Correlation between pill counts and biologic effects in an HIV-1 prevention clinical trial

Implications for measuring adherence

Deborah J. Donnell, Jared M. Baeten, Ting Hong, Jairam R. Lingappa, Andrew Mujugira, Edith Nakku-Joloba, David Bangsberg, Connie Celum

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)632-639
Number of pages8
JournalAIDS and Behavior
Volume17
Issue number2
DOIs
StatePublished - Feb 2013
Externally publishedYes

Fingerprint

HIV-1
Clinical Trials
Acyclovir
Ulcer
Human Herpesvirus 2
RNA
Placebos
Double-Blind Method
HIV
Pharmaceutical Preparations

Keywords

  • HIV prevention
  • Medication adherence
  • Pill count

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Infectious Diseases
  • Social Psychology

Cite this

Donnell, D. J., Baeten, J. M., Hong, T., Lingappa, J. R., Mujugira, A., Nakku-Joloba, E., ... Celum, C. (2013). Correlation between pill counts and biologic effects in an HIV-1 prevention clinical trial: Implications for measuring adherence. AIDS and Behavior, 17(2), 632-639. https://doi.org/10.1007/s10461-012-0268-0

Correlation between pill counts and biologic effects in an HIV-1 prevention clinical trial : Implications for measuring adherence. / Donnell, Deborah J.; Baeten, Jared M.; Hong, Ting; Lingappa, Jairam R.; Mujugira, Andrew; Nakku-Joloba, Edith; Bangsberg, David; Celum, Connie.

In: AIDS and Behavior, Vol. 17, No. 2, 02.2013, p. 632-639.

Research output: Contribution to journalArticle

Donnell, Deborah J. ; Baeten, Jared M. ; Hong, Ting ; Lingappa, Jairam R. ; Mujugira, Andrew ; Nakku-Joloba, Edith ; Bangsberg, David ; Celum, Connie. / Correlation between pill counts and biologic effects in an HIV-1 prevention clinical trial : Implications for measuring adherence. In: AIDS and Behavior. 2013 ; Vol. 17, No. 2. pp. 632-639.
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