NCT00137631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
341

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

May 14, 2010

Completed
Last Updated

June 24, 2010

Status Verified

April 1, 2010

Enrollment Period

2 years

First QC Date

August 26, 2005

Results QC Date

March 10, 2010

Last Update Submit

June 23, 2010

Conditions

Keywords

AdultHIV Infections / pc [Prevention & Control]Homosexuality, MaleHumansMaleRisk-TakingSafe SexSexual BehaviorHIV

Outcome Measures

Primary Outcomes (5)

  • 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

  • Number of Participants Reporting HIV Testing Behavior

    6 months

  • Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior

    6 months

  • Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners

    6 months

  • Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners

    6 months

Study Arms (2)

Many Men, Many Voices (3MV) Intervention

EXPERIMENTAL

Receive 6-session intervention immediately after baseline assessment and randomization

Behavioral: Many Men, Many Voices (3MV)

Wait list comparison

NO INTERVENTION

Receive intervention after 6-month delay (wait list control group)

Interventions

Small-group, 6-session HIV prevention intervention for Black MSM.

Many Men, Many Voices (3MV) Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • Individuals indicating an HIV positive serostatus
  • Under 17 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

People of Color in Crisis, Inc.

Brooklyn, New York, 11217, United States

Location

Related Publications (3)

  • 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.

    PMID: 20019294BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted DiseasesHomosexuality, MaleRisk-TakingSafe SexSexual Behavior

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHomosexualitySexualityBehavior

Results Point of Contact

Title
Leo Wilton, PhD
Organization
Department of Human Development, State University of New York at Binghamton

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 30, 2005

Study Start

August 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

June 24, 2010

Results First Posted

May 14, 2010

Record last verified: 2010-04

Locations