MyLife MyStyle Evaluation Project

Study Overview
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Brief Summary
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The purpose of the MyLife MyStyle Evaluation Project is to determine whether the MyLife MyStyle group-level intervention reduces HIV sexual-risk behaviors among 18- to 29-year-old African American men who have sex with men (MSM). Specifically, the project will test whether participants of the MyLife MyStyle program will report at least a 15% absolute decrease in frequency of unprotected anal sex with male partners at three and six months post-intervention compared with the wait-list control participants.

Detailed Description
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In Los Angeles County, as well as nationally, the primary mode of HIV transmission for African American men is sexual contact with another man. According to national data from 45 states with name-based HIV surveillance in 2006, the majority of all new HIV infections among African American males were associated with sex with other men. The disproportionate impact of HIV in AAMSM in Los Angeles County is also observed in provisional HIV surveillance data. Between 2002 and 2004, AAMSM composed 16.3% of the new HIV diagnoses among males in Los Angeles County, with an average annual HIV diagnosis rate 2.0 and 2.5 times greater than the rates of new HIV diagnosis for White and Latino MSM, respectively. In addition to demonstrating the highest HIV prevalence and incidence estimates, AAMSM also had the highest proportion of previously unrecognized HIV infection (67%) compared with all other racial/ethnic groups. Given significant and continuing disparities in HIV infection among African Americans in the United States, and specifically among AAMSM, more intervention programs must be planned, implemented, and tested in order to reduce the heavy toll of HIV/AIDS in this population. Components of these intervention programs must be culturally competent and should include promotion of HIV counseling and testing to reduce the high prevalence of unrecognized HIV infection in AAMSM. Interventions should also take into consideration the many co-factors that may hinder AAMSM from addressing their HIV risk such as racism, poverty, stigma, and homophobia. The MyLife MyStyle Evaluation Project aims to implement and evaluate the efficacy of a homegrown group-level intervention to reduce HIV risk (unprotected anal sex with male partners) among young African American MSM in Los Angeles County, CA.

Official Title
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Evaluating Locally Developed Homegrown HIV Prevention Interventions

Conditions
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Unsafe Sex

Intervention / Treatment
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* Behavioral: MyLife MyStyle group-level intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Identify as African American or Black Identify as male Age 18 to 29 years Reside within Los Angeles County Self-reported anal sex with a male partner in the past 12 months Has not participated in an HIV prevention intervention in the past 3 months Able to complete ACASI and MyLife sessions in English Exclusion Criteria: Identify as a transgender female Plan to move out of Los Angeles County before the end of their follow-up period (within 7 months)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV prevention groups<br>Participants randomly assigned to the MyLife Intervention arm receive three 1.5-hour HIV behavioral risk-reduction group sessions over a 1-3 week period. | Behavioral: MyLife MyStyle group-level intervention<br>* Three 1.5-hour HIV behavioral risk-reduction group sessions conducted with up to 12 young African American/Black men (ages 18-29 years) over a 1-3 week period.<br>|
| No Intervention: Wait-list control<br>Participants randomly assigned to the Wait-list Control arm receive the MyLife MyStyle group sessions once they have completed a 6-month follow-up assessment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced unprotected anal sex with male partners | Proportion of intervention participants reporting any unprotected anal intercourse (either insertive or receptive) with male partners at six-month follow-up (and three months for short-term effects) compared with those in the wait-list control arm. | up to 6 months following Intervention groups' third (final) session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased communication with partners | Increase frequency of communication with partner(s) about safer sex, HIV status, STI status | 3 months and 6 months following intervention groups' third (final) session | 
| Decrease unprotected sex because condom was not available | Proportion of intervention participants reporting episodes of unprotected anal sex when a condom is not available at six-month follow-up (and three months for short-term effects) compared with those in the wait-list control arm. | 3 months and 6 months following Intervention groups' third (final) session | 
| Decrease number of sexual partners | Number of sexual partners reported by intervention participants at six-month follow-up (and three months for short-term effects) compared with the number reported by the wait-list control participants. | 3 months and 6 months following Intervention groups' third (final) session | 
| Increase help-seeking behaviors for sexual health, e.g., STI testing, HIV testing, health screenings | Proportion of intervention participants reporting help-seeking behaviors for sexual health at six-month follow-up (and three months for short-term effects) compared with those in the wait-list control arm. | 3 months and 6 months following Intervention groups' third (final) session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gay men, African American males, Unprotected anal sex, HIV risk, behavioral intervention, group-level intervention