Clinical trial NCT00137631: Evaluation of Many Men, Many Voices, An STD/HIV Prevention Intervention for Black MSM
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Sexually Transmitted Diseases
Keywords: Adult
HIV Infections / pc [Prevention & Control]
Homosexuality, Male
Humans
Male
Risk-Taking
Safe Sex
Sexual Behavior
HIV
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: University of Rochester
First posted: 2005-08-30
Enrollment: 341
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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

Primary outcomes:
measure: Any Unprotected Anal Intercourse (UAI) With Casual Partners
timeFrame: 6 months
measure: Number of Participants Reporting HIV Testing Behavior
timeFrame: 6 months
measure: Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior
timeFrame: 6 months
measure: Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners
timeFrame: 6 months
measure: Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: People of Color in Crisis, Inc.
state: New York
Study officials:
affiliation: Project Officer, Division of HIV/AIDS Prevention, NCHSTP, Centers for Disease Control and Prevention
name: Thomas M Painter, PhD
role: STUDY_DIRECTOR
affiliation: Project Officer, Division of HIV/AIDS Prevention, NCHSTP, Centers for Disease Control and Prevention
name: Jeffrey H Herbst, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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 (3MV) project. AIDS Behav. 2009 Jun;13(3):532-44. doi: 10.1007/s10461-009-9529-y. Epub 2009 Mar 9.
citation: 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.