Condition category
Cancer
Date applied
07/05/2019
Date assigned
03/06/2019
Last edited
03/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Human papillomavirus (HPV) is a common sexually transmitted infection which causes nearly all cervical cancers. There are around 3,000 new cases of cervical cancer every year in the UK. The NHS Cervical Screening Programme (NHSCSP) aims to prevent cervical cancer by looking for abnormal cells in the cervix and removing them before they turn into cancer. The NHSCSP will soon test all cervical screening samples for HPV before deciding whether to look for abnormal cell changes. This is called HPV primary testing and it will be rolled out across England from 2019. This means that all women attending cervical screening will learn their HPV test results through letters delivered to their home. The results letters will tell women whether they are HPV positive or HPV negative, as well as whether they have any abnormal cell changes. It is very important that psychological research helps decide what NHSCSP results letters and information leaflets say. It is known that knowledge about HPV and its connection to cervical cancer is poor among women in the UK, and that some women can get upset, confused and/or experience stigma after testing positive for HPV, partly because of it being sexually transmitted. Therefore, the wording and information in NHSCSP letters needs to make sense and be clear so that women correctly understand their risk of getting cervical cancer. It is also very important that women are not worried about their results if they do not need to be. In HPV primary testing, one group of women who might especially struggle to understand their screening results is those who test positive for HPV but have no abnormal cell changes. This is because they will find out they have HPV, but they will not get invited to screening again for another 12 months and will not get any treatment. This is because although HPV puts them at higher risk of getting cervical cancer, without any abnormal cell changes it is very unlikely that they will get cervical cancer within 12 months. It is likely that their immune system will get rid of HPV in this time. However, this can be complicated for women to understand and difficult for the NHSCSP to know how to communicate in letters. The researchers think that some women in this group may not understand these test results. It is important that these women are not too worried or upset about their test results, and they come back to cervical screening again in 12 months. The aim of this study is to identify psychological predictors of anxiety and attendance in women testing HPV positive with no abnormal cell changes, with a sub-study built in to test whether the application of behavioural science in cover letters influences response rate. An interview study also assesses anxiety and beliefs in women testing HPV positive with normal cytology.

Who can participate?
Women aged 24-65 who have tested positive for HPV with normal cytology within the last 2 weeks at NHSCSP HPV primary screening

What does the study involve?
Anxiety and beliefs about HPV are assessed in women testing positive for HPV with normal cytology within 2 weeks of receiving their test result.
Participants are randomly allocated to receive either a standard invite to participation cover letter or a cover letter that uses behavioural science techniques (wording, format, layout etc), to see whether this influences the response rate.
Participants fill in a questionnaire and send it back to UCL using a pre-paid envelope provided. They can also indicate whether they would like to be considered for a confidential 1:1 interview 2-8 weeks later. If they select “yes, I would like to be considered” in their questionnaire, and they are chosen to take part, the interview lasts for around 1-1.5 hours and is audio-recorded. Participants are asked about their views on their test result and cervical screening, and their opinion on information to include in NHS test results letters.

What are the possible benefits and risks of participating?
There are no guaranteed benefits from taking part in this study. However, participation will contribute to important research and may help to improve the quality of NHS services for other women in the future. Participants may also find taking part in this research enjoyable and interesting.

Where is the study run from?
1. NHS London North West Trust (UK)
2. NHS Manchester University Trust (UK)

When is the study starting and how long is it expected to run for?
October 2017 to December 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Emily McBride
e.mcbride@ucl.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Emily McBride

ORCID ID

Contact details

1-19 Torrington Place
Department of Behavioural Science and Health
University College London (UCL)
London
N7 9FU
United Kingdom
+44 (0)207 679 1940
e.mcbride@ucl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

DRF-2017-10-105; 39303

Study information

Scientific title

HPV primary testing in cervical cancer screening: using behavioural science to understand anxiety and attendance

Acronym

Study hypothesis

What are the strongest predictors of anxiety in women testing positive for HPV with normal cytology?

Ethics approval

Approved 24/08/2018, East Midlands - Leicester South Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, Tel: +44 (0)207 104 8107; Email: nrescommittee.eastmidlands-leicestersouth@nhs.net), Research Ethics Committee ref: 18/EM/0227, Confidentiality Advisory Group ref: 18/CAG/0118

Study design

Observational cross-sectional, with embedded RCT (study within a trial; SWAT) and a separate qualitative study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Cervical cancer screening

Intervention

The primary observational component is assessing anxiety and beliefs about HPV in women testing positive for HPV with normal cytology within 2 weeks of receiving their test result. It is a cross-sectional study (one timepoint).

The interventional component is testing whether the use of behavioural science techniques (wording, format, layout etc) within invite to participation cover letters vs standard invite to participation cover letters influences recruitment response rate. Approached patients are randomised to receive the control or intervention invite letter to take part in the study. This is also cross-sectional (one timepoint).

Participants fill in a questionnaire and send it back to UCL using a pre-paid envelope provided. They can also indicate whether they would like to be considered for a confidential 1:1 interview 2-8 weeks later. If they select “yes, I would like to be considered” in their questionnaire, and they are chosen to take part, the interview will last for around 1-1.5 hours and will be audio-recorded. Participants will be asked about their views on their test result and cervical screening, and their opinion on information to include in NHS test results letters.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

For the observational component:
State anxiety and anxiety specific to cervical screening, measured using the State Trait Anxiety Inventory (S-STAI-6) and Cervical Screening Questionnaire (CSQ), respectively

For the interventional component:
Participation response rate

All outcomes measured at one timepoint only

Secondary outcome measures

1. Illness beliefs measured using B-IPQ
2. Symptom perception measured using adapted IPQ-R
3. Coping style measured using adapted Brief COPE
4. Concerns about HPV, disclosure of results, intention to re-attend screening, barriers to screening re-attendance, all measured using questions developed for the study
5. Prospective 12-month screening attendance, measured using clinical records
6. Demographics including: ethnicity, marital status, and highest level of education (all self-report)
7. Age, index of multiple deprivation score, number of previous cervical screens, and NHS site, collected via clinical records
8. Self-reported history of anxiety or depression

All outcomes with the exception of prospective 12-month cervical screening attendance measured at one timepoint only

Overall trial start date

01/10/2017

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Women aged 24-65 who have tested positive for HPV with normal cytology within the last 2 weeks at NHSCSP HPV primary screening

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

300

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

07/05/2019

Recruitment end date

01/05/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS London North West Trust
Pathology Department
London
HA1 3UJ
United Kingdom

Trial participating centre

NHS Manchester University Trust
Cytology Centre
Manchester
M13 9WL
United Kingdom

Sponsor information

Organisation

University College London (UCL)

Sponsor details

Joint Research Office
Gower Street
London
WC1E 6BT
United Kingdom
+44 (0)203 447 2198
uclh.randd@nhs.net

Sponsor type

University/education

Website

www.ucl.ac.uk/jro

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Research findings will be disseminated via internal report, presented at scientific conferences and published in peer-reviewed journals.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Emily McBride (e.mcbride@ucl.ac.uk). Only quantitative data will become available and will be anonymised, it will become available after the work has been published.

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes