The HALT Hepatitis study
| 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
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
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 |
|---|---|
| i.abubakar@ucl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | NRES Committee London, Brent, 21/02/2013, ref: 13/LO/0077 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2013 |
| Completion date | 30/06/2015 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 660 |
| Key inclusion criteria | Homeless or substance misusing individuals |
| Key exclusion criteria | 1. Individuals unable to give informed consent 2. Under 16 years of age |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 01/07/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
WC1E 6JB
United Kingdom
Sponsor information
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" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
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? |
|---|---|---|---|---|---|
| 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.
