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Article History

Received: 19 May 2022

Accepted: 25 October 2022

First Online: 24 November 2022

Declarations

:

: Ethics approval: The English HPV screening pilot study was considered the first stage in national implementation, so it was referred to as an implementation pilot and therefore exempt from ethics approval.Consent to participate<u>:</u> Women participating in the HPV primary screening pilot were invited to make an informed choice on participating in the cervical screening programme. A decision is made to accept or decline a screening test based on access to accurate and up-to-date information on the condition being screened for, the testing process and potential outcomes. Specific information was provided at the invitation stage allowing for personalised informed choice. There was further opportunity to reflect on what the test and its results might mean when they attended for screening with the clinician taking the sample. Regulation 5, Health Service Regulations 2002, Confidentiality Advisory Group Reference: 15/CAG/0207, was the legal basis to process the data.

: Not applicable.

: JD and AB: declare no conflict of interest. CM: Held an honorary appointment at Public Health England to process the data for the pilot. KD: Adviser to PHE; this position is funded by PHE as a secondment from her main employment. She chairs the PHE Laboratory Clinical professional group, the HPV development group and several groups related to the evaluation of self-sampling. Consultant to the Scally Review of cervical screening in Ireland and the RCOG review of cervical cancer audit in Ireland, both completed in 2019. Expert medicolegal reports prepared for claimants and defendants including in cases of cervical cancer. Received support with travel expenses to attend an international meeting in May 2019 from Hologic, a company manufacturing equipment and consumables for cytology and HPV testing. MR: Public Health England provided financing for the epidemiological evaluation of the pilot; member of the Public Health England Laboratory Technology Group and HPV Self-sampling Operational Steering Group and Project Board; attended meetings with various HPV assay manufacturers; fee for lecture from Hologic paid to employer. The views expressed in this manuscript are those of the authors and do not represent the view of Public Health England.