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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Stein, MD, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218192
First received: September 16, 2005
Last updated: April 15, 2013
Last verified: April 2013

September 16, 2005
April 15, 2013
September 2000
November 2006   (final data collection date for primary outcome measure)
Hepatitis C seroconversion
Same as current
Complete list of historical versions of study NCT00218192 on ClinicalTrials.gov Archive Site
Substance use
Same as current
Not Provided
Not Provided
 
A Trial to Reduce Hepatitis C Among Injection Drug Users - 1
A Trial to Reduce Hepatitis C Among Injection Drug Users

The purpose of this study is to examine the efficacy of a brief motivational intervention on the cumulative incidence of Hepatitis C.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HCV Negative Status
  • HCV Risk Behavior
Behavioral: Behavior Therapy
Not Provided
Stein MD, Herman DS, Anderson BJ. A trial to reduce hepatitis C seroincidence in drug users. J Addict Dis. 2009 Oct;28(4):389-98. doi: 10.1080/10550880903183034.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
277
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00218192
NIDA-13759-1, R01DA013759, R01-13759-1
No
Michael Stein, MD, National Institute on Drug Abuse (NIDA)
Butler Hospital
National Institute on Drug Abuse (NIDA)
Principal Investigator: Michael Stein, M.D. Rhode Island Hospital
Butler Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP