Direct mailing of HPV self-sampling kits to older women non-participating in cervical screening in the Czech Republic

Background A population-based cervical cancer screening programme is implemented in the Czech Republic. However, participation is insufficient among women over 50 years. This study aimed to estimate the potential improvement in participation through directly mailed HPV self-sampling kits (HPVssk) compared to standard invitation letters in women aged 50-65 non-participating in screening. Methods The study recruited 1,564 eligible women (no cervical cancer screening in the last 3 years or more, no previous treatment associated with cervical lesions or cervical cancer). Eight hundred women were mailed with an HPVssk (HPVssk group), and 764 women were sent a standard invitation letter (control group) inviting them to a routine screening (Pap test). The primary outcome was a comparison of the overall participation rate between study groups using a binominal regression model. Results The participation rate in the HPVssk group was 13.4% (95% CI 11.2–15.9%; 7.4% of women returned the HPVssk and 6.0% attended gynaecological examination) and 5.0% (95% CI 3.6–6.8%) in the control group. Using the binominal regression model, the difference between the groups was estimated as 7.6% (95% CI 5.0-10.2%; p < 0.001). In the HPVssk group, 22% of women who returned HPVssk had a positive result and 70% of them underwent a follow-up examination. Conclusions Compared to traditional invitation letters, the direct mailing of the HPVssk achieved a significantly higher participation rate, along with a notable HPV positivity rate among HPVssk responders. This approach offers a potentially viable method for engaging women who have not yet attended a cervical screening programme. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04226313 ### Funding Statement This work was supported by the European Union within the framework of the European Social Fund, Operation Programme Employment [Optimisation of the cervical cancer screening programme by introducing HPV DNA detection by self-testing kits in women who do not attend the current screening programme in the long term, grant no. CZ.03.2.63/0.0/0.0/15_039/0008171]. We acknowledge the use of the research infrastructure for translational medicine (EATRIS-CZ, [www.eatris.cz][1]). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: All study participants provided written informed consent. This study was performed in compliance with the Helsinki Declaration according to the study ethics proposal approved by the Ethics Committee of the Faculty of Medicine and Dentistry at Palacky University and the University Hospital in Olomouc (protocol no. 150/18). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The authors are not authorised to share any potentially identifiable patient level data. In justified cases, data may be formally requested through the corresponding author and the request for data will be assessed by the Institute of Health Information and Statistics of the Czech Republic. [1]: http://www.eatris.cz