ChiCTR2500099806 版本V1.0 版本创建时间2025/03/28 16:43:20 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：

 ChiCTR2500099806 

最近更新日期：

Date of Last Refreshed on：

 2025-03-28 16:43:07 

注册时间：

Date of Registration：

 2025-03-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

在农村低资源地区宫颈癌筛查难触及人群中应用基于村医投放的HPV自采样干预的效果与实施评估研究

Public title：

Village Doctor-Delivered HPV Self-Sampling for Hard-to-Reach Populations in Low-Resource Rural Areas: An Implementation and Effectiveness Evaluation Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

在农村低资源地区宫颈癌筛查难触及人群中应用基于村医投放的HPV自采样干预的效果与实施评估研究

Scientific title：

Village Doctor-Delivered HPV Self-Sampling for Hard-to-Reach Populations in Low-Resource Rural Areas: An Implementation and Effectiveness Evaluation Study

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：

王乾坤 

研究负责人：

乔友林 

Applicant：

Qiankun Wang 

Study leader：

Youlin Qiao 

申请注册联系人电话：

Applicant telephone：

 +86 137 1680 3078

研究负责人电话：

Study leader's
telephone：

+86 10 8778 8489

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：

 wqk201912014@aliyun.com

研究负责人电子邮件：

Study leader's E-mail：

 qiaoy@cicams.ac.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：

北京市东城区东单三条9号

研究负责人通讯地址：

北京市东城区东单三条9号

Applicant address：

9 Dong Dan San Tiao, Dongcheng District, Beijing

Study leader's address：

9 Dong Dan San Tiao, Dongcheng District, Beijing

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：

中国医学科学院北京协和医学院群医学及公共卫生学院

Applicant's institution：

School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College

研究负责人所在单位：

中国医学科学院北京协和医学院群医学及公共卫生学院

Affiliation of the Leader：

School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College

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：

 CAMS&PUMC-IEC-2025-042

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：

中国医学科学院北京协和医学院伦理委员会

Name of the ethic committee：

Chinese Academy of Medical Sciences and Peking Union Medical College Independent Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-14 00:00:00

伦理委员会联系人：

王灿

Contact Name of the ethic committee：

Can Wang

伦理委员会联系地址：

北京市东城区东单三条9号

Contact Address of the ethic committee：

9 Dong Dan San Tiao, Dongcheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 6510 5716

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：

中国医学科学院北京协和医学院群医学及公共卫生学院

Primary sponsor：

School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College

研究实施负责（组长）单位地址：

北京市东城区东单三条9号

Primary sponsor's address：

9 Dong Dan San Tiao, Dongcheng District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

Beijing

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国医学科学院北京协和医学院群医学及公共卫生学院

具体地址：

北京市东城区东单三条9号

Institution
hospital：

School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College

Address：

9 Dong Dan San Tiao, Dongcheng District, Beijing

经费或物资来源：

总理基金项目

Source(s) of funding：

The Premier Fund Project

研究疾病：

宫颈癌  

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：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

