Malignant neoplasms of female genital organs due to Human papillomavirus (HPV) infection Cancer Human papillomavirus (HPV)
Conditions
Interventions
The study aims to test a new pathway for the implementation of self-sampling for non-attenders within the NHS cervical screening in England, and to provide the evidence-base that self-sampling can imp
Sponsors
University College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged between 25 and 64 years 2. Eligible for cervical screening under the NHS Cervical Screening Programme (NHSCSP) in England 3. =6 months overdue cervical screening 4. Registered at a participating GP practice A subgroup of eligible women will also be eligible for direct mailout of self-sampling kits who reach the 15 month anniversary of their last test due date without being screened. *Women aged 65 will not be targeted but if included will not be considered a protocol violation. This is because although women aged 65+ are not invited to routine cervical screening they may still be offered a test if they have not been screened since age 50, or if they have not yet met the criteria to be ceased from the programme.
Exclusion criteria
Exclusion criteria: 1. Unable to provide informed consent. 2. Under the care of colposcopy within the last 36 months and/or due for a test of cure (HPV test to confirm successful treatment following treatment for cervical abnormalities) 3. Documented in NHAIS to have opted out of cervical screening by returning a signed cervical screening disclaimer form will not be sent a self-sampling kit by direct mail-out. By contrast, women who have opted out of cervical screening may be offered a kit opportunistically at their GP practice at the discretion of the health professional consulted. 4. Pregnant individuals will be advised to not take part in the study. There are no safety concerns with pregnant women self-collecting a vaginal swab, however the study will advise against it for two reasons. The first is that the CE-mark for the Copan 552C.80 FLOQ swab does not cover pregnancy because pregnant women were not included in Copan’s validation studies. The second is that there are potential issues with ensuring adequate follow up within the study lifetime if they test HPV positive on a self-sample (colposcopy is less inaccurate due to hormone changes and excisional treatment to the cervix for high-grade cervical disease is sometimes deferred until post-partum). The NHSCSP recommend that those who are pregnant defer cervical screening until 12 weeks post-partum. 5. Documented as being HIV positive in the Cervical Screening Programme are recalled annually (as opposed to 3 or 5 yearly). These individuals will only be included in the opportunistic offering of self-sampling. By definition, they will never reach the 15 month anniversary of last test due date to trigger direct mail out of a kit as their Next Test Due date is reset every 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 12/05/2023: 1. Uptake of kits at 30 days, 90 days and at the end of the trial 2. Change in coverage at participating GP practices from the start vs the end of the trial 3. Change in the proportion of nonattenders screened each month due to the intervention Previous primary outcome measure: Uptake and increase in coverage associated with self-sampling measured at 30 and 90 days after kits are mailed out and at the end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rates of compliance with follow-up for women who test HPV positive on a self-sample, measured by their attendance for conventional cervical screening within 6 months of testing HPV positive 2. CIN2+ detection rate of self-sampling, measured by the number of women who have CIN2+ detected at 3 and 6 years after the end of the study 3. Impact of self-sampling on colposcopy referral, measured by the number of referrals for women who returned a self-sample at the end of the study 4. Uptake of self-sampling according to the mode of kit offer, measured by the number of women returned self-sample from each pathway, at the end of the study 5. Impact of self-sampling on inequalities, measured by the distribution of women who have a self-sample result according to ethnic group and area of deprivation, at the end of the study 6. Cost effectiveness of this intervention, measured by the cost of self-sampling kits for the number of women who return a self-sample as a percentage of those women who receive a CIN2+diagnosis, at the end of the study 7. Logistics of testing samples, recording results, and giving women their results in a timely manner, measured by the turnaround time for HPV testing samples, by the mean number of days between laboratory timepoints of sample receipt, analysis, and result reporting 8. Acceptability of self-sampling in cervical screening non-attenders, measured from survey sub-study for all women who return a questionnaire, examined at the end of the study | — |
Countries
England, United Kingdom
Contacts
Public ContactAnita Lim
Outcome results
None listed