Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE)
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project ABLE
Sponsored by

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Prevention, African American, Black, gay, Men who have sex men, HIV Seronegativity
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
Sites / Locations
- Diverse and Resilient
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Participants receive HIV counseling and testing and 8 intervention sessions to assist them with reducing unsafe sexual behaviors.
Participants receive HIV counseling and testing only.
Outcomes
Primary Outcome Measures
The HCT-plus intervention will result in a greater proportion of men who abstain from anal and vaginal intercourse.
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.
Full Information
NCT ID
NCT00691561
First Posted
June 3, 2008
Last Updated
March 10, 2010
Sponsor
Medical College of Wisconsin
Collaborators
Centers for Disease Control and Prevention, Diverse and Resilient, Charles D Productions, Milwaukee LGBT Community Center
1. Study Identification
Unique Protocol Identification Number
NCT00691561
Brief Title
Culturally-Tailored HIV Risk Reduction for African-American MSM
Acronym
Project ABLE
Official Title
Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE: African-Americans Building Life Empowerment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Centers for Disease Control and Prevention, Diverse and Resilient, Charles D Productions, Milwaukee LGBT Community Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Prevention, African American, Black, gay, Men who have sex men, HIV Seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants receive HIV counseling and testing and 8 intervention sessions to assist them with reducing unsafe sexual behaviors.
Arm Title
2
Arm Type
No Intervention
Arm Description
Participants receive HIV counseling and testing only.
Intervention Type
Behavioral
Intervention Name(s)
Project ABLE
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Seal, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diverse and Resilient
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Culturally-Tailored HIV Risk Reduction for African-American MSM
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