Behavioral Intervention for HIV and HCV-Uninfected Injection Drug Users

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00164372
First received: September 9, 2005
Last updated: September 26, 2012
Last verified: September 2012

September 9, 2005
September 26, 2012
May 2002
December 2006   (final data collection date for primary outcome measure)
  • 1. decrease in the number and proportion of times participants practiced vaginal or anal sex without a condom.
  • 2. decrease in the overall number of persons participants shared syringes or injection equipment with.
  • 3. decrease in the number and proportion of injections done with a syringe previously used by another person.
  • 4. decrease in the number and proportion of times participant used another person's equipment to prepare or divide drugs before injecting.
Same as current
Complete list of historical versions of study NCT00164372 on ClinicalTrials.gov Archive Site
  • 1. decrease the incidence of HCV infection.
  • 2. decrease the frequency of injecting in high-risk settings.
  • 3. increase the frequency of drug treatment entry or decrease the frequency of injection drug use.
Same as current
Not Provided
Not Provided
 
Behavioral Intervention for HIV and HCV-Uninfected Injection Drug Users
Collaborative Injection Drug Users Study III/Drug Users Intervention Trial (CIDUS III/DUIT)

The purpose of this study is to test whether a six-session behavioral intervention for HIV and HCV seronegative injection drug users is effective in reducing sexual and injection risk behaviors that could lead to primary HIV and HCV infection.

CIDUS III/DUIT is a five-city (Baltimore, Chicago, Los Angeles, New York, and Seattle) randomized controlled trial to develop and evaluate the efficacy of a six-session behavioral intervention for HIV and HCV uninfected injection drug users between the ages of 15 and 30 years. The primary goals of the intervention are to:

  1. decrease the shared use of syringes and other injection paraphernalia,
  2. decrease sexual risk behaviors associated with HIV and HCV infection, and
  3. decrease the incidence of hepatitis C virus (HCV) infection.

The intervention arm consists of six small-group training and skills-building sessions to teach and reinforce peer education activities around decreasing sex and injection risk behaviors for HIV and HCV infection. In the fifth session, participants practice peer education around sex or injection risk behaviors within their community. The control arm consists of six video and discussion sessions to control for attention. Prior to study enrollment, all participants in both arms receive HIV and HCV testing with client-centered pre- and post-test counseling to also control for the demand for risk reduction information. Behavioral assessments (by audio computer assisted self interviewing) and blood draws (for serologic testing) occur at baseline, 3 and 6 month follow-up. 3285 participants completed the baseline visit, of whom 1564 tested HIV and HCV seronegative and returned for test results making them eligible to enroll in the intervention trial. Of the eligible participants, 854 were randomized into the trial. 606 and 591 returned for 3 and 6 month follow-up assessments, respectively, and 712 participants completed at least one follow-up visit.

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1400
December 2006
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 15-30 years old
  • self-reported illicit drug injection within the past 6 months
  • live in the geographic region under study and plan to stay for >12 months
  • willing to provide a blood sample for serologic testing
  • willing to provide basic contact information for follow-up
  • able to communicate in English
  • had not participated in the pilot study or previously enrolled in the trial
  • not concurrently participating in other HIV or HCV intervention trials
  • tested HIV and HCV seronegative at baseline

Exclusion Criteria:

-

Both
15 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00164372
CDC-NCHSTP-2934, U64/CCU317662,, U64/CCU517656,, U64/CCU917655,, U64 CCU217659,, U64/CCU071615
No
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
Not Provided
Principal Investigator: Richard S. Garfein, PhD, MPH 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