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The Acceptability and Feasibility of an HIV Preexposure Prophylaxis (PrEP) Trial With Young Men Who Have Sex With Men

Hosek, Sybil G. PhD*; Siberry, George MD; Bell, Margo MD; Lally, Michelle MD, MSc§; Kapogiannis, Bill MD; Green, Keith MSW*; Isabel Fernandez, M. PhD; Rutledge, Brandy PhD; Martinez, Jaime MD*; Garofalo, Robert MD#; Wilson, Craig M. MD**the Adolescent Trials Network for HIVAIDS Interventions (ATN)

JAIDS Journal of Acquired Immune Deficiency Syndromes: April 1st, 2013 - Volume 62 - Issue 4 - p 447–456
doi: 10.1097/QAI.0b013e3182801081
Epidemiology and Prevention

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 preexposure prophylaxis (PrEP).

Methods: 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.

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%), 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.

Conclusions: 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.

*Department of Psychiatry, John Stroger Hospital of Cook County, Chicago, IL

Maternal and Pediatric Infectious Disease Branch, NICHD/PAMAB, Bethesda, MD

Department of Pediatrics, John Stroger Hospital of Cook County, Chicago, IL

§Department of Medicine, Alpert Medical School of Brown University, Providence, RI

Department of Osteopathic Medicine, Nova Southeastern University, Ft. Lauderdale, FL

Westat, Rockville, MD

#Department of Pediatrics, Children’s Memorial Hospital, Chicago, IL

**Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL.

Correspondence to: Sybil G. Hosek, PhD, Department of Psychiatry, John Stroger Hospital of Cook County, 1900 W Polk Street, Room 854, Chicago, IL 60612 (e-mail: shosek@cookcountyhhs.org).

Supported by the grant U01 HD040533-06 from the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Development with supplemental funding from the National Institute on Drug Abuse and National Institute of Mental Health.

The authors have no conflicts of interest to disclose.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jaids.com).

Received June 12, 2012

Accepted November 15, 2012

© 2013 Lippincott Williams & Wilkins, Inc.