Nguyen Binh Hoa, Dang Tho T H, Hoang Duy Trinh, Do Thu Thuong, Van Dinh Luong, Nguyen Viet Nhung, Vu Dinh Hoa, Drabarek Dorothy, Nguyen Tram N B, Vu Dang, Nguyen Thu Anh, Marks Guy B, Negin Joel, Fox Greg J, Bernays Sarah, Yapa H Manisha
The National Lung Hospital, Hanoi, Vietnam.
Hanoi Medical University, Hanoi, Vietnam.
Trop Med Int Health. 2025 Apr;30(4):273-282. doi: 10.1111/tmi.14091. Epub 2025 Feb 16.
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.
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.
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.
与药物相关的不良事件会导致耐多药结核病患者的治疗效果更差，加剧了一个重大的全球公共卫生问题。越南利用新型移动健康技术加强耐多药结核病管理（V-SMART）试验旨在测试一款移动健康（mHealth）应用程序（app）能否在越南的常规卫生服务中优化与药物相关不良事件的管理。在常规服务中实施数字健康很复杂，受行为改变以及一系列卫生系统因素驱动。尽管数字健康具有潜在吸引力，但了解其实施情况是在扩大规模之前为数字健康证据基础提供信息的关键。
通过对V-SMART试验的过程评估，我们旨在：（i）了解耐多药结核病服务提供情况以及试验程序在服务中的实施方式；（ii）描述该应用程序的“使用量”和“覆盖范围”；（iii）了解卫生工作者和患者对应用程序实施的看法并确定改进领域。为实现这一目标，我们将：（i）绘制流程图（患者流程图），以描述mHealth干预措施在常规耐多药结核病卫生服务中的实施情况，包括卫生系统不同层面的不良事件管理途径；（ii）长期测量所有参与的卫生工作者和耐多药结核病患者对应用程序的使用情况；（iii）在七个省份总共进行多达45次半结构化访谈，访谈对象包括耐多药结核病患者、卫生工作者和政策制定者，以确定应用程序采用的决定因素以及未来以患者为中心的应用程序设计建议。访谈主题指南分别参考了可接受性理论框架、正常化过程理论和慢性病定制实施框架。
该过程评估将有力地补充主要试验的影响评估和经济评估。此外，它将为未来扩大数字健康规模的定制方法提供信息，作为更广泛的卫生系统加强举措的一部分。
