title: Psychological Impact of Primary Screening (PIPS) for HPV: a protocol for a cross-sectional evaluation within the NHS cervical screening programme.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Epidemiology and Public Health, Health Behaviour Research Centre, University College London, London, UK.
authors.forename: Emily
authors.initials: E
authors.lastname: McBride
authors.affiliation: Epidemiology and Public Health, Health Behaviour Research Centre, University College London, London, UK.
authors.forename: Laura
authors.initials: L
authors.lastname: Marlow
authors.affiliation: Epidemiology and Public Health, Health Behaviour Research Centre, University College London, London, UK.
authors.forename: Alice S
authors.initials: AS
authors.lastname: Forster
authors.affiliation: Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.
authors.forename: Sue
authors.initials: S
authors.lastname: Moss
authors.affiliation: Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Myles
authors.affiliation: Women's Cancer Centre, Institute of Cancer Sciences, University of Manchester, Manchester, UK.
authors.forename: Henry
authors.initials: H
authors.lastname: Kitchener
authors.affiliation: Cancer Epidemiology Unit, University of Oxford, Oxford, UK.
authors.forename: Julietta
authors.initials: J
authors.lastname: Patnick
authors.affiliation: Epidemiology and Public Health, Health Behaviour Research Centre, University College London, London, UK.
authors.forename: Jo
authors.initials: J
authors.lastname: Waller
mesh_terms: D000328:Adult; D001007:Anxiety / Q000209:etiology*; D032882:Comprehension; D003430:Cross-Sectional Studies; D055088:Early Detection of Cancer / Q000523:psychology*; D004739:England; D005069:Evaluation Studies as Topic; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008131:London; D008403:Mass Screening / Q000523:psychology*; D008875:Middle Aged; D027383:Papillomaviridae; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000517:prevention & control / Q000523:psychology* / Q000821:virology; D012107:Research Design; D013222:State Medicine; D013315:Stress, Psychological / Q000209:etiology*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000517:prevention & control / Q000523:psychology* / Q000821:virology; D014626:Vaginal Smears
keywords: HPV primary testing, cervics; Mass screening; NHS cervical screening programme; Psychological evaluation HPV