Plain English Summary
Background and study aims
Hepatitis is the term used to describe inflammation of the liver, which can result from either a viral infection or exposure to a harmful substance (for example, alcohol). Chronic viral hepatitis is common in people born outside the UK and involves long-term infection with either the hepatitis B or C virus. The disease may not cause any symptoms but can, in time, lead to cirrhosis (scarring of the liver) or potentially hepatocellular carcinoma (a form of liver cancer) as well as death in a large proportion of those who are infected. Approximately 0.5% of the UK population is known to have viral hepatitis. However, it is believed that about 5% of first and second generation immigrants from at risk countries are affected. Current data relating to immigrant populations within the UK is limited. However, it is thought that 7 million first and second generation immigrants from countries where there is a high number of people with a hepatitis infection currently live in the UK. The UK has one of the lowest rates of therapy for viral hepatitis in Europe and this is undoubtedly contributing to the observed rising death rates from liver disease. This is in contrast to the rest of Europe, where mortality from liver disease is decreasing. This study looks at how to effectively identify and screen immigrants from ‘at risk’ ethnic minority communities as well as assessing the impact of primary care on engagement of targeted newly diagnosed chronic viral hepatitis patients.
Who can participate?
Adults aged at least 18 who are first generation immigrants born in a country at risk of viral hepatitis or second generation immigrants (as outlined by WHO classification of HBV prevalence >2%)
What does the study involve?
GP practices known be in an area where there are a high number of immigrant populations from ‘at risk’ countries are recruited. They are randomly allocated into one of three groups. Those in group 1 are control practices. Those in group 2 are in intervention group 1. Those in group 3 are in intervention group 2. In the GP practices in the interventional groups , existing GP registers of patients are screened to identify possible patients by recorded ethnicity, country of birth or their parents country of birth and first language spoken. Selected participants identified as first or second generation immigrants without HBV or HCV status, are then even contacted or approached to take part within the study. Patients are contacted either by letter, text message or when visiting the GP. Interventional practices are further randomised with half of the participants being sent a ‘standard’ invitation’ letter and the other half a 'augmented' invitation letter. All those screened and tested positive for viral hepatitis are offered treatment in the specialist out patients clinic in their local hospital or in an intervention practice as part of community care. They are also monitored for their level of engagement as well as treatment compliance. Up to approximately 48,000 patients will be approached within the next 12-18 months. In the control group, existing GP registers of patients are screened to identify potential patients by their country of birth or their parents country of birth. A local hepatologist or a trained member of the study team also visit the GP practices, highlighting the study to the GPs and their teams and educating them about hepatitis B and C. These practices continue with their standard care policy relating to screening over the 12-18 months.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Queen Mary University of London (UK)
When is the study starting and how long is it expected to run for?
February 2014 to June 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Stuart Flanagan
Trial website
Contact information
Type
Public
Primary contact
Dr Stuart Flanagan
ORCID ID
Contact details
Queen Mary University of London
Hepatology Unit
Blizard Institute
4 Newark Street
London
E1 2AT
United Kingdom
Type
Scientific
Additional contact
Prof Graham Foster
ORCID ID
Contact details
Barts and The London
School of Medicine & Dentistry
Queen Mary
University of London
4 Newark Street
London
E1 2AT
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14034
Study information
Scientific title
Chronic viral hepatitis in ethnic minorities: A controlled randomised cross sectional cluster trial to assess the impact of identifying, screening and treating immigrants with viral hepatitis
Acronym
HepFree
Study hypothesis
1. To assess the most cost effective method of screening for chronic viral hepatitis in primary care patients within at risk ethnic minority communities
2. To assess the impact of the interventional approach based strategy
3. To establish whether the involvement of community therapy is likely to have an impact on a patients engagement after having been positively tested for viral hepatitis
4. To assess differences in treatment compliance between patients groups receiving treatment within the community against those who have standard hospital care
Ethics approval
NRES Committee London-Fulham, 24/12/2012, ref: 12/LO/1768
Study design
A controlled randomised cross sectional cluster trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Hepatology
Intervention
The study will involve approaching/contacting approximately 48,000 males or females, first/second generation immigrants over the age of 18 from their GP practice to be screened for Hepatitis B and C. Any participants that test positive for either Hepatitis B and/or C will either be referred as per standard care to their local hospital outpatients department or receive care within the community by the local specialist hepatology team at local 'interventional' practices.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
1. The proportion of patients eligible to be screened (determined by a review of the number of immigrants registered at the GP practice at the initiation of the study)
2. The proportion of potential patients that attend for testing
3. The proportion of potential patients that engage in therapy (defined as attending on at least 3 different occasions) in the different treatment arms
Secondary outcome measures
Compliance will be measured upon 80% completion of prescribed therapy, as confirmed at 12 month follow
Overall trial start date
06/02/2014
Overall trial end date
30/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients of either gender who have been identified as first generation immigrants born in a country of high risk or second generation immigrants (as outlined by WHO classification of HBV prevalence >2%)
2. At least 18 years of age
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 19200; UK Sample Size: 19200; Description: It is assumed that there are 500 potential (ie high risk due to country of birth/ethnicity) patients per practice, on average. We have assumed an intra cluster correlation co-efficient of 0.05 for all outcomes and a coefficient of variation of cluster size of 0.65. The sample size is driven by comparison due to smaller number of practices and patients. We assume that 40% of invited patients will be screened and 3% will test positive, giving approx 6 patients per practice, on average.
Participant exclusion criteria
Participants that are lacking capacity
Recruitment start date
06/02/2014
Recruitment end date
31/03/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Mary University of London
Wolfson Institute of Preventative Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom
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
Planned publication in a high-impact peer reviewed journal.
IPD sharing plan:
The datasets generated and/or analysed during the current study will be included in the subsequent results publication.
Intention to publish date
31/03/2018
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list