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AIDS and Behavior

, Volume 23, Issue 1, pp 252–258 | Cite as

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. MarzinkeEmail author
Original Paper

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.

Keywords

PrEP Adherence Enema Topical Validation 

Notes

Acknowledgements

This study was funded by a U19 Grant under the Integrated Preclinical-Clinical Program for HIV Topical Microbicides (IPCP-HTM), Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH) (AI113127).

Funding

This study was funded by a U19 Grant under the Integrated Preclinical-Clinical Program for HIV Topical Microbicides (IPCP-HTM), Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH) (AI113127).

Compliance with Ethical Standards

Conflict of interest

CWH has research contracts with ViiV/GSK and the Bill and Melinda Gates Foundation. WSA, RPB JB, JEJ, EW, EJF, and MAM declare no conflicts of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Within this study, all samples were collected following informed consent under Johns Hopkins University School of Medicine IRB-approved protocols.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Wutyi S. Aung
    • 1
  • Rahul P. Bakshi
    • 1
  • Jennifer Breakey
    • 1
  • James E. Johnson
    • 1
  • Craig W. Hendrix
    • 1
  • Ethel Weld
    • 1
  • Edward J. Fuchs
    • 1
  • Mark A. Marzinke
    • 1
    • 2
    Email author
  1. 1.Division of Clinical Pharmacology, Department of MedicineJohns Hopkins University School of MedicineBaltimoreUSA
  2. 2.Departments of Pathology and MedicineJohns Hopkins University School of MedicineBaltimoreUSA

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