Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE)

Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE: African-Americans Building Life Empowerment

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).

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Project ABLE

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: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53202
      • Diverse and Resilient

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The HCT-plus intervention will result in a greater proportion of men who abstain from anal and vaginal intercourse.	3 months after completing intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	3 months after completing the intervention

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: June 3, 2008
• First Submitted That Met QC Criteria: June 4, 2008
• First Posted (Estimate): June 5, 2008

Study Record Updates

• Last Update Posted (Estimate): March 11, 2010
• Last Update Submitted That Met QC Criteria: March 10, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: HIV Seronegativity; African American; HIV Prevention; Black; gay; Men who have sex men
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: CDC-NCHHSTP-5394