本研究分为两个阶段： 第一阶段为一项整群随机对照试验，旨在小规模人群中验证自采样干预措施和实施策略的效果和实施可行性：在两个研究地点（山西省长治市襄垣县和山西晋城市泽州县）的30个行政村开展，以行政村为整群进行整群分层随机化，1:1平行分配至干预组“加强动员+提供自采样选项”和对照组“加强动员”，预计覆盖2100人； 第二阶段为一项单臂干预的真实世界研究，旨在验证自采样干预措施和实施策略在真实世界大样本人群中的效果、实施可行性和可持续性，预计在10个研究地点推广干预，在500个行政村完成5000人的干预覆盖；同时，该阶段在自采样阳性人群中内嵌一项随机对照试验，将自采样阳性人群进行个体随机化，1:1平行分配至“村医召回组”和“妇幼保健院召回组”，旨在探索适合农村低资源地区自采样阳性人群的召回策略。第二阶段研究地点包括：山西省长治市襄垣县、山西省晋城市泽州县、四川省阿坝藏族羌族自治州松潘县、云南省德宏傣族景颇族自治州芒市、甘肃省白银市景泰县、云南省玉溪市新平县、山西省长治市武乡县、云南省大理白族自治州鹤庆县、四川省雅安市石棉县、四川省绵阳市盐亭县。 总目标： 本研究旨针对自采样在农村低资源地区解决难触及人群筛查问题的效果和实施进行科学评估。 分目标： 1）评价自采样干预在提高难触及人群筛查覆盖率的效果以及实施可行性、可持续性和成本效益； 2）筛选适宜中国农村低资源地区使用的自采样检测技术与阳性人群召回的实施策略； 3）将经验证的自采样干预措施与实施策略转化为公共卫生实践，评估其推广在真实世界的效果与实施情况。  

Objectives of Study：

Study Design This study consists of two phases: Phase 1: A Cluster Randomized Controlled Trial The first phase is a cluster randomized controlled trial aimed at evaluating the effectiveness and feasibility of self-sampling interventions and implementation strategies in a small-scale population. The trial will be conducted in 30 administrative villages across two study sites—Xiangyuan County, Changzhi City, and Zezhou County, Jincheng City, Shanxi Province. Using a cluster-based stratified randomization approach, villages will be randomly assigned in a 1:1 ratio to either the intervention group ("enhanced mobilization + self-sampling option") or the control group ("enhanced mobilization"). The trial is expected to cover approximately 2,100 participants. Phase 2: A Real-World, Single-Arm Interventional Study The second phase is a real-world study designed to assess the effectiveness, feasibility, and sustainability of self-sampling interventions and implementation strategies in a large-scale population. The intervention will be expanded to 10 study sites, covering 5,000 participants across 500 administrative villages. Additionally, this phase will incorporate an embedded randomized controlled trial among HPV-positive individuals identified through self-sampling. These individuals will be randomly assigned at the individual level in a 1:1 ratio to either the "village doctor recall group" or the "maternal and child health hospital recall group". The objective is to explore optimal recall strategies for HPV-positive individuals in low-resource rural settings. The study sites for the second phase include: Xiangyuan County, Changzhi City, Shanxi Province; Zezhou County, Jincheng City, Shanxi Province; Songpan County, Aba Tibetan and Qiang Autonomous Prefecture, Sichuan Province; Mangshi City, Dehong Dai and Jingpo Autonomous Prefecture, Yunnan Province; Jingtai County, Baiyin City, Gansu Province; Xinping County, Yuxi City, Yunnan Province; Wuxiang County, Changzhi City, Shanxi Province; Heqing County, Dali Bai Autonomous Prefecture, Yunnan Province; Shimian County, Ya'an City, Sichuan Province; and Yanting County, Mianyang City, Sichuan Province. Overall Objective: This study aims to scientifically evaluate the effectiveness and implementation of self-sampling in addressing cervical cancer screening challenges for hard-to-reach populations in low-resource rural areas. Specific Objectives: 1. To assess the effectiveness of the self-sampling intervention in improving screening coverage among hard-to-reach populations, as well as its feasibility, sustainability, and cost-effectiveness. 2. To identify appropriate self-sampling detection technologies and implementation strategies for recalling HPV-positive individuals suitable for use in low-resource rural areas in China. 3. To translate the validated self-sampling interventions and implementation strategies into public health practice and evaluate their real-world effectiveness and implementation.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

