MyLife MyStyle Evaluation Project (MLMS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Unsafe Sex |
Behavioral: MyLife MyStyle group-level intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Evaluating Locally Developed Homegrown HIV Prevention Interventions |
- Reduced unprotected anal sex with male partners [ Time Frame: up to 6 months following Intervention groups' third (final) session ] [ Designated as safety issue: No ]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.
- Increased communication with partners [ Time Frame: 3 months and 6 months following intervention groups' third (final) session ] [ Designated as safety issue: No ]Increase frequency of communication with partner(s) about safer sex, HIV status, STI status
- Decrease unprotected sex because condom was not available [ Time Frame: 3 months and 6 months following Intervention groups' third (final) session ] [ Designated as safety issue: No ]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.
- Decrease number of sexual partners [ Time Frame: 3 months and 6 months following Intervention groups' third (final) session ] [ Designated as safety issue: No ]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.
- Increase help-seeking behaviors for sexual health, e.g., STI testing, HIV testing, health screenings [ Time Frame: 3 months and 6 months following Intervention groups' third (final) session ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 528 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HIV prevention groups
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
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.
|
|
No Intervention: Wait-list control
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.
|
Behavioral: MyLife MyStyle group-level intervention
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.
|
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| Ages Eligible for Study: | 18 Years to 29 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations| Contact: Trista Bingham, MPH, PhD | 213-351-8175 | tbingham@ph.lacounty.gov |
| Contact: Juli-Ann Carlos-Henderson, MPH | 213-351-8173 | jcarlos@ph.lacounty.gov |
| United States, California | |
| In The Meantime Men's Group, Inc. | Recruiting |
| Los Angeles, California, United States, 90019 | |
| Contact: Jeffrey King 323-733-4868 inthemeantimemen@aol.com | |
| Contact: Kyle Gordon, MA 323-733-4868 kyle.itmt@yahoo.com | |
| Principal Investigator: Jeffrey King | |
| Principal Investigator: | Trista Bingham, MPH, PhD | Los Angeles County Department of Public Health |
More Information
No publications provided
| Responsible Party: | Los Angeles County Department of Public Health |
| ClinicalTrials.gov Identifier: | NCT01640392 History of Changes |
| Other Study ID Numbers: | 1 U01SP001573-01 |
| Study First Received: | July 11, 2012 |
| Last Updated: | July 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Los Angeles County Department of Public Health:
|
Gay men African American males Unprotected anal sex |
HIV risk behavioral intervention group-level intervention |
ClinicalTrials.gov processed this record on May 16, 2013