Behavioral Intervention Trial for HIV-infected Injection Drug Users

Phase 2

Completed

• Conditions: HIV

• Registration Number: NCT00146445
• Lead Sponsor: Centers for Disease Control and Prevention

Brief 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.

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-07
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-26
• Last Update Posted: 2012-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 18 years of age or older
• self-identify as a person who has injected drugs in the last 12 months
• self-identify as a person who has had sex with at least one opposite sex partner within the last 3 months
• self-identify as HIV-seropositive
• be confirmed as HIV seropositive through oral fluid (saliva) HIV testing
• live in the geographic region under study,
• agree to have their blood drawn for CD4 count and viral load testing
• be willing to provide basic contact information (for follow-up)
• be able to communicate in English
• not have participated in the full-pilot of this intervention and not have enrolled previously in the present study.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
- unprotected vaginal/anal sex with HIV-negative or unknown serostatus partners in the past 3 months
- lending needle or sharing cotton, cooker, or rinse water with HIV-negative or unknown serostatus partners in the past 3 months
-health care visits for HIV primary care in the past 6 months
-90% or more adherence to HIV medication yesterday and in the past week

Secondary Outcome Measures

Name	Time	Method
-Proportion of HIV status disclosure to sex partners

Trial Locations

Locations (5)

New York Academy of Medicine; 🇺🇸 New York, New York, United States

University of California - San Francisco; 🇺🇸 San Fransisco, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States