title: A cluster randomised trial of strategies to increase cervical screening uptake at first invitation (STRATEGIC).
abstract: Falling participation by young women in cervical screening has been observed at a time that has seen an increase in the incidence of cervical cancer in the UK in women aged < 35 years. Various barriers to screening have been documented, including fear, embarrassment and inconvenience.
  
  
  
  To measure the feasibility, clinical effectiveness and cost-effectiveness of a range of interventions to increase the uptake of cervical screening among young women.
  
  
  
  A cluster randomised trial based on general practices performed in two phases.
  
  
  
  Primary care in Greater Manchester and the Grampian region in Scotland.
  
  
  
  Phase 1: 20,879 women receiving their first invitation for cervical screening. Phase 2: 10,126 women who had not attended by 6 months.
  
  
  
  Phase 1: pre-invitation leaflet or not, and access to online booking (Manchester only). Phase 2: (1) vaginal self-sampling kits (SSKs) sent unrequested (n = 1141); or (2) offered on request (n = 1290); (3) provided with a timed appointment (n = 1629); (4) offered access to a nurse navigator (NN) (n = 1007); or (5) offered a choice between a NN or a SSK (n = 1277); and 3782 women in control practices.
  
  
  
  Uplift in screening compared with control practices, cost-effectiveness of interventions, and the women's preferences explored in a discrete choice experiment.
  
  
  
  The pre-invitation leaflet and offer of online booking were ineffective when compared with control practices at 3 months, 18.8% versus 19.2% [odds ratio (OR) 0.96, 95% confidence interval (CI) 0.88 to 1.06; p = 0.485] and 17.8% versus 17.2% (OR 1.02, 95% CI 0.87 to 1.20; p = 0.802), respectively. The uptake of screening at 3 months was higher among previously human papillomavirus (HPV)-vaccinated women than unvaccinated women, 23.7% versus 11% (OR 2.07, 95% CI 1.69 to 2.53; p < 0.001). Among non-attenders, the SSK sent intervention showed a statistically significant increase in uptake at 12 months post invitation, 21.3% versus 16.2% (OR 1.51, 95% CI 1.20 to 1.91; p = 0.001), as did timed appointments, 19.8% versus 16.2% (OR 1.41, 95% CI 1.14 to 1.74; p = 0.001). The offer of a NN, a SSK on request, and a choice between timed appointments and NN were ineffective. Overall, there was a gradual rather than prompt response, as demonstrated by uptake among control practices. A discrete choice experiment indicated that women invited who had not yet attended valued the attributes inherent in self-sampling. The health economic analysis showed that both timed appointments and unsolicited SSK sent were likely to be cost-effective at a cost per quality-adjusted life-year (QALY) gained of £7593 and £8434, respectively, if extended across the national 25-year-old cohort throughout the duration of screening. The certainty of these being cost-effective at a ceiling ratio of £20,000 per QALY gained was > 90%.
  
  
  
  Women receiving their initial screening invitation frequently delay taking up the offer and the net impact of interventions was small. Timed appointments and SSKs sent to non-attenders at 6 months are likely to be a cost-effective means of increasing uptake and should be considered further. HPV vaccination in the catch-up programme was associated with an increased uptake of cervical screening. Future work should focus on optimising self-sampling in terms of age range, timing of offer for non-attenders and use of urine testing instead of vaginal samples.
  
  
  
  Current Controlled Trials ISRCTN52303479.
  
  
  
  This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 68. See the NIHR Journals Library website for further project information.
authors.affiliation: Institute of Cancer Sciences, University of Manchester, St Mary's Hospital, Manchester, UK.
authors.forename: Henry C
authors.initials: HC
authors.lastname: Kitchener
authors.affiliation: Centre for Biostatistics, Institute of Population Health, University of Manchester, Manchester, UK.
authors.forename: Matthew
authors.initials: M
authors.lastname: Gittins
authors.affiliation: National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
authors.forename: Oliver
authors.initials: O
authors.lastname: Rivero-Arias
authors.affiliation: Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
authors.forename: Apostolos
authors.initials: A
authors.lastname: Tsiachristas
authors.affiliation: Department of Obstetrics and Gynaecology, Aberdeen Maternity Hospital, Aberdeen, UK.
authors.forename: Margaret
authors.initials: M
authors.lastname: Cruickshank
authors.affiliation: Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
authors.forename: Alastair
authors.initials: A
authors.lastname: Gray
authors.affiliation: Institute of Cancer Sciences, University of Manchester, St Mary's Hospital, Manchester, UK.
authors.forename: Loretta
authors.initials: L
authors.lastname: Brabin
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: David
authors.initials: D
authors.lastname: Torgerson
authors.affiliation: Institute of Cancer Sciences, University of Manchester, St Mary's Hospital, Manchester, UK.
authors.forename: Emma J
authors.initials: EJ
authors.lastname: Crosbie
authors.affiliation: Virology Department, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Sargent
authors.affiliation: Centre for Biostatistics, Institute of Population Health, University of Manchester, Manchester, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Roberts
mesh_terms: D000367:Age Factors; D001071:Appointments and Schedules; D002755:Choice Behavior; D003362:Cost-Benefit Analysis; D055088:Early Detection of Cancer / Q000191:economics* / Q000379:methods*; D005260:Female; D058006:General Practice / Q000191:economics / Q000458:organization & administration*; D006801:Humans; D053918:Papillomavirus Vaccines / Q000008:administration & dosage; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data*; D062526:Patient Navigation / Q000706:statistics & numerical data; D010358:Patient Participation / Q000706:statistics & numerical data; D019057:Quality-Adjusted Life Years; D012606:Scotland; D013222:State Medicine; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D055815:Young Adult
chemical_list: D053918:Papillomavirus Vaccines