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Centre for Infectious Disease Epidemiology 

The Centre undertakes research on the epidemiology, prevention and treatment of infections including sexually transmitted diseases, influenza, tuberculosis, antimicrobial resistance and other common problems particularly among vulnerable populations in primary care. It has developed the UK Infectious Disease Research Network.

The Centre is based at both the Farr Institute and also the Mortimer Market Centre, and is jointly led by Dr Andrew Hayward and Professor Ibrahim Abubakar. 

For CIDE staff profiles, click here

Current Research Studies:

(based at The Farr Institute)

Epidemiology of severe community onset staphylococcal infections

There has been international concern about the emergence of highly pathogenic community strains of staphylococcus aureus. These strains can cause outbreaks of severe soft tissue infections and life-threatening pneumonias in young and healthy individuals. The surveillance systems that are currently in place are not well designed to estimate the size of the problem. Unpublished work from the UCL Centre for Infectious Disease Epidemiology suggests that there has been a doubling in the hospital admission rate for skin infections and staphylococcal pneumonias. 

In this MRC-funded fellowship, the overall aims are to describe the epidemiology of these severe community onset staphylococcal infections and to investigate the factors underlying the increased admission rate.

Laura Shallcross is the principal investigator. The study team also includes Andrew Hayward and Anne Johnson. 

FIT: Feedback Intervention Trial

This is a cluster randomised controlled trial (CRCT) comparing the Cleanyourhands Campaign, with and without feedback in ICUs & General Medical/Acute Care of the Elderly Units (GM/ACE) in 16 hospitals. The primary outcome is Hand Hygiene (HH). Secondary outcomes are Healthcare-Associated Infections (HCAI) mainly from routine data, and cost effectiveness. Results will be extrapolated nationally. The study design will be practical with a feedback intervention and a package of simple measures of HH and HCAI suitable for routine use in the NHS. Sheldon Stone (UCL Medical School) is the principal investigator. Chris Fuller is the research fellow. 

Flu Watch

This is a community study of behavioral & biological determinants of transmission to inform seasonal & pandemic planning.

The study commenced in 2006, and is funded by the Medical Research Council (MRC). Households distributed across England have been recruited through the MRC General Practice Research Framework (GPRF). We have followed the cohort through several influenza seasons, and defined cases of influenza infection through pre-and post season serology and divided them into symptomatic and asymptomatic cases based on symptom diaries. Viral shedding has been identified through self-submitted nasal swabs for RT-PCR identification of influenza, and nformation on patient contact patterns has been collected, providing empirical data to inform models of pandemic and seasonal influenza transmission. In nested case control studies, pre and post season blood samples from patients with confirmed influenza and controls have been used to assess the T cell response to influenza using a validated interferon-gamma elispot assay. External collaborators include colleagues at University of Oxford and the Health Protection Agency.

Andrew Hayward is the principal investigator. The study team also includes Faiza Tabassum, Ellen Fragaszy, Fatima Wurie and Cherry Constantine.

Flu Watch/MOSAIC collaborative study

UCL Study Coordinator – Fatima Wurie

MOSAIC (Mechanisms of Severe Acute Influenza Consortium) is a UK-wide consortium of research groups studying influenza pathogenesis in patients hospitalised with severe H1N1 disease during the pandemic. It is a MRC/Wellcome Trust funded study led by Chief Investigator Professor Peter Openshaw, Imperial College London.

Flu Watch are collaborating with MOSAIC in comparing the genetic profiles of subjects mildly infected with H1N1 and seasonal strains with that of those who were severely ill and hospitalised or died as a result of influenza infection. It is anticipated that this collaborative study will provide useful insights into understanding genetic determinants of severe infection.

Geographic profiling and infectious disease outbreaks

Geographic profiling (GP) is a statistical technique developed in criminology to identify likely candidates from large lists of suspects in cases of serial crime such as murder or rape. GP uses the spatial locations of crime sites to make inferences about the location of the offender’s home or workplace and is used by law enforcement agencies around the world. Recently, GP has been adapted to identify the geographical source of infectious disease outbreaks. This project will apply the technique to clusters of infections identified by DNA fingerprinting of isolates (analogous to clusters of crimes with the same offence profile). The work will focus on the exemplars of Legionnaires’ disease (usually due to poorly maintained cooling towers or other water systems) and tuberculosis (often centred around transmission “venues” such as pubs, clubs, crack houses or QAT houses).

