He Tapu Te Whare Tanagata - Does offer of Human Papilloma Virus self -testing to under-screened Maori women increase cervical screening coverage?

INTERVENTION: The study uses a parallel group comparison design, where usual standard care (control group) or the intervention (HPV self‐testing program) will be allocated by primary health care clinic. Inclusion criteria: Maori women who have not had a cervical smear screen in the last 4 years. Brief title Offer of self ‐testing HPV swab to under‐screened Maori women 1) Educational Intervention for clinicians and community workers Materials ‐ Educational material (written/presentation/teaching sessions) given to doctors, nurses, community workers by experts in HPV from research team Who will deliver intervention ‐ Research team (Professor oncological gynaecology, professor Obstetrics and Gynaecology, sexual health physician/ senior research fellow, family physician/ researcher with expertise in women’s health) will provide educational material and sessions for nurse, doctors and community workers Mode of delivery ‐ Educational sessions to clinicians will be offered to groups of clinicians from intervention primary care practices in small tutorial setting Number of times intervention offered ‐ Education sessions will be offered twice to groups of clinicians over 3 months ‐ 2 x 1 hour sessions Location‐ Education sessions will be offered in primary care setting/clinic/local community hall 2) Intervention for participants – under‐screened Maori women offered self –taken vaginal swab for HPV Materials ‐ Instructions and diagrams for women being offered HPV self‐testing will be co‐designed by research team plus input from primary health clinicians, community workers and the women themselves (focus groups) ( draft HPV information and consent is attached to ANZCTR registration form) Procedures ‐Women will receive verbal, written and /or pictorial instructions from a doctor, nurse or kaiawhina (community health worker) about how to perform the HPV self‐test, a self‐collected vaginal sample. Women will self‐collect a vaginal sample using a swab. The instructions will detail how to insert the swab into the vagina and place it into a collection container that has been labelled by the healthcare worker with the name, date of birth and unique NHI (National Health Index) number. Specimens are transported at room temperature to local Laboratories, who have agreed to handle the transportation of the samples, with their daily shipments, to national central Laboratories. HPV genotyping will be carried out using Real‐time High Risk HPV assay validated for the use of dry swabs. This distinguishes HPV‐16 and HPV‐18 from other high‐risk types and from negative samples. Who will deliver intervention – the (participants) woman’s usual primary care clinician (family doctor or nurse) or community health worker will deliver the information to participants Mode of delivery ‐ HPV swab testing will be offered by doctor, nurse or community worker, face‐to‐face individually HPV self‐testing will be offered between 1 ‐ 5 times over one year to under‐screened Maori women Location‐ HPV self‐ testing will be offered in patients home, community venues such as local meeting houses (Maraes) if facilities allow, primary care clinic Any positive result will be followed up and referred for colposcopy by the woman’s usual primary care clinician. CONDITION: Cervical cancer and pre‐cancer PRIMARY OUTCOME: Primary outcome: Rate of HPV self‐testing in intervention practices compared to rate of cervical smear uptake in control practices. ; Outcome assessed by data linkage to primary care clinic records, laboratory results data and data from National Screening Unit NSU. SECONDARY OUTCOME: Composite proportion of women with CIN2, CIN3, ; These higer grade diagnoses are often measured compostiely in the literature. Results – results of self‐ testing for HPV will be given by the woman’s usual primary care clinician ( doctor or nurse.) This can be done by phone or text if the result is negative or if results positive for high risk HPV an appointment will be made for the woman to obtain result and explanation face to face. Results will be available 7‐14 days after test has been taken. Results will also be entered into the National Screening Unit data base (as per usual cervical smear results). This process has been discussed with the screening unit CEO and clinician in charge of cervical screening database. Our study site is Northland where Maori women have almost twice the incidence of cervical cancer compared to non‐Maori but almost four times the mortality. In Northland, cervical screening for Maori is approximately 66%. Women fulfilling inclusion criteria will be identified by primary care and matched with the National Screening Unit (NSU) on NHI to confirm screening history. All primary care clinics in the geographical area will be approached and recruited and randomised to intervention or control (usual care). We will recruit until target met. ; Data linkage to primary care clinic records and national screening unit data which collects results from colposcopy ( specialist gynaecology hospital services). Secondary outcomes: For those HPV tested: ; proportion of women with abnormal screen (positive for oncogenic HPV), ; Data linkage to primary care clinic records and national screening unit data which collects results from colposcopy ( specialist gynaecology hospital services). proportion of HPV negative women. ; Data linkage to primary care clinic records and national screening unit data proportion of women with HPV attending colposcopy, ; Data linkage to primary care clinic records and national screening unit data which collects results from colposcopy ( specialist gynaecology hospital services). proportion of women with abnormal histology on colposcopy, ; Data linkage to primary care clinic records and national screening unit data which collects results from colposcopy ( specialist gynaecology hospital services). proportion of women with carcinoma‐in situ ; Data linkage to primary care clinic records and national screening unit data which collects results from colposcopy ( specialist gynaecology hospital services). proportion of women with cervical cancer ; Data linkage to primary care clinic records and national screening unit data which collects results from colposcopy ( specialist gynaecology hospital services). INCLUSION CRITERIA: Women aged 25 to 60 years of age who have not had a cervical smear in the last 4 years registered or casual patients with 8 primary care centres in Northland , New Zealand .