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

• ClinicalTrials.gov Identifier: NCT00137631
• Recruitment Status: Completed
• First Posted: August 30, 2005
• Results First Posted: May 14, 2010
• Last Update Posted: June 24, 2010
• Sponsor: Centers for Disease Control and Prevention
• Collaborator: University of Rochester
• Information provided by: Centers for Disease Control and Prevention

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
HIV Infections; Sexually Transmitted Diseases	Behavioral: Many Men, Many Voices (3MV)	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 341 participants
• 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
• Study Start Date: August 2005
• Actual Primary Completion Date: August 2007
• Actual Study Completion Date: August 2007

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. 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)
2. Number of Participants Reporting HIV Testing Behavior [ Time Frame: 6 months ]
3. Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior [ Time Frame: 6 months ]
4. Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners [ Time Frame: 6 months ]
5. Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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 of Results:

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.

Other Publications:

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. No abstract available.

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
• Other Study ID Numbers: CDC-NCHSTP-CCU224517; U65/CCU224517-01 ( Other Grant/Funding Number: Centers for Disease Control and Prevention )
• First Posted: August 30, 2005
• Results First Posted: May 14, 2010
• Last Update Posted: June 24, 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; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes