Postnatal instead of normally-timed cervical screening (PINCS-1): a protocol for a feasibility study of paired-sample cervical screening and urine self-sampling at 6 weeks and 12 weeks postnatal in the UK.

introductionCervical screening rates in the UK are falling, limiting our ability to prevent cervical cancer. Peak incidence of cervical cancer coincides with average age of childbirth, and women with young children are less likely to be screened. Current UK guidelines advise waiting 12 weeks after delivery to perform cervical screening, but this recommendation is not based on evidence from the era of liquid-based cytology or high-risk human papillomavirus (HPV) testing. New mums suggested offering cervical screening at 6 weeks postdelivery, in conjunction with the postnatal check-up with the general practice team in primary care. This study aims to assess the feasibility and acceptability of a paired-sample study design for cervical screening at 6 weeks and 12 weeks postnatal. METHODS AND ANALYSIS: A study of 100 participants will be performed to assess feasibility and acceptability of cervical screening at both 6 weeks and 12 weeks postnatal, with urine self-sampling using a Colli-pee collection device at each time point. This will inform whether women are prepared to undergo cervical screening at 6 weeks postnatal and the feasibility of a future pair-wise diagnostic test accuracy (of HPV and abnormal cervical cytology) study or whether alternative study designs are needed. Participants must be aged 24.5-64 years old and eligible for the National Health Service Cervical Screening Programme (NHS CSP). At each appointment, participants will complete a questionnaire about their experience and thoughts regarding screening. Substudies ask participants who withdraw or decline to participate their reasons, to identify barriers. The study will be closed for recruitment once 100 participants have completed the 6-week screen in Postnatal Instead of Normally-Timed Cervical Screening (PINCS-1) or if recruitment is poor and 50% not recruited by 6 months, indicating that a paired-sample design is not feasible. ETHICS AND DISSEMINATION: Ethical approval for PINCS-1 was given by the Stanmore Research Ethics Committee. The results, including participant feedback at each stage, built into the trial design, will inform the design of large studies to determine accuracy and clinical impact of cervical screening at 6 weeks postnatal, identifying whether giving choice (eg, from timing of appointments and/or offering self-sampling) will improve screening uptake. Data will inform the sample size needed for future studies to have adequate power. Results will also inform future NHS CSP management. Results will be shared via scientific publication and via conventional and social media channels accessed by young women. TRIAL REGISTRATION NUMBER: ISRCTN10071810.