EPSYLON EA 4556, Univ. Paul Valéry Montpellier 3, Montpellier, France.
Desbrest Institute for Epidemiology and Public Health, University of Montpellier, INSERM, Montpellier University Hospital, Montpellier, France.
Womens Health (Lond). 2024 Jan-Dec;20:17455057241292693. doi: 10.1177/17455057241292693.
In France, approximately 40% of women, including menopausal women, do not participate in cervical cancer screening. Many studies and meta-analyses have shown that self-sampling devices for high-risk human papillomavirus (HR-HPV) testing are valuable tools to increase participation. The success of self-sampling screening strategies depends on several factors, including the manner and circumstances in which the women are invited to participate. The acceptability and effectiveness of these strategies should be evaluated before further implementation.
The primary objective is to evaluate the uptake of cervical cancer screening in under-screened women, based on a direct offer of a vaginal self-sampling device by a midwife.
RIDECA is an interventional research project located in the South of France.
Six hundred women aged 50-65 with no cervical smear or HR-HPV test for 3 years or more will be recruited at two sites. The device will be offered to enrolled women to utilize at home and return to the Montpellier Hospital laboratory for HR-HPV testing. Completion of self-sampling by women who have accepted the device and follow-up of those with positive HR-HPV DNA tests will be monitored. During recruitment, participants will complete questionnaires on their socio-economic environment and motivational factors based on the psychosocial I-Change model. Semi-structured interviews will be conducted with a sub-group to identify barriers and levers to participation. Statistical analyses will be conducted for the full research sample and for each recruitment site.
The project was approved by the Ethical Research Committee Ile de France VI and by the French Data Protection Authority.
The results will provide useful information on the effectiveness (acceptability, efficiency) of this outreach strategy and identify barriers and levers that facilitate its implementation.
ClinicalTrials.gov (NCT04716127), January 20, 2021.
在法国，约 40%的女性，包括围绝经期女性，并未参与宫颈癌筛查。多项研究和荟萃分析表明，高危型人乳头瘤病毒（HPV）自我采样检测设备是提高参与度的有效工具。自我采样筛查策略的成功与否取决于多个因素，包括邀请女性参与的方式和环境。在进一步实施之前，应评估这些策略的可接受性和有效性。
本研究旨在评估通过助产士直接提供阴道自我采样设备对未充分筛查女性进行宫颈癌筛查的参与率。
RIDECA 是一项位于法国南部的干预性研究项目。
在两个地点招募 600 名年龄在 50-65 岁之间、3 年以上未进行宫颈涂片或高危型 HPV 检测的女性。将向入组女性提供设备，以便其在家中使用，并将其送回蒙彼利埃医院实验室进行 HPV 检测。将监测接受设备的女性完成自我采样的情况，并对 HPV-DNA 检测呈阳性的女性进行随访。在招募过程中，参与者将根据心理社会 I-Change 模型完成关于其社会经济环境和动机因素的问卷。将对一个亚组进行半结构式访谈，以确定参与的障碍和促进因素。将对全样本和每个招募地点进行统计分析。
该项目已获得法兰西岛六区伦理研究委员会和法国数据保护局的批准。
研究结果将为该外展策略的有效性（可接受性、效率）提供有用信息，并确定促进其实施的障碍和促进因素。
ClinicalTrials.gov（NCT04716127），2021 年 1 月 20 日。
