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

Primary Purpose

HCV Negative Status, HCV Risk Behavior

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Behavior Therapy
Sponsored by
Butler Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCV Negative Status focused on measuring hepatitis c, injection drug use

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rhode Island Hospital

Outcomes

Primary Outcome Measures

Hepatitis C seroconversion

Secondary Outcome Measures

Substance use

Full Information

First Posted
September 16, 2005
Last Updated
May 21, 2015
Sponsor
Butler Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00218192
Brief Title
A Trial to Reduce Hepatitis C Among Injection Drug Users - 1
Official Title
A Trial to Reduce Hepatitis C Among Injection Drug Users
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCV Negative Status, HCV Risk Behavior
Keywords
hepatitis c, injection drug use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Behavior Therapy
Primary Outcome Measure Information:
Title
Hepatitis C seroconversion
Secondary Outcome Measure Information:
Title
Substance use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stein, M.D.
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20155608
Citation
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.
Results Reference
derived

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

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