Men of African American Legacy Empowering Self — MAALES  

HIV Clinical Trial

Official title: Reducing HIV Risk Behaviors and Psychosocial Stressors Among Bisexual African American Men

Status Completed

Clinical Trial Summary

The MAALES Project is a community collaborative intervention designed to prevent HIV infection and transmission among African American men who have sex with both men and women. The investigators are a collaboration of researchers, community service providers and activists who are committed to developing and testing effective HIV prevention interventions that employ holistic and culturally relevant approaches. This includes recognizing the impact of forces such as racism, homophobia, heterosexism, sexism, and gender expectations on individual behavior and relationship dynamics in African American communities.

Clinical Trial Description

HIV directly or indirectly related to male-to-male sexual intercourse is the largest contributor to HIV infection among Blacks (CDC 2002), accounting for approximately half of all US AIDS cases diagnosed among Black men and a substantial but unknown portion of cases diagnosed among Black women in 2001 (CDC 2002). The Men of African American Legacy Empowering Self (MAALES) Project is an intervention, designed to reduce HIV risk-related behaviors among African American men who have sex with men and women (MSMW) in Los Angeles.

We propose to test the efficacy of the Men of African American Legacy Empowering Self (MAALES) Project, a newly developed, novel, and culturally congruent intervention designed to reduce HIV risk-related behaviors and improve psychosocial outcomes. The MAALES intervention, which originally pilot tested with 50 men using funds from the University of California's University wide AIDS Research Program (UARP), is guided by the Theory of Reasoned Action and Planned Behavior (9; 10), the Critical Thinking and Cultural Affirmation (CTCA) Model developed by a collaborating community-based organization (11), and the Empowerment Theory (12). The small group MAALES intervention was developed through an extensive formative research process and involves six two-hour group sessions held over three weeks and lead by two ethnically matched co-facilitators. In the proposed study, we will conduct a Phase 2a test of an enhanced version of the intervention with a total of 350-400 MSMW, evenly randomized to intervention and wait listed control conditions. The enhanced intervention includes two booster sessions conducted at 1.5- and 4.5-months post conclusion of the six sessions and dialogues regarding assumptions about prospective partners' HIV serostatus. Post-intervention survey assessments will occur immediately (for psychosocial outcomes and mediators) and at three and six months post conclusion of the intervention (for all outcomes and mediators). This project will be among the first to develop and test an HIV risk-reduction intervention designed specifically for African American MSMW.

The Primary Specifics Aims are to:

1. Determine the impact of the MAALES intervention on: (a) HIV-related sexual risk behaviors and (b) sex under the influence of drugs and alcohol among African American MSMW.

1. Hypothesis: Compared to the control condition, the MAALES Intervention condition will be more effective in decreasing episodes of unprotected anal and vaginal intercourse and number of intercourse partners at the 3- and 6-month post assessments.

2. Hypothesis: Compared to the control condition, the MAALES Intervention condition will be more effective in decreasing the number of episodes of drug and alcohol use prior to or during sex at the 3- and 6-month post assessments.

2. Determine the impact of the MAALES intervention condition on psychosocial outcomes, including reducing HIV stigma and increasing racial/cultural pride among African American MSMW.

Hypothesis: Compared to the control condition, the MAALES Intervention condition will be more effective in decreasing HIV stigma and improving racial/cultural pride at the immediate, 3- and 6-month post assessments. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

• NCT number: NCT01492530
• Study type: Interventional
• Source: Charles Drew University of Medicine and Science
• Status: Completed
• Phase: Phase 2
• Start date: August 2007
• Completion date: March 2012