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

NCT ID: NCT01647191

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-01
• Study Completion Date: 2015-05-31

Brief Summary

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.

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

intervention group

Intervention Type: 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.

control group

The investigators will adopt previous treatment in the clinics to intervent the patients without any type of target intervention for this group.

Group Type: ACTIVE_COMPARATOR

control group

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

control group

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

Intervention Type: BEHAVIORAL

Other Intervention Names

some types intervention activities for this group; without any type of target intervention for this group

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiang Du, M.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Hong Kou MMT clinic

Shanghai, Shanghai Municipality, China

Shanghai Yang Pu MMT clinic

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 31488064 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29096647 (View on PubMed)

Other Identifiers

JDu-001

Identifier Type: -

Identifier Source: org_study_id