Screening for viral hepatitis in migrants in East London

ISRCTN	ISRCTN82598401
DOI	https://doi.org/10.1186/ISRCTN82598401
Secondary identifying numbers	14808

Submission date: 25/10/2013
Registration date: 25/10/2013
Last edited: 07/08/2019

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jan Kunkel
Scientific

Centre for Digestive Diseases
Blizard Institute
The Blizard Building
4 Newark Street
London
E1 2AT
United Kingdom

Phone	+44 20 7882 2483
Email	j.kunkel@qmul.ac.uk

Study information

Study design	Randomised interventional screening trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Screening for viral hepatitis in migrants in East London: a pilot study of the HEPscreen project comparing screening invitation with and without HIV testing
Study acronym	HEPscreen
Study objectives	The aim of this study is to determine any difference in the number of candidates attending for testing in primary health care facilities when offered testing for viral hepatitis with or without concomitant testing for HIV.
Ethics approval(s)	NRES Committee London - Brent, 08/04/2013, ref: 13/LO/0215
Health condition(s) or problem(s) studied	Screening for viral hepatitis
Intervention	Screening, Addition of invitation for HIV testing to testing for viral hepatitis. The participants will be sent a letter inviting them to come to their GP practice for a questionnaire and a blood test. The difference between the two arms is the text in the invitation letter. The visit to the practice is a one-stop appointment and follow-up is determined by the test results and will take place in the way of usual clinical care. The primary outcome is the number of participants that attend for testing in each arm. Follow Up Length: 12 months Study Entry : Single Randomisation only
Intervention type	Other
Primary outcome measure	Number of participants responding to invitation letter; Timepoint(s): 31/03/2013
Secondary outcome measures	1. To determine the prevalence of viral hepatitis in different migrant populations when approached for testing in primary health care facilities. 2. To determine the number of persons infected with hepatitis B or C who then proceed on to secondary, tertiary health care and treatment, respectively. These secondary outcomes will be measured at the end of the study.
Overall study start date	15/08/2013
Completion date	31/03/2014
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	UK Sample Size: 500; Description: 500 people to be invited for testing. The study takes place in the London Borough of Hackney in Primary Care.
Key inclusion criteria	1. Migrants (i.e. person or parents born outside the UK in high or intermediate Hepatitis B and C prevalence countries) 2. Male & female, 18 years and older 3. Registered with primary care practices in East London
Key exclusion criteria	1. Withheld consent 2. Age < 18 years 3. Previously known infection with HBV, HCV or HIV or previous test 4. Lacking capacity
Date of first enrolment	15/08/2013
Date of final enrolment	31/03/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Centre for Digestive Diseases

London
E1 2AT
United Kingdom

Sponsor information

Queen Mary University of London (UK)
University/education

Centre for Digestive Diseases
Blizard Institute
London
E1 2AD
England
United Kingdom

Website	http://www.qmul.ac.uk/
"ROR"	https://ror.org/026zzn846

Funders

Funder type

Government

EU Commission Framework 7; Grant Codes: 20101105

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

07/08/2019: The trial status has been changed to 'Stopped'. According to http://hepscreen.eu/wp-content/uploads/2014/12/HEPscreen_Final-WP6-report_Pilot-studies.pdf, the study was terminated because of poor recruitment.
13/09/2016: No publications found in PubMed, verifying study status with principal investigator.