Clinical trial NCT01640392: MyLife MyStyle Evaluation Project
Official title: Evaluating Locally Developed Homegrown HIV Prevention Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unsafe Sex
Keywords: Gay men
African American males
Unprotected anal sex
HIV risk
behavioral intervention
group-level intervention
Lead sponsor: Los Angeles County Department of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: Centers for Disease Control and Prevention
name: In The Meantime Men's Group, Inc.
First posted: 2012-07-13
Enrollment: 528
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Reduced unprotected anal sex with male partners
timeFrame: up to 6 months following Intervention groups' third (final) session
Secondary outcomes:
measure: Increased communication with partners
timeFrame: 3 months and 6 months following intervention groups' third (final) session
measure: Decrease unprotected sex because condom was not available
timeFrame: 3 months and 6 months following Intervention groups' third (final) session
measure: Decrease number of sexual partners
timeFrame: 3 months and 6 months following Intervention groups' third (final) session
measure: Increase help-seeking behaviors for sexual health, e.g., STI testing, HIV testing, health screenings
timeFrame: 3 months and 6 months following Intervention groups' third (final) session
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: In The Meantime Men's Group, Inc.
state: California
Study officials:
affiliation: Los Angeles County Department of Public Health
name: Trista Bingham, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: