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Crowdsourcing to Promote Hepatitis C Testing and Linkage-to-care in China: a Randomized Controlled Trial Protocol
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注册号：

Registration number：

 ChiCTR1900025771 

最近更新日期：

Date of Last Refreshed on：

 2019-09-07 16:15:36 

注册时间：

Date of Registration：

 2019-09-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Crowdsourcing to Promote Hepatitis C Testing and Linkage-to-care in China: a Randomized Controlled Trial Protocol

Public title：

Crowdsourcing to Promote Hepatitis C Testing and Linkage-to-care in China: a Randomized Controlled Trial Protocol

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Crowdsourcing to Promote Hepatitis C Testing and Linkage-to-care in China: a Randomized Controlled Trial Protocol

Scientific title：

Crowdsourcing to Promote Hepatitis C Testing and Linkage-to-care in China: a Randomized Controlled Trial Protocol

研究课题代号(代码)：

Study subject ID：

 IN-CN-987-5376

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

William Chi Wai Wong 

研究负责人：

William Chi Wai Wong 

Applicant：

William Chi Wai Wong 

Study leader：

William Chi Wai Wong 

申请注册联系人电话：

Applicant telephone：

 +852 2518 5650

研究负责人电话：

Study leader's
telephone：

+852 2518 5650

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 wongwcw@hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 wongwcw@hku.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

中国广东深圳市福田区海园一路

研究负责人通讯地址：

中国广东深圳市福田区海园一路

Applicant address：

1 First Haiyuan Road, Futian District, Shenzhen, Guangdong, China

Study leader's address：

The University of Hong Kong-Shenzhen Hospital,1, Haiyuan 1st Road, Futian District, Shenzhen, Guangdong, P.R.C

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港大学深圳医院

Applicant's institution：

University of Hong Kong-Shenzhen Hospital

研究负责人所在单位：

香港大学深圳医院

Affiliation of the Leader：

University of Hong Kong-Shenzhen Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 hsuszh201888

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

香港大学深圳医院医学研究伦理委员会

Name of the ethic committee：

University of Hong Kong-Shenzhen Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 1990-01-01 00:00:00

伦理委员会联系人：

Dr Homer W.K. Tso

Contact Name of the ethic committee：

Dr Homer W.K. Tso

伦理委员会联系地址：

中国广东深圳市福田区海园一路香港大学深圳医院

Contact Address of the ethic committee：

The University of Hong Kong-Shenzhen Hospital,1 First Haiyuan Road, Futian District, Shenzhen, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Gilead Sciences

Primary sponsor：

Gilead Sciences

研究实施负责（组长）单位地址：

333 Lakeside Drive Foster City, CA 94404, USA

Primary sponsor's address：

333 Lakeside Drive Foster City, CA 94404, USA

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Conquering Hepatitis via Micro-Elimination (CHIME) grant (ref no: IN-CN-987-5376)

Source(s) of funding：

Conquering Hepatitis via Micro-Elimination (CHIME) grant (ref no: IN-CN-987-5376)

研究疾病：

丙型肝炎  

Target disease：

Hepatitis C

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

Specific aim 1: To compare the effects of a crowdsourcing intervention to the control on HCV test uptake among patients attending the primary care department in a tertiary hospital in China. Hypothesis 1: A crowdsourced intervention will be superior to the control in promoting HCV test uptake among patients attending the primary care department in a tertiary hospital in China.  

Objectives of Study：

Specific aim 1: To compare the effects of a crowdsourcing intervention to the control on HCV test uptake among patients attending the primary care department in a tertiary hospital in China. Hypothesis 1: A crowdsourced intervention will be superior to the control in promoting HCV test uptake among patients attending the primary care department in a tertiary hospital in China. Specific aim 2: To compare the effect of a crowdsourced intervention to the control on HCV linkage-to-care in Shenzhen, China Hypothesis 2: A crowdsourced intervention will be superior to the control in promoting HCV linkage-to-care among a primary care population in Shenzhen, China.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

Participants will be excluded if they self-report one of the followings: known chronic HCV infection, testing for serum anti-HCV in the past 12 months, current or planned pregnancy, currently undergoing complex medical treatment for other conditions.

