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Article History

Received: 12 April 2021

Revised: 31 January 2022

Accepted: 8 March 2022

First Online: 26 March 2022

Competing interests

: MR: funding from Public Health England for the epidemiological evaluation of the HPV primary screening pilot; attended meetings with various HPV assay manufacturers; fee for lecture from Hologic paid to employer (2018); member of various groups convened by Public Health England providing advice to the English Cervical Screening Programme. CM: held an honorary appointment at Public Health England to process the data for the pilot. FP: declares no conflict of interest. DM and KS: The Blood Safety, Hepatitis, Sexually Transmitted Infections (STI) and HIV Service has provided GSK with post-marketing surveillance reports on HPV infections; a cost recovery charge is made for these reports. HK: Former chair of the Advisory Committee for Cervical Screening (Public Health England), but the views expressed in this manuscript are those of the author and do not represent the view of Public Health England.

: The study was considered the first stage in national implementation, so it was referred to as an implementation pilot and therefore exempt from ethics approval. 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 the 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.