Dr Andrew Hayward and Catherine Smith are working on this project with Dr Steve Le Comber (Queen Mary University of London), Dr Hannah Fry, (UCL Centre for Advanced Spatial Analysis), and Public Health England.

Contact catherine.smith.13@ucl.ac.uk for more information.

I’m a Scientist, Decipher my Data: Flu!

Decipher my data! Flu! is the first in a planned series of projects. The study is led by Dr Rob Aldridge working alongside a team at the Centre for Infectious Disease Epidemiology. We want to see if school illness absence data can provide a good warning system for spotting flu outbreaks.  The project aims to enable students to be part of and conduct real science experiments. To give them a chance to understand how science works in reality, to deal with real unadulterated data, to deal with ethical issues, to deal with peer review with reporting of results. One of the reasons we wanted to do this project was to show students that science doesn’t always produce a nice straight line or smooth curve and that quite often it doesn’t work at all! Last winter had the lowest incidence of flu on record and we learnt a lot about baseline illness data in schools but our results weren’t significant enough to publish. We’ve learnt some lessons about what went well and what didn’t go so well last time so we’re hoping this year the project will be bigger and better.

Dr Rob Aldridge is leading on the study. Andrew Hayward and Colette Smith are also collaborating and contributors.

ICONIC: Infection Response through Virus Genomics

Summary: ICONIC is a 3-year research Health Innovation Challenge Fund project funded by the Department of Health and the Wellcome Trust running from October 2013.

The project is a collaborative effort led by UCL and involving the Wellcome Trust Sanger Institute, UCLH, PHE, Barts Health, HCVRUK and the Universities of Edinburgh and Nottingham.

ICONIC aims to utilise next generation sequencing technology, in order to (i) stratify therapy (HIV and Hepatitis C virus used as a case example), (ii) guide hospital infection control responses (Norovirus), and (iii) inform surveillance and epidemiological responses to community outbreaks (Measles and Influenza viruses).

ICONIC will advance the capacity for embedding this new technology within the UK diagnostic environment, in a sustainable and cost effective manner. In so doing, we aim to embed into the NHS the ability to rapidly respond to new and emerging viral infections in the future. 

I&I Project Personnel: Dr Andrew Hayward, Professor Paul Kellam, Dr Zisis Kozlakidis and Dr Dan Frampton.

Contact z.kozlakidis@ucl.ac.uk for more information. 

Infectious Disease Research Network (IDRN)

The Network has been active since 2001, when it was piloted as a London-focused initiative, and is funded by the Department of Health. Now the remit of the IDRN extends to a UK-wide focus, and aims to promote collaborations and working across disciplines, provide training opportunities, and act as a forum for encouraging high quality infectious disease research. Amongst our activities have been the organisation of research strategy workshops and training events, the designing and hosting study webpages and surveys, the comprehensive funding and training bulletins,and the online researchers database. The IDRN has had an input into infectious disease research strategy, and has provided academic and administrative support for grants and fellowships. 

For more information about the Network, see www.idrn.org . Andrew Hayward and Anne Johnson are the principal investigators, and the study team also includes Michael Head (Network Manager), Fatima Wurie and Cherry Constantine. 

Investigating the epidemiology of tuberculosis and the cost effectiveness of novel diagnostic screening pathways in migrants to the UK

Tuberculosis is an infectious disease that has a wide range of complications and symptoms. The number of cases detected each year in the UK is increasing despite our best efforts to control it. Tuberculosis is therefore a significant public health problem requiring further research to establish the best ways to tackle it.

In 2009 73% of cases were in individuals born outside the UK, a figure that continues to rise despite a screening programme in new migrants. This study aims to establish rates of disease in migrants on entry to the country; the subsequent levels of newly occurring disease; and the proportion of tuberculosis acquired in the UK or abroad. Using all of these data, the project will create a mathematical model to compare the effectiveness of different screening options, including newly available diagnostic tests, to establish the most cost effective combination of screening investigations.

