Can a urine test improve uptake in cervical screening?
| ISRCTN | ISRCTN58902324 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58902324 |
| IRAS number | 321531 |
| Secondary identifying numbers | CPMS 62478, IRAS 321531 |
- Submission date
- 22/05/2024
- Registration date
- 22/05/2024
- Last edited
- 17/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
Cervical screening can save lives, yet only 7 in 10 in the UK attend, the lowest rate in 20 years. Reasons include embarrassment, fear of examination and inconvenience. The aim of this study is to find out if self-collected urine and vaginal tests could increase uptake in cervical screening. The tests have the potential to remove many of the current barriers to screening. They can be taken at home at a time most convenient for the patient.
Who can participate?
To be eligible to take part in this study participants must be aged 25-65 years and overdue cervical screening by 6 months or more
What does the study involve?
The researchers will work with GP practices across Greater Manchester to identify potential participants through overdue cervical screening lists. Participants will be randomly allocated into one of five groups.
1. Group 1 will be posted a urine sample collection pack.
2. Group 2 will be posted a vaginal sample collection pack.
3. Group 3 will receive a letter offering the choice of a urine or vaginal sample collection pack.
4. Group 4 will receive a letter offering a urine sample collection pack.
5. Group 5 will receive a letter offering a vaginal sample collection pack.
The researchers will also advertise through social media, at face-to-face community events, and using posters and leaflets in community settings. Participants recruited through this method will not be randomly allocated and will instead be offered the choice of a urine or vaginal self-sample kit.
Participants will self-collect a sample at home and complete a questionnaire. samples will be returned via Royal Mail. Samples will be tested for high-risk human papillomavirus – the virus known to cause cervical cancer. The researchers will look at how many samples are returned and whether there is a preference for urine or vaginal sample collection.
What are the possible benefits and risks of participating?
There are no expected risks or direct benefits expected for participants, however, a positive urine sample may prompt a non-attender to book routine cervical screening which in turn could prevent cervical cancer. Self-sampling may encourage more people to attend cervical screening in future.
Where is the study run from?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
September 2020 to December 2026
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
ACES@manchester.ac.uk
Contact information
Principal Investigator
University of Manchester
Division of Cancer Sciences
School of Medical Sciences
Faculty of Biology Medicine and Health
St Mary's Hospital
Manchester
M16 9WL
United Kingdom
 ORCID ID |
0000-0003-0284-8630 |
|---|---|
| Phone | +44 (0)1617016942 |
| emma.crosbie@manchester.ac.uk |
Public
The University of Manchester
Division of Cancer Sciences
School of Medical Sciences
Faculty of Biology Medicine and Health
St Mary's Hospital
Manchester
M13 9WL
United Kingdom
| Phone | +44 (0)1617016941 |
|---|---|
| suzanne.carter@manchester.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Screening, Prevention, Active Monitoring |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Alternative CErvical Screening study - ACES At Home: can a urine test improve uptake in cervical screening? |
| Study acronym | ACES At Home |
| Study hypothesis | Self sampling for HPV testing as an alternative to routine cervical screening, will improve cervical screening attendance in people overdue screening by 6 months or more. |
| Ethics approval(s) | Approved 23/05/2024, London - Camberwell St Giles Research Ethics Committee (postal address not available; +44 (0)20 7104 8222; camberwellstgiles.rec@hra.nhs.uk), ref: 24/LO/0385 |
| Condition | Cervical screening |
