An implementation study of text invitation, mailed at-home human papillomavirus (HPV) self-testing and telehealth management in Aotearoa New Zealand, with a nested randomised controlled trial that compared offering an incentive vs. no offer with a re

INTRODUCTION: In Aotearoa New Zealand, human papillomavirus (HPV) self-testing was introduced simultaneously with HPV primary screening in September 2023 to improve access and reduce inequities for priority populations, including Indigenous Māori, Pacific and under-screened people. To contribute policy-relevant information, we implemented non-standard engagement and screening strategies, including text message invitation, mailed test kits, at-home self-testing, telehealth support and follow-up by a central nurse-led co-ordination team. METHODS: We partnered with an Auckland primary health organisation (PHO) with high enrolment of priority populations. We invited people eligible for cervical screening aged 30-69 years by text message to receive mailed test kits (April-October 2023); people who did not respond were re-invited (October-November 2023). Offering a financial incentive to return a sample (intervention group) was compared with no offer (control group) in a sub-group of eligible Māori and Pacific who received a repeat mailed test kit in a nested randomised controlled trial (April-May 2024). Self-tested participants were invited by text message to an online survey. RESULTS: We invited 25,315 people and 24.0% opted in. Lower initial consent rates were increased after additional re-invitation reminders for Māori (20.0% to 30.4%) and Pacific (13.7% to 24.9%), with the final consent rate in Māori equal to European/Other (29.2%; p = 0.284). Almost half (48.2%) of consenting participants returned a sample, giving a self-test uptake of 11.6% (n = 2,925). Uptake was significantly lower (all p < 0.001) for Māori (12.7%) and Pacific (8.4%) vs. European/Other (19.0%), and for those under-screened (10.5%) vs. those overdue by < 6 months (19.4%). In the RCT, sample return rate did not differ significantly (p = 0.704) between the intervention (7.9%) and control (8.5%) groups. HPV was detected in 7.7% of 3,018 valid results. Follow-up test rates were high (96.8% for cytology, 90.5% for colposcopy). Almost all survey respondents preferred a mailed at-home self-test for their next screen (91.9%; n = 193 of 210). DISCUSSION: Invitation by text message to mailed at-home HPV self-testing engaged priority populations in cervical screening. Central co-ordination support achieved high rates of sample return and follow-up testing where required. A mailed at-home testing option, strongly preferred by survey respondents, warrants consideration in a broader programme to improve access to cervical screening, with additional targeted strategies to improve sample return rates for priority populations. CLINICAL TRIAL REGISTRATION: While the overall study did not reach the ICJME or WHO criteria for clinical trial registration, the nested RCT was retrospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12625000798460) and World Health Organization (WHO UTN U1111-1324-8454).