Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE)
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ClinicalTrials.gov Identifier: NCT00691561 |
Recruitment Status
:
Completed
First Posted
: June 5, 2008
Last Update Posted
: March 11, 2010
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Condition or disease | Intervention/treatment | Phase |
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HIV Infections | Behavioral: Project ABLE | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 220 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE: African-Americans Building Life Empowerment |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Participants receive HIV counseling and testing and 8 intervention sessions to assist them with reducing unsafe sexual behaviors.
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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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No Intervention: 2
Participants receive HIV counseling and testing only.
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691561
United States, Wisconsin | |
Diverse and Resilient | |
Milwaukee, Wisconsin, United States, 53202 |
Principal Investigator: | David Seal, PhD | Medical College of Wisconsin |
Responsible Party: | David Seal, Principal Investigator, Medical College of Wisconsin- Center for AIDS Intervention Research |
ClinicalTrials.gov Identifier: | NCT00691561 History of Changes |
Other Study ID Numbers: |
CDC-NCHHSTP-5394 |
First Posted: | June 5, 2008 Key Record Dates |
Last Update Posted: | March 11, 2010 |
Last Verified: | March 2010 |
Keywords provided by Centers for Disease Control and Prevention:
HIV Prevention African American Black |
gay Men who have sex men HIV Seronegativity |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |