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Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE)

This study has been completed.
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Diverse and Resilient
Charles D Productions
Milwaukee LGBT Community Center
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00691561
First received: June 3, 2008
Last updated: March 10, 2010
Last verified: March 2010
History of Changes
  Purpose

The purpose of this study to conduct a small randomized control trial to compare the relative effectiveness of a single-session of HIV testing and counseling risk reduction intervention (HCT-only) to an enhanced intervention that includes the standard HCT intervention plus a theory-based and culturally-tailored group-level intervention designed to reduce or eliminate HIV and STI risk behaviors (HCT-plus) among African-American men who have sex with men (AA-MSM).


Condition Intervention
HIV Infections
 Behavioral: Project ABLE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE: African-Americans Building Life Empowerment

Resource links provided by NLM:

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

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • The HCT-plus intervention will result in a greater proportion of men who abstain from anal and vaginal intercourse. [ Time Frame: 3 months after completing intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The HCT-plus intervention will result in a smaller proportion of men who had an act of anal or vaginal intercourse without the use of a condom. [ Time Frame: 3 months after completing the intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: June 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants receive HIV counseling and testing and 8 intervention sessions to assist them with reducing unsafe sexual behaviors.
 Behavioral: Project ABLE
Participants will receive HIV counseling and testing. Those selected for the intervention arm will attend small groups consisting of 10 men who meet once a week for 8 consecutive weeks. The weekly two hour discussion sessions will address HIV risk behavior within a framework of contextual influences that may moderate men's risk reduction motivation and behavior. The factors include identity, stigma, connections to community, and situation factors.
No Intervention: 2
Participants receive HIV counseling and testing only.

Detailed Description:

The HCT-plus intervention will consist of the HCT-only intervention, as well as 8 small group intervention sessions focused on HIV risk reduction. Small groups will consist of 10 men who will meet once-a-week for 8 consecutive weeks. Each meeting will last approximately 2 hours. In each small group session, staff will work with men to reassess their HIV risk behavior, re-prioritize their goals as appropriate, and provide motivational support for their risk reduction accomplishments. Participants will be asked to discuss ways they have successfully avoided HIV risk behavior since the previous session, as well as to discuss situations in which they found it difficult to avoid risk. Staff will reinforce successful risk avoidance, and problem-solve with men to overcome barriers to risk reduction.

  Eligibility

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

Inclusion Criteria:

  • reside in Milwaukee county;
  • are at least 18 years of age;
  • self-identify as male;
  • self-identify as Black or African-American;
  • can provide informed consent;
  • report unprotected anal sex with a man in the past 3 months;
  • report at least two sexual partners with whom they have had unprotected anal or vaginal sex in the past 3 months;
  • are willing to be tested for HIV using rapid oral fluid procedures or willing to provide evidence of HIV seropositivity

Exclusion Criteria:

  • Under 18 years of age,
  • involvement in a HIV prevention study currently or in the past 6 months,
  • Participation in the pilot phase
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691561

Locations
United States, Wisconsin
Diverse and Resilient
Milwaukee, Wisconsin, United States, 53202
Sponsors and Collaborators
Medical College of Wisconsin
Centers for Disease Control and Prevention
Diverse and Resilient
Charles D Productions
Milwaukee LGBT Community Center
Investigators
Principal Investigator: David Seal, PhD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: David Seal, Principal Investigator, Medical College of Wisconsin- Center for AIDS Intervention Research
ClinicalTrials.gov Identifier: NCT00691561     History of Changes
Other Study ID Numbers: CDC-NCHHSTP-5394
Study First Received: June 3, 2008
Last Updated: March 10, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Centers for Disease Control and Prevention:
HIV Prevention
African American
Black
 gay
Men who have sex men
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on March 14, 2013