title: Directly observed antiretroviral therapy: a systematic review and meta-analysis of randomised clinical trials.
abstract: BACKGROUND
  Directly observed therapy has been recommended to improve adherence for patients with HIV infection who are on highly active antiretroviral therapy, but the benefit and cost-effectiveness of this approach has not been established conclusively. We did a systematic review and meta-analysis of randomised trials of directly observed versus self-administered antiretroviral treatment.
  
  
  METHODS
  We did duplicate searches of databases (from inception to July 27, 2009), searchable websites of major HIV conferences (up to July, 2009), and lay publications and websites (March-July, 2009) to identify randomised trials assessing directly observed therapy to promote adherence to antiretroviral therapy in adults. Our primary outcome was virological suppression at study completion. We calculated relative risks (95% CIs), and pooled estimates using a random-effects method.
  
  
  RESULTS
  12 studies met our inclusion criteria; four of these were done in groups that were judged to be at high risk of poor adherence (drug users and homeless people). Ten studies reported on the primary outcome (n=1862 participants); we calculated a pooled relative risk of 1.04 (95% CI 0.91-1.20, p=0.55), and noted moderate heterogeneity between the studies (I(2)= 53.8%, 95% CI 0-75.7, p=0.0247) for directly observed versus self-administered treatment.
  
  
  CONCLUSIONS
  Directly observed antiretroviral therapy seems to offer no benefit over self-administered treatment, which calls into question the use of such an approach to support adherence in the general patient population.
  
  
  BACKGROUND
  None.
authors: Médecins Sans Frontières, Cape Town, Western Cape, South Africa. Electronic address: Nathan.ford@joburg.msf.org.
authors: Nathan
authors: N
authors: Ford
authors: Department of Medicine and Centre for Infectious Diseases, Faculty of Health Sciences, Stellenbosch University, Cape Town, Western Cape, South Africa; Department of International Health and Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Department of Medicine, University of Cape Town, Cape Town, Western Cape, South Africa.
authors: Jean B
authors: JB
authors: Nachega
authors: Department of Medicine, University of Cape Town, Cape Town, Western Cape, South Africa.
authors: Mark E
authors: ME
authors: Engel
authors: Faculty of Health Sciences, University of Ottawa, Ottawa, ON, Canada.
authors: Edward J
authors: EJ
authors: Mills
mesh_terms: D023241:Antiretroviral Therapy, Highly Active; D006801:Humans; D016032:Randomized Controlled Trials as Topic