Hepatitis CNCT01647191
Reducing Hepatitis C Virus (HCV)/Human Immunodeficient Virus (HIV) Risk Behaviors Among Injection Drug Users in China
A study testing intervention group in people with Hepatitis C, run by Shanghai Mental Health Center at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2011to 31 May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- there is no exclusion criteria
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Hong Kou MMT clinic
Shanghai, Shanghai Municipality
Shanghai Yang Pu MMT clinic
Shanghai, Shanghai Municipality
About this study
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.
Read the 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
- Being tested
- intervention group, control group
- Keywords
- HCV，, drug users，, intervention
- Medical subject headings
- Hepatitis C, Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention groupBehavioural
Also called some types intervention activities for this 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.
control groupBehavioural
Also called without any type of target intervention for this group
The investigators will adopt previous treatment in the clinics to intervent the patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (2)
The barriers will be measured.
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?.
Measured: 3 months
The ways will be measured.
The ways to facilitate MMT staff to provide HCV/HIV-related services to IDUs will be measured by HCV/HIV self-efficacy scale.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study start1 Jul 2011
- Primary completion1 May 2015
- Study completion31 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiang Du, M.D, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647191
- Sponsor's protocol ID
- JDu-001
- Status last verified
- Jul 2012
- First submitted
- 17 Apr 2012
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31488064Li 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.
PubMed 29096647
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Hepatitis C Virus (HCV)/Human Immunodeficient Virus (HIV) Risk Behaviors Among Injection Drug Users in China
- ClinicalTrials.gov ID
- NCT01647191
- Acronym / sponsor ID
- JDu-001
- Conditions
- Hepatitis C
- Keywords
- HCV，, drug users，, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 31 May 2015 (actual)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: intervention groupThe 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 | Active comparator | Behavioral: control groupThe investigators will adopt previous treatment in the clinics to intervent the patients without any type of target intervention for this group. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- there is no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intervention groupAlso: some types intervention activities for this groupThe 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. | Behavioural | intervention group |
| control groupAlso: without any type of target intervention for this groupThe investigators will adopt previous treatment in the clinics to intervent the patients | Behavioural | control group |
Primary outcome
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
2 secondary outcomes
The barriers will be measured.
Time frame: 3 months
The ways will be measured.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 31488064Zhang 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.
- Derived from this study: PubMed 29096647Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang Du, M.D principal investigator
Shanghai Mental Health Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention group in people with Hepatitis C, run by Shanghai Mental Health Center at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge、Risk Behaviors and some other aspects related to HCV/HIV will be measured among IDUs in MMT (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01647191, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.