title: Rates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trial.
abstract: BACKGROUND
  Identification of new ways to increase access to antiretroviral therapy in Africa is an urgent priority. We assessed whether home-based HIV care was as effective as was facility-based care.
  
  
  METHODS
  We undertook a cluster-randomised equivalence trial in Jinja, Uganda. 44 geographical areas in nine strata, defined according to ratio of urban and rural participants and distance from the clinic, were randomised to home-based or facility-based care by drawing sealed cards from a box. The trial was integrated into normal service delivery. All patients with WHO stage IV or late stage III disease or CD4-cell counts fewer than 200 cells per microL who started antiretroviral therapy between Feb 15, 2005, and Dec 19, 2006, were eligible, apart from those living on islands. Follow-up continued until Jan 31, 2009. The primary endpoint was virological failure, defined as RNA more than 500 copies per mL after 6 months of treatment. The margin of equivalence was 9% (equivalence limits 0.69-1.45). Analyses were by intention to treat and adjusted for baseline CD4-cell count and study stratum. This trial is registered at http://isrctn.org, number ISRCTN 17184129.
  
  
  RESULTS
  859 patients (22 clusters) were randomly assigned to home and 594 (22 clusters) to facility care. During the first year, 93 (11%) receiving home care and 66 (11%) receiving facility care died, 29 (3%) receiving home and 36 (6%) receiving facility care withdrew, and 8 (1%) receiving home and 9 (2%) receiving facility care were lost to follow-up. 117 of 729 (16%) in home care had virological failure versus 80 of 483 (17%) in facility care: rates per 100 person-years were 8.19 (95% CI 6.84-9.82) for home and 8.67 (6.96-10.79) for facility care (rate ratio [RR] 1.04, 0.78-1.40; equivalence shown). Two patients from each group were immediately lost to follow-up. Mortality rates were similar between groups (0.95 [0.71-1.28]). 97 of 857 (11%) patients in home and 75 of 592 (13%) in facility care were admitted at least once (0.91, 0.64-1.28).
  
  
  CONCLUSIONS
  This home-based HIV-care strategy is as effective as is a clinic-based strategy, and therefore could enable improved and equitable access to HIV treatment, especially in areas with poor infrastructure and access to clinic care.
authors: Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK. Electronic address: shabbar.jaffar@lshtm.ac.uk.
authors: Shabbar
authors: S
authors: Jaffar
authors: Medical Research Council/Uganda Virus Research Institute, Uganda Research Unit on AIDS, Entebbe, Uganda.
authors: Barbara
authors: B
authors: Amuron
authors: Department of International Health, Boston University School of Public Health, Boston, MA, USA.
authors: Susan
authors: S
authors: Foster
authors: The AIDS Support Organisation, Kampala, Uganda.
authors: Josephine
authors: J
authors: Birungi
authors: Medical Research Council/Uganda Virus Research Institute, Uganda Research Unit on AIDS, Entebbe, Uganda.
authors: Jonathan
authors: J
authors: Levin
authors: Medical Research Council/Uganda Virus Research Institute, Uganda Research Unit on AIDS, Entebbe, Uganda.
authors: Geoffrey
authors: G
authors: Namara
authors: The AIDS Support Organisation, Kampala, Uganda.
authors: Christine
authors: C
authors: Nabiryo
authors: Medical Research Council/Uganda Virus Research Institute, Uganda Research Unit on AIDS, Entebbe, Uganda.
authors: Nicaise
authors: N
authors: Ndembi
authors: Medical Research Council/Uganda Virus Research Institute, Uganda Research Unit on AIDS, Entebbe, Uganda.
authors: Rosette
authors: R
authors: Kyomuhangi
authors: Department of National Disease Control, Ministry of Health, Kampala, Uganda.
authors: Alex
authors: A
authors: Opio
authors: US Centers for Disease Control and Prevention, Nairobi, Kenya.
authors: Rebecca
authors: R
authors: Bunnell
authors: US Centers for Disease Control and Prevention, Entebbe, Uganda.
authors: Jordan W
authors: JW
authors: Tappero
authors: US Centers for Disease Control and Prevention, Nairobi, Kenya.
authors: Jonathan
authors: J
authors: Mermin
authors: Infectious Disease Institute, Mulago Hospital, Kampala, Uganda.
authors: Alex
authors: A
authors: Coutinho
authors: Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK; Medical Research Council/Uganda Virus Research Institute, Uganda Research Unit on AIDS, Entebbe, Uganda.
authors: Heiner
authors: H
authors: Grosskurth
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D003153:Community Health Services / Q000379:methods; D005260:Female; D006678:HIV / Q000302:isolation & purification; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006699:Home Care Services; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage; D008297:Male; D019829:Nevirapine / Q000008:administration & dosage; D063065:Organophosphonates / Q000627:therapeutic use; D018119:Stavudine / Q000008:administration & dosage; D000068698:Tenofovir; D014454:Uganda; D015215:Zidovudine / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D019259:Lamivudine; D015215:Zidovudine; D019829:Nevirapine; D000068698:Tenofovir; D018119:Stavudine; D000225:Adenine