Skip to content

The HJ MILE HIV Prevention Intervention for Post-incarcerated Men

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01427543
Enrollment
212
Registered
2011-09-01
Start date
2011-07-31
Completion date
2013-04-30
Last updated
2018-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Risk Reduction Behavior

Keywords

behavioral intervention, HIV risk reduction, African Americans, incarceration, bisexual, reduce risk behaviors

Brief summary

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.

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.

Interventions

BEHAVIORALMILE 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.

Sponsors

Charles Drew University of Medicine and Science
CollaboratorOTHER
Centers for Disease Control and Prevention
CollaboratorFED
University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Condom useLast 3 monthsThis 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 drugsLast 3 monthsSelf-reported vaginal or anal sex while under the influence of alcohol or drugs.
Number of sex partnersLast 3 monthParticipant's self-report of number of sex partners in the last 3 months.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026