Ensuring a successful transition from Pap to HPV-based primary screening in Canada: a study protocol to investigate the psychosocial correlates of women’s screening intentions

Introduction The Human Papillomavirus (HPV) test has emerged as a significant improvement over cytology for primary cervical cancer screening. In Canada, provinces and territories are moving towards implementing HPV testing in cervical cancer screening programs. While an abundance of research exists on the benefits of HPV-based screening, there is a dearth of research examining women’s understanding of HPV testing. In other countries, failure to adequately address women’s concerns about changes has disrupted implementation of HPV-based screening. This study protocol describes a multi-step approach to develop psychometrically valid measures and to investigate psychosocial correlates of women’s intentions to participate in HPV-based cervical cancer screening. Materials and Methods We conducted a web-based survey of Canadian women to assess the acceptability and feasibility of a questionnaire, including validation of scales examining: cervical cancer knowledge, HPV testing knowledge, HPV testing attitudes and beliefs, and HPV test self-sampling attitudes and beliefs. Preferences for cervical cancer screening were assessed using Best-Worst Scaling methodology. A second web-based survey will be administered to a national sample of Canadian women in June-July of 2022 using the validated scales. Differences in the knowledge, attitudes, beliefs, and preferences of women who are currently either underscreened or adequately screened for cervical cancer will be examined through bivariate analyses. Multinomial logistic regression will be used to estimate the associations between psychosocial and sociodemographic factors and intentions to screen using HPV-based screening. Study Impact and Dissemination Findings will provide direction for Canadian public health authorities to align guidelines to address women’s concerns and optimize acceptability and uptake of HPV-based primary screening. Validated scales can be used by other researchers to improve and standardize measurement of psychosocial factors impacting HPV test acceptability. Study results will be disseminated through peer-reviewed journal articles, conference presentations, and direct communication with researchers, clinicians, policymakers, media, and specialty organizations. ### Competing Interest Statement GDZ has served as a consultant and advisory board member to Merck and as an advisory board member to Moderna and Pfizer. He also has received investigator-initiated research funding from Merck administered through Indiana University. GKS reports consulting fees from the World Health Organization outside the submitted work. AKL is the Provincial Prime Care Lead for Cancer Screening at Ontario Health (Cancer Care Ontario). MS has received grants from Abbott, BD, Bio- Fire, Hologic, Roche, GlaxoSmithKline and Merck. ### Funding Statement This work was supported by the Canadian Institutes of Health Research Project Grant (funding reference number 165905). OT is supported by the Canadian Institutes of Health Research (CIHR)-Frederick Banting and Charles Best Doctoral award (Award No. FBD-170837) outside the submitted work. GKS is supported by the Edith Kirchmann Postdoctoral Fellowship at Princess Margaret Cancer Centre and by a CIHR 2019 Fellowship Award (CIHR MFE 171271) outside the submitted work. ### 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: Ethical approval was obtained from the Research Ethics Board of the Centre intégré universitaire de santé et de services sociaux (CIUSSS) West-Central Montreal (Project IDs: 2021-2632; 2022-2960). 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 and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors and depending on the guidelines set out by the approving research ethics board.