Measuring adherence by visual inspection of returned empty gel applicators in the CAPRISA 004 microbicide trial. Academic Article uri icon

Overview

abstract

  • In the CAPRISA 004 trial, adherence was estimated as the proportion of reported sex acts covered by two gel doses, which was assessed by counting returned empty gel applicators. The returned empty applicators were inspected visually in a standardized manner for residue on the outside of the applicator, as an indicator of vaginal insertion. Over 15 months, spanning 11,839 study visits by 838 women, a total of 59,800 returned empty applicators were inspected. By visual assessment, 77.5 % of these applicators appeared to have been inserted. To test the accuracy of the assessment we fitted a Cox model and found that the risk for HIV infection was doubled when less than half of the returned empty applicators had been assessed as not inserted in the vagina. Visual inspection enhanced both the accuracy of the adherence measurement and aided identification of mechanical problems with applicator use experienced by women in the trial.

publication date

  • May 1, 2014

Research

keywords

  • Adenine
  • Anti-Infective Agents
  • Coitus
  • Drug Delivery Systems
  • HIV Infections
  • Organophosphonates
  • Patient Compliance

Identity

PubMed Central ID

  • PMC4036812

Scopus Document Identifier

  • 84899640463

Digital Object Identifier (DOI)

  • 10.1007/s10461-014-0749-4

PubMed ID

  • 24623069

Additional Document Info

volume

  • 18

issue

  • 5