Introduction Cervical cancer screening ceases between the ages of 60 and 65 in most countries. Yet, a relatively high proportion of cervical cancers are diagnosed in women above the screening age. This study will evaluate if screening of women aged 65–69 years may result in increased detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared with women not invited to screening. Invited women may choose between general practitioner (GP)-based screening or cervico-vaginal self-sampling. Furthermore, the study will assess if self-sampling is superior to GP-based screening in reaching long-term unscreened women.
Methods and analysis This population-based non-randomised intervention study will include 10 000 women aged 65–69 years, with no record of a cervical cytology sample or screening invitation in the 5 years before inclusion. Women who have opted-out of the screening programme or have a record of hysterectomy or cervical amputation are excluded. Women residing in the Central Denmark Region (CDR) are allocated to the intervention group, while women residing in the remaining four Danish regions are allocated to the reference group. The intervention group is invited for human papillomavirus-based screening by attending routine screening at the GP or by requesting a self-sampling kit. The reference group receives standard care which is the opportunity to have a cervical cytology sample obtained at the GP or by a gynaecologist. The study started in April 2019 and will run over the next 4.5 years. The primary outcome will be the proportion of CIN2+ detected in the intervention and reference groups. In the intervention group, the proportion of long-term unscreened women attending GP-based screening or self-sampling will be compared.
Ethics and dissemination The study has been submitted to the Ethical Committee in the CDR which deemed that the study was not notifiable to the Committee and informed consent is therefore not required. The study is approved by the Danish Data Protection Regulation and the Danish Patient Safety Authority. Results will be disseminated in peer-reviewed journals.
Trial registration number NCT04114968.
- preventive medicine
- public health
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Collaborators Mette Tranberg, Lone Kjeld Petersen, Klara Miriam Elfström, Anne HammerJan Blaakær, Mary Holten Bennetsen, Jørgen Skov Jensen and Berit Andersen.
Contributors MT is the principal investigator of the study and is responsible for conducting the study overall. BA and MT conceived the original idea. Subsequently, LKP, KME, AH, MHB and JB also contributed to the design of the study. JSJ especially contributed with comments on the laboratory part of the protocol, while LKP, JB and AH have provided clinical advice on follow-up of women with abnormal results. MT is the first author and drafted the first version of this protocol article, which was subsequently further developed by all authors, who also reviewed and approved the final version.
Funding The initiative and the study was partly funded by the Department of Public Health Programmes, Randers Regional Hospital, which is located in the Central Denmark Region. Some public funding had been provided by the Health Foundation (grant no.:18-B-0125) and other fundraising is on-going. The Health foundation had no role in the design of the study and collection, analysis, and interpretation of the data, and in writing the manuscript
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Competing interests Roche sponsors the Cobas HPV-DNA test kits and CINtec Plus test kits for the study. According to the contract between Roche and the Department of Public Health Programmes, Randers Regional Hospital, Roche has commented on the protocol article, but had no influence on the scientific process and no editorial rights pertaining to this manuscript. The authors retained the right to submit the manuscript. MT, JB, JSJ and BA have participated in other studies with HPV test kits sponsored by Roche and self-sampling devices sponsored by Axlab. MT has received honoraria from Roche Diagnostics and AstraZeneca for lectures on HPV self-sampling and HPV triage-methods, respectively. AH has received lecture fees from AstraZeneca. All authors declare no conflicts of interest.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.