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临床试验/NCT00218192
NCT00218192已完成3 期

A Trial to Reduce Hepatitis C Among Injection Drug Users

Butler Hospital2 个研究点 分布在 1 个国家目标入组 277 人开始时间: 2000年9月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
277
试验地点
2
主要终点
Hepatitis C seroconversion

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • current opiate or cocaine use
  • HCV seronegative
  • able to complete the study procedures in English

排除标准

  • current enrollment in a formal substance abuse treatment program

结局指标

主要结局

Hepatitis C seroconversion

次要结局

  • Substance use

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Stein, MD

PI

National Institute on Drug Abuse (NIDA)

研究点 (2)

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