Plain English Summary
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 2016
Who is funding the study?
Department of Health - National Specialised Commissioning Team (UK)
Who is the main contact?
Dr Kirsty Roberts
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18696
Study information
Scientific title
Evaluation of interventions designed to increase diagnosis and treatment of patients with Hepatitis C virus infection in primary care
Acronym
HepCATT
Study hypothesis
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
15/SW/0094
Study design
Randomised; Interventional and Observational; Design type: Diagnosis, Screening, Qualitative
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/07/2014
Overall trial end date
31/12/2016
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 920; UK Sample Size: 920
Participant exclusion criteria
For the patient interviews:
Unable to provide informed consent
Recruitment start date
01/06/2015
Recruitment end date
31/12/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bristol Primary Care Trust (lead)
Bristol
-
United Kingdom
Trial participating centre
North Somerset Primary Care Trust
Somerset
-
United Kingdom
Trial participating centre
South Gloucestershire Primary Care Trust
Gloucestershire
-
United Kingdom
Funders
Funder type
Government
Funder name
Department of Health - National Specialised Commissioning Team; Grant Codes: 015/0309
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We plan to publish the results of the trial in a peer reviewed journal and at national conferences.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27473371