Observational studyPloS one2026
Study on the safety evaluation of latent tuberculosis treatment in high‑risk groups for tuberculosis development: Study protocol for a multi‑center prospective observational cohort study in Korea (STEP-TB).
Observational study in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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.
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Who cites it
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTuberculosis preventive treatment (TPT) is essential for tuberculosis elimination; however, evidence on its safety and feasibility in medically complex, high-risk populations is limited. Concerns regarding adverse events frequently hinder treatment initiation and completion in routine clinical practice.
objectivesThe Safety of Preventive Treatment in People at Risk for Tuberculosis (STEP-TB) study aims to generate real-world evidence on the safety of TPT among individuals at high risk of developing active tuberculosis disease and to identify factors associated with adverse events, treatment initiation, adherence, and completion.
methodsSTEP-TB is a multicenter, prospective observational cohort study conducted at four university-affiliated hospitals in the Republic of Korea. Adults aged ≥19 years who are eligible for latent tuberculosis infection (LTBI) testing or TPT according to national guidelines will be enrolled, including individuals with chronic kidney disease, chronic lung disease, diabetes mellitus, immunosuppressive conditions, malignancy, or occupational risk. LTBI testing will be performed using interferon-gamma release assays, and TPT regimens will follow national guidelines. Participants initiating TPT will be followed for up to 12 months from treatment initiation. Those with negative LTBI results or without TPT will be also followed for up to 12 months. Adverse events, treatment adherence, and completion will be systematically assessed. Blood samples, including volumetric absorptive microsampling, will be collected in a subset of participants for pharmacokinetic and pharmacogenetic analyses. OUTCOMES: The primary outcome is the occurrence of adverse events during TPT. Secondary outcomes include TPT completion rates, predictors of non-initiation and discontinuation, and progression to active TB.
conclusionSTEP-TB will provide condition-specific, real-world evidence on TPT safety and implementation, informing clinical decision-making, patient-centered care, and national TB control policies to support the safe expansion of LTBI treatment strategies in Korea. CRIS Registration Number: KCT0011063.
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