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

HCV Negative Status Clinical Trial

Official title:

A Trial to Reduce Hepatitis C Among Injection Drug Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218192
• Other study ID #: NIDA-13759-1
• Secondary ID: R01DA013759R01-1
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2005
• Last updated: May 21, 2015
• Start date: September 2000
• Est. completion date: November 2006

Study information

• Verified date: April 2013
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HCV Negative Status
• HCV Risk Behavior
• Hepatitis C

Intervention

Behavioral:
• Behavior Therapy

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatitis C seroconversion
Secondary	Substance use