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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00137631

First Posted: August 30, 2005

Last Update Posted: June 25, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

University of Rochester

Information provided by:

Centers for Disease Control and Prevention

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 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (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:

MedlinePlus related topics: African American 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 ]
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 ]
Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior [ Time Frame: 6 months ]
Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners [ Time Frame: 6 months ]
Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners [ Time Frame: 6 months ]


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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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. doi: 10.1007/s10461-009-9529-y. 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. doi: 10.2105/AJPH.2009.182485. Epub 2009 Dec 17.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Herbst JH, Painter TM, Tomlinson HL, Alvarez ME; Centers for Disease Control and Prevention (CDC). Evidence-based HIV/STD prevention intervention for black men who have sex with men. MMWR Suppl. 2014 Apr 18;63(1):21-7.


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 ( Other Grant/Funding Number: Centers for Disease Control and Prevention )
First Submitted:	August 26, 2005
First Posted:	August 30, 2005
Results First Submitted:	March 10, 2010
Results First Posted:	May 14, 2010
Last Update Posted:	June 25, 2010
Last Verified:	April 2010

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 Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Infection Genital Diseases, Male Genital Diseases, Female

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