Evidence map›Paper›PMID 29971733›Full record

ArticleAIDS and behavior2019

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

Abstract read
In one paragraph

Article in AIDS and behavior, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Wutyi S AungDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.
Rahul P BakshiDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.
Jennifer BreakeyDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.
James E JohnsonDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.
Craig W HendrixDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.
Ethel WeldDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.
Edward J FuchsDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.
Mark A MarzinkeDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA. mmarzin1@jhmi.edu.

Funding

Tissue pharmacology imaging and modelingU19AI113127 · NIAID · JOHNS HOPKINS UNIVERSITY · PI ANTON, PETER A · 2014 to 2018
$20.7M
Clinical Pharmacology Training ProgramT32GM066691 · NIGMS · JOHNS HOPKINS UNIVERSITY · PI Matthew Michael Ippolito · 2003 to 2026
$6.4M
National Institute of Allergy and Infectious Diseases AI113127NIAID NIH HHS U19 AI113127NIGMS NIH HHS T32 GM066691
6 · The paper itself

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.

Indexed as

Medication AdherencePre-Exposure ProphylaxisAdministration, RectalAdultAnti-HIV AgentsEnemaEnterobacteriaceaeFecesHIV InfectionsHumansMaleMiddle AgedSensitivity and SpecificitySexual BehaviorTenofovirAnti-HIV AgentsTenofovirAdherenceEnemaPrEPTopicalValidation

Identifiers

PMID29971733
PMCPMC6883768

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.