Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion
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Date
2020
Journal Title
Journal ISSN
Volume Title
Publisher
BMJ Open
Abstract
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.
Description
Keywords
Study protocol, Stepped-wedge cluster, Digital adherence technology, Tuberculosis treatment
Citation
Crowder R, Kityamuwesi A, Kiwanuka N, et al. 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 2020;10:e039895. doi:10.1136/ bmjopen-2020-039895