Human Papillomavirus (HPV) self-sampling among un- and under-screened Maori, Pacific and Asian women: a randomised controlled community trial to examine the effect of self-sampling on participation in cervical-cancer screening

Assessing uptake and acceptability of a new human papilloma virus (HPV) detection method (low vaginal self-sampling with cotton swab and HPV molecular testing with the Roche cobas 4800 platform) in comparison to (minimally altered) usual care, for primary cervical-cancer screening. Invitation through the primary care clinic (monthly matched lists between primary care enrolled patient and cervical screening register is routine practice, these lists will be used for identifying eligible women). Women will be randomised to one of three arms: clinic-based self-sampling (clinic-based SS), mail-out self-sampling (mail-out SS) or usual care. Clinic-based SS women will be invited to attend the clinic, discuss the study, consent, and complete a questionnaire. Clinic-based SS women able to complete the self-sampling at the clinic (in the bathroom) during this visit or, to ensure clinical safety, they will be able to take the kit home and return it to the clinic, but this will be recorded and analysed separately. Mail-out SS women will be posted a kit (to their home) and asked to complete the consent & laboratory forms, take the sample, complete the questionnaire, and arrange (free) courier pick-up of the completed kit, or to take the completed kit to a community laboratory. Uptake of the invitation to participate will be monitored via receipt of test results into the study IT system and, for the clinic-based SS group, via clinic attendance record. Four weeks after the invitation letters have been sent, all non-responding women will be sent a reminder text message. The reminder text message for the mail-out SS group will include a telephone number that the woman can use to request that a second sampling kit be sent. Contact details for research nurses are included in the invitation letters. The research nurses will answer any questions that the women have over the telephone. All results will be provided to women, even if it is usual practice for the clinic not to return negative results. Positive results women will be phoned and asked to attend the clinic to discuss with the GP, practice nurse or research nurse. All screening (including usual care) will be provided free of charge (most women have to pay for cervical screening; secondary care is free of charge in NZ). The study is assessing the impact of this intervention, and the two different invitation methods, on participation rates for cervical screening among un- and under-screened women.