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一种在中国少数民族地区宫颈癌筛查中采用“传递善意”方法提高基于人乳头瘤病毒的自我采样反馈率的随机对照试验方案。

A pay-it-forward approach to improve feedback rate of HPV-based self-sampling in cervical cancer screening among women in ethnic minority regions of China: a randomized controlled trial protocol.

作者信息

Zhou Xueyuan, Bao Rantong, Guan Xin, Li Wenzhuo, Yang Chenxin, Zhu Ruijin, Li Hui, Wang Xiaohua

机构信息

Department of Genetics, Inner Mongolia Maternity and Child Health Care Hospital, Hohhot, China.

Center for Clinical Epidemiology Research, the Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.

出版信息

Front Psychiatry. 2025 May 29;16:1586076. doi: 10.3389/fpsyt.2025.1586076. eCollection 2025.

Abstract

BACKGROUND

Human papillomavirus (HPV) infection is the primary cause of cervical cancer, and HPV self-sampling has emerged as a novel screening method with the potential to increase screening coverage and early detection of cervical cancer. However, the implementation of HPV self-sampling in China faces several challenges, including sociocultural factors, economic burdens, and low feedback rates. This study will aim to improve the feedback rate of HPV self-sampling results through a Pay-It-Forward approach and explore its impact on HPV positivity rates and subsequent treatment compliance.

METHODS

This study employs a randomized controlled trial (RCT) design, enrolling women aged 24 and older who have not received the HPV vaccine and have not undergone HPV self-sampling or cervical cancer screening in the past 12 months. Participants will be randomly divided into a control group (free distribution of HPV self-sampling kits) and an intervention group (pay up front for HPV self-sampling). The prepayment amount is 20 RMB, which is fully refunded upon completion of the self-sampling and feedback of results. The primary outcome measure is the feedback rate of HPV self-sampling results. The study is conducted at maternal and child health care and family planning service centers in Hohhot, Inner Mongolia Autonomous Region, with an expected enrollment of 108 participants.

DISCUSSION

The Pay-It-Forward approach is expected to significantly improve the feedback rate of HPV self-sampling results by enhancing participants' psychological commitment and sense of responsibility. Additionally, this strategy may positively affect HPV positivity rates and subsequent treatment compliance. The innovation of this study lies in the first application of the Pay-It-Forward method to HPV self-sampling and the comprehensive analysis of urban-rural differences. The results of this study will provide a scientific basis for improving women's cervical health awareness and optimizing HPV self-sampling intervention strategies, thereby promoting the widespread application of HPV self-sampling in cervical cancer screening.

TRIAL REGISTRATION

This study registered at ClinicalTrials.gov (ChiCTR2500095770) on January 13, 2025.

摘要

背景

人乳头瘤病毒(HPV)感染是宫颈癌的主要病因,HPV自我采样已成为一种新型筛查方法,具有提高宫颈癌筛查覆盖率和早期检测率的潜力。然而,HPV自我采样在中国的实施面临诸多挑战,包括社会文化因素、经济负担和低反馈率。本研究旨在通过“传递支付”方法提高HPV自我采样结果的反馈率,并探讨其对HPV阳性率及后续治疗依从性的影响。

方法

本研究采用随机对照试验(RCT)设计,招募24岁及以上未接种HPV疫苗且在过去12个月内未进行过HPV自我采样或宫颈癌筛查的女性。参与者将被随机分为对照组(免费发放HPV自我采样试剂盒)和干预组(预先支付HPV自我采样费用)。预付款金额为20元,在完成自我采样并反馈结果后全额退还。主要结局指标是HPV自我采样结果的反馈率。该研究在内蒙古自治区呼和浩特市的妇幼保健和计划生育服务中心进行,预计招募108名参与者。

讨论

“传递支付”方法有望通过增强参与者的心理承诺和责任感,显著提高HPV自我采样结果的反馈率。此外,该策略可能对HPV阳性率及后续治疗依从性产生积极影响。本研究的创新之处在于首次将“传递支付”方法应用于HPV自我采样,并对城乡差异进行综合分析。本研究结果将为提高女性宫颈癌健康意识和优化HPV自我采样干预策略提供科学依据,从而促进HPV自我采样在宫颈癌筛查中的广泛应用。

试验注册

本研究于2025年1月13日在ClinicalTrials.gov(ChiCTR2500095770)注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/68a4/12158934/c2304c0e4419/fpsyt-16-1586076-g001.jpg

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