Project ICARE: Intervening for Community Awareness, Respect, & Empowerment

HIV Infections Clinical Trial

Official title:

Project ICARE: Intervening for Community Awareness, Respect, & Empowerment - Behavioral Intervention to Reduce Sexual Risk Behavior of African American Men Who Have Sex With Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712088
• Other study ID #: CDC-NCHHSTP-5159
• Status: Completed
• Phase: N/A
• First received: June 3, 2008
• Last updated: March 10, 2010
• Start date: July 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This project will test the efficacy of a behavioral intervention to reduce sexual risk for HIV infection among African American Men who Have Sex with Men (MSM).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be 18 years of age or older;

• Self-identify as African American

• Understand and read English;

• Live within the Chicago area;

• Report at least two (male or female) sex partners in the past three months, and unprotected anal sex with at least one male sex partner in the past three months.

Exclusion Criteria:

• Have been diagnosed with HIV within the past three months (to allow for psychological and behavioral adjustment following an initial HIV diagnosis);

• Have a specific plan to move from the Chicago area within the next nine months;

• Report active injection drug use other than hormones or steroids.

• Participated in the intervention video or the pilot phase of this study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Project ICARE
Group-level intervention (Project ICARE)
• HCT
Offer of HIV counseling and testing

Locations

Country	Name	City	State
United States	Howard Brown Health Center	Chicago	Illinois

Sponsors (5)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Chicago Department of Public Health, Howard Brown Health Center, South Side Help Center, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unprotected Sex		past three months	No