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山东男男性行为人群艾滋病创新干预模式研究
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注册号:

Registration number:

ChiCTR1900024350 

最近更新日期:

Date of Last Refreshed on:

2019-07-06 

注册时间:

Date of Registration:

2019-07-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

山东男男性行为人群艾滋病创新干预模式研究 

Public title:

Study for innovative approaches to AIDS control and prevention among (MSM) in Shandong Province 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

男男性行为人群及青年学生艾滋病创新干预模式研究 

Scientific title:

Study for innovative approaches to AIDS control and prevention among men who have sex with men(MSM) and young students 

研究课题代号(代码):

Study subject ID:

2017YFE0103800 

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:

马伟 

研究负责人:

马伟 

Applicant:

Wei Ma 

Study leader:

Wei Ma 

申请注册联系人电话:

Applicant telephone:

+86 0531 88382141-8806 

研究负责人电话:

Study leader's telephone:

+86 15098729082 

申请注册联系人传真 :

Applicant Fax:

+86 0531 88382553 

研究负责人传真:

Study leader's fax:

+86 0531 88382553 

申请注册联系人电子邮件:

Applicant E-mail:

weima@sdu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

weima@sdu.edu.cn 

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:

山东省济南市文化西路44号山东大学公共卫生学院流行病学系 

研究负责人通讯地址:

山东省济南市文化西路44号山东大学公共卫生学院流行病学系 

Applicant address:

44 West Wenhua Road, Ji'nan, Shandong, China 

Study leader's address:

44 West Wenhua Road, Ji'nan, Shandong, China 

申请注册联系人邮政编码:

Applicant postcode:

250012 

研究负责人邮政编码:

Study leader's postcode:

250012 

申请人所在单位:

山东大学公共卫生学院 

Applicant's institution:

School of Public Health of Shandong 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:

20190210 

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:

山东大学公共卫生伦理学委员会 

Name of the ethic committee:

Ethics Committee of Public Health in Shandong University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-06 

伦理委员会联系人:

孙淑爱 

Contact Name of the ethic committee:

Shuai Sun 

伦理委员会联系地址:

山东省济南市文化西路44号山东大学公共卫生学院 

Contact Address of the ethic committee:

School of Public Health, Shandong University, 44 West Wenhua Road, Ji'nan, Shandong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0531 88382091 

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:

山东大学公共卫生学院 

Primary sponsor:

School of Public Health of Shandong University 

研究实施负责(组长)单位地址:

山东省济南市文化西路44号山东大学公共卫生学院 

Primary sponsor's address:

44 West Wenhua Road, Ji'nan, Shandong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山东

市(区县):

济南

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东大学公共卫生学院

具体地址:

山东省济南市文化西路44号

Institution
hospital:

School of Public health of Shandong University

Address:

44 West Wenhua Road, Jinan, Shandong Province, China

国家:

中国

省(直辖市):

山东

市(区县):

济南

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东省疾病预防控制中心

具体地址:

山东省济南市经十路16992号

Institution
hospital:

Shandong Provincial Center for Disease Control and Prevention

Address:

16992 Jingshi Road, Jinan, Shandong Province, China

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

单位(医院):

广东省皮肤病医院

具体地址:

广东省广州市越秀区麓景路2号

Institution
hospital:

Guangdong Provincial Dermatology Hospital

Address:

2 Lujing Road, Yuexiu District, Guangzhou, Guangdong Province, China

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

南方医科大学

具体地址:

广州市白云区沙太南路1023号-1063号

Institution
hospital:

Southern Medical University

Address:

1023-1063 South Shatai Road, Baiyun District, Guangzhou, Guangdong, China

经费或物资来源:

国家重点研发计划 

Source(s) of funding:

National Key R&D Program 

研究疾病:

艾滋病 

Target disease:

AIDS 

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.使用众包方法在中国MSM人群中开展干预; 2.在多水平干预模式中应用社会学理论,使干预更具科学性和指导意义; 3.使用新媒体等技术解决在MSM人群中开展研究时常遇到的代表性差、失访严重、信息偏倚等问题。 

Objectives of Study:

1.To use crowdsourcing approaches among MSM in China. 2.To apply sociological theory in a multi-level intervention model to make interventions more scientific and instructive. 3.To use New Media and other technologies to solve problems such as poor representativeness, high missing rate, informationg bias, etc. 

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:

1.HIV检测结果为阴性; 2.年龄在18周岁及以上; 3.在过去一年内有过肛交同性性行为的男性; 4.居住在研究地区且愿意提供知情同意。 

Inclusion criteria

1. AIDS negative; 2. Aged at least 18 years; 3. Man who had anal sex with man in the past one year; 4. Living in the study area and willing to provide informed consent. 

排除标准:

No 

Exclusion criteria:

No 

研究实施时间:

Study execute time:

From2019-07-01To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2019-07-01To 2020-06-30 

干预措施:

Interventions:

组别:

对照组

样本量:

1000

Group:

Control Group

Sample size:

干预措施:

干预措施代码:

Intervention:

null

Intervention code:

组别:

干预组

样本量:

1000

Group:

Intervention Grooup

Sample size:

干预措施:

向研究对象推送与艾滋病预防相关的图片与视频; 建立50人微信群 ; 分享HIV检测信息至朋友圈; 发放自检包

干预措施代码:

Intervention:

Sending pictures and videos about AIDS Prevention to participants; Creating wechat group with 50 participants in it; Share HIV testing information to wechat moments; Send HIV test kits for home use to participants

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

德州 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

 

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

艾滋病毒检测率

指标类型:

主要指标 

Outcome:

HIV testing rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

艾滋病新发感染率

指标类型:

主要指标 

Outcome:

Incidence of AIDS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无保护性行为比例

指标类型:

主要指标 

Outcome:

Proportion of unprotected sex

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:

血液或唾液

组织:

指尖或口腔

Sample Name:

Blood or saliva

Tissue:

Fingertip or oral cavity

人体标本去向

使用后销毁 

说明

样本仅限研究对象自检使用

Fate of sample:

Destruction after use 

Note:

Tissues will be used for HIV home test only

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 18 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):

由项目组成员使用SAS 9.4软件产生随机序列,语句如下: proc plan seed=1574638; factors block=4 random treat=2 random; run;

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

Project team member used the following statement in SAS 9.4 to generate the random number sequence, proc plan seed=1574638; factors block=4 random treat=2 random; run;

盲法:

单盲

Blinding:

Single blind

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:

即时公开/Real time access

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):

2020年以后,按需提供

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

After 2020, on demand based

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:

数据采集和管理方式包:MSM人群电子调查问卷,网络干预过程记录;

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

Methods of Data collection and management include: MSM electronic questionnaire,Internet-based intervention record,etc.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-06
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