Sustained Benefit From a Long-Term Antiretroviral Adherence Intervention

Authors:
  • EMEdward Morse
    Edward Morse
  • JMJohn P Matts
    John P Matts
  • LALaurie Andrews
    Laurie Andrews
  • CCCarroll Child
    Carroll Child
  • BSBarry Schmetter
    Barry Schmetter
  • GFGerald H Friedland
    Gerald H Friedland
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Abstract
To assess the efficacy of 2 adherence interventions, medication managers (MM) and medication alarms (ALR), among antiretroviral (ARV)-naive persons with HIV initiating ARV therapy. A multicenter, randomized, adherence intervention clinical trial was conducted among participants coenrolled in an HIV ARV strategy study for ARV-naive individuals. Sites were assigned by cluster randomization using a 2 x 2 factorial design to administer MM, ALR, MM + ALR, or neither (control). MM participants received individualized, structured, long-term adherence support from trained MMs. ALR participants received individually programmed ALR alarms for use throughout the study. The 928 participants, followed a median of 30 months, included 22% women and 75% nonwhites; the median baseline CD4 count was 155 cells/mm. First virologic failure was 13% lower in all MM versus no-MM groups (P = 0.13) and 28% lower in MM versus no-MM subgroups randomized to 2-class ARV arms in the parent ARV study (P = 0.01). MM (vs. no-MM) participants had significantly better CD4 cells count (P = 0.01) and adherence (P < 0.001) outcomes. ALR (vs. no-ALR) participants had worse virologic outcomes. This large randomized clinical trial demonstrated that interpersonal structured adherence support was associated with improved long-term medication adherence and virologic and immunologic HIV outcomes.

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