Full title: Effectiveness of HIV screening in primary care: a cluster RCT and economic analysis
Acronym: RHIVA 2
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.
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
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
Dr Sarah Creighton, Consultant in HIV Medicine and Sexual Health; Homerton University Hospital NHS Foundation Trust
Dr Jose Figueroa, NHS manager and Deputy Director of Public Health; City and Hackney Teaching Primary Care Trust
Professor Graham Hart, Director, Centre for Sexual Health & HIV Research; Royal Free and University College London Medical School
Professor Richard Ashcroft, Professor of Bioethics; Department of Law, Queen Mary, University of London
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
Heather McMullen, Research Assistant, Centre for Primary Care and Public Health; Blizard Institute, Barts and The London School of Medicine and Dentistry
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
Other Study Contacts
Dr Ines Ushiro-Lumb, Consultant Virologist; Department of Virology; Barts and The London NHS Trust
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
Department of Virology
Barts and The London NHS Trust