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促进中国男男性行为者梅毒常规检测:一项梅毒自检和众包彩票激励的随机对照试验
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注册号:

Registration number:

ChiCTR1900022409 

最近更新日期:

Date of Last Refreshed on:

2019-04-10 

注册时间:

Date of Registration:

2019-04-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

促进中国男男性行为者梅毒常规检测:一项梅毒自检和众包彩票激励的随机对照试验 

Public title:

Promoting routine syphilis screening among men who have sex with men in China: a randomized controlled trial of syphilis self-testing and crowdsourced lottery incentive 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

促进中国男男性行为者梅毒常规检测:一项梅毒自检和众包彩票激励的随机对照试验 

Scientific title:

Promoting routine syphilis screening among men who have sex with men in China: a randomized controlled trial of syphilis self-testing and crowdsourced lottery incentive 

研究课题代号(代码):

Study subject ID:

 

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:

程伟彬 

研究负责人:

王成 

Applicant:

Weibin Cheng 

Study leader:

Cheng Wang 

申请注册联系人电话:

Applicant telephone:

+86 13929587059 

研究负责人电话:

Study leader's telephone:

+86 13602463723 

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:

chwb817@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

wangcheng090705@gmail.com 

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:

广州市越秀区麓景路2号 

研究负责人通讯地址:

广州市越秀区麓景路2号 

Applicant address:

2 Lujing Road, Guangzhou, Guangdong, China 

Study leader's address:

2 Lujing Road, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510000 

研究负责人邮政编码:

Study leader's postcode:

510000 

申请人所在单位:

南方医科大学皮肤病医院 

Applicant's institution:

Dermatology Hospital of Southern Medical University 

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:

GDDHLS-20181206 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

南方医科大学皮肤病医院伦理委员会 

Name of the ethic committee:

Ethic Committe of Dermatology Hospital of Southern Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-12 

伦理委员会联系人:

吕萍 

Contact Name of the ethic committee:

Ping Lv 

伦理委员会联系地址:

广州市越秀区麓景路2号 

Contact Address of the ethic committee:

2 Lujing Road, Guangzhou, 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:

南方医科大学皮肤病医院 

Primary sponsor:

Dermatology Hospital of Southern Medical University 

研究实施负责(组长)单位地址:

广州市越秀区麓景路2号 

Primary sponsor's address:

2 Lujing Road, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

南方医科大学皮肤病医院 

Source(s) of funding:

Dermatology Hospital of Southern Medical University 

研究疾病:

梅毒 

Target disease:

Syphilis 

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:

研究目的:

(1)研究梅毒自检在促进MSM人群梅毒检测的效果; (2)检验抽奖激励在促进梅毒自检的利用的效果。 

Objectives of Study:

(1) To test the syphilis self-testing in promoting syphilis testing by comparing the syphilis testing rate (self-report) between control arm and standard self-testing arm; (2) To test the lottery incentive in enhancing syphilis self-testing utilization by comparing the use of syphilis self-testing and result reporting rate between standard self-testing arm and crowdsourced lottery incentives self-testing arm. By doing so, we examine the acceptability and preliminary effects of SST in a sample of high-risk MSM in China. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

男性,16岁及以上,过去六个月与男性有过无保护性肛交,过去六个月未进行梅毒和HIV检测,HIV和梅毒感染状态为阴性或未知,在研究期间不离开中国以及并提供一个可以接收梅毒自检试剂快递的地址。 

Inclusion criteria

Men aged 16 years or above; had unprotected anal sex with other men in the past six months; reported NOT testing for syphilis and HIV in the last six months; NOT living with syphilis and HIV or NOT known about HIV and syphilis infection status; plan to live in China for the next month and willing to provide a reliable postal address where they can securely receive package.  

排除标准:

正在参与与HIV和梅毒检测相关的研究项目,不能提供邮寄地址或不能遵循研究的其他要求。 

Exclusion criteria:

Participants are excluded if they: participating in similar clinical trials or other programs involving HIV/Syphilis testing; cannot provide mailing address; unwilling or unable to comply with all the requirements of the study.  

研究实施时间:

Study execute time:

From2019-04-15To 2019-08-31 

征募观察对象时间:

Recruiting time:

From2019-04-15To 2019-04-30 

干预措施:

Interventions:

组别:

对照组

样本量:

50

Group:

Control arm

Sample size:

干预措施:

转介到自愿咨询检测门诊进行免费梅毒检测

干预措施代码:

Intervention:

Referral to get free syphilis test at the facilities.

Intervention code:

组别:

标准自检组

样本量:

50

Group:

Standard self-testing arm

Sample size:

干预措施:

邮寄梅毒自检试剂

干预措施代码:

Intervention:

Home delivery of self-test kits for free.

Intervention code:

组别:

众包彩票奖励自检组

样本量:

50

Group:

Crowdsourced lottery incentives self-testing arm

Sample size:

干预措施:

邮寄梅毒自检试剂,完成检测上传证明可获得一次抽奖机会。

干预措施代码:

Intervention:

Home delivery of self-test kits for free. And one lottery draw with 0.1 probability to win 100RMB for those upload SST results.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

南方医科大学皮肤病医院 

单位级别:

三甲医院 

Institution
hospital:

Dermatology Hospital of Southern Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

自报梅毒检测

指标类型:

主要指标 

Outcome:

Self-report uptake of syphilis testing

Type:

Primary 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:

组织:

Sample Name:

N.A.

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 16 years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

由生物统计学人员应用计算机产生一套随机数字(简单随机方法)。生物统计学人员根据研究对象的入组顺序与预设的随机数字分配入干预组和对照组。

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

Computer-generated randomisation codes will be produced by a biostatistician. Allocation will be based on an a priori randomization sequence that was managed by the study statistician.

盲法:

This is single-blinded design trial. It would be impossible to blind the arms which participants are going to be assigned, because they can infer it via the procedures they are provided. However, investigators and staff assessing the outcomes will be blinded to participants' group assignments.

Blinding:

This is single-blinded design trial. It would be impossible to blind the arms which participants are going to be assigned, because they can infer it via the procedures they are provided. However, investigators and staff assessing the outcomes will be blinded to participants' group assignments.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

通过www.chictr.org.cn平台

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

ResMan

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:

采用在线问卷调查收集研究的资料。 基线调查收集的信息包括:人口统计信息,梅毒检测史,HIV检测史,性行为和强制性梅毒检测情况。 招募和随机化后一个月内将进行跟踪调查,收集有关上个月梅毒检测频率,时间,地点,方法和结果,以及过去1个月的性行为的信息。

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

Online survey will be used to collect information. Baseline survey collects information including: demographic information, syphilis testing, HIV testing, sexual behavior and coercive syphilis testing. Follow-up survey will be conducted in one month after recruitment and randomization, which collects information on syphilis testing frequency, time, location, method, and result(s) in the last month, sexual behaviors in the past months.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-10
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