NCT00146445

Behavioral Intervention Trial for HIV-infected Injection Drug Users

Intervention for Seropositive Injection Drug Users - Research and Evaluation (INSPIRE)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,000 (planned)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test whether a ten-session behavioral intervention for HIV-infected injection drug users is effective in reducing sex and injection risk behaviors that put others at risk for HIV infection, increasing access to or utilization of HIV primary health care, and increasing adherence to HIV medications.

Detailed description

INSPIRE is a four-site (Baltimore, Miami, New York and San Francisco) randomized control trial to develop and evaluate the efficacy of a ten-session intervention for HIV-positive injection drug users. The primary goals of the intervention are to: 1. decrease sex and injection risk behaviors that put others at risk for HIV infection, 2. increase access to or utilization of HIV primary health care, and 3. increase adherence to HIV medications. The intervention arm consists of 7 group sessions, 2 individual sessions, and one community experience. The control arm consists of 8 group sessions, aiming at controlling for demand (1st session) and attention (8 group sessions). Behavioral assessments and blood draws (for viral load and CD4 testing) occur at baseline, 6, and 12 month follow-up; a 3 month assessment involves behavioral assessment only. 1161 participants took baseline. Of these, 966 were randomized into the study, and 840, 807, and 821 participants took 3, 6, and 12 month follow-up assessments, respectively.

Conditions

• HIV

Interventions

Type	Name	Description
BEHAVIORAL	Peer Mentoring Intervention

Timeline

• Start date: 2001-08-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2005-09-07
• Last updated: 2012-09-27

Locations

5 sites across 1 country: United States