Title: Enhanced management and contract tracing among antenatally screened HBV-infected women and chronically infected individual to improve testing uptake, vaccination and onward referral of household contacts
Funder: Department of Health and Social Care

Abstract: Background: In England approximately 326,000 individuals are chronically infected with the hepatitis B virus (HBV), most of whom are among known risk groups. Many infected individuals remain undiagnosed, and are unlikely to be treated, but more likely to transmit infection, and develop chronic liver disease, cirrhosis and primary liver cancer, resulting in significant resource implications for the NHS and the wider society. In the UK, populations for testing have traditionally included household contacts and partners of acutely infected individuals and of those testing positive antenatally. However, despite well disseminated guidelines and models of best practice, contact tracing among those acutely infected is highly variable, with antenatal care focuses upon the prevention of transmission to the child. Therefore developing a sustainable model through which household contacts of all individuals diagnosed with HBV, either antenatally, chronically, maybe tested, vaccinated and referred, as appropriate, will be beneficial both in terms of economic savings to the NHS and public health improvement of disease management. The advent of new and effective therapies for chronic HBV infection emphasises the importance of early identification of infected individuals to optimise health outcomes. Developing models of service delivery to reduce barriers to testing and increase referrals to specialist care will contribute towards improving control of HBV in the UK. Aims: Determine whether enhanced management and contact tracing, along with offer of oral fluid testing of the household contacts and partners of antenatal HBV-positive women and those with a chronic infection improves testing uptake, vaccination and onward referral. In addition, through a social science approach, explore structural issues that may act as barriers for individuals to engaging in the clinical care pathway, as well as knowledge gaps among their GPs. Research plan and methods: A dedicated study nurse will provide an enhanced follow-up and contact tracing service for all chronically infected individuals across three Public Health England (PHE) regions (currently 4 HPU regions). The study nurse will liaise with the contact s GP to facilitate attendance, testing and specialist referral. Oral fluid testing will be offered to individuals who either refuse or fail to attend their GP appointment. The study nurse will follow-up individuals to the conclusion of their clinical care, either vaccination, testing or onward referral, recording the outcome of their interaction. Postal questionnaires will be used among those engaging in testing services, and those who did not to explore structural issues that may act as barriers for individuals to engaging in the clinical care pathway, as well as knowledge gaps among their GPs. Results will be used in an economic evaluation of the public health impact of this enhanced public health action. Research team: Study team includes those with epidemiological and clinical expertise in hepatitis B, social science methodologies and statistics modelling. Drs Abubakar and Ramsay have lead substantial research projects; Drs Southern, Lattimore and Gupta have managed such projects. Impact and influence: Treatment for hepatitis B has been demonstrated to be cost effective, therefore prompt diagnosis and improved case finding could result in cost savings through timely treatment rather than treatment of advanced disease and the prevention of onward transmission. In addition, exploring structural issues that may act as barriers to engaging in the clinical care pathway for HBV testing, vaccination or treatment will enable the development of locally effective interventions. This work has the potential to contribute towards a revision in practice and or guidance for the management of HBV in the UK.

Lay abstract: In addition to identifying and vaccinating at-risk infants, transmission of hepatitis B can be further reduced through contact tracing. In the UK, hepatitis B (HBV) testing has included household contacts and partners of individuals with a recently acquired (acute) infection and of those testing positive through antenatal screenin. Identifying and managing infectious individuals is critical in the public health response to gaining control of HBV in the UK. However, despite well disseminated guidelines, contact tracing practice is highly variable. Therefore developing a sustainable model to improve engagement across a large geographical patch where overall prevalence is low but pockets of high prevalence, from a wide range of ethnic groups, may exist, is likely to be beneficial in terms of economic savings to the NHS and public health improvement of disease management. This study provides an opportunity to engage a wider group of individuals who are at increased risk of HBV infection in testing, vaccination or clinical care. Using an enhanced management and contact tracing programme, including self administered oral fluid testing and questionnaires, we will explore structural barriers and enablers to engaging in clinical care. In addition, as part of a retrospective study to gain baseline information, questionnaires will be used to explore knowledge gaps and understanding of hepatitis B among GPs. This study will include three Public Health England centre, approximately mapping to four current Health Protection Unit (HPU) regions in the North West and East of England, with a low antenatal HBV prevalence when compared to London, but high compared to other regions outside London, along with a high mix of ethnic groups from countries with high/intermediate HBV prevalence. The primary outcome will be an increase in the number of household contacts tested, vaccinated and referred for care, as appropriate. The team is ideally placed to deliver this study, involving those with expertise in HBV (epidemiology and clinical), statistics, social sciences and economic modelling, who have lead a number of substantial research projects to fruition. Furthermore, close links and case reporting pathways already exist between the Health Protection Agency, and the HPUs who currently undertake contact tracing activity.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;4.4 POPULATION SCREENING
Health categories: INFECTION;REPRODUCTIVE HEALTH AND CHILDBIRTH