ArticleJournal of acquired immune deficiency syndromes (1999)2019
Brief Report: Validation of a Urine Tenofovir Immunoassay for Adherence Monitoring to PrEP and ART and Establishing the Cutoff for a Point-of-Care Test.
Article in Journal of acquired immune deficiency syndromes (1999), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 66 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Pilot Trial to Examine the Feasibility, Acceptability and Impact of an Intervention Using a New Urine-based Tenofovir Adherence Assay
Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)
Who cites it
66 citing papers in PubMed, 1 synthesis or guideline pooled it, 88 citations in OpenAlex.
- Methods to Assess Adult and Adolescent Patients' Adherence to Antimalarial Treatment: A Systematic Review.Frontiers in pharmacology · 2022Pooled it
- Trial
- A Real-Time Urine Tenofovir Assay Improves Drug Adherence Among People With HIV With Prior Virologic Failure in a Randomized Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- Combining HIV prevention Options with Mental health service delivery for Adolescent girls and young women (CHOMA): results of a pilot hybrid effectiveness-implementation randomized trial in South Africa.Journal of the International AIDS Society · 2025Trial
- The Association Between Use of Adherence Support Interventions and Adherence to HIV Preexposure Prophylaxis Among Young South African and Zimbabwean Women in HPTN 082.AIDS and behavior · 2025Trial
- Cost and clinical flow of point-of-care urine tenofovir testing for treatment monitoring among people living with HIV initiating ART in South Africa.Journal of the International AIDS Society · 2025Trial
- The effect of a social network-based intervention on adherence to HIV preexposure prophylaxis and HIV viral suppression among Kenyan fishermen.AIDS (London, England) · 2025Trial
- Comparing PrEP adherence via objective and self-reported measures among fishermen working on Lake Victoria, Kenya.AIDS care · 2025Trial
- Integrated PrEP and STI Services for Transgender Women in Uganda: Qualitative Findings from a Randomized Trial.AIDS and behavior · 2025Trial
- Impact of a point-of-care urine tenofovir assay on adherence to HIV pre-exposure prophylaxis among women in Kenya: a randomised pilot trial.The lancet. HIV · 2024Trial
- Tenofovir, emtricitabine, lamivudine and dolutegravir concentrations in plasma and urine following drug intake cessation in a randomized controlled directly observed pharmacokinetic trial to aid point-of-care testing.The Journal of antimicrobial chemotherapy · 2024Trial
- Contingency Management for Integrated Harm Reduction Among Men Who Have Sex with Men Who Use Methamphetamine in Los Angeles: A Pilot Assessment.AIDS and behavior · 2023Trial
- Women's experience receiving drug feedback and adherence counseling in MTN-025/HOPE - an HIV Prevention open-label trial of the Dapivirine Vaginal Ring.AIDS and behavior · 2022Trial
- Trial
- TransPrEP: Results from the Pilot Study of a Social Network-Based Intervention to Support PrEP Adherence Among Transgender Women in Lima, Peru.AIDS and behavior · 2021Trial
- 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 · 2020Trial
- Urine Tenofovir Concentrations Correlate With Plasma and Relate to Tenofovir Disoproxil Fumarate Adherence: A Randomized, Directly Observed Pharmacokinetic Trial (TARGET Study).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020Trial
- Brief Report: Association Between Pharmacologic Tenofovir Adherence Measures and Subsequent 24-Week Viral Load Outcomes for People With HIV in South Africa.Journal of acquired immune deficiency syndromes (1999) · 2026Article
- Baseline Data on Viral Suppression, Treatment Adherence and Mental Health in Peripartum Girls and Young Women With HIV in Zimbabwe.Journal of the International AIDS Society · 2026Observational
- A Narrative Review of Remote Biospecimen Collection Product and Implementation Considerations for Sexual Health Clinical Research.AIDS and behavior · 2026Review
6 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 5 institutions in 3 countries.
Funding
Abstract
backgroundCurrent pharmacologic adherence monitoring for antiretrovirals involves expensive, labor-intensive liquid chromatography/tandem mass spectrometry (LC-MS/MS)-based methods. Antibody-based assays can monitor and support adherence in real time. We developed a tenofovir (TFV)-based immunoassay and further validated it in a directly observed therapy (DOT) study.
designPharmacologic DOT study of TFV disoproxil fumarate (TDF)/emtricitabine (FTC) administered to HIV-noninfected volunteers.
methodsThe TARGET study provided directly observed TDF 300 mg/FTC 200 mg 7 (high adherence), 4 (moderate), and 2 doses/week (low) to 30 volunteers (10/group) in Thailand, collecting a total of 637 urine samples over 6 weeks of administration and during washout. ELISA measured urine TFV levels by the immunoassay and LC-MS/MS-based concentrations served as the gold standard. A mixed-effects regression model evaluated cutoffs for a point-of-care assay. Performance characteristics of the immunoassay were compared with LC-MS/MS at a chosen cutoff.
resultsMedian TFV levels were 12,000 ng/mL by the immunoassay 1 day after dosing; 5000 ng/mL 2 days after dosing; 1500 ng/mL 3 days after dosing; and below the lower limit of quantification thereafter (≥4 days). An immunoassay cutoff of 1500 ng/mL accurately classified 98% of patients who took a dose 24 hours ago as adherent. The specificity and sensitivity of the immunoassay compared with LC-MS/MS at the 1500 ng/mL cutoff were 99% and 94%; the correlation between TFV levels by the 2 assays was high (0.92, P < 0.00001).
conclusionsWe have developed a novel TFV immunoassay that is highly specific, sensitive, and correlates strongly with LC-MS/MS measurements in a large DOT study. Adherence benchmarks from this DOT study will guide the development of a low-cost rapid point-of-care test for pre-exposure prophylaxis and antiretroviral treatment adherence monitoring and interventions.
Indexed as
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What OpenQuestion holds
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.