title: Hepatitis C - Assessment to Treatment Trial (HepCATT) in primary care: study protocol for a cluster randomised controlled trial.
abstract: Public Health England (PHE) estimates that there are upwards of 160,000 individuals in England and Wales with chronic hepatitis C virus (HCV) infection, but until now only around 100,000 laboratory diagnoses have been reported to PHE and of these 28,000 have been treated. Targeted case-finding in primary care is estimated to be cost-effective; however, there has been no robust randomised controlled trial evidence available of specific interventions. Therefore, this study aims to develop and conduct a complex intervention within primary care and to evaluate this approach using a cluster randomised controlled trial.
  
  
  
  A total of 46 general practices in South West England will be randomised in a 1:1 ratio to receive either a complex intervention comprising: educational training on HCV for the practice; poster and leaflet display in the practice waiting rooms to raise awareness and encourage opportunistic testing; a HCV risk prediction algorithm based on information on possible risk markers in the electronic patient record run using Audit + software (BMJ Informatica). The audit will then be used to recall and offer patients a HCV test. Control practices will follow usual care. The effectiveness of the intervention will be measured by comparing number and rates of HCV testing, the number and proportion of patients testing positive, onward referral, rates of specialist assessment and treatment in control and intervention practices. Intervention costs and health service utilisation will be recorded to estimate the NHS cost per new HCV diagnosis and new HCV patient initiating treatment. Longer-term cost-effectiveness of the intervention in improving quality-adjusted life years (QALYs) will be extrapolated using a pre-existing dynamic health economic model. Patients' and health care workers' experiences and acceptability of the intervention will be explored through semi-structured qualitative interviews.
  
  
  
  This trial has the potential to make an important impact on patient care and will provide high-quality evidence to help general practitioners make important decisions on HCV testing and onward referral. If found to be effective and cost-effective the intervention is readily scalable and can be used to support the implementation of NICE recommendations on HCV case-finding.
  
  
  
  ISRCTN61788850 . Registered on 24 April 2015; Protocol Version: 2.0, 22 May 2015.
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Kirsty
authors.initials: K
authors.lastname: Roberts
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: John
authors.initials: J
authors.lastname: Macleod
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.|Bristol Randomised Trials Collaboration, 39 Whatley Road, Bristol, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Metcalfe
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.|Bristol Randomised Trials Collaboration, 39 Whatley Road, Bristol, UK.
authors.forename: Joanne
authors.initials: J
authors.lastname: Simon
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.|Bristol Randomised Trials Collaboration, 39 Whatley Road, Bristol, UK.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Horwood
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: William
authors.initials: W
authors.lastname: Hollingworth
authors.affiliation: University Hospitals Bristol, Bristol Royal Infirmary, Marlborough Street, Bristol, UK.
authors.forename: Sharon
authors.initials: S
authors.lastname: Marlowe
authors.affiliation: University Hospitals Bristol, Bristol Royal Infirmary, Marlborough Street, Bristol, UK.
authors.forename: Fiona H
authors.initials: FH
authors.lastname: Gordon
authors.affiliation: Public Health Laboratory Bristol, Public Health England, Myrtle Road, Bristol, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Muir
authors.affiliation: Public Health Commissioning and Performance, Avonquay, Merchants Road, Cumberland Basin, Bristol, UK.
authors.forename: Barbara
authors.initials: B
authors.lastname: Coleman
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Vickerman
authors.affiliation: NIHR Nottingham Digestive Diseases Biomedical Research Unit, University Hospital Nottingham, Nottingham, UK.
authors.forename: Graham I
authors.initials: GI
authors.lastname: Harrison
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.|South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK.
authors.forename: Cherry-Ann
authors.initials: CA
authors.lastname: Waldron
authors.affiliation: NIHR Nottingham Digestive Diseases Biomedical Research Unit, University Hospital Nottingham, Nottingham, UK.
authors.forename: William
authors.initials: W
authors.lastname: Irving
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK. Matthew.Hickman@bristol.ac.uk.
authors.forename: Matthew
authors.initials: M
authors.lastname: Hickman
mesh_terms: D002985:Clinical Protocols; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D017063:Outcome Assessment, Health Care; D010353:Patient Education as Topic; D011320:Primary Health Care; D012017:Referral and Consultation
keywords: Case-finding; Complex intervention; HCV; Hepatitis C; Primary care; RCT