NCT00712088

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2008

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 11, 2010

Status Verified

March 1, 2010

Enrollment Period

1.7 years

First QC Date

June 3, 2008

Last Update Submit

March 10, 2010

Conditions

HIV Infections

Keywords

HIVUnsafe SexHigh Risk SexHIV PreventionAfrican-Americangaybisexualintervention trial

Outcome Measures

Primary Outcomes (1)

  • Unprotected Sex

    past three months

Study Arms (2)

1: Group Intervention

EXPERIMENTAL

Group level intervention

Behavioral: Project ICARE

2: HCT

ACTIVE COMPARATOR

Offer of HIV counseling and testing

Behavioral: HCT

Interventions

Project ICAREBEHAVIORAL

Group-level intervention (Project ICARE)

Also known as: Intervening for Community Awareness, Respect, & Empowerment
1: Group Intervention
HCTBEHAVIORAL

Offer of HIV counseling and testing

2: HCT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Howard Brown Health Center

Chicago, Illinois, 60613, United States

Location

MeSH Terms

Conditions

HIV InfectionsUnsafe SexHomosexualityBisexuality

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexual BehaviorBehaviorSexuality

Study Officials

  • David McKirnan, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

June 3, 2008

First Posted

July 9, 2008

Study Start

July 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 11, 2010

Record last verified: 2010-03

Locations

US(1)