ISRCTN ISRCTN24707359
DOI https://doi.org/10.1186/ISRCTN24707359
Secondary identifying numbers 12/0445
Submission date
19/10/2012
Registration date
15/11/2012
Last edited
24/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Ibrahim Abubakar
Scientific

University College London
Research Department of Infection and Population Health
4th floor Mortimer Market, off Capper Street
London
WC1E 6JB
United Kingdom

Phone +44 (0)20 7679 0954
Email i.abubakar@ucl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe HALT study: effectiveness of testing for, and treatment of, hard-to-reach groups for hepatitis B virus and hepatitis C virus in England
Study objectivesProviding 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(s)NRES Committee London, Brent, 21/02/2013, ref: 13/LO/0077
Health condition(s) or problem(s) studiedHepatitis C virus (HCV) or B virus (HBV)
InterventionCurrent 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 typeOther
Primary outcome measureCurrent 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 measuresCurrent 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 study start date01/01/2013
Completion date30/06/2015

Eligibility

Participant type(s)Other
Age groupAdult
SexBoth
Target number of participants660
Key inclusion criteriaHomeless or substance misusing individuals
Key exclusion criteria1. Individuals unable to give informed consent
2. Under 16 years of age
Date of first enrolment01/01/2013
Date of final enrolment01/07/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University College London
London
WC1E 6JB
United Kingdom

Sponsor information

University College London (UK)
University/education

c/o David Wilson
Joint Research Office
1st Floor, Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom

Website http://www.ucl.ac.uk/
ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results for participants with chronic HCV infection 01/04/2019 24/10/2019 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

24/10/2019: Publication reference added.
18/09/2017: No publications found, verifying study status with principal investigator.
10/04/2014: The overall trial end date was changed from 31/05/2015 to 30/06/15.
06/12/2012: The overall trial start date was changed from 01/12/2012 to 01/01/2013.