Condition category
Infections and Infestations
Date applied
27/01/2020
Date assigned
17/02/2020
Last edited
17/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hepatitis B (HBV) and C virus (HCV) infections are infections of the liver and, if not diagnosed and treated, result in life-threatening liver scarring (cirrhosis), liver cancer and end-stage liver disease (ESLD). Previously, HBV and HCV infections have been difficult to treat successfully. Advances in the available and emerging therapies mean HCV infection is potentially curable and HBV infection treatable. HBV and HCV infection rates are rising disproportionately in the UK, with ethnic minorities having more HCV-related ESLD. The researchers' experience shows a that large number of first-generation South Asian (SA) patients come for the first time to the Liver Unit with advanced, untreated liver disease. This group typically have not previously engaged with health services. If people were tested and had the infection identified earlier, they could receive more effective treatment.
Through initial research, the researchers realised a lack of engagement by the SA population is due to cultural, language and educational barriers to disease awareness, testing and treatment. As set out by NICE, to prevent further death and disease spread the healthcare system needs to find new ways of informing this 'hard to reach' group.
In an earlier phase of this work, the researchers ran focus groups with the South Asian community to understand their current knowledge, concerns and expectations and used the results to inform the production of an educational video.
In this study, the researchers plan to show this video in community settings to understand whether a larger-scale study is possible and how that larger-scale study should be designed. The larger-scale study would test whether the video is successful in improving uptake of testing for viral hepatitis.

Who can participate?
Adults who speak English, Urdu or Hindi

What does the study involve?
People who agree to participate in this study will be contacted by a member of the research team to arrange a time that suits them to watch the film together with other members of their community. Participants who come to the film screening will fill out a questionnaire including their knowledge, attitudes and behaviours relevant to HBV and HCV infections and testing. They will then watch the video, which takes 10-15 min, and afterwards they fill out another questionnaire. Participants will be offered a blood test for HBV and HCV there and then or at another time. The test involves a finger prick to collect a drop of blood. It takes up to 2 weeks to get the result. There is no obligation to get a blood test.

What are the possible benefits and risks of participating?
The researchers do not foresee any disadvantages or risks associated with taking part in this study. If a participant becomes distressed, they can withdraw from viewing/participating and will be offered immediate support. If someone is tested and has a positive result for HBV or HCV infection, they will be provided with support and will potentially benefit from earlier treatment.

Where is the study run from?
Royal Surrey County Hospital NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
September 2015 to February 2020

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

Who is the main contact?
Dr Claire Kelly, clairekelly4@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Claire Kelly

ORCID ID

http://orcid.org/0000-0002-0029-9597

Contact details

Department of Gastroenterology and Hepatology
Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom
+44 (0)1483 571122
clairekelly4@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 34774, IRAS 224711

Study information

Scientific title

A novel educational intervention to improve the uptake of testing for viral hepatitis in South Asians (SA): A feasibility study

Acronym

Study hypothesis

Hepatitis B (HBV) and C viruses (HCV) are infections of the liver and if not diagnosed and treated result in life threatening liver scarring (cirrhosis), liver cancer and end stage liver disease (ESLD). Previously, HBV & HCV have been difficult to treat successfully. Advances in the available and emerging therapies mean HCV infection is potentially curable and HBV treatable. HBV & HCV rates are rising disproportionately in the UK, with ethnic minorities having more HCV related ESLD. Our experience shows a that large number of first generation South Asian (SA) patients present to our Liver Unit with advanced, untreated liver disease. This group typically have not engaged with health services.
Through pilot work we realised a lack of engagement by the SA population is due to cultural, language and educational barriers to disease awareness, testing and treatment. As set out by NICE, to prevent further death and disease spread we need to find new ways of informing this ‘hard to reach’ group.
In an earlier phase of our work we ran focus groups with the South Asian community to understand current knowledge, concerns and expectations amongst this population and then inform the production of an educational video.
In this current phase of the work we plan to show this video in community settings as a feasibility for a randomized control trial to test whether it is successful in improving uptake of testing for viral hepatitis and to identify methodological issues, recruitment and retention figures.
Those who consent will complete pre-video questionnaires,watch the video and complete post video questionnaires. There will also be the option of dried blood spot testing for hepatitis on the day (or at a later date for those who wish more time to consider). Not all who watch the video are expected to undergo testing.

Ethics approval

Approved 10/07/2017, London-Surrey Research Ethics Committee (Whitefriars, Level 3, Block B, Lewins Mead, Bristol BS1 2NT; NRESCommittee.SECoast-Surrey@nhs.net), ref: 17/LO/0881

Study design

Non-randomised; Interventional; Design type: Screening, Diagnosis, Prevention, Education or Self-Management

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hepatitis B virus (HBV) and hepatitis C virus (HCV) testing

Intervention

We will advertise our study by placing flyers in community centres. We will also work with PPI and stakeholders from earlier phases of the work to identify appropriate venues to show the film. We have calculated we require n=200 and we propose to run sessions showing the video until this target recruitment is met. To allow adequate time to fully discuss and consent the processes, in particular blood testing, we will limit each individual session to a maximum of n=30.

Potential participants will be provided with contact details for the research team (this will include Urdu-speaking members of the team). Initially a discussion on what is involved will take place with potential participants who show interest and a PiS (viewing the film) will be given. This PiS will include contact details for the research team in case further questions arise. The participant will then be able to ask any questions and if still interested a date and venue suitable to the potential participant and research team will be identified. This will be at least 24 hours later to allow time to consider participation.

On the day of the film showing those who attend the event will be given the opportunity to discuss further and thereafter sign the consent form if they are willing to participate. A pre film questionnaire will be filled out with help as needed (e.g. interpreter). The questionnaire will take approximately 15 minutes to complete. Thereafter the participants will watch the film alongside other participants. The video will last 10-15 minutes. At the end of the video we will announce to participants the opportunity for testing now, later or not at all. All participants will be asked to complete the post-intervention questionnaire. At this point we will remind participants they are free to leave and are not obliged to be tested. Blood testing areas will be located elsewhere in the building so that participants can leave without explanation.

On completion of the post-intervention questionnaire, those participants who wish to discuss further will be asked if they wish to be tested. Various options will be given to participants: testing on the day, testing on another occasion and not getting testing. Research team members will be present and participants can ask any questions on blood testing. Given the potential significance of testing the discussion around this is important and we expect will take a minimum of 15 minutes per participant. It will be strongly emphasized that this is not compulsory and it is possible to come back on another day for testing to allow more time for those who are unsure. We feel it is important to offer testing on the day as well as later after discussion with our PPI and stakeholder groups who both felt a period of time waiting for a test after deciding to test after watching our film may be unduly stressful for some participants.

Those who choose to be tested will be taken to the blood testing area for consenting which will include consent for informing the GP of results. The process will be explained again to them. A finger-prick blood test (dried blood spot) will then be taken and labelled (pseudonymised). The participant will be asked for their preferred contact method to arrange attendance for the results. It will be explained that results will take up to 2 weeks. The participant will be given contact details for the research team after testing so that they have a point of contact if they require more information or support between testing and obtaining the results. They will receive the results in person and will be able to bring a family member if they wish to. For those who test negative that is the end of their involvement. For those who test positive the results and further steps will be explained to the participant.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Proportion of people taking up testing after viewing the film assessed using testing centre records during the 1 month after the film has been shown

Secondary outcome measures

1. Prevalence of viral hepatitis in the South Asian Surrey population assessed by analysing results of our testing population
2. Attitudes, knowledge and behaviours before and after exposure to the film by distributing a pre- and post-film (time 1) questionnaires incorporating 5-point Likert scale scoring

Overall trial start date

07/09/2015

Overall trial end date

29/02/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged over 18 years
2. Able to consent to participation
3. Able to speak English, Urdu or Hindi

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200

Participant exclusion criteria

Does not meet the inclusion criteria

Recruitment start date

01/02/2018

Recruitment end date

30/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Surrey County Hospital
Egerton Road
Guildford
GU27XX
United Kingdom

Sponsor information

Organisation

Royal Surrey County Hospital NHS Foundation Trust

Sponsor details

Department of Research
Development and Innovation
Leggett Building
Daphne Jackson Road
Guildford
GU2 7WG
United Kingdom
+44 (0)1483 686729
sarah.martin33@nhs.net

Sponsor type

Hospital/treatment centre

Website

http://www.royalsurrey.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-1013-32094

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a 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

01/05/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

27/01/2020: Trial's existence confirmed by the National Institute for Health Research (NIHR).