The Acceptability and Feasibility of an HIV Pre-Exposure Prophylaxis (PrEP) Trial with Young Men who Have Sex with Men (YMSM).

1John Stroger Hospital of Cook County, Chicago, IL 2NICHD/PAMAB, Bethesda, MD 3Lifespan Hospital System and Brown Medical School, Providence, RI 4Nova Southeastern University, Ft. Lauderdale, FL 5Westat, Rockville, MD 6Children's Memorial Hospital, Chicago, IL 7University of Alabama at Birmingham, Birmingham, AL.
JAIDS Journal of Acquired Immune Deficiency Syndromes (Impact Factor: 4.39). 12/2012; DOI: 10.1097/QAI.0b013e3182801081
Source: PubMed

ABSTRACT BACKGROUND:: 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 pre-exposure prophylaxis (PrEP). METHODS:: Project PrEPare, a pilot study using a randomized 3-arm design, compared an efficacious behavioral HIV-prevention intervention (3MV) alone, 3MV combined with PrEP (tenofovir/emtricitabine), and 3MV combined with placebo. Eligible participants were 18-22 year old HIV-uninfected men who reported unprotected anal intercourse (UAI) 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. RESULTS:: 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%) while rates of detectable tenofovir in plasma of participants in the FTC/TDF 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. CONCLUSIONS:: The feasibility of enrolling at risk youth, particularly YMSM 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 non-randomized, open label trials is warranted.

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