HIV InfectionsPhase 1/23MVNCT00137631
Evaluation of Many Men, Many Voices, An STD/HIV Prevention Intervention for Black MSM
A Phase 1/2 study testing Many Men, Many Voices (3MV) in people with HIV Infections and Sexually Transmitted Diseases, run by Centers for Disease Control and Prevention at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- Many Men, Many Voices (3MV)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Aug 2007
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals indicating an HIV positive serostatus
- Under 17 years of age
- Individuals not meeting the inclusion criteria specified above
Trial locations and contacts
1 site in 1 country.
United States1 site
People of Color in Crisis, Inc.
Brooklyn, New York, 11217
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- Many Men, Many Voices (3MV)
- Keywords
- Adult, HIV Infections / pc [Prevention & Control], Homosexuality, Male, Humans, Male, Risk-Taking, Safe Sex, Sexual Behavior, HIV
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Homosexuality, Male, Risk-Taking, Safe Sex, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Many Men, Many Voices (3MV)Behavioural
Small-group, 6-session HIV prevention intervention for Black MSM.
| Study group | Role | What they receive |
|---|---|---|
| Many Men, Many Voices (3MV) Intervention | Experimental | Receive 6-session intervention immediately after baseline assessment and randomization Receives: Behavioral: Many Men, Many Voices (3MV) |
| Wait list comparison | No intervention | Receive intervention after 6-month delay (wait list control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Number of Participants Reporting HIV Testing Behavior
Measured: 6 months
Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior
Measured: 6 months
Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners
Measured: 6 months
Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- University of Rochester
- Investigators
- Thomas M Painter, PhD, Study director, Project Officer, Division of HIV/AIDS Prevention, NCHSTP, Centers for Disease Control and PreventionJeffrey H Herbst, PhD, Study director, Project Officer, Division of HIV/AIDS Prevention, NCHSTP, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137631
- Sponsor's protocol ID
- CDC-NCHSTP-CCU224517
- Other IDs
- U65/CCU224517-01
- Acronym
- 3MV
- Status last verified
- Apr 2010
- First submitted
- 26 Aug 2005
- Last updated
- 24 Jun 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 20019294Wilton 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.
PubMed 19267264Herbst 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.
PubMed 24743663
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00137631
- Acronym / sponsor ID
- 3MV / CDC-NCHSTP-CCU224517
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Keywords
- Adult, HIV Infections / pc [Prevention & Control], Homosexuality, Male, Humans, Male, Risk-Taking, Safe Sex, Sexual Behavior
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- University of Rochester
- Study start
- Aug 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Posted 14 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Many Men, Many Voices (3MV) Intervention | Experimental | Behavioral: Many Men, Many Voices (3MV)Receive 6-session intervention immediately after baseline assessment and randomization |
| Wait list comparison | No intervention | –Receive intervention after 6-month delay (wait list control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Individuals indicating an HIV positive serostatus
- Under 17 years of age
- Individuals not meeting the inclusion criteria specified above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Many Men, Many Voices (3MV)Small-group, 6-session HIV prevention intervention for Black MSM. | Behavioural | Many Men, Many Voices (3MV) Intervention |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20019294Coury-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.
- Results publication: PubMed 19267264Wilton 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.
- Derived from this study: PubMed 24743663Herbst 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas M Painter, PhD study director
Project Officer, Division of HIV/AIDS Prevention, NCHSTP, Centers for Disease Control and Prevention
Jeffrey H Herbst, PhD study director
Project Officer, Division of HIV/AIDS Prevention, NCHSTP, Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Many Men, Many Voices (3MV) in people with HIV Infections and Sexually Transmitted Diseases, run by Centers for Disease Control and Prevention at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any Unprotected Anal Intercourse (UAI) With Casual Partners (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00137631, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2010.