Effective screening in migrants has the potential to reverse the increasing number of tuberculosis cases in individuals not born in the UK and subsequently in the general population. This will benefit wider society and migrants, who represent a particularly vulnerable group with a high burden of disease.

The research fellow is Rob Aldridge. Co-investigator is Andrew Hayward.

I-STRAT trial: Do Isolation Strategies reduce endemic levels of MRSA and Clostridium difficile associated diarrhoea?

This is an MRC-funded trial of one or more isolation strategies, examining their effect on CDAD as well as MRSA, in settings where these infections are common, and where other infection control practice is maximal.

To do this we will scope interest from acute NHS Trusts, identify the barriers to different interventions at institutional, ward and Health care worker levels, seek ways of addressing these, establish Trusts’ preferred intervention(s) and target population(s), explore ethical issues with patient groups, carry out an exploratory trial to establish a pragmatic intervention.

  1. nationwide consultation through questionnaire
  2. site visits to 20-30 interested Trusts
  3. national focus meeting involving patient groups & trusts to gain consensus on target population, trial and control interventions. 
  4. Pilot trial in four hospitals. 
  5. National focus meeting agreeing definitive trial & design.

We will do this through a combination of -

Sheldon Stone (UCL Medical School) is the principal investigator. The study team also includes Chris Fuller and Ellen Fragaszy. 

Migration as a social determinant of dengue fever transmission in Colombia

In Colombia as a consequence of internal armed conflict there are large groups of displaced populations; their health needs vary from malnutrition, infectious diseases and mental illnesses.

In this context, Colombia’s faces several problems regarding the health status of displaced populations. Despite the public health policies -which have tried to respond to this complex situation, the perpetuation of the migration process accentuates the incidence of health problems and, especially, infectious diseases such as dengue fever in Colombia. It seems that forced migration could affect the dynamic of infectious diseases transmission in host cities. The aim of this study is assessing the role of migration process in dengue’s transmission at endemic regions that are host cities for displaced population.

Adriana Pacheco-Coral is the PhD research student and Andrew Hayward the principal supervisor. Maria Kett from Department of Epidemiology & Public Health is the subsidiary supervisor.

This study is sponsor partially by Colombian Agency for Science and Technology Development and the 2012 UCL Grand Challenges Small Grants awards http://www.ucl.ac.uk/grand-challenges/small-grants-2012. A specific grant for community participation in dengue -among displaced populations, was awarded from the Train and Engage Science Life Medical School funding stream 2012.

NOSEC: National Observation Study of the Effectiveness of the Clean Your Hands Campaign

This observation study provides an independent assessment of the cleanyourhands campaign. Questionnaires are sent out on a six monthly basis to infection control eams at NHS acute trusts in England and Wales. Questions review the level of implementation of the cleanyourhands campaign and the monthly number of hospital related infections. The consumption of soaps and alcohol hand rubs for each Trust is also collected separately from NHS logistics. The completed study will show how implementation varies between trusts, which factors predict success and whether the campaign is sustainable over time. 

Sheldon Stone (UCL Medical School) is the principal investigator. Chris Fuller is the research fellow. 

Role of influenza as a trigger for acute myocardial infarction: evidence from clinical, epidemiological and statistical studies

The role of influenza as a trigger for acute myocardial infarction: evidence from clinical, epidemiological and statistical studiesInfluenza (flu) is one of many common viruses that cause respiratory symptoms. Some respiratory infections may trigger more serious conditions such as heart attacks. This study, funded by an MRC fellowship grant, will study whether flu triggers heart attacks, if so how often this happens, and whether vaccinating people against influenza also protects them from heart attacks. This will involve an analysis of medical records from a national general practice database and studying of recent influenza infection in patients hospitalised for heart attacks. One of the major anticipated benefits of this research is If flu does trigger heart attacks, some might be prevented either through vaccinating people against flu or by treating flu with antiviral drugs. 

Charlotte Warren-Gash is the principal investigator. The study team also includes Andrew Hayward. 

TB: Droplet Study – Effect of variations in bio-aerosol production on TB infectivity

Tuberculosis (TB) transmits via bio-aerosols. “Bio-aerosols” are submicron particles (<1µm diameter) of lung mucus containing glycoproteins, surfactant and pathogens formed in the respiratory tract. The vast majority of these particles are exhaled during normal breathing.  Our previous work using Optical Particle Counter technology shows substantial variations in bio-aerosol production amongst healthy volunteers.

