title: Randomized controlled trial of trained patient-nominated treatment supporters providing partial directly observed antiretroviral therapy.
abstract: BACKGROUND
  Directly observed therapy (DOT) for antiretroviral therapy (ART) may improve adherence, but there are limited data on its clinical effectiveness.
  
  
  METHODS
  Adult patients initiating ART in a public clinic in Cape Town, South Africa, were randomized to treatment-supporter DOT-ART or self-administered ART. DOT-ART patients and supporters received baseline and follow-up training and monitoring. The primary endpoints were the proportions of patients with HIV viral load less than 400 copies/ml and change in CD4 cell counts at 12 and 24 months.
  
  
  RESULTS
  Two hundred and seventy-four patients enrolled (137 in each arm) and baseline characteristics were similar for both arms. The study was stopped early for futility by an independent Data and Safety Monitoring Board. In an intention-to-treat analysis, the proportions of patients with viral load less than 400 copies/ml at 12 months were 72.8% in the DOT-ART arm and 68.4% in the Self-ART arm (P = 0.42). DOT-ART patients had greater median CD4 cell count (cells/microl) increases at 6 months [148 (IQR 84-222) vs. 111 (IQR 44-196) P = 0.02] but similar results at all other time-points. Survival was significantly better in the DOT-ART arm (9 deaths, 6.6%) than in the Self-ART arm (20 deaths, 14.6%; log-rank P = 0.02). In Cox regression analysis, mortality was independently associated with study arm [DOT vs. self-ART; HR 0.38, 95% confidence interval (CI) 0.17-0.86].
  
  
  CONCLUSIONS
  DOT-ART showed no effect on virologic outcomes but was associated with greater CD4 cell count increases at 6-month follow-up. Survival was significantly better for DOT-ART compared to Self-ART, but this was not explained by improved virologic or immunologic outcomes.
authors.affiliation: Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
authors.forename: Jean B
authors.initials: JB
authors.lastname: Nachega
authors.forename: Richard E
authors.initials: RE
authors.lastname: Chaisson
authors.forename: Rene
authors.initials: R
authors.lastname: Goliath
authors.forename: Anne
authors.initials: A
authors.lastname: Efron
authors.forename: Mohammad A
authors.initials: MA
authors.lastname: Chaudhary
authors.forename: Malathi
authors.initials: M
authors.lastname: Ram
authors.forename: Chelsea
authors.initials: C
authors.lastname: Morroni
authors.forename: Hennie
authors.initials: H
authors.lastname: Schoeman
authors.forename: Amy R
authors.initials: AR
authors.lastname: Knowlton
authors.forename: Gary
authors.initials: G
authors.lastname: Maartens
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D023801:Directly Observed Therapy / Q000379:methods* / Q000523:psychology; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000523:psychology / Q000821:virology; D015497:HIV-1; D006801:Humans; D008297:Male; D055118:Medication Adherence / Q000523:psychology; D012648:Self Care; D013019:South Africa; D016896:Treatment Outcome; D019562:Viral Load; D016903:Drug Monitoring
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