Behavioral Intervention for HIV and HCV-Uninfected Injection Drug Users

Sponsor

Centers for Disease Control and Prevention (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00164372

Collaborator

(none)

1,400

Enrollment

Locations

Duration (Months)

280

Patients Per Site

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test whether a six-session behavioral intervention for HIV and HCV seronegative injection drug users is effective in reducing sexual and injection risk behaviors that could lead to primary HIV and HCV infection.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Hepatitis C	Behavioral: Peer Education Intervention	Phase 2/Phase 3

Detailed Description

CIDUS III/DUIT is a five-city (Baltimore, Chicago, Los Angeles, New York, and Seattle) randomized controlled trial to develop and evaluate the efficacy of a six-session behavioral intervention for HIV and HCV uninfected injection drug users between the ages of 15 and 30 years. The primary goals of the intervention are to:

decrease the shared use of syringes and other injection paraphernalia,
decrease sexual risk behaviors associated with HIV and HCV infection, and
decrease the incidence of hepatitis C virus (HCV) infection.

The intervention arm consists of six small-group training and skills-building sessions to teach and reinforce peer education activities around decreasing sex and injection risk behaviors for HIV and HCV infection. In the fifth session, participants practice peer education around sex or injection risk behaviors within their community. The control arm consists of six video and discussion sessions to control for attention. Prior to study enrollment, all participants in both arms receive HIV and HCV testing with client-centered pre- and post-test counseling to also control for the demand for risk reduction information. Behavioral assessments (by audio computer assisted self interviewing) and blood draws (for serologic testing) occur at baseline, 3 and 6 month follow-up. 3285 participants completed the baseline visit, of whom 1564 tested HIV and HCV seronegative and returned for test results making them eligible to enroll in the intervention trial. Of the eligible participants, 854 were randomized into the trial. 606 and 591 returned for 3 and 6 month follow-up assessments, respectively, and 712 participants completed at least one follow-up visit.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Collaborative Injection Drug Users Study III/Drug Users Intervention Trial (CIDUS III/DUIT)

Study Start Date :

May 1, 2002

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

1. decrease in the number and proportion of times participants practiced vaginal or anal sex without a condom. []
2. decrease in the overall number of persons participants shared syringes or injection equipment with. []
3. decrease in the number and proportion of injections done with a syringe previously used by another person. []
4. decrease in the number and proportion of times participant used another person's equipment to prepare or divide drugs before injecting. []

Secondary Outcome Measures

1. decrease the incidence of HCV infection. []
2. decrease the frequency of injecting in high-risk settings. []
3. increase the frequency of drug treatment entry or decrease the frequency of injection drug use. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

age 15-30 years old
self-reported illicit drug injection within the past 6 months
live in the geographic region under study and plan to stay for >12 months
willing to provide a blood sample for serologic testing
willing to provide basic contact information for follow-up
able to communicate in English
had not participated in the pilot study or previously enrolled in the trial
not concurrently participating in other HIV or HCV intervention trials
tested HIV and HCV seronegative at baseline

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health Research Association	Los Angeles	California	United States	90010
2	University of Illinois at Chicago	Chicago	Illinois	United States	60612
3	Johns Hopkins University	Baltimore	Maryland	United States	21205
4	New York Academy of Medicine	New York	New York	United States	10029
5	Public Health Seattle and King County	Seattle	Washington	United States	98104