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Psychological Impact of Primary Screening (PIPS) for HPV: a protocol for a cross-sectional evaluation within the NHS cervical screening programme
  1. Emily McBride1,
  2. Laura Marlow1,
  3. Alice S Forster1,
  4. Sue Moss2,
  5. Jonathan Myles2,
  6. Henry Kitchener3,
  7. Julietta Patnick4,
  8. Jo Waller1
  1. 1Epidemiology and Public Health, Health Behaviour Research Centre, University College London, London, UK
  2. 2Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK
  3. 3Women's Cancer Centre, Institute of Cancer Sciences, University of Manchester, Manchester, UK
  4. 4Cancer Epidemiology Unit, University of Oxford, Oxford, UK
  1. Correspondence to Dr Jo Waller; j.waller{at}


Introduction The NHS Cervical Screening Programme is now using human papillomavirus (HPV) testing as the primary test in six sentinel sites in England, with the intention of rolling this out across the whole of England. Previous research evaluating HPV testing in the cervical screening context suggests that an HPV-positive result may increase anxiety beyond that associated with abnormal cytology, but this has not been explored in the context of primary HPV testing. The main aim of this study is to explore the impact of the HPV primary screening programme on anxiety and distress.

Methods and analysis A cross-sectional between-groups design (total N ∼ 673) will be employed to assess the psychological impact of different HPV and cytology results at three time points: shortly after receiving the results, and 6 and 12 months later. Women will fall into one of six groups based on their screening results. The primary outcomes will be anxiety and general distress. Secondary outcomes will include understanding of screening results, perceived risk of cervical cancer, psychosexual functioning, intention to attend future screening and knowledge of HPV. General linear modelling will be used to test for differences between groups and changes over the three time points.

Ethics and dissemination Health Research Authority approval was received on 26 September 2016. Ethical approval was received from London- Surrey Borders NHS Research Ethics Committee on 30 August 2016. Section 251 approval was received from the Confidentiality Advisory Group on 24 August 2016. Results will be disseminated via peer-reviewed publication and presentation at national and international conferences.

  • NHS cervical screening programme
  • Psychological evaluation HPV
  • HPV primary testing, cervics
  • Mass screening

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  • Contributors JW, HK and JP conceived the study. JW, LM, ASF, EMcB and HK developed the protocol, with statistical input from SM and JM. EMcB, JW, LM and AF developed the study measures and applied for HRA, REC and CAG approval. EMcB, JW, ASF and LM drafted the paper. All authors contributed to the final version of the manuscript.

  • Funding This project is funded by Public Health England. JW and LM are funded by Cancer Research UK (C7492/A17219) and AF is also funded by Cancer Research UK (C49896/A17429).

  • Competing interests None declared.

  • Ethics approval Health Research Authority approval was obtained on 24 September 2016 and approval from London-Surrey NHS Research Ethics Committee (REC) on 30 August 2016. Section 251 approval was also obtained from the Confidentiality Advisory Group (CAG) for use of patient name and address without consent for the purposes of participant approach on 24 August 2016.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Data will be available for data sharing from the corresponding author, after publication of our final paper.