Cervical screening pathway - A model for empowering rural solutions

This is a cluster crossover intervention trial, with communities (study sites) as clusters. Pathway 1 ( Intervention) is an HPV self-test with onsite Point of Care (POC) results within one hour paired with kanohi ki te kanohi (face to face) information, support and immediate appointments for a secondary service colposcopy for those who are HPV positive. Pathway 2 (Control) is HPV self-test with swab sent to laboratory, and the usual result giving, information and support, and usual referral pathways to colposcopy for those who are HPV highr risk positive. Results are usually received within 7 working days from the lab, referral to colposcopy entails the primary care clnican writing a letter to the gynaecology department and and once triaged by the gyanecologist an appointment is sent to the patient (woman). The Ministry of Health guidelins recommend 20 working days from receiving referral to appointment for high grade cervcial changes and 40 working days for low grade cervcial changes. We hypothesise that Pathway 1 will improve timely diagnosis and treatment access for women with high risk HPV compared to Pathway 2. Information written , pitcorial and verbal will be provided for recruited women by trained clinicians and community health workers on how to take the swab,. Information will also be provided on the process of colposcopy and support will be given to help attendance at colposcopy appointments for women with positive high risk HPV results ( such as a support person to accompany the womanand petrol vouchers or transport help). The clinicians ( primary care doctors and nurses) and community health workers will be provided with training on HPV by a team of HPV experts before recruitment starts; its role in cervical cancer and the science on HPV testing to detect pre-cancerous cervical changes compared to cytology from a cervical smear sample A training will be held for each intervention site ( pathway 1) on the Point of Care machine by certified trainers- both quality audit and processing of swabs. The trainees will be GPs, nurses and community health workers who have a knowledge and connection with their community and the primary care clinics. - training will be provide face to face in small groups - trainng will be provided before recruitment starts and the trainers /experts will remain on site for the first few days of recruitment to ensure no issues with the POC testing and results. Repeat training updates will be provided at appropriate intervals - 6 monthly updates The HPV self test can be taken by the woman herself or by a clinician at the woman's request. The sample can be taken in the clinic, at home or in a community centre or suitable venue that has a private toilet facility. For all trials: The HPV swab is to be offered to all women aged between 25-69 who are registered with the primary care site who are due a cervical smear but priority will be given to women who are currently underscreened ( no smear for 4 years or more) or who have never had a cervical smear. The pathway to colposcopy in both arms ( pathways) will be assessed using the NZ Ministry of Health guidelines for time to colposcopy for a high grade cytology result.