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

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Health economics
Protocol
mHealth application for improving treatment outcomes for patients with multidrug-resistant tuberculosis in Vietnam: an economic evaluation protocol for the V-SMART trial
  1. Qinglu Cheng1,
  2. Tho Dang2,
  3. Thu-Anh Nguyen2,3,
  4. Kavindhran Velen3,
  5. Viet Nhung Nguyen4,
  6. Binh Hoa Nguyen4,
  7. Dinh Hoa Vu5,
  8. Chuong Huynh Long2,
  9. Thu Thuong Do4,
  10. Truong-Minh Vu6,
  11. Guy B Marks2,7,
  12. Manisha Yapa3,
  13. Gregory J Fox2,3,
  14. Virginia Wiseman1,8
  1. 1Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia
  2. 2Woolcock Institute of Medical Research, Hanoi, Vietnam
  3. 3Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
  4. 4Vietnam National Tuberculosis Control Program, Hanoi, Vietnam
  5. 5Hanoi University of Pharmacy, Hanoi, Vietnam
  6. 6Ho Chi Minh City Institute for Development Studies, Ho Chi Minh City, Vietnam
  7. 7School of Clinical Medicine, University of New South Wales, Sydney, New South Wales, Australia
  8. 8Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK
  1. Correspondence to Dr Qinglu Cheng; qcheng{at}kirby.unsw.edu.au

Abstract

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.

  • health economics
  • tuberculosis
  • clinical trial
  • quality of life
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2023-076778

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    Footnotes

    • QC and TD contributed equally.

    • Contributors GJF wrote the proposal for V-SMART project that was awarded funding. VW, GJF, QC and TD conceived and led the design of the study. TAN and KV made important contributions to the design of the study. QC and TD wrote the first draft of the manuscript. TAN, KV, VNN, BHN, DHV, CHL, TTD, T-MV, MY and GBM contributed substantially to manuscript versions. VW supervised the study. All authors revised and approved the final manuscript.

    • Funding This work was supported by funding from the Australian National Health and Medical Research Council (NHMRC; APP 1157643) and the Vietnam National Foundation for Science and Technology Development (NAFOSTED) under grant number NHMRC.108.02-2018.01. GF was supported by a NHMRC Career Development Fellowship (APP 1148372) and NHMRC Leadership Fellowship (APP2007920). The trial sponsor is the Woolcock Institute of Medical Research, Australia.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.