Evaluation of Many Men, Many Voices, An STD/HIV Prevention Intervention for Black MSM (3MV)

June 23, 2010 updated by: Centers for Disease Control and Prevention

Evaluation of Many Men, Many Voices, A Group Intervention for STD/HIV Prevention for Black Men Who Have Sex With Men (MSM) in the New York Metropolitan Area by People of Color in Crisis, Brooklyn, NY

The purpose of this program evaluation is to determine whether the "Many Men, Many Voices" HIV/STD prevention intervention is effective in reducing HIV sex risk behaviors and increasing HIV testing among African-American men who have sex with men (MSM), who may or may not self-identify as gay. The intent of this program is to support the evaluation of an existing intervention and provide feedback to the implementing organization for improved program effectiveness, not to conduct research.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Black men who have sex with men (MSM) in the United States experience disproportionately high rates of HIV and other sexually transmitted infections (STIs); however, the number of evidence-based interventions for Black MSM is limited. This study evaluated the efficacy of Many Men, Many Voices (3MV), a small-group HIV/STI prevention intervention developed by Black MSM-serving community-based organizations and a university-based HIV/STI prevention and training program. The study sample included 338 Black MSM of HIV-negative or unknown HIV serostatus residing in New York city. Participants were randomly assigned to the 3MV intervention condition (n = 164) or wait-list comparison condition (n = 174). Relative to comparison participants, 3MV participants reported significantly greater reductions in any unprotected anal intercourse with casual male partners; a trend for consistent condom use during receptive anal intercourse with casual male partners; and significantly greater reductions in the number of male sex partners and greater increases in HIV testing. This study is the first randomized trial to demonstrate the efficacy of an HIV/STI prevention intervention for Black MSM.

Study Type

Interventional

Enrollment (Actual)

341

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11217
        • People of Color in Crisis, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Black men who have sex with other men (i.e., self-identify as gay or bisexual or same gender-loving, or sexually active with other men and do not identify as gay or bisexual, or have sexual or emotional attraction to other men)
  • 18 years of age or older
  • Self-report their HIV serostatus as negative or unknown
  • Willing to attend an intervention retreat (without their primary partner)
  • Willing to discuss male-to-male sex
  • Resident of the New York Metropolitan area and plan to reside in that area for at least 6 months
  • Not previously participated in a Many Men, Many Voices intervention program

Exclusion Criteria:

  • Individuals indicating an HIV positive serostatus
  • Under 17 years of age
  • Individuals not meeting the inclusion criteria specified above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Many Men, Many Voices (3MV) Intervention
Receive 6-session intervention immediately after baseline assessment and randomization
Behavioral: Many Men, Many Voices (3MV)
Small-group, 6-session HIV prevention intervention for Black MSM.
No Intervention: Wait list comparison
Receive intervention after 6-month delay (wait list control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any Unprotected Anal Intercourse (UAI) With Casual Partners
Time Frame: 6 months
Sexual activities with casual male partners in past 3 months (i.e., any unprotected insertive or receptive anal sex)
6 months
Number of Participants Reporting HIV Testing Behavior
Time Frame: 6 months
6 months
Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior
Time Frame: 6 months
6 months
Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners
Time Frame: 6 months
6 months
Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

University of Rochester

Investigators

  • Study Director: Thomas M Painter, PhD, Project Officer, Division of HIV/AIDS Prevention, NCHSTP, Centers for Disease Control and Prevention
  • Study Director: Jeffrey H Herbst, PhD, Project Officer, Division of HIV/AIDS Prevention, NCHSTP, Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria

August 26, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

June 24, 2010

Last Update Submitted That Met QC Criteria

June 23, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCHSTP-CCU224517
  • U65/CCU224517-01 (Other Grant/Funding Number: Centers for Disease Control and Prevention)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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