Implementation of enhanced 99DOTS for TB treatment supervision in Uganda: An interrupted time series analysis

Rationale: Digital adherence technologies are being scaled-up for tuberculosis treatment despite limited evidence of their effectiveness and concerns about accessibility. Objectives: To determine whether an enhanced 99DOTS-based treatment supervision improves uptake of 99DOTS and tuberculosis treatment outcomes. Methods: We included all adults initiated on treatment for drug-suceptible pulmonary tuberculosis between August 2019 and June 2021 at 18 99DOTS-experienced health (n=6,382) facilities and 12 99DOTS-naive health facilities (n=4,253) in Uganda. Using an interrupted time series design, we compared the proportions with treatment success (primary outcome) and enrolled on 99DOTS in the 9 months before and the 12 months after implementing an 'enhanced 99DOTS' intervention that included components to increase uptake (providing low-cost phones to people with TB when needed) and enhance treatment monitoring and support (task shifting to community health workers and automated task lists). Data on treatment initiation and outcomes were derived from routine TB treatment registers. Measurements and Main Results: At 99DOTS-experienced facilities, the proportion enrolled on 99DOTS increased from 49.2% to 86.4%. The proportion completing treatment remained similar across periods (78.3% vs. 78.6%). There was no immediate level change in treatment success following the intervention but there was a significant change in monthly slope (proportion ratio 1.01, 95% CI 1.00-1.02), reflecting an improved treatment success trend following the intervention. Results were similar at 99DOTS-naive facilities, except there was no significant change in treatment success slope. Conclusions: Enhanced 99DOTS had high uptake and did not negatively affect treatment outcomes. Equity in access should be prioritized during implementation. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This project was supported by the Stop TB Partnership's TB REACH initiative, grant number STBP/TBREACH/GSA/W6SU-08, which was funded by the Government of Canada, the Bill and Melinda Gates Foundation, and the United States Agency for International Development. The study sponsor was not involved in data collection, analysis, or interpretation. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committees at Makerere University School of Public Health and the University of California San Francisco gave ethical approval for this work. The Uganda National Council for Science and Technology gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors.