The UK Collaborative HIV Cohort (UK CHIC) Study

Background

Information on HIV infection in the UK comes from a variety of sources; these are often limited in scope

Many clinical centres routinely collect information about HIV-positive patients when they attend:

• This provides an ideal opportunity to study HIV-positive individuals in their clinical setting.

• Existing infrastructure can be used for data collection.• Patients from a wide variety of clinics are included so that the

cohort becomes more representative of HIV-positive people in the UK.

UK CHIC: Objectives

UK CHIC initiated in 2001 to collate routinely collected data from HIV-positive patients attending some of the largest clinical centres in the UK since 1st January 1996

Specific aims are:• to describe the characteristics of patients with HIV under

care • to provide information on exposure to combination antiretroviral therapy (cART) and changes to the immunological, virological and clinical status of patients over time• to monitor the frequency of AIDS and survival over time.

UK CHIC: Participating clinicsClinical centres Clinical centres

Brighton and Sussex University Hospitals NHS Trust

York Teaching Hospital NHS Foundation Trust

Chelsea & Westminster NHS Trust Coventry, University Hospitals Coventry and Warwickshire NHS Trust

Mortimer Market Centre, Central and NW London NHS Foundation Trust

Wolverhampton, The Royal Wolverhampton NHS Trust

Kings College Hospital NHS Trust Chertsey, Ashford and St Peter’s Hospitals NHS Foundation Trust

Royal Free NHS Trust Milton Keynes University Hospital NHS Foundation Trust

St Mary’s, Imperial College Healthcare NHS Trust North Manchester, Pennine Acute Hospitals NHS Trust

Barts and the London NHS Trust

Homerton University Hospital NHS Trust

Edinburgh, The Lothian University Hospitals NHS Trust

North Middlesex University Hospital NHS Trust Collaborators

North Bristol NHS Trust Research Dept. of Infection and Population Health, UCL

Leicester, University Hospitals of Leicester NHS Trust Medical Research Council Clinical Trials Unit at UCL

Middlesbrough, South Tees Hospitals NHS Foundation Trust Public Health England (formerly HPA-CfI)

Woolwich, South London Healthcare NHS Trust

St George’s Healthcare NHS Trust

Inclusion criteria

Patients:• aged > 16 years and seen at any of the centres

since 1/1/1996

Clinics:• electronic data are already available • able to provide data on an annual basis

Funding

Study funded by the MRC since 2001

Funding provides:• some database programming support• project co-ordination• statistical support• limited funding for clinics for provision of data

The database is physically located at MRC CTU – centrally located and ‘independent’ of all clinical centres

The project co-ordinator and principal investigator are based at UCL (Royal Free campus)

Study management

Steering committee meets every 3-6 months with representatives from: - each clinical centre - the coordinating centre - the UK Resistance Database - the patient community

Specific sub-groups: - data management - viral hepatitis co-infection - pregnancy - HIV and ageing - renal outcomes

Data protection policy

• Policy drafted by a sub-group with input from experts in health informatics.

• Data are submitted by secure web-based transfer (FTP), plus encryption.

• Database access is restricted and monitored.• Datasets released for research analyses are approved by the

steering committee, are anonymised, and only include necessary data.

• Personnel with access to the data are made aware of data confidentiality requirements.

Processes

Errors checked and corrected on

source and submitted dataset

Results fed back to clinics and data

managers

Data sent to coordinator by centres

Data checked for consistency

Data entered into main database; error and logical checks performed

Datasets and formats agreed upon by all centres

Data from all centres merged and possible duplicates identified

Final dataset distributed for analysis

Subset of records audited

Datasets

Demographics(patient, centre,

ethnicity, risk group, first and last attendance)

Clinical events - AIDS - serious non-AIDS - death

Antiretroviraltherapy

Hepatitis - A/B/C tests- clinical data

Laboratory-defined toxicities

Adherence Prophylaxis (PCP)(No longer collected) CD4

viral loads

HLA-B*5701Attendance

? future

data items

Data quality checks

missing data items (demographics, drug names, CD4/CD8 counts, HIV RNA)

duplicate patients within same centre duplicate laboratory measurements or AIDS events undetectable viral load at start of treatment CD4 or CD8 counts of zero inconsistent data and dates (e.g. HIV+ve date before HIV-ve

date, any odd or future dates) overlapping drug start/stop dates All queries are investigated and both CHIC and clinic databases

are updated with corrected information

De-duplication process

Individuals may have attended more than one clinical centre.

Potential matches identified by matching date of birth and soundex; other demographic variables are used to determine whether potential matches are definite or indeterminate, e.g.

- HIV+ve dates in same calendar year- dates of death within 1 month- transferred to/from same centre- first/last seen dates are consistent- same country of birth (non-UK only)

Once duplicate patients have been identified, data from individual records are combined.

Improving death data

Many patients do not ‘reappear’ at their clinics for long periods of time; some of these may have left the country and/or may have died.

UK CHIC records are matched to records held at the PHE (which include death data from the Office of National Statistics).

Matches are sent to centres to check that no evidence exists that the patient is still alive; when confirmed, the database is updated.

Cause of death information is collected on forms for deaths =>2006

Audit of data 1% of records from each centre are audited.

Each record ‘recreated’ using data obtained from clinical notes and compared with information stored on database (not CD4 or viral load).

Exact match required for demographic data, and date to within 1 month for dates of starting ART and AIDS events.

Demographic data generally reasonable (a few problems with ethnicity and country of birth); some discrepancies in AIDS events or dates.

Some AIDS events and ARV drugs found in notes but not database and vice versa.

Link to UK HIV Drug Resistance Database

UK CHIC is linked with UK Collaborative Group on HIV Drug Resistance, set up in 2001 to collect information on routinely performed resistance tests in the UK.

Resistance test data (sequences) are collected.

There is substantial overlap of patients in the two databases so clinical information is shared.

Results of over 106,000 resistance tests relating to 66,100 patients are stored on the database – 24,700 patients have linked clinical data in the UK CHIC study (data to end of 2012).

Key findings

Characteristics of cohort

n %

Total number of patients 54153 100.0

Sex: Male

Female

39226

14967

72.4

27.6

Risk group:

MSM

IDU

27023

1764

49.9

3.3Heterosexual

Other/not known

20422

4944

37.7

9.1

Ethnicity: White 28266 52.2

Black African 15051 27.8

Other 7978 14.7

Not known 2858 5.3

Deaths 4799 8.8

CHIC 2014 dataset

Study outputs

Collaborations

UK HIV Drug Resistance database

National Study of HIV in Pregnancy

and Childhood (NSHPC)

Collaborative HIV Paediatric Study

(CHIPS)

TDM RegistryUniversity of

Liverpool

European COHERE

collaboration

Public Health England

(surveillance)

Statistical research/

methodology groups

AcknowledgementsSteering Committee: Jonathan Ainsworth, Sris Allan, Jane Anderson, Abdel Babiker, David Chadwick, Valerie Delpech, David Dunn, Martin Fisher, Brian Gazzard, Richard Gilson, Mark Gompels, Phillip Hay, Teresa Hill, Margaret Johnson, Sophie Jose, Stephen Kegg, Clifford Leen, Fabiola Martin, Dushyant Mital, Mark Nelson, Chloe Orkin, Adrian Palfreeman, Andrew Phillips, Deenan Pillay, Frank Post, Jillian Pritchard, Caroline Sabin (PI), Roy Trevelion, Achim Schwenk, Anjum Tariq, John Walsh.

Central Co-ordination: Teresa Hill, Sophie Jose, Andrew Phillips, Caroline Sabin, Alicia Thornton, Susie Huntington (UCL); David Dunn, Adam Glabay (Medical Research Council Clinical Trials Unit [MRC CTU at UCL]).

Participating sites:Brighton and Sussex University Hospitals NHS Trust (M Fisher, N Perry, S Tilbury, E Youssef, D Churchill); Chelsea and Westminster Hospital NHS Foundation Trust, London (B Gazzard, M Nelson, R Everett, D Asboe, S Mandalia); King’s College Hospital NHS Foundation Trust, London (F Post, A Adefisan, C Taylor, Z Gleisner, F Ibrahim, L Campbell); Mortimer Market Centre, University College London (R Gilson, N Brima, I Williams); Royal Free NHS Foundation Trust/University College London (M Johnson, M Youle, F Lampe, C Smith, R Tsintas, C Chaloner, S Hutchinson, C Sabin, A Phillips, T Hill, S Jose, A Thornton, S Huntington); Imperial College Healthcare NHS Trust, London (J Walsh, N Mackie, A Winston, J Weber, F Ramzan, M Carder); Barts and The London NHS Trust, London (C Orkin, J Lynch, J Hand, C de Souza); Homerton University Hospital NHS Trust, London (J Anderson, S Munshi); North Middlesex University Hospital NHS Trust, London (J Ainsworth, A Schwenk, S Miller, C Wood); The Lothian University Hospitals NHS Trust, Edinburgh (C Leen, A Wilson, S Morris); North Bristol NHS Trust (M Gompels, S Allan); Leicester, University Hospitals of Leicester NHS Trust (A Palfreeman, K Memon, A Lewszuk); Middlesbrough, South Tees Hospitals NHS Foundation Trust (D Chadwick, K Baillie); Woolwich, Lewisham and Greenwich NHS Trust (S Kegg, Dr Mitchell, Dr Hunter), St George’s Healthcare NHS Trust (P Hay, M Dhillon); York Teaching Hospital NHS Foundation Trust (F Martin, S Russell-Sharpe, J Gravely); Coventry, University Hospitals Coventry and Warwickshire NHS Trust (S Allan, A Harte, S Clay); Wolverhampton, The Royal Wolverhampton Hospitals NHS Trust (A Tariq, H Spencer, R Jones); Chertsey, Ashford and St Peter’s Hospitals NHS Foundation Trust (J Pritchard, S Cumming, C Atkinson); Milton Keynes University Hospital NHS Foundation Trust (D Mital, V Edgell, J Allen); North Manchester, Pennine Acute Hospitals NHS Trust (A Ustianowski, C Murphy, I Gunder); Public Health England, London (V Delpech); i-Base (R Trevelion).Funding:UK CHIC is funded by the UK Medical Research Council

www.ukchic.org.uk