Human Papillomavirus (HPV) testing on self-collected samples to increase uptake of cervical screening in non-attenders

ISRCTN	ISRCTN35286331
DOI	https://doi.org/10.1186/ISRCTN35286331
Secondary identifying numbers	15712

Submission date: 21/11/2013
Registration date: 21/11/2013
Last edited: 07/07/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-at-hpv-self-testing-for-women-who-have-not-been-for-cervical-screening

Contact information

Dr Anita Lim
Scientific

Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom

ORCID ID	0000-0002-4407-7451
Phone	+44 (0)20 7882 5555
Email	a.lim@qmul.ac.uk

Study information

Study design	Non-randomised; Interventional; Design type: Screening
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	GP practice
Study type	Screening
Participant information sheet	ISRCTN35286331_PIS_v2_16Oct13.pdf
Scientific title	Human Papillomavirus (HPV) testing on self-collected samples to increase uptake of cervical screening in non-attenders: a pilot study
Study objectives	The aim of this study is to assess the feasibility and acceptability of offering vaginal self-sampling for HPV testing in general practice to cervical screening non-attenders to increase coverage.
Ethics approval(s)	South East Coast – Brighton & Sussex Research Ethics Committee, 24/10/2013, ref: 13/LO/1441
Health condition(s) or problem(s) studied	Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
Intervention	Women aged 28-64 who are at least 6 months overdue their smear will be flagged in the EMIS electronic patient record system at GP surgeries. GPs, nurses and healthcare practitioners will be asked to offer flagged women a self-sampling study kit for HPV testing, when they consult for any reason. Women will take their sample in the GP surgery bathrooms or at home. Samples will be analysed by Barts Health NHS Trust pathology lab. Results will be sent to the women via post. Women who test HPV negative will be exited from the study. Women who test HPV positive will be asked to attend their GP surgery for a smear. Women who attend for a smear will be managed according to their cytology (as usual) on the NHS Cervical Screening Programme. Women who test HPV positive and have not attended for a smear by the end of the study will be invited for a study colposcopy at Whipp's Cross Hospital.
Intervention type	Other
Primary outcome measure	Proportion of women who return a self-collected sample for HPV testing measured at the end of the study
Secondary outcome measures	1. Proportion of women who are found to have cervical intraepithelial neoplasia; Timepoint(s): End of study 2. Proportion of women who are found to test HPV positive; Timepoint(s): End of study
Overall study start date	23/11/2012
Completion date	15/04/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned Sample Size: 200; UK Sample Size: 200; We have estimated that with 5 GP surgeries, the sample size will be anywhere between 45 and 337. 200 women is our rough estimate.
Key inclusion criteria	Women aged 28-64 years who are eligible for cervical screening and are at least 6 months overdue (i.e. no cervical cytology recorded in the GP records in the past 3.5 years if aged 28-49 or 5.5 years if aged women 50-64)
Key exclusion criteria	1. Women unable to provide informed consent (e.g. because of learning difficulties) 2. Women whose command of English is not sufficient to obtain informed consent 3. Women in whom cervical screening is inappropriate, for example because they are pregnant or terminally ill
Date of first enrolment	22/12/2013
Date of final enrolment	05/12/2014

Locations

Countries of recruitment

United Kingdom

Study participating centres

The Blithehale Health Centre

22 Dunbridge Street
Bethnal Green
London
E2 6JA

The Neaman Practice

15 Half Moon Court
London
EC1A 7HF

Hoxton Surgery

12 Rushton Street
London
N1 5DR

Chrisp Street Health Centre

100 Chrisp Street
London
E14 6PG

Amersham Vale Training Practice Suite 5 – Waldron Health Centre

Amersham Vale
New Cross
London
SE14 6LD

Kingfisher Medical Centre

Staunton Street
Deptford
SE8 5DA

Sponsor information

Queen Mary University of London (UK)
University/education

R&D Office, Queen Mary University of London
Barts & London School of Medicine The QMI building
5 Walden Street
London
E1 2EF
England
United Kingdom

"ROR"	https://ror.org/026zzn846

Funders

Funder type

Charity

Cancer Research UK; Grant Codes: C8162/A10406
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 date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Anita Lim (a.lim@qmul.ac.uk).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2017		Yes	No
Participant information sheet	version v2	16/10/2013	07/07/2017	No	Yes
HRA research summary			28/06/2023	No	No

Additional files

ISRCTN35286331_PIS_v2_16Oct13.pdf: Uploaded 07/07/2017

Editorial Notes

07/07/2017: The following changes were made to the trial record:
1. Publication reference added.
2. The overall trial start date was changed from 06/01/2014 to 23/11/2012.
3. The overall trial end date was changed from 06/06/2014 to 15/04/2015.
4. Participant information sheet uploaded.
5. Trial participating centres added.
6. Recruitment dates added.
7. IPD sharing statement added.