A Randomized Controlled Trial of the Bruthas Project
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      African Americans account for half of all Americans currently living with AIDS, and men
      account for two-thirds of all African Americans with HIV. AAMSMW are at particular risk for
      contracting and transmitting HIV, and represent a priority population for developing
      effective interventions. Studies of AAMSMW conducted in multiple HIV-epicenters in the United
      States have reported high rates of unprotected intercourse with male and female partners,
      concurrent partnerships, and frequent substance use before sex, accompanied by non-disclosure
      and secrecy regarding sexual risk behaviors. These behavioral dynamics are likely to fuel
      transmission of HIV and other STDs in diverse sexual networks and communities. 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.

      We propose to test a behavioral prevention intervention, the BP, to reduce HIV-related sexual
      risk behavior among AAMSMW. The intervention was designed through four years of formative
      research with AAMSMW consisting of: (1) qualitative in-depth interviews, focus groups and
      field ethnography; (2) protocol and measure development; (3) pilot testing and evaluation;
      and (4) further refinement following process and preliminary outcome data. The BP counseling
      process was formulated on principles of the Information-Motivation-Behavior (IMB) theory of
      HIV prevention, and is characterized by an individual-level counseling process that is
      specifically tailored to recognize the social and cultural contexts that inform sexual
      behavior for AAMSMW. 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. Evidence thus far indicates
      that BP is an acceptable and feasible model for providing HIV prevention counseling to this
      population, and pilot outcome data show promising indications of behavior change. A team of
      trained BP staff have successfully utilized a multi-tiered outreach approach to identify
      AAMSMW, recruit eligible individuals, and engage and retain participants in a longitudinal
      evaluation design. 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.
    

Intervention name(s): Bruthas Project; Standard HIV Testing and Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Bruthas Project HIV prevention intervention is a four-session, semi-structured individual risk reduction counseling program based on the Information-Motivation-Behavior (IMB) theoretical model. The counseling sessions are designed to complement standardized HIV-Counseling and Testing, and are delivered every 2-3 weeks over the course of 3 months. Each session lasts for approximately one hour, and is facilitated by a trained African American male counselor. The counselors engage with participants using open-ended questions and a non-judgmental, conversational style designed to elicit feedback on an individual's current level of HIV-related risk. The counselor then provides information and strengthens the participant's prevention skills.; This arm represents those receiving the standard HIV testing and counseling. We ultimately settled on the standard-of-care comparison group because our primary research question is whether the implementation of the intervention cast against the backdrop of usual care, in this case, HIV testing and counseling as mandated by the CDC, is efficacious. Thus, participants randomized to the comparison group will receive the current standard intervention which involves HIV testing, pre- and post-test counseling, plus linkage to case management. Individuals who test HIV-positive will be referred to post-test services including counseling for treatment options, HIV-positive support groups, and harm reduction workshops.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Prevention Intervention; African American Men who have Sex with Men