TY - JOUR
T1 - Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion
AU - Crowder, Rebecca
AU - Kityamuwesi, Alex
AU - Kiwanuka, Noah
AU - Lamunu, Maureen
AU - Namale, Catherine
AU - Tinka, Lynn Kunihira
AU - Nakate, Agnes Sanyu
AU - Ggita, Joseph
AU - Turimumahoro, Patricia
AU - Babirye, DIana
AU - Oyuku, Denis
AU - Berger, Christopher Allen
AU - Tucker, Austin
AU - Patel, Devika
AU - Sammann, Amanda
AU - Dowdy, David
AU - Stavia, Turyahabwe
AU - Cattamanchi, Adithya
AU - Katamba, Achilles
N1 - Funding Information:
Funding This Project is supported by the Stop TB Partnership’s TB REACH initiative, grant number STBP/TBREACH/GSA/W6-37, which is funded by the Government of Canada, the Bill & Melinda Gates Foundation, and the United States Agency for International Development. The study sponsor is not involved in data collection, analysis or interpretation.
Publisher Copyright:
©
PY - 2020/11/27
Y1 - 2020/11/27
N2 - 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.
AB - 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.
KW - international health services
KW - public health
KW - tuberculosis
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U2 - 10.1136/bmjopen-2020-039895
DO - 10.1136/bmjopen-2020-039895
M3 - Article
C2 - 33247012
AN - SCOPUS:85096948091
SN - 2044-6055
VL - 10
JO - BMJ open
JF - BMJ open
IS - 11
M1 - 039895
ER -