In Budget 2021 published earlier this month, the Government made the welcome and long-awaited announcement that they will invest “up to $53 million to complete the design of and implement a new human papillomavirus (HPV) test” in 2023.[[1]] Here we explain HPV self-testing and the background to this announcement, and we make evidence-based recommendations as to how the Government can most equitably and effectively implement rollout of HPV self-testing.

HPV self-testing

High-risk types of HPV cause more than 90% of cervical cancers.[[2]] HPV-based screening offers 60% to 70% greater protection against the development of invasive cervical cancer compared to cytology-based screening.[[3]] Many countries (eg, Australia, UK, US, Netherlands) have now introduced HPV testing as the primary screening test. Under HPV primary screening, the procedure remains the same. However, an HPV test is conducted on the cervical sample rather than cytology. If the HPV test is positive, the cells are then examined using liquid-based cytology. Crucially, by moving to HPV primary screening, HPV self-testing becomes possible. HPV self-testing, in which the participant carries out their own vaginal swab, does not require a speculum, does not require finding the cervix and can be done in a clinic or potentially in the privacy of the home. A Cochrane review found self-testing for HPV using polymerase chain reaction (PCR) assays reliably offers equivalent sensitivity to clinician-collected samples.[[4]]

Background

Cervical cancer is almost entirely preventable through screening and HPV vaccination. Despite this, there are approximately 150 new diagnoses and 50 deaths from cervical cancer in Aotearoa New Zealand every year. Although these figures represent a dramatic decrease since the National Cervical Screening Programme (NCSP) was established in 1990, there are longstanding ethnic and socioeconomic inequities in cervical cancer incidence and mortality, with cancers concentrated in unscreened and under-screened groups, in particular Māori and Pacific women and other women living in higher deprivation. For example, there are more than twice as many Māori (wāhine Māori, tangata Māori with a cervix (including tangata trans, non-binary and intersex)) with diagnoses and deaths from cervical cancer as for non-Māori.[[5]] The importance of cervical cancer for Māori was highlighted with Cabinet Minister Kiritapu Allan’s recent diagnosis with stage III cervical cancer.

The NCSP currently recommends three-yearly routine cytology screening for 25–69-year-old people with a cervix (the start age was recently changed in the NCSP from 20 to 25 years). The current test requires attendance at a clinic with a health-professional collected sample of cells from their cervix during pelvic exam (requiring insertion of a speculum). The cells are sent for microscopic examination. Cervical screening attendance in New Zealand has declined from a high of 76% of all eligible women in 2009 to 70% in August 2020, including the impact of COVID-19, leaving more women at risk of developing cervical cancer. Screening figures for Māori, Pacific and Asian women are even lower. In March 2021, the national coverage was 61.4% for Asian, 63.1% for Pacific and 61.2% for Māori, compared to 75.6% for others (the coverage equity gap between Māori and others (mostly European) is 14.4%).[[6]]

There are many explanations why the present cervical screening programme has failed to reach some women. For example, direct and opportunity costs including work or family commitments, the nature and invasiveness of the test, a previous negative experience of screening or cancer, history of sexual violence, embarrassment and shyness or whakamā.[[7,8]] Women with physical or intellectual disability and members of the LGBTQI community frequently face additional and multiple barriers.[[9,10]]

However, the new HPV self-test is likely to overcome many of these barriers, improve the cervical screening programme coverage and reduce the incidence of cervical cancer. International research, and our collective local research, demonstrates HPV self-testing is more acceptable and likely to improve equitable access compared with current screening.

What we have learned from research into HPV self-testing in Aotearoa?

The acceptability of HPV self-testing for never- and under-screened Indigenous populations and minoritised groups has been explored internationally, as well as in Aotearoa. Kaupapa Māori hui-based research confirmed the acceptability, empowerment, potential for improving coverage and equity of HPV self-testing, and showed that the majority of Māori surveyed were positive about attending follow-up cytology or colposcopy appointments if required.[[7]] A feasibility study in seven West Auckland general practices included co-design of tailored participant materials taking a health literacy and ethnic-specific approach. The study demonstrated high acceptability, found women with cervical abnormalities and highlighted the importance of support to follow-up.[[11]]

A Northland community-based trial in never- and under-screened women found a high 51% uptake of self-testing, with Māori 2.8 time more likely to self-test than attend usual care.[[12]] The study found an 11% positivity rate, which is comparable to international studies. In a recent urban Auckland-based randomised controlled trial,[[13]] 3,553 Māori, Pacific and Asian women were invited to take part in clinic-based HPV self-testing, home-based self-testing or a standard smear test. Women were much more likely to take part if they were in the home-based group, particularly Māori women (9.8 times more likely to complete a mailed screen at home compared to usual care). With tailored support more than 90% follow-up of participants with positive HPV tests was achieved in this community trial. In a survey alongside the community trial the most frequently cited reasons for choosing a self-testing were its simplicity, being less embarrassing, not requiring an appointment with a clinician, not requiring a speculum and that the test is free.[[8]]

In a small pilot testing different device types, the feedback from Māori, Pacific and Asian women was positive, underscoring the need for a flexible programme with different options and the importance of the relationship with the health professional, such as preferring a female and, usually, a culturally concordant sample taker.[[14]]

It was notable that Māori reported the current screening programme as being disempowering, whereas their involvement with HPV self-testing, by comparison, was empowering. Similarly in Australia, Aboriginal participants perceived self-testing as a way of exerting control over their own health.[[15]] It may be that exploring and promoting messages of empowerment might further increase uptake of self-testing in Māori and indeed other groups.

