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请与我们联系上传伦理批件。 夕阳无艾:一项简短循证视频干预以提高老年男性艾滋病预防能力的随机对照试验方案
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注册号:

Registration number:

ChiCTR2100045708 

最近更新日期:

Date of Last Refreshed on:

2021-12-07 

注册时间:

Date of Registration:

2021-04-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请与我们联系上传伦理批件。 夕阳无艾:一项简短循证视频干预以提高老年男性艾滋病预防能力的随机对照试验方案 

Public title:

Sunset Without AIDS:Protocol for a Randomized Controlled Trial of a brief evidence-based video intervention to improve the ability of AIDS prevention in elderly men 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于IMB理论的老年男性艾滋病相关危险性行为教育微电影的开发与效果评价 

Scientific title:

Development and effect evaluation of AIDS-related risky sexual behavior education microfilms for elderly men based on IMB theory 

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:

任建兰 

研究负责人:

任建兰 

Applicant:

Ren Jianlan 

Study leader:

Ren Jianlan 

申请注册联系人电话:

Applicant telephone:

+86 13667626252 

研究负责人电话:

Study leader's telephone:

+86 13667626252 

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:

370319003@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

370319003@qq.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:

四川省泸州市太平街25号 

研究负责人通讯地址:

四川省泸州市太平街25号 

Applicant address:

25 Taiping Street, Luzhou, Sichuan 

Study leader's address:

25 Taiping Street, Luzhou, Sichuan 

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:

西南医科大学附属医院 

Applicant's institution:

Affiliated Hospital of Southwest 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:

KY2021071 

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:

西南医科大学附属医院临床试验伦理委员会 

Name of the ethic committee:

Ethics Committee of Affiliated Hospital of Southwest Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

张增瑞 

Contact Name of the ethic committee:

Zhang Zengrui 

伦理委员会联系地址:

四川省泸州市太平街25号 

Contact Address of the ethic committee:

25 Taiping Street, Luzhou, Sichuan 

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:

西南医科大学附属医院 

Primary sponsor:

Affiliated Hospital of Southwest Medical University 

研究实施负责(组长)单位地址:

四川省泸州市太平街25号 

Primary sponsor's address:

25 Taiping Street, Luzhou, Sichuan 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

泸州

Country:

China

Province:

Sichuan

City:

Luzhou

单位(医院):

西南医科大学附属医院

具体地址:

太平街25号

Institution
hospital:

Affiliated Hospital of Southwest Medical University

Address:

25 Taiping Street

经费或物资来源:

课题经费 

Source(s) of funding:

Project funding 

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:

评价夕阳无艾滋病视频干预对提高老年男性预防艾滋病能力的作用。 

Objectives of Study:

To evaluate the effect of Sunset Without AIDS intervention on improving the ability of AIDS prevention in elderly men. 

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.自愿提供知情同意书,自愿参与本研究; 2.年龄≥60; 3.意识清晰,无精神疾病和严重视力障碍,有一定的阅读能力和语言表达能力。 

Inclusion criteria

1.Willing to provide informed consent, volunteer to participate in this study; 2.The man aged over 60 years old; 3.Clear consciousness, no mental illness and serious visual impairment,have certain reading ability and language expression ability. 

排除标准:

无 

Exclusion criteria:

Nil 

研究实施时间:

Study execute time:

From2021-06-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2021-05-01To 2021-05-31 

干预措施:

Interventions:

组别:

组1

样本量:

150

Group:

Group 1

Sample size:

干预措施:

接受《夕阳无艾》视频干预

干预措施代码:

Intervention:

Accept sunset without AIDS video intervention

Intervention code:

组别:

组2

样本量:

150

Group:

Group 2

Sample size:

干预措施:

接受普通艾滋病科普视频干预

干预措施代码:

Intervention:

Accept general AIDS popular science video intervention

Intervention code:

组别:

组3

样本量:

150

Group:

Group 3

Sample size:

干预措施:

接受艾滋病健康讲座

干预措施代码:

Intervention:

Receive AIDS health talks

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

泸州 

Country:

China 

Province:

Sichuan 

City:

Luzhou 

单位(医院):

西南医科大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Southwest Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

艾滋病相关知识

指标类型:

主要指标 

Outcome:

AIDS-related knowledge

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

艾滋病相关态度

指标类型:

主要指标 

Outcome:

AIDS-related attitudes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

艾滋病相关行为

指标类型:

主要指标 

Outcome:

AIDS-related behavior

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:

none

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 60 years
最大 Max age 90 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):

研究人员用随机对照表产生随机序列

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

The researchers use a random control table to generate random sequences.

盲法:

未说明

Blinding:

Not stated

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

是Yes

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):

研究负责人邮箱

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

Email address of the person in charge of the research

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:

电子采集和管理系统

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

Electronic Data Capture

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-04-23
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