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
  Purpose

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.


Condition Intervention Phase
HIV
Behavioral: Peer Mentoring Intervention
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intervention for Seropositive Injection Drug Users - Research and Evaluation (INSPIRE)

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • - 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:
  • -Proportion of HIV status disclosure to sex partners

Estimated Enrollment: 1000
Study Start Date: August 2001
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146445

Locations
United States, California
University of California - San Francisco
San Fransisco, California, United States, 94105
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
New York Academy of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Health Services Resource Adminstration - HIV/AIDS Bureau
Investigators
Principal Investigator: David W Purcell, JD, PhD Centers for Disease Control and Prevention
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00146445     History of Changes
Other Study ID Numbers: CDC-NCHSTP-2864, U22/CCU217990, U22/CCU317999, U22/CCU417998, U22/CCU918003
Study First Received: September 2, 2005
Last Updated: September 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
IV drug users

ClinicalTrials.gov processed this record on September 16, 2014