{"doi":"10.1093/cid/ciaf337","title":"A Real-Time Urine Tenofovir Assay Improves Drug Adherence Among People With HIV With Prior Virologic Failure in a Randomized Controlled Trial","abstract":"BACKGROUND: Scalable 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. METHODS: Participants 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. RESULTS: At 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). CONCLUSIONS: UTRA-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).","journal":"Clinical Infectious Diseases","year":2025,"id":526107,"datarank":0.20794415416798362,"base_score":1.3862943611198906,"endowment":1.3862943611198906,"self_citation_contribution":0.20794415416798362,"citation_network_contribution":0.0,"self_endowment_contribution":0.20794415416798362,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":3,"citer_count":2,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9555,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT05333679"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":261696,"name":"Eric Decloedt","orcid":"0000-0003-1815-5150","position":1,"is_corresponding":false},{"id":1069991,"name":"Lauren Jennings","orcid":"0000-0003-4749-2404","position":2,"is_corresponding":false},{"id":1401169,"name":"Tracy Kellermann","orcid":"0000-0003-1542-4976","position":3,"is_corresponding":false},{"id":1401170,"name":"Khethiwe Motha","orcid":"0000-0001-9003-851X","position":4,"is_corresponding":false},{"id":328859,"name":"Marije Van Schalkwyk","orcid":"0000-0003-2679-901X","position":5,"is_corresponding":false},{"id":1401171,"name":"Chantel Schreuder","orcid":"0009-0007-9456-3996","position":6,"is_corresponding":false},{"id":1401617,"name":"N. Coetzee","orcid":null,"position":7,"is_corresponding":false},{"id":316641,"name":"David V. Glidden","orcid":"0000-0001-5888-1419","position":8,"is_corresponding":false},{"id":371103,"name":"Catherine Orrell","orcid":"0000-0003-1134-7475","position":9,"is_corresponding":false},{"id":639943,"name":"Monica Gandhi","orcid":"0000-0001-6674-5388","position":10,"is_corresponding":false},{"id":69675,"name":"Gert U. van Zyl","orcid":"0000-0003-3021-5101","position":0,"is_corresponding":true}],"reference_count":27,"raw_metadata":null,"created_at":"2026-07-19T02:50:25.860105Z","pmid":"40578842","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}