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

This study has been completed.
Sponsor:
Collaborator:
University of Rochester
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00137631
First received: August 26, 2005
Last updated: June 23, 2010
Last verified: April 2010

August 26, 2005
June 23, 2010
August 2005
August 2007   (final data collection date for primary outcome measure)
  • Any Unprotected Anal Intercourse (UAI) With Casual Partners [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Sexual activities with casual male partners in past 3 months (i.e., any unprotected insertive or receptive anal sex)
  • Number of Participants Reporting HIV Testing Behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • HIV testing behavior
  • STD testing behavior
  • Self-reported frequency of unprotected vaginal/anal intercourse with and without ejaculation with women
  • Sexual activities with main male partner in past 3 months (i.e., unprotected insertive and receptive anal sex with and without ejaculation, and protected insertive and receptive anal sex with and without ejaculation)
  • Sexual activities with casual male partners in past 3 months (i.e., unprotected insertive and receptive anal sex with and without ejaculation, and protected insertive and receptive anal sex with and without ejaculation)
Complete list of historical versions of study NCT00137631 on ClinicalTrials.gov Archive Site
Not Provided
  • Behavioral intentions for condom use
  • Mutual monogamy with uninfected partner
  • Perceived risk of HIV/AIDS and other STDs
  • Self-efficacy for condom use
  • Cultural factors
Not Provided
Not Provided
 
Evaluation of Many Men, Many Voices, An STD/HIV Prevention Intervention for Black MSM
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • HIV Infections
  • Sexually Transmitted Diseases
Behavioral: Many Men, Many Voices (3MV)
Small-group, 6-session HIV prevention intervention for Black MSM.
  • Experimental: Many Men, Many Voices (3MV) Intervention
    Receive 6-session intervention immediately after baseline assessment and randomization
    Intervention: Behavioral: Many Men, Many Voices (3MV)
  • No Intervention: Wait list comparison
    Receive intervention after 6-month delay (wait list control group)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
341
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00137631
CDC-NCHSTP-CCU224517, U65/CCU224517-01
No
Executive Director, People of Color in Crisis, Inc.
Centers for Disease Control and Prevention
University of Rochester
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
Centers for Disease Control and Prevention
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP