Behavioral Intervention Trial for HIV-infected Injection Drug Users

This study has been completed.
Sponsor:
Collaborator:
Health Services Resource Adminstration - HIV/AIDS Bureau
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00146445
First received: September 2, 2005
Last updated: September 26, 2012
Last verified: September 2012

September 2, 2005
September 26, 2012
August 2001
July 2006   (final data collection date for primary outcome measure)
  • - 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
Same as current
Complete list of historical versions of study NCT00146445 on ClinicalTrials.gov Archive Site
-Proportion of HIV status disclosure to sex partners
Same as current
Not Provided
Not Provided
 
Behavioral Intervention Trial for HIV-infected Injection Drug Users
Intervention for Seropositive Injection Drug Users - Research and Evaluation (INSPIRE)

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
Behavioral: Peer Mentoring Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
July 2006
July 2006   (final data collection date for primary outcome measure)

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:

-

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00146445
CDC-NCHSTP-2864, U22/CCU217990, U22/CCU317999, U22/CCU417998, U22/CCU918003
No
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
Health Services Resource Adminstration - HIV/AIDS Bureau
Principal Investigator: David W Purcell, JD, PhD Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP