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Completed

NCT Number: NCT00218192

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavior Therapy

Behavioral

Primary outcomes

  1. Hepatitis C seroconversion

Secondary outcomes

  1. Substance use

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

A Trial to Reduce Hepatitis C Among Injection Drug Users

Important dates

Study start
2000
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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