Catch-Up Screen Project: A urine test for cervical screening
Screening for cervical pre-cancer
This is a one-arm study. The “Catch-up Screen” project will offer the identification of cervical pre-cancer using a catch-up HPV test from a urine self-sample taken at home by women aged 60-79 who have ceased the NHS Cervical Screening Programme without a primary HPV test. This includes women who had their last screening invitation before the introduction of primary HPV testing in 2019 and women who did not attend their last test after 2019. All participants will be provided with an at-home urine sampling kit (a Colli-Pee device) which reliably collects a standardised volume of first void urine (10ml) for the purpose of HPV testing. Willing participants will post their urine samples back to the laboratory, where they will be tested for HPV. Because HPV is known to cause almost all cervical cancers, testing for HPV will identify women at risk of developing cervical cancer. Unlike traditional screening, which can sometimes be painful or embarrassing, Catch-up Screen offers women the opportunity to provide a urine sample from the privacy of their home for the purpose of detecting the presence of HPV. It is hoped that this will encourage women who were not screened regularly to take part. Women testing HPV positive will be referred for further tests and treatment if necessary. HPV-negative women will receive a letter with their test results, explaining that their future risk of cervical cancer is extremely low. They will not need any further tests. HPV-positive women will be offered a hospital outpatient appointment with a gynaecologist and followed up according to NHS guidelines. The catch-up screen aims to screen at least 10,000 women across the Hull and Manchester areas via GP practices. In the first year, the feasibility phase, 3,000 women will be invited to test the methodology and determine the uptake, and the second stage will be a wider roll-out inviting about 15,000 women to estimate the rates of pre-cancer detection and cancer prevention. Response rates wi
1. Female or person with a cervix who is registered with GP practice 2. Ceased from the NHS Cervical Screening Programme without an exit primary HPV test 3. Aged 60-79 years at invitation
1. Previous total hysterectomy 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 5. Those who have opted out of sharing data for research purposes (this includes Type 1 and Type 2/National opt-out)