Condition category
Digestive System
Date applied
21/01/2015
Date assigned
22/01/2015
Last edited
22/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 March 2016

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

Who is the main contact?
Miss Jessica Gaviria

Trial website

Contact information

Type

Public

Primary contact

Miss Jessica Gaviria

ORCID ID

Contact details

Queen Mary University of London
Wolfson Institute of Preventative Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Type

Scientific

Additional contact

Professor 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 patient’s 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 measures

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

31/03/2016

Reason abandoned

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

Sponsor information

Organisation

Queen Mary, University of London

Sponsor details

Joint Research Management Office
Queen Mary's Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2EF
United Kingdom

Sponsor type

University/education

Website

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes