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

This study has been completed.
Sponsor:
Collaborators:
Howard Brown Health Center
University of Illinois
South Side Help Center
Chicago Department of Public Health
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00712088
First received: June 3, 2008
Last updated: March 10, 2010
Last verified: March 2010
History of Changes
  Purpose

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).


Condition Intervention
HIV Infections
 Behavioral: Project ICARE
Behavioral: HCT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Unprotected Sex [ Time Frame: past three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 275
Study Start Date: July 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Group Intervention
Group level intervention
 Behavioral: Project ICARE
Group-level intervention (Project ICARE)
Other Name: Intervening for Community Awareness, Respect, & Empowerment
Active Comparator: 2: HCT
Offer of HIV counseling and testing
 Behavioral: HCT
Offer of HIV counseling and testing

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712088

Locations
United States, Illinois
Howard Brown Health Center
Chicago, Illinois, United States, 60613
Sponsors and Collaborators
Centers for Disease Control and Prevention
Howard Brown Health Center
University of Illinois
South Side Help Center
Chicago Department of Public Health
Investigators
Principal Investigator: David McKirnan, PhD University of Illinois
  More Information

No publications provided

Responsible Party: David McKirnan, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00712088     History of Changes
Other Study ID Numbers: CDC-NCHHSTP-5159
Study First Received: June 3, 2008
Last Updated: March 10, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Centers for Disease Control and Prevention:
HIV
Unsafe Sex
High Risk Sex
HIV Prevention
 African-American
gay
bisexual
intervention trial

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 23, 2013