Culturally-Tailored HIV Risk Reduction for African-American MSM - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 3, 2008

Last Updated Date

July 7, 2008

Start Date ^†

June 2008

Current Primary Outcome Measures ^†

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00691561 on ClinicalTrials.gov Archive Site

Current 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. [ Time Frame: 3 months after completing the intervention ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

Condition ^†

HIV Infections

Intervention ^†

Behavioral: Project ABLE

Study Arms / Comparison Groups

Experimental: Participants receive HIV counseling and testing and 8 intervention sessions to assist them with reducing unsafe sexual behaviors.
No Intervention: Participants receive HIV counseling and testing only.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

220

Estimated Completion Date

September 2009

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: David Seal, PhD

414-955-7750

dseal@mcw.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00691561

Responsible Party

David Seal, Principal Investigator, Medical College of Wisconsin- Center for AIDS Intervention Research

Secondary IDs ^††

Study 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

Information Provided By

Centers for Disease Control and Prevention

Verification Date

July 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.