| Intervention | This study will see if a urine or vaginal at-home self-sample test can improve cervical screening uptake in non-attenders. Women, and people with a cervix, who are registered at GP Practices, who meet the eligibility criteria will be randomised into five groups in the ratio 1:1:1:1:1. Group one will receive a text message/letter to advise them that they will receive a urine self-sampling pack by post to their registered home address. Urine collection packs will then be sent to their home address 2 weeks later. Group two will receive a text message/letter to advise them that they will receive a vaginal self-sampling pack by post to their registered home address. Vaginal sample collection packs will then be sent to their home address 2 weeks later. Group three will receive an invitation letter and participant information sheet offering them the opportunity to request a urine or vaginal self-sampling pack. Group four will receive an invitation letter and participant information sheet offering them the opportunity to request a urine self-sampling pack. Group five will receive an invitation letter and participant information sheet offering them the opportunity to request a vaginal self-sampling pack Samples will be tested for high-risk HPV. The participant and GP will receive a copy of the results. The study sample will not replace or update the NHS cervical screening record. In each intervention group the researchers will record and compare the number and type of requested packs (where applicable), the number of returned samples and the number of participants who attend routine cervical screening if they test HPV positive. If an inadequate sample result is returned, the participant will be asked to collect a second sample using the same method. Participants will answer a short acceptability questionnaire to gauge their views on self-sample testing for cervical screening. The researchers will collect cervical screening data on all participants invited to ACES At Home. This will be extracted from the GP practice records at the time of identifying and inviting eligible participants approximately 6 months later. Added 28/01/2025: The researchers will estimate spontaneous attendance for routine cervical screening within the 3 months prior to the study invitation for each GP practice. This will be compared to the proportion in each randomisation arm who do not respond to self-sampling but instead are prompted to attend cervical screening at their GP practice. A sub-study (ACES Choice) will invite individuals who self-identify as non-attenders to routine cervical screening to take part: in person, at community events and gatherings; social media/web adverts; posters/leaflets at GP practices, clinics, pharmacies and community settings. Participants will be given a choice between a urine or vaginal at-home self-sampling pack. People will also have the option to contact the research team via email. The researchers will assess community choice for urine or vaginal self-sampling according to demographics to ascertain if certain communities are likely to prefer one method of self-sampling over another. |
| Intervention type | Other |
| Primary outcome measure | ACES AT Home: Improvement in uptake is measured by the number of individuals returning an adequate self-sample within the study period. The preference for urine testing will be measured by the proportion of individuals opting for urine self-sampling in the choice arm during the study period. ACES Choice sub-study: Preference for type of self-sampling is measured by the proportion of individuals requesting a urine or vaginal self-sampling pack during the study period |
| Secondary outcome measures | ACES At Home: 1. The proportion of individuals who test HPV+; who attend follow-up procedures; referred for colposcopy; CIN2+ on histology measured by medical record follow-up 2. The proportion of individuals with inadequate samples providing repeat samples during the study period 3. The acceptability of urine and vaginal self-sampling to individuals who are overdue cervical screening and previous barriers to screening measured using study questionnaire at the point of sample collection 4. The impact of age, gender, sexual identity, disability status, time since last cervical screen, ethnicity, religion, education/ employment status and postcode (as a measure of socioeconomic deprivation) on uptake of urine and vaginal self-sampling measured using study questionnaire at the point of sample collection 5. The proportion of invited individuals who attend cervical screening during the study period measured by medical record data extraction at baseline and end of study 6. The proportion of non-responders from ACES at Home who respond to ACES Choice measured 6 months and onwards following ACES At Home invitation ACES Choice: 1. The proportion of individuals who return a self-sampling kit within the study period 2. The proportion of individuals who return a self-sampling kit within the study period based on method of approach (in the community, via social media, at GP practice or clinic) 3. The acceptability of urine and vaginal self-sampling to women who are overdue cervical screening and previous barriers to screening measured using study questionnaire at the point of sample collection (baseline) 4. The impact of age, ethnicity, religion, disability status, gender, sexual orientation, education/ employment status, socioeconomic status and time since last screen on uptake of urine or vaginal self-sampling measured using study questionnaire at the point of sample collection |
