None listed
Conditions
Brief summary
The purpose of this study is to describe the impacts of implementing hrHPV testing for cervical cancer screening in a range of General Practice (GP) clinics in New Zealand. Patients who are due or overdue for a cervical cancer screening test will be invited to have an hrHPV test instead of their regular smear test. They can opt to have an hrHPV test via one of the following methods: 1. A self test taken from the vagina, done at home 2. A self test taken from the vagina, done in clinic, with or without staff support 3. A test taken from the cervix by a doctor. Patients who have a positive hrHPV test will be referred for further investigations and treatment, if required. These outcomes will be recorded as well as the resources required for completion of the screening process.
Interventions
Over a six month* screening period patients who are due or overdue for their smear test will be invited to take part in the study. They will undertake a high risk human papillomavirus (hrHPV) screening test for cervical cancer.**
Participants will be able to select one of the following ways to take the hrHPV test:
1 Vaginal hrHPV self sample at home
2 Vaginal hrHPV self sample at their General Practice (GP) clinic (with or without medical staff assistance)
3 Cervical hrHPV sample taken by a do
Over a six month* screening period patients who are due or overdue for their smear test will be invited to take part in the study. They will undertake a high risk human papillomavirus (hrHPV) screening test for cervical cancer.** Participants will be able to select one of the following ways to take the hrHPV test: 1 Vaginal hrHPV self sample at home 2 Vaginal hrHPV self sample at their General Practice (GP) clinic (with or without medical staff assistance) 3 Cervical hrHPV sample taken by a doctor or nurse (with or without concurrent cytology). Vaginal hrHPV self tests will be taken utilising a dry floq swab inserted in the vagina and transported in a sterile sealed container. Cervical hrHPV tests will be taken under direct visualisation by an accredited smear-taker using a cervibroom or equivalent and placed in liquid-based cytology medium. Self testing will take around 5 minutes to complete. A clinician taken test will take up to 10 minutes. The hrHPV test will be performed utilising an accredited lab and an hrHPV assay validated for cervical hrHPV screening. Test results will be returned to the participant's GP. The GP will provide appropriate follow up and inform participants of their results. * The screening period may be extended for an additional 3 months to allow time for patients who have been contacted to decide whether they wish to take part. ** Only one hrHPV test will be required during the screening period, unless the sample is deemed insufficient (e.g. incorrectly labelled), in which case the participant will be asked to repeat it.
Sponsors
Otago University
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
People enrolled in the practice who are eligible for cervical screening as part of the National Cervical Screening Programme (NCSP)* and are recalled for cervical screening or opportunistically attend the provider and are due for a cervical screen within the study enrolment period. Notes Patients who are recalled for screening but report symptoms at the time of their screening test will be eligible for the study, however a strong recommendation for a clinical assessment will be made. Patients who are invited to participate in this study can do so if they agree to participate within 3 months of the completion of the recruitment period (i.e., before 1 April 2023). *For full details of inclusion for NCSP screening, please refer to the 2020 Ministry of Health Clinical Practice Guidelines for Cervical Screening in New Zealand at www.nsu.govt.nz.
Exclusion criteria
Patients who are unable or unwilling to provide informed consent.
Outcome results
None listed