Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE)
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ClinicalTrials.gov Identifier: NCT00691561 |
Recruitment Status
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Completed
First Posted
: June 5, 2008
Last Update Posted
: March 11, 2010
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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 | ||||
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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 |
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 |
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 |
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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. |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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Investigators ICMJE |
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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 |