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Completed

NCT Number: NCT00691561

Culturally-Tailored HIV Risk Reduction for African-American MSM

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Project ABLE

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Charles D Productions
  • Diverse and Resilient
  • Milwaukee LGBT Community Center

Registry information

Official study title

Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE: African-Americans Building Life Empowerment

Acronym: Project ABLE

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 5, 2008
Registry last updated
Mar 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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