HIV Infections, Sexually Transmitted Diseases
Conditions
Keywords
Adult, HIV Infections / pc [Prevention & Control], Homosexuality, Male, Humans, Male, Risk-Taking, Safe Sex, Sexual Behavior, HIV
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.
Interventions
BEHAVIORALMany Men, Many Voices (3MV)
Small-group, 6-session HIV prevention intervention for Black MSM.
Sponsors
University of Rochester
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any Unprotected Anal Intercourse (UAI) With Casual Partners | 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 | 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 | — |
Countries
United States
Participant flow
Recruitment details
From August 2005 through November 2006, People of Color in Crisis Inc. recruited potential participants from venues throughout New York City.
Participants by arm
| Arm | Count |
|---|---|
| Many Men, Many Voices (3MV) Intervention Receive 6-session intervention immediately after baseline assessment and randomization | 164 |
| Wait List Comparison Receive intervention after 6-month delay (wait list control group) | 174 |
| Total | 338 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 37 | 41 |
Baseline characteristics
| Characteristic | Many Men, Many Voices (3MV) Intervention | Wait List Comparison | Total |
|---|---|---|---|
| Age Continuous | 29.5 years STANDARD_DEVIATION 9.1 | 29.7 years STANDARD_DEVIATION 9.5 | 29.6 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment United States | 164 participants | 174 participants | 338.0 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0.0 Participants |
| Sex: Female, Male Male | 164 Participants | 174 Participants | 338.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 164 | 0 / 174 |
| serious Total, serious adverse events | 0 / 164 | 0 / 174 |
Outcome results
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)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Many Men, Many Voices (3MV) Intervention | Any Unprotected Anal Intercourse (UAI) With Casual Partners | 2.0 Number of episodes | Standard Deviation 5.6 |
| Wait List Comparison | Any Unprotected Anal Intercourse (UAI) With Casual Partners | 6.2 Number of episodes | Standard Deviation 22.7 |
p-value: <0.0595% CI: [0.33, 1.01]negative binomial regression
Primary
Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Many Men, Many Voices (3MV) Intervention | Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners | 1.1 number of episodes | Standard Deviation 3.4 |
| Wait List Comparison | Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners | 4.5 number of episodes | Standard Deviation 18.6 |
p-value: <0.0595% CI: [0.28, 0.87]generalized estimating equations
Primary
Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Many Men, Many Voices (3MV) Intervention | Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners | 0.9 number of episodes | Standard Deviation 3.3 |
| Wait List Comparison | Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners | 1.7 number of episodes | Standard Deviation 6.8 |
p-value: <0.0595% CI: [0.42, 1.53]generalized estimating equations
Primary
Number of Participants Reporting HIV Testing Behavior
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Many Men, Many Voices (3MV) Intervention | Number of Participants Reporting HIV Testing Behavior | 69 participants |
| Wait List Comparison | Number of Participants Reporting HIV Testing Behavior | 58 participants |
p-value: <0.0595% CI: [1.05, 1.68]generalized estimating equations
Primary
Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Many Men, Many Voices (3MV) Intervention | Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior | 43 participants |
| Wait List Comparison | Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior | 43 participants |
p-value: <0.0595% CI: [0.69, 1.98]Mixed Models Analysis