Implementation, feasibility, and acceptability of 99DOTS-based supervision of treatment for drug-susceptible TB in Uganda

99DOTS is a low-cost digital adherence technology that allows people with tuberculosis (TB) to self-report treatment adherence. There are limited data on its implementation, feasibility, and acceptability from sub-Saharan Africa. We conducted a longitudinal analysis and cross-sectional surveys nested within a stepped-wedge randomized trial at 18 health facilities in Uganda between December 2018 and January 2020. The longitudinal analysis assessed implementation of key components of a 99DOTS-based intervention, including self-reporting of TB medication adherence via toll-free phone calls, automated text message reminders and support actions by health workers monitoring adherence data. Cross-sectional surveys administered to a subset of people with TB and health workers assessed 99DOTS feasibility and acceptability. Composite scores for capability, opportunity, and motivation to use 99DOTS were estimated as mean Likert scale responses. Among 462 people with pulmonary TB enrolled on 99DOTS, median adherence was 58.4% (inter-quartile range [IQR] 38.7-75.6) as confirmed by self-reporting dosing via phone calls and 99.4% (IQR 96.4-100) when also including doses confirmed by health workers. Phone call-confirmed adherence declined over the treatment period and was lower among people with HIV (median 50.6% vs. 63.7%, p<0.001). People with TB received SMS dosing reminders on 90.5% of treatment days. Health worker support actions were documented for 261/409 (63.8%) people with TB who missed >3 consecutive doses. Surveys were completed by 83 people with TB and 22 health workers. Composite scores for capability, opportunity, and motivation were high; among people with TB, composite scores did not differ by gender or HIV status. Barriers to using 99DOTS included technical issues (phone access, charging, and network connection) and concerns regarding disclosure. 99DOTS was feasible to implement and highly acceptable to people with TB and their health workers. National TB Programs should offer 99DOTS as an option for TB treatment supervision. AUTHOR SUMMARY This is the first study from sub-Saharan Africa reporting both implementation metrics and implementation feedback on 99DOTS, a low-cost DAT which is already widely used in India. The implementation assessment was nested within a pragmatic implementation trial of 99DOTS at 18 health facilities in Uganda with National Tuberculosis and Leprosy Program (NTLP)-affiliated TB treatment units. Using process metric data from the trial and theory-informed surveys to subsets of people with TB and health workers, the study demonstrated that 99DOTS is feasible to implement with high fidelity and more acceptable to both people with TB and health workers than previously reported in the literature. We found that 99DOTS is feasible to implement as an alternative method of TB treatment supervision, and highly acceptable to both people with TB and health workers in Uganda, supporting its further scale-up as an option for TB treatment supervision. The findings highlight the importance of adapting and contextualizing DATs prior to implementation, with specific attention to modifications that reduce stigma and enhance education/motivation as well as connection between people with TB and their health workers. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial Pan-African Clinical Trials Registry (PACTR201808609844917) ### Clinical Protocols ### Funding Statement This project was supported by the Stop TB Partnership’s TB REACH initiative and was funded by the Government of Canada, the Bill & Melinda Gates Foundation, and the United States Agency for International Development, as well as the UCSF Nina Ireland Program for Lung Health. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ### 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: The study was approved by Institutional Review Boards at the University of California San Francisco and Makerere University School of Public Health. A waiver of informed consent was granted to extract demographic and clinical data from TB treatment registers and the 99DOTS server. Survey participants provided verbal consent. 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Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Data is available without restriction upon request.