Abstract
Background: Treatment non-adherence is a serious challenge to effective tuberculosis (TB) control in Tibet. In this study, we will pilot and evaluate the effectiveness of using new technologies, including electronic monitors (e-monitors) and a smartphone app, to improve treatment adherence among new pulmonary TB patients in Tibet, China.
Methods: This is a prospective, pragmatic, multicentre, individual-randomized trial with blinded evaluation of outcomes and data analysis, and unblinded treatment. New pulmonary TB patients of Shigatse, Tibet will be randomized to either the intervention or control arm in a 1:1 ration at the time of their diagnoses. All patients will be treated according to the WHO standard TB treatment regimens and China National TB program guidelines. In the control arm, patients will receive their medicines in e-monitors that are deactivated for its reminder function but are able to collect medication adherence history. In the intervention arm, patients will take medications in e-monitors that will record their medication adherence and share with health staff via a smartphone app. Patients will be opted to receive video observed treatment when adherence is problematic. The primary outcome is the rate of poor adherence measured per month during their treatment. It will be calculated from monthly-level data for each patient indicating the number of doses missed per month, with poor monthly adherence defined as the patient having missed ≥20% of doses per month. We will conduct a qualitative process evaluation to explore operational questions regarding acceptability, cultural appropriateness and burden of technology use, a cost-effectiveness analysis and long-term effects on TB control.
Discussion: Our study is one of the first trials to evaluate the use of e-monitors and smartphone app to improve communications between TB patients and health staff in low-and-middle income countries (LMICs). All intervention activities are designed to be embedded into routine practice of TB care with strong local ownership. Through the trial, we intend to understand the effectiveness of our intervention, as well as its feasibility, cost-effectiveness and long-term impact to inform future scale-up in remote areas of China and LMICs.
Trial Registration: Current Controlled Trials ISRCTN52132803, registered on 9 November 2018.
Keywords: Tuberculosis, treatment adherence, mhealth, randomised controlled trial, Tibet
Protocol for a randomised controlled trial to evaluate the effectiveness of improving tuberculosis patients’ treatment adherence via electronic monitors and an app versus usual care in Tibet
