A Randomized Controlled Trial of the Bruthas Project

Completed · Phase 2

Conditions studied: HIV Infection

In brief

African American men who have sex with men and women (AAMSMW) are at particular risk for contracting and transmitting HIV, and represent a priority population for developing effective interventions. Despite the urgent need for effective prevention approaches for AAMSMW, to our knowledge no evidence-based HIV interventions have been developed and tested for this population. This study is a randomized controlled trial of the Bruthas Project(BP), an individual-level HIV prevention intervention, which builds on standardized HIV counseling and testing. Delivered in a series of four sessions by trained African American male counselors, the BP focuses on reviewing HIV transmission routes for male and female partners, strengthening sexual communication skills with both male and female partners, and improving condom use skills and other safer sex negotiation strategies. A randomized controlled trial of BP is necessary to determine the efficacy of the intervention and can lead to improved public health efforts at reducing HIV risk behavior among AAMSMW and in the African American community more generally. To evaluate the effect of the BP, the investigators will recruit and enroll a cohort of 400 AAMSMW who will be randomly assigned to either the intervention condition, in which they will be offered BP, or to the comparison condition, in which they will receive standardized HIV testing and counseling with referral to case management. The investigators will follow the cohort over 9 months and will assess participants at three time points: baseline, 3 months follow-up, and 6 months follow-up.

Key facts

Study ID
NCT01270230
Run by
University of California, San Francisco
People needed
396
Starts
2011-02-01
Expected to finish
2016-08-01
Last updated by the study team
2016-10-27

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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