A Randomized Controlled Trial of the Bruthas Project

NCT01270230 | Completed Phase 2

• 2 other identifiers: 1R01MH09089901-A1R01MH090899
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection

Keywords

HIV Prevention Intervention; African American Men who have Sex with Men

Outcome Measures

Primary Outcomes (1)

• sexual risk behavior with male and female partners

  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).

  9-months

Secondary Outcomes (1)

• HIV Testing

  9 months follow up

Study Arms (2)

Comparison Group, Standard HIV-CT

EXPERIMENTAL

The comparison group will receive standardized HIV counseling and testing (HIV-CT), with referrals to case management.

Behavioral: Standard HIV Testing and Counseling

Intervention Group, Bruthas Counseling

EXPERIMENTAL

Participants assigned to this arm receive four individual HIV prevention counseling sessions.

Behavioral: Bruthas Project

Interventions

Bruthas Project BEHAVIORAL

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.

Intervention Group, Bruthas Counseling

Standard HIV Testing and Counseling BEHAVIORAL

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.

Comparison Group, Standard HIV-CT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94105, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Counseling

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Emily A Arnold, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: January 5, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: August 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)