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 nat...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e052633.full |
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| author | Ben J Marais Joel Negin James Johnston Virginia Wiseman Greg J Fox Thu Anh Nguyen Binh Hoa Nguyen Viet Nhung Nguyen Justin Beardsley Guy Barrington Marks Kavindhran Velen Tho Dang Hoang Anh Nguyen Dinh Hoa Vu Thu Thuong Do Cuong Pham Duc Huu Lan Nguyen Huu Thuong Pham Warwick Britton |
| author_facet | Ben J Marais Joel Negin James Johnston Virginia Wiseman Greg J Fox Thu Anh Nguyen Binh Hoa Nguyen Viet Nhung Nguyen Justin Beardsley Guy Barrington Marks Kavindhran Velen Tho Dang Hoang Anh Nguyen Dinh Hoa Vu Thu Thuong Do Cuong Pham Duc Huu Lan Nguyen Huu Thuong Pham Warwick Britton |
| author_sort | Ben J Marais |
| collection | DOAJ |
| 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 | Article |
| id | doaj-art-58999d1e049c417094d67755599a79b2 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-58999d1e049c417094d67755599a79b22025-01-27T23:55:09ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-052633Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trialBen J Marais0Joel Negin1James Johnston2Virginia Wiseman3Greg J Fox4Thu Anh Nguyen5Binh Hoa Nguyen6Viet Nhung Nguyen7Justin Beardsley8Guy Barrington Marks9Kavindhran Velen10Tho Dang11Hoang Anh Nguyen12Dinh Hoa Vu13Thu Thuong Do14Cuong Pham Duc15Huu Lan Nguyen16Huu Thuong Pham17Warwick Britton18Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia10 Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, AustraliaDivision of Respiratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada1 Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK1 Central Clinical School, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, AustraliaWoolcock Institute of Medical Research, Hanoi, Viet NamVietnam National Tuberculosis Control Program, Hanoi, VietnamVietnam National Tuberculosis Control Program, Hanoi, VietnamThe Marie Bashir Institute, Westmead Institute for Medical Research, The University of Sydney, Sydney, New South Wales, AustraliaSouth Western Sydney School of Clinical Medicine, University of New South Wales, Sydney, New South Wales, AustraliaFaculty of Health and Medicine, The University of Sydney, Sydney, New South Wales, AustraliaWoolcock Institute of Medical Research, Hanoi, VietnamNational Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi, VietnamHanoi University of Pharmacy, Hanoi, VietnamVietnam National Tuberculosis Control Program, Hanoi, VietnamWoolcock Institute of Medical Research, Glebe, New South Wales, AustraliaPham Ngoc Thach Hospital, Ho Chi Minh City, VietnamHanoi Lung Hospital, Hanoi, VietnamCentenary Institute of Cancer Medicine and Cell Biology, The University of Sydney, Sydney, New South Wales, AustraliaIntroduction 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.https://bmjopen.bmj.com/content/12/6/e052633.full |
| spellingShingle | Ben J Marais Joel Negin James Johnston Virginia Wiseman Greg J Fox Thu Anh Nguyen Binh Hoa Nguyen Viet Nhung Nguyen Justin Beardsley Guy Barrington Marks Kavindhran Velen Tho Dang Hoang Anh Nguyen Dinh Hoa Vu Thu Thuong Do Cuong Pham Duc Huu Lan Nguyen Huu Thuong Pham Warwick Britton Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial BMJ Open |
| 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 |
| url | https://bmjopen.bmj.com/content/12/6/e052633.full |
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