Human Papillomavirus (HPV) testing on self-collected samples to increase uptake of cervical screening in non-attenders
ISRCTN | ISRCTN35286331 |
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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
Plain English summary of protocol
Contact information
Scientific
Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom
0000-0002-4407-7451 | |
Phone | +44 (0)20 7882 5555 |
a.lim@qmul.ac.uk |
Study information
Study design | Non-randomised; Interventional; Design type: Screening |
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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 |
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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
Bethnal Green
London
E2 6JA
London
EC1A 7HF
London
N1 5DR
London
E14 6PG
New Cross
London
SE14 6LD
Deptford
SE8 5DA
Sponsor information
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
https://ror.org/026zzn846 |
Funders
Funder type
Charity
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 | |
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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.