The HJ MILE HIV Prevention Intervention for Post-incarcerated Men
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|ClinicalTrials.gov Identifier: NCT01427543|
Recruitment Status : Completed
First Posted : September 1, 2011
Last Update Posted : May 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV Risk Reduction Behavior||Behavioral: MILE intervention||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||212 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The HJ MILE HIV Prevention Intervention for Post-incarcerated Bisexual African American Men|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
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.
- 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.
- 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.
- Number of sex partners [ Time Frame: Last 3 month ]Participant's self-report of number of sex partners in the last 3 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427543
|United States, California|
|Center for Health Justice|
|Los Angeles, California, United States, 90012|
|Principal Investigator:||Ricky Bluthenthal, Ph.D.||University of Southern California|