跳至主要内容
临床试验/NCT00241917
NCT00241917已完成不适用

Cooperative Agreement to Develop, Implement, and Evaluate Viral Hepatitis and Training

Organization to Achieve Solutions in Substance Abuse (OASIS)6 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2005年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
450
试验地点
6
主要终点
HCV testing rates, intervention vs. usual care

研究概览

简要总结

The investigators hypothesize that a well-designed hepatitis C (HCV)video education curriculum for high-risk drug users will show measurable benefits in improving HCV testing, hepatitis A and B vaccinations, and HCV knowledge, attitudes, and motivations toward transmission behavior change. The investigators will use a 4-part modular video series designed for at-risk drug users, and in this 12 week study will assess its impact on testing/vaccinations as well as knowledge, attitudes, and motivations in methadone-maintained drug users as compared to a usual-care intervention.

详细描述

Injection drug users are at high risk for contracting hepatitis C (HCV). Very few culturally-specific educational tools have been developed to improve outcomes in this population. We hypothesize that measurable improvements in HCV testing, hepatitis A and B vaccinations, and testable knowledge, attitudes, and motivations may be elicited by such a curriculum.

In this study, we will investigate the impact of a 4-module short video educational series on these measures in in-treatment drug users maintained on methadone. Subjects will be enrolled in 3 sequential cohorts of 150 each: usual care, a 4 weekly sequential video cohort, and a single-session intervention in which the 4 videos are viewed at once. Subjects will undergo written testing for knowledge, attitudes about transmission behaviors, and motivations toward behavior change before the intervention, 4 weeks after the intervention, and 12 weeks after the intervention. Additionally, we will measure and compare the rates of HCV testing and HAV/HBV vaccinations before and at the 12-week time point in all cohorts.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • Enrolled on methadone maintenance within last 30 days

排除标准

  • Unable to provide informed consent
  • Not interested in study
  • Not able to speak or understand English

结局指标

主要结局

HCV testing rates, intervention vs. usual care

HAV vaccination rates, intervention vs. usual care

HBV vaccination rates, intervention vs. usual care

次要结局

  • Improvement in knowledge, intervention vs. usual care
  • Improvement in attitudes toward behavior change, intervention vs. usual care
  • Improvement in motivation toward behavior change, intervention vs. usual care

研究者

发起方
Organization to Achieve Solutions in Substance Abuse (OASIS)
申办方类型
Other

研究点 (6)

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