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

PLoS One. 2023 Mar 23;18(3):e0280643. doi: 10.1371/journal.pone.0280643. eCollection 2023.

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 Tai Tokerau/Northland which covers a diverse range of urban and rural areas and has a large Indigenous Māori 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.

Discussion: 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.

Trial registration: Prospectively registered with the Australian New Zealand Clinical Trials Registry 07/12/2021: ACTRN12621001675819.

Publication types

  • Equivalence Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Australia
  • Early Detection of Cancer / methods
  • Female
  • Human Papillomavirus Viruses
  • Humans
  • Mass Screening / methods
  • Middle Aged
  • New Zealand / epidemiology
  • Papillomaviridae
  • Papillomavirus Infections* / complications
  • Papillomavirus Infections* / diagnosis
  • Papillomavirus Infections* / prevention & control
  • Uterine Cervical Dysplasia*
  • Uterine Cervical Neoplasms* / diagnosis
  • Uterine Cervical Neoplasms* / prevention & control
  • Vaginal Smears
  • Young Adult

Associated data

  • ANZCTR/ACTRN12621001675819

Grants and funding

This project received funding from The Health Research Council of New Zealand: Health Delivery Research Project Grant 20/960, The Ministry of Health – Manatū Hauora, New Zealand, and Mahitahi Hauora Primary Health Entity. The study sponsor (Victoria University of Wellington), the Health Research Council of New Zealand, and the Ministry of Health – Manatū Hauora, have no role in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. Mahitahi Hauora fund a proportion of the laboratory tests. Two co-investigators from Mahitahi Hauora (M-AC and GJ) contributed to adapting the study database canSCREEN® and operational management of the study and will contribute to writing of the report. Neither the study sponsor nor any of the funders have ultimate authority over any of the above-mentioned activities.