Exclusion criteria：

Participants will be excluded if they self-report one of the followings: known chronic HCV infection, testing for serum anti-HCV in the past 12 months, current or planned pregnancy, currently undergoing complex medical treatment for other conditions.

研究实施时间：

Study execute time：

从 From 2019-09-02 00:00:00至 To 2021-09-02 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-09-16 00:00:00 至 To 2020-09-16 00:00:00

干预措施：

Interventions：

组别：

Group 2

样本量：

 503

Group：

Group 2

Sample size：

干预措施：

Crowd-sourcing contest materials to increase HCV uptake

干预措施代码：

Intervention：

Crowd-sourcing contest materials to increase HCV uptake

Intervention code：

组别：

Group 1

样本量：

 503

Group：

Group 1

Sample size：

干预措施：

Standard of care on HCV testing uptake

干预措施代码：

Intervention：

Standard of care on HCV testing uptake

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 香港大学深圳医院 

单位级别：

 三甲医院 

Institution
hospital：

University of Hong Kong-Shenzhen Hospital

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

Number of HCV antibody screening test uptake

指标类型：

主要指标

Outcome：

Number of HCV antibody screening test uptake

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Number of participants that additionally self-report HBsAg testing with/without confirmation by medical records or HBsAg viral load confirmatory testing

指标类型：

次要指标

Outcome：

Number of participants that additionally self-report HBsAg testing with/without confirmation by medical records or HBsAg viral load confirmatory testing

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Rate of participation in the crowdsourcing intervention

指标类型：

次要指标

Outcome：

Rate of participation in the crowdsourcing intervention

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Content of feedback submissions

指标类型：

次要指标

Outcome：

Content of feedback submissions

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Number of participants that self-report HCV antibody testing but are not confirmed by medical records

指标类型：

次要指标

Outcome：

Number of participants that self-report HCV antibody testing but are not confirmed by medical records

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Number of participants that enrol in VCT service at HKU-SZH

指标类型：

次要指标

Outcome：

Number of participants that enrol in VCT service at HKU-SZH

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Number of participants that follow-up for HCV confirmatory testing

指标类型：

次要指标

Outcome：

Number of participants that follow-up for HCV confirmatory testing

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Number of participants that join the peer training program at HKU-SZH

指标类型：

次要指标

Outcome：

Number of participants that join the peer training program at HKU-SZH

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Number of HCV diagnosed participants to continue with anti-HCV treatment, versus those who decline treatment for any reason

指标类型：

次要指标

Outcome：

Number of HCV diagnosed participants to continue with anti-HCV treatment, versus those who decline treatment for any reason

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Number of participants that will be completely cured of HCV infection, versus number that drop out prior to completing treatment

指标类型：

次要指标

Outcome：

Number of participants that will be completely cured of HCV infection, versus number that drop out prior to completing treatment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Number of participants diagnosed with chronic liver disease (including cirrhosis, liver failure, or hepatocellular carcinoma)

指标类型：

次要指标

Outcome：

Number of participants diagnosed with chronic liver disease (including cirrhosis, liver failure, or hepatocellular carcinoma)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Number of participants that will return to primary care for chronic liver disease follow-up or future screening of HCV and other conditions

指标类型：

次要指标

Outcome：

Number of participants that will return to primary care for chronic liver disease follow-up or future screening of HCV and other conditions

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 30 岁 years
最大 Max age 100 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Participants will be randomly allocated on a 1:1 ratio to either the intervention or control group through a randomization procedure using permuted blocks. SAS software (Cary, North Carolina, USA) will be used to create the allocation sequence using PROC PLAN and RANUNI functions.

Randomization Procedure (please state who generates the random number sequence and by what method)：

Participants will be randomly allocated on a 1:1 ratio to either the intervention or control group through a randomization procedure using permuted blocks. SAS software (Cary, North Carolina, USA) will be used to create the allocation sequence using PROC PLAN and RANUNI functions.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

This study is not blinded since participants will know their randomization assignment based on whether they receive the intervention, and investigators will be aware of the randomization assignment.

