A London HPV self-sampling pilot
| ISRCTN | ISRCTN23940319 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23940319 |
| IRAS number | 205691 |
| Secondary identifying numbers | CPMS 36156 |
- Submission date
- 19/06/2018
- Registration date
- 25/07/2018
- Last edited
- 04/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Underscreened women are at the highest risk of developing cervical cancer, yet the number of women attending cervical screening continues to fall. A potential solution is to offer self-sampling for human papillomavirus (HPV) testing. Self-sampling addresses many of the barriers to conventional screening (cervical cytology): women can take their own sample, in private and at a time and place of their choosing. Self-sampling is slightly less accurate than HPV testing on clinician-taken samples, so would not be suitable as a primary screening test. UK studies have already shown that HPV self-sampling can increase screening uptake in non-attenders but the best approach for offering self-sampling kits (SSK) is unclear. London has consistently has the lowest cervical screening uptake nationally, making it an ideal population to assess the potential for self-sampling and provide evidence for its use in England. The aim of this study is to establish the best design for a large study of self-sampling.
Who can participate?
Women aged 25-64 who are eligible for cervical screening and are at least 6 months overdue (i.e. no cervical screening recorded in the GP records in the past 3.5 years if aged 25-49 or 5.5 years if aged 50-64)
What does the study involve?
Participating GP practices are randomly allocated to either offer self-sampling opportunistically when eligible women consult for any reason, or to provide usual care. In both groups women who have never been screened or are overdue are randomly allocated either to usual care, to receive a letter inviting them to order a self-sampling kit, or to receive a self-sampling kit in the post. Uptake of self-sampling is assessed for each approach. Cervical screening data for all eligible women is collected from GP records for 12 months after recruitment ends to assess changes in screening coverage.
What are the possible benefits and risks of participating?
Some women find it difficult to make an appointment for cervical screening because they are busy or because their GP practice is busy. Some women may find it uncomfortable or embarrassing to have a test taken by a doctor or nurse. Participants will be able to take a test for cervical screening themselves without having to be examined or to make an appointment. In other studies, some women who had not been for routine cervical screening and took a self-test were found to have abnormal cervical cells and were successfully treated. Women who have taken self-tests in previous studies have not reported any particular problems. Feedback from women is that they found the test easy and convenient to do.
Where is the study run from?
1. Thornbury Road Centre for Health (UK)
2. Albany Practice (UK)
3. Argyle Health - Isleworth Practice (UK)
4. The Practice Heart Of Hounslow (UK)
5. Chiswick Health Centre (UK)
6. Grove Park Surgery (UK)
7. Grove Park Terrace Surgery (UK)
8. Wellesley Road Practice (UK)
9. The Medical Centre - Twickenham Park Medical Surgery (UK)
10. Gill Medical Practice (UK)
11. Crosslands Surgery (UK)
12. Firstcare Practice (UK)
13. Hounslow Family Practice (UK)
When is the study starting and how long is it expected to run for?
November 2017 to November 2021
Who is funding the study?
Cancer Research UK
Who is the main contact?
Dr Anita Lim
anita.lim@kcl.ac.uk
Contact information
Scientific
Rm GH0603334
Research Oncology
3rd Floor
Bermondsey Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
 ORCID ID |
0000-0002-4407-7451 |
|---|---|
| Phone | +44 (0)2078485494 |
| anita.lim@kcl.ac.uk |
Study information
| Study design | Randomised; Both; Design type: Screening, Other, Cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Self-sampling for HPV testing in cervical screening nonattenders in London |
| Study acronym | ALOHA |
| Study objectives | Underscreened women are at the highest risk of developing cervical cancer, yet the number of women attending cervical screening continues to fall. A potential solution is to offer self-sampling for HPV (human papillomavirus) testing. Self-sampling addresses many of the barriers to conventional screening (cervical cytology): women can take their own sample, in private and at a time and place of their choosing. Self-sampling is slightly less accurate than HPV testing on clinician-taken samples, so would not be suitable as a primary screening test. UK studies have already shown that HPV self-sampling can increase screening uptake in non-attenders but the optimal approach for offering self-sampling kits (SSK) is unclear. London has consistently has the lowest cervical screening uptake nationally making it an ideal population to assess the potential for self-sampling and provide the evidence-base for its implementation in England. This will be a randomised-controlled pilot to establish the optimal study design for a large implementation trial of self-sampling. |
| Ethics approval(s) | London – Brighton & Sussex Research Ethics Committee, 27/11/2017, ref: 17/LO/1655 |
| Health condition(s) or problem(s) studied | Cervical cancer |
