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

This study has been completed.

Sponsor:

Collaborators:

Centers for Disease Control and Prevention

Diverse and Resilient

Charles D Productions

Milwaukee LGBT Community Center

Information provided by:

Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT00691561

First received: June 3, 2008

Last updated: March 10, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 3, 2008

Last Updated Date

March 10, 2010

Start Date ^ICMJE

June 2008

Primary Completion Date

March 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

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

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Culturally-Tailored HIV Risk Reduction for African-American MSM

Official Title ^ICMJE

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

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.

Study Arms

Experimental: 1
Participants receive HIV counseling and testing and 8 intervention sessions to assist them with reducing unsafe sexual behaviors.

Intervention: Behavioral: Project ABLE
No Intervention: 2
Participants receive HIV counseling and testing only.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

220

Completion Date

March 2010

Primary Completion Date

March 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00691561

Other Study ID Numbers ^ICMJE

CDC-NCHHSTP-5394

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

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

Study Sponsor ^ICMJE

Medical College of Wisconsin

Collaborators ^ICMJE

Centers for Disease Control and Prevention
Diverse and Resilient
Charles D Productions
Milwaukee LGBT Community Center

Investigators ^ICMJE

Principal Investigator:

David Seal, PhD

Medical College of Wisconsin

PRS Account

Centers for Disease Control and Prevention

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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