A Model for Empowering Rural Solutions for Cervical Cancer Prevention (He Tapu Te Whare Tangata): Protocol for a Cluster Randomized Crossover Trial
Authors: Lawton Beverley , MacDonald Evelyn Jane , Storey Francesca , Stanton Jo-Ann , Adcock Anna , Gibson Melanie , Parag Varsha , Sparkes Ngaire Kereru , Kaimoana Bobby , King Frances , Terry Marion , Watson Huti , Bennett Matthew , Lambert Charles Seymour , Geller Stacie , Paasi Isitokia , Hibma Merilyn , Sykes Peter , Hawkes David , Saville Marion 
Published: September 2023

Background
Māori are the Indigenous people of Aotearoa (New Zealand). Despite global acceptance that cervical cancer is almost entirely preventable through vaccination and screening, wāhine Māori (Māori women) are more likely to have cervical cancer and 2.5 times more likely to die from it than non-Māori women. Rural Māori residents diagnosed with cervical cancer have worse outcomes than urban residents. Living in rural Aotearoa means experiencing barriers to appropriate and timely health care, resulting from distance, the lack of community resourcing, and low prioritization of rural needs by the health system and government. These barriers are compounded by the current screening processes and referral pathways that create delays at each step. Screening for high-risk human papillomavirus (hrHPV) and point-of-care (POC) testing are scientific advances used globally to prevent cervical cancer.

Objective
This study aims to compare acceptability, feasibility, timeliness, referral to, and attendance for colposcopy following hrHPV detection between a community-controlled pathway and standard care.

Methods
This is a cluster randomized crossover trial, with 2 primary care practices (study sites) as clusters. Each site was randomized to implement either pathway 1 or 2, with crossover occurring at 15 months. Pathway 1 (community-controlled pathway) comprises HPV self-testing, 1-hour POC results, face-to-face information, support, and immediate referral to colposcopy for women with a positive test result. Pathway 2 (standard care) comprises HPV self-testing, laboratory analysis, usual results giving, information, support, and standard referral pathways for women with a positive test result. The primary outcome is the proportion of women with hrHPV-positive results having a colposcopy within 20 working days of the HPV test (national performance indicator). Qualitative research will analyze successes and challenges of both pathways from the perspectives of governance groups, clinical staff, women, and their family. This information will directly inform the new National Cervical Screening Program.

Results
In the first 15-month period, 743 eligible HPV self-tests were performed: 370 in pathway 1 with POC testing and 373 in pathway 2 with laboratory testing. The positivity rate for hrHPV was 7.3% (54/743). Data collection for the second period, qualitative interviews, and analyses are ongoing.

Conclusions
This Māori-centered study combines quantitative and qualitative research to compare 2 clinical pathways from detection of hrHPV to colposcopy. This protocol draws on rural community practices strengths, successfully engaging Māori from a whānau ora (family wellness) approach including kanohi ki te kanohi (face-to-face), kaiāwhina (nonclinical community health workers), and multiple venues for interventions. It will inform the theory and practice of rural models of the use of innovative technology, addressing Māori cervical cancer inequities and facilitating Māori wellness. The findings are anticipated to be applicable to other Indigenous and rural people in high-income countries.

Trial Registration
Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621000553875; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621000553875

International Registered Report Identifier (IRRID)
DERR1-10.2196/51643