The study aims to address whether variations in bio-aerosol production in TB patients act as a source of heterogeneity in infectivity.

This is a cohort study of pulmonary and non-pulmonary TB patients. Bio-aerosol measurements will be collected from pulmonary cases over 6 months. Exhaled breath of sputum smear positive cases at diagnosis will be examined using PCR to look for evidence of Mycobacteria tuberculosis in the aerosol component of exhaled breath. It will include a cross-sectional study of pulmonary patients and their contacts already on treatment will be followed up until the end of their treatment regime.  

Pam Sonnenberg is the Chief Investigator. Principal Investigators are Andrew Hayward and Helen Booth. Fatima Wurie is the Study Coordinator.

Tuberculosis in hard-to-reach groups - programme grant

B Reach - Improving the Management and Control of Tuberculosis among Hard to Reach Groups.

NIHR TB Programme Grant 2009-2014

AIMS AND OBJECTIVES:

To improve the management and control of tuberculosis (TB) among homeless people, prisoners and problem drug users (hard to reach groups) by developing and evaluating the effectiveness of novel approaches to case finding and management tailored to the needs of these groups. This will inform service commissioning and augment TB control in London throughout the programme and beyond.

BACKGROUND:

Prisoners, homeless people and problem drug users in London have rates of TB exceeding those seen in many developing countries. They are “hard to reach” because they do not engage well with traditional hospital based services and have chaotic lifestyle factors that complicate management through insecure housing tenure, addiction issues and frequent contact with the criminal justice system. They have a disproportionate impact on TB transmission and control.

RESEARCH PLAN:

We propose a series of interconnected projects which spans the care pathway to evaluate novel interventions for hard to reach TB patients.

Study 1: Cross sectional survey of latent TB infection (using Interferon Gamma Release Assays), HIV, and hepatitis B and C in prisoners and homeless people. Long term follow up using data linkage with national enhanced tuberculosis surveillance (ETS) to assess the risk of progression to active disease.

Study 2: Evaluation of the effectiveness of the new prison X-ray screening system using teleradiology network of static digital X-ray units to reduce the risk from TB in prisons. Long term follow up using data linkage with national ETS will also be established.

Study 3: Cluster randomised controlled trial evaluating impact of peer educators to increase uptake of MXU screening for TB among homeless populations.

Study 4: Establishment and evaluation of a rapid diagnostic pathway for suspected TB cases. This pathway aims to reduce loss to follow up prior to confirmation or rejection of diagnosis of TB.

Study 5: Individually randomised controlled trial of clinic led directly observed therapy (DOT) versus community based DOT organised by a specialist team to inform optimal treatment delivery.

Study 6: Development of a dynamic transmission model to predict public health impact of the interventions and inform economic analysis comparing costs to the savings made through averting future cases.

The study team – The study is led by Professor John Watson (Head of Respiratory Disease at the Health Protection Agency Centre for Infections). The lead researcher is Dr. Andrew Hayward (Reader, UCL Centre for Infectious Disease Epidemiology), co-researcher Alistair Story (Manager, “Find&Treat”), the clinical lead is Dr. Marc Lipman (Clinical Lead – NCL Non-inpatient TB service), and Project Manager is Elizabeth Garber. Sara Hemming and Sue Yates are research nurses on the study. 

For further information about this study please contact the Chief Researcher, Dr. Andrew Hayward at a.hayward@ucl.ac.uk; or Project Manager, Elizabeth Garber at e.garber@ucl.ac.uk – UCL Centre for Infectious Disease Epidemiology.

(based at Mortimer Market)

Ace study- Improving The Detection Active and Latent Tb in Accident and Emergency Departments and Evaluation of Health Protection Service Interventions against Tuberculosis

Background

Accident and Emergency (A&E) Departments are an important point of testing and referral for those groups at greatest risk of Tuberculosis (TB) infection.  Currently, A&E Departments contribute about 20% of those diagnosed with TB. The majority of these individuals are most likely to present with symptoms indicative of tuberculosis disease, compared to those attending for other reasons that would have been unlikely to have been tested or referred.

