title: Promotion of rapid testing for HIV in primary care (RHIVA2): a cluster-randomised controlled trial.
abstract: BACKGROUND
  Many people with HIV are undiagnosed. Early diagnosis saves lives and reduces onward transmission. We assessed whether an education programme promoting rapid HIV testing in general practice would lead to increased and earlier HIV diagnosis.
  
  
  METHODS
  In this cluster randomised controlled trial in Hackney (London, UK), general practices were randomly assigned (1:1) to offer either opt-out rapid HIV testing to newly registering adults or continue usual care. All practices were invited to take part. Practices were randomised by an independent clinical trials unit statistician with a minimisation program, maintaining allocation concealment. Neither patients nor investigators were masked to treatment allocation. The primary outcome was CD4 count at diagnosis. Secondary outcomes were rate of diagnosis, proportion with CD4 count less than 350 cells per μL, and proportion with CD4 count less than 200 cells per μL. This study is registered with ClinicalTrials.gov, number ISRCTN63473710.
  
  
  RESULTS
  40 of 45 (89%) general practices agreed to participate: 20 were assigned to the intervention group (44 971 newly registered adult patients) and 20 to the control group (38 464 newly registered adult patients), between April 19, 2010, and Aug 31, 2012. Intervention practices diagnosed 32 people with HIV versus 14 in control practices. Mean CD4 count at diagnosis was 356 cells per μL (SD 254) intervention practices versus 270 (SD 257) in control practices (adjusted difference of square root CD4 count 3·1, 95% CI -1·2 to 7·4; p=0·16);); in a pre-planned sensitivity analysis excluding patients diagnosed via antenatal care, the difference was 6·4 (95% CI, 1·2 to 11·6; p=0·017). Rate of HIV diagnosis was 0·30 (95% CI 0·11 to 0·85) per 10 000 patients per year in intervention practices versus 0·07 (0·02 to 0·20) in control practices (adjusted ratio of geometric means 4·51, 95% CI 1·27 to 16·05; p=0·021). 55% of patients in intervention practices versus 73% in control practices had CD4 count less than 350 cells per μL (risk ratio 0·75, 95% CI 0·53 to 1·07). 28% versus 46% had CD4 count less than 200 cells per μL (0·60, 0·32 to 1·13). All patients diagnosed by rapid testing were successfully transferred into specialist care. No adverse events occurred.
  
  
  CONCLUSIONS
  Promotion of opt-out rapid testing in general practice led to increased rate of diagnosis, and might increase early detection, of HIV. We therefore recommend implementation of HIV screening in general practices in areas with high HIV prevalence.
  
  
  BACKGROUND
  UK Department of Health, NHS City and Hackney.
authors.affiliation: Centre for Primary Care and Public Health, Queen Mary University of London, London, UK. Electronic address: w.leber@qmul.ac.uk.
authors.forename: Werner
authors.initials: W
authors.lastname: Leber
authors.affiliation: Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
authors.forename: Heather
authors.initials: H
authors.lastname: McMullen
authors.affiliation: Homerton Sexual Health Services, Homerton University Hospital NHS Foundation Trust, London, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Anderson
authors.affiliation: Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
authors.forename: Nadine
authors.initials: N
authors.lastname: Marlin
authors.affiliation: Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Andreia C
authors.initials: AC
authors.lastname: Santos
authors.affiliation: Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Bremner
authors.affiliation: Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
authors.forename: Kambiz
authors.initials: K
authors.lastname: Boomla
authors.affiliation: Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Kerry
authors.affiliation: Homerton Sexual Health Services, Homerton University Hospital NHS Foundation Trust, London, UK.
authors.forename: Danna
authors.initials: D
authors.lastname: Millett
authors.affiliation: Homerton Sexual Health Services, Homerton University Hospital NHS Foundation Trust, London, UK.
authors.forename: Sifiso
authors.initials: S
authors.lastname: Mguni
authors.affiliation: Homerton Sexual Health Services, Homerton University Hospital NHS Foundation Trust, London, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Creighton
authors.affiliation: NHS City and Hackney, London, UK.
authors.forename: Jose
authors.initials: J
authors.lastname: Figueroa
authors.affiliation: School of Law, Queen Mary University of London, London, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Ashcroft
authors.affiliation: Faculty of Population Health Sciences, University College London, London, UK.
authors.forename: Graham
authors.initials: G
authors.lastname: Hart
authors.affiliation: Centre for Infectious Disease Surveillance and Control, Public Health England, London, UK.
authors.forename: Valerie
authors.initials: V
authors.lastname: Delpech
authors.affiliation: Centre for Infectious Disease Surveillance and Control, Public Health England, London, UK.
authors.forename: Alison
authors.initials: A
authors.lastname: Brown
authors.affiliation: Centre for Infectious Disease Surveillance and Control, Public Health England, London, UK.
authors.forename: Graeme
authors.initials: G
authors.lastname: Rooney
authors.affiliation: Department of Virology, Barts Health NHS Trust, London, UK.
authors.forename: Maria
authors.initials: M
authors.lastname: Sampson
authors.affiliation: Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
authors.forename: Adrian
authors.initials: A
authors.lastname: Martineau
authors.affiliation: Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Fern
authors.initials: F
authors.lastname: Terris-Prestholt
authors.affiliation: Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Griffiths
mesh_terms: D000293:Adolescent; D000328:Adult; D018791:CD4 Lymphocyte Count; D042241:Early Diagnosis; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis*; D006293:Health Promotion; D006801:Humans; D008131:London; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care; D055815:Young Adult