PINCS-1: protocol for a feasibility study investigating the acceptability and accuracy of cervical screening and self-sampling in women at 6-weeks postnatal

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 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 (LBC) or high-risk Human Papilloma Virus (hrHPV) testing. New mums suggested that cervical screening could be offered at 6-weeks post-delivery, in conjunction with the postnatal check-up with the general practice team in primary care. Methods and analysisA study of 100 participants will be performed to assess feasibility and acceptability of cervical screening at 6- and 12-weeks postnatal, with urine self-sampling at each time point. This will inform whether women are prepared to undergo cervical screening at 6-weeks postnatal and feasibility of a future pair-wise diagnostic test accuracy study, or whether alternative study designs are needed. At each appointment, participants will complete a questionnaire about their experience and thoughts regarding screening. Sub-studies ask participants who withdraw or decline their reasons, to identify barriers. The study will move to a second phase, when 100 participants will be individually randomised to sampling at 6-weeks or 12-weeks, once 100 participants have completed the 6-week screen in PINCS-1, or recruitment is poor, indicating that a paired-sample design is not feasible. Ethics and disseminationEthical approval for PINCS-1 was given by the Stanmore Research Ethics Committee. The results, including participant feedback at each stage, will inform design of large studies to determine accuracy and clinical impact of cervical screening at 6-weeks postnatal, identifying whether giving choice will improve screening uptake. Data will inform sample size needed for future studies to have adequate power. Results will also inform future NHS Cervical Screening Programme management. Results will be shared via scientific publication and via conventional and social media channels accessed by young women. Strengths and limitations of PINCS-1O_ST_ABSStrengthsC_ST_ABSO_LIThe first study to focus on acceptability and reliability of screening, including self-sampling in postnatal women, to test hypothesis and generate data to inform further study design, following recommendations by Elridge et al.1 C_LIO_LIMultiple points at which acceptability will be assessed by collecting participants views and participant-reported outcomes. C_LIO_LIOffering self-screening at the time of another appointment was a successful strategy in the YouScreen study.2 C_LI LimitationsO_LIThis study has a limited sample size and is not statistically powered to evaluate the diagnostic test accuracy or the impact of offering screening during postnatal visits on overall screening uptake C_LIO_LIScreening will be performed in secondary care settings throughout this study. However, anticipated changes to screening would be expected to be relevant to primary care in the future studies. C_LI