Back to resultsProject ICARE: Intervening for Community Awareness, Respect, & Empowerment
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project ICARE
HCT
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV, Unsafe Sex, High Risk Sex, HIV Prevention, African-American, gay, bisexual, intervention trial
Eligibility 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.
Sites / Locations
- Howard Brown Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1: Group Intervention
2: HCT
Arm Description
Group level intervention
Offer of HIV counseling and testing
Outcomes
Primary Outcome Measures
Unprotected Sex
Secondary Outcome Measures
Full Information
NCT ID
NCT00712088
First Posted
June 3, 2008
Last Updated
March 10, 2010
Sponsor
Centers for Disease Control and Prevention
Collaborators
Howard Brown Health Center, University of Illinois at Chicago, South Side Help Center, Chicago Department of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT00712088
Brief Title
Project ICARE: Intervening for Community Awareness, Respect, & Empowerment
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Howard Brown Health Center, University of Illinois at Chicago, South Side Help Center, Chicago Department of Public Health
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Unsafe Sex, High Risk Sex, HIV Prevention, African-American, gay, bisexual, intervention trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
275 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1: Group Intervention
Arm Type
Experimental
Arm Description
Group level intervention
Arm Title
2: HCT
Arm Type
Active Comparator
Arm Description
Offer of HIV counseling and testing
Intervention Type
Behavioral
Intervention Name(s)
Project ICARE
Other Intervention Name(s)
Intervening for Community Awareness, Respect, & Empowerment
Intervention Description
Group-level intervention (Project ICARE)
Intervention Type
Behavioral
Intervention Name(s)
HCT
Intervention Description
Offer of HIV counseling and testing
Primary Outcome Measure Information:
Title
Unprotected Sex
Time Frame
past three months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David McKirnan, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Howard Brown Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Project ICARE: Intervening for Community Awareness, Respect, & Empowerment
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