Culturally-Tailored HIV Risk Reduction for African-American MSM - Full Text View

Sponsors and Collaborators:	Medical College of Wisconsin 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

Purpose

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	Intervention
HIV Infections	Behavioral: Project ABLE

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE: African-Americans Building Life Empowerment

Further study details as provided by Centers for Disease Control and Prevention:

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 ]

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 ]

Estimated Enrollment:	220
Study Start Date:	June 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: No Intervention Participants receive HIV counseling and testing only.

Arms

Assigned Interventions

1: Experimental

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.

2: No Intervention

Participants receive HIV counseling and testing only.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691561

Contacts

Contact: David Seal, PhD

414-955-7750

dseal@mcw.edu

Locations

United States, Wisconsin
Diverse and Resilient	Recruiting
Milwaukee, Wisconsin, United States, 53202
Contact: Brenda Coley 414-390-0444 bcoley@diverseandresilient.org

Sponsors and Collaborators

Medical College of Wisconsin

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

More Information

Responsible Party:	Medical College of Wisconsin- Center for AIDS Intervention Research ( David Seal, Principal Investigator )
Study ID Numbers:	CDC-NCHHSTP-5394
Study First Received:	June 3, 2008
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00691561
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by Centers for Disease Control and Prevention:

HIV Prevention
African American
Black

gay
Men who have sex men
HIV Seronegativity

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009