Culturally-Tailored HIV Risk Reduction for African-American MSM

HIV Infections Clinical Trial

— Project ABLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691561
• Other study ID #: CDC-NCHHSTP-5394
• Status: Completed
• Phase: N/A
• First received: June 3, 2008
• Last updated: March 10, 2010
• Start date: June 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Diverse and Resilient	Milwaukee	Wisconsin

Sponsors (5)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Centers for Disease Control and Prevention, Charles D Productions, Diverse and Resilient, Milwaukee LGBT Community Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The HCT-plus intervention will result in a greater proportion of men who abstain from anal and vaginal intercourse.		3 months after completing intervention	No
Secondary	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	No