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Completed

NCT Number: NCT01640392

MyLife MyStyle Evaluation Project

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.

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Key information

Conditions

Unsafe Sex Behavior Sexual Behavior

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

In The Meantime Men's Group, Inc.

Los Angeles, California, 90019, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MyLife MyStyle group-level intervention

Behavioral

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.

Primary outcomes

  1. Reduced unprotected anal sex with male partners

    Time frame: up to 6 months following Intervention groups' third (final) session

    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 outcomes

  1. Increased communication with partners

    Time frame: 3 months and 6 months following intervention groups' third (final) session

    Increase frequency of communication with partner(s) about safer sex, HIV status, STI status

  2. Decrease unprotected sex because condom was not available

    Time frame: 3 months and 6 months following Intervention groups' third (final) session

    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. Decrease number of sexual partners

    Time frame: 3 months and 6 months following Intervention groups' third (final) session

    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.

  4. 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

    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.

Sponsors and collaborators

Lead sponsor

Los Angeles County Department of Public Health

Other Gov

Collaborators

  • Centers for Disease Control and Prevention
  • In The Meantime Men's Group, Inc.

Registry information

Official study title

Evaluating Locally Developed Homegrown HIV Prevention Interventions

Acronym: MLMS

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 13, 2012
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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