Hepatitis C assessment to treatment trial
| ISRCTN | ISRCTN61788850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61788850 |
| Secondary identifying numbers | 18696 |
- Submission date
- 22/04/2015
- Registration date
- 24/04/2015
- Last edited
- 10/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Hepatitis C is a virus that can infect the liver. Most people do not have any symptoms as they do not arise until the virus has caused significant damage to the liver. When they do occur, they tend to be vague and similar to a number of other conditions. They include flu-like symptoms, feeling tired and depression. People can get infected with the virus if they come into contact with the blood of an infected person, for example, by sharing drug needles. Due to the condition not having any obvious symptoms, regular testing is recommended for people considered to be in a high risk group, for example drug users. Here, we want to see if we can increase testing and diagnosis of people at an increased risk of hepatitis C virus (HCV) infection in the primary care setting (for example, at GP surgeries).
Who can participate?
Patients that have been approached by their GPs for HCV testing and attending a participating GP practice.
What does the study involve?
Participating GP practices are randomly allocated into one of two groups. Those in group one are given a complex intervention (or programme) consisting mainly of targeted case finding and inviting high risk patients to the practice for a test. Those in group two are not given the intervention and carry on as usual. We also look at how acceptable both patients and health care providers find the intervention and identify potential modifications that may be required to encourage HCV testing in primary care. At the end of the study we compare HCV testing, diagnosis, assessment and treatment rates between intervention and control sites. If the interventions are acceptable, work well and cost-effective then we will encourage their roll-out in primary care.
What are the possible benefits and risks of participating?
Some high-risk HCV patients registered at the intervention practices may be given an earlier test or diagnosis as a result of the practice being involved in the study. For the participants involved in the qualitative study, although there may not be any direct benefit from taking part, they will be helping to improve future services and treatment accessibility for people living with HCV. We do not foresee any potential risks to the patients. For the qualitative interviews, the only risk we foresee is related to patient inconvenience related to consent procedures and participation in the interviews.
Where is the study run from?
Primary care practices in the South West of England (UK)
When is the study starting and how long is it expected to run for?
June 2015 to December 2017
Who is funding the study?
Department of Health - National Specialised Commissioning Team (UK)
Who is the main contact?
Dr Kirsty Roberts
Contact information
Scientific
School of Social and Community Medicine
Oakfield House
Oakfield Grove Bristol
Bristol
BS8 2BN
United Kingdom
Study information
| Study design | Randomised; Interventional and Observational; Design type: Diagnosis, Screening, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Evaluation of interventions designed to increase diagnosis and treatment of patients with Hepatitis C virus infection in primary care |
| Study acronym | HepCATT |
| Study objectives | This study will determine whether we can increase testing and diagnosis of individuals at increased risk of HCV infection in primary care with a complex intervention consisting mainly of targeted case finding and inviting high risk patients to the practice for a test. We will also conduct a nested qualitative study with patients and health-care providers to assess the acceptability of the intervention and identify potential modifications that may be required to encourage HCV testing in primary care. |
| Ethics approval(s) | 15/SW/0094 |
| Health condition(s) or problem(s) studied | Topic: Primary Care; Subtopic: Primary care; Disease: All Diseases |
| Intervention | HCV test algorithm: The HCV test algorithm will run a search on GP systems to generate a list of individuals with risk markers for HCV infection 1. Increasing patient awareness, displaying Hepatitis C posters and leaflets in the practice waiting rooms 2. Increasing practice awareness 3. An offer of educational training on HCV for practice staff |
| Intervention type | Other |
| Primary outcome measure | Number/proportion of patients tested for HCV; Timepoint(s): 12 months |
| Secondary outcome measures | 1. Cost of case finding and testing; Timepoint(s): 12 months 2. Incremental cost per case detected; Timepoint(s): 12 months 3. Number and proportion testing positive (yield); Timepoint(s): 12 months 4. Number/ proportion attending for assessment; Timepoint(s): 12 months 5. Number/ proportion initiating treatment; Timepoint(s): 12 months 6. Number/ proportion referred for specialist assessment; Timepoint(s): 12 months |
| Overall study start date | 01/07/2014 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 920; UK Sample Size: 920 |
| Key inclusion criteria | For patient interviews: 1. Individuals approached by their GP for a HCV test in participating intervention practices who are aged over 18 years old 2. Able to provide informed consent and who have a telephone they can be contacted on |
| Key exclusion criteria | For the patient interviews: Unable to provide informed consent |
| Date of first enrolment | 01/06/2015 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
-
United Kingdom
-
United Kingdom
-
United Kingdom
Sponsor information
University/education
Department of Social Medicine
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
England
United Kingdom
"ROR" |
https://ror.org/0524sp257 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/07/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We plan to publish the results of the trial in a peer-reviewed journal and at national conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Prof. Matthew Hickman (matthew.hickman@bristol.ac.uk), the CI for HepCATT and the data controller. Access to this data will be available shortly. The anonymised data set will be stored in the research data facility at the University of Bristol. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/07/2016 | Yes | No | |
| Results article | results | 30/07/2020 | 26/02/2020 | Yes | No |
| Results article | cost-effectiveness results | 26/02/2020 | 10/03/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/03/2020: Publication reference and IPD sharing statement added.
26/02/2020: Publication reference added.
17/01/2020: The overall trial end date was changed from 30/04/2018 to 31/12/2017.
04/04/2019: The intention to publish date was added.
13/12/2017: The overall trial end date was changed from 31/12/2016 to 30/04/2018.
01/08/2016: Publication reference added.
