Document Detail

Randomized controlled trial of trained patient-nominated treatment supporters providing partial directly observed antiretroviral therapy.
MedLine Citation:
PMID:  20453627     Owner:  NLM     Status:  MEDLINE    
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].
CONCLUSION: 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.
Jean B Nachega; Richard E Chaisson; Rene Goliath; Anne Efron; Mohammad A Chaudhary; Malathi Ram; Chelsea Morroni; Hennie Schoeman; Amy R Knowlton; Gary Maartens
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  AIDS (London, England)     Volume:  24     ISSN:  1473-5571     ISO Abbreviation:  AIDS     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-06-18     Completed Date:  2010-12-30     Revised Date:  2013-08-16    
Medline Journal Info:
Nlm Unique ID:  8710219     Medline TA:  AIDS     Country:  England    
Other Details:
Languages:  eng     Pagination:  1273-80     Citation Subset:  IM; X    
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
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MeSH Terms
Antiretroviral Therapy, Highly Active
CD4 Lymphocyte Count
Directly Observed Therapy / methods*,  psychology
Drug Administration Schedule
HIV Infections / drug therapy*,  psychology,  virology
Medication Adherence / psychology,  statistics & numerical data*
Self Care
South Africa
Treatment Outcome
Viral Load
Grant Support
AI 016137/AI/NIAID NIH HHS; AI 068582-01/AI/NIAID NIH HHS; AI 5535901/AI/NIAID NIH HHS; K24 AI001637/AI/NIAID NIH HHS; K24 AI001637-05/AI/NIAID NIH HHS; K24 AI001637-06/AI/NIAID NIH HHS; K24 AI001637-07/AI/NIAID NIH HHS; K24 AI001637-08/AI/NIAID NIH HHS; K24 AI001637-09/AI/NIAID NIH HHS; K24 AI001637-10/AI/NIAID NIH HHS; R01 AI055359/AI/NIAID NIH HHS; R01 AI055359-01A1/AI/NIAID NIH HHS; R01 AI055359-02/AI/NIAID NIH HHS; R01 AI055359-03/AI/NIAID NIH HHS; R01 AI055359-03S1/AI/NIAID NIH HHS; R01 AI055359-04A1/AI/NIAID NIH HHS; R01 AI055359-05/AI/NIAID NIH HHS

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