Clinical trial NCT01427543: The HJ MILE HIV Prevention Intervention for Post-incarcerated Men
Official title: The HJ MILE HIV Prevention Intervention for Post-incarcerated Bisexual African American Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Risk Reduction Behavior
Keywords: behavioral intervention
HIV risk reduction
African Americans
incarceration
bisexual
reduce risk behaviors
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Charles Drew University of Medicine and Science
name: Centers for Disease Control and Prevention
First posted: 2011-09-01
Enrollment: 212
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Condom use
timeFrame: Last 3 months
measure: Sex under the influence of alcohol and drugs
timeFrame: Last 3 months
measure: Number of sex partners
timeFrame: Last 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Center for Health Justice
state: California
Study officials:
affiliation: University of Southern California
name: Ricky Bluthenthal, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dangerfield DT 2nd, Harawa NT, Smith LR, Jeffries WL 4th, Baezconde-Garbanati L, Bluthenthal R. Latent Classes of Sexual Risk Among Black Men Who Have Sex with Men and Women. Arch Sex Behav. 2018 Oct;47(7):2071-2080. doi: 10.1007/s10508-017-1142-y. Epub 2018 Mar 14.
citation: Harawa NT, Guentzel-Frank H, McCuller WJ, Williams JK, Millet G, Belcher L, Joseph HA, Bluthenthal RN. Efficacy of a Small-Group Intervention for Post-Incarcerated Black Men Who Have Sex with Men and Women (MSMW). J Urban Health. 2018 Apr;95(2):159-170. doi: 10.1007/s11524-018-0227-9.
citation: Joseph HA, Pan Y, Mendoza M, Harawa NT, Lauby J, Hosek SG, Bluthenthal RN, Milnamow M, Fernandez MI, Jeffries WL 4th, Belcher L, Millett GA. HIV Acquisition and Transmission Potential Among African American Men Who Have Sex with Men and Women in Three U.S. Cities. Arch Sex Behav. 2018 Jan;47(1):183-194. doi: 10.1007/s10508-017-1052-z. Epub 2017 Nov 9.
citation: Li MJ, Frank HG, Harawa NT, Williams JK, Chou CP, Bluthenthal RN. Racial Pride and Condom Use in Post-Incarcerated African-American Men Who Have Sex With Men and Women: Test of a Conceptual Model for the Men in Life Environments Intervention. Arch Sex Behav. 2018 Jan;47(1):169-181. doi: 10.1007/s10508-016-0734-2. Epub 2016 Apr 26.