Evidence map›Paper›PMID 32167963›Full record

ArticleJournal of acquired immune deficiency syndromes (1999)2020

Brief Report: High Accuracy of a Real-Time Urine Antibody-Based Tenofovir Point-of-Care Test Compared With Laboratory-Based ELISA in Diverse Populations.

Matthew A Spinelli, Warren C Rodrigues, Guohong Wang, Michael Vincent, David V Glidden, Hideaki Okochi, Randy Stalter, Patricia Defechereux, Madeline Deutsch, Robert M Grant and 5 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Journal of acquired immune deficiency syndromes (1999), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05353283 (PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
0.3field-weighted citation impact, top 30% 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.

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

20 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
  2. Trial
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  4. Point-of-Care Urine Tenofovir Drug-Level Feedback Counseling Improves Long-Term Pre-exposure Prophylaxis Adherence for US Men Who Have Sex With Men in Pilot RCT.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Trial
  5. Trial
  6. Trial
  7. Plasma pharmacokinetics and urinary excretion of tenofovir following cessation in adults with controlled levels of adherence to tenofovir disoproxil fumarate.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2020
    Trial
  8. Observational
  9. Integrating HIV and Stimulant-Use Disorder Treatment: A Pilot Implementation Effectiveness Trial of Contingency Management in HIV Care.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
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  14. Review
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  20. 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

15 authors at 5 institutions in 2 countries.

Matthew A SpinelliDepartment of Medicine, University of California, San Francisco (UCSF), San Francisco, CA.
Warren C RodriguesAbbott Rapid Diagnostics, Pomona, CA.
Guohong WangAbbott Rapid Diagnostics, Pomona, CA.
Michael VincentAbbott Rapid Diagnostics, Pomona, CA.
David V GliddenDepartment of Medicine, University of California, San Francisco (UCSF), San Francisco, CA.
Hideaki OkochiDepartment of Medicine, University of California, San Francisco (UCSF), San Francisco, CA.
Randy StalterDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA.
Patricia DefechereuxDepartment of Medicine, University of California, San Francisco (UCSF), San Francisco, CA.
Madeline DeutschDepartment of Medicine, University of California, San Francisco (UCSF), San Francisco, CA.
Robert M GrantDepartment of Medicine, University of California, San Francisco (UCSF), San Francisco, CA.
Kenneth NgureDepartment of Community Health, Jomo Kenyatta University of Agriculture and Technology, Juja, Kenya; and.
Nelly R MugoCenter for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
Jared M BaetenDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA.
Monica GandhiDepartment of Medicine, University of California, San Francisco (UCSF), San Francisco, CA.
Partners PrEP Study Team
University of California, San Francisco · USAbbott (United States) · USUniversity of Washington · USJomo Kenyatta University of Agriculture and Technology · KEKenya Medical Research Institute · KE

Funding

Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 1988 to 2026
$93.6M
VENEREAL DISEASET32AI007140 · NIAID · UNIVERSITY OF WASHINGTON · PI Julia Cook Dombrowski · 1985 to 2026
$19.4M
Training in HIV Translational ResearchT32AI060530 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Diane V Havlir · 2005 to 2026
$6.4M
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
Chemoprophylaxis and HIV Host InteractionsR01AI118575 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANT, ROBERT M. · 2015 to 2019
$2.9M
PrEP Point-of-Care Brief-Intervention for Adherence among Young Men Who Have Sex with Men (PrEP2-BAY Study)K23MH122286 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI SPINELLI, MATTHEW A. · 2020 to 2024
$1.0M
NIAID NIH HHS P30 AI027763NIAID NIH HHS R01 AI118575NIAID NIH HHS R01 AI143340NIAID NIH HHS T32 AI007140NIAID NIH HHS T32 AI060530NIMH NIH HHS K23 MH122286
6 · The paper itself

Abstract

backgroundTherapeutic drug monitoring measures antiretroviral adherence more accurately than self-report but has not been available at the point-of-care (POC) until now. We compare a novel POC test for urine tenofovir to laboratory-based enzyme-linked immunosorbent assay (ELISA) testing in diverse patient populations urine pre-exposure prophylaxis (PrEP).

settingUrine samples were analyzed using ELISA and the POC lateral flow immunoassay (LFA) test from 2 cohorts of PrEP users taking tenofovir disoproxil fumarate/emtricitabine: the Partners PrEP Study, which recruited Kenyan and Ugandan heterosexual men and women, and the IBrEATHe Study, which recruited US transgender women and men using gender-affirming hormone therapy.

methodsWe calculated the sensitivity, specificity, and accuracy of the POC test compared with ELISA at a cutoff of 1500 ng/mL.

resultsOverall, 684 urine samples were tested from 324 participants in the 2 cohorts. In Partners PrEP, 454 samples from 278 participants (41% women) were tested with a median age of 33 years. In IBrEATHe, 231 samples from 46 individuals (50% transwomen) were tested with a median age of 31 years. Comparison of the LFA read-out to ELISA yielded 100% sensitivity [97.5% one-sided confidence interval (CI) = 99.3%], 98.3% specificity (95% CI = 95.2% to 99.7%), and 99.6% accuracy (95% CI = 98.7% to 99.9%).

conclusionThe sensitivity, specificity, and accuracy of a novel POC test for urine tenofovir all exceeded 98% when compared with a laboratory-based ELISA method when tested in diverse patient populations. Given the LFA's high accuracy and expected low cost, this POC test is a promising tool to support antiretroviral adherence that could be widely scalable to real-world clinical settings.

Indexed as

AdultAntibodiesAnti-HIV AgentsDrug CombinationsDrug MonitoringEmtricitabineEnzyme-Linked Immunosorbent AssayFemaleHIV InfectionsHumansKenyaLaboratoriesMalePatient CompliancePoint-of-Care TestingSensitivity and SpecificityAntibodiesAnti-HIV AgentsDrug CombinationsEmtricitabineTenofovir

Identifiers

PMID32167963
PMCPMC7228855
OpenAlexW3011593245

What OpenQuestion holds

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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.