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

TitleAn HIV Preexposure Prophylaxis Demonstration Project and Safety Study for Young MSM.
Publication TypePublication
Year of Publication2017
AuthorsHosek SG, Rudy B, Landovitz R, Kapogiannis B, Siberry G, Rutledge B, Liu N, Brothers J, Mulligan K, Zimet G, Lally M, Mayer KH, Anderson P, Kiser J, Rooney JF, Wilson CM
Corporate AuthorsAdolescent Trials Network(ATN) for HIVAIDS Interventions
JournalJ Acquir Immune Defic Syndr
Date Published2017 01 01
KeywordsAdolescent, Anti-HIV Agents, Cities, Disease Transmission, Infectious, HIV Infections, Homosexuality, Male, Humans, Male, Medication Adherence, Patient Acceptance of Health Care, Pre-Exposure Prophylaxis, United States, Young Adult

<p><b>BACKGROUND: </b>Young men who have sex with men (YMSM) are a key population for implementation of preexposure prophylaxis (PrEP) interventions. This open-label study examined adherence to PrEP and assessed sexual behavior among a diverse sample of YMSM in 12 US cities.</p><p><b>METHODS: </b>Eligible participants were 18- to 22-year-old HIV-uninfected MSM who reported HIV transmission risk behavior in the previous 6 months. Participants were provided daily tenofovir disoproxil fumarate/emtricitabine (Truvada). Study visits occurred at baseline, monthly through week 12, and then quarterly through week 48. Dried blood spots were serially collected for the quantification of tenofovir diphosphate (TFV-DP).</p><p><b>RESULTS: </b>Between March and 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). Diagnosis of sexually transmitted infections, 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 per week. By week 48, 34% of participants had TFV-DP levels consistent with ≥4 pills per 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.</p><p><b>CONCLUSIONS: </b>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 United States may need PrEP access in youth-friendly settings with tailored adherence support and potentially augmented visit schedules.</p>

Alternate JournalJ. Acquir. Immune Defic. Syndr.
PubMed ID27632233
PubMed Central IDPMC5140725
Grant ListU01 HD040474 / HD / NICHD NIH HHS / United States
U01 HD040533 / HD / NICHD NIH HHS / United States
U01 HD068040 / HD / NICHD NIH HHS / United States