Te Ara Waiora - Implementing human papillomavirus (HPV) primary testing to prevent cervical cancer in Aotearoa New Zealand: A protocol for a noninferiority trial

Sep 24, 2026

Uploaded by Patrick

Background: Cervical cancer is driven by high-risk human papillomavirus (HPV). High-risk HPV testing provides a more sensitive screening approach than cervical cytology, and Aotearoa New Zealand plans to transition to HPV primary screening from mid-2023. An equitable programme must perform across diverse groups, yet the best model for implementing HPV self-testing remains unclear. Methods: A 12-month implementation trial in Te Tai Tokerau/Northland will compare universal HPV self-testing against universal cervical cytology for non-inferior screening coverage, using quantitative and qualitative secondary outcomes exploring barriers and facilitators.

LanguageEnglish

CategoryHealthcare

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Pages19

Reading Time48 min

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Abstract

Background

Methods

PLOS ONE OPEN ACCESS Citation: Gibson-Helm M, Slater T, MacDonald EJ, Stevenson K, Adcock A, Geller S, et al. (2023) Te Ara Waiora–Implementing human papillomavirus (HPV) primary testing to prevent cervical cancer in Aotearoa New Zealand: A protocol for a noninferiority trial. PLoS ONE 18(3): e0280643 . [https://](https://)[ ](https://)[doi.org/10.1371/journal.pone.0280643](doi.org/10.1371/journal.pone.0280643) Editor: James Mockridge, PLOS: Public Library of Science, UNITED KINGDOM Received: December 5, 2022 Accepted: December 7, 2022 Published: March 23, 2023 Copyright: © 2023 Gibson-Helm et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: All named investigators will have access to the final trial dataset. This research aligns with Te Mana Raraunga Principles of Māori Data Sovereignty, which strictly govern Māori data use and sharing. Data requests with evidence that the proposed use addresses and upholds these principles may be sent to Te Ara Waiora Data Management Committee at [ncwhra@vuw.ac.nz](ncwhra@vuw.ac.nz for consideration)[ for consideration](ncwhra@vuw.ac.nz for consideration)[ ](ncwhra@vuw.ac.nz for consideration)by the project’s data management and steering committees. STUDY PROTOCOL TeAraWaiora–Implementing human papillomavirus (HPV) primary testing to prevent cervical cancer in Aotearoa New Zealand: A protocol for a non-inferiority trial Melanie Gibson-Helm1, Tania Slater1, Evelyn J. MacDonald1, Kendall Stevenson1, Anna Adcock1, Stacie Geller2, Varsha Parag3, Charles Lambert1, Matthew Bennett1, Merilyn Hibma4, Peter Sykes5, Marion Saville6, David Hawkes6, Jo-Ann Stanton1, MaryAnn Clueard7, Grahame Jelley7, Bev Lawton1 * 1 Te Tātai Hauora o Hine–National Centre for Women’s Health Research Aotearoa (NCWHRA), Victoria University of Wellington, Wellington, New Zealand, 2 National Center of Excellence in Women’s Health, University of Illinois, Chicago, IL, United States of America, 3 National Institute for Health Innovation, University of Auckland, Auckland, New Zealand, 4 Department of Pathology, University of Otago, Dunedin, New Zealand, 5 Christchurch Hospital and University of Otago, Canterbury, New Zealand, 6 Australian Centre for the Prevention of Cervical Cancer, Melbourne, Australia, 7 Mahitahi Hauora Primary Health Entity, Northland, New Zealand * [Bev.Lawton@vuw.ac.nz](Bev.Lawton@vuw.ac.nz) Abstract Background 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 Māori and those in rural areas. Currently, we do not know the best model for implementing an equitable HPV self-testing screening programme. Methods 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 Ta

FAQs

Why is HPV primary testing considered for cervical cancer screening in Aotearoa New Zealand?

Cervical cancer is caused by high-risk HPV, and testing for high-risk HPV is described as more sensitive than cervical cytology for detecting cervical changes that may lead to cancer.

What does the study compare to evaluate the HPV self-testing implementation?

It assesses whether universal offer of HPV self-testing achieves non-inferior screening coverage compared with universal offer of cervical cytology alone, the current programme.

Who is included in the implementation trial and where is it conducted?

The population includes people aged 24.5 to 70 years due for cervical screening in a 12-month period, including overdue and never-screened individuals. The study takes place in Te Tai Tokerau/Northland and involves fourteen practices.

Sep 24, 2026

Uploaded by Patrick