Exploring cervical screening without a speculum in women aged 50-64

ISRCTN ISRCTN69709352
DOI https://doi.org/10.1186/ISRCTN69709352
IRAS number 228847
Secondary identifying numbers IRAS 228847
Submission date
20/07/2020
Registration date
04/08/2020
Last edited
15/08/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
HPV is the name of a very common group of viruses. They do not cause any problems in most people, but some types can cause genital warts or cancer.
Women aged over 65 account for almost half of all cervical cancer deaths, most are in women not adequately screened when aged 50-64. Smears can become uncomfortable after the menopause and this can put some women off coming for cervical screening. One of the main causes of discomfort is the speculum (the instrument used to hold the walls of the vagina open). It is now possible to do cervical screening by testing for the virus that causes cervical cancer; human papillomavirus (HPV). An advantage of HPV testing is that samples can be taken without a speculum. Women can even collect a sample themselves (self-testing). Unfortunately, over half of women who take a self-test worry about not taking a good sample. Another option is to do HPV testing on a sample taken by a clinician without a speculum (non-speculum). Women would have the reassurance of having a clinician take the sample but with much less discomfort. This has not been tried before.
This study will assess the test performance and acceptability of non-speculum clinician samples for HPV testing in women aged 50+.

Who can participate?
There are 2 parallel studies; (i) GP primary care - women aged 50 - 64 attending routine cervical screening (to assess if non-speculum clinician samples can correctly identify women without disease) and (ii) colposcopy - women aged 50+ being investigated for possible cervical disease (to assess if non-speculum clinician samples can correctly identify women with disease).

What does the study involve?
A non-speculum clinician sample will be collected followed by a speculum clinician sample (in the GP study the second sample will be the routine smear). HPV test results from non-speculum samples will be compared with results from speculum samples and routine screening tests. Women in the GP study will complete a short questionnaire asking them about their experiences with the test.

What are the possible benefits and risks of participating?
Benefits: No personal benefit by taking part in this study. However, women will be contributing to research that will help improve cervical screening in the future.
Risk: We do not anticipate any risks associated with taking part in this study. Vaginal samples are routinely collected in the NHS.

Where is the study run from?
King's College London (UK)

When is the study starting and how long is it expected to run for?
April 2017 to January 2019

Who is funding the study?
Cancer Research UK

Who is the main contact?
Jane Rigney, hpvstudy@kcl.ac.uk

Contact information

Mrs Jane Rigney
Scientific

Kings College London
Faculty of Life Sciences & Medicine
London
SE1 9RT
United Kingdom

Phone +44 (0)2078485494
Email jane.rigney@kcl.ac.uk

Study information

Study designMulti centre observational cross sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)GP practice
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA cross-sectional study to assess the test performance and acceptability of non-speculum HPV testing in older women
Study acronymSHOW
Study objectivesThe test performance and acceptability of non-speculum clinician samples for HPV testing in
women aged 50+ is as good as routine cervical screening using a speculum.
Ethics approval(s)Approved 03/08/2017, North East - Tyne & Wear South Research Ethics Committee (Jarrow Business Centre Room 001 Rolling Mill Road, Jarrow, NE32 3DT; UK; +44 (0)207 1048084; tyneandwearsouth.rec@hra.nhs.uk), ref: 17/NE/0268
Health condition(s) or problem(s) studiedHuman papillomavirus (HPV)
InterventionEligible women will be consented to allow the GP or nurse to take a non-speculum sample before their rotuine sample. Study samples will be collected using a flocked vaginal swab (this is like a long cotton bud). HPV testing will be performed by the Barts Health NHS Trust Cytology laboratory. Only anonymous data will be collected for the study. This will be provided by the laboratory. HPV test results from non-speculum samples will be compared with results from speculum samples and routine screening tests.
Study HPV results will not be reported to women since they will not inform management (women will be managed according to their usual care under the NHS Cervical screening programme). An exception to this is women in the routine screening arm (GP sub-study) who test cytology negative/HPV positive. These women will be referred by their GP for colposcopy.

