Harti Hauora Tamariki: randomised controlled trial protocol for an opportunistic, holistic and family centred approach to improving outcomes for hospitalised children and their families in Aotearoa, New Zealand.

Background: Health and wellbeing inequities between the Indigenous Maori and non-Maori populations in Aotearoa, New Zealand continue to be unresolved. Within this context, and of particular concern, hospitalisations for diseases of poverty are increasing for tamariki Maori (Maori children). To provide hospitalised tamariki Maori, and their whanau (families) comprehensive support, a wellbeing needs assessment; the Harti Hauora Tamariki Tool (The Harti tool) was developed. The purpose of this study is to determine how effective the Harti tool is at identifying wellbeing needs, ensuring the documentation of needs, enabling access to services and improving wellbeing outcomes for tamariki and their whanau. Methods: The study uses a Kaupapa Maori methodology with qualitative and quantitative methods. Qualitative methods include in-depth interviews with whanau. This paper presents an overview of a randomised, two parallel, controlled, single blinded, superiority trial for quantitative evaluation of the Harti programme, and hospital satisfaction with care survey. Participants will be Maori and non-Maori tamariki/children aged 0-4 years admitted acutely to the paediatric medical wards at Waikato Hospital, Hamilton, Aotearoa New Zealand. They will be randomised electronically into the intervention or usual care group. The intervention group will receive usual care in addition to the Harti programme, which includes a 24-section health needs assessment delivered by trained Maori navigators to whanau during the time they are in hospital. The primary endpoint is the relative risk of an acute hospital readmission in the 30 days following discharge for the intervention group patients compared with control group patients. Secondary outcomes include access and utilisation of preventative health services including: oral health care, general practice enrolment, immunisation, healthy home initiatives, smoking cessation and the Well Child Tamariki Ora universal health checks available free of charge for children in Aotearoa New Zealand. Discussion: Randomised controlled trials are a gold standard for measuring efficacy of complex multifaceted interventions and the results will provide high quality evidence for implementing the intervention nationwide. We expect that this study will provide valuable evidence for health services and policy makers who are considering how to improve the configuration of paediatric hospital services. Trial registration: The study is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), registration number: ACTRN12618001079235.

Equity of travel to access surgery and radiation therapy for lung cancer in New Zealand.

PURPOSE: Centralisation of lung cancer treatment can improve outcomes, but may result in differential access to care for those who do not reside within treatment centres. METHODS: We used national-level cancer registration and health care access data and used Geographic Information Systems (GIS) methods to determine the distance and time to access first relevant surgery and first radiation therapy among all New Zealanders diagnosed with lung cancer (2007-2019; N = 27,869), and compared these outcomes between ethnic groups. We also explored the likelihood of being treated at a high-, medium-, or low-volume hospital. Analysis involved both descriptive and adjusted logistic regression modelling. RESULTS: We found that Maori tend to need to travel further (with longer travel times) to access both surgery (median travel distance: Maori 57 km, European 34 km) and radiation therapy (Maori 75 km, European 35 km) than Europeans. Maori have greater odds of living more than 200 km away from both surgery (adjusted odds ratio [aOR] 1.83, 95% CI 1.49-2.25) and radiation therapy (aOR 1.41, 95% CI 1.25-1.60). CONCLUSIONS: Centralisation of care may often improve treatment outcomes, but it also makes accessing treatment even more difficult for populations who are more likely to live rurally and in deprivation, such as Maori.

Receipt of mastectomy and adjuvant radiotherapy following breast conserving surgery (BCS) in New Zealand women with BCS-eligible breast cancer, 2010-2015: an observational study focusing on ethnic differences.

