Evidence map›Paper›PMID 31634188›Full record

ArticleAIDS (London, England)2020

Development and validation of the first point-of-care assay to objectively monitor adherence to HIV treatment and prevention in real-time in routine settings.

Monica Gandhi, Guohong Wang, Roger King, Warren C Rodrigues, Michael Vincent, David V Glidden, Tim R Cressey, Peter Bacchetti, Matthew A Spinelli, Hideaki Okochi and 6 more

2 registry-linked trialsOpen access · greenAbstract readValidation Study
In one paragraph

Article in AIDS (London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 51 papers.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed
4.3field-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.

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
NCT06423612 narecruitingnot on this mapstarted 2025, after this paper: background citation

Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING PUMA)

TypeinterventionalSponsorUniversity of California, San FranciscoRan2025 to 2026Enrolled500ConditionsART AdherenceArmsPOC urine assay informed enhanced ART adherence counselling for viral suppression
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 69 citations in OpenAlex.

  1. 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
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  16. 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
  17. Observational
  18. Review
  19. 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
  20. Article
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

16 authors at 7 institutions in 4 countries.

Monica GandhiDivision of HIV, Infectious Disease, and Global Medicine, Department of Medicine, University of California, San Francisco (UCSF), San Francisco.
Guohong WangAlere Rapid Diagnostics/Abbott Rapid Diagnostics Division (ARDx), Pomona.
Roger KingAlere Rapid Diagnostics/Abbott Rapid Diagnostics Division (ARDx), Pomona.
Warren C RodriguesAlere Rapid Diagnostics/Abbott Rapid Diagnostics Division (ARDx), Pomona.
Michael VincentAlere Rapid Diagnostics/Abbott Rapid Diagnostics Division (ARDx), Pomona.
David V GliddenDepartment of Epidemiology and Biostatistics, UCSF, San Francisco, California, USA.
Tim R CresseyDepartment of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Peter BacchettiDepartment of Epidemiology and Biostatistics, UCSF, San Francisco, California, USA.
Matthew A SpinelliDivision of HIV, Infectious Disease, and Global Medicine, Department of Medicine, University of California, San Francisco (UCSF), San Francisco.
Hideaki OkochiDivision of HIV, Infectious Disease, and Global Medicine, Department of Medicine, University of California, San Francisco (UCSF), San Francisco.
Oraphan SiriprakaisilSanpatong Hospital, Sanpatong, Chiang Mai, Thailand.
Virat KlinbuayaemSanpatong Hospital, Sanpatong, Chiang Mai, Thailand.
Nelly R MugoCentre for Clinical Research, Kenya Medical Research Institute (KEMRI), Thika, Kenya.
Kenneth NgureDepartments of Global Health, Medicine and Epidemiology, University of Washington, Seattle, Washington, USA.
Paul K DrainDepartment of Community Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
Jared M BaetenDepartment of Community Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
University of California, San Francisco · USAbbott (United Kingdom) · GBJomo Kenyatta University of Agriculture and Technology · KESanPaTong Hospital · THHarvard University · USKenya Medical Research Institute · KEUniversity of Washington · US

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI CONNIE L CELUM · 1988 to 2026
$104.9M
Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MALLORY O JOHNSON · 2001 to 2026
$57.4M
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
A Rapid Point-of-Care Test to Improve ART and PrEP AdherenceR01AI136648 · NIAID · UNIVERSITY OF WASHINGTON · PI DRAIN, PAUL K · 2018 to 2020
$2.3M
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
A Point-of-Care Assay to Measure Tenofovir for Monitoring PrEP and ART AdherenceR21AI127200 · NIAID · UNIVERSITY OF WASHINGTON · PI DRAIN, PAUL K · 2016 to 2017
$396k
NIAID NIH HHS P30 AI027757NIAID NIH HHS P30 AI027763NIAID NIH HHS R01 AI098472NIAID NIH HHS R01 AI136648NIAID NIH HHS R01 AI143340NIAID NIH HHS R21 AI127200NIAID NIH HHS T32 AI060530NIMH NIH HHS K23 MH122286NIMH NIH HHS P30 MH062246
6 · The paper itself

Abstract

objectiveHIV prevention and treatment studies demonstrate that pharmacologic adherence metrics are more accurate than self-report. Currently available metrics use liquid-chromatography/tandem-mass-spectrometry (LC-MS/MS), which is expensive and laboratory-based. We developed a specific and sensitive antibody against tenofovir, the backbone of treatment and prevention, but conversion to a lateral flow assay (LFA) - analogous to a urine pregnancy test - is required for point-of-care testing. We describe the development of the first LFA to measure antiretroviral adherence in real-time.

methodsPrevious work in a directly observed therapy study of providing tenofovir disoproxil fumarate (TDF) to HIV-noninfected volunteers at various simulated adherence patterns defined the appropriate cut-off for the LFA (1500 ng tenofovir/ml urine). We developed the LFA using a sample pad for urine; a conjugate pad coated with TFV-specific antibodies conjugated to colloidal gold nanoparticles; a nitrocellulose membrane striped with tenofovir-antigen (test line) and a control line; with an absorbent pad to draw urine across the reaction membrane.

resultsWe tested 300 urine samples collected from the directly observed therapy study by this LFA and the gold-standard method of LC-MS/MS. The LFA demonstrated 97% specificity (95% CI 93-99%) and 99% sensitivity (94-100%) compared with LC-MS/MS. The LFA accurately classified 98% of patients who took a dose within 24 h as adherent.

conclusionWe describe the development and validation of the first point-of-care assay to measure short-term adherence to HIV prevention and treatment in routine settings. The assay is low-cost, easy-to-perform and measures the breakdown product (tenofovir) of both TDF and tenofovir alafenamide (TAF). This assay has the potential to improve HIV and PrEP outcomes worldwide by triggering differentiated service delivery with further study merited.

Indexed as

Drug MonitoringPoint-of-Care TestingAnti-HIV AgentsChromatography, LiquidGoldHIV InfectionsHumansMetal NanoparticlesPre-Exposure ProphylaxisTandem Mass SpectrometryTenofovirAnti-HIV AgentsGoldTenofovir

Identifiers

PMID31634188
PMCPMC7021226
OpenAlexW2980588809

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.