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A Trial to Reduce Hepatitis C Among Injection Drug Users - 1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00218192
First Posted: September 22, 2005
Last Update Posted: May 22, 2015
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michael Stein, MD, National Institute on Drug Abuse (NIDA)
  Purpose
The purpose of this study is to examine the efficacy of a brief motivational intervention on the cumulative incidence of Hepatitis C.

Condition Intervention Phase
HCV Negative Status HCV Risk Behavior Behavioral: Behavior Therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial to Reduce Hepatitis C Among Injection Drug Users

Resource links provided by NLM:


Further study details as provided by Michael Stein, MD, National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Hepatitis C seroconversion

Secondary Outcome Measures:
  • Substance use

Enrollment: 277
Study Start Date: September 2000
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Injection drug users are at high risk for blood-borne viral infections during their first years of injecting when they are least likely to seek formal substance abuse treatment, and are likely to be practicing risky drug-use behaviors. Research has demonstrated that a brief motivational intervention that includes booster sessions and addresses drug and sex risks is effective in reducing HIV risk behaviors among injection drug users.

Because Hepatitis C Virus is a bloodborne pathogen like HIV, and transmission occurs via similar behaviors, successful HIV prevention strategies should be robust in preventing HCV but need to be tested. Motivational interventions, which aim to elicit a goal and plan from the patient to reduce injection and sexual risk taking, are particularly suited to address behaviorally-based changes. Motivational interventions are individualized and tailored to the risks and concerns of the participant, but can be standardized and evaluated to make this technique applicable in a variety of settings. The occurrence of injection drug use in a population with traditionally poor linkage to primary care, an enormous burden of illness, and high HCV and other blood-borne pathogen transmission risk, supports the use of motivational interventions in this group.

Comparison(s): Participants are assigned, in this 24 month longitudinal study, to an assessment-only condition or an assessment plus motivational intervention condition. Participants in the intervention condition receive up to 4 sessions of motivational interviewing during the first 6 months of the study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • current opiate or cocaine use
  • HCV seronegative
  • able to complete the study procedures in English

Exclusion Criteria:

  • current enrollment in a formal substance abuse treatment program
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00218192


Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Butler Hospital
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Michael Stein, M.D. Rhode Island Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Stein, MD, PI, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00218192     History of Changes
Other Study ID Numbers: NIDA-13759-1
R01DA013759 ( U.S. NIH Grant/Contract )
R01-13759-1
First Submitted: September 16, 2005
First Posted: September 22, 2005
Last Update Posted: May 22, 2015
Last Verified: April 2013

Keywords provided by Michael Stein, MD, National Institute on Drug Abuse (NIDA):
hepatitis c
injection drug use

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections