Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 7, 2023
Date Accepted: Aug 17, 2023
He Tapu Te Whare Tangata - A Model for Empowering Rural Solutions for Cervical Cancer Prevention: Protocol for a Cluster Randomised Crossover Trial.
ABSTRACT
Background:
Whānau (families) living in rural Aotearoa New Zealand have barriers to appropriate and timely health care, resulting from distance, lack of community resourcing and low prioritization of rural needs by the national health care system and government. Current screening processes and referral pathways create delays at each step which in turn creates barriers to access. Point of Care (POC) testing is being utilised globally for HPV screening to prevent cervical cancer. Utilising the cervical cancer screening pathway, the objective of this study is to improve timely diagnosis and treatment for rural women who require secondary care colposcopy following a positive high-risk HPV (hrHPV) result. Our overall aim is to explore the acceptability and feasibility of community control of care pathways combined with innovative technology (POC) to overcome the barriers existing for rural Māori communities.
Objective:
1: To compare two pathways of care on the timeliness, referral to and attendance for colposcopy following hrHPV detection. (Quantitative) 2: To assess the acceptability and feasibility of the two cervical cancer prevention pathways (Qualitative)
Methods:
This is a cluster-randomised crossover trial comparing two pathways for cervical screening and follow-up in two rural areas (sites). Pathway A is hrHPV self-testing with onsite POC results in one hour, face-to-face provision of information, support, and immediate referral for colposcopy for women with positive hrHPV results - a community-controlled pathway. Pathway B is HPV self-testing and laboratory analysis, followed by usual result giving, information and support, and standard referral pathways for those with positive hrHPV results - current standard pathway. Each site was randomised to implementing either Pathway A or Pathway B in the first study period (15 months), then crossing over to implement the other pathway in the second study period. The primary outcome is the proportion of women with hrHPV positive results having a colposcopy within 20 working days from HPV test. A range of quantitative and qualitative secondary outcomes will be explored, including the successes and challenges of both pathways from the perspectives of a range of stakeholders and women being tested.
Results:
results pending end of recruitment and analysis
Conclusions:
This Māori centred study combines a cluster randomised crossover trial with qualitative work to compare two clinical pathways from detection of hrHPV to colposcopy. This protocol draws on the strengths of rural community practices who are successfully engaging Māori (the Indigenous people of Aotearoa New Zealand) from a whānau ora (family wellness) approach through locally appropriate practices such as kanohi ki te kanohi (face to face), kaiāwhina (non-clinical community health workers), and multiple venues for interventions. It will inform theory and practice about rural models of utilisation of innovative technology, addressing Māori cervical cancer inequities, and facilitating Māori wellness. It is hoped that these impacts and solutions may well be appropriate for other Indigenous and rural peoples in high income countries. Clinical Trial: Registered with the Australian New Zealand Clinical Trials Registry 12/5/2021 ACTRN12621000553875
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