Effectiveness and Cost-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

OBJECTIVES:

World Health Organisation recommends that electronic medication monitors (EMMs), a form of digital adherence technology, complement directly observed treatment for tuberculosis (TB). However, existing evidence about EMMs effectiveness is inconclusive. We evaluated the effectiveness of a comprehensive package based on EMMs among TB patients in Tibet.

METHODS:

We conducted this pragmatic, unblinded, multi-centre, individually-randomised, controlled, superiority trial in six counties in rural Shigatse, Tibet. Eligible participants were drug-susceptible TB patients aged ≥15 years starting standard TB treatment. TB doctors recruited patients from the public TB dispensary in each county and randomised them to intervention or control. 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, no access to the app, and we did not train family treatment supporters. Our primary outcome was a binary indicator of poor monthly adherence.

RESULTS:

There were 143 to the intervention and 135 to the control. In the intervention arm 9.8% (84/854) of patient treatment months showed poor adherence compared to 36% (287/798) in the control arm. The corresponding intervention versus control adjusted risk difference was -28.7 percentage points (p≤0.001). Five out of six secondary treatment outcomes also demonstrated clear improvements including treatment success, which was 93% (132/142) in the intervention arm and 70.9% in the control arm (95/134), with an adjusted risk difference of 39.8 percentage points (p≤0.001). We will have cost-effectiveness analysis by time of presentation.

CONCLUSIONS:

Our interventions were considerably effective at improving TB treatment adherence and outcomes, and our trial suggests that EMMs adapted to local context may positively impact TB programmes in high-burden and low-resource settings.