Urine HPV testing in women over 65 years of age

Urine HPV testing for cervical screening in women over 65: Alternative CErvical Screening (ACES) Over 65's

Registry ID
ISRCTN39388293
Source registry
ISRCTN
Status
No longer recruiting
Study type
OBSERVATIONAL
Sponsor
University of Manchester
Enrollment
3000
Start date
2022-05-23
Completion date
2027-12-31
Last update
2026-08-17

Conditions

Summary

Identification of cervical cancer risk in women over 65 years of age using urine HPV testing

Detailed description

This study will establish the feasibility of combining cancer screening services in a community setting, the uptake of urine HPV testing in underserved communities, and whether the prevalence of HR-HPV in women aged 65-79 justifies reviewing the current age cut off for UK NHS cervical screening. Women attending community based lung cancer screening clinics will be asked to provide medical history data and a voided urine sample. Urine will be collected with a Colli-Pee device, which reliably collects a standardised volume of first void urine. Urine samples may be provided at the time of the lung health check clinic appointment or collected at home. Samples will be tested for high risk HPV. Women who test HR-HPV positive will be offered a routine cervical sample (‘smear test’) at MFT and treated according to the results of this sample, using NHS Cervical Screening programme algorithms. Participants will answer a short acceptability questionnaire to gauge their views on urine testing for cervical screening. Those who decline participation will be asked to record their reasons on a short questionnaire. This is entirely optional

Interventions

Inclusion criteria

1. Age 65-79 years 2. Written, informed consent to participate 3. Attending MFT Community based lung health check 4. Female or person with a cervix

Exclusion criteria

1. Previous total hysterectomy (no cervix) 2. Unable to provide a urine sample 3. Unable to understand the Patient Information Sheet and consent form 4. Any condition that would compromise participant safety or data integrity

Locations

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