Project ICARE: Intervening for Community Awareness, Respe... | NCT00712088

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

NCT00712088

Sponsor

Centers for Disease Control and Prevention

Status

Completed

Last Update Posted

Mar 11, 2010Estimated

Enrollment

275Estimated

Phase

Not Applicable

Conditions

HIV Infections

Interventions

Project ICARE
HCT

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jun 3, 2008

First Submission Date that Met QC Criteria

Jul 8, 2008

First Posted Date

Jul 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2010

Last Update Posted Date

Mar 11, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Centers for Disease Control and PreventionFED

Collaborators

Name	Class
Howard Brown Health Center	OTHER
University of Illinois at Chicago	OTHER
South Side Help Center	UNKNOWN
Chicago Department of Public Health

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

275Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1: Group Intervention	Experimental	Group level intervention	Behavioral: Project ICARE
2: HCT	Active Comparator	Offer of HIV counseling and testing	Behavioral: HCT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Project ICARE	Behavioral	Group-level intervention (Project ICARE)	1: Group Intervention

Measure	Description	Time Frame
Unprotected Sex		past three months

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David McKirnan, PhD	University of Illinois at Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Howard Brown Health Center		Chicago	Illinois	60613	United States

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D047568	Unsafe Sex
D006716	Homosexuality
D001727	Bisexuality

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided