Title: Evaluation of interventions designed to increase diagnosis and treatment of patients with hepatitis C virus infection in primary care and drug treatment settings [Reducing Barriers PRP 04 - drug treatment centres] + [Improving access PRP 03 - primary care]
Funder: Department of Health and Social Care

Abstract: Backgound Chronic hepatitis C virus (HCV) infection results in cirrhosis and associated life-threatening complications in around 20% of infected individuals over an average period of 20-30 years. However, it is potentially curable &ndash; combination therapy with pegylated interferon alpha (PEG) and ribavirin (RV) results in an overall sustained virological response (SVR) in around 50% of patients. This figure will improve with the advent of directly-acting antiviral agents for the treatment of HCV infection. Over 90% of chronic infections acquired in theUKare among people who inject drugs (PWID). Economic models show that the higher the treatment rate the more cost-effective case finding is in specialist drug agencies. However, routine data on current testing and treatment rates are unavailable. Aims Our ultimate aim is to identify ways and means of increasing diagnosis and treatment of patients with chronic HCV infection in two linked applications, PRP (05-01-03) and PRP (05-01-04) In the former application we focus primarily on diagnosis and treatment in primary care. In this application we focus on specialist drug clinics including people in specialist drug treatment in shared care arrangements with primary care. To this end, we will (a) undertake a service evaluation in selected sites/geographical areas in order to quantify current diagnostic and treatment patterns and characterise specific interventions in place to promote HCV testing and treatment (b) develop and pilot an intervention in 3 sites involving an HCV facilitator to train health care workers and coordinate a range of activities aimed at increasing diagnosis and treatment (c) undertake a nested qualitative study to explore participants experiences and responses to the intervention and unpack relative potential effects of different intervention components (d) conduct a cluster randomised controlled trial of an complex intervention in primary care designed to increase testing and diagnosis of individuals at increased risk of HCV infection and to enhance onward referral to initiation of treatment (e) perform cost-effectiveness modeling of the intervention Research plan The service evaluation will collate data from HPA laboratory surveillance and local laboratory records, specialist drug clinics and specialist hepatology to determine rates of diagnosis, assessment and treatment initiation. A check-list of potential interventions to promote testing will be completed with key local practitioners and policy-makers. Diagnosis and treatment rates between sites and by intervention intensity will be compared. Three pilot sites where treatment and diagnosis rates could be improved will be selected in discussion with local commissioners and specialist services. The drug treatment centre intervention will include appointment of an HCV facilitator with multiple roles in education, training, and enhancing patient referral; establishment of peer support teams (with the Hepatitis C Trust and non-statutory drug agency); staff and patient educational initiatives; introduction of dried blood spot testing; and streamlining of service provision by integration of HCV assessment and treatment where possible with opiate substitution therapy. Testing and diagnosis rates before and after the intervention and with expected rates from other sites will be compared. In depth qualitative interviews and focus groups will be conducted with staff and PWID exposed to the intervention. We will assess the impact of HCWs obtaining the Part 1 of the Royal College of General Practitioners (RCGP) Certificate in the detection, diagnosis and management of hepatitis B and C in primary care on testing and referral patterns. The RCT of primary care intervention will include flagging of records of patients identified as being at increased risk of HCV infection, or having been diagnosed with HCV infection but without onward referral; increasing patient awareness via posters, leaflets or self-completion check-lists; inclusion of relevant questions addressing risk factors for infection on new-patient registration forms; and the use of a facilitator to assist in onward referral of newly diagnosed patients and/or pursue active case-finding Dynamic economic models used for NICE will be re-paramaterised with data from the study in order to test cost-effectiveness. Research team The team is multidisciplinary including hepatologists, primary care physicians, patient representatives, local policy-makers, non-statutory drug agencies, expertise in public health and epidemiology of addiction, social science, health economic modelling, trial design and virology. We have an extensive track record of working in the area of improving diagnosis and treatment of patients with HCV infection. Potential impact Information and guidance for commissioning HCV testing and treatment:- evaluation and template on how to collect data on HCV testing and diagnosis rates; testing of an intervention that could improve testing and treatment rates, that if shown to be effective and cost-effective could be delivered in other sites in theUK.

Lay abstract: We will determine whether we can increase testing and diagnosis of individuals at increased risk of hepatitis C virus (HCV) infection in primary care and drug treatment centres. We will determine whether we can increase the number of patients in these settings who are properly managed and, if necessary, treated for their infection. HCV infection leads to life-threatening liver disease in a significant percentage of infected patients. It is treatable, with current cure rates of well over 50%. However, there are tens of thousands of individuals in the UK living with chronic HCV infection in whom the infection has not been diagnosed, and many patients who have been diagnosed do not manage to access the very effective treatments that are recommended. Approximately 90% of chronic HCV infections acquired in UK are among people who inject drugs (PWID); therefore, it is essential for HCV prevention that studies are conducted among PWID, the majority of whom will be found either through specialist drug treatment centres and/or primary care if they have ceased injecting and opiate substitution treatment. The studies will be carried out at multiple sites including Nottingham, Bristol, London, and sites identified in partnership with Public Health England and Addaction. The key outcomes are HCV testing, assessment and treatment rates, cost-effectiveness, and experiences and perceptions of patients and health care workers participating in the intervention. If the interventions are both effective and cost-effective, then we will encourage their roll-out across other centres in the UK. We have experience of utilising all the aspects of our interventions in similar studies, and have had no difficulty in acquiring ethical approval for those studies. We have a multi-disciplinary team (including patient representatives and local commissioning and experts in hepatology, primary care, virology, social science, trial design, health economic modeling) who have a considerable track record of published work in these areas. We propose to draw upon additional expertise from Scotland, Wales and Manchester HCV Action plans in our steering group.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: INFECTION