An mHealth app technology to strengthen adverse event management of multi-drug-resistant tuberculosis in Vietnam: Protocol for a process evaluation of the V-SMART trial.

Abstract

Background: Drug-related adverse events cause poorer treatment outcomes amongst people with multi-drug-resistant tuberculosis, exacerbating a major global public health problem. The Harnessing new mHealth technologies to Strengthen the Management of Multi-Drug-Resistant Tuberculosis in Vietnam (V-SMART) trial tests whether a mobile health (mHealth) application (app) can optimise management of drug-related adverse events, within routine health services in Vietnam. Implementation of digital health within routine services is complex and driven by behaviour change as well as a range of health system factors. Understanding implementation is key to informing the evidence base for digital health prior to scale up, despite its potential appeal.

Methods: Through a process evaluation of the V-SMART trial, we aim to (i) understand the multi-drug-resistant tuberculosis service delivery context and how trial procedures are implemented within services; (ii) describe 'dose' and 'reach' of the app; and (iii) understand health worker and patient perspectives of app implementation and identify areas for improvement. To achieve this, we will (i) conduct process maps (patient flow maps) to describe implementation of the mHealth intervention within routine multi-drug-resistant tuberculosis health services including adverse event management pathways at different levels of the health system; (ii) measure app usage by all participating health workers and people with multi-drug-resistant tuberculosis over time; and (iii) conduct a total of up to 45 semi-structured interviews in seven provinces, with people with multi-drug-resistant tuberculosis, health workers, and policymakers, to identify determinants of app uptake and suggestions for future person-centred app design. Interview topic guides are informed by the Theoretical Framework for Acceptability, Normalisation Process Theory, and the Tailored Implementation of Chronic Diseases framework respectively.

Discussion: The process evaluation will strongly complement the parent trial impact evaluation, and the economic evaluation. Moreover, it will inform future tailored approaches to scaling up digital health as part of broader health system strengthening initiatives.