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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT01647191
First received: April 17, 2012
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Hepatitis C
 Behavioral: intervention group
Behavioral: control group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing Hepatitis C Virus (HCV)/Human Immunodeficient Virus (HIV) Risk Behaviors Among Injection Drug Users in China

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai Mental Health Center:

Primary Outcome Measures:
  • Knowledge、Risk Behaviors and some other aspects related to HCV/HIV will be measured among IDUs in MMT [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • The barriers will be measured. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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?.

  • The ways will be measured. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The ways to facilitate MMT staff to provide HCV/HIV-related services to IDUs will be measured by HCV/HIV self-efficacy scale.


Estimated Enrollment: 340
Study Start Date: July 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Behavioral: 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.
Other Name: some types intervention activities for this group
Active Comparator: control group
The investigators will adopt previous treatment in the clinics to intervent the patients without any type of target intervention for this group.
 Behavioral: control group
The investigators will adopt previous treatment in the clinics to intervent the patients
Other Name: without any type of target intervention for this group

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647191

Locations
China, Shanghai
Shanghai Yang Pu MMT clinic
Shanghai, Shanghai, China
Shanghai Hong Kou MMT clinic
Shanghai, Shanghai, China
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
Principal Investigator: Jiang Du, M.D Shanghai Mental Health Center
  More Information

No publications provided

Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT01647191     History of Changes
Other Study ID Numbers: JDu-001
Study First Received: April 17, 2012
Last Updated: July 18, 2012
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Mental Health Center:
HCV，
drug users，
intervention

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Immunologic Deficiency Syndromes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013