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

Tracking Information
First Submitted Date ICMJE	June 3, 2008
First Posted Date ICMJE	June 5, 2008
Last Update Posted Date	March 11, 2010
Study Start Date ICMJE	June 2008
Actual Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (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 ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00691561 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (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 ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Culturally-Tailored HIV Risk Reduction for African-American MSM
Official Title ICMJE	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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	HIV Infections
Intervention ICMJE	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
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: June 4, 2008)	220
Original Estimated Enrollment ICMJE	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 ICMJE	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, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00691561
Other Study ID Numbers ICMJE	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 ICMJE	Medical College of Wisconsin
Collaborators ICMJE	Centers for Disease Control and Prevention; Diverse and Resilient; Charles D Productions; Milwaukee LGBT Community Center
Investigators ICMJE	Principal Investigator: David Seal, PhD Medical College of Wisconsin
PRS Account	Centers for Disease Control and Prevention
Verification Date	March 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP