None listed
Conditions
Brief summary
The hypothesis of the trial is that the approach of the universal offer of HPV self-testing will screen at least as many women as the offer of cervical cytology in the current screening program. The objective of this study is to screen 3200 eligible wahine (women) in the implementation arm by offer of self-taken vaginal HPV test and compare to 3200 women in the comparison arm of the study who have a standard cervical smear. These results will inform an efficient, accessible, wahine-centred primary HPV screening programme to reduce cervical cancer incidence and death in Aotearoa New Zealand.
Interventions
Te Ara Waiora-Implementing HPV primary testing to prevent cervical cancer in NZ- Te Tai Tokerau : A non-inferiority trial The primary aim of this project is to test whether the universal offer of HPV self- test to all women is non-inferior to the cervical screening coverage in the current cytology cervical screening program. The intervention is therefore the offer of an HPV self-test. Clinics will be randomly selected to be implementation clinics ( i.e offer of HPV self-test) or comparison clinics ( ie offer of routine standard are - cervical smear for cytology) and screening uptake over 2 years recruitment will be compared. Posters and flyers with self-test HPV information specifically designed for this study will be displayed in implementation clinics. There is written and verbal information specifically designed for this study, supplied to the women to explain the HPV tests and to explain how to take the swab. Women will be able to take the swab in the clinic . In some circumstances the woman may be visited at home by a health worker and will be able to take the swab at home. The time needed to take the swab if it is self collected is around 1 minute. Women will be contacted if they are due their cervical smear in the usual way (phone, letter, text) , overdue women ( over due a smear is defined as 4 or more years since last smear) will be contacted in the usual way to explain the HPV tests and women who are due or overdue will be approached opportunistically if they attend the clinic for another reason. Clinicians (nurses, doctors) and kaiawhina ( community health workers) in the primary care practices will deliver the intervention with prior training. These clinicians and community health workers are the womens' usual primary care givers. The offer of the HPV self-test swab will be delivered face to face and provided individually. The offer of HPV tests will be made once to women over the two years of recruitment if they accept the offer. If they don't accept the offer, several attempts may be made over the two years of recruitment, usually every 3 months up to 6 attempts or more. The offer of the HPV self-test swab will be made in the clinic or in the participant's home if visited by the community health worker or in a community centre. It is anticipated that most women will take the swab themselves but there may be women who choose to have it taken by their clinician in the clinic. Intervention adherence will be measured as this is the primary outcome - the screening coverage compared with comparison clinics.
Sponsors
Study design
Eligibility
Inclusion criteria
Maori and non-Maori women aged 25-69 years living in Te Tai Tokerau/Northland region due or over due a cervical smear
Exclusion criteria
Women who have had treatment for pre-cancer or cervical cancer and are under active follow up by the National Cervical Screening Program for test of cure.