HPTN 061 was a multi-site study conducted in Atlanta, Boston, Los Angeles, New York City, San Francisco, and Washington, DC to determine the feasibility and acceptability of a multi-component HIV prevention intervention for Black MSM.
From July 2009 to October 2010, men were recruited directly from the community or as sexual network partners referred by index participants. Index participants were: (1) HIV infected but unaware of their infection; (2) previously diagnosed with HIV infection but not receiving HIV care and having unprotected sex with partners of negative or unknown HIV status; or (3) HIV-uninfected. Recruitment methods were developed at each site and included: community outreach; engagement of key informants and local community-based groups; print advertising; and online strategies. At each site, enrollment of community-recruited HIV-uninfected participants was capped at 200 participants; enrollment of community-recruited participants who had a prior diagnosis of HIV infection and were already in care, or reported only having unprotected anal intercourse (UAI) with HIV-positive partners, was capped at 10 participants.
Men were eligible to participate in the study if they: self-identified as a man or male at birth and as Black, African American, Caribbean Black, or multiethnic Black; were at least 18 years old; reported ≥1 instance of UAI with a man in the prior six months; resided in the metropolitan area; did not plan to move away during the time of study participation; and provided informed consent for the study. Men were ineligible if they were enrolled in any other HIV interventional research study, had been a participant in an HIV vaccine trial, or were a community-recruited participant in a category that had already reached its enrollment cap. Prescreening to determine eligibility was performed either in person or over the telephone.
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