Today is 2020-11-25

Internet-based HIV Prevention among men who have sex with men
download

注册号:

Registration number:

ChiCTR1800014260 

最近更新日期:

Date of Last Refreshed on:

2018-01-02 

注册时间:

Date of Registration:

2018-01-02 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

男男性行为者预防艾滋病互联网在线干预研究 

Public title:

Internet-based HIV Prevention among men who have sex with men 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

利用互联网干预男男性行为者高危行为的效果评价 

Scientific title:

Effect evaluation of the internet-based intervention targeted to HIV high risk behaviors among men who have sex with men 

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:

徐慧芳 

Applicant:

Weibin Cheng 

Study leader:

Huifang Xu 

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 13751898290 

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:

bin_cheng817@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xuhuifang1027@21cn.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:

广州市白云区启德路1号 

研究负责人通讯地址:

广州市白云区启德路1号 

Applicant address:

1 Qide road, Guangzhou, Guangdong, China 

Study leader's address:

1 Qide road, Guangzhou, Guangdong, 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:

 

申请人所在单位:

广州市疾病预防控制中心 

Applicant's institution:

Guangzhou Center for Disease Control and Prevention 

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:

GZCDC2009003 

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:

广州市疾病预防控制中心 

Name of the ethic committee:

Guangzhou Center for Disease Control and Prevention 

伦理委员会批准日期:

Date of approved by ethic committee:

2009-01-15 

伦理委员会联系人:

杨智聪 

Contact Name of the ethic committee:

Zhicong Yang 

伦理委员会联系地址:

广州市白云区启德路1号 

Contact Address of the ethic committee:

1 Qide 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:

广州市疾病预防控制中心 

Primary sponsor:

Guangzhou Center for Disease Control and Prevention 

研究实施负责(组长)单位地址:

广州市白云区启德路1号 

Primary sponsor's address:

1 Qide road, Guangzhou, Guangdong, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州市疾病预防控制中心

具体地址:

广州市白云区启德路1号

Institution
hospital:

Guangzhou Center for Disease Control and Prevention

Address:

1 Qide road, Guangzhou, Guangdong, China

经费或物资来源:

广州市医学科研基金 

Source(s) of funding:

Guangzhou Medical Scientific Research Foundation 

研究疾病:

艾滋病 

Target disease:

HIV/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:

其它 

Study phase:

N/A 

研究目的:

评估互联网干预对MSM人群高危行为的效果,为MSM人群艾滋病防治提供参考建议。 研究目标: 1)了解MSM人群使用互联网的特征; 2)了解使用互联网的MSM人群高危行为的危险因素; 3)采用随机、对照的方法,对MSM人群进行干预,评估互联网干预对MSM人群高危行为的效果。 

Objectives of Study:

To evaluate Internet-based HIV prevention in reducing risk behaviors among men who have sex with men (MSM), and to provide HIV prevention guidance. 1) To explore characteristics of Internet using preference among MSM; 2) To study factors correlated with risk behaviors among MSM who frequent Internet use; 3) To evalate the efficacy on Internet-based HIV intervention in reducing risk behaviors by using a randomized, controlled desgin.  

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:

网站注册用户,男性,18岁及以上,曾经与男性发生过性行为。 

Inclusion criteria

Internet surfers who were male aged 18 years old or above, and had ever been engaged in sexual intercourses with other men.  

排除标准:

18周岁以下; 既往参加过干预活动。 登陆论坛次数少于10次的。 

Exclusion criteria:

Participated HIV intervention program before; Logon less than 10 times. 

研究实施时间:

Study execute time:

From2009-03-01To 2011-06-30 

征募观察对象时间:

Recruiting time:

From2010-09-26To 2011-04-18 

干预措施:

Interventions:

组别:

干预组

样本量:

550

Group:

intervention group

Sample size:

干预措施:

在线情景嵌入式干预

干预措施代码:

Intervention:

Online scenario experiencing intervention

Intervention code:

组别:

干预组

样本量:

550

Group:

intervention group

Sample size:

干预措施:

预防艾滋病信息推送

干预措施代码:

Intervention:

HIV information dissemination

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):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州市疾病预防控制中心 

单位级别:

市级 

Institution
hospital:

Guangzhou Center for Disease Control and Prevention  

Level of the institution:

city CDC 

测量指标:

Outcomes:

指标中文名:

与男性无套性行为

指标类型:

主要指标 

Outcome:

Condomless sex with male

Type:

Primary indicator 

测量时间点:

基线和6月随访调查

测量方法:

在线问卷

Measure time point of outcome:

baseline and post-survey at six month

Measure method:

online survey

指标中文名:

性伴数量

指标类型:

次要指标 

Outcome:

Number of sex partners

Type:

Secondary indicator 

测量时间点:

基线和6月随访调查

测量方法:

在线问卷

Measure time point of outcome:

baseline and post-survey at six month

Measure method:

online survey

指标中文名:

艾滋病相关知识、态度

指标类型:

次要指标 

Outcome:

AIDS related knowledge and attitude

Type:

Secondary indicator 

测量时间点:

基线和6月随访调查

测量方法:

在线问卷

Measure time point of outcome:

baseline and post-survey at six month

Measure method:

online survey

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

Not available

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 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):

简单随机分组方法,由研究生陈章颖采用SPSS软件产生随机数字并进行分组。

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

Simple randomization method,peformed by postgraduate student Zhangyin Chen, by using SPSS to generate a set of random digit and divided into two groups.

盲法:

这是一项“开放标签”设计。

Blinding:

This was an 'open-label' design.

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):

尚未公开。

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

Not yet available.

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:

数据采样SAV格式保存,包含年龄、婚姻状况、收入等所有一般人口学资料、性行为资料和艾滋病相关行为资料。

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

Data was stored using SAV format, included demographic information, such as age, marriage status, and income, etc., sexual behaviors, and AIDS related behaviors.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-01-02
return list