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Efficacy of Self-testing Kits Availability on Improving HIV Testing Frequency for Chinese MSM persons and Their Sexual Partners: a Multicenter Randomised Controlled Trial
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注册号:

Registration number:

ChiCTR1800015584 

最近更新日期:

Date of Last Refreshed on:

2018-04-09 

注册时间:

Date of Registration:

2018-04-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

自我检测试剂可及性对男男性行者及其性伴HIV检测频率影响的多中心随机对照试验研究 

Public title:

Efficacy of Self-testing Kits Availability on Improving HIV Testing Frequency for Chinese MSM persons and Their Sexual Partners: a Multicenter Randomised Controlled Trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

自我检测试剂可及性对男男性行者及其性伴HIV检测频率影响的多中心随机对照试验研究 

Scientific title:

Efficacy of Self-testing Kits Availability on Improving HIV Testing Frequency for Chinese MSM persons and Their Sexual Partners: a Multicenter Randomised Controlled Trial 

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:

张慈 

研究负责人:

李现红 

Applicant:

Zhang Ci 

Study leader:

Li Xianhong 

申请注册联系人电话:

Applicant telephone:

+86 0731-82650264 

研究负责人电话:

Study leader's telephone:

+86 0731-82650264 

申请注册联系人传真 :

Applicant Fax:

+86 0731-82650262 

研究负责人传真:

Study leader's fax:

+86 0731-82650262 

申请注册联系人电子邮件:

Applicant E-mail:

zhangci2017@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

xianhong_li228@hotmail.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:

湖南省长沙市岳麓区桐梓坡172号 

研究负责人通讯地址:

湖南省长沙市岳麓区桐梓坡172号 

Applicant address:

172 Tongzipo Road, Yuelu District, Changsha, Hu'nan, China 

Study leader's address:

172 Tongzipo Road, Yuelu District, Changsha, Hu'nan, China 

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:

410013 

申请人所在单位:

中南大学湘雅护理学院 

Applicant's institution:

Xiangya Nursing School of Central South 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:

2018002 

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:

中南大学护理学院行为医学与护理学研究伦理审查委员会 

Name of the ethic committee:

Institutional Review Board of behavioral and nursing research in School of Nursing of Central South University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-01-09 

伦理委员会联系人:

孙玫 

Contact Name of the ethic committee:

Mei Sun 

伦理委员会联系地址:

湖南省长沙市岳麓区桐梓坡路172号 

Contact Address of the ethic committee:

172 Tongzipo Road, Yuelu District, Changsha, Hu'nan, 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:

中南大学湘雅护理学院 

Primary sponsor:

Xiangya Nursing School of Central South University 

研究实施负责(组长)单位地址:

湖南省长沙市岳麓区桐梓坡172号 

Primary sponsor's address:

172 Tongzipo Road, Yuelu District,Changsha, Hu'nan, 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):

湖南省

市(区县):

长沙市

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

中南大学湘雅护理学院

具体地址:

湖南省长沙市岳麓区桐梓坡172号

Institution
hospital:

Xiangya Nursing School of Central South University

Address:

172 Tongzipo Road, Yuelu District,Changsha, Hu'nan, China

经费或物资来源:

中南大学创新驱动项目(项目号:2018CX036 )、Fogarty International ( D43 TW009579) 

Source(s) of funding:

Central South University Innovation-driven project 2018CX036、Fogarty International D43 TW009579 

研究疾病:

艾滋病 

Target disease:

Acquired Immune Deficiency Syndrome 

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:

其它 

Study phase:

N/A 

研究目的:

1.探索HIV自检试剂可及性对提高男男性行为人群HIV检测频率的影响;2.探索男男性行为者向其性伴传递自检试剂对扩大HIV检测的影响;3.探索自检试剂的应用对男男性行为人群高危性行为的影响。 

Objectives of Study:

The primary objective of the study is to test the efficacy of HIVST on improving HIV testing frequency for MSM. The secondary objective is to evaluate the efficacy of HIVST on improving HIV testing frequency of the sexual partners of MSM by their distribution of the kits. The tertiary objective is to explore whether HIVST could reduce high risk sexual behaviors of MSM. 

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)年龄18岁及以上的男性;(2)最近三个月内发生过无保护性同性性行为(包括无套口交、肛交);(3)HIV阴性者;(4)接下来的一年会在湖南省居住;(5)小学及以上文化程度;(6)拥有智能手机并能熟练应用微信;(7)自愿参加本项研究者 

Inclusion criteria

(1) anatomical men aged 18 years or older; (2) having condomless anal or oral sex with men in the past 3 months; (3) HIV negative when being recruited in the study; (4) residing in Hunan Province in the coming 1 years; (5) having entered primary school at least; (6) possessing a smartphone and can use WeChat deftly; and (7) voluntarily participating in the study and could provide written informed consent. 

排除标准:

(1)精神障碍和智力缺陷者;(2)严重视力障碍,不能填写调查问卷者;(3)正在参加其它研究项目者;(4)有语言表达及交流障碍不能配合完成试验者 

Exclusion criteria:

(1) have serious psychiatric illness; (2) are participating in other research programs; (3) cannot read the questionnaire; (4) cannot speak and/or read Chinese. 

研究实施时间:

Study execute time:

From2018-04-14To 2019-06-14 

征募观察对象时间:

Recruiting time:

From2018-04-14To 2018-06-14 

干预措施:

Interventions:

组别:

试验组

样本量:

105

Group:

Intervention group

Sample size:

干预措施:

提供免费HIV自检试剂

干预措施代码:

Intervention:

HIV self-testing kits

Intervention code:

组别:

试验组

样本量:

105

Group:

Intervention group

Sample size:

干预措施:

站点检测

干预措施代码:

Intervention:

site-based HIV testing

Intervention code:

组别:

对照组

样本量:

105

Group:

control group

Sample size:

干预措施:

进行常规站点检测

干预措施代码:

Intervention:

site-based HIV testing

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南省 

市(区县):

 

Country:

China 

Province:

Hu'nan 

City:

 

单位(医院):

左岸彩虹 

单位级别:

同志友好社区组织 

Institution
hospital:

Zuo An Cai Hong Community  

Level of the institution:

Gay friendly community-based organization 

测量指标:

Outcomes:

指标中文名:

男男性行为人群年均HIV检测频次

指标类型:

主要指标 

Outcome:

HIV testing frequency of men who have sex with men

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

男男性行为人群的性伴年均HIV检测频次

指标类型:

次要指标 

Outcome:

HIV testing frequency for sexual partners of men who have sex with men

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

MSM人群平均三个月的肛交安全套使用率

指标类型:

次要指标 

Outcome:

the proportions of consistent condom usage for anal sexes

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

MSM平均三个月的性伴数量

指标类型:

次要指标 

Outcome:

numbers of sexual partners

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 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1名统计学专家使用SPSS18.0软件制作出两份随机数字表,分别针对经常检测组和非经常检测组(经常检测组:最近2年内做过HIV检测;非经常检测组:最近2年内未做过HIV检测或从未做过HIV检测)。根据计算机产生的随机数表法,将招募的研究对象随机分到试验组和对照组。

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

Participants will be randomized divided into intervention group and control group according to the computer-generated randomized number tables which are developed by a statistician using SPSS 18.0. There are two randomized number tables for recent testers (men who had HIV tests within two years) and non-recent test

盲法:

由于研究性质需要告知研究对象干预方法及分组情况。分析数据的人员并不知道研究对象的分组情况。

Blinding:

The data analyst will be blinded to the group assignments.

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

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):

目前还未确定原始数据共享方式。

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

The way of sharing is uncertain.

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:

Epidata数据库

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

Epidata database

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-04-09
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