{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:11:48Z","timestamp":1777385508953,"version":"3.51.4"},"reference-count":31,"publisher":"BMJ","issue":"1","funder":[{"name":"Victorian Cytology Service Ltd"},{"name":"Roche Molecular Systems and Ventana Inc USA"},{"DOI":"10.13039\/501100001102","name":"Cancer Council New South Wales","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100001102","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2017,8,15]]},"published-print":{"date-parts":[[2018,1]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Australia\u2019s National Cervical Screening Program (NCSP) currently recommends 2-year cytology in women aged 18\u201369 years. Following a review of the NCSP prompted by the implementation of human papillomavirus (HPV) vaccination, the programme will transition in 2017 to 5-year primary HPV screening with partial genotyping for HPV16\/18 in women aged 25\u201374 years. Compass is a sentinel experience for the renewed NCSP and the first prospectively randomised trial of primary HPV screening compared with cytology to be conducted in a population with high uptake of HPV vaccination. This protocol describes the main Compass trial, which commenced after a pilot study of ~5000 women completed recruitment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      Women aged 25\u201369 years will be randomised at a 1:2 allocation to (1) 2.5-year image-read, liquid-based cytology (LBC) screening with HPV triage of low-grade smears (active control Arm A) or (2) 5-year HPV screening with partial genotyping and referral of HPV16\/18-positive women to colposcopy (intervention Arm B). Women in Arm B positive for other oncogenic HPV (not 16\/18) will undergo secondary randomisation at a 1:1 allocation to either LBC or dual-stained (p16\n                      <jats:sup>INK4a<\/jats:sup>\n                      and Ki-67) cytology testing (dual-stained cytology). The primary outcome is cumulative CIN3+ (CIN3, adenocarcinoma in situ and invasive cervical cancer) following a 5-year HPV exit testing round in both arms, in women randomised to the HPV arm versus women randomised to the LBC arm, based on an intention-to-treat analysis. The primary outcome will first be tested for non-inferiority and if declared, the primary outcome will be tested for superiority. A total of 36\u2009300 women in birth cohorts not offered vaccination and 84\u2009700 women in cohorts offered vaccination will be recruited, bringing the final sample size to 121\u2009000. The trial is powered for the secondary outcome of cumulative CIN3+ in\u2009screen-negative women, adjusted for censoring after CIN2+ treatment\u2009and hysterectomy.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Approved by the Bellberry Ethics Committee (2014-11-592). Findings will be reported in peer-reviewed journals and presented at scientific meetings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT02328872\" ext-link-type=\"clintrialgov\">NCT02328872<\/jats:ext-link>\n                      ; Pre-results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2017-016700","type":"journal-article","created":{"date-parts":[[2018,1,26]],"date-time":"2018-01-26T23:00:21Z","timestamp":1517007621000},"page":"e016700","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":23,"title":["Protocol for Compass: a randomised controlled trial of primary HPV testing versus cytology screening for cervical cancer in HPV-unvaccinated and vaccinated women aged 25\u201369 years living in Australia"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"nct02328872","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Karen","family":"Canfell","sequence":"first","affiliation":[{"name":"Cancer Research Division, Cancer Council NSW, Sydney, New South Wales, Australia"},{"name":"School of Public Health, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia"},{"name":"Prince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marion","family":"Saville","sequence":"additional","affiliation":[{"name":"Victorian Cytology Service Ltd, Carlton, Victoria, Australia"},{"name":"Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Caruana","sequence":"additional","affiliation":[{"name":"Cancer Research Division, Cancer Council NSW, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Val","family":"Gebski","sequence":"additional","affiliation":[{"name":"NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica","family":"Darlington-Brown","sequence":"additional","affiliation":[{"name":"Cancer Research Division, Cancer Council NSW, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julia","family":"Brotherton","sequence":"additional","affiliation":[{"name":"Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Registries Division, Victorian Cytology Service Ltd, Carlton, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stella","family":"Heley","sequence":"additional","affiliation":[{"name":"Victorian Cytology Service Ltd, Carlton, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philip E","family":"Castle","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Population Health, Albert Einstein College of Medicine, New York, New York, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2018,1,26]]},"reference":[{"key":"2025121513340487000_8.1.e016700.1","unstructured":"AIHW. 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High Sensitivity and High Specificity of P16\/Ki-67 Dual-Stained Cytology for High-Grade CIN - Results from Screening and Triage Trials in Over 28,000 Women. Cancer Cytopathol 2010:305\u20136. American Society of Cytopathology 58th Annual Scientific Meeting Platform and Poster Presentions (Supplement)."},{"key":"2025121513340487000_8.1.e016700.20","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(11)70188-7"},{"key":"2025121513340487000_8.1.e016700.21","unstructured":"Lew JB , Simms K , Smith MA , et al ; National Cervical Screening Program Renewal: Effectiveness modelling and economic evaluation in the Australian setting (Assessment Report). MSAC application number 1276. 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