PMID- 38081668 OWN - NLM STAT- MEDLINE DCOM- 20231216 LR - 20240124 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 13 IP - 12 DP - 2023 Dec 11 TI - mHealth application for improving treatment outcomes for patients with multidrug-resistant tuberculosis in Vietnam: an economic evaluation protocol for the V-SMART trial. PG - e076778 LID - 10.1136/bmjopen-2023-076778 [doi] LID - e076778 AB - 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. CI - (c) Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Cheng, Qinglu AU - Cheng Q AUID- ORCID: 0000-0002-3701-8760 AD - Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia qcheng@kirby.unsw.edu.au. FAU - Dang, Tho AU - Dang T AD - Woolcock Institute of Medical Research, Hanoi, Vietnam. FAU - Nguyen, Thu-Anh AU - Nguyen TA AUID- ORCID: 0000-0002-2089-2902 AD - Woolcock Institute of Medical Research, Hanoi, Vietnam. AD - Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia. FAU - Velen, Kavindhran AU - Velen K AD - Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia. FAU - Nguyen, Viet Nhung AU - Nguyen VN AD - Vietnam National Tuberculosis Control Program, Hanoi, Vietnam. FAU - Nguyen, Binh Hoa AU - Nguyen BH AUID- ORCID: 0000-0002-1543-4907 AD - Vietnam National Tuberculosis Control Program, Hanoi, Vietnam. FAU - Vu, Dinh Hoa AU - Vu DH AD - Hanoi University of Pharmacy, Hanoi, Vietnam. FAU - Long, Chuong Huynh AU - Long CH AD - Woolcock Institute of Medical Research, Hanoi, Vietnam. FAU - Do, Thu Thuong AU - Do TT AD - Vietnam National Tuberculosis Control Program, Hanoi, Vietnam. FAU - Vu, Truong-Minh AU - Vu TM AD - Ho Chi Minh City Institute for Development Studies, Ho Chi Minh City, Vietnam. FAU - Marks, Guy B AU - Marks GB AUID- ORCID: 0000-0002-8976-8053 AD - Woolcock Institute of Medical Research, Hanoi, Vietnam. AD - School of Clinical Medicine, University of New South Wales, Sydney, New South Wales, Australia. FAU - Yapa, Manisha AU - Yapa M AD - Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia. FAU - Fox, Gregory J AU - Fox GJ AD - Woolcock Institute of Medical Research, Hanoi, Vietnam. AD - Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia. FAU - Wiseman, Virginia AU - Wiseman V AD - Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia. AD - Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK. LA - eng PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20231211 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - Humans MH - *Mobile Applications MH - Cost-Benefit Analysis MH - Vietnam MH - Quality of Life MH - *Tuberculosis, Multidrug-Resistant/drug therapy MH - Treatment Outcome MH - *Telemedicine MH - Randomized Controlled Trials as Topic PMC - PMC10729151 OTO - NOTNLM OT - clinical trial OT - health economics OT - quality of life OT - tuberculosis COIS- Competing interests: None declared. EDAT- 2023/12/12 00:42 MHDA- 2023/12/17 09:45 PMCR- 2023/12/10 CRDT- 2023/12/11 20:53 PHST- 2023/12/17 09:45 [medline] PHST- 2023/12/12 00:42 [pubmed] PHST- 2023/12/11 20:53 [entrez] PHST- 2023/12/10 00:00 [pmc-release] AID - bmjopen-2023-076778 [pii] AID - 10.1136/bmjopen-2023-076778 [doi] PST - epublish SO - BMJ Open. 2023 Dec 11;13(12):e076778. doi: 10.1136/bmjopen-2023-076778.