Condition category
Infections and Infestations
Date applied
25/10/2013
Date assigned
25/10/2013
Last edited
13/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.qmul.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/09/2016: No publications found in PubMed, verifying study status with principal investigator.