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
  Purpose

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 Intervention Phase
HIV Infections
Hepatitis C
Behavioral: Peer Education 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: Collaborative Injection Drug Users Study III/Drug Users Intervention Trial (CIDUS III/DUIT)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 1400
Study Start Date: May 2002
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

-

  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: NCT00164372

Locations
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
Investigators
Principal Investigator: Richard S. Garfein, PhD, MPH Centers for Disease Control and Prevention
  More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00164372     History of Changes
Other Study ID Numbers: CDC-NCHSTP-2934, U64/CCU317662,, U64/CCU517656,, U64/CCU917655,, U64 CCU217659,, U64/CCU071615
Study First Received: September 9, 2005
Last Updated: September 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
IV Drug users
HIV
hepatitis C virus
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis C
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 11, 2014