Behavioral Intervention for HIV and HCV-Uninfected Injection Drug Users

HIV Infections Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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:

1. decrease the shared use of syringes and other injection paraphernalia,

2. decrease sexual risk behaviors associated with HIV and HCV infection, and

3. 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis C
• HIV Infections

• NCT number: NCT00164372
• Study type: Interventional
• Source: Centers for Disease Control and Prevention
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2002
• Completion date: December 2006