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

Abstract

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 Māori women, as well as Pacific, and Asian women. Methods: We invited never- and markedly under-screened (≥5 years overdue) 30-69-year-old Māori, 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 Māori, 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: Māori 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.

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

“…The three trial arms were as follows: usual care , in which women were invited to attend a clinic for a standard smear sample; clinic‐based self‐testing , in which women were invited to take a self‐test at their usual general practice; and mail‐out self‐testing , in which women were posted a kit and invited to take a self‐test at home. This showed that, although screening uptake was lower than in the first RCT, self‐testing uptake was again statistically significantly preferred over usual care, with the highest participation in the mail‐out self‐test arm 13 …”

“…All Māori, Pasifika and Asian women who were invited to take part in one of the two self‐testing arms of the RCT 13 were given a survey to complete about their experience of self‐testing, which they completed at home or in the clinic, depending on where they completed the self‐testing. The women were all aged 30‐69 years, were resident in Waitematā or Auckland District Health Board (DHB) areas and had never been screened or were overdue (≥5 years) for cervical screening.…”