Evaluation of Many Men, Many Voices, An STD/HIV Prevention Intervention for Black MSM - Full Text View

Sponsor:	Centers for Disease Control and Prevention
Collaborator:	University of Rochester
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00137631

Purpose

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.

Condition	Intervention	Phase
HIV Infections Sexually Transmitted Diseases	Behavioral: Many Men, Many Voices (3MV)	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Gay, Lesbian and Transgender Health HIV/AIDS Sexually Transmitted Diseases

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

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 ]

Enrollment:	341
Study Start Date:	August 2005
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137631

Locations

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

Sponsors and Collaborators

Centers for Disease Control and Prevention

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

More Information

Additional Information:

Many Men, Many Voices intervention at CDC DEBI website This link exits the ClinicalTrials.gov site

Publications:

Wilton L, Herbst JH, Coury-Doniger P, Painter TM, English G, Alvarez ME, Scahill M, Roberson MA, Lucas B, Johnson WD, Carey JW. Efficacy of an HIV/STI prevention intervention for black men who have sex with men: findings from the Many Men, Many Voices (3MV) project. AIDS Behav. 2009 Jun;13(3):532-44. Epub 2009 Mar 9.

Coury-Doniger P, Wilton L, Herbst JH, Painter TM. HIV prevention interventions for black MSM. Am J Public Health. 2010 Feb;100(2):198. Epub 2009 Dec 17. No abstract available.

Responsible Party:	Executive Director, People of Color in Crisis, Inc.
ClinicalTrials.gov Identifier:	NCT00137631 History of Changes
Other Study ID Numbers:	CDC-NCHSTP-CCU224517, U65/CCU224517-01
Study First Received:	August 26, 2005
Results First Received:	March 10, 2010
Last Updated:	June 23, 2010
Health Authority:	United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:

Adult
HIV Infections / pc [Prevention & Control]
Homosexuality, Male
Humans
Male

Risk-Taking
Safe Sex
Sexual Behavior
HIV

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on February 12, 2012