第一阶段： 1）行政村（整群）：①难触及人群规模在20至50人之间；②村中至少有一名愿意参与项目的村医，村医年龄不高于60岁、会使用智能手机且平日在村中行医； 2）参与者（个体）：①35-64周岁本地常住妇女；②既往三或五年内未参与过任何形式的宫颈癌筛查（根据现场既往使用宫颈癌初筛方法判断该条件：既往使用细胞学初筛的现场条件为三年；既往使用HPV检测初筛的现场该条件为五年）；③所常住村所在乡镇本年度已被妇幼保健院组织性筛查覆盖，且经本村村医动员后仍然不愿、拒绝或无法前往妇幼保健院或乡镇卫生院完成宫颈癌筛查；④理解项目程序，自愿参与，并签署知情同意书。 第二阶段筛查人群： 1）行政村（整群）：村中至少有一名愿意参与项目的村医，村医年龄不高于60岁、会使用智能手机且平日在村中行医； 2）参与者（个体）：①35-64周岁本地常住妇女；②既往三或五年内未参与过任何形式的宫颈癌筛查（根据现场既往使用宫颈癌初筛方法判断该条件：既往使用细胞学初筛的现场条件为三年；既往使用HPV检测初筛的现场该条件为五年）；③所常住村所在乡镇本年度已被妇幼保健院组织性筛查覆盖，且经本村村医动员后仍然不愿、拒绝或无法前往妇幼保健院或乡镇卫生院完成宫颈癌筛查；④理解项目程序，自愿参与，并签署知情同意书。 第二阶段阳性人群： ①既往接受本研究第二阶段干预措施且HPV检测为阳性；②召回时仍居住在第二阶段干预期间所在的行政村。

Inclusion criteria

Phase 1: 1 Administrative Villages (Cluster-Level): (1) The number of hard-to-reach individuals in the village ranges between 20 and 50. (2) At least one village doctor in the village must be willing to participate, be no older than 60 years, be capable of using a smartphone, and regularly provide medical services to villagers. 2 Participants (Individual-Level): (1) Local resident women aged 35–64. (2) Have not undergone any form of cervical cancer screening in the past three or five years (this criterion is determined based on the primary screening method previously used at the site: three years if cytology was used for primary screening, and five years if HPV testing was used). (3) Reside in a township that has already been covered by an organized screening program led by the maternal and child health hospital this year, but remain unwilling, refuse, or are unable to visit the maternal and child health hospital or township health center for cervical cancer screening despite mobilization by the village doctor. (4) Understand the study procedures, voluntarily participate, and sign the informed consent form. Phase 2: Screening Population 1 Administrative Villages (Cluster-Level): At least one village doctor in the village must be willing to participate, be no older than 60 years, be capable of using a smartphone, and regularly provide medical services to villagers. 2 Participants (Individual-Level): (1) Local resident women aged 35–64. (2) Have not undergone any form of cervical cancer screening in the past three or five years (this criterion is determined based on the primary screening method previously used at the site: three years if cytology was used for primary screening, and five years if HPV testing was used). (3) Reside in a township that has already been covered by an organized screening program led by the maternal and child health hospital this year, but remain unwilling, refuse, or are unable to visit the maternal and child health hospital or township health center for cervical cancer screening despite mobilization by the village doctor. (4) Understand the study procedures, voluntarily participate, and sign the informed consent form. Phase 2: HPV-Positive Population (1) Individuals who previously participated in the Phase 2 intervention and tested HPV-positive. (2) At the time of recall, they still reside in the administrative villages where the Phase 2 intervention was conducted.

排除标准：

1）行政村（整群）：村医不愿或拒绝参与项目。 2）参与者（个体）：①既往宫颈癌疾病史，宫颈癌及癌前病变手术史；②认知或行为障碍，难以完成自采样和问卷调查。

Exclusion criteria：

1 Administrative Villages (Cluster-Level): The village doctor is unwilling or refuses to participate in the project. 2 Participants (Individual-Level): (1) A history of cervical cancer or previous cervical cancer-related surgeries (including precancerous lesions). (2) Cognitive or behavioral barriers that make it difficult for the individual to complete self-sampling or the questionnaire survey.