| Intervention | This will be a randomised controlled pilot study at ~12 GP practices in London within the Hounslow Clinical Commissioning Group (CCG). Each GP practice will recruit over a period of 12 months and will be randomised 1:1 to: 1. An intervention arm - offering self-sampling kits (SSK) opportunistically to women who are overdue cervical screening by at least 6 months, when they consult for any reason, or 2. A control arm – usual care Within both arms, women will also be individually randomised. Women who have not been screened (by cytology or self-sampling) ever or by the 15 month or 27 month anniversary of the date their last test was due will be randomised 2:1:1 to: Group A – usual care (control) Group B – Receiving a letter inviting them to order a SSK Group C – Receiving a SSK in the post STUDY PROCEDURES 1. Opportunistic offering of self-sampling Eligible women will be automatically flagged during consultation using the electronic patient record software. GPs, nurses and healthcare practitioners will: -confirm eligibility -briefly explain the study -provide a SSK to those willing to take part -document which women are offered, accept and decline SSK in the electronic patient records Women will collect their self-sample in the GP surgery bathroom or at home. Samples will be sent to a commercial laboratory (The Doctor's Laboratory (TDL)) for analysis. Women who take their sample at the GP practice will hand it to a member of staff who will send it to the lab via the post (daily) using postage paid envelopes. Samples taken by women at home will be posted to the lab (postage paid envelope). 2. Women who have never been screened or reach the 15 or 27 month anniversary of their last test due date Women will be identified using the GP electronic patient records and randomised by the GP practice. Women randomised to Group B or C will receive and return SSKs in the post. Women randomised to receive a letter inviting them to order a SSK will have several options for ordering kits: online, via post and possibly text message. HPV TEST RESULTS REPORTING HPV test results from kits sent to or ordered by women will be sent by the lab to the women and copied to their GP. CLINICAL MANAGEMENT Women who test HPV negative will not be required to do anything further for the study. Women who test HPV positive will be advised to have a routine clinician-taken cervical screening test at their GP practice. They will be managed according to their cytology results under the NHS cervical screening programme. DATA COLLECTION We will collect details of the participant’s cervical screening results from their GP medical records. We will also collect anonymous aggregate data on cervical screening for all eligible women (including those who do not return a self-sample) from the national screening database in order to calculate coverage. RESIDUAL SAMPLES Residual samples will be anonymised by the laboratory and sent to researchers at Queen Mary University for possible future analysis. |
| Intervention type | Other |
| Primary outcome measure | This is a pilot study therefore there is no formal primary outcome measure. The study will calculate measures of feasibility and acceptability such as the proportion of eligible women who are offered kits, accept and return a self-sample following each intervention (i.e. (i) opportunistic offer of self-sampling kits, (ii) women invited to order a self-sampling kit, and (iii) women sent self sampling kit) at 6 months and 12 months after the invitation/offer of self sampling |
| Secondary outcome measures | 1. The proportion of eligible women who test HPV positive and a) attend for follow up (cytology or colposcopy) within 6 months of testing HPV positive on a SS and b) who are treated for CIN2+ 2. “Coverage” of cervical screening following different interventions – when additionally counting an HPV negative test on self-sample as “screened” 3. Use of website in the intervention arm (women invited to order a kit) |
| Overall study start date | 27/11/2017 |
| Completion date | 24/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 8420 |
| Total final enrolment | 12657 |
| Key inclusion criteria | 1. Women aged 25-64 years 2. Eligible for cervical screening 3. At least 6 months overdue (i.e. no cervical screening recorded in the GP records in the past 3.5 years if aged 25-49 or 5.5 years if aged 50-64) |
| Key exclusion criteria | Women unable to provide informed consent |
| Date of first enrolment | 09/04/2019 |
| Date of final enrolment | 31/03/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Isleworth
TW7 4HQ
United Kingdom
Brentford Health Centre
Brentford
TW8 8DS
United Kingdom
Isleworth
TW7 7DJ
United Kingdom
Hounslow
TW3 3LN
United Kingdom
London
W4 1RX
United Kingdom
Chiswick
London
W4 3ET
United Kingdom
Chiswick
W4 3JL
United Kingdom
Chiswick
London
W4 4BJ
United Kingdom
Twickenham
Feltham
TW13 6HD
United Kingdom
Feltham
TW14 0AB
United Kingdom
Southall
UB2 5QY
United Kingdom
Prince Regent Road
Hounslow
TW3 1NL
United Kingdom
Hounslow
TW3 4JX
United Kingdom
Sponsor information
University/education
Joint R&D Office
5 Walden Street
London
E1 2EF
England
United Kingdom
| Phone | +44 (0)20 7882 7260 |
|---|---|
| sponsorsrep@bartshealth.nhs.uk | |
"ROR" |
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 | 31/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 9.0 | 12/10/2021 | 15/08/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
04/12/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 16/05/2017 to 09/04/2019.
2. The recruitment end date was changed from 26/03/2020 to 31/03/2020.
3. The overall end date was changed from 31/01/2021 to 24/11/2021.
4. The target number of participants was changed from Planned Sample Size: 3196; UK Sample Size: 3196 to 8420.
5. The total final enrolment was added.
6. The overall start date was changed from 01/05/2017 to 27/11/2017.
12/12/2023: The following changes were made to the trial record:
1. The IRAS number was added.
2. The intention to publish date was changed from 31/12/2022 to 31/03/2024.
15/08/2022: Protocol file uploaded.
11/02/2022: The intention to publish date has been changed from 31/01/2022 to 31/12/2022.
06/04/2021: The following changes have been made:
1. The overall trial end date has been changed from 01/04/2021 to 31/01/2021.
2. The intention to publish date has been changed from 30/04/2021 to 31/01/2022.
17/04/2020: The following changes have been made:
1. The recruitment end date has been changed from 28/02/2020 to 26/03/2020.
2. The overall trial end date has been changed from 31/03/2020 to 01/04/2021.
3. The intention to publish date has been changed from 31/03/2021 to 30/04/2021.
22/03/2019: The condition was updated from "Specialty: Primary Care, Primary sub-specialty: Public Health; UKCRC code/ Disease: Cancer and neoplasms/ Malignant neoplasms of female genital organs" to "Cervical cancer".
11/12/2018: The recruitment end date has been updated from 30/09/2019 to 28/02/2020.