This study will seek to evaluate specific measures currently being undertaken by Public Health England and the NHS to control TB as well as investigate whether case finding for latent and active TB in A&E departments would improve TB control. The economic impact of these interventions will be evaluated, providing a measure of its value for money.     

Study aims and objectives

Aim

To understand the prevalence and cost effectiveness of screening for latent tuberculosis infection and active TB disease in high risk groups attending Accident and Emergency Departments; and evaluate health protection services aimed at improving the diagnosis and management of tuberculosis in high risk groups.

Primary objectives

Work programme 1:

1. To determine the prevalence of latent and active tuberculosis among migrants attending A&E Departments.

2. To investigate the cost effectiveness of screening for latent and active TB in migrants attending A&E Departments.

Work Programme 2:

1. To evaluate the effectiveness and cost effectiveness of the following health protection service developments aimed at improving the diagnosis and management of tuberculosis in high risk groups.

a. Contact tracing around large incidents

b. Screening for latent tuberculosis in primary care in North West London

c. Pre-entry screening for active tuberculosis

2. To evaluate the structure, process and impact of the following health protection service developments aimed at improving the control of tuberculosis

a. Improving the coordination of tuberculosis control in Birmingham

b. Whole system service reviews in Yorkshire and North West London

c. Supporting cohort reviews 

The cost effectiveness of assays of genetic markers for antibiotic resistance in tuberculosis

This review will answer key questions on the clinical impact and cost effectiveness of the use and role of different assays identifying genetic markers associated with multidrug and extensively drug resistant TB in patients with tuberculosis across the UK through

a. Systematic review of the published and grey literature 
b. Transmission dynamic model to determine the implications of secondary transmission. 
c. Decision analytic health economic model of various screening strategies (including different commercial/in house assays, geographically dispersed versus centralised models of service and targeting of rapid testing at various high-risk sub-groups)


Review team

Professor Francis Drobniewski, Queen Mary, University of London 
Dr Ibrahim Abubakar, University College London 
Dr Mark Jit, Public Health England 
Dr Peter White, Imperial College London/Public Health England 
Dr Marc Lipman, University College London 
Dr Joanne Lord, Brunel University 
Dr Andre Charlett, Public Health England 
Dr Nicola Casali, Queen Mary, University of London

HALT (Hepatitis and Latent Tuberculosis) studies

Department of Health Policy Research Programme 015/0306 

Effectiveness of Testing for, and Treatment of, Hard-to-Reach Groups for Hepatitis B Virus and Hepatitis C Virus in England (HALT: Hepatitis)

1. Background

Hard-to-reach groups are defined by lifestyle factors that render engagement with healthcare services problematic; they include homeless persons, people who inject drugs and ex-prisoners. These groups are vulnerable to a range of infectious diseases, often due to living conditions, exposure to injecting drug use, alcoholism, chaotic lifestyle factors, and generally poor physical and psychiatric health. Exposure to, and prevalence of tuberculosis, Hepatitis B virus (HBV) and Hepatitis C virus (HCV), amongst the hard-to-reach is known to be high. Additionally, the same factors that increase exposure can also create barriers to passive presentation for diagnosis and adherence to treatment, both from the groups themselves and within the healthcare system. Thus support mechanisms are often needed to help people through the clinical process after they test positive for an infection.

Peer support and accompanied referrals can be effective measures to improve engagement with clinical services among difficult populations, although there is very little published literature surrounding this approach (particularly in developed countries), within hard-to-reach populations and in the field of hepatitis.

2. Objectives

Evaluate the cost-effectiveness of measures to improve active case finding and case holding in hard-to-reach groups for a) HCV infection and b) HBV infection.

3.  Design

Patient information sheet

Intervention: peer support and accompanied referrals.

Baseline: normal NHS care.

Hard-to-reach individuals who have given informed consent will be screened for HCV, HBV and HIV on mobile screening vans using point-of-care tests. Those who test positive for HIV will be referred to normal care. Those who test positive for HCV or HBV will have venous blood drawn for a second level of testing. Individuals positive for HCV will be randomised to either normal care or the intervention arm. Those positive for HBV will all be placed in the intervention arm. All enrolled participants will be followed up until either completion of their clinical referral or the end of the study.

