Contact information
Type
Scientific
Primary contact
Dr Jan Kunkel
ORCID ID
Contact details
Centre for Digestive Diseases
Blizard Institute
The Blizard Building
4 Newark Street
London
E1 2AT
United Kingdom
+44 20 7882 2483
j.kunkel@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14808
Study information
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
Acronym
HEPscreen
Study hypothesis
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
NRES Committee London - Brent, 08/04/2013, ref: 13/LO/0215
Study design
Randomised interventional screening trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
15/08/2013
Overall trial end date
31/03/2014
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
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.
Participant exclusion criteria
1. Withheld consent
2. Age < 18 years
3. Previously known infection with HBV, HCV or HIV or previous test
4. Lacking capacity
Recruitment start date
15/08/2013
Recruitment end date
31/03/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Digestive Diseases
London
E1 2AT
United Kingdom
Sponsor information
Organisation
Queen Mary University of London (UK)
Sponsor details
Centre for Digestive Diseases
Blizard Institute
London
E1 2AD
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
EU Commission Framework 7; Grant Codes: 20101105
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list