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

March 10, 2010 updated by: Centers for Disease Control and Prevention

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

275

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60613
        • Howard Brown Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1: Group Intervention
Group level intervention
Behavioral: Project ICARE
Group-level intervention (Project ICARE)
Other Names:
  • Intervening for Community Awareness, Respect, & Empowerment
Active Comparator: 2: HCT
Offer of HIV counseling and testing
Behavioral: HCT
Offer of HIV counseling and testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Unprotected Sex
Time Frame: past three months
past three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

University of Illinois at Chicago
Howard Brown Health Center
Chicago Department of Public Health
South Side Help Center

Investigators

  • Principal Investigator: David McKirnan, PhD, University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

July 8, 2008

First Posted (Estimate)

July 9, 2008

Study Record Updates

Last Update Posted (Estimate)

March 11, 2010

Last Update Submitted That Met QC Criteria

March 10, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCHHSTP-5159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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