Condition category
Infections and Infestations
Date applied
20/07/2020
Date assigned
04/08/2020
Last edited
04/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Jane Rigney

ORCID ID

Contact details

Kings College London
Faculty of Life Sciences & Medicine
London
SE1 9RT
United Kingdom
+44 (0)2078485494
jane.rigney@kcl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 228847

Study information

Scientific title

A cross-sectional study to assess the test performance and acceptability of non-speculum HPV testing in older women

Acronym

SHOW

Study hypothesis

The 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

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

Study design

Multi centre observational cross sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

GP practices

Trial type

Screening

Patient information sheet

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

Condition

Human papillomavirus (HPV)

Intervention

Eligible 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 type

Other

Phase

Drug names

Primary outcome measure

Measured 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 measures

There are no secondary outcome measures

Overall trial start date

03/04/2017

Overall trial end date

31/01/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 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)

Participant type

Mixed

Age group

Adult

Gender

Female

Target number of participants

250

Total final enrolment

298

Participant exclusion criteria

1. Women unable to provide informed consent
2. Women whose command of English is not sufficient to obtain informed consent.

Recruitment start date

20/08/2017

Recruitment end date

31/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

XX Place Health Centre
Alderney Building Mile End Hospital Site Bancroft Road
London
E1 4DG
United Kingdom

Trial participating centre

Albion Health Centre
333 Whitechapel Rd Shadwell
London
E1 1BU
United Kingdom

Trial participating centre

Blithehale Medical Centre
22 Dunbridge St
London
E2 6JA
United Kingdom

Trial participating centre

Whipps Cross Hospital
Whipps Cross Rd Leytonstone
London
E11 1NR
United Kingdom

Trial participating centre

Royal London Hospital
Whitechapel Rd Whitechapel
London
E1 1FR
United Kingdom

Trial participating centre

Newham Hospital
Glen Rd
London
E13 8S
United Kingdom

Trial participating centre

St Stephen's Health Centre
Bow Community Hall William Pl Bow
London
E3 5ED
United Kingdom

Trial participating centre

Queens Road Medical Centre
48 Queens Rd Walthamstow
London
E17 8PX
United Kingdom

Trial participating centre

Chrisp Street Health Centre
100 Chrisp St Poplar
London
E14 6PG
United Kingdom

Trial participating centre

Well Street Surgery
28 Shore Rd Hackney
London
E9 7TA
United Kingdom

Trial participating centre

Somerford Grove Practice
Somerford Grove Hackney Downs
London
N16 7UA
United Kingdom

Trial participating centre

Sorsby Health Centre
3 Mandeville St Lower Clapton
London
E5 0DH
United Kingdom

Trial participating centre

Lower Clapton Health Centre
36 Lower Clapton Rd Clapton
London
E5 0PQ
United Kingdom

Trial participating centre

Jubilee Street Practice
368-374 Commercial Rd
London
E1 0LS
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Faculty of Life Sciences & Medicine
London
SE1 9RT
United Kingdom
+44 (0)2078485494
reza.razavi@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/index.aspx

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

01/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/07/2020: Trial’s existence confirmed by North East - Tyne & Wear South Research Ethics Committee.