Evidence map›Paper›PMID 36622798›Full record

ArticleClinical pharmacology and therapeutics2023

A Novel Algorithm to Improve PrEP Adherence Monitoring Using Dried Blood Spots.

Aaron S Devanathan, Julie B Dumond, Daijha J C Anderson, Kristen Moody, Amanda J Poliseno, Amanda P Schauer, Craig Sykes, Cynthia L Gay, Elias P Rosen, Angela D M Kashuba and 1 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03218592 (ENLIGHTEN), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.7field-weighted citation impact, top 10% of its field
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.

NCT03218592 phase4completednot on this map

ENLIGHTEN: Establishing Novel Antiretroviral (ARV) Imaging for Hair to Elucidate Non-Adherence

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2017 to 2018Enrolled36ConditionsHIV/AIDSArmsMaraviroc Pill, Dolutegravir Pill, Truvada Pill
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
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  12. A Cross-Biomeasure Study to Optimize Antiretroviral Adherence Estimation.Journal of acquired immune deficiency syndromes (1999) · 2025
    Article
  13. Observational
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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

11 authors at 1 institution in 1 country.

Aaron S DevanathanUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.ORCID 0000-0002-2778-3725
Julie B DumondUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.ORCID 0000-0002-3500-5819
Daijha J C AndersonUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.ORCID 0000-0002-9509-6978
Kristen MoodyUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.
Amanda J PolisenoUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.
Amanda P SchauerUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.
Craig SykesUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.
Cynthia L GayUniversity of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Elias P RosenUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.ORCID 0000-0001-5531-7281
Angela D M KashubaUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.
Mackenzie L CottrellUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.
University of North Carolina at Chapel Hill · US

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Novel Mass Spectrometry Imaging Methods to Quantify Antiretroviral AdherenceR01AI122319 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KASHUBA, ANGELA D, ROSEN, ELIAS · 2016 to 2021
$5.3M
Preventing HIV Infection in Women: Targeting Antiretrovirals to Mucosal TissuesR34AI087065 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KASHUBA, ANGELA D · 2010 to 2010
$111k
NIAID NIH HHS P30 AI050410NIAID NIH HHS R01 AI122319NIAID NIH HHS R34 AI087065
6 · The paper itself

Abstract

Tenofovir diphosphate (TFVdp; an active metabolite of oral HIV pre-exposure prophylaxis (PrEP)) is measured in dried blood spots (DBS) to estimate adherence. However, TFVdp's long half-life in whole blood may lead to misclassification following a recent change in adherence. PrEP's other metabolite, emtricitabine triphosphate (FTCtp), has a shorter half-life in whole blood but adherence thresholds are undefined. We characterized DBS TFVdp and FTCtp concentrations across many dosing scenarios. Population pharmacokinetic models were fit to TFVdp and FTCtp DBS concentrations from a directly observed therapy study (NCT03218592). Concentrations were simulated for 90 days of daily dosing followed by 90 days of 1 to 7 doses/week and for event-driven PrEP (edPrEP) scenarios. Thresholds of 1,000 and 200 fmol/punch, for TFVdp and FTCtp, respectively, were reflective of taking 4 doses/week (a minimum target for effective PrEP in men). TFVdp was < 1,000 fmol/punch for 17 days after initiating daily PrEP and > 1,000 fmol/punch for 62 days after decreasing to 3 doses/week. Respectively, FTCtp was < 200 fmol/punch for 4 days and > 200 fmol/punch for 6 days. Accuracy of edPrEP adherence classification depended on duration between last sex act and DBS sampling for both measures with misclassification ranging from 9-100%. These data demonstrate adherence misclassification by DBS TFVdp for 2 months following a decline in adherence, elucidating the need for FTCtp to estimate recent adherence. We provide proof of principle that individualized interpretation is needed to support edPrEP adherence monitoring. Our collective approach facilitates clinicians' ability to interpret DBS results and administer patient-centric interventions.

Indexed as

Anti-HIV AgentsHIV InfectionsCytidine TriphosphateHumansMaleMedication AdherenceTenofovirThiophenes5-fluoro-1-(2-hydroxymethyl)-1,3-oxathiolane-5-yl-cytidine-5'-triphosphateAnti-HIV AgentsCytidine TriphosphateTenofovirThiophenes

Identifiers

PMID36622798
PMCPMC10023501
OpenAlexW4313830257

What OpenQuestion holds

Textmetadata
LicenceTDM
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Registered trials

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.