Blinding：

This study is not blinded since participants will know their randomization assignment based on whether they receive the intervention, and investigators will be aware of the randomization assignment.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

https://trialsjournal.biomedcentral.com/

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

https://trialsjournal.biomedcentral.com/

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Data collection and measures Pre-intervention and post-intervention surveys will be delivered to the participants’ mobile devices and completed using Survey Star@ (Wechat, China), a web-based survey platform that meets industry standards for security and functionality. Both surveys were written in Chinese and verified for clarity and cultural appropriateness with 13 Chinese individuals in Guangdong province, including both genders and ages groups. Recruited individuals will first be assessed for eligibility by the researcher. Eligible participants will then be asked to complete the baseline survey on Survey Star@. The baseline survey will include the following domains: sociodemographic characteristics, including migrant status; access to healthcare at HKU-SZH; trust in healthcare providers; knowledge of and attitudes towards and HCV; and risk of contracting HCV. Migrant status will be define based on the definition of internal migrant from the National Bureau of Statistics of China (26). Trust in healthcare providers will be assessed using three items previously used to measure provider trust in young Chinese men (19). Stigma towards HCV will be assessed using a combination of items adapted from the Toronto. Risk of contracting HCV was assessed using 8 items typically used by HKU-SZH providers for assessing HCV risk. Confidentiality Baseline and follow-up survey data will be collected on Survey Star@. For follow-up on HCV testing results at HKU-SZH or in one of the connected public hospitals in Shenzhen, patient records in the electronic medical system will be traced by the research team using self-reported hospital registration ID and demographic information. All study data will be encrypted prior to transmission and will be stored in a secure server and can be access by login information known only to the research team. Ethics approval is obtained through the IRB of HKU-SZH (hkuszh201888). Monitoring A researcher will check each survey for completion and internal consistency. Each participant’s baseline and follow-up survey and test report will be checked for consistency of their verified cell phone number and demographic information. Test results must be confirmed by testing records at HKU-SZH or verified based on participant socio-demographics as reported in their baseline survey. A telephone number and WeChat account managed by the research team will be made available to participants for any questions or concerns that may come up during the study.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection and measures Pre-intervention and post-intervention surveys will be delivered to the participants’ mobile devices and completed using Survey Star@ (Wechat, China), a web-based survey platform that meets industry standards for security and functionality. Both surveys were written in Chinese and verified for clarity and cultural appropriateness with 13 Chinese individuals in Guangdong province, including both genders and ages groups. Recruited individuals will first be assessed for eligibility by the researcher. Eligible participants will then be asked to complete the baseline survey on Survey Star@. The baseline survey will include the following domains: sociodemographic characteristics, including migrant status; access to healthcare at HKU-SZH; trust in healthcare providers; knowledge of and attitudes towards and HCV; and risk of contracting HCV. Migrant status will be define based on the definition of internal migrant from the National Bureau of Statistics of China (26). Trust in healthcare providers will be assessed using three items previously used to measure provider trust in young Chinese men (19). Stigma towards HCV will be assessed using a combination of items adapted from the Toronto. Risk of contracting HCV was assessed using 8 items typically used by HKU-SZH providers for assessing HCV risk. Confidentiality Baseline and follow-up survey data will be collected on Survey Star@. For follow-up on HCV testing results at HKU-SZH or in one of the connected public hospitals in Shenzhen, patient records in the electronic medical system will be traced by the research team using self-reported hospital registration ID and demographic information. All study data will be encrypted prior to transmission and will be stored in a secure server and can be access by login information known only to the research team. Ethics approval is obtained through the IRB of HKU-SZH (hkuszh201888). Monitoring A researcher will check each survey for completion and internal consistency. Each participant’s baseline and follow-up survey and test report will be checked for consistency of their verified cell phone number and demographic information. Test results must be confirmed by testing records at HKU-SZH or verified based on participant socio-demographics as reported in their baseline survey. A telephone number and WeChat account managed by the research team will be made available to participants for any questions or concerns that may come up during the study.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-09-07 16:15:36
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