Correlation between pill counts and biologic effects in an HIV-1 prevention clinical trial: implications for measuring adherence

AIDS Behav. 2013 Feb;17(2):632-9. doi: 10.1007/s10461-012-0268-0.

Abstract

Clinic-based pill counts of unused study medication are frequently used to measure adherence in HIV-1 prevention trials. Monthly pill count adherence data from the Partners in Prevention HSV/HIV Transmission Study, a double-blind, placebo controlled trial of twice-daily acyclovir suppression of herpes simplex virus type 2 (HSV-2) in HIV-1 infected persons was used to compare changes between 3,381 placebo and active arm participants in two objective biologic measures of acyclovir's drug activity: reduction in plasma HIV-1 RNA and HSV-2 genital ulcer disease (GUD). Higher acyclovir pill count adherence was associated with greater reductions in plasma HIV-1 RNA and GUD, indicating pill count data is strongly correlated with biological effects of adherence. However, when calculated adherence exceeded 102 % (i.e., fewer pills returned than expected) and when pill counts were missing because bottles were not returned, plasma HIV-1 RNA and GUD effects were diminished, likely indicating periods of non-adherence.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acyclovir / administration & dosage*
  • Adult
  • Africa / epidemiology
  • Antiviral Agents / administration & dosage*
  • Assessment of Medication Adherence*
  • CD4 Lymphocyte Count
  • Double-Blind Method
  • Drug Monitoring / instrumentation
  • Family Characteristics
  • Female
  • HIV Infections / drug therapy
  • HIV Infections / epidemiology
  • HIV Infections / prevention & control*
  • HIV-1 / drug effects*
  • Herpes Genitalis / drug therapy
  • Herpes Genitalis / epidemiology
  • Herpes Genitalis / prevention & control*
  • Humans
  • Male
  • RNA, Viral
  • Reproducibility of Results
  • Viral Load

Substances

  • Antiviral Agents
  • RNA, Viral
  • Acyclovir