Evidence map›Paper›PMID 30649051›Full record

ArticleAIDS (London, England)2019

Low tenofovir level in urine by a novel immunoassay is associated with seroconversion in a preexposure prophylaxis demonstration project.

Matthew A Spinelli, David V Glidden, Warren C Rodrigues, Guohong Wang, Michael Vincent, Hideaki Okochi, Karen Kuncze, Megha Mehrotra, Patricia Defechereux, Susan P Buchbinder and 2 more

4 registry-linked trialsAbstract read
In one paragraph

Article in AIDS (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
4.2field-weighted citation impact, top 5% 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.

NCT03935464 nacompletednot on this mapstarted 2021, after this paper: background citation

Pilot Trial to Examine the Feasibility, Acceptability and Impact of an Intervention Using a New Urine-based Tenofovir Adherence Assay

TypeinterventionalSponsorUniversity of California, San FranciscoRan2021 to 2024Enrolled100ConditionsRisk ReductionArmsPUMA
NCT04772469 nacompletednot on this mapstarted 2021, after this paper: background citation

Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men

TypeinterventionalSponsorUniversity of California, San FranciscoRan2021 to 2023Enrolled934ConditionsHuman Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, HIV Infections, Sexually Transmitted Diseases, ViralArmsProvision of multiple self-tests, Small monetary incentives, Use of SMS/text reminders to motivate adherence to ART or PrEP
NCT05333679 nacompletednot on this mapstarted 2022, after this paper: background citation

Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)

TypeinterventionalSponsorUniversity of California, San FranciscoRan2022 to 2025Enrolled200ConditionsRisk ReductionArmsUTRA, UTRA feedback
NCT05353283 nacompletednot on this mapstarted 2023, after this paper: background citation

PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men

TypeinterventionalSponsorUniversity of California, San FranciscoRan2023 to 2025Enrolled63ConditionsRisk ReductionArmsMotivational Interviewing Counselling, Point-of-care Urine Tenofovir Measurement
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 42 citations in OpenAlex.

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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

12 authors at 5 institutions in 2 countries.

Matthew A SpinelliDivision of HIV, ID, and Global Medicine.
David V GliddenDepartment of Epidemiology and Biostastistics, University of California, San Francisco, San Francisco.
Warren C RodriguesAlere Rapid Diagnostics/Abbott Rapid Diagnostics Division, Pomona.
Guohong WangAlere Rapid Diagnostics/Abbott Rapid Diagnostics Division, Pomona.
Michael VincentAlere Rapid Diagnostics/Abbott Rapid Diagnostics Division, Pomona.
Hideaki OkochiDepartment of Bioengineering and Therapeutic Sciences.
Karen KunczeDepartment of Bioengineering and Therapeutic Sciences.
Megha MehrotraDepartment of Epidemiology and Biostastistics, University of California, San Francisco, San Francisco.
Patricia DefechereuxDepartment of Medicine, University of California, San Francisco.
Susan P BuchbinderBridge HIV, San Francisco Department of Public Health, San Francisco, California, USA.
Robert M GrantDepartment of Medicine, University of California, San Francisco.
Monica GandhiDivision of HIV, ID, and Global Medicine.
University of California, San Francisco · USAbbott (United Kingdom) · GBCenter for Global Health · USSan Francisco Department of Public Health · USSan Francisco General Hospital · US

Funding

Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
Training in HIV Translational ResearchT32AI060530 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Diane V Havlir · 2005 to 2026
$6.4M
Plugging Hair ARV Levels as Adherence Biomarkers into HIV Prevention TrialsR01AI098472 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GANDHI, MONICA · 2012 to 2021
$5.6M
Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING-PUMA)R01AI143340 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 2018 to 2026
$5.6M
“Hair Lengthening”: Using Hair Levels to Interpret Long-Acting PrEP Studies.R37AI098472 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 2023 to 2026
$3.2M
Chemoprophylaxis and HIV Host InteractionsR01AI118575 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANT, ROBERT M. · 2015 to 2019
$2.9M
NIAID NIH HHS P30 AI027763NIAID NIH HHS R01 AI098472NIAID NIH HHS R01 AI118575NIAID NIH HHS R01 AI143340NIAID NIH HHS R37 AI098472NIAID NIH HHS T32 AI060530
6 · The paper itself

Abstract

objectiveWe examined the relationship between urine tenofovir (TFV) levels measured with a novel immunoassay, which permits point-of-care testing, with HIV seroconversion and objective adherence metrics in a large preexposure prophylaxis (PrEP) demonstration project.

designSecondary analysis of stored specimens from an open-label PrEP cohort study.

methodsWe examined the association between undetectable urine TFV levels and HIV seroconversion in iPrEx open-label extension using generalized estimating equations. We examined rank correlations between levels of TFV and emtricitabine in urine, dried blood spots (DBS), and hair and determined the sensitivity and specificity of undetectable urine TFV for predicting dosing cut-offs in DBS.

resultsThe median urinary TFV level was 15 000 ng/ml in those who remained HIV-negative (n = 105; interquartile range: 1000-45 000); 5500 in those who eventually seroconverted (n = 11; interquartile range: 1000-12 500); and all were undetectable at seroconversion (n = 9; P < 0.001). Decreasing strata of urine TFV levels were associated with future HIV seroconversion (P = 0.03). An undetectable urine TFV was 100% sensitive and 81% specific when compared with an undetectable DBS TFV-diphosphate level and 69% sensitive, but 94% specific when compared with low adherence by DBS (<2 doses/week).

conclusionUrine TFV detection by a novel antibody-based assay was associated with protection from HIV acquisition among individuals on PrEP. Urine TFV levels were correlated with hair and DBS levels and undetectable urine TFV was 100% sensitive in detecting nonadherence. By implementing the immunoassay into a point-of-care strip test, PrEP nonadherence could be detected in real-time, allowing rapid intervention.

Indexed as

Pre-Exposure ProphylaxisUrinalysisAdultAnti-HIV AgentsDried Blood Spot TestingFemaleHIV InfectionsHumansImmunoassayMaleMedication AdherencePoint-of-Care TestingProspective StudiesSeroconversionTenofovirAnti-HIV AgentsTenofovir

Identifiers

PMID30649051
PMCPMC6375797
OpenAlexW2910367847

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

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.