HCV Negative Status Clinical Trial
Official title:
A Trial to Reduce Hepatitis C Among Injection Drug Users
The purpose of this study is to examine the efficacy of a brief motivational intervention on the cumulative incidence of Hepatitis C.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment