Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion
Introduction Low-cost digital adherence technologies (DATs) such as 99DOTS have emerged as an alternative to directly observed therapy (DOT), the current standard for tuberculosis (TB) treatment supervision. However, there are limited data to support DAT scale-up. The ‘DOT to DAT’ trial aims to eval...
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BMJ Publishing Group
2020-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/11/e039895.full |
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| author | Noah Kiwanuka Rebecca Crowder Alex Kityamuwesi Maureen Lamunu Catherine Namale Lynn Kunihira Tinka Agnes Sanyu Nakate Joseph Ggita Patricia Turimumahoro Diana Babirye Denis Oyuku Christopher Allen Berger Austin Tucker Devika Patel Amanda Sammann David Dowdy Turyahabwe Stavia Adithya Cattamanchi Achilles Katamba |
| author_facet | Noah Kiwanuka Rebecca Crowder Alex Kityamuwesi Maureen Lamunu Catherine Namale Lynn Kunihira Tinka Agnes Sanyu Nakate Joseph Ggita Patricia Turimumahoro Diana Babirye Denis Oyuku Christopher Allen Berger Austin Tucker Devika Patel Amanda Sammann David Dowdy Turyahabwe Stavia Adithya Cattamanchi Achilles Katamba |
| author_sort | Noah Kiwanuka |
| collection | DOAJ |
| description | Introduction Low-cost digital adherence technologies (DATs) such as 99DOTS have emerged as an alternative to directly observed therapy (DOT), the current standard for tuberculosis (TB) treatment supervision. However, there are limited data to support DAT scale-up. The ‘DOT to DAT’ trial aims to evaluate the effectiveness and implementation of a 99DOTS-based TB treatment supervision strategy.Methods and analysis This is a pragmatic, stepped-wedge cluster randomised trial, with hybrid type 2 effectiveness-implementation design. The trial will include all adults (estimated N=1890) treated for drug-susceptible pulmonary TB over an 8-month period at 18 TB treatment units in Uganda. Three sites per month will switch from routine care (DOT) to the intervention (99DOTS-based treatment supervision) beginning in month 2, with the order determined randomly. 99DOTS enables patients to be monitored while self-administering TB medicines. Patients receive daily automated short message service (SMS) dosing reminders and confirm dosing by calling toll-free numbers. The primary effectiveness outcome is the proportion of patients completing TB treatment. With 18 clusters randomised into six steps and an average cluster size of 15 patients per month, the study will have 89% power to detect a 10% or greater increase in treatment completion between the routine care and intervention periods. Secondary outcomes include more proximal effectiveness measures as well as quantitative and qualitative assessments of the reach, adoption and implementation of the intervention.Ethics and dissemination Ethics approval was granted by institutional review boards at Makerere University School of Public Health and the University of California San Francisco. Findings will be disseminated through peer-reviewed publications, presentations at scientific conferences and presentations to key stakeholders.Trial registration number PACTR201808609844917. |
| format | Article |
| id | doaj-art-f39a5d1809e54d029cfe921bd3003779 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-f39a5d1809e54d029cfe921bd30037792024-11-26T11:10:10ZengBMJ Publishing GroupBMJ Open2044-60552020-11-01101110.1136/bmjopen-2020-039895Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completionNoah Kiwanuka0Rebecca Crowder1Alex Kityamuwesi2Maureen Lamunu3Catherine Namale4Lynn Kunihira Tinka5Agnes Sanyu Nakate6Joseph Ggita7Patricia Turimumahoro8Diana Babirye9Denis Oyuku10Christopher Allen Berger11Austin Tucker12Devika Patel13Amanda Sammann14David Dowdy15Turyahabwe Stavia16Adithya Cattamanchi17Achilles Katamba18School of Public Health, Makerere University College of Health Sciences, Kampala, UgandaCenter for Tuberculosis and Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, California, USAUganda Tuberculosis Implementation Research Consortium, Kampala, UgandaUganda Tuberculosis Implementation Research Consortium, Kampala, UgandaUganda Tuberculosis Implementation Research Consortium, Kampala, UgandaUganda Tuberculosis Implementation Research Consortium, Kampala, UgandaUganda Tuberculosis Implementation Research Consortium, Kampala, Uganda2 Uganda Tuberculosis Implementation Research Consortium, Kampala, UgandaUganda Tuberculosis Implementation Research Consortium, Kampala, UgandaUganda Tuberculosis Implementation Research Consortium, Kampala, UgandaUganda Tuberculosis Implementation Research Consortium, Kampala, UgandaCenter for Tuberculosis and Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, California, USADepartment of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USAThe Better Lab, Department of Surgery, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, California, USAThe Better Lab, Department of Surgery, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, California, USADepartment of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USANational Tuberculosis and Leprosy Program, Republic of Uganda Ministry of Health, Kampala, Uganda2 Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda2 Uganda Tuberculosis Implementation Research Consortium, Kampala, UgandaIntroduction Low-cost digital adherence technologies (DATs) such as 99DOTS have emerged as an alternative to directly observed therapy (DOT), the current standard for tuberculosis (TB) treatment supervision. However, there are limited data to support DAT scale-up. The ‘DOT to DAT’ trial aims to evaluate the effectiveness and implementation of a 99DOTS-based TB treatment supervision strategy.Methods and analysis This is a pragmatic, stepped-wedge cluster randomised trial, with hybrid type 2 effectiveness-implementation design. The trial will include all adults (estimated N=1890) treated for drug-susceptible pulmonary TB over an 8-month period at 18 TB treatment units in Uganda. Three sites per month will switch from routine care (DOT) to the intervention (99DOTS-based treatment supervision) beginning in month 2, with the order determined randomly. 99DOTS enables patients to be monitored while self-administering TB medicines. Patients receive daily automated short message service (SMS) dosing reminders and confirm dosing by calling toll-free numbers. The primary effectiveness outcome is the proportion of patients completing TB treatment. With 18 clusters randomised into six steps and an average cluster size of 15 patients per month, the study will have 89% power to detect a 10% or greater increase in treatment completion between the routine care and intervention periods. Secondary outcomes include more proximal effectiveness measures as well as quantitative and qualitative assessments of the reach, adoption and implementation of the intervention.Ethics and dissemination Ethics approval was granted by institutional review boards at Makerere University School of Public Health and the University of California San Francisco. Findings will be disseminated through peer-reviewed publications, presentations at scientific conferences and presentations to key stakeholders.Trial registration number PACTR201808609844917.https://bmjopen.bmj.com/content/10/11/e039895.full |
| spellingShingle | Noah Kiwanuka Rebecca Crowder Alex Kityamuwesi Maureen Lamunu Catherine Namale Lynn Kunihira Tinka Agnes Sanyu Nakate Joseph Ggita Patricia Turimumahoro Diana Babirye Denis Oyuku Christopher Allen Berger Austin Tucker Devika Patel Amanda Sammann David Dowdy Turyahabwe Stavia Adithya Cattamanchi Achilles Katamba Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion BMJ Open |
| title | Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion |
| title_full | Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion |
| title_fullStr | Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion |
| title_full_unstemmed | Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion |
| title_short | Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion |
| title_sort | study protocol and implementation details for a pragmatic stepped wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion |
| url | https://bmjopen.bmj.com/content/10/11/e039895.full |
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