ChiCTR2500105761 版本V1.0 版本创建时间2025/07/10 09:40:36 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500105761 

最近更新日期：

Date of Last Refreshed on：

 2025-07-10 09:40:18 

注册时间：

Date of Registration：

 2025-07-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The effects of motivational interviewing on promoting human papillomavirus vaccination initiation and completion among South Asian mother/daughter dyads: A randomised controlled trial

Public title：

The effects of motivational interviewing on promoting human papillomavirus vaccination initiation and completion among South Asian mother/daughter dyads: A randomised controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The effects of motivational interviewing on promoting human papillomavirus vaccination initiation and completion among South Asian mother/daughter dyads: A randomised controlled trial

Scientific title：

The effects of motivational interviewing on promoting human papillomavirus vaccination initiation and completion among South Asian mother/daughter dyads: A 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：

Chan Ngo Sheung Dorothy 

研究负责人：

Chan Ngo Sheung Dorothy  

Applicant：

Chan Ngo Sheung Dorothy 

Study leader：

Chan Ngo Sheung Dorothy 

申请注册联系人电话：

Applicant telephone：

 +852 3943 8165

研究负责人电话：

Study leader's
telephone：

+852 3943 8165

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：

 dorothycns@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 dorothycns@cuhk.edu.hk

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：

Room 821, 8/F, Esther Lee Building, CUHK

研究负责人通讯地址：

Room 821, 8/F, Esther Lee Building, CUHK

Applicant address：

Room 821, 8/F, Esther Lee Building, CUHK

Study leader's address：

Room 821, 8/F, Esther Lee Building, CUHK

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：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

Affiliation of the Leader：

The Chinese University of Hong Kong

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：

 2025.156T

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：

Joint Chinese University of Hong Kong -New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong -New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-06-04 00:00:00

伦理委员会联系人：

Amy Li

Contact Name of the ethic committee：

Amy Li

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

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：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

6-8/F, Esther Lee Building, the Chinese University of Hong Kong

Primary sponsor's address：

6-8/F, Esther Lee Building, the Chinese University of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong SAR

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

The Chinese University of Hong Kong

具体地址：

6-8/F, Esther Lee Building, the Chinese University of Hong Kong

Institution
hospital：

The Chinese University of Hong Kong

Address：

6-8/F, Esther Lee Building, the Chinese University of Hong Kong

经费或物资来源：

N/A

Source(s) of funding：

N/A

研究疾病：

Cervical cancer  

Target disease：

Cervical cancer

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To test the effects of motivational interviewing on the self-efficacy, knowledge and beliefs, intention to vaccinate and initiation and completion of HPV vaccine series.  

Objectives of Study：

To test the effects of motivational interviewing on the self-efficacy, knowledge and beliefs, intention to vaccinate and initiation and completion of HPV vaccine series.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. South Asian mothers who originate from India, Pakistan or Nepal; 2. At least one daughter aged 10 and above and who are eligible to receive HPV vaccine as suggested by the Department of Health, Hong Kong; 3. No history of HPV vaccination of the daughters; 4. Dyads who can read or communicate in Cantonese, English, Hindi, Urdu or Nepali.

Inclusion criteria

1. South Asian mothers who originate from India, Pakistan or Nepal; 2. At least one daughter aged 10 and above and who are eligible to receive HPV vaccine as suggested by the Department of Health, Hong Kong; 3. No history of HPV vaccination of the daughters; 4. Dyads who can read or communicate in Cantonese, English, Hindi, Urdu or Nepali.

排除标准：

Those who are diagnosed with psychiatric illnesses, such as mood or anxiety disorders, or schizophrenia will be excluded from the study.

Exclusion criteria：

Those who are diagnosed with psychiatric illnesses, such as mood or anxiety disorders, or schizophrenia will be excluded from the study.

研究实施时间：

Study execute time：

从 From 2025-09-01 00:00:00至 To 2027-03-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-08 00:00:00 至 To 2027-03-01 00:00:00

干预措施：

Interventions：

组别：

intervention group

样本量：

 73

Group：

intervention group

Sample size：

干预措施：

motivational interviewing session supported by community health worker

干预措施代码：

Intervention：

motivational interviewing session supported by community health worker

Intervention code：

组别：

control group

样本量：

 73

Group：

control group

Sample size：

干预措施：

a brief information sheet about healthy living measures

干预措施代码：

Intervention：

a brief information sheet about healthy living measures

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong SAR 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 community centres 

单位级别：

 N/A 

Institution
hospital：

community centres

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

intention to vaccination

指标类型：

主要指标

Outcome：

intention to vaccination

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

vaccine initiation

指标类型：

主要指标

Outcome：

vaccine initiation

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

knowledge

指标类型：

次要指标

Outcome：

knowledge

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

perceived susceptibility

指标类型：

次要指标

Outcome：

perceived susceptibility

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

perceived severity

指标类型：

次要指标

Outcome：

perceived severity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

perceived benefits

指标类型：

次要指标

Outcome：

perceived benefits

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

perceived barriers

指标类型：

次要指标

Outcome：

perceived barriers

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

self-efficacy

指标类型：

次要指标

Outcome：

self-efficacy

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

acceptability of intervention

指标类型：

次要指标

Outcome：

acceptability of intervention

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：

N/A

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 18 岁 years
最大 Max age 80 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

Block randomisation with a varying block size of two, four or six will be used to allocate eligible participants into either the intervention or control group. Randomisation will be performed by a statistician who is not involved in the study via a computer-generated random schedule. The assignments to the intervention or control groups will be sealed in opaque envelopes.

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

Block randomisation with a varying block size of two, four or six will be used to allocate eligible participants into either the intervention or control group. Randomisation will be performed by a statistician who is not involved in the study via a computer-generated random schedule. The assignments to the intervention or control groups will be sealed in opaque envelopes.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

the outcome assessor will be blinded

Blinding：

the outcome assessor will be blinded

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

否No

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）：

N/A

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

N/A

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：

Data will be save in password-locked computer. Data will be destroyed after 5 years (after completion of study).

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

Data will be save in password-locked computer. Data will be destroyed after 5 years (after completion of study).

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-07-10 09:40:18