A Trial to Reduce Hepatitis C Among Injection Drug Users - 1
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|ClinicalTrials.gov Identifier: NCT00218192|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|HCV Negative Status HCV Risk Behavior||Behavioral: Behavior Therapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||277 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial to Reduce Hepatitis C Among Injection Drug Users|
|Study Start Date :||September 2000|
|Actual Primary Completion Date :||November 2006|
|Actual Study Completion Date :||November 2006|
- Hepatitis C seroconversion
- Substance use
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218192
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Michael Stein, M.D.||Rhode Island Hospital|