BACKGROUND: Women with early breast cancer who meet guideline-based criteria should be offered breast conserving surgery (BCS) with adjuvant radiotherapy as an alternative to mastectomy. New Zealand (NZ) has documented ethnic disparities in screening access and in breast cancer treatment pathways. This study aimed to determine whether, among BCS-eligible women, rates of receipt of mastectomy or radiotherapy differed by ethnicity and other factors. METHODS: The study assessed management of women with early breast cancer (ductal carcinoma in situ [DCIS] and invasive stages I-IIIA) registered between 2010 and 2015, extracted from the recently consolidated New Zealand Breast Cancer Registry (now Te Rehita Mate Utaetae NZBCF National Breast Cancer Register). Specific criteria were applied to determine women eligible for BCS. Uni- and multivariable analyses were undertaken to examine differences by demographic and clinicopathological factors with a primary focus on ethnicity (Maori, Pacific, Asian, and Other; the latter is defined as NZ European, Other European, and Middle Eastern Latin American and African). RESULTS: Overall 22.2% of 5520 BCS-eligible women were treated with mastectomy, and 91.1% of 3807 women who undertook BCS received adjuvant radiotherapy (93.5% for invasive cancer, and 78.3% for DCIS). Asian ethnicity was associated with a higher mastectomy rate in the invasive cancer group (OR 2.18; 95%CI 1.72-2.75), compared to Other ethnicity, along with older age, symptomatic diagnosis, advanced stage, larger tumour, HER2-positive, and hormone receptor-negative groups. Pacific ethnicity was associated with a lower adjuvant radiotherapy rate, compared to Other ethnicity, in both invasive and DCIS groups, along with older age, symptomatic diagnosis, and lower grade tumour in the invasive group. Both mastectomy and adjuvant radiotherapy rates decreased over time. For those who did not receive radiotherapy, non-referral by a clinician was the most common documented reason (8%), followed by patient decline after being referred (5%). CONCLUSION: Rates of radiotherapy use are high by international standards. Further research is required to understand differences by ethnicity in both rates of mastectomy and lower rates of radiotherapy after BCS for Pacific women, and the reasons for non-referral by clinicians.

Equity of Cancer and Diabetes Co-Occurrence: A National Study With 44 Million Person-Years of Follow-Up.

PURPOSE: The co-occurrence of diabetes and cancer is becoming increasingly common, and this is likely to compound existing inequities in outcomes from both conditions within populations. METHODS: In this study, we investigate the co-occurrence of cancer and diabetes by ethnic groups in New Zealand. National-level diabetes and cancer data on nearly five million individuals over 44 million person-years were used to describe the rate of cancer in a national prevalent cohort of peoples with diabetes versus those without diabetes, by ethnic group (Maori, Pacific, South Asian, Other Asian, and European peoples). RESULTS: The rate of cancer was greater for those with diabetes regardless of ethnic group (age-adjusted rate ratios, Maori, 1.37; 95% CI, 1.33 to 1.42; Pacific, 1.35; 95% CI, 1.28 to 1.43; South Asian, 1.23; 95% CI, 1.12 to 1.36; Other Asian, 1.31; 95% CI, 1.21 to 1.43; European, 1.29; 95% CI, 1.27 to 1.31). Maori had the highest rate of diabetes and cancer co-occurrence. Rates of GI, endocrine, and obesity-related cancers comprised a bulk of the excess cancers occurring among Maori and Pacific peoples with diabetes. CONCLUSION: Our observations reinforce the need for the primordial prevention of risk factors that are shared between diabetes and cancer. Also, the commonality of diabetes and cancer co-occurrence, particularly for Maori, reinforces the need for a multidisciplinary, joined-up approach to the detection and care of both conditions. Given the disproportionate burden of diabetes and those cancers that share risk factors with diabetes, action in these areas is likely to reduce ethnic inequities in outcomes from both conditions.

Feasibility and acceptability of telehealth and contactless delivery of human papillomavirus (HPV) self-testing for cervical screening with Maori and Pacific women in a COVID-19 outbreak in Aotearoa New Zealand.

AIM: To determine the feasibility and acceptability of a telehealth offer and contactless delivery of human papillomavirus (HPV) cervical screening self-test during the 2021 COVID-19 Level 4 lockdown in Auckland, New Zealand. METHODS: A small proof-of-concept study was undertaken to test telehealth approaches in never-screened, due or overdue Maori and Pacific women enrolled in a local Primary Health Organisation (PHO). Study invitation, active follow-up, nurse-led discussions, result notification and a post-test questionnaire were all delivered through telehealth. RESULTS: A sample of 197 eligible Maori and Pacific women were invited to take part, of which 86 women were successfully contacted. Sixty-six agreed to take part. Overall uptake was 61 samples returned (31.8%) and uptake of all contactable women was 70.9%. Six of the 61 HPV self-tests (9.8%) were positive, all for non 16/18 types, and were referred for cytology. Three had negative cytology results, and three with positive cytology results were referred for colposcopy. CONCLUSION: The offer of HPV self-testing during COVID-19 lockdown was both feasible and highly acceptable for Maori and Pacific women. Importantly, HPV self-testing via telehealth and mail-out, alongside other options, offers a potential pro-equity approach for addressing the impact of deferred screens due to COVID-19 and other longstanding coverage issues.

Development and Validation of a Machine Learning Approach Leveraging Real-World Clinical Narratives as a Predictor of Survival in Advanced Cancer.

PURPOSE: Predicting short-term mortality in patients with advanced cancer remains challenging. Whether digitalized clinical text can be used to build models to enhance survival prediction in this population is unclear. MATERIALS AND METHODS: We conducted a single-centered retrospective cohort study in patients with advanced solid tumors. Clinical correspondence authored by oncologists at the first patient encounter was extracted from the electronic medical records. Machine learning (ML) models were trained using narratives from the derivation cohort, before being tested on a temporal validation cohort at the same site. Performance was benchmarked against Eastern Cooperative Oncology Group performance status (PS), comparing ML models alone (comparison 1) or in combination with PS (comparison 2), assessed by areas under receiver operating characteristic curves (AUCs) for predicting vital status at 11 time points from 2 to 52 weeks. RESULTS: ML models were built on the derivation cohort (4,791 patients from 2001 to April 2017) and tested on the validation cohort of 726 patients (May 2017-June 2019). In 441 patients (61%) where clinical narratives were available and PS was documented, ML models outperformed the predictivity of PS (mean AUC improvement, 0.039, P < .001, comparison 1). Inclusion of both clinical text and PS in ML models resulted in further improvement in prediction accuracy over PS with a mean AUC improvement of 0.050 (P < .001, comparison 2); the AUC was > 0.80 at all assessed time points for models incorporating clinical text. Exploratory analysis of oncologist's narratives revealed recurring descriptors correlating with survival, including referral patterns, mobility, physical functions, and concomitant medications. CONCLUSION: Applying ML to oncologists' narratives with or without including patient's PS significantly improved survival prediction to 12 months, suggesting the utility of clinical text in building prognostic support tools.

Te Aho o Te Kahu: weaving equity into national-level cancer control.

The purpose of this manuscript was to consider how mainstream health organisations can develop structures, processes, and functions to address inequity, using the New Zealand Cancer Control Agency (Te Aho o Te Kahu) as an example. In New Zealand (Aotearoa), as in other countries, inequities in cancer incidence and outcomes exist between population groups, including for indigenous populations. Despite much discussion regarding the need to address racial inequities, often the proposed solutions are at operational or programmatic levels, and disadvantaged communities are unable to have much of a say in the system design and service delivery of these solutions. The establishment of a dedicated cancer control agency has created a unique opportunity to centralise principles and approaches to achieving equity within the core functions of the agency, and enabled a new method of approaching cancer control with the aim of achieving equity for the most disadvantaged populations. Using a framework based on the founding agreement between New Zealand's Indigenous Maori people and the British Government (Te Tiriti o Waitangi), we consider how health system organisations can develop structures, processes, and functions to achieve equity, and summarise how this new agency has been shaped to achieve these objectives for Maori people in particular, including the innovative and equity-first approach to organisational structure and focus. Within this framework, we highlight the key equity-focused work programmes, initiatives, and other actions taken since the inception of the agency. Finally, we discuss the ongoing equity-related challenges the agency faces, as well as the current and future opportunities for achieving equity in health outcomes.

Human papillomavirus self-testing among unscreened and under-screened Maori, Pasifika and Asian women in Aotearoa New Zealand: A preference survey among responders and interviews with clinical-trial nonresponders.

INTRODUCTION: Maori, Pasifika and Asian women are less likely to attend cervical screening and Maori and Pasifika women are more likely to be diagnosed with later-stage cervical cancer than other women in Aotearoa New Zealand. This study-with under-screened women taking part in a randomized-controlled trial comparing self-testing and standard screening-explored the acceptability of a human papillomavirus (HPV) self-test kit and the preferred method for receiving it. METHODS: Maori, Pasifika and Asian women (N= 376) completed a cross-sectional postal questionnaire. Twenty-six women who had not accepted the trial invitation were interviewed to understand their reasons for nonparticipation. RESULTS: Most women found the self-test kit easy and convenient to use and reported that they did not find it painful, uncomfortable or embarrassing. This was reflected in the preference for a self-test over a future smear test on the same grounds. Most women preferred to receive the kit by mail and take the test themselves, rather than having it done by a doctor or nurse. There was a range of preferences relating to how to return the kit. Phone calls with nonresponders revealed that, although most had received the test kit, the reasons for not choosing to be involved included not wanting to, being too busy or forgetting. CONCLUSION: HPV self-testing was acceptable for Maori, Pasifika and Asian women in Aotearoa New Zealand. HPV self-testing has considerable potential to reduce the inequities in the current screening programme and should be made available with appropriate delivery options as soon as possible. PATIENT OR PUBLIC CONTRIBUTION: This study explored the acceptability of HPV self-testing and their preferences for engaging with it among Maori, Pasifika and Asian women. Thus, women from these underserved communities were the participants and focus of this study.

Human Papillomavirus (HPV) Self-Sampling among Never-and Under-Screened Indigenous Maori, Pacific and Asian Women in Aotearoa New Zealand: A Feasibility Study.

In Aotearoa, New Zealand, the majority of cervical cancer cases occur in women who have never been screened or are under-screened. Wahine Maori, Pacific and Asian women have the lowest rate of cervical screening. Self-sampling for human papillomavirus (HPV-SS) has been shown to increase participation in cervical cancer screening. A whole-of-system approach, driven by evidence in the most effective delivery of HPV-SS, is required to mitigate further widening of the avoidable gap in cervical screening access and outcomes between groups of women in Aotearoa. This single-arm feasibility and acceptability study of HPV self-sampling invited never- and under-screened (≥5 years overdue) 30-69-year-old women from general practices in Auckland, Aotearoa. Eligible women were identified by data matching between the National Cervical Programme (NCSP) Register and practice data. Focus groups were additionally held with eligible wahine Maori, Asian and Pacific women to co-design new patient information materials. Questionnaires on HPV knowledge and post-test experience were offered to women. Our follow-up protocols included shared decision-making principles, and we committed to follow-up ≥90% of women who tested positive for HPV. Data matching identified 366 eligible never- and under-screened wahine Maori, Pacific and Asian women in participating practices. We were only able to contact 114 women, and 17, during the discussion, were found to be ineligible. Identifying and contacting women overdue for a cervical screen was resource-intensive, with a high rate of un-contactability despite multiple attempts. We found the best uptake of self-sampling was at focus groups. Of the total 84 HPV-SS tests, there were five positive results (6%), including one participant with HPV18 who was found to have a cervical Adenocarcinoma at colposcopy. In our feasibility study, self-sampling was acceptable and effective at detecting HPV and preventing cervical cancer in under-screened urban wahine Maori, Pacific and Asian women in Aotearoa. This is the first report of cervical Adenocarcinoma (Grade 1B) as a result of an HPV-18 positive self-sample in Aotearoa. We co-designed new patient information materials taking a health literacy and ethnicity-specific approach. This work provides policy-relevant information to the NCSP on the resources required to implement an effective HPV self-sampling programme to improve equity in national cervical cancer screening.

Acceptability of human papillomavirus (HPV) self-sampling among never- and under-screened Indigenous and other minority women: a randomised three-arm community trial in Aotearoa New Zealand.

BACKGROUND: Internationally, self-sampling for human papillomavirus (HPV) has been shown to increase participation in cervical-cancer screening. In Aotearoa New Zealand, there are long-standing ethnic inequalities in cervical-cancer screening, incidence, and mortality, particularly for indigenous Maori women, as well as Pacific and Asian women. METHODS: We invited never- and markedly under-screened (≥5 years overdue) 30-69-year-old Maori, Pacific, and Asian women to participate in an open-label, three-arm, community-based, randomised controlled trial, with a nested sub-study. We aimed to assess whether two specific invitation methods for self-sampling improved screening participation over usual care among the least medically served populations. Women were individually randomised 3:3:1 to: clinic-based self-sampling (CLINIC - invited to take a self-sample at their usual general practice); home-based self-sampling (HOME - mailed a kit and invited to take a self-sample at home); and usual care (USUAL - invited to attend a clinic for collection of a standard cytology sample). Neither participants nor research staff could be blinded to the intervention. In a subset of general practices, women who did not participate within three months of invitation were opportunistically invited to take a self-sample, either next time they attended a clinic or by mail. FINDINGS: We randomised 3,553 women: 1,574 to CLINIC, 1,467 to HOME, and 512 to USUAL. Participation was highest in HOME (14.6% among Maori, 8.8% among Pacific, and 18.5% among Asian) with CLINIC (7.0%, 5.3% and 6.9%, respectively) and USUAL (2.0%, 1.7% and 4.5%, respectively) being lower. In fully adjusted models, participation was statistically significantly more likely in HOME than USUAL: Maori OR=9.7, (95%CI 3.0-31.5); Pacific OR=6.0 (1.8-19.5); and Asian OR=5.1 (2.4-10.9). There were no adverse outcomes reported. After three months, 2,780 non-responding women were invited to participate in a non-randomised, opportunistic, follow-on substudy. After 6 months,192 (6.9%) additional women had taken a self-sample. INTERPRETATION: Using recruitment methods that mimic usual practice, we provide critical evidence that self-sampling increases screening among the groups of women (never and under-screened) who experience the most barriers in Aotearoa New Zealand, although the absolute level of participation through this population approach was modest. Follow-up for most women was routine but a small proportion required intensive support. TRIAL REGISTRATION: ANZCTR Identifier: ACTRN12618000367246 (date registered 12/3/2018) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371741&isReview=true; UTN: U1111-1189-0531. FUNDING: Health Research Council of New Zealand (HRC 16/405). PROTOCOL: http://publichealth.massey.ac.nz/assets/Uploads/Study-protocol-V2.1Self-sampling-for-HPV-screening-a-community-trial.pdf.

Bowel cancer screening age range for Maori: what is all the fuss about?

The current New Zealand Bowel Screening Programme (BSP) is inequitable. At present, just over half of bowel cancers in Maori present before the age of 60 years (58% in females and 52% in males), whereas just under a third of bowel cancers in non-Maori are diagnosed before the same age (27% in females and 29% in males). The argument for extending the bowel screening age range down to 50 years for Maori is extremely simple-in comparison to non-Maori, a greater percentage of bowel cancers in Maori occur before the age of 60 years (when screening starts). Commencing the BSP at 50 years of age for Maori with high coverage will help fix this inequity. In this paper we review the current epidemiology of colorectal cancer with respect to the age range extension for Maori.

The impact of the COVID-19 pandemic on cancer diagnosis and service access in New Zealand-a country pursuing COVID-19 elimination.

BACKGROUND: The COVID-19 pandemic has disrupted cancer services globally. New Zealand has pursued an elimination strategy to COVID-19, reducing (but not eliminating) this disruption. Early in the pandemic, our national Cancer Control Agency (Te Aho o Te Kahu) began monitoring and reporting on service access to inform national and regional decision-making. In this manuscript we use high-quality, national-level data to describe changes in cancer registrations, diagnosis and treatment over the course of New Zealand's response to COVID-19. METHODS: Data were sourced (2018-2020) from national collections, including cancer registrations, inpatient hospitalisations and outpatient events. Cancer registrations, diagnostic testing (gastrointestinal endoscopy), surgery (colorectal, lung and prostate surgeries), medical oncology access (first specialist appointments [FSAs] and intravenous chemotherapy attendances) and radiation oncology access (FSAs and megavoltage attendances) were extracted. Descriptive analyses of count data were performed, stratified by ethnicity (Indigenous Maori, Pacific Island, non-Maori/non-Pacific). FINDINGS: Compared to 2018-2019, there was a 40% decline in cancer registrations during New Zealand's national shutdown in March-April 2020, increasing back to pre-shutdown levels over subsequent months. While there was a sharp decline in endoscopies, pre-shutdown volumes were achieved again by August. The impact on cancer surgery and medical oncology has been minimal, but there has been an 8% year-to-date decrease in radiation therapy attendances. With the exception of lung cancer, there is no evidence that existing inequities in service access between ethnic groups have been exacerbated by COVID-19. INTERPRETATION: The impact of COVID-19 on cancer care in New Zealand has been largely mitigated. The New Zealand experience may provide other agencies or organisations with a sense of the impact of the COVID-19 pandemic on cancer services within a country that has actively pursued elimination of COVID-19. FUNDING: Data were provided by New Zealand's Ministry of Health, and analyses completed by Te Aho o Te Kahu staff.

What's Lost in Translation: A Dialogue-Based Intervention That Improves Interpreter Confidence in Palliative Care Conversations.

BACKGROUND: For US patients with limited English proficiency (LEP), diversity of language and culture can create potential health care disparities in discussions of prognosis and goals of care. Although professional medical interpreters are often thought of as language conduits, they are also trained as clarifiers and mediators of cultural barriers between providers, patients and their families. Identifying interpreter challenges in Palliative Care (PC) conversations and brainstorming and rehearsing solutions could improve their confidence interpreting PC encounters and being cultural mediators. MEASURES: Pre- and Pre/Postintervention PC confidence questionnaires. INTERVENTION: six-session monthly dialogue-based course. OUTCOMES: Interpreters showed significant increases in postintervention confidence in PC communication compared with pre-intervention (z = -5.646, P< 0.000). CONCLUSIONS/LESSONS LEARNED: This dialogue-based intervention eliciting ongoing interpreter challenges, with PC social work facilitation and role-play with PC clinicians in a mutually respectful environment, significantly improved interpreter confidence in partnering with clinicians in PC conversations.

The most commonly diagnosed and most common causes of cancer death for Maori New Zealanders.

Cancer is an important cause of morbidity and avoidable mortality for Maori-and substantial disparities exist in cancer incidence, mortality and survival for Maori compared to non-Maori New Zealanders. In this viewpoint, we draw together cancer incidence, mortality and survival data from the previous decade, in order to provide clarity regarding the most important causes of cancer burden for Maori. Covering the decade 2007-2016, our manuscript directly leads on from the landmark Unequal Impact II report (which covered 1996-2006), and provides the most up-to-date record of this burden as is currently possible. While focusing on the absolute burden of cancer for Maori, we also compare this burden to that experienced by non-Maori, and consider how this relative disparity may (or may not) have changed over time. Finally, we discuss how to reduce the occurrence and the overall cancer mortality burden for Maori, with a focus on those cancers that confer the greatest burden.

Correction to: Comparison of two invitation-based methods for human papillomavirus (HPV) self-sampling with usual care among un- and under-screened Maori, Pacific and Asian women: study protocol for a randomised controlled community trial to examine the effect of self-sampling on participation in cervical-cancer screening.

Following publication of the original article [1], the authors reported an error in the authorship list associated with the paper. Georgina McPherson has therefore been added.

Comparison of two invitation-based methods for human papillomavirus (HPV) self-sampling with usual care among un- and under-screened Maori, Pacific and Asian women: study protocol for a randomised controlled community trial to examine the effect of self-sampling on participation in cervical-cancer screening.

BACKGROUND: Maori, Pacific and Asian women in New Zealand have lower cervical-cancer screening rates than European women, and there are persistent inequities in cervical cancer outcomes for Maori and Pacific women. Innovative ways to address access barriers are required. New Zealand is transitioning to screening with human papillomavirus (HPV) DNA testing, which could allow women themselves, rather than a clinician, to take the sample. Internationally, self-sampling has been found to increase screening participation rates. The aim of this open-label community-based randomised controlled trial is to investigate whether self-sampling increases screening participation among un- and under-screened Maori, Pacific and Asian women in New Zealand. METHODS/DESIGN: We aim to invite at least 3550 un- or under-screened (≥5 years overdue) Maori, Pacific and Asian women (1050, 1250, 1250 respectively), aged 30-69 years, for screening. The three study arms are: usual care in which women are invited to attend a clinic for a standard clinician-collected cytology test; clinic-based self-sampling in which women are invited to take a self-sample at their usual general practice; and mail-out self-sampling in which women are mailed a kit and invited to take a self-sample at home. Women will be randomised 3:3:1 to the clinic and mail-out self-sampling groups, and usual care. There is also a nested sub-study in which non-responding women in all allocation groups, when they subsequently present to the clinic for other reasons, are offered clinic or home-kit self-sampling. The primary outcome will be the proportion of women who participate (by taking a self-sample or cytology test). DISCUSSION: This trial is the first to evaluate the effectiveness of mailed self-sampling in New Zealand and will be one of the first internationally to evaluate the effectiveness of opportunistic in-clinic invitations for self-sampling. The trial will provide robust evidence on the impact on participation proportions from different invitation approaches for HPV self-sampling in New Zealand un- and under-screened Maori, Pacific and Asian women. TRIAL REGISTRATION: ANZCTR Identifier: ACTRN12618000367246 (date registered 12/3/2018) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371741&isReview=true; UTN: U1111-1189-0531.