An outreach strategy to increase uptake of vaginal self-sampling for cervical cancer screening in older French women: The RIDECA interventional research protocol.

BACKGROUND: 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. OBJECTIVES: 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. DESIGN: RIDECA is an interventional research project located in the South of France. METHODS AND ANALYSIS: 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. ETHICS: The project was approved by the Ethical Research Committee Ile de France VI and by the French Data Protection Authority. DISCUSSION: The results will provide useful information on the effectiveness (acceptability, efficiency) of this outreach strategy and identify barriers and levers that facilitate its implementation. REGISTRATION: ClinicalTrials.gov (NCT04716127), January 20, 2021.

Can we improve postmenopausal women's adherence to cervical cancer screening by using vaginal self-sampling and a direct approach by a midwife?Why is this study being done?In France, 40% of women, especially postmenopausal women, do not participate in cervical cancer screening. We already know that vaginal self-collection with HPV testing is highly accepted by women and increases their participation in screening. Different strategies have been proposed as the most appropriate approach to utilize when offering the vaginal self-sampling option to women.What are the researchers doing?The study, set up in the Occitania region of France, is still ongoing and is targeting women aged 50­65 who have not been screened for cervical cancer. The aim of the study is to assess whether reaching women in their everyday environment and offering them a vaginal self-collection device during an educational session with a midwife improves their adherence to and participation in cervical cancer screening.To answer these questions, we will recruit six hundred women aged 50­65 who have not been screened for cervical cancer for three years or more at two sites:- In the department of Hérault, where midwives will approach women visiting a mobile breast cancer screening unit,- in the department of Aude, where a midwife can easily arrange appointments for interested women, following an information campaign.Participants who agree to take part will receive a self-sampling kit to use at home and return to the laboratory for HR-HPV testing. During recruitment, we will also use questionnaires and interviews to assess women's socio-economic situation and motivations for participating (or not) in cervical cancer screening.What are the expected results?This study will allow us to assess women's adherence to this "direct" "face-to-face" cervical screening strategy and the potential influence of socio-economic and motivational factors on adherence. Through gaining these vital insights, we hope to identify the barriers and levers that will facilitate its implementation.

Acceptability of vaginal self-sampling with high-risk human papillomavirus testing for cervical cancer screening: a French questionnaire-based study.

In France, cervical cancer screening based on cervical smear has a participation rate of around 60%. New screening strategies are encouraged to increase the participation of under-screened women, including vaginal self-sampling with high-risk human papillomavirus (HR-HPV) testing. This study was based on the distribution of an anonymous self-administered questionnaire to assess the acceptability of vaginal self-sampling with HR-HPV testing by women aged 25 to 65 years in two French Departments of the South of France, Aude, and Hérault, showing low participation in cervical cancer screening. Factors influencing this acceptability were also analyzed. From May to July 2017, 349 completed questionnaires were collected. Women declared high acceptability for vaginal self-sampling (81%) preferably at home (82.6%). Acceptability was statistically higher in the Department of Herault (p = .001) and for women older than 50 years (p = .018). There was no difference according to educational level or attendance to cervical cancer screening. Knowledge about cervical cancer and cervical cancer screening was significantly influenced by educational level. This study confirmed that vaginal self-sampling with HR-HPV testing was highly accepted, including by under-screened women, encouraging further interventional studies. Education about cervical cancer and cervical cancer screening should be part of these programs, especially for women with lower educational level.