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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00712088
First Posted: July 9, 2008
Last Update Posted: March 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Howard Brown Health Center
University of Illinois at Chicago
South Side Help Center
Chicago Department of Public Health
Information provided by:
Centers for Disease Control and Prevention
  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: None (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:


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

Primary Outcome Measures:
  • Unprotected Sex [ Time Frame: past three months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 at Chicago
South Side Help Center
Chicago Department of Public Health
Investigators
Principal Investigator: David McKirnan, PhD University of Illinois at Chicago
  More Information

Responsible Party: David McKirnan, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00712088     History of Changes
Other Study ID Numbers: CDC-NCHHSTP-5159
First Submitted: June 3, 2008
First Posted: July 9, 2008
Last Update Posted: March 11, 2010
Last Verified: March 2010

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases