Effect of SMS Reminders, Telephone Calls, and Transport Incentives on Enhancing the Completion of Tuberculosis Diagnosis and Initiation of Treatment for Diagnosed Patients: Protocol for a Randomized Controlled Trial.

Background: Globally, tuberculosis (TB) programs have enhanced efforts to improve case detection, treatment initiation, and monitoring of treatment outcomes. However, less attention has been given to reducing the number of persons with presumed TB who never get tested for TB or those with confirmed TB who never start treatment in endemic regions such as Uganda. Such losses hinder progress toward attaining the 2035 End TB goals. The World Health Organization recommends mobile health (mHealth) interventions such as SMS reminders, telephone calls, mobile apps, and digital monitoring devices to foster universal health coverage. To our knowledge, there is limited evidence on whether these mHealth interventions can increase linkage to care for persons with presumed TB, particularly in sub-Saharan Africa. Objective: We aim to conduct a randomized controlled trial (MILEAGE4TB) whose aim is to assess the effect of SMS reminders, telephone calls, and transport incentives on improving completion of TB diagnosis among persons with presumed TB and initiation of treatment for diagnosed patients in Uganda. Methods: This will be a 5-arm individual randomized controlled trial among persons with presumed TB aged 18 years or older who are referred for Xpert MTB/RIF testing. Participants will be randomly assigned (2:2:2:1:1) to (1) standard of care, (2) SMS reminders only, (3) telephone calls only, (4) SMS reminders and a transport incentive, and (5) telephone calls and a transport incentive. An estimated sample size of 2389 participants will be considered. The primary outcome will be completion of TB diagnosis, defined as submitting a sputum sample for Xpert MTB/RIF testing and receiving test results within 30 days of being identified as having presumptive TB. The secondary outcomes will include (1) TB treatment initiation, which will be defined as starting TB treatment within 30 days of being diagnosed; (2) median turnaround times for TB diagnosis and treatment initiation; and (3) acceptability and feasibility of the interventions. Participants will be followed for 30 days to check whether they have tested for TB and collected their results. Chi-square tests will be performed for categorical outcomes. Analysis will be by intention to treat. Modified Poisson regression models will be used to estimate the effects of the interventions on completion of TB diagnosis and treatment initiation. Results: The study was funded in June 2020 and data collection for the trial started in August 2023. Results from this trial are not yet available. As of August 28, 2025, a total of 2355 participants had been recruited. Data from the preliminary analysis will be ready by December 2025 after all trial activities. Conclusions: This randomized controlled trial will provide insights on the use of mHealth interventions to improve the completion of TB diagnosis among persons with presumed TB and initiation of treatment for diagnosed patients.