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Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial
INTRODUCTION: Multidrug-resistant tuberculosis (MDR-TB) remains a major public health problem globally. Long, complex treatment regimens coupled with frequent adverse events have resulted in poor treatment adherence and patient outcomes. Smartphone-based mobile health (mHealth) technologies offer na...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9226862/ https://www.ncbi.nlm.nih.gov/pubmed/35732397 http://dx.doi.org/10.1136/bmjopen-2021-052633 |
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author | Velen, Kavindhran Nguyen, Viet Nhung Nguyen, Binh Hoa Dang, Tho Nguyen, Hoang Anh Vu, Dinh Hoa Do, Thu Thuong Pham Duc, Cuong Nguyen, Huu Lan Pham, Huu Thuong Marais, Ben J Johnston, James Britton, Warwick Beardsley, Justin Negin, Joel Wiseman, Virginia Marks, Guy Barrington Nguyen, Thu Anh Fox, Greg J |
author_facet | Velen, Kavindhran Nguyen, Viet Nhung Nguyen, Binh Hoa Dang, Tho Nguyen, Hoang Anh Vu, Dinh Hoa Do, Thu Thuong Pham Duc, Cuong Nguyen, Huu Lan Pham, Huu Thuong Marais, Ben J Johnston, James Britton, Warwick Beardsley, Justin Negin, Joel Wiseman, Virginia Marks, Guy Barrington Nguyen, Thu Anh Fox, Greg J |
author_sort | Velen, Kavindhran |
collection | PubMed |
description | INTRODUCTION: Multidrug-resistant tuberculosis (MDR-TB) remains a major public health problem globally. Long, complex treatment regimens coupled with frequent adverse events have resulted in poor treatment adherence and patient outcomes. Smartphone-based mobile health (mHealth) technologies offer national TB programmes an appealing platform to improve patient care and management; however, clinical trial evidence to support their use is lacking. This trial will test the hypothesis that an mHealth intervention can improve treatment success among patients with MDR-TB and is cost-effective compared with standard practice. METHODS AND ANALYSIS: A community-based, open-label, parallel-group randomised controlled trial will be conducted among patients treated for MDR-TB in seven provinces of Vietnam. Patients commencing therapy for microbiologically confirmed rifampicin-resistant or multidrug-resistant tuberculosis within the past 30 days will be recruited to the study. Participants will be individually randomised to an intervention arm, comprising use of an mHealth application for treatment support, or a ‘standard care’ arm. In both arms, patients will be managed by the national TB programme according to current national treatment guidelines. The primary outcome measure of effectiveness will be the proportion of patients with treatment success (defined as treatment completion and/or bacteriological cure) after 24 months. A marginal Poisson regression model estimated via a generalised estimating equation will be used to test the effect of the intervention on treatment success. A prospective microcosting of the intervention and within-trial cost-effectiveness analysis will also be undertaken from a societal perspective. Cost-effectiveness will be presented as an incremental cost per patient successfully treated and an incremental cost per quality-adjusted life-year gained. ETHICS: Ethical approval for the study was granted by The University of Sydney Human Research Ethics Committee (2019/676). DISSEMINATION: Study findings will be disseminated to participants and published in peer-reviewed journals and conference proceedings. TRIAL REGISTRATION NUMBER: ACTRN12620000681954. |
format | Online Article Text |
id | pubmed-9226862 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-92268622022-07-08 Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial Velen, Kavindhran Nguyen, Viet Nhung Nguyen, Binh Hoa Dang, Tho Nguyen, Hoang Anh Vu, Dinh Hoa Do, Thu Thuong Pham Duc, Cuong Nguyen, Huu Lan Pham, Huu Thuong Marais, Ben J Johnston, James Britton, Warwick Beardsley, Justin Negin, Joel Wiseman, Virginia Marks, Guy Barrington Nguyen, Thu Anh Fox, Greg J BMJ Open Public Health INTRODUCTION: Multidrug-resistant tuberculosis (MDR-TB) remains a major public health problem globally. Long, complex treatment regimens coupled with frequent adverse events have resulted in poor treatment adherence and patient outcomes. Smartphone-based mobile health (mHealth) technologies offer national TB programmes an appealing platform to improve patient care and management; however, clinical trial evidence to support their use is lacking. This trial will test the hypothesis that an mHealth intervention can improve treatment success among patients with MDR-TB and is cost-effective compared with standard practice. METHODS AND ANALYSIS: A community-based, open-label, parallel-group randomised controlled trial will be conducted among patients treated for MDR-TB in seven provinces of Vietnam. Patients commencing therapy for microbiologically confirmed rifampicin-resistant or multidrug-resistant tuberculosis within the past 30 days will be recruited to the study. Participants will be individually randomised to an intervention arm, comprising use of an mHealth application for treatment support, or a ‘standard care’ arm. In both arms, patients will be managed by the national TB programme according to current national treatment guidelines. The primary outcome measure of effectiveness will be the proportion of patients with treatment success (defined as treatment completion and/or bacteriological cure) after 24 months. A marginal Poisson regression model estimated via a generalised estimating equation will be used to test the effect of the intervention on treatment success. A prospective microcosting of the intervention and within-trial cost-effectiveness analysis will also be undertaken from a societal perspective. Cost-effectiveness will be presented as an incremental cost per patient successfully treated and an incremental cost per quality-adjusted life-year gained. ETHICS: Ethical approval for the study was granted by The University of Sydney Human Research Ethics Committee (2019/676). DISSEMINATION: Study findings will be disseminated to participants and published in peer-reviewed journals and conference proceedings. TRIAL REGISTRATION NUMBER: ACTRN12620000681954. BMJ Publishing Group 2022-06-21 /pmc/articles/PMC9226862/ /pubmed/35732397 http://dx.doi.org/10.1136/bmjopen-2021-052633 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://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://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Public Health Velen, Kavindhran Nguyen, Viet Nhung Nguyen, Binh Hoa Dang, Tho Nguyen, Hoang Anh Vu, Dinh Hoa Do, Thu Thuong Pham Duc, Cuong Nguyen, Huu Lan Pham, Huu Thuong Marais, Ben J Johnston, James Britton, Warwick Beardsley, Justin Negin, Joel Wiseman, Virginia Marks, Guy Barrington Nguyen, Thu Anh Fox, Greg J Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial |
title | Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial |
title_full | Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial |
title_fullStr | Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial |
title_full_unstemmed | Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial |
title_short | Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial |
title_sort | harnessing new mhealth technologies to strengthen the management of multidrug-resistant tuberculosis in vietnam (v-smart trial): a protocol for a randomised controlled trial |
topic | Public Health |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9226862/ https://www.ncbi.nlm.nih.gov/pubmed/35732397 http://dx.doi.org/10.1136/bmjopen-2021-052633 |
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