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RHIVA 2

Full title: Effectiveness of HIV screening in primary care: a cluster RCT and economic analysis

Acronym: RHIVA 2

Research Funder: National Institute for Health Research, Health Technology Assessment Programme

Research status: Ongoing

Study aims and objectives:

The primary objective is to demonstrate that rapid HIV testing integrated into the GP registration health check, when combined with an educational package for health care professionals, increases the rate of HIV testing and diagnoses over and above usual care.

The secondary objective is to demonstrate an increase in proportion of HIV cases diagnosed during early stages of infection, defined as a CD4 count higher than 200 cells per cubic millimetre.

Background:

HIV is a serious but treatable chronic disease affecting more than 80.000 patients in the UK, of who about a quarter (28%) are unaware of their infection (HPA, 2008a). Despite enormous public health efforts, HIV continues to spread in the community. In the year 2007 alone, 7700 new cases of HIV were reported in the UK and nearly a third (31%) of those presented with advanced disease. Until recently, standard HIV care focused on testing of high−risk groups and of those presenting with AIDS−related conditions such as tuberculosis. Early detection of HIV is important to reduce unwitting onward transmission of HIV to partners and children, and to prevent late presentation that is associated with adverse outcomes, notably risk of AIDS and death.

Rapid point of care HIV testing:

Rapid point of care (near patient) HIV testing combined with pre− and post−test counseling has been accepted as an important tool for the prevention and early management of HIV. For patients with a negative test result, rapid point of care HIV testing is a great opportunity for sexual health education to prevent future disease. Patients with a positive test are more likely to attend specialist services to receive adequate treatment and psycho−social support for both the individuals affected and their families.

In East London, rapid HIV testing is being offered routinely on an ‘opt−out’ basis to risk groups in sexual health clinics, charities and community programs. It is now commonly believed that the widening of access to rapid HIV testing in GP surgeries in Hackney would promote both prevention and identification of HIV infection. New expert guidelines recently published by the British HIV Association (BHIVA) recommend universal opt−out HIV testing in primary care in areas where two or more people per 1000 are infected with HIV (BHIVA, 2008). Estimates based on unlinked anonymous data indicate that the numbers for Hackney are four times as high (8 per 1000) (HPA, 2008b). In addition, we have recently demonstrated in a pilot study that rapid point of care HIV testing performed during the new patient health check in a single GP surgery in Hackney was welcomed and accepted by patients and achieved an uptake of 45% (Prost et al., 2009).

Rationale and risk/benefit assessment:

For the reasons given above, data from clinical trials evaluating the feasibility of large-scale rapid HIV testing are timely to inform the ongoing implementation of testing guidelines in Primary Care. More specifically, expansion of rapid point of HIV testing across a large number of surgeries has the potential to:

Demonstrate an increase in the number of patients being tested and diagnosed with HIV

Demonstrate an increase in the number of early diagnoses to reduce unwitting onward transmission of the virus, to prevent medical complications and to lower socio−economic costs associated with late presentation

Normalise and de−stigmatise HIV by strengthening the central role of General Practice in diagnosing and preventing the disease

Investigators

Chief investigator:

Professor Christopher Griffiths, Professor of Primary Care; Centre for Primary Care and Public Health; Blizard Institute, Barts and The London School of Medicine and Dentistry 
Email: c.j.griffiths@qmul.ac.uk

Co-investigator:

Professor Jane Anderson, Consultant in HIV Medicine; Director, Centre for the Study of Sexual Health and HIV; Homerton University Hospital NHS Foundation Trust 
Email: jane.anderson@homerton.nhs.uk

Dr Sarah Creighton, Consultant in HIV Medicine and Sexual Health; Homerton University Hospital NHS Foundation Trust 
Email: sarahcreighton@nhs.net

Dr Jose Figueroa, NHS manager and Deputy Director of Public Health; City and Hackney Teaching Primary Care Trust
Email: jose.figueroa@chpct.nhs.uk

Professor Graham Hart, Director, Centre for Sexual Health & HIV Research; Royal Free and University College London Medical School 
Email: ghart@gum.ucl.ac.uk

Dr Audrey Prost, Lecturer in Medical Anthropology; Centre for International Health & Development; Institute of Child Health, University College London 
Email: audrey.prost@ucl.uk

Dr Fern Terris-Presthold, Lecturer in Economics of HIV; Department of Public Health and Policy; London School of Hygiene and Tropical Medicine 
Email: Fern.Terris-Presthold@lshtm.ac.uk

Professor Richard Ashcroft, Professor of Bioethics; Department of Law, Queen Mary, University of London
Email: r.ashcroft@qmul.ac.uk

Dr Kambiz Boomla, Clinical Senior Lecturer; Centre for Primary Care and Public Health; Blizard Institute, Barts and The London School of Medicine and Dentistry 
Email: k.boomla@qmul.ac.uk

Research team

Project Manager

Dr Werner Leber, NIHR Clinical Lecturer in Primary Care; Centre for Primary Care and Public Health; Blizard Institute, Barts and The London School of Medicine and Dentistry 
Email: werner.leber@nhs.net

Trial Coordinator

Heather McMullen, Research Assistant, Centre for Primary Care and Public Health; Blizard Institute, Barts and The London School of Medicine and Dentistry 
Email: h.mcmullen@qmul.ac.uk

Study Statistician

Dr Stephen Bremner, Lecturer in Medical Statistics; Centre for Primary Care and Public Health; Blizard Institute, Barts and The London School of Medicine and Dentistry 
Email: s.bremner@qmul.ac.uk

Other Study Contacts

Dr Ines Ushiro-Lumb, Consultant Virologist; Department of Virology; Barts and The London NHS Trust 
Email: Ines.Ushiro-Lumb@bartsandthelondon.nhs.uk

Mr Peter Timms, Consultant Clinical Biochemist; Department of Clinical Chemistry; Homerton University Hospital 
Email: peter.timms@homerton.nhs.uk

Staff: Dr Kambiz Boomla; Dr Stephen Bremner; Professor Christopher Griffiths; Heather McMullen.

Collaborators

Barts and The London School of Medicine and Dentistry

Centre for Primary Care and Public Health

City and Hackney Teaching Primary Care Trust

Homerton University Hospital NHS Foundation Trust

Royal Free and UCL Medical School

Centre for Sexual Health & HIV Research

Institute of Child Health, University College London

Centre for International Health & Development

The London School of Hygiene and Tropical Medicine

Laboratories:

Department of Virology

Barts and The London NHS Trust

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