Evidence map›Paper›PMID 40578842›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025

A Real-Time Urine Tenofovir Assay Improves Drug Adherence Among People With HIV With Prior Virologic Failure in a Randomized Controlled Trial.

Gert U van Zyl, Eric Decloedt, Lauren Jennings, Tracy Kellermann, Khethiwe Motha, Marije van Schalkwyk, Chantel Schreuder, Nicola Coetzee, David V Glidden, Catherine Orrell and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05333679 (Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT05333679 nacompletednot on this map

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
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Trial
  3. 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

11 authors.

Gert U van ZylDivision of Medical Virology, Department of Pathology, Stellenbosch University, Cape Town, South Africa.ORCID 0000-0003-3021-5101
Eric DecloedtDivision of Clinical Pharmacology, Department of Medicine, Stellenbosch University, Cape Town, South Africa.ORCID 0000-0003-1815-5150
Lauren JenningsDesmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine and Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0003-4749-2404
Tracy KellermannDivision of Clinical Pharmacology, Department of Medicine, Stellenbosch University, Cape Town, South Africa.ORCID 0000-0003-1542-4976
Khethiwe MothaDivision of Clinical Pharmacology, Department of Medicine, Stellenbosch University, Cape Town, South Africa.ORCID 0000-0001-9003-851X
Marije van SchalkwykDivision of Infectious Diseases, Department of Medicine, Stellenbosch University, Cape Town, South Africa.ORCID 0000-0003-2679-901X
Chantel SchreuderDesmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine and Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0009-0007-9456-3996
Nicola CoetzeeDivision of Medical Virology, Department of Pathology, Stellenbosch University, Cape Town, South Africa.ORCID 0009-0007-5039-3083
David V GliddenDivision of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, UCSF/San Francisco General Hospital, San Francisco, California, USA.ORCID 0000-0001-5888-1419
Catherine OrrellDesmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine and Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0003-1134-7475
Monica GandhiDivision of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, UCSF/San Francisco General Hospital, San Francisco, California, USA.ORCID 0000-0001-6674-5388

Funding

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
Novel methods of pharmacologic monitoring for multidrug resistant tuberculosis treatment in the setting of HIV infectionR01AI123024 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GANDHI, MONICA, METCALFE, JOHN ZAPATA · 2016 to 2020
$3.6M
Urine tenofovir point-of-care test to identify patients in need of ART adherence supportR01AI152119 · NIAID · STELLENBOSCH UNIVERSITY · PI GANDHI, MONICA, ORRELL, CATHERINE · 2020 to 2024
$1.7M
Collaborative Biomedical Research R01AI152119NIAIDNIAID NIH HHS R01 AI123024NIAID NIH HHS R01 AI143340NIAID NIH HHS R01 AI152119NIH HHS 2R01AI143340US National Institutes of Health (NIH) and South African Medical Research Council
6 · The paper itself

Abstract

backgroundScalable strategies to detect and address inadequate adherence to antiretroviral therapy (ART) are a high priority towards meeting UNAIDS 95-95-95 targets. A urine tenofovir rapid assay (UTRA) at the point-of-care improves adherence among pre-exposure prophylaxis recipients and virologic suppression (VS) in a pre-post study of people with HIV (PWH). Here, we conducted the first randomized trial of UTRA-enhanced adherence support vs standard of care among PWH.

methodsParticipants receiving dolutegravir (DTG)- or protease inhibitor (PI)-based ART were randomized to UTRA-enhanced adherence support (n = 100) vs standard of care (n = 100). The primary outcome was VS, HIV-1 RNA <50 copies/mL, at 12-months and secondary outcome was VS at 6 months. To explore ART adherence over the preceding 6-8 weeks, tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) was quantified. C-reactive protein (CRP) was measured as an inflammatory marker.

resultsAt the 12-month visit, 59/80 (74%) in the intervention and 48/75 (64%) in the control arm achieved VS (the same proportion as at 6 months; P = .2); TFV-DP concentrations (median, IQR) in DBS were significantly higher in the intervention arm: 884 (491-1296) vs 598 (239-964) fmol/3-mm DBS punch in the control arm (P < .01). Higher TFV-DP DBS concentrations correlated with a slight decrease in CRP (Spearman's rho = -0.19; P = .02).

conclusionsUTRA-enhanced adherence support did not result in a significantly higher VS rate but was associated with increased TFV-DP in DBS-in turn, associated with lower CRP levels-suggesting that UTRA-enhanced adherence support improves long-term drug exposure and could also reduce HIV-associated inflammation. CLINICAL TRIALS REGISTRATION: clinicaltrials.gov (https://clinicaltrials.gov/study/NCT05333679).

Indexed as

Anti-HIV AgentsHIV InfectionsMedication AdherenceTenofovirAdenineAdultC-Reactive ProteinDolutegravirFemaleHeterocyclic Compounds, 3-RingHIV-1HumansMaleMiddle AgedOrganophosphatesOxazinesAdenineAnti-HIV AgentsC-Reactive ProteinDolutegravirHeterocyclic Compounds, 3-RingOrganophosphatesOxazinesPhosphorous AcidsPiperazinesPyridonesTenofovirtenofovir diphosphateantiretroviral therapy adherencepoint-of-care assaytenofovir diphosphateurine tenofovirvirologic suppression

Identifiers

PMID40578842
PMCPMC12728291

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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.