Effectiveness of a comprehensive package based on electronic medication monitors at improving treatment outcomes among tuberculosis patients in Tibet: a multi-centre randomised controlled trial

Electronic medication monitors (EMMs) are recommended to complement directly observed treatment (DOT) for tuberculosis (TB) but without conclusive evidence. We conducted this pragmatic, superiority trial in six counties in Shigatse, Tibet. Eligible participants were drug-susceptible TB patients aged ≥15 years starting standard TB treatment. Intervention patients received an EMM box. This included audio medication-adherence reminders and recorded box-opening data, which were transmitted to a cloud-based server accessible to healthcare providers to allow remote adherence monitoring. A linked smartphone app enabled communication between patients and healthcare providers. Control patients received usual care plus a deactivated EMM. Our primary outcome was poor monthly adherence and other secondary treatment outcomes based on national tuberculosis reporting data. We recruited 143 patients to the intervention and 135 to the control. In the intervention arm 10.2% of patient treatment months showed poor adherence compared to 36.5% in the control arm. The corresponding intervention versus control adjusted risk difference was -29.2 percentage points (95% CI: -35.3, -22.2; p≤0.001). Five out of six secondary treatment outcomes also demonstrated clear improvements including treatment success, which was 93.7% in the intervention arm and 73.1% in the control arm, with an adjusted risk difference of 21 percentage points (95% CI: 12.4, 29.4); p≤0.001. Our interventions were considerably effective at improving TB treatment adherence and outcomes, suggesting the comprehensive package for LMICs.