NCT01647191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2015

Completed
Last Updated

January 13, 2020

Status Verified

July 1, 2012

Enrollment Period

3.8 years

First QC Date

April 17, 2012

Last Update Submit

January 8, 2020

Conditions

Hepatitis C

Keywords

HCV，drug users，intervention

Outcome Measures

Primary Outcomes (1)

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

    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

    3 months

Secondary Outcomes (2)

  • The barriers will be measured.

    3 months

  • The ways will be measured.

    3 months

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

intervention groupBEHAVIORAL

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.

Also known as: some types intervention activities for this group
intervention group
control groupBEHAVIORAL

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

Also known as: without any type of target intervention for this group
control group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai Hong Kou MMT clinic

Shanghai, Shanghai Municipality, China

Location

Shanghai Yang Pu MMT clinic

Shanghai, Shanghai Municipality, China

Location

Related Publications (2)

  • 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.

    PMID: 31488064DERIVED

  • 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.

    PMID: 29096647DERIVED

MeSH Terms

Conditions

Hepatitis CDrug Misuse

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Jiang Du, M.D

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2012

First Posted

July 23, 2012

Study Start

July 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 31, 2015

Last Updated

January 13, 2020

Record last verified: 2012-07

Locations

CN(2)