The HJ MILE HIV Prevention Intervention for Post-incarcerated Men

October 9, 2018 updated by: Ricky Bluthenthal, University of Southern California

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90012
        • Center for Health Justice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Last 3 months
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.
Last 3 months
Number of sex partners
Time Frame: Last 3 month
Participant's self-report of number of sex partners in the last 3 months.
Last 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

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

Investigators

  • Principal Investigator: Ricky Bluthenthal, Ph.D., University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

August 30, 2011

First Submitted That Met QC Criteria

August 31, 2011

First Posted (ESTIMATE)

September 1, 2011

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HS-10-00590
  • 5UR6PS001098 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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