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Completed

NCT Number: NCT01427543

The HJ MILE HIV Prevention Intervention for Post-incarcerated Men

The goal of this study is to determine whether a culturally congruent, group intervention can reduce HIV risk behaviors among recently incarcerated, bisexual, African American men.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Center for Health Justice

Los Angeles, California, 90012, United States

About this study

The goal of this study is to evaluate the efficacy of the Men in Life Environments (MILE) intervention, adapted from the Men of African American Legacy Empowering Self (MAALES) Project, an innovative and culturally congruent intervention designed to reduce HIV risk-related behaviors and improve psychosocial outcomes in recently incarcerated African American men who have sex with men and women (MSMW). The MILE intervention is guided by the Theory of Reasoned Action and Planned Behavior, the Critical Thinking and Cultural Affirmation (CTCA) Model, and the Empowerment Theory. The small group MILE intervention involves six two-hour group sessions held over three weeks and is lead by two African-American co-facilitators. The investigators will test the intervention with a total of 260 African American MSMW, evenly randomized to intervention and control conditions. For this study, participants will be interviewed at baseline, shortly after completion of the intervention (~ 4 weeks after baseline), and again 3 months following the second interview. This project will be among the first to develop and test an HIV risk-reduction intervention designed specifically for African American post-incarcerated MSMW. Study aims are as follows:

Aim 1: To evaluate the impact of the MILE intervention on rates of condom use, having sex while under the influence of drugs and alcohol, and number of sex partners among recently incarcerated bisexual African American MSMW.

Hypothesis: Compared to the control condition, the MILE intervention condition will be more effective in decreasing episodes of unprotected anal and vaginal intercourse, incidents of sex under the influence of drugs and alcohol and numbers of intercourse partners at the 3-month follow-up assessment.

Aim 2: To evaluate the impact of the MILE intervention on uptake of testing for sexually transmitted infections (STI) among recently incarcerated African American MSMW.

Hypothesis: Compared to the control condition, the MILE intervention participants will be more likely to accept STI testing after the post-intervention assessment.

Aim 3: To describe social support and social networks of recently incarcerated African American MSMW and to examine whether these factors are associated with HIV risk in this population.

The MILE intervention will be implemented by The Center for Health Justice (CHJ) - a community-based HIV prevention and care advocacy organization that has been working with incarcerated and post-incarcerated populations since 1997. The adaptation and implementation of this intervention by CHJ should increase the dissemination and applicability of the intervention to other locales should it prove to be effective.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • self-identified as African American or Black
  • male
  • 18 years of age or greater
  • Los Angeles County resident
  • Been incarcerated in the last 12 months
  • oral or anal sex with a man in the last 12 months
  • any unprotected anal or vaginal sex in the last 3 months
  • two or more sex partners in the last 3 months

Exclusion criteria

  • Female or transgendered
  • not self-identified as African American or Black
  • any self-reported illicit drug injection in the last 12 months

Treatment and study plan

MILE intervention

Behavioral

Participants will be asked to attend 6 - 2 hour group sessions over the course of 3 weeks. The intervention aims to reduce HIV risk taking related to sex risk and alcohol and drug use.

Primary outcomes

  1. Condom use

    Time frame: Last 3 months

    This measure captures the percentage of times that participants self-report using a condom during vaginal and anal sex.

  2. Sex under the influence of alcohol and drugs

    Time frame: Last 3 months

    Self-reported vaginal or anal sex while under the influence of alcohol or drugs.

  3. Number of sex partners

    Time frame: Last 3 month

    Participant's self-report of number of sex partners in the last 3 months.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Charles Drew University of Medicine and Science

Registry information

Official study title

The HJ MILE HIV Prevention Intervention for Post-incarcerated Bisexual African American Men

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 1, 2011
Registry last updated
Oct 12, 2018

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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