ArticleEClinicalMedicine
Development and Validation of an Immunoassay for Tenofovir in Urine as a Real-Time Metric of Antiretroviral Adherence.
Article in EClinicalMedicine. 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 53 papers.
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
53 citing papers in PubMed, 74 citations in OpenAlex.
- A Urine Tenofovir Point-of-Care Assay Facilitates Positive Antiretroviral Therapy Adherence Discussions Among People Living With HIV and Healthcare Providers-A Mixed-Methods Evaluation in Cape Town, South Africa.Journal of the International AIDS Society · 2026Trial
- Trial
- 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
- 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
- Acceptability and feasibility of a urine-based tenofovir adherence assay for monitoring and providing feedback on PrEP adherence in 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
- Urine tenofovir testing for real-time PrEP adherence feedback: a qualitative study involving transgender women in Uganda.Journal of the International AIDS Society · 2024Trial
- 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
- 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 · 2026Article
- Oral PrEP Use by Transgender Men in Uganda: A Multi-method Evaluation.AIDS and behavior · 2026Article
- Harm Reduction Contingency Management for Stimulant Use Reduction and Antiretroviral Therapy Adherence in HIV Primary Care: Protocol for an Implementation Effectiveness Study.JMIR research protocols · 2025Article
- Rapid Enzymatic Assay for Antiretroviral Drug Monitoring Using CRISPR-Cas12a-Enabled Readout.ACS synthetic biology · 2025Article
- Phone calls to enhance PrEP persistence among Kenyan women accessing postabortal care: a cluster randomized trial.Frontiers in reproductive health · 2025Article
- High recent PrEP adherence with point-of-care urine tenofovir testing and adherence counselling among young African women: results from the INSIGHT cohort.Journal of the International AIDS Society · 2024Observational
- Factors Associated with Usage of Oral-PrEP among Female Sex Workers in Nairobi, Kenya, Assessed by Self-Report and a Point-of-Care Urine Tenofovir Immunoassay.AIDS and behavior · 2024Article
- The Effect of Stigma on Family Planning and HIV Pre-exposure Prophylaxis Decisions of Young Women Accessing Post-Abortion Care in Kenya.AIDS and behavior · 2024Article
- Point-of-care urine tenofovir monitoring of adherence to drive interventions for HIV treatment and prevention.Expert review of molecular diagnostics · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundPharmacologic adherence measures were critical to the interpretation of the tenofovir (TFV)-disoproxil-fumarate/emtricitabine (TDF/FTC) PrEP trials. These measures are being incorporated into PrEP demonstration projects, but currently-available metrics in plasma, cells, hair or urine involve expensive and time-intensive mass-spectrometry (MS)-based methods. No point-of-care method to assess PrEP adherence in real-time has yet been implemented. Antibody-based tests allow for low-cost, easy-to-perform, point-of-care drug detection. In this study, we developed an antibody-based TFV immunoassay and evaluated its test characteristics among individuals taking TDF/FTC.
methodsWe synthesized possible immunogens based on TFV's molecular structure, injected rabbits with the conjugated derivatives, and bled them monthly for subsequent ELISA-testing for TFV-specific antibodies. We purified an antibody with specific TFV binding and created dose-response curves for ELISA-quantification. We then quantified TFV in urine from human participants not taking TDF/FTC and from individuals taking daily TDF/FTC 300 mg/200 mg for 7 days with a 7-day washout period using ELISA with this TFV-specific antibody. ELISA results were compared with the gold-standard test for TFV detection/quantification using liquid-chromatography-tandem-MS (LC-MS/MS).
findingsNone of the urine samples from 115 participants not taking TDF/FTC showed ELISA- reactivity, indicating 100% specificity (95% CI 97-100%) of the immunoassay. Among participants taking TDF/FTC, 67 of 70 samples positive by LC-MS/MS were positive by the ELISA-immunoassay for an estimated diagnostic sensitivity of 96% (95% CI 88-99%). The precision of the assay was high (coefficient of variationb15%). The rank correlation between ELISA and LC-MS/MS values in the 70 quantitative urine TFV levels positive by LC-MS/MS across a wide range of concentrations among participants on TDF/FTC was high (r = 0.96).
interpretationOur antibody-based immunoassay for measuring TFV in urine performed well compared to the gold-standard of LC-MS/MS among individuals taking TDF/FTC. A sensitive and specific immunoassay paves the way for real-time monitoring/feedback on recent adherence to TFV-based regimens, which should optimize interpretation and outcomes during PrEP and ART roll-out.
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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.