The acceptability and feasibility of an HIV preexposure prophylaxis (PrEP) trial with young men who have sex with men.

TitleThe acceptability and feasibility of an HIV preexposure prophylaxis (PrEP) trial with young men who have sex with men.
Publication TypePublication
Year of Publication2013
AuthorsHosek SG, Siberry G, Bell M, Lally M, Kapogiannis B, Green K, M Fernández I, Rutledge B, Martinez J, Garofalo R, Wilson CM
Corporate AuthorsAdolescent Trials Network for HIVAIDS Interventions(ATN)
JournalJ Acquir Immune Defic Syndr
Volume62
Issue4
Pagination447-56
Date Published2013 Apr 01
ISSN1944-7884
KeywordsAdolescent, Adult, Feasibility Studies, HIV Infections, Humans, Male, Pilot Projects, Risk Factors, Young Adult
Abstract

<p><b>BACKGROUND: </b>This study examined the feasibility of a combination prevention intervention for young men who have sex with men (YMSM), an anticipated target population for HIV preexposure prophylaxis (PrEP).</p><p><b>METHODS: </b>Project PrEPare, a pilot study using a randomized 3-arm design, compared an efficacious behavioral HIV prevention intervention (Many Men, Many Voices-3 MV) alone, 3 MV combined with PrEP (tenofovir/emtricitabine), and 3 MV combined with placebo. Eligible participants were 18- to 22-year-old HIV-uninfected men who reported unprotected anal intercourse in the past year. Participants were screened for preliminary eligibility at youth venues and community organizations and were also referred through social networks. Laboratory screening determined final eligibility. Behavioral and biomedical data were collected at baseline and every 4 weeks thereafter for 24 weeks.</p><p><b>RESULTS: </b>Sixty-eight youth (mean age = 19.97 years; 53% African American, 40% Latino) were enrolled; 58 were randomized. Self-reported medication adherence averaged 62% (range, 43%-83%), whereas rates of detectable tenofovir in plasma of participants in the emtricitabine/tenofovir disoproxil fumarate arm ranged from 63.2% (week 4) to 20% (week 24). There were 5 ≥ grade 2 adverse events possibly/probably related to the study medication. Sexual risk behavior declined from baseline to week 24 in all study arms.</p><p><b>CONCLUSIONS: </b>The feasibility of enrolling at-risk youth, particularly young men who have sex with men of color, into Project PrEPare has been demonstrated. The acceptability of the group intervention along with counseling and testing was high. Self-reported medication adherence and corresponding plasma drug concentrations were low indicating the need for enhanced adherence counseling. Exploration of PrEP use among youth in nonrandomized open label trials is warranted.</p>

DOI10.1097/QAI.0b013e3182801081
Alternate JournalJ. Acquir. Immune Defic. Syndr.
PubMed ID24135734
PubMed Central IDPMC3656981
Grant ListU01 HD040515 / HD / NICHD NIH HHS / United States
U01 HD040533 / HD / NICHD NIH HHS / United States
U01 HD040533-06 / HD / NICHD NIH HHS / United States