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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

June 3, 2008
March 10, 2010
June 2008
March 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00691561 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Culturally-Tailored HIV Risk Reduction for African-American MSM
Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE: African-Americans Building Life Empowerment
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).
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
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.
  • Experimental: 1
    Participants receive HIV counseling and testing and 8 intervention sessions to assist them with reducing unsafe sexual behaviors.
    Intervention: Behavioral: Project ABLE
  • No Intervention: 2
    Participants receive HIV counseling and testing only.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00691561
CDC-NCHHSTP-5394
No
Not Provided
Not Provided
David Seal, Principal Investigator, Medical College of Wisconsin- Center for AIDS Intervention Research
Medical College of Wisconsin
  • Centers for Disease Control and Prevention
  • Diverse and Resilient
  • Charles D Productions
  • Milwaukee LGBT Community Center
Principal Investigator: David Seal, PhD Medical College of Wisconsin
Centers for Disease Control and Prevention
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP