ISRCTN - ISRCTN24707359: The HALT Hepatitis study

Plain English Summary

Background and study aims
Hard-to-reach groups are defined by lifestyle factors that render engagement with healthcare services problematic; they include homeless persons, people who inject drugs and ex-prisoners. These groups are at risk of a range of infectious diseases, often due to living conditions, injecting drug use, alcoholism, chaotic lifestyle factors, and generally poor physical and psychiatric health. Exposure to, and prevalence (percentage of a population affected with the disease at a given time) of, tuberculosis, hepatitis B virus (HBV) and hepatitis C virus (HCV) among the hard-to-reach is known to be high. The same factors that put individuals at risk of infection can also create barriers to passive presentation for diagnosis and adherence to treatment, including within the healthcare system. Therefore, support mechanisms are often needed to help people through the clinical process after they test positive for an infection.
This study aims to determine whether screening and peer support for HCV or HBV infected individuals in hard-to-reach groups is effective and cost-effective.

Who can participate?
Males or females over 16 years old who are homeless or substance abusers

What does the study involve?
If found to be positive for HCV participants are randomly allocated to either peer support and accompanied referrals or supported during clinical diagnostic and treatment by normal care. If found to be positive for HBV participants are allocated to either peer support and accompanied referrals.

What are the possible benefits and risks of participating?
Participants are offered the opportunity to be tested for HIV, HBV and HCV. Individuals benefit from knowing their infection status and from engagement with the healthcare system if found to be positive. No risks are foreseen.

Where is the study run from?
University College London (UK)

When is the study starting and how long is it expected to run for?
January 2013 to June 2015

Who is funding the study?
Department of Health (UK)

Who is the main contact?
Prof. Ibrahim Abubakar
i.abubakar@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ibrahim Abubakar

ORCID ID

Contact details

University College London
Research Department of Infection and Population Health
4th floor Mortimer Market
off Capper Street
London
WC1E 6JB
United Kingdom
+44 (0)20 7679 0954
i.abubakar@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12/0445

Study information

Scientific title

The HALT study: effectiveness of testing for, and treatment of, hard-to-reach groups for hepatitis B virus and hepatitis C virus in England

Acronym

Study hypothesis

Providing peer support and accompanied referrals to hard-to-reach individuals infected with hepatitis C virus (HCV) or B virus (HBV) will increase the likelihood of a full diagnosis and treatment completion, where appropriate.

Ethics approval

NRES Committee London, Brent, 21/02/2013, ref: 13/LO/0077

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Hepatitis C virus (HCV) or B virus (HBV)

Intervention

Current interventions as of 06/02/2014:
Screening of hard-to-reach individuals, random allocation of those infected with HCV to either peer support and accompanied referrals or normal care, allocation of those infected with HBV to peer support and accompanied referrals.

Previous interventions:
Mobile screening of hard-to-reach individuals, random allocation of those infected with HCV or HBV to either peer support and accompanied referrals or normal care.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Current primary outcome measures as of 06/12/2012:
1. Cost effectiveness evaluation of the interventions
2. Successfully reaching an appropriate clinical endpoint for those HCV infected

Previous primary outcome measures until 06/12/2012:
1. Cost effectiveness evaluation of the interventions
2. Successful completion of full HCV clinical diagnosis

Secondary outcome measures

Current secondary outcome measures as of 06/12/2012:
1. Sustained virological response to HCV treatment
2. Successfully reaching an appropriate clinical endpoint, full diagnosis and commencement of treatment, where appropriate, for those HBV infected
3. Proportion of hard-to-reach with adequate immune response to HBV vaccine
4. Factors influencing lack of vaccine uptake

Previous secondary outcome measures until 06/12/2012:
1. Sustained virological response to HCV treatment
2. Successful full HBV clinical diagnosis and commencement of treatment
3. Proportion of hard-to-reach with adequate immune response to HBV vaccine
4. Factors influencing lack of vaccine uptake

Overall trial start date

01/01/2013

Overall trial end date

30/06/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Homeless or substance misusing individuals

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

660

Participant exclusion criteria

1. Individuals unable to give informed consent
2. Under 16 years of age

Recruitment start date

01/01/2013

Recruitment end date

01/07/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
WC1E 6JB
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Government

Funder name

Department of Health Policy Research Programme (UK), ref: 015/0306

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