Reducing Hepatitis C Virus (HCV)/Human Immunodeficient Virus (HIV) Risk Behaviors Among Injection Drug Users in China
2020年1月8日 更新者：Shanghai Mental Health Center
The proposed study will investigate the knowledge level, attitudes, and perceptions among staff of Methadone Maintenance Treatment (MMT) clinics and intravenous drug users (IDUs) who attending MMT clinics, which is the most reachable population for HCV/HIV intervention in China.
This study will also explore the barriers that prevent IDUs from getting HCV/HIV intervention/prevention and medical care services.
This study will help to understand and address this important problem in China and other Asian countries.
研究概览
详细说明
The investigators propose to conduct 3 inter-related studies over 4 years using both qualitative and quantitative research methods to address a series of research questions.
Firstly, The investigators will begin by assessing HCV/HIV knowledge, attitudes, perceptions, risk behaviors, and infection among IDUs in MMT clinics (Study 1) and HCV/HIV knowledge, attitudes, and HCV/HIV-related services among MMT staff (Study 2).
Secondly, based on knowledge accumulated from Studies 1 & 2; The investigators will adapt and develop HCV/HIV education materials appropriate for Chinese IDUs and drug treatment service providers, and then use the Transtheoretical Model of Behavior Change as a conceptual model to measure if our educational program will increase patients' readiness to consider changing HCV/HIV risk behaviors and getting medical care for HCV/HIV (Study 3).
Finally, by integrating findings of these three studies and by consulting with leading experts in HCV/HIV.
The investigators plan to develop HCV/HIV intervention program applicable in China, which can be tested in future formal experimental trials.
研究类型
介入性
注册 (实际的)
240
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Shanghai
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Shanghai、Shanghai、中国
- Shanghai Hong Kou MMT clinic
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Shanghai、Shanghai、中国
- Shanghai Yang Pu MMT clinic
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- several failed attempts to quit the use of heroin
- at least two terms in a detoxification center
- age at least 20 years
- being a registered local resident of the area in which the clinic is located
- being of good civil character
Exclusion Criteria:
- there is no exclusion criteria
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：intervention group
The investigators will use a variety of learning techniques, including lecture, brainstorming, small and large group activity, individual worksheets, role-play, and video player.
For example, small teams of up to 5 participants will conduct role-plays; large groups also will be assembled to encourage talking about HCV-related risk reduction behavior.
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The investigators will use a variety of learning techniques, including lecture, brainstorming, small and large group activity, individual worksheets, role-play, and video player.
For example, small teams of up to 5 participants will conduct role-plays; large groups also will be assembled to encourage talking about HCV-related risk reduction behavior.
其他名称：
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有源比较器：control group
The investigators will adopt previous treatment in the clinics to intervent the patients without any type of target intervention for this group.
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The investigators will adopt previous treatment in the clinics to intervent the patients
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Knowledge、Risk Behaviors and some other aspects related to HCV/HIV will be measured among IDUs in MMT
大体时间：3 months
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HCV/HIV knowledge, attitudes, perceptions, risk behaviors, and infections (HIV, HCV, and HIV/HCV co-infection) will be measured by HCV/HIV knowledge questionnaire,HCV/HIV self-efficacy scale,Attitudes and practices regarding HCV/HIV infection among IDUs in MMT
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The barriers will be measured.
大体时间：3 months
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The barriers that impact IDUs receiving HCV/HIV-related intervention and medical service will be measured by Focus group instruments,which including potential topics as follow: what kind of HCV/HIV service do you provide to IDUs?
What are the most important barriers that impact IDUs obtaining HCV services?
What are the important barriers that prevent you from offering HCV/HIV-related service to IDUs?
What recommendation do you have to increase HCV/HIV-related medical services in MMT clinics?.
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3 months
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The ways will be measured.
大体时间：3 months
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The ways to facilitate MMT staff to provide HCV/HIV-related services to IDUs will be measured by HCV/HIV self-efficacy scale.
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3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jiang Du, M.D、Shanghai Mental Health Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Zhang JY, Li ZB, Zhang L, Wang J, Huang LP, Zhan GL, Li Z, Du J, Zhao M. DOES IT WORK? -a randomized controlled trial to test the efficacy of HCV and HIV-related education on drug users in MMT, China. BMC Infect Dis. 2019 Sep 5;19(1):774. doi: 10.1186/s12879-019-4421-5.
- Li ZB, Zhang L, Wang J, Huang LP, Zhou ZR, Cao YN, Zhao M, Du J. Hepatitis C infection, related services, and barriers to HCV treatment among drug users in methadone maintenance treatment (MMT) clinics in Shanghai, China. Harm Reduct J. 2017 Nov 2;14(1):71. doi: 10.1186/s12954-017-0197-3.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年7月1日
初级完成 (实际的)
2015年5月1日
研究完成 (实际的)
2015年5月31日
研究注册日期
首次提交
2012年4月17日
首先提交符合 QC 标准的
2012年7月18日
首次发布 (估计)
2012年7月23日
研究记录更新
最后更新发布 (实际的)
2020年1月13日
上次提交的符合 QC 标准的更新
2020年1月8日
最后验证
2012年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.