mHealth application for improving treatment outcomes for patients with multidrug-resistant tuberculosis in Vietnam: an economic evaluation protocol for the V-SMART trial

BMJ Open - Tập 13 Số 12 - Trang e076778 - 2023
Qinglu Cheng1,2, Tho Dang3, Thu-Anh Nguyen3,4,5, Kavindhran Velen4,5, Viet Nhung Nguyen6, Binh Hoa Nguyen6, Dinh Hoa Vu7, Chuong Huynh Long3, Thu Thuong Do6, Truong-Minh Vu8, Guy B Marks3,9,2, Manisha Yapa4,5, Gregory J Fox3,4,5, Virginia Wiseman1,2,10,11
1Kirby Institute
2University of New South Wales
3Woolcock Institute of Medical Research
4Faculty of Medicine and Health
5The University of Sydney
6Vietnam National Tuberculosis Control Program
8Ho Chi Minh city Institute for Development Studies
9School of Clinical Medicine
10Department of Global Health and Development
11London School of Hygiene & Tropical Medicine

Tóm tắt

Introduction The Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART) trial is a randomised controlled trial of using mobile health (mHealth) technologies to improve adherence to medications and management of adverse events (AEs) in people with multidrug-resistant tuberculosis (MDR-TB) undergoing treatment in Vietnam. This economic evaluation seeks to quantify the cost-effectiveness of this mHealth intervention from a healthcare provider and societal perspective. Methods and analysis The V-SMART trial will recruit 902 patients treated for MDR-TB across seven participating provinces in Vietnam. Participants in both intervention and control groups will receive standard community-based therapy for MDR-TB. Participants in the intervention group will also have a purpose-designed App installed on their smartphones to report AEs to health workers and to facilitate timely management of AEs. This economic evaluation will compare the costs and health outcomes between the intervention group (mHealth) and the control group (standard of care). Costs associated with delivering the intervention and health service utilisation will be recorded, as well as patient out-of-pocket costs. The health-related quality of life (HRQoL) of study participants will be captured using the 36-Item Short Form Survey (SF-36) questionnaire and used to calculate quality-adjusted life-years (QALYs). Incremental cost-effectiveness ratios (ICERs) will be based on the primary outcome (proportion of patients with treatment success after 24 months) and QALYs gained. Sensitivity analysis will be conducted to test the robustness of the ICERs. A budget impact analysis will be conducted from a payer perspective to provide an estimate of the total budget required to scale-up delivery of the intervention. Ethics and dissemination Ethical approval for the study was granted by the University of Sydney Human Research Ethics Committee (2019/676), the Scientific Committee of the Ministry of Science and Technology, Vietnam (08/QD-HDQL-NAFOSTED) and the Institutional Review Board of the National Lung Hospital, Vietnam (13/19/CT-HDDD). Study findings will be published in peer-reviewed journals and conference proceedings. Trial registration number ACTRN12620000681954.

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