Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 19, 2024
Date Accepted: Aug 27, 2025
Effect of Short Message Service reminders (SMS), phone calls and a transport incentive on enhancing completion of TB diagnosis and initiation of treatment for diagnosed patients in Uganda: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Globally, TB programs have enhanced efforts to improve case detection, treatment initiation and monitoring of treatment outcomes. However, there is less attention on reducing the number of presumptive TB patients that never get tested for TB or the confirmed ones that never start treatment in endemic areas, such as Uganda. These losses slow down progress towards attaining the 2035 End TB goals. The World Health Organization (WHO) recommends mobile health (mHealth) interventions such as short message services (SMS), phone calls, mobile phone applications and digital monitoring devices to improve universal health coverage. To our knowledge, there is limited evidence on whether these mHealth interventions can increase linkage to care for presumptive TB patients, particularly in sub-Saharan Africa.
Objective:
We propose a trial (MILEAGE4TB) whose aim is to assess the effect of SMS reminders, phone call reminders and transport incentives on improving linkage to care of presumptive TB patients in Uganda.
Methods:
This will be a five-arm individually randomised controlled trial among presumptive TB patients aged 18 years and above, who are referred for Xpert MTB/RIF testing. Participants will be randomized (2:2:2:1:1) to: (i) standard of care (ii) SMS only (iii) phone call only (iv) SMS and a transport incentive (v) phone call and a transport incentive. An estimated sample size of 2389 participants will be considered. Participants will be followed up for 30 days to see if they tested for TB and collected their results. Those who test positive for TB, will be followed for 14 days to measure treatment initiation. 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:
Results from this trial are not yet available. Recruitment of participants commenced on 14th August 2023. As of 28th December 2024, a total of 2355 participants (98.6%) were recruited. Results are expected once all study activities are complete in June 2025.
Conclusions:
This randomized controlled trial will provide insights on use of mHealth interventions to improve linkage to care of presumptive TB patients. Clinical Trial: The trial was registered at ClinicalTrials.gov, Number:NCT05964842.
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