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Behavioral Intervention for HIV and HCV-Uninfected Injection Drug Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00164372
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : September 27, 2012
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Hepatitis C Behavioral: Peer Education Intervention Phase 2 Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Collaborative Injection Drug Users Study III/Drug Users Intervention Trial (CIDUS III/DUIT)
Study Start Date : May 2002
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 1. decrease in the number and proportion of times participants practiced vaginal or anal sex without a condom.
  2. 2. decrease in the overall number of persons participants shared syringes or injection equipment with.
  3. 3. decrease in the number and proportion of injections done with a syringe previously used by another person.
  4. 4. decrease in the number and proportion of times participant used another person's equipment to prepare or divide drugs before injecting.

Secondary Outcome Measures :
  1. 1. decrease the incidence of HCV infection.
  2. 2. decrease the frequency of injecting in high-risk settings.
  3. 3. increase the frequency of drug treatment entry or decrease the frequency of injection drug use.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00164372

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United States, California
Health Research Association
Los Angeles, California, United States, 90010
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, New York
New York Academy of Medicine
New York, New York, United States, 10029
United States, Washington
Public Health Seattle and King County
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Centers for Disease Control and Prevention
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Principal Investigator: Richard S. Garfein, PhD, MPH Centers for Disease Control and Prevention
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Centers for Disease Control and Prevention Identifier: NCT00164372    
Other Study ID Numbers: CDC-NCHSTP-2934
U64 CCU217659,
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: September 2012
Keywords provided by Centers for Disease Control and Prevention:
IV Drug users
hepatitis C virus
HIV Seronegativity
Additional relevant MeSH terms:
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Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections