrEP access in youth-friendly settings with tailored adherence support and potentially augmented visit schedules.

HIV preexposure prophylaxis for adolescents and young adults

“…Some studies have shown that older age is associated with greater adherence as measured by drug levels [8, 10]. Adolescent Trials Network (ATN) 113 and ATN 110—U.S.-based studies that tested the acceptability, safety, and adherence to PrEP among 78 MSM ages 15–17 years and 200 MSM 18–24 years, respectively—show lower adherence among these groups than what has been described in adult studies [14**,15]. In ATN 110, over 90% of participants had some detectable drug level through the first 12 weeks of the study, and over 50% had levels consistent with at least 4 pills per week.…”

“…By week 48, protective levels of drug were detected in only 34% of participants. Racial disparities in adherence were described; median drug levels for black participants were below the protective threshold at all time points [14**]. In ATN 113, the majority of participants reached protective drug levels through 12 weeks, with similar drop off at 24 weeks, when visits became less frequent [15].…”

“…Racial disparities in adherence were described; median drug levels for black participants were below the protective threshold at all time points [14**]. In ATN 113, the majority of participants reached protective drug levels through 12 weeks, with similar drop off at 24 weeks, when visits became less frequent [15]. Early data from PlusPills, an open-label study exploring the acceptability, safety, and use of oral PrEP for HIV-negative youth 15–19 years old in Soweto and Cape Town, South Africa, similarly showed 76% of participants with levels of TDF considered adequate for prevention at 12 weeks [16].…”

Pre-exposure prophylaxis (PrEP) for men who have sex with men in Europe: review of evidence for a much needed prevention tool

“…Adherence to PrEP is essential, and new ways to support MSM in appropriate use of PrEP are much needed (eg, mobile phone applications) 30. Appropriate use of PrEP entails adherence to the daily medication, and correct use of the medication in situations or periods of increased risk for HIV for those following a non-daily regimen.…”

Acute HIV Infection in Youth: Protocol for the Adolescent Trials Network 147 (ATN147) Comprehensive Adolescent Research and Engagement Studies (CARES) Study (Preprint)

“…According to a 2015 surveillance report, the New Orleans Metairie area was ranked 3rd based on rate (per 100,000) of HIV diagnosis [33]. The Adolescent Trials Network (ATN) 110 Study in New Orleans screened a total of 200 gay, transgender, bisexual youth (GTBY) between January and September 2013 and found 9 to be acutely infected, demonstrating the magnitude of the problem in this population [35].…”