Can a urine test improve uptake in cervical screening?

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

Study website

Type

Principal Investigator

Contact name

Prof Emma Crosbie

ORCID ID

http://orcid.org/0000-0003-0284-8630

Contact details

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
+44 (0)1617016942
emma.crosbie@manchester.ac.uk

Type

Public

Contact name

Miss Suzanne Carter

ORCID ID

Contact details

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
+44 (0)1617016941
suzanne.carter@manchester.ac.uk

EudraCT/CTIS number

Nil known

IRAS number

321531

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 62478, IRAS 321531

Scientific title

Alternative CErvical Screening study - ACES At Home: can a urine test improve uptake in cervical screening?

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)

Approval pending, 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

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

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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.

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

Reason abandoned (if study stopped)

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 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 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

Countries of recruitment

England, United Kingdom

Study participating centre

Bowland Medical Centre
52 Bowland Road
`
Manchester
M23 1JX
United Kingdom

Organisation

University of Manchester

Sponsor details

Faculty of Biology
Medicine and Health
Carys Bannister Building
Dover Street
Manchester
M13 9PL
England
United Kingdom
+44 (0)161 275 5436
fbmhethics@manchester.ac.uk

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

ROR

https://ror.org/027m9bs27

Funder type

Government

Funder name

NIHR Academy; Grant Codes: NIHR300650

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

Intention to publish date

31/12/2027

Individual participant data (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.

IPD sharing plan summary

Available on request

Study outputs