Mobile Tuberculosis Treatment Support Tools to Increase Treatment Success in Patients with Tuberculosis in Argentina: Protocol for a Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Tuberculosis (TB) is an urgent global health threat and the world’s deadliest infectious disease despite it being largely curable. A critical challenge is to ensure that patients adhere to the full course of treatment to prevent the continued spread of disease and the development of drug resistant disease. Mobile health (mHealth) interventions hold promise to provide the needed adherence support to improve TB treatment outcomes. OBJECTIVE To evaluate the effectiveness of the TB treatment support tools (TB-TSTs) intervention on treatment outcomes (success, default) and to assess patient and provider perceptions of the facilitators and barriers to TB-TST implementation. METHODS The TB-TSTs study is a randomized controlled trial (RCT) with two parallel groups in which 400 adult patients newly diagnosed with TB will be randomly assigned to receive usual care or usual care plus TB-TSTs. Intervention group participants will report treatment progress and interact with a treatment supporter using an innovative interactive smartphone App and a paper-based drug metabolite urine test strip engineered for home use. The primary outcome will be treatment success. Secondary outcomes will include treatment default rates, self-reported adherence, technology use, and usability. We will assess patient and provider perceptions of barriers to implementation and synthesize lessons learned. We hypothesize that the TB-TSTs intervention will be more effective because it allows patients and TB supporters to monitor and address issues in real time and provide tailored support. We will share results with stakeholders and policymakers. RESULTS We anticipated the start of enrollment in November 2020, a delayed start due to the COVID-19 pandemic and complete enrollment by approximately July 2022. Data collection and follow-up is expected to be completed six months after the last patient is enrolled. Results from the analyses based on the primary endpoints are expected to be submitted for publication within a year of data collection completion. CONCLUSIONS This RCT will be the first to our knowledge to evaluate a patient centered remote treatment support strategy using a mobile tool and a home-based direct drug metabolite test. The results will provide robust scientific evidence on effectiveness, implementation, and adoption of the mHealth tools. Findings have broader implications not only for TB adherence but also chronic disease management more generally and will improve our understanding of how to support patients facing challenging treatment regimens. CLINICALTRIAL ClinicalTrials.gov NCT04221789; https://clinicaltrials.gov/ct2/show/NCT04221789