4.  Outcomes

Primary outcome measures:

Successful engagement with clinical services for HCV (attending three appointments at the Hepatitis Clinic).

Cost effectiveness evaluation of the interventions.

Secondary outcome measures: Successfully reaching a sustained virological response (SVR; an undetectable viral load for 6 months after the end of treatment) against HCV.

Successful engagement, reaching a full clinical diagnosis, or commencing treatment for HBV.

Proportion of hard-to-reach with adequate immune response to HBV vaccine. Factors influencing lack of vaccine uptake

HALT LTBI study: Multi-site, unblinded, randomised trial of prophylactic daily  rifampicin/isoniazid vs. weekly rifapentine/isoniazid  for latent tuberculosis infection (LTBI)

1. Background

Although surveillance systems from western European countries generally indicate a decline in tuberculosis (TB) case rates over the last few decades, there are certain areas with a decreasing pace of reduction or even an increasing rate over recent years. A major obstacle to the control of TB is poor adherence with lengthy and complicated treatment regimens for active (usually 6-9 months)  and latent TB infection (LTBI) (3-6 months). The development of novel treatment strategies with more potent antimycobacterial activity could lead to shorter and simpler regimens, easier to adhere for patients, especially in the LTBI group where patients are healthy, with poor awareness of illness and are at a high risk of discontinuing preventive treatment early.

NICE guidelines, which form the basis of TB management in the UK, do not recommend LTBI treatment in people over 35 years, as the risk of adverse events (mainly liver toxicity) was considered to be too high when balanced across the lifetime risk of developing active TB. However, due to epidemiologic changes in the UK TB patients’ profile, this risk may have risen in the last decade. Elimination requires a focus on sterilising the pool of latently infected individuals from which future TB cases would be generated.

However, the pool of latently infected individuals from which future TB cases would be generated, includes adults aged over 35 years. US, Dutch and Spanish guidelines recommend LTBI treatment with careful monitoring for individuals at risk for developing TB, irrespective of age. A recent paper by Sterling et al (NEJM 2011) described a 12-dose regimen of rifapentine/isoniazid with a low rate of drug-related hepatotoxicity (0.4%) in a group of 3986 LTBI patients with a median age of 36 years (IQR 25-47). Completion rates of this regimen could not be evaluated beyond this study, as these patients had their treatment given under directed observed treatment.

In this study, we will compare the UK standard regimen for LTBI with three months of daily rifampicin/isoniazid, including those patients older than 35 and less than 65, with that described in Sterling’s trial. If a better adherence to treatment and similar rate of adverse events are demonstrated, this study could offer an option to first-choice treatment for LTBI in the UK, both by adding a new regimen and extending it to a larger population.

2. Objectives

Primary objective: To assess completion rates of two different LTBI treatment regimens (daily rifampicin/isoniazid vs. weekly rifapentine/isoniazid).

·     Secondary objectives:

-To assess frequency of adverse events (AE) when individuals are treated for LTBI.

-To build an integrated transmission-dynamic and health economic model to assess the cost-effectiveness of the interventions, as well as cost per quality adjusted life year.

3.  Design

Phase IV, unblinded, randomised, multi-site UK trial

Individuals who present with latent tuberculosis infection (LTBI) at TB clinics and who agree to preventative therapy and give their written informed consent to take part will participate in the trial. Recruited individuals will be randomised to receive either a daily combination of rifampicin/isoniazid (standard practice) vs. a weekly combination of rifapentine/isoniazid (experimental practice) for three months, without Directly Observed Therapy (DOT).

The primary outcome will be treatment completion assessed using self-report, pill counts, a validated questionnaire, and urine tests for Isoniazid metabolites; Secondary outcomes will include: (1) frequency of AE, which will be assessed by a standardised interview procedure and blood tests, including liver function tests (LFT) at baseline and at each visit, utilising a validated grading procedure; (2) cost per quality adjusted life year, using EQ-5D test at baseline and at each visit.

4.  Outcomes

Primary: Completion of treatment regimen.

Secondary: frequency of AE related to treatment for LTBI and cost-effectiveness of the interventions.

How do Peer Advocates in the HALT Hepatitis study gain the trust and acceptance of their clients and NHS staff to help the client attend clinic appointments?

