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Completed

NCT Number: NCT01647191

Reducing Hepatitis C Virus (HCV)/Human Immunodeficient Virus (HIV) Risk Behaviors Among Injection Drug Users in China

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Digestive System Diseases Drug Misuse Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Mental Disorders RNA Virus Infections Substance-Related Disorders Virus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Hong Kou MMT clinic, Shanghai, Shanghai Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group

Behavioral

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.

Other names: some types intervention activities for this group

Control Group

Behavioral

The investigators will adopt previous treatment in the clinics to intervent the patients

Other names: without any type of target intervention for this group

Primary outcomes

  1. Knowledge、Risk Behaviors and some other aspects related to HCV/HIV will be measured among IDUs in MMT

    Time frame: 3 months

    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

Secondary outcomes

  1. The barriers will be measured.

    Time frame: 3 months

    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?.

  2. The ways will be measured.

    Time frame: 3 months

    The ways to facilitate MMT staff to provide HCV/HIV-related services to IDUs will be measured by HCV/HIV self-efficacy scale.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 23, 2012
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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