Effect of implementing digital adherence technologies on the use of health care providers time and the human resource cost of tuberculosis treatment adherence support in Ethiopia

Background. The management of human resources for health is a key priority for resource constrained health systems. Digital adherence technologies (DATs) for treatment support offer an opportunity to reorganise existing healthcare worker workload. Historically, tuberculosis treatment services involved directly observed treatment with frequent patient visits to the clinic for treatment adherence support. More recently, digital technologies have offered an option for the digital monitoring of treatment adherence and remote support. The aim of this study was to determine how health care workers use their time following the implementation of digital adherence support, and the human resource cost of tuberculosis treatment adherence support. Methods. As part of the ASCENT three-arm cluster randomised trial of DATs for tuberculosis treatment support, we conducted time-and-motion studies in 15 of 78 ASCENT-trial health facilities for six-weeks. Healthcare workers recorded time spent on direct patient care and in-person adherence monitoring for 10 patients, as well as time spent on above-service activities. Total time use was calculated by multiplying time spent per visit by number of patient visits at the facility for six weeks and adding above-service time. In a facility-level analysis, we used negative binomial regression models to investigate associations between total time use and facility-level factors. Findings. HCWs spent 4% (126/2892) of time in minutes on in-person adherence monitoring in the Labels, compared to 7% (206/3126) in the Pillbox and 13% (587/4673) in the standard-of-care study arms. More time was spent on above-service activities in the standard-of-care (2360 minutes [SD:1951]) compared to the DAT arms (Pillbox: 2057min [SD:1570]; Labels: 2261min [SD:1360]). After adjusting for facility workload and number of people lost-to-follow-up, we did not find sufficient evidence of a difference in the human resource costs between the study arms (Labels IRR (95%CI): 0.71 (0.33; 1.52); Pillbox (95% CI) 0.71 (0.33; 1.52)). Conclusion. We found a small, although not statistically significant reduction, in human resource costs in the facilities where DATs were implemented. We observed changes in how healthcare workers spent their time, including a shift towards fewer health facility visits but more time spent on in-person adherence support. Further work is ongoing to assess the implications for the cost-effectiveness of the interventions. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial PACTR202008776694999 ### Clinical Protocols ### Funding Statement The study is funded by Unitaid (Grant Agreement Number: 2019-33-ASCENT) through the Adherence Support Coalition to End TB (ASCENT) project. The funder played no role in the study design, implementation, data collection, analysis, or decision to publish. The corresponding author and first authors confirm that they had full access to all the data in the study and had final responsibility for the decision to submit for publication. ### 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 the ethics committees at the London School of Hygiene & Tropical Medicine (approval reference: 19120); World Health Organisation Ethical Review Committee (approval reference: ERC.0003297); the Addis Ababa City Administration Health Bureau Public Emergency and Health Research Directorate Institutional Review Board (approval reference: BEFO/HBTFH/1-16/10415). 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 Facility-level data analysed in this study are part of the ASCENT Consortium Trials data and will be made available with the publication of the paper describing the ASCENT-Ethiopia within-trial cost-effectiveness analysis. A description of the ASCENT-Ethiopia 6-week provider costs dataset, the survey materials, plus the code required to reproduce the analysis may be found at https://doi.org/10.17037/DATA.00003801. Following publication of the trial cost-effectiveness results, the minimal dataset will be available for non-commercial use upon request, after signing a data sharing agreement, to studies approved by an ethics committee. Any publications arising from the shared data must acknowledge the investigators who collected the data, the institutions involved, and the funding sources by citing the data record and including the standard acknowledgement statement provided.