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CompletedObservational

Urine HPV testing in women over 65 years of age

In the UK, routine cervical screening (smear tests) stops at age 65. However, cervical cancer can still develop in older age, and pelvic examinations often become uncomfortable after the menopause. This study, known as the ACES study, looks at an easier, pain-free alternative: testing a urine sample for human papillomavirus (HPV), the virus that causes most cervical cancers. The trial is open to women and people with a cervix aged 65 to 79 who are already attending an NHS community lung health check in Manchester. Participants give a urine sample and complete a brief questionnaire about their health and opinions on screening. If HPV is detected, participants are offered a follow-up smear test to check for early cell changes before cancer can start. The goal is to see if combining screening services makes prevention simpler and more accessible.

At a glance

Status
Completed
Sponsor
University of Manchester
Enrolment target
3,000
Start
23 May 2022
Estimated completion
31 Oct 2025

What is this study about?

Cervical screening saves thousands of lives each year by finding abnormal cell changes before they turn into cancer. In the UK, routine invitations for smear tests end at age 65. However, cervical cancer rates remain significant in older adults, particularly for those who have missed screenings in the past. In addition, traditional pelvic examinations using a speculum can feel uncomfortable or painful after the menopause, leading many people to avoid them.

Researchers at the University of Manchester are testing whether a simple urine sample could offer a gentle, pain-free alternative. Most cervical cancers are linked to high-risk strains of human papillomavirus (HPV). A sensitive urine test can detect traces of this virus without the need for an internal physical examination.

This study tests whether offering urine HPV tests alongside community lung health checks is practical and welcome. By creating a convenient 'one-stop shop' for cancer screening, researchers hope to reach people who might otherwise miss out. If successful, the results could help modernise UK screening policies and ensure older adults stay protected.

Key takeaways

  • Tests whether a painless urine sample can check for cervical cancer risk in people aged 65 to 79.
  • Open to people attending an NHS community lung health check in Manchester.
  • Avoids the need for an uncomfortable internal speculum examination.
  • Anyone with a positive HPV result is offered follow-up care through the NHS.
  • Taking part is voluntary and adds only 10 to 15 minutes to your clinic visit.

Who may be eligible?

This study is open to women and people with a cervix who are aged between 65 and 79. To take part, you must already be attending a community-based NHS lung health check run by Manchester University NHS Foundation Trust.

You cannot join the study if you have had a total hysterectomy (an operation to remove your womb and cervix), as you no longer have a cervix to test. You also need to be able to provide a urine sample and understand the study information so you can give your consent.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you female or a person with a cervix?
  2. Are you between 65 and 79 years of age?
  3. Are you attending a Manchester NHS community lung health check?
  4. Do you still have your cervix (you have not had a total hysterectomy)?
  5. Are you able to provide a urine sample at your visit?
Answer every question to see your result.

What does participation involve?

Taking part happens during your scheduled lung health check and adds about 10 to 15 minutes to your appointment. You will be asked a few questions about your health and will complete a short survey sharing your views on cervical screening. You will then collect a urine sample in a private clinic toilet. There are no study medications, injections, or treatments. Your sample will be sent to a laboratory to check for HPV. If your test is negative, you do not need to do anything else. If HPV is found, you will be invited to Manchester University NHS Trust for a standard cervical smear test to make sure the cells on your cervix are healthy.

Potential risks and benefits

There are no physical risks from giving a urine sample, and the test is completely painless. It will make your clinic visit about 10 to 15 minutes longer. While taking part may not offer an immediate personal benefit to everyone, it can detect HPV early, allowing you to receive care that prevents cervical cancer. Your participation also helps improve cancer screening for older adults in the future. Taking part is entirely your choice, and you can leave the study at any point without it affecting your standard NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Manchester University Hospital NHS Ft (hq)
    City only
    Manchester, England

Common questions

Does giving a urine sample hurt?

No. Giving a urine sample is completely painless and non-invasive, just like providing a sample at your GP surgery.

What happens if my urine test detects HPV?

Testing positive for HPV does not mean you have cancer. It simply means the virus is present. You will be invited for a standard NHS smear test to check whether any cervical cells need treatment.

Why does routine cervical screening stop at age 65?

The NHS programme currently stops invites at 65 based on older guidelines and concerns about exam discomfort, but doctors now know that cancer risks can continue past this age.

Will taking part interfere with my lung health check?

Not at all. Your lung health appointment will carry on as normal, and the study simply adds a few questions and a urine test.

Do I have to pay anything to take part?

No. Taking part is completely free as part of NHS research.

How to find out more

Suzanne Carter

Always speak to your GP or specialist before deciding to take part in a study.

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