Fecal Coliform Bacterial Detection to Assess Enema Adherence in HIV Prevention Clinical Studies

Wutyi S. Aung, Rahul P. Bakshi, Jennifer Breakey, James E. Johnson, Craig W. Hendrix, Ethel Weld, Edward J. Fuchs, Mark A. Marzinke

Research output: Contribution to journalArticlepeer-review

Abstract

Evaluating the efficacy of any HIV prevention strategy is dependent on ensuring and objectively monitoring adherence to the intervention. Medicated rectal enemas are a potential method for providing topical, episodic HIV prophylaxis during receptive anal intercourse. Assessing adherence to recommended enema dosing regimens is essential in evaluating the utility of this strategy. We utilized fecal coliform bacteria on used enema tips as a marker for enema use. Enema tip coliforms were tested by repurposing a microtiter plate-based water quality test designed to detect fecal contamination of water. Coliform detection occurred with 100% sensitivity and specificity when tips were assayed on day of use. The assay performed well post-7 day sample storage at room temperature, yielding a sensitivity of 80% and specificity of 93%. All (n = 64) samples collected in a subset of the DREAM-01 rectal microbicide enema clinical trial tested positive, even when tips were evaluated > 7 days post-reported use. The coliform-based enema tip assay allows monitoring of adherence in interventions involving rectal enemas in a sensitive, specific and inexpensive manner. The test performs well in clinical trial settings.

Original languageEnglish (US)
Pages (from-to)252-258
Number of pages7
JournalAIDS and behavior
Volume23
Issue number1
DOIs
StatePublished - Jan 15 2019

Keywords

  • Adherence
  • Enema
  • PrEP
  • Topical
  • Validation

ASJC Scopus subject areas

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

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