Men of African American Legacy Empowering Self

NCT01492530 | Completed Phase 2 DMC

• 2 other identifiers: AL04-DREW-8402P20MD000182
• Study Type: interventional
• Target: 437
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV

Keywords

Men who have sex with Men and Women; HIV Prevention; Behavioral Intervention; Condom use; African American MSMW

Outcome Measures

Primary Outcomes (1)

• Reduced HIV-related risk sexual behaviors

  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.

  6 months

Secondary Outcomes (3)

• Internalized Homophobia

  6 months

• Psychological distress

  6 months

• Psychosocial outcomes

  6 months

Study Arms (2)

6-session, small group

EXPERIMENTAL

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

HIV Education & Risk Reduction Session

ACTIVE COMPARATOR

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

Interventions

Men of African American Legacy Empowering Self BEHAVIORAL

Small group intervention. 6 main sessions + 2 booster sessions. Each session lasts 2 hours. Main sessions held over 3 weeks.

Also known as: MAALES

6-session, small group

Standard HIV Education & Risk Reduction BEHAVIORAL

Single, individual counseling and education session. Lasting 20-30 minutes.

Also known as: Standard HERR Counseling Session

HIV Education & Risk Reduction Session

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identified man of African descent (black)
• 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.

You may not qualify if:

• Participated in another HIV prevention study, in a small-group HIV prevention program or HIV prevention case management in the prior 6 months.

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• California HIV/AIDS Research Program: collaborator
• University of California, Los Angeles: collaborator

Study Sites (2)

JWCH Institute, Inc.

Los Angeles, California, 90013, United States

Location

Charles Drew University

Los Angeles, California, 90059, United States

Location

Related Publications (3)

• Williams JK, Ramamurthi HC, Manago C, Harawa NT. Learning from successful interventions: A culturally congruent HIV risk-reduction intervention for African American men who have sex with men and women. Am J Public Health. 2009 Jun;99(6):1008-12. doi: 10.2105/AJPH.2008.140558. Epub 2009 Apr 16.

  PMID: 19372517 BACKGROUND

• Bingham TA, Harawa NT, Williams JK. Gender role conflict among African American men who have sex with men and women: associations with mental health and sexual risk and disclosure behaviors. Am J Public Health. 2013 Jan;103(1):127-33. doi: 10.2105/AJPH.2012.300855. Epub 2012 Nov 15.

  PMID: 23153143 BACKGROUND

• Harawa NT, Williams JK, McCuller WJ, Ramamurthi HC, Lee M, Shapiro MF, Norris KC, Cunningham WE. Efficacy of a culturally congruent HIV risk-reduction intervention for behaviorally bisexual black men: results of a randomized trial. AIDS. 2013 Jul 31;27(12):1979-88. doi: 10.1097/qad.0b013e3283617500.

  PMID: 24180003 RESULT

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 15, 2011
• Study Start: August 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: March 1, 2012
• Last Updated: June 11, 2014

Record last verified: 2014-06

Locations

US (2)