The HJ MILE HIV Prevention Intervention for Post-incarcerated Men

This study has been completed.
Sponsor:
Collaborators:
Charles Drew University of Medicine and Science
Information provided by (Responsible Party):
Ricky Bluthenthal, University of Southern California
ClinicalTrials.gov Identifier:
NCT01427543
First received: August 30, 2011
Last updated: May 15, 2014
Last verified: May 2014

August 30, 2011
May 15, 2014
July 2011
April 2013   (final data collection date for primary outcome measure)
  • Condom use [ Time Frame: Last 3 months ] [ Designated as safety issue: No ]
    This measure captures the percentage of times that participants self-report using a condom during vaginal and anal sex.
  • Sex under the influence of alcohol and drugs [ Time Frame: Last 3 months ] [ Designated as safety issue: No ]
    Self-reported vaginal or anal sex while under the influence of alcohol or drugs.
  • Number of sex partners [ Time Frame: Last 3 month ] [ Designated as safety issue: No ]
    Participant's self-report of number of sex partners in the last 3 months.
Same as current
Complete list of historical versions of study NCT01427543 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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The HJ MILE HIV Prevention Intervention for Post-incarcerated Men
The HJ MILE HIV Prevention Intervention for Post-incarcerated Bisexual African American 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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV
  • Risk Reduction Behavior
Behavioral: MILE intervention
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.
  • Experimental: MILE group sessions
    Participants will attend 6 - 2 hour long, interactive, culturally congruent, group sessions that address knowledge, beliefs, attitudes, and skills related to reducing HIV risk behaviors.
    Intervention: Behavioral: MILE intervention
  • No Intervention: Control
    These subjects will be provided with access to post-incarcerations services that will be provided by the Center for Health Justice.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
212
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01427543
HS-10-00590, 5UR6PS001098
Yes
Ricky Bluthenthal, University of Southern California
University of Southern California
  • Charles Drew University of Medicine and Science
  • Centers for Disease Control and Prevention
Principal Investigator: Ricky Bluthenthal, Ph.D. University of Southern California
University of Southern California
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP