A Trial to Reduce Hepatitis C Among Injection Drug Users - 1
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Trial to Reduce Hepatitis C Among Injection Drug Users |
- Hepatitis C seroconversion
- 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) |
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| Principal Investigator: | Michael Stein, M.D. | Rhode Island Hospital |
More Information
No publications provided by Butler Hospital
Additional 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, R01-13759-1 |
| Study First Received: | September 16, 2005 |
| Last Updated: | April 15, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 23, 2013