Plain English Summary
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?
May 2017 to March 2020
Who is funding the study?
Cancer Research UK
Who is the main contact?
Dr Anita Lim
anita.lim@kcl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Anita Lim
ORCID ID
http://orcid.org/0000-0002-4407-7451
Contact details
Rm GH0603334
Research Oncology
3rd Floor
Bermondsey Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
+44 (0)2078485494
anita.lim@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
36156
Study information
Scientific title
Self-sampling for HPV testing in cervical screening nonattenders in London
Acronym
ALOHA
Study hypothesis
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
London – Brighton & Sussex Research Ethics Committee, 27/11/2017, ref: 17/LO/1655
Study design
Randomised; Both; Design type: Screening, Other, Cohort study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/05/2017
Overall trial end date
01/04/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 3196; UK Sample Size: 3196
Participant exclusion criteria
Women unable to provide informed consent
Recruitment start date
16/05/2017
Recruitment end date
26/03/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Thornbury Road Centre for Health
Thornbury Road
Isleworth
TW7 4HQ
United Kingdom
Trial participating centre
Albany Practice
Boston Manor Road
Brentford Health Centre
Brentford
TW8 8DS
United Kingdom
Trial participating centre
Argyle Health - Isleworth Practice
146 Twickenham Road
Isleworth
TW7 7DJ
United Kingdom
Trial participating centre
The Practice Heart Of Hounslow
92 Bath Road
Hounslow
TW3 3LN
United Kingdom
Trial participating centre
Chiswick Health Centre
Fisher's Lane
London
W4 1RX
United Kingdom
Trial participating centre
Grove Park Surgery
95 Burlington Lane
Chiswick
London
W4 3ET
United Kingdom
Trial participating centre
Grove Park Terrace Surgery
25 Grove Park Terrace
Chiswick
W4 3JL
United Kingdom
Trial participating centre
Wellesley Road Practice
7 Wellesley Road
Chiswick
London
W4 4BJ
United Kingdom
Trial participating centre
The Medical Centre - Twickenham Park Medical Surgery
192 Twickenham Road
Twickenham
Feltham
TW13 6HD
United Kingdom
Trial participating centre
Gill Medical Practice
32 Harlington Road East
Feltham
TW14 0AB
United Kingdom
Trial participating centre
Crosslands Surgery
1 Crosslands Avenue
Southall
UB2 5QY
United Kingdom
Trial participating centre
Firstcare Practice
Blenheim Centre
Prince Regent Road
Hounslow
TW3 1NL
United Kingdom
Trial participating centre
Hounslow Family Practice
77 Lampton Road
Hounslow
TW3 4JX
United Kingdom
Sponsor information
Organisation
Queen Mary University of London
Sponsor details
Joint R&D Office
5 Walden Street
London
E1 2EF
United Kingdom
+44 (0)20 7882 7260
sponsorsrep@bartshealth.nhs.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK; Grant Codes: C8162/A16892
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/04/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list