Evaluation of Many Men, Many Voices, An STD/HIV Prevention Intervention for Black MSM

HIV Infections Clinical Trial

— 3MV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137631
• Other study ID #: CDC-NCHSTP-CCU224517
• Secondary ID: U65/CCU224517-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 26, 2005
• Last updated: June 23, 2010
• Start date: August 2005
• Est. completion date: August 2007

Study information

• Verified date: April 2010
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV Infections
• Sexually Transmitted Diseases

Intervention

Behavioral:
• Many Men, Many Voices (3MV)
Small-group, 6-session HIV prevention intervention for Black MSM.

Locations

Country	Name	City	State
United States	People of Color in Crisis, Inc.	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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 (3M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any Unprotected Anal Intercourse (UAI) With Casual Partners	Sexual activities with casual male partners in past 3 months (i.e., any unprotected insertive or receptive anal sex)	6 months	No
Primary	Number of Participants Reporting HIV Testing Behavior		6 months	No
Primary	Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior		6 months	No
Primary	Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners		6 months	No
Primary	Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners		6 months	No