Clinical trial NCT00691561: Culturally-Tailored HIV Risk Reduction for African-American MSM
Official title: Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE: African-Americans Building Life Empowerment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV Prevention
African American
Black
gay
Men who have sex men
HIV Seronegativity
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Centers for Disease Control and Prevention
name: Diverse and Resilient
name: Charles D Productions
name: Milwaukee LGBT Community Center
First posted: 2008-06-05
Enrollment: 220
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The HCT-plus intervention will result in a greater proportion of men who abstain from anal and vaginal intercourse.
timeFrame: 3 months after completing intervention
Secondary outcomes:
measure: 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.
timeFrame: 3 months after completing the intervention
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Diverse and Resilient
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: David Seal, PhD
role: PRINCIPAL_INVESTIGATOR
References: