{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,26]],"date-time":"2026-03-26T10:12:07Z","timestamp":1774519927459,"version":"3.50.1"},"reference-count":29,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2023,3,23]],"date-time":"2023-03-23T00:00:00Z","timestamp":1679529600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001505","name":"Health Research Council of New Zealand","doi-asserted-by":"crossref","award":["20\/960"],"award-info":[{"award-number":["20\/960"]}],"id":[{"id":"10.13039\/501100001505","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100001504","name":"Ministry of Health, New Zealand","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001504","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Mahitahi Hauora, Primary Health Entity"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>Cervical cancer is caused by high-risk types of human papillomavirus (HPV). Testing for high-risk HPV is a more sensitive screening method than cervical cytology for detecting cervical changes that may lead to cancer. Consistent with recent evidence of efficacy and acceptability, Aotearoa New Zealand plans to introduce HPV testing as the primary approach to screening, replacing cervical cytology, from mid-2023. Any equitable cervical screening programme must be effective across a diverse population, including women that the current programme fails to reach, particularly M\u0101ori and those in rural areas. Currently, we do not know the best model for implementing an equitable HPV self-testing screening programme.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>This implementation trial aims to assess whether a universal offer of HPV self-testing (offered to all people eligible for cervical screening) achieves non-inferior screening coverage (equal) to a universal offer of cervical cytology alone (the present programme). The study population is all people aged from 24.5 to 70 years due for cervical screening in a 12-month period (including those whose screening is overdue or who have never had screening). A range of quantitative and qualitative secondary outcomes will be explored, including barriers and facilitators across screening and diagnostic pathways. This study takes place in Te Tai Tokerau\/Northland which covers a diverse range of urban and rural areas and has a large Indigenous M\u0101ori population. A total of fourteen practices will be involved. Seven practices will offer HPV self-testing universally to approximately 2800 women and will be compared to seven practices providing routine clinical care (offer of cervical cytology) to an approximately equal number of women.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Discussion<\/jats:title>\n<jats:p>This trial will answer important questions about how to implement an equitable, high-quality, effective national programme offering HPV self-testing as the primary screening method for cervical cancer prevention.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Trial registration<\/jats:title>\n<jats:p>Prospectively registered with the Australian New Zealand Clinical Trials Registry 07\/12\/2021: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.anzctr.org.au\/ACTRN12621001675819\" xlink:type=\"simple\">ACTRN12621001675819<\/jats:ext-link>.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0280643","type":"journal-article","created":{"date-parts":[[2023,3,23]],"date-time":"2023-03-23T18:20:55Z","timestamp":1679595655000},"page":"e0280643","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":8,"title":["Te Ara Waiora\u2013Implementing human papillomavirus (HPV) primary testing to prevent cervical cancer in Aotearoa New Zealand: A protocol for a non-inferiority trial"],"prefix":"10.1371","volume":"18","author":[{"given":"Melanie","family":"Gibson-Helm","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tania","family":"Slater","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Evelyn J.","family":"MacDonald","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kendall","family":"Stevenson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Adcock","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stacie","family":"Geller","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Varsha","family":"Parag","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles","family":"Lambert","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Bennett","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Merilyn","family":"Hibma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Sykes","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marion","family":"Saville","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Hawkes","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jo-Ann","family":"Stanton","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary-Ann","family":"Clueard","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Grahame","family":"Jelley","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bev","family":"Lawton","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2023,3,23]]},"reference":[{"key":"pone.0280643.ref001","article-title":"Global Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health Problem.","author":"World Health Organization","year":"2020","journal-title":"Geneva"},{"issue":"1","key":"pone.0280643.ref002","doi-asserted-by":"crossref","first-page":"400","DOI":"10.1093\/jnci\/dju400","article-title":"Performance of self-collected cervical samples in screening for future precancer using human papillomavirus DNA testing.","volume":"107","author":"C Porras","year":"2015","journal-title":"J Natl Cancer Inst"},{"issue":"9916","key":"pone.0280643.ref003","doi-asserted-by":"crossref","first-page":"524","DOI":"10.1016\/S0140-6736(13)62218-7","article-title":"Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials","volume":"383","author":"G Ronco","year":"2014","journal-title":"Lancet"},{"issue":"26","key":"pone.0280643.ref004","doi-asserted-by":"crossref","first-page":"3003","DOI":"10.1200\/JCO.22.00609","article-title":"Cervical Cancer Elimination Is Dependent on Women\u2019s Self-Tests for Primary Human Papillomavirus Testing Triaged by Methylation Status.","volume":"40","author":"DM Harper","year":"2022","journal-title":"J Clin Oncol"},{"key":"pone.0280643.ref005","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1016\/j.ypmed.2019.04.025","article-title":"Experience with HPV self-sampling and clinician-based sampling in women attending routine cervical screening in the Netherlands.","volume":"125","author":"NJ Polman","year":"2019","journal-title":"Prev Med."},{"issue":"1","key":"pone.0280643.ref006","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1111\/ajo.13285","article-title":"Reaching under-screened\/never-screened indigenous peoples with human papilloma virus self-testing: A community-based cluster randomised controlled trial.","volume":"61","author":"EJ MacDonald","year":"2021","journal-title":"Aust N Z J Obstet Gynaecol"},{"issue":"2","key":"pone.0280643.ref007","doi-asserted-by":"crossref","first-page":"301","DOI":"10.1111\/ajo.12933","article-title":"Acceptability of self-taken vaginal HPV sample for cervical screening among an under-screened Indigenous population.","volume":"59","author":"A Adcock","year":"2019","journal-title":"Aust N Z J Obstet Gynaecol"},{"issue":"2","key":"pone.0280643.ref008","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1002\/ijgo.13873","article-title":"He Tapu Te Whare Tangata (sacred house of humanity): Under-screened M\u0101ori women talk about HPV self-testing cervical screening clinical pathways.","volume":"155","author":"A Adcock","year":"2021","journal-title":"Int J Gynaecol Obstet."},{"key":"pone.0280643.ref009","article-title":"Clinical impact and cost-effectiveness of primary cytology versus human papillomavirus testing for cervical cancer screening in England","author":"I Bains","year":"2019","journal-title":"Int J Gynecol Cancer"},{"key":"pone.0280643.ref010","unstructured":"Medical Service Advisory Committee. Medical Services Advisory Committee recommendations for HPV testing [Available from: https:\/\/www.cancer.org.au\/clinical-guidelines\/cervical-cancer-screening\/management-of-oncogenic-hpv-test-results\/medical-services-advisory-committee-recommendations-for-hpv-testing\/?title=Guidelines:Cervical_cancer\/Screening\/Medical_Services_Advisory_Committee_recommendations_for_HPV_testing."},{"key":"pone.0280643.ref011","unstructured":"National Screening Unit. National Cervical Screening Programme [updated 20\/02\/2020. Available from: https:\/\/www.nsu.govt.nz\/health-professionals\/national-cervical-screening-programme."},{"key":"pone.0280643.ref012","article-title":"National Cervical Screening Programme Incidence and Mortality Report 2018 to 2019.","author":"Te Whatu Ora\u2014Health New Zealand","year":"2022","journal-title":"PO Box 5013, Wellington 6140, New Zealand"},{"key":"pone.0280643.ref013","article-title":"Review of Cervical Cancer Occurences in relation to Screening History in New Zealand for the years 2013\u20132017.","author":"P Sykes","year":"2019","journal-title":"University of Otago\u2014Christchurch, Gynaecology Oa"},{"key":"pone.0280643.ref014","article-title":"National Cervical Screening Programme Monitoring Report Number 52.","author":"M Smith","year":"2021","journal-title":"Wellington"},{"key":"pone.0280643.ref015","unstructured":"National Screening Unit. National Cervical Screening Programme interactive coverage data tool: National Screening Unit; [Available from: https:\/\/minhealthnz.shinyapps.io\/nsu-ncsp-coverage\/."},{"issue":"3","key":"pone.0280643.ref016","doi-asserted-by":"crossref","first-page":"547","DOI":"10.1016\/j.ygyno.2018.10.004","article-title":"Too many women are dying from cervix cancer: Problems and solutions","volume":"151","author":"DK Gaffney","year":"2018","journal-title":"Gynecol Oncol"},{"key":"pone.0280643.ref017","doi-asserted-by":"crossref","first-page":"100191","DOI":"10.1016\/j.pvr.2019.100191","article-title":"IPVS Policy Statement addressing the burden of HPV disease for Indigenous peoples.","volume":"9","author":"B Lawton","year":"2020","journal-title":"Papillomavirus Res."},{"key":"pone.0280643.ref018","unstructured":"Ministry of Health. Cancer: Ministry of Health; [updated 02\/08\/2018. Available from: https:\/\/www.health.govt.nz\/our-work\/populations\/maori-health\/tatau-kahukura-maori-health-statistics\/nga-mana-hauora-tutohu-health-status-indicators\/cancer."},{"key":"pone.0280643.ref019","author":"Cervical Cancer Elimination Initiative","year":"2020","journal-title":"Draft Global Strategy towards eliminating cervical cancer as a public health problem"},{"key":"pone.0280643.ref020","author":"Northland District Health Board","year":"2017","journal-title":"Our Population: Te Whatu Ora Health New Zealand Te Tai Tokerau"},{"key":"pone.0280643.ref021","volume-title":"Northland District Health Board M\u0101ori Health Profile 2015. PO Box 7343","author":"B Robson","year":"2015"},{"key":"pone.0280643.ref022","unstructured":"Ministry of Health. About primary health organisations [Available from: https:\/\/www.health.govt.nz\/our-work\/primary-health-care\/about-primary-health-organisations."},{"issue":"2","key":"pone.0280643.ref023","first-page":"43","article-title":"The Abbott RealTime High Risk HPV test is a clinically validated human papillomavirus assay for triage in the referral population and use in primary cervical cancer screening in women 30 years and older: a review of validation studies.","volume":"22","author":"M Poljak","year":"2013","journal-title":"Acta Dermatovenerol Alp Pannonica Adriat."},{"key":"pone.0280643.ref024","doi-asserted-by":"crossref","first-page":"210","DOI":"10.1016\/j.jcv.2015.06.080","article-title":"A pilot study to compare dry cervical sample collection with standard practice of wet cervical samples for human papillomavirus testing.","volume":"69","author":"F Sultana","year":"2015","journal-title":"J Clin Virol"},{"key":"pone.0280643.ref025","doi-asserted-by":"crossref","first-page":"104375","DOI":"10.1016\/j.jcv.2020.104375","article-title":"Analytical performance of HPV assays on vaginal self-collected vs practitioner-collected cervical samples: the SCoPE study.","volume":"127","author":"M Saville","year":"2020","journal-title":"J Clin Virol"},{"key":"pone.0280643.ref026","unstructured":"Australian Centre for the Prevention of Cervical Cancer. Our Products [Available from: https:\/\/www.vcs.org.au\/digital-health\/products\/."},{"key":"pone.0280643.ref027","volume-title":"7 Cynthia Street","author":"L. Smith","year":"1999"},{"key":"pone.0280643.ref028","first-page":"28","volume-title":"He Tikanga Whakaaro Research Ethics in the M\u0101ori Community: A Discussion Paper","author":"N. Te Awekotuku","year":"1991"},{"key":"pone.0280643.ref029","first-page":"57","volume-title":"APA handbook of research methods in psychology, Vol 2: Research designs: Quantitative, qualitative, neuropsychological, and biological. 2.","author":"Thematic Analysis","year":"2012"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0280643","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,3,23]],"date-time":"2023-03-23T18:21:20Z","timestamp":1679595680000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0280643"}},"subtitle":[],"editor":[{"given":"James","family":"Mockridge","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2023,3,23]]},"references-count":29,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2023,3,23]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0280643","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,3,23]]}}}