A Randomized Controlled Trial of the Bruthas Project

Phase 2

Completed

• Conditions: HIV Infection
• Interventions: Behavioral: Standard HIV Testing and Counseling; Behavioral: Bruthas Project

• Registration Number: NCT01270230
• Lead Sponsor: University of California, San Francisco

Brief 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.

Study Timeline

• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-05
• Study Start: 2011-02
• Primary Completion: 2015-02
• Study Completion: 2016-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 396

Inclusion Criteria

• 18 or older
• African American
• Male
• History of sex with male and female partners in the past two years
• English speaker

Read More

Exclusion Criteria

• participation in previous research with Bruthas Project
• non English speaker
• identifies as gay

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison Group, Standard HIV-CT	Standard HIV Testing and Counseling	The comparison group will receive standardized HIV counseling and testing (HIV-CT), with referrals to case management.
Intervention Group, Bruthas Counseling	Bruthas Project	Participants assigned to this arm receive four individual HIV prevention counseling sessions.

Primary Outcome Measures

Name	Time	Method
sexual risk behavior with male and female partners	9-months	Our primary outcome measure will feature two approaches to assessing HIV risk: we will assess (a) general sexual risk behaviors during the past 3 months and (b) event-level characteristics of sexual risk episodes for the past 1 month. Participants will report on general sexual activity during the past 3 months, including insertive vaginal sex, insertive/receptive anal sex, and giving/receiving oral sex. They will report on overall number of episodes, number of unprotected episodes, and episodes by partner type (main, casual, paying) and by partner gender (male, female).

Secondary Outcome Measures

Name	Time	Method
HIV Testing	9 months follow up	We will ask participants the date of their most recent HIV test.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States