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…
- 18 or older
- African American
- Male
- History of sex with male and female partners in the past two years
- English speaker
You may not qualify if…
- participation in previous research with Bruthas Project
- non English speaker
- identifies as gay
Where it is running
- University of California San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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