HPV and healthcare providers

New Zealand healthcare providers have talked about the importance of delivering empathetic cervical screening services and wanted an assurance that women would be supported appropriately to have cytology or colposcopy if they had a positive HPV self-test result. Many supported HPV-positive women going straight to colposcopy and stressed the importance of avoiding multiple clinic visits.[[7]] Additionally, in a recent survey of New Zealand healthcare providers’ knowledge and understanding about HPV testing, it was evident that more targeted education is required before the rollout of HPV primary screening. Many healthcare providers surveyed agreed they did not feel adequately informed to confidently respond to patients’ questions about HPV testing. Ongoing education for sample takers is essential to ensure that misinformation, stigma associated with the sexually transmitted nature of HPV and the widening of inequalities are not inadvertent consequences of interactions between health professionals and the public.[[16]]

Recommendations for implementation

We outline key recommendations from our collective expertise to the NCSP in the Ministry of Health as they develop the HPV self-testing implementation plan for Aotearoa New Zealand:

• Centralisation of equity, specifically Māori health equity. Universal access is likely to be pro-equity. However, ensuring access equity requires intentional action in planning and implementation. Hei Āhuru Mōwai, the national Māori Cancer Leadership Aotearoa group, have outlined a number of recommendations on HPV self-testing;[[17]] two key recommendations are Māori governance and the need to consider interim measures due to the lead time for implementation.
• With universal access, many well-screened women will access self-testing and their needs will not be the same as those who are under-screened. In addition to equity of access, we recommend a focus on equity in follow-up, colposcopy and treatment to ensure equity of outcomes. Building on the recent review of current cervical and breast support-to-service models, consideration should be given to redirection of resources to enable tailored follow-up of people who are HPV positive, particularly for those currently underserved. Support services will need to be available and culturally safe. Achieving follow-up can be intensive and has to be adequately resourced and performed by skilled staff using a shared decision-making approach.
• Rapid review and reconsideration of Part 4A of the Health Act 1956 (National Cervical Screening Programme) to remove the current data-related barriers to equitable access to screening, and to realign and strengthen Māori data governance and sovereignty, including the opportunity to restore cultural licence for use of data.
• Ensure that the new IT solution is population-based and facilitates easy access to screening, including providing multiple methods for invitation of eligible women. The IT solution must integrate with primary care systems and be able to capture participant preferences for receipt of self-test kits.
• Review the place of cervical screening in the broader context of women’s health and reproductive health in general practice, with particular emphasis on the importance of diagnostic investigations for gynaecological symptoms.
• Plan for a facility within the programme for at least an ‘on-request’ service of mailed self-testing kits, leveraging knowledge from local research and approaches used in the National Bowel Screening Programme.
• Review positive result triage/follow-up pathways to ensure that these are risk-stratified, women-centred and have an equity lens applied. Expected colposcopy demand from primary HPV screening and self-testing needs proactive management and additional resource. Workforce development needs to consider the wider implementation of the nurse colposcopist role.
• Rapid development and implementation of an education package for healthcare providers ahead of the implementation start date, as well as ongoing updates and continuing professional education opportunities in HPV and cervical cancer.
• There needs to be simple, well-designed resources based on local research that explain how to take a self-test, what happens next and when to see a health professional. Culturally appropriate health promotion and materials that cater to Māori, Pacific and Asian women’s health literacy needs are required.
• Alongside health professional education and communication, there needs to be a public communications strategy, including timelines for implementation to manage public expectations and pressure on primary care. Consideration of the empowerment potential of self-testing in promotional messages is recommended.

Our two research groups are progressing implementation studies in Northland and Auckland in upcoming months, to inform NCSP implementation planning on a range of the recommended issues.

Conclusions

There is considerable support across New Zealand for the introduction of HPV self-testing, with local evidence and expertise available to shape implementation planning. Hei Āhuru Mōwai have outlined their recommendations in a position paper calling for the urgent implementation of a national ‘māu anō he kuhu—do it yourself HPV test’ programme alongside Māori governance.[[17]] Support has also been expressed by the Royal New Zealand College of General Practitioners, Te Rōpū Whakakaupapa Urutā (National Māori Pandemic Group), the Royal Australian and New Zealand College of Obstetricians and Gynaecologists and Smear Your Mea, a community funded and whānau-driven campaign to encourage women to attend cervical screening—all of whom also backed a recent petition calling for the introduction of HPV self-testing.[[18]] As a collective, we welcome the Government’s commitment to and investment in HPV testing. Evidence-based implementation strategies are now required to maximise the potential for this technology to address current inequities.