Abstract
BackgroundThroughout the last decade, tuberculosis (TB) treatment success has not surpassed 90%, the global target. The impact of mobile health interventions (MHIs) on TB treatment outcomes is unknown, especially in low- and middle-income countries (LMICs). MHIs, including interactive voice response technology (IVRT), may enhance adherence and retention in the care of patients with tuberculosis and improve TB treatment outcomes. This study seeks to determine the impact of IVRT-based MHI on TB treatment success (treatment completion and cure rates) in patients with TB receiving care at five public health facilities in Uganda.MethodsWe used a theory-based and human-centered design (HCD) to adapt an already piloted software to design “Call for life-TB” (CFL-TB), an MHI that utilizes IVRT to deliver adherence and appointment reminders and allows remote symptom reporting. This open-label, multicenter, randomized controlled trial (RCT), with nested qualitative and economic evaluation studies, will determine the impact of CFL-TB on TB treatment success in patients with drug-susceptible TB in Uganda. Participants (n = 274) at the five study sites will be randomized (1:1 ratio) to either control (standard of care) or intervention (adherence and appointment reminders, and health tips) arms. Multivariable regression models will be used to compare treatment success, adherence to treatment and clinic appointments, and treatment completion at 6 months post-enrolment. Additionally, we will determine the cost-effectiveness, acceptability, and perceptions of stakeholders. The study received national ethical approval and was conducted in accordance with the international ethical guidelines.DiscussionThis randomized controlled trial aims to evaluate interactive voice response technology in the context of resource-limited settings with a high burden of TB and high illiteracy rates. The software to be evaluated was developed using HCD and the intervention was based on the IMB model. The software is tailored to the local context and is interoperable with the MHI ecosystem. The HCD approach ensures higher usability of the MHI by integrating human factors in the prototype development. This research will contribute towards the understanding of the implementation and impact of the MHI on TB treatment outcomes and the health system, especially in LMICs.Trial registrationClinicalTrials.govNCT04709159. Registered on January 14, 2021.
Highlights
The burden and impact of TB on low- and middleincome countries (LMICs) is unprecedented
Study hypothesis We hypothesized that interactive voice response technology (IVRT) will have a 10% higher impact on treatment success than short message service (SMS) intervention; we predict that Call for life-TB” (CFL-TB) will lead to a 15%-point increase in treatment success rate in the intervention arm compared to the standard of care
Sample size determination Based on results from a randomized controlled trial in Kenya that demonstrated a 9% increase in TB treatment success following the use of SMS [12], we hypothesize that the interactive voice response platform will lead to at least a 6% higher impact as compared to SMS reminder treatment success (i.e., a 15%-point difference compared to the control arm)
Summary
The burden and impact of TB on low- and middleincome countries (LMICs) is unprecedented. The disease is one of the leading causes of hospitalization [2] and in-hospital mortality in sub-Saharan Africa [2, 3]. There are limited data on the role and impact of mobile health interventions (MHI) in strengthening TB care systems [9]. The impact of mobile health interventions (MHIs) on TB treatment outcomes is unknown, especially in lowand middle-income countries (LMICs). MHIs, including interactive voice response technology (IVRT), may enhance adherence and retention in the care of patients with tuberculosis and improve TB treatment outcomes. This study seeks to determine the impact of IVRT-based MHI on TB treatment success (treatment completion and cure rates) in patients with TB receiving care at five public health facilities in Uganda
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