Peer support programmes first started in mental health services. They were successful in getting people, who are often described as ‘hard to reach’ due to their difficulties engaging with health services, or who would struggle with their complexity, on to treatment. A Peer is someone who has had similar life or disease experiences to the client who support them through diagnosis and treatment. In the HALT Hepatitis study this might be a history of homelessness, substance misuse or previous hepatitis. Being able to understand each other’s experiences can develop trust and understanding in the relationship. Evaluations of Peer support programmes have shown the relationship, or connection, to be the reason why they are successful.

Within the health service, patients have been described as having to follow  the ‘rules’ of the health service.  Peer support workers have described themselves as feeling powerless in this system of ‘rules’, but they are able to create a bridge between this world and the client. The shared experiences and relationship they use to do this has been noted but not explored in any other research. Therefore, the specific characteristics or skills of a successful Peer have not been identified. This information could increase the success of Peer support programmes by improving recruitment and training programmes for Peer support workers. This study will try to identify the specific characteristics and skills of a successful Peer.

HALT (Hepatitis and Latent Tuberculosis) studies

Department of Health Policy Research Programme 015/0306 

Effectiveness of Testing for, and Treatment of, Hard-to-Reach Groups for Hepatitis B Virus and Hepatitis C Virus in England (HALT: Hepatitis)

1. Background

Hard-to-reach groups are defined by lifestyle factors that render engagement with healthcare services problematic; they include homeless persons, people who inject drugs and ex-prisoners. These groups are vulnerable to a range of infectious diseases, often due to living conditions, exposure to injecting drug use, alcoholism, chaotic lifestyle factors, and generally poor physical and psychiatric health. Exposure to, and prevalence of tuberculosis, Hepatitis B virus (HBV) and Hepatitis C virus (HCV), amongst the hard-to-reach is known to be high. Additionally, the same factors that increase exposure can also create barriers to passive presentation for diagnosis and adherence to treatment, both from the groups themselves and within the healthcare system. Thus support mechanisms are often needed to help people through the clinical process after they test positive for an infection.

Peer support and accompanied referrals can be effective measures to improve engagement with clinical services among difficult populations, although there is very little published literature surrounding this approach (particularly in developed countries), within hard-to-reach populations and in the field of hepatitis.

2. Objectives

Evaluate the cost-effectiveness of measures to improve active case finding and case holding in hard-to-reach groups for a) HCV infection and b) HBV infection.

3.  Design

Patient information sheet

Intervention: peer support and accompanied referrals.

Baseline: normal NHS care.

Hard-to-reach individuals who have given informed consent will be screened for HCV, HBV and HIV on mobile screening vans using point-of-care tests. Those who test positive for HIV will be referred to normal care. Those who test positive for HCV or HBV will have venous blood drawn for a second level of testing. Individuals positive for HCV will be randomised to either normal care or the intervention arm. Those positive for HBV will all be placed in the intervention arm. All enrolled participants will be followed up until either completion of their clinical referral or the end of the study.

4.  Outcomes

Primary outcome measures:

Successful engagement with clinical services for HCV (attending three appointments at the Hepatitis Clinic).

Cost effectiveness evaluation of the interventions.

Secondary outcome measures: Successfully reaching a sustained virological response (SVR; an undetectable viral load for 6 months after the end of treatment) against HCV.

Successful engagement, reaching a full clinical diagnosis, or commencing treatment for HBV.

Proportion of hard-to-reach with adequate immune response to HBV vaccine. Factors influencing lack of vaccine uptake

HALT LTBI study: Multi-site, unblinded, randomised trial of prophylactic daily  rifampicin/isoniazid vs. weekly rifapentine/isoniazid  for latent tuberculosis infection (LTBI)

1. Background

Although surveillance systems from western European countries generally indicate a decline in tuberculosis (TB) case rates over the last few decades, there are certain areas with a decreasing pace of reduction or even an increasing rate over recent years. A major obstacle to the control of TB is poor adherence with lengthy and complicated treatment regimens for active (usually 6-9 months)  and latent TB infection (LTBI) (3-6 months). The development of novel treatment strategies with more potent antimycobacterial activity could lead to shorter and simpler regimens, easier to adhere for patients, especially in the LTBI group where patients are healthy, with poor awareness of illness and are at a high risk of discontinuing preventive treatment early.

