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Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE)
This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00691561
First received: June 3, 2008
Last updated: March 10, 2010
Last verified: March 2010
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Purpose
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).
| Condition | Intervention |
|---|---|
| HIV Infections | Behavioral: Project ABLE |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Centers for Disease Control and Prevention:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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 ]
| Estimated Enrollment: | 220 |
| Study Start Date: | June 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants receive HIV counseling and testing and 8 intervention sessions to assist them with reducing unsafe sexual behaviors.
|
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.
|
|
No Intervention: 2
Participants receive HIV counseling and testing only.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691561
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691561
Locations
| United States, Wisconsin | |
| Diverse and Resilient | |
| Milwaukee, Wisconsin, United States, 53202 | |
Sponsors and Collaborators
Medical College of Wisconsin
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 |
More Information
| 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 |
| Study First Received: | June 3, 2008 |
| Last Updated: | March 10, 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 |
ClinicalTrials.gov processed this record on September 21, 2017