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

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Completed

CT.gov ID

NCT00691561

Collaborator

Centers for Disease Control and Prevention (U.S. Fed), Diverse and Resilient (Other), Charles D Productions (Other), Milwaukee LGBT Community Center (Other)

220

Enrollment

Location

Arms

Duration (Months)

10.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Behavioral: Project ABLE	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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