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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
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

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
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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

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Culturally-Tailored HIV Risk Reduction for African-American MSM

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