研究实施时间：

Study execute time：

从 From 2025-04-03 00:00:00至 To 2026-04-03 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-04-03 00:00:00 至 To 2026-01-31 00:00:00

干预措施：

Interventions：

组别：

干预组（第一阶段）

样本量：

 1050

Group：

Intervention Group (Phase 1)

Sample size：

干预措施：

“加强动员+提供自采样选项”：先动员妇女前往当地妇幼保健院完成医生采样的宫颈癌筛查，若其拒绝则提供自采样选项，包括教学、采样、信息收集、样本检测与结果通知。 样本量：30个行政村，1050人。

干预措施代码：

Intervention：

"Strengthen Mobilization + Provide Self-Sampling Options": First, mobilize women to undergo doctor-assisted cervical cancer screening at the local maternal and child health hospital. If they refuse, provide self-sampling options, including sampling guidance, collection, information collection, sample testing, and result notification. Sample size: 30 villages, 1050 women.

Intervention code：

组别：

对照组（第一阶段）

样本量：

 1050

Group：

Control Group (Phase 1)

Sample size：

干预措施：

“加强动员”：动员妇女前往当地妇幼保健院完成医生采样的宫颈癌筛查。 样本量：30个行政村，1050人。

干预措施代码：

Intervention：

"Strengthen Mobilization": Mobilize women to undergo doctor-assisted cervical cancer screening at the local maternal and child health hospital. Sample size: 30 villages, 1050 women.

Intervention code：

组别：

干预组（第二阶段筛查人群）

样本量：

 5000

Group：

Intervention Group (Phase 2 Screening Population)

Sample size：

干预措施：

“加强动员+提供自采样选项”：先动员妇女前往当地妇幼保健院完成医生采样的宫颈癌筛查，若其拒绝则提供自采样选项，包括教学、采样、信息收集、样本检测与结果通知。 样本量：500个行政村，5000人。

干预措施代码：

Intervention：

"Strengthen Mobilization + Provide Self-Sampling Options": First, mobilize women to undergo doctor-assisted cervical cancer screening at the local maternal and child health hospital. If they refuse, provide self-sampling options, including sampling guidance, collection, information collection, sample testing, and result notification. Sample size: 500 villages, 5000 women.

Intervention code：

组别：

村医召回组（第二阶段阳性人群）

样本量：

 400

Group：

Village Doctor Recall Group (Phase 2 Positive Population)

Sample size：

干预措施：

由村医完成对本村HPV检出阳性人群进行召回，令其前往妇幼保健院完成分流检查。 样本量：400人（该部分人群来自于第二阶段筛查人群干预组人群中检出HPV阳性的人群，因此不需要重复计算在总样本中）

干预措施代码：

Intervention：

The village doctor is responsible for recalling HPV-positive individuals in the village and directing them to the maternal and child health hospital for triage examination. Sample size: 400 women (This population consists of individuals who tested HPV-positive in the intervention group of the Phase 2 screening population; therefore, they should not be counted again in the total sample.)

Intervention code：

组别：

妇幼保健院召回组（第二阶段阳性人群）

样本量：

 400

Group：

MCHH Recall Group (Phase 2 Positive Population)

Sample size：

干预措施：

由妇幼保健院工作人员完成对HPV检出阳性人群进行召回，令其前往妇幼保健院完成分流检查。

干预措施代码：

Intervention：

The staff of the maternal and child health hospital is responsible for recalling HPV-positive individuals and directing them to the hospital for triage examination. Sample size: 400 women (This population consists of individuals who tested HPV-positive in the intervention group of the Phase 2 screening population; therefore, they should not be counted again in the total sample.)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山西 

