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 |
| Protocol serial number | 15712 |
| Sponsor | Queen Mary University of London (UK) |
| Funder | Cancer Research UK; Grant Codes: C8162/A10406 |
- 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
Contact information
Dr Anita Lim
Scientific
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 |
| a.lim@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised; Interventional; Design type: Screening |
| Secondary study design | Non randomised study |
| 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(s) |
Proportion of women who return a self-collected sample for HPV testing measured at the end of the study |
| Key secondary outcome measure(s) |
1. Proportion of women who are found to have cervical intraepithelial neoplasia; Timepoint(s): End of study |
| Completion date | 15/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 200 |
| 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
Bethnal Green
London
E2 6JA
The Neaman Practice
15 Half Moon Court
London
EC1A 7HF
London
EC1A 7HF
Hoxton Surgery
12 Rushton Street
London
N1 5DR
London
N1 5DR
Chrisp Street Health Centre
100 Chrisp Street
London
E14 6PG
London
E14 6PG
Amersham Vale Training Practice Suite 5 – Waldron Health Centre
Amersham Vale
New Cross
London
SE14 6LD
New Cross
London
SE14 6LD
Kingfisher Medical Centre
Staunton Street
Deptford
SE8 5DA
Deptford
SE8 5DA
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version v2 | 16/10/2013 | 07/07/2017 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
