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
  Purpose

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.


Condition Intervention Phase
HIV
Risk Reduction Behavior
Behavioral: MILE intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The HJ MILE HIV Prevention Intervention for Post-incarcerated Bisexual African American Men

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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.


Enrollment: 212
Study Start Date: July 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: Control
These subjects will be provided with access to post-incarcerations services that will be provided by the Center for Health Justice.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01427543

Locations
United States, California
Center for Health Justice
Los Angeles, California, United States, 90012
Sponsors and Collaborators
University of Southern California
Charles Drew University of Medicine and Science
Investigators
Principal Investigator: Ricky Bluthenthal, Ph.D. University of Southern California
  More Information

No publications provided

Responsible Party: Ricky Bluthenthal, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT01427543     History of Changes
Other Study ID Numbers: HS-10-00590, 5UR6PS001098
Study First Received: August 30, 2011
Last Updated: May 15, 2014
Health Authority: United States: Centers for Disease Control and Prevention

Keywords provided by University of Southern California:
behavioral intervention
HIV risk reduction
African Americans
incarceration
bisexual
reduce risk behaviors

ClinicalTrials.gov processed this record on September 29, 2014