MyLife MyStyle Evaluation Project (MLMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Los Angeles County Department of Public Health
Sponsor:
Collaborators:
In The Meantime Men's Group, Inc.
Information provided by (Responsible Party):
Los Angeles County Department of Public Health
ClinicalTrials.gov Identifier:
NCT01640392
First received: July 11, 2012
Last updated: July 12, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by Los Angeles County Department of Public Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640392

Contacts
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

Locations
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         
Sponsors and Collaborators
Los Angeles County Department of Public Health
In The Meantime Men's Group, Inc.
Investigators
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 October 20, 2014