Men of African American Legacy Empowering Self (MAALES)
|ClinicalTrials.gov Identifier: NCT01492530|
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : June 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Men of African American Legacy Empowering Self Behavioral: Standard HIV Education & Risk Reduction||Phase 2|
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:
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.
- 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.
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||437 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reducing HIV Risk Behaviors and Psychosocial Stressors Among Bisexual African American Men|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||March 2012|
Experimental: 6-session, small group
Men of African American Legacy Empowering Self (MAALES) Intervention, a six-session, theoretically grounded, small-group intervention held over 3 weeks. Includes an additional 2 booster sessions at 6 and 18 weeks following Session 6.
Behavioral: Men of African American Legacy Empowering Self
Small group intervention. 6 main sessions + 2 booster sessions. Each session lasts 2 hours. Main sessions held over 3 weeks.
Other Name: MAALES
Active Comparator: HIV Education & Risk Reduction Session
20-30 minute standard, client-centered HIV education and risk-reduction session administered over the phone or in person. Similar to that received during pre-test counseling for HIV testing.
Behavioral: Standard HIV Education & Risk Reduction
Single, individual counseling and education session. Lasting 20-30 minutes.
Other Name: Standard HERR Counseling Session
- Reduced HIV-related risk sexual behaviors [ Time Frame: 6 months ]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.
- Internalized Homophobia [ Time Frame: 6 months ]Examine whether reductions in internalized homophobia and gender role conflicts act as mediators of the effect of the MAALES Intervention condition on HIV risk behaviors (i.e., unprotected sexual intercourse and sex under the influence of drugs).
- Psychological distress [ Time Frame: 6 months ]Examine whether psychological distress (i.e., depression and anxiety) predicts for risky sexual behaviors and moderates the MAALES intervention condition's efficacy.
- Psychosocial outcomes [ Time Frame: 6 months ]Determine the impact of the MAALES Intervention condition on psychosocial outcomes including reducing stigma and increasing racial/cultural pride among African American MSMW.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492530
|United States, California|
|JWCH Institute, Inc.|
|Los Angeles, California, United States, 90013|
|Charles Drew University|
|Los Angeles, California, United States, 90059|
|Principal Investigator:||Nina Hawara, MPH, Ph. D||Charles Drew University|
|Principal Investigator:||John K. Williams, MD||University of California, Los Angeles|
|Principal Investigator:||Cleo Manago||AmASSI Health and Cultural Center|
|Principal Investigator:||Sergio Avina||JWCH Institute, Inc.|
|Principal Investigator:||Kevin Pickett||Palms Residential Care Facility|