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

• ClinicalTrials.gov Identifier: NCT00691561
• Recruitment Status: Completed
• First Posted: June 5, 2008
• Last Update Posted: March 11, 2010
• Sponsor: Medical College of Wisconsin
• 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

Tracking Information

• First Submitted Date: June 3, 2008
• First Posted Date: June 5, 2008
• Last Update Posted Date: March 11, 2010
• Study Start Date: June 2008
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 4, 2008): 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 ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00691561 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: June 4, 2008): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Culturally-Tailored HIV Risk Reduction for African-American MSM
• Official Title: Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE: African-Americans Building Life Empowerment
• Brief Summary: 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).
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: HIV Infections

Intervention

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.

Study Arms

• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: June 4, 2008): 220
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2010
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00691561
• Other Study ID Numbers: CDC-NCHHSTP-5394
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: David Seal, Principal Investigator, Medical College of Wisconsin- Center for AIDS Intervention Research
• Study Sponsor: Medical College of Wisconsin

Collaborators

• 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

• PRS Account: Centers for Disease Control and Prevention
• Verification Date: March 2010