Evaluation of patient centred digital adherence technology for tuberculosis treatment outcomes: pragmatic randomised controlled trial

Abstract Objective To evaluate the effectiveness of Tuberculosis Treatment Support Tools (TB-TST), a patient centred digital adherence technology, in improving treatment outcomes among individuals with drug susceptible tuberculosis in Argentina. Design Pragmatic, two arm, parallel randomised controlled trial. Setting Four public reference hospitals in Buenos Aires, Argentina. Participants 555 patients aged ≥16 years with newly diagnosed drug susceptible tuberculosis, recruited between November 2020 and July 2023, randomised to standard of care (n=278) or standard of care plus TB-TST (n=277). Intervention A mobile application that enabled daily adherence reporting, bidirectional messaging with treatment supporters, educational content, and a weekly urine based isoniazid test for verification of adherence. Participants and care givers were aware of their group assignment, but data collectors and data analysts were masked. Main outcome measures The primary outcome was treatment success (cure or treatment completion). Secondary outcomes included loss to follow-up. Analyses used intention-to-treat and per protocol approaches. Results 525 participants (94.6% of the enrolled population) were included in the analysis after exclusion of 30 individuals who deviated from the protocol. In the intention-to-treat analysis, treatment success was higher in the intervention group (208/255; 82%) than in the control group (201/270; 74%). The risk difference was 7.1% (95% confidence interval 1.1% to 14.1%), and the risk ratio was 1.10 (1.00 to 1.20; P=0.04). Loss to follow-up was lower in the intervention group (17% v 24%; risk ratio 0.70, 0.50 to 0.98; P=0.04). Greater benefit was observed among female participants and those aged under 35 years. Conclusions A multifaceted, interactive digital adherence tool improved tuberculosis treatment outcomes, particularly among younger participants and women, showing feasibility and effectiveness in supporting adherence to tuberculosis treatment in low resource settings. Future research should evaluate the impact of app engagement, context factors such as the covid-19 pandemic, cost effectiveness, and use of the tool beyond tuberculosis in the management of chronic diseases. AI powered features and integrated mental health support may enhance the scalability and personalisation of care. Trial registration ClinicalTrials.gov NCT04221789 ; International Registered Report Identifier DERR1-10.2196/28094.