Principal investigator Dr Karen Bartholomew Clinical Director, Public Health Physician, Health Gain Team Planning, Funding and Outcomes Waitemata DHB and Auckland DHB Level 1, 15 Shea Tce, Takapuna, Auckland 0622 09-486-8920 extension 5434, 021-211-5629 Co-investigator Dr Helen Wihongi Research Advisor – Māori, Waitemata DHB and Auckland DHB Level 2, 15 Shea Tce, Takapuna, Auckland 0622 021-020-31167 Co-investigator Dr Collette Bromhead Senior Lecturer in Microbiology and Health (HPV expert), Massey University College of Health, PO Box 756, Wellington 6140 04-801-5799x63174 Co-investigator Dr Mee Ling Yeong Clinical Lead, Anatomical Pathology Service, Lab Plus, Auckland City Hospital Labtests NZ, 37-41 Carbine Rd, Mt Wellington, Auckland 1060 09-638-0161, 021-764-622 Co-investigator Ms Georgina McPherson Women’s Health Nurse Practitioner, Colposcopy Clinic, Waitemata DHB Woodford House, Waitakere Hospital, 55 Lincoln Rd, Auckland 0610 027-612-0572 Co-investigator Dr Tanya Allport Director Wai Research, Te Whānau O Waipareira, Māori Provider PO Box 21081, Henderson, Auckland 0605 09-836-6683, 021-831-159 Note: WaiResearch Evaluation team includes Georgina Martin () and Hector Kawai () WaiResearch Evaluators Georgina Martin and Hector Kaiwai Wai Research Evaluation Unit, Te Whānau O Waipareira PO Box 21081, Henderson, Auckland 0605 , Waipareira DHB Liaison Ngaire Harris and Lorraine Symons Te Whānau O Waipareira, Māori Provider 331 Great North Rd, Auckland 0612 09-836-6683 , Funder Aroha Haggie Manager Māori Health Gain Team, Planning, Funding and Outcomes Waitemata DHB and Auckland DHB Level 1, 17 Shea Tce, Takapuna, Auckland 0622 09-486-8920 extension 3915, 021-763-706
List of Abbreviations CI confidence interval CIN2+ cervical intraepithelial neoplasia grade ≥2 CIN3+ cervical intraepithelial neoplasia grade ≥3 CRF case report form DHB District Health Board GP general practitioner HPV human papillomavirus hrHPV high risk human papillomavirus LBC liquid-based cytology NCSP National Cervical Screening Programme PCR polymerase chain reaction PHO Primary Health Organisation SAE serious adverse event STI sexually transmitted infection WOW Te Whānau o Waipareira The New Zealand National Cervical Screening Programme (NCSP) has been established for 27 years. Although cervical cancer incidence has declined in both Māori and non-Māori, invasive disease persists, predominantly women who are not screened or who are Cervical cancer is the fifth most common cancer type in Māori women, and cervical cancer registration and mortality rates in Māori women are two-fold higher than those in non-Māori women. The cervical screening coverage rate of Māori women in the Auckland and Waitemata District Health Boards (DHBs) is currently the lowest and third lowest of all DHBs in the country, at 56.4% and 59.2%, respectively. This requires 2,373 and 2,673 more Māori women in each respective DHB to be screened to reach the national coverage target of 80%. Large ethnic inequalities in cervical cancer outcomes and in access to cervical screening services (as measured by coverage) are longstanding and unacceptable (see Figure 1). Figure 1 Cervical screening coverage. Source NCSP. Reasons for low programme participation include cost, embarrassment, time, inconvenience, and discomfort. Actions to reduce these barriers, including no-cost targeted testing (‘free smears’) and tailored practice-level data-matching with support, have been undertaken in an Auckland regional cervical screening coordination approach since 2012; despite these measures there has been very little change in coverage for Māori women. Novel strategies screened.,
Team member Organisation Role in Feasibility project Functions and time commitment Qualitative or quantitative expertise Clinical Māori health/ kaupapa Māori expertise Governance Karen Bartholomew ADHB/WDHB Public Health Physician Māori Health Gain Team/Child, Women and Youth Team, Chair Cervical Screening Advisory Group Principal Investigator Chair Steering Group Estimated 0.2FTE contributed in kind Lead protocol development, oversee implementation and analysis of the study Qualitative and Quantitative  Helen Wihongi ADHB/WDHB Research Advisor – Māori Steering group member Chair Māori Advisory / Peer Review Group Involvement in development and delivery of project, ensuring the project is culturally appropriate, relevant and has benefit for Māori Qualitative and Quantitative   Tanya Allport Te Whānau O Waipareira Trust, Director of Research and Evaluation; Collaborating organisation Steering Group Member Involvement in development and delivery of project, ensuring the project is culturally appropriate, relevant and has benefit for Māori women in West Auckland Qualitative  Georgina McPherson Waitemata DHB Women’s Health Nurse Practitioner, Colposcopy Clinic Steering Group Member and oversight clinical management of HPV results. Management of Clinic attendance of study participants and meeting attendance Qualitative and Quantitative 
discordant results via MDT Dr Collette Bromhead Massey University, Senior Lecturer Molecular Microbiology, HPV expert Steering Group Member and involved in sample testing with Dr Yeong Contribution FTE in kind for protocol development, study analysis and sample testing assistance as required Qualitative and Quantitative  GP Rep TBA PHO/General Practice Rep Steering Group member Provide general practice advice to assist in protocol development and study implementation  Aroha Haggie ADHB/WDHB Māori Health Gain Team Manager DHB Project Sponsor Funder Meeting attendance and document review Project sign-off Budget approval  Pam Hewlett ADHB/WDHB Women’s Health Funding Manager, Chair Metro-Auckland Cervical Screening Operations Group Steering Group Member Funder Estimated 0.1FTE contribution in kind Relationship management with collaborating organisations and other relevant groups (e.g. PHOs, primary care governance groups, NSU etc.)  Operations Lily Yang Waitemata DHB Research coordinator 0.4FTE
Primary care staff TBA East Tamaki Healthcare National Hauora Coalition ProCare Direct interaction with women as per the study protocol   Study Advice and Analysis Dr Sue Crengle Primary Care Invercargill Māori Health and screening expert advisor Māori Advisory / Peer Review Group   Dr Nina Scott Waikato DHB Māori Health and screening expert advisor Māori Advisory / Peer Review Group   TBA Advisory Māori Advisory / Peer Review Group  Prof Marion Saville Executive Director Victoria Cytology Service, Melbourne, Australia; investigator of the iPAP Advisor Advice on study design and research protocol, peer review of findings and report writing Quantitative and qualitative  Lynn Sadler ADHB, Women’s Health Intelligence Advisor and analysis Advice on study design and research protocol, oversight of analysis and report writing Quantitative  TBA ADHB/WDHB Health Gain Team, Health Economist Economic Analysis Advice on collection of cost data and assistance with analysis Quantitative
42. Ministry of Health. Guidelines for Cervical Screening in New Zealand. Wellington: National Cervical Screening Programme, National Screening Unit, Ministry of Health, 2008. 43. Arbyn M, Snijders PJ, Meijer CJ, Berkhof J, Cuschieri K, Kocjan BJ, et al. Which high-risk HPV assays fulfil criteria for use in primary cervical cancer screening? Clinical Microbiology and Infection. 2015;21(9):817-26. 44. US Food and Drug Administration. Approval letter for the cobas HPV test, Roche. Silver Spring, MD: US Food and Drug Administration, 2011. 45. Ministry of Health. National Cervical Screening Programme Policies and Standards. Section 5: providing a laboratory service. Wellington: Ministry of Health, 2015. 46. Roche Molecular Systems Inc. The Netherlands is the first country to transition its national cervical cancer screening program from Pap to primary HPV screening. 2016 [cited 2016 1 Sep]; Available from: 47. Sultana F, English DR, Simpson JA, Brotherton JML, Drennan K, Mullins R, et al. Rationale and design of the iPap trial: a randomized controlled trial of home-based HPV self-sampling for improving participation in cervical screening by never- and under-screened women in Australia. BMC Cancer. 2014;14:207-. 48. Canfell K, Castle P, Caruana M, Gebski V, Darlington-Brown J, Heley S, et al. Protocol for Compass: a randomised controlled trial of primary HPV vs. cytology screening for cervical cancer in HPV-unvaccinated and vaccinated women in Australia (version 1.2). Carlton, Victoria: Victorian Cytology Service, 2016. 49. Sultana F, Mullins R, Murphy M, English DR, Simpson JA, Drennan KT, et al. Women’s views on human papillomavirus self-sampling: focus groups to assess acceptability, invitation letters and a test kit in the Australian setting. Sexual Health. 2015;12(4):279-86.