Condition category
Cancer
Date applied
19/06/2018
Date assigned
25/07/2018
Last edited
22/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

31/03/2020

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

28/02/2020

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

31/03/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.