| Overall study start date | 01/09/2020 |
| Overall study end date | 01/12/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 10000; UK Sample Size: 10000; ACEs Choice substudy <500 |
| Participant inclusion criteria | 1. Aged 25-65 years 2. Person with a cervix 3. Written, informed consent to participate* 4. Overdue routine cervical screening by 6 months or more 5. Reside in the catchment for laboratory (Aces Choice only) *Does not apply for data extraction for all invited participants |
| Participant exclusion criteria | 1. Pregnant 2. Person without a uterus 3. Unable to provide vaginal or a urine sample, including indwelling urinary catheter (for offering urine HPV testing only) 4. Unable to understand the Participant Information Sheet and consent form 5. Any condition that would compromise participant safety or data integrity 6. Due screening in the next 3 months 7. Type 1 objectors (i.e. those who dissent from their medical data being shared) |
| Recruitment start date | 01/08/2024 |
| Recruitment end date | 01/12/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
`
Manchester
M23 1JX
United Kingdom
Birchfields Road
Manchester
M14 6FS
United Kingdom
Manchester
M4 6EE
United Kingdom
Finney Lane
Heald Green
Cheadle
SK8 3JD
United Kingdom
Manchester
M12 5JE
United Kingdom
Sale
M33 7SS
United Kingdom
Oldham
OL8 1DF
United Kingdom
Didsbury
Manchester
M20 6BA
United Kingdom
Bury
BL9 0NJ
United Kingdom
31-33 Market Street
Altrincham
WA14 1PF
United Kingdom
Glodwick
Oldham
OL4 1YN
United Kingdom
Ashton-under-lyne
OL6 6EW
United Kingdom
27-29 Manchester Road
Knutsford
WA16 0LY
United Kingdom
Oldham
OL8 3TR
United Kingdom
Fitton Hill Neighbourhood Centre
Fircroft Road
Oldham
OL8 2QD
United Kingdom
Westway
Shaw
Oldham
OL2 8BF
United Kingdom
Heywood
OL10 4PW
United Kingdom
Middleton Shopping Centre
Middleton
Manchester
M24 4EL
United Kingdom
Newall Green
Manchester
M23 2SY
United Kingdom
Fallowfield
Manchester
M14 6WP
United Kingdom
Brinnington
Stockport
SK5 8BS
United Kingdom
Reddish
Stockport
SK5 6ET
United Kingdom
Walmer Street
Rusholme
Manchester
M14 5NP
United Kingdom
Eccles
Manchester
M30 8QD
United Kingdom
Sponsor information
University/education
Faculty of Biology
Medicine and Health
Carys Bannister Building
Dover Street
Manchester
M13 9PL
England
United Kingdom
| Phone | +44 (0)161 275 5436 |
|---|---|
| fbmhethics@manchester.ac.uk | |
| Website | http://www.manchester.ac.uk/ |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Prof. Emma Crosbie (emma.crosbie@manchester.ac.uk). The consent form includes permission to share anonymised data with other researchers. |
Editorial Notes
17/04/2025: Springfield Medical Centre was added to the study participating centres.
16/04/2025: Park View Group Practice and The Robert Darbishire Practice were added to the study participating centres.
11/04/2025: Bodey Medical Centre and Brinnington Health Centre were added to the study participating centres.
28/02/2025: The Maples Medical Centre was added to the study participating centres.
12/02/2025: Birtle View Medical Practice and Middleton Health Centre were added to the study participating centres.
28/01/2025: The interventions were updated. Hollinwood Medical Practice, Hill Top Surgery and Village Medical Practice were added to the study participating centres.
09/01/2025: Knutsford Medical Partnership was added as the study participating centre.
25/11/2024: Ashton Medical Group was added as the study participating centre.
08/11/2024: St Johns Medical Centre and Glodwick Primary Care Centre were added as study participating centres.
30/10/2024: Tower Family Healthcare - Minden was added as a study participating centre.
24/10/2024: The study participating centres John Street Medical Practice and Didsbury Medical Centre were added. Ethics approval details added.
17/10/2024: The study participating centres Heald Green Health Centre 2, West Gorton Medical Centre, Washway Road Medical Centre were added.
24/09/2024: Pds Medical - Hawthorn Medical Centre and Ancoats Urban Village Medical Practice were added to the study participating centres.
04/06/2024: Internal review.
22/05/2024: Study's existence confirmed by the NIHR.