市(区县)：

 襄垣 

Country：

China

Province：

Shanxi

City：

Xiangyuan

单位(医院)：

 襄垣妇幼保健计划生育服务中心 

单位级别：

 一级 

Institution
hospital：

Xiangyuan County Maternal and Child Health Family Planning Service Center

Level of the institution：

Primary

国家：

 中国

省(直辖市)：

 山西 

市(区县)：

 泽州 

Country：

China

Province：

Shanxi

City：

Zezhou

单位(医院)：

 泽州妇幼保健院 

单位级别：

 一级 

Institution
hospital：

Zezhou Maternal and Child Health Hospital

Level of the institution：

Primary

国家：

 中国

省(直辖市)：

 山西 

市(区县)：

 武乡 

Country：

China

Province：

Shanxi

City：

Wuxiang

单位(医院)：

 武乡妇幼保健院 

单位级别：

 一级 

Institution
hospital：

Wuxiang Maternal and Child Health Hospital

Level of the institution：

Primary

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

 松潘 

Country：

China

Province：

Sichuan

City：

Songpan

单位(医院)：

 松潘妇幼保健院 

单位级别：

 一级 

Institution
hospital：

Songpan Maternal and Child Health Hospital

Level of the institution：

Primary

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

 盐亭 

Country：

China

Province：

Sichuan

City：

Yanting

单位(医院)：

 盐亭妇幼保健院 

单位级别：

 一级 

Institution
hospital：

Yanting Maternal and Child Health Hospital

Level of the institution：

Primary

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

 石棉 

Country：

China

Province：

Sichuan

City：

Shimian

单位(医院)：

 石棉妇幼保健院 

单位级别：

 一级 

Institution
hospital：

Shimian Maternal and Child Health Hospital

Level of the institution：

Primary

国家：

 中国

省(直辖市)：

 云南 

市(区县)：

 新平 

Country：

China

Province：

Yunnan

City：

Xinping

单位(医院)：

 新平妇幼保健院 

单位级别：

 一级 

Institution
hospital：

Xinping Maternal and Child Health Hospital

Level of the institution：

Primary

国家：

 中国

省(直辖市)：

 云南 

市(区县)：

 鹤庆 

Country：

China

Province：

Yunnan

City：

Heqing

单位(医院)：

 鹤庆妇幼保健院 

单位级别：

 一级 

Institution
hospital：

Heqing Maternal and Child Health Hospital

Level of the institution：

Primary

国家：

 中国

省(直辖市)：

 云南 

市(区县)：

 芒市 

Country：

China

Province：

Yunnan

City：

Mangshi

单位(医院)：

 芒市妇幼保健院 

单位级别：

 一级 

Institution
hospital：

Mangshi Maternal and Child Health Hospital

Level of the institution：

Primary

国家：

 中国

省(直辖市)：

 甘肃 

市(区县)：

 景泰 

Country：

China

Province：

Gansu

City：

Jingtai

单位(医院)：

 景泰妇幼保健院 

单位级别：

 一级 

Institution
hospital：

Jingtai Maternal and Child Health Hospital

Level of the institution：

Primary

测量指标：

Outcomes：

指标中文名：

难触及人群筛查覆盖率

指标类型：

主要指标

Outcome：

Screening coverage rate for hard-to-reach populations

Type：

Primary indicator

测量时间点：

干预结束后三个月

测量方法：

信息化平台

Measure time point of outcome：

3 months after the intervention

Measure method：

Information platform

指标中文名：

HPV阳性率

指标类型：

次要指标

Outcome：

HPV positive rate

Type：

Secondary indicator

测量时间点：

干预结束后三个月

测量方法：

信息化平台和检测结果

Measure time point of outcome：

3 months after the intervention

Measure method：

Information platform&results of HPV test

指标中文名：

自采样干预的实施结局（覆盖、采纳、实施、维持等）

指标类型：

次要指标

Outcome：

Implementation outcomes of the self-sampling intervention (the degree and process of reach, adoption, implementation, and maintenance achieved)

