Condition category
Cancer
Date applied
03/10/2012
Date assigned
04/10/2012
Last edited
19/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this research study is to find out whether women who have already been invited more than once to attend for a cervical smear test, and have not been for one, would be more likely to:
1. respond to another invitation to attend for a cervical smear.
2. respond to the chance to collect their own sample at home which will be tested for HPV (human papillomavirus). HPV is a very common virus which, in some women, can cause abnormal smears and even cancer.
We would also like to find out whether women who have an abnormal test result go on to get themself checked by a doctor or nurse.

Who can participate?
Women who take part will need to live in the Newcastle upon Tyne area and have already been sent at least one invitation and a reminder to attend for a smear test. They will then be sent an invitation with a self-collection test kit (3000 women) or a cervical smear reminder letter (3000 women). Which group each woman will be in is decided completely by chance, for example like tossing a coin.

What does the study involve?
Women who are sent a self-collection kit and would like to take part are asked:
1. to complete a consent form
2. to complete a form with their contact information so that they can receive their results.
3. to read the HPV Test Instruction Sheet enclosed and take their sample.
4. to package and send as explained on the instruction sheet. The postage is pre-paid and does not cost the woman herself any money.
The sample is sent to the Centre for Cancer Prevention where it is tested for HPV. Women will receive their test result in a letter. All women are advised that they should still consider attending for a smear test but especially if the HPV result is abnormal (positive). Women with this result will be asked to go to their GP or a sexual health clinic for a cervical smear. If the HPV test is negative we would still encourage her to attend for a smear test but she can be reassured that your risk of having an abnormality on her cervix is lower. We will also write to the woman's GP letting him or her know that she is taking part in the study and her test result.

What are the possible benefits and risks of participating?
We believe that there are no specific risks from taking the tests; in the studies we have already carried out using this self-test, women told us they did not encounter any particular problems.
Some women find making time to have a cervical smear difficult or the test uncomfortable or embarrassing when taken in a clinic. Those who take part in this study will be able to try using a test at home, without the need for an appointment. It is also hoped that we can collect some useful information which will be published in a professional journal. This would mean that what we learn may benefit women in the future.

Where is the study run from?
The study is being run from the Centre for Cancer Prevention at the Wolfson Institute of Preventive Medicine, Queen Mary University of London.

When is the study starting and how long is it expected to run for?
The study will start in September 2012 and women invited will be given three months to return their sample. After this the study teams will be looking at whether women have been for smear tests or further checks following on from this. It should all be finished in just over a year.

Who is funding the study?
Cancer Research UK

Who is the main contact?
Dr Anne Szarewski
Louise Cadman
cervix.studies@qmcr.qmul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Louise Cadman

ORCID ID

Contact details

Wolfson Institute of Preventative Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom
-
l.cadman@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13096

Study information

Scientific title

A pragmatic randomised controlled trial of response to an invitation to self-sampling for human papillomavirus (HPV) versus repeat invitation for cervical screening in persistent non-responders in Newcastle upon Tyne

Acronym

SHINE

Study hypothesis

In recent years attendance for cervical screening has been falling with coverage now below the NHS Cervical Screening Programme (NHSCSP) stated target of 80%. Self-sampling means the woman can collect a sample (using a swab, a bit like a long cotton bud) in the comfort and privacy of her own home, without the need for a speculum (which is the instrument used to open the vagina often responsible for the discomfort which may be felt). We have already carried out studies which have shown that women of different educational levels find this self-test easy to do without help, only using a leaflet which we developed with the help of psychologists.

There have been studies in Scandinavian countries and Holland, in which they found that around a third of the non-attenders were willing to send back a self-sample. The only UK study to date of HPV self-sampling in persistent non-responders was carried out in Westminster, London (Szarewski et al, 2011) and showed a low uptake of 6.4%. We are concerned that that study was not representative of the UK, and therefore wish to do a study in a more stable population. Newcastle upon Tyne is a mixed urban / rural location, typical of the UK and results from this socially heterogeneous population are more likely to be representative of the broader UK population.

We will randomly select 6000 non-attenders in the Newcastle upon Tyne region: half will just be sent a further invitation for a smear and the other half will be sent a self-sampling kit, together with information and consent forms to sign. We will then compare how many women send back a self-test or attend for cytology, and also go for further investigations if necessary.

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13096

Ethics approval

Sunderland Research Ethics Committee, First MREC approval date 23/07/2012, ref: 12/NE/0242

Study design

Randomised; Interventional; Design type: Screening

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please contact cervix.studies@qmcr.qmul.ac.uk to request a patient information sheet

Condition

Cervical screening

Intervention

Self-collection: Women who have failed to attend for cervical cytology screening and have reached Point 4 as detailed above (NEPCSA cervical screening invitation schedule) will be posted an invitation letter to take their own HPV self-sample, a Participant Information Leaflet (PIL) and ICF, an HPV self-sampling test instruction sheet and an HPV self-sampling test kit.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Response to the intervention - The proportion of women responding to the intervention.

Secondary outcome measures

1. The proportion of women responding to the intervention by returning the HPV self-sampling test within 3 months
2. The proportion of women responding to the intervention by attending for cervical cytology within 3 months
3. The proportion of women responding to the further invitation to attend for cervical cytology within 3 months
4. The proportion of women attending for a cervical cytology within 3 months having had a positive HPV test
5. The proportion of women attending for colposcopy (within 7 months of being sent their HPV self-sampling kit) having had a positive HPV test and abnormal cervical cytology of borderline or mild dyskaryosis and HPV triage positive or cytology of moderate dyskaryosis or worse.
6. The proportion of women in the comparator group attending for colposcopy within 3 months of abnormal cervical cytology of borderline or mild dyskaryosis and HPV triage positive or cytology of moderate dyskaryosis or worse
7. The proportion of women in the comparator group attending for colposcopy within 3 months of abnormal cervical cytology of borderline or mild dyskaryosis and HPV triage positive or cytology of moderate dyskaryosis or worse compared with the proportion of women attending for colposcopy (within 7 months of being sent their HPV self-sampling kit) having had a positive HPV test and abnormal cervical cytology of borderline or mild dyskaryosis and HPV triage positive or cytology of moderate dyskaryosis or worse

Overall trial start date

10/09/2012

Overall trial end date

10/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Non-responders according to the North East Primary Care Services Agency (NEPCSA) recall process. They will have received their initial screening letter, plus a first reminder letter, plus at least two non-responder cards will have been sent to their General Practitioner, identified using the NEPCSA Exeter National Health Applications and Infrastructure Services (NHAISs) System.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 300; UK Sample Size: 300

Participant exclusion criteria

1. Women who have written to the NEPCSA to document their refusal to take part in the NHSCSP
2. Women who contact the trial team and ask to be excluded from the trial
3. Pregnancy
4. Total abdominal hysterectomy
5. Never been sexually active
6. Women who are identified as becoming pregnant or undergoing hysterectomy following the initial test will be excluded from the analysis of data for secondary outcomes
7. HPV self-sample returned without a signed Informed Consent Form (ICF) (the Participant Information Leaflet (PIL) will state that samples returned without a signed consent form cannot be processed)
8. Informed Consent Form (ICF) returned with incomplete contact details whereby the test results cannot be sent

Recruitment start date

10/09/2012

Recruitment end date

10/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Institute of Preventative Medicine
London
EC1M 6BQ
United Kingdom

Sponsor information

Organisation

Queen Mary University of London (UK)

Sponsor details

Joint R&D Office
5 Walden Street
London
E1 2EF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25403717

Publication citations

Additional files

Editorial Notes