Behavioral Intervention Trial for HIV-infected Injection Drug Users

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146445
• Other study ID #: CDC-NCHSTP-2864
• Secondary ID: U22/CCU217990U22
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 2, 2005
• Last updated: September 26, 2012
• Start date: August 2001
• Est. completion date: July 2006

Study information

• Verified date: September 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Peer Mentoring Intervention

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	University of Miami	Miami	Florida
United States	New York Academy of Medicine	New York	New York
United States	University of California - San Francisco	San Fransisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Health Services Resource Adminstration - HIV/AIDS Bureau

Country where clinical trial is conducted

United States, 

References & Publications (1)

Purcell DW, Metsch LR, Latka M, Santibanez S, Gómez CA, Eldred L, Latkin CA; INSPIRE Study Group. Interventions for seropositive injectors-research and evaluation: an integrated behavioral intervention with HIV-positive injection drug users to address medical care, adherence, and risk reduction. J Acquir Immune Defic Syndr. 2004 Oct 1;37 Suppl 2:S110-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- unprotected vaginal/anal sex with HIV-negative or unknown serostatus partners in the past 3 months
Primary	- lending needle or sharing cotton, cooker, or rinse water with HIV-negative or unknown serostatus partners in the past 3 months
Primary	-health care visits for HIV primary care in the past 6 months
Primary	-90% or more adherence to HIV medication yesterday and in the past week
Secondary	-Proportion of HIV status disclosure to sex partners