Type：

Secondary indicator

测量时间点：

测量方法：

信息化平台

Measure time point of outcome：

Measure method：

Information platform

指标中文名：

宫颈癌及癌前病变检出率

指标类型：

次要指标

Outcome：

Detection rate of cervical cancer and precancerous lesions

Type：

Secondary indicator

测量时间点：

干预结束后六个月

测量方法：

信息化平台

Measure time point of outcome：

6 months after the intervention

Measure method：

Information platform

指标中文名：

阳性召回率

指标类型：

主要指标

Outcome：

Positive recall rate

Type：

Primary indicator

测量时间点：

干预结束后1个月

测量方法：

信息化平台

Measure time point of outcome：

One months after the intervention

Measure method：

Information platform

指标中文名：

检测信度评价

指标类型：

次要指标

Outcome：

Detection reliability evaluation

Type：

Secondary indicator

测量时间点：

干预结束后三个月

测量方法：

检测结果

Measure time point of outcome：

3 months after the intervention

Measure method：

Results of HPV test

指标中文名：

癌前病变治疗率

指标类型：

次要指标

Outcome：

Treatment rate of precancerous lesions

Type：

Secondary indicator

测量时间点：

干预结束后六个月

测量方法：

信息化平台

Measure time point of outcome：

6 months after the intervention

Measure method：

Information platform

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

宫颈和阴道脱落细胞样本

组织：

阴道

Sample Name：

Exfoliated Cervicovaginal Samples

Tissue：

Vagina

人体标本去向

 使用后销毁  

说明

采集后一个月内完成检测，检测后销毁

Fate of sample：

Destruction after use  

Note：

The test shall be completed within one month after collection and destroyed after detection

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 35 岁 years
最大 Max age 64 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）：

采用整群分层随机设计（Cluster Stratified Randomized Design），以行政村为整群（Cluster），按乡镇和行政村内难触及人口规模进行分层随机化。在两个研究地点（山西省长治市襄垣县和山西省晋城市泽州县）分别随机抽取3和4个2025年度未被下乡筛查覆盖的乡镇，在每个乡镇中按照纳入排除标准选取6-12个行政村；在乡镇内，依据行政村内难触及人群规模进行分层，具体按照难触及人群规模20-35人及36-50人划分为两亚组。随后，一位独立研究者使用计算机生成的随机序列，按照1:1比例将行政村随机分配至干预组或对照组。最后，整群层面共纳入60个已经被下乡筛查覆盖后的行政村，每个行政村平均触及35名妇女，覆盖村子中剩余全部具有筛查资格的适龄妇女，预计共覆盖约2100人；干预组和对照组每组各30村、约1050人。

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

A cluster stratified randomized design will be adopted, using administrative villages as clusters. Stratification and randomization will be conducted based on townships and the size of the hard-to-reach population within each administrative village. In the two study sites—Xiangyuan County, Changzhi City, Shanxi Province, and Zezhou County, Jincheng City, Shanxi Province—three and four townships, respectively, that will not be covered by rural screening in 2025 will be randomly selected. Within each selected township, 6 to 12 administrative villages will be chosen according to inclusion and exclusion criteria. Within each township, stratification will be performed based on the size of the hard-to-reach population in administrative villages. Specifically, villages will be categorized into two subgroups: those with a hard-to-reach population of 20–35 people and those with 36–50 people. An independent researcher will then use a computer-generated random sequence to randomly assign administrative villages to either the intervention group or the control group in a 1:1 ratio. At the cluster level, a total of 60 administrative villages that have already been covered by rural screening will be included. On average, each administrative village is expected to reach 35 women, covering all remaining eligible women in the village. The total estimated coverage will be approximately 2,100 people, with 30 villages (about 1,050 people) in each of the intervention and control groups.

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：

因为干预性质原因，无法使用盲法。

Blinding：

Due to the intervention's features, blinding is not possible.

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）：

不共享原始数据

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

Raw data is not shared

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：

独立存储管理

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

Manage storage independently

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-03-28 16:43:07