Eligible women will be identified by the colposcopy administrative team and sent the study information (invitation letter, patient information leaflet and HPV information sheet) with their colposcopy appointment letter. At their colposcopy appointment written informed consent will be taken by the colposcopist or colposcopist nurse. Before the colposcopy examination, the colposcopist/colposcopist nurse will collect a vaginal sample without a speculum, followed by a sample with a speculum. Almost all of these women will be HPV positive, and many will have high-grade cervical disease. This will allow us to assess how good HPV testing on non-speculum clinician samples is at correctl identifying women with high-grade cervical disease.
Intervention typeOther
Primary outcome measureMeasured at a single time point:
1. “Sensitivity” as the proportion of non-speculum HPV positives among (i) speculum HPV positives and (ii) women with high-grade disease (CIN2+ on histology and/or moderate dyskaryosis or worse on cytology)
2. “Specificity” as the proportion of non-speculum HPV negatives among women attending routine screening who are not found to have high-grade disease who are speculum HPV negatives and cytology screen-negative women (normal/borderline/mild dyskaryosis on cytology)
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date03/04/2017
Completion date31/01/2019

Eligibility

Participant type(s)Mixed
Age groupAdult
SexFemale
Target number of participants250
Total final enrolment298
Key inclusion criteria1. Women aged 50 - 64 years attending routine cervical screening in GP primary care
2. Women aged ≥ 50 years attending colposcopy who are likely or known to be HPV positive (e.g. referred with a cytology result of moderate or worse or positive on HPV triage testing)
Key exclusion criteria1. Women unable to provide informed consent
2. Women whose command of English is not sufficient to obtain informed consent.
Date of first enrolment20/08/2017
Date of final enrolment31/01/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

XX Place Health Centre
Alderney Building
Mile End Hospital Site
Bancroft Road
London
E1 4DG
United Kingdom
Albion Health Centre
333 Whitechapel Rd
Shadwell
London
E1 1BU
United Kingdom
Blithehale Medical Centre
22 Dunbridge St
London
E2 6JA
United Kingdom
Whipps Cross Hospital
Whipps Cross Rd
Leytonstone
London
E11 1NR
United Kingdom
Royal London Hospital
Whitechapel Rd
Whitechapel
London
E1 1FR
United Kingdom
Newham Hospital
Glen Rd
London
E13 8S
United Kingdom
St Stephen's Health Centre
Bow Community Hall
William Pl
Bow
London
E3 5ED
United Kingdom
Queens Road Medical Centre
48 Queens Rd
Walthamstow
London
E17 8PX
United Kingdom
Chrisp Street Health Centre
100 Chrisp St
Poplar
London
E14 6PG
United Kingdom
Well Street Surgery
28 Shore Rd
Hackney
London
E9 7TA
United Kingdom
Somerford Grove Practice
Somerford Grove
Hackney Downs
London
N16 7UA
United Kingdom
Sorsby Health Centre
3 Mandeville St
Lower Clapton
London
E5 0DH
United Kingdom
Lower Clapton Health Centre
36 Lower Clapton Rd
Clapton
London
E5 0PQ
United Kingdom
Jubilee Street Practice
368-374 Commercial Rd
London
E1 0LS
United Kingdom

Sponsor information

King's College London
University/education

Faculty of Life Sciences & Medicine
London
SE1 9RT
England
United Kingdom

Phone +44 (0)2078485494
Email reza.razavi@kcl.ac.uk
Website http://www.kcl.ac.uk/index.aspx
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date01/12/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 3.0 18/03/2019 15/08/2022 No No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN69709352_PROTOCOL_V3.0_18Mar19.pdf

Editorial Notes

15/08/2022: Protocol file uploaded.
20/07/2020: Trial’s existence confirmed by North East - Tyne & Wear South Research Ethics Committee.