Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Anita Lim
ORCID ID
http://orcid.org/0000-0002-4407-7451
Contact details
Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom
+44 (0)20 7882 5555
a.lim@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15712
Study information
Scientific title
Human Papillomavirus (HPV) testing on self-collected samples to increase uptake of cervical screening in non-attenders: a pilot study
Acronym
Study hypothesis
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
South East Coast – Brighton & Sussex Research Ethics Committee, 24/10/2013, ref: 13/LO/1441
Study design
Non-randomised; Interventional; Design type: Screening
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
GP practices
Trial type
Screening
Patient information sheet
See additional files
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
23/11/2012
Overall trial end date
15/04/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
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.
Participant 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
Recruitment start date
22/12/2013
Recruitment end date
05/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Blithehale Health Centre
22 Dunbridge Street
Bethnal Green
London
E2 6JA
Trial participating centre
The Neaman Practice
15 Half Moon Court
London
EC1A 7HF
Trial participating centre
Hoxton Surgery
12 Rushton Street
London
N1 5DR
Trial participating centre
Chrisp Street Health Centre
100 Chrisp Street
London
E14 6PG
Trial participating centre
Amersham Vale Training Practice Suite 5 – Waldron Health Centre
Amersham Vale
New Cross
London
SE14 6LD
Trial participating centre
Kingfisher Medical Centre
Staunton Street
Deptford
SE8 5DA
Funders
Funder type
Charity
Funder name
Cancer Research UK; Grant Codes: C8162/A10406
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
IPD sharing statement
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).
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/27235844
Publication citations
Additional files
- ISRCTN35286331_PIS_v2_16Oct13.pdf Uploaded 07/07/2017