Patient-centred digital adherence technology for tuberculosis treatment outcomes: data from a pragmatic randomized controlled trial in Argentina
Description
The dataset contains anonymized individual-level data from a pragmatic two-arm randomized controlled trial conducted in Argentina evaluating the effectiveness of a patient-centred digital adherence technology for tuberculosis (TB) treatment against usual practice for self-administered TB therapy under real-world conditions. The study enrolled 555 patients newly diagnosed with drug-susceptible tuberculosis and compared an intervention integrating: an interactive smartphone application,direct communication with a treatment supporter, and INH adherence verification using a urine-based drug metabolite home test. Participants were randomized in a 1:1 ratio to either the intervention arm or the control arm and followed to assess treatment success and loss to follow-up. Eligibility criteria included: age ≥16 years, newly diagnosed with drug-susceptible TB, regular access to and ability to operate a smart phone independently or with assistance. The TB-TST interactive digital adherence tool improved tuberculosis treatment outcomes. Treatment success was achieved in 82% compared to 74% and loss to follow-up occurred in 17% versus 24.4% in the intervention arm compared to the control arm in the ITT analysis. Greater benefit was observed among females, participants under 35 years and those more engaged with the app. The dataset includes demographic characteristics, clinical baseline variables, randomization arm, adherence-related measures, and treatment outcomes. All data were fully anonymized prior to sharing. No direct identifiers are included. This dataset supports the findings reported in the manuscript currently under peer review at The BMJ (Manuscript ID: BMJ-2025-086808.R1) and is intended to enable transparency, reproducibility, and secondary analyses.
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Steps to reproduce
All participants received standard TB education. Intervention participants were assisted with downloading the app and provided verbal and written instructions, including a demonstration of key app features and how to complete the metabolite test and submit a photo. The app also featured an interactive walkthrough and instructional videos. Participants in the intervention group were instructed to log daily medication intake, report potential side effects, and submit weekly urine test results when prompted via push notifications. Treatment supporters were available during clinical hours and participants were informed that the app was not designed for emergency use. Training, SOPs and treatment supporters’ activities were standardised in the 4 hospitals. They had to access their app's web dashboard daily to check the information sent by patients such as reported symptoms, requests for help, photos of the metabolite test and the daily medication intake report. Follow up: If the patient reported regularly, a positive reinforcement message was sent each week through the app; if patients did not report in the prior 3 days, a message offering help was sent to contact the treatment supporter. If the patient still did not respond within 48 hours, the message was resent and if the patient still did not respond after a week, the supporter was instructed to contact the patient directly by phone, offer to help them restart reporting via the app and record the lack of response on the platform. On average, treatment supporters spent approximately 1 hour a day interacting with their patients. Site coordinators blind to the intervention ascertained treatment outcomes based on the documented follow up information for each visit and the patient's clinical record. Information on control patients was collected from routine follow up documentation of the National TB Program
Institutions
- Instituto de Efectividad Clínica y SanitariaBuenos Aires F.D., Buenos Aires
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Funders
- National Institute of Allergy and Infectious DiseasesNational Institutes of HealthMaryland, BethesdaGrant ID: Grant Number: 1R01AI147129-01