NICE guidelines, which form the basis of TB management in the UK, do not recommend LTBI treatment in people over 35 years, as the risk of adverse events (mainly liver toxicity) was considered to be too high when balanced across the lifetime risk of developing active TB. However, due to epidemiologic changes in the UK TB patients’ profile, this risk may have risen in the last decade. Elimination requires a focus on sterilising the pool of latently infected individuals from which future TB cases would be generated.

However, the pool of latently infected individuals from which future TB cases would be generated, includes adults aged over 35 years. US, Dutch and Spanish guidelines recommend LTBI treatment with careful monitoring for individuals at risk for developing TB, irrespective of age. A recent paper by Sterling et al (NEJM 2011) described a 12-dose regimen of rifapentine/isoniazid with a low rate of drug-related hepatotoxicity (0.4%) in a group of 3986 LTBI patients with a median age of 36 years (IQR 25-47). Completion rates of this regimen could not be evaluated beyond this study, as these patients had their treatment given under directed observed treatment.

In this study, we will compare the UK standard regimen for LTBI with three months of daily rifampicin/isoniazid, including those patients older than 35 and less than 65, with that described in Sterling’s trial. If a better adherence to treatment and similar rate of adverse events are demonstrated, this study could offer an option to first-choice treatment for LTBI in the UK, both by adding a new regimen and extending it to a larger population.

2. Objectives

Primary objective: To assess completion rates of two different LTBI treatment regimens (daily rifampicin/isoniazid vs. weekly rifapentine/isoniazid).

·     Secondary objectives:

-To assess frequency of adverse events (AE) when individuals are treated for LTBI.

-To build an integrated transmission-dynamic and health economic model to assess the cost-effectiveness of the interventions, as well as cost per quality adjusted life year.

3.  Design

Phase IV, unblinded, randomised, multi-site UK trial

Individuals who present with latent tuberculosis infection (LTBI) at TB clinics and who agree to preventative therapy and give their written informed consent to take part will participate in the trial. Recruited individuals will be randomised to receive either a daily combination of rifampicin/isoniazid (standard practice) vs. a weekly combination of rifapentine/isoniazid (experimental practice) for three months, without Directly Observed Therapy (DOT).

The primary outcome will be treatment completion assessed using self-report, pill counts, a validated questionnaire, and urine tests for Isoniazid metabolites; Secondary outcomes will include: (1) frequency of AE, which will be assessed by a standardised interview procedure and blood tests, including liver function tests (LFT) at baseline and at each visit, utilising a validated grading procedure; (2) cost per quality adjusted life year, using EQ-5D test at baseline and at each visit.

4.  Outcomes

Primary: Completion of treatment regimen.

Secondary: frequency of AE related to treatment for LTBI and cost-effectiveness of the interventions.

How do Peer Advocates in the HALT Hepatitis study gain the trust and acceptance of their clients and NHS staff to help the client attend clinic appointments?

Peer support programmes first started in mental health services. They were successful in getting people, who are often described as ‘hard to reach’ due to their difficulties engaging with health services, or who would struggle with their complexity, on to treatment. A Peer is someone who has had similar life or disease experiences to the client who support them through diagnosis and treatment. In the HALT Hepatitis study this might be a history of homelessness, substance misuse or previous hepatitis. Being able to understand each other’s experiences can develop trust and understanding in the relationship. Evaluations of Peer support programmes have shown the relationship, or connection, to be the reason why they are successful.

Within the health service, patients have been described as having to follow  the ‘rules’ of the health service.  Peer support workers have described themselves as feeling powerless in this system of ‘rules’, but they are able to create a bridge between this world and the client. The shared experiences and relationship they use to do this has been noted but not explored in any other research. Therefore, the specific characteristics or skills of a successful Peer have not been identified. This information could increase the success of Peer support programmes by improving recruitment and training programmes for Peer support workers. This study will try to identify the specific characteristics and skills of a successful Peer.

For general information about our group and research, contact Cherry Heaven, Centre Administrator, at c.heaven@ucl.ac.uk


Page last modified on 12 mar 15 09:17