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Men of African American Legacy Empowering Self (MAALES)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Center on Minority Health and Health Disparities (NCMHD)
California HIV/AIDS Research Program
University of California, Los Angeles
Information provided by (Responsible Party):
Nina Harawa, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT01492530
First received: December 9, 2011
Last updated: December 14, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV
 Behavioral: Men of African American Legacy Empowering Self
Behavioral: Standard HIV Education & Risk Reduction
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing HIV Risk Behaviors and Psychosocial Stressors Among Bisexual African American Men

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Charles Drew University of Medicine and Science:

Primary Outcome Measures:
  • Reduced HIV-related risk sexual behaviors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Internalized Homophobia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Determine the impact of the MAALES Intervention condition on psychosocial outcomes including reducing stigma and increasing racial/cultural pride among African American MSMW.


Enrollment: 437
Study Start Date: August 2007
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-identified man of African descent (black)
  • 18 years of age or older
  • English speaking
  • Has had sex (oral, anal, mutual masturbation) with man or with a male-to-female transgender within the past 24 months.
  • Has had sex (oral, anal, mutual masturbation) with a woman within the past 24 months.

Exclusion criteria:

  • Participated in another HIV prevention study, in a small-group HIV prevention program or HIV prevention case management in the prior 6 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492530

Locations
United States, California
Charles Drew University
Los Angeles, California, United States, 90059
JWCH Institute, Inc.
Los Angeles, California, United States, 90013
Sponsors and Collaborators
Charles Drew University of Medicine and Science
National Center on Minority Health and Health Disparities (NCMHD)
California HIV/AIDS Research Program
University of California, Los Angeles
Investigators
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
  More Information

Additional Information:
Study Website  This link exits the ClinicalTrials.gov site
MAALES website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Nina Harawa, Associate Professor, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT01492530     History of Changes
Other Study ID Numbers: AL04-DREW-840, 2P20MD000182
Study First Received: December 9, 2011
Last Updated: December 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Charles Drew University of Medicine and Science:
Men who have sex with Men and Women
HIV Prevention
Behavioral Intervention
Condom use
African American MSMW

ClinicalTrials.gov processed this record on June 17, 2013