A hybrid effectiveness-implementation trial of innovative digital diagnostic solutions for tuberculosis in Low- and Middle-Income Countries

• Applicant: Professorin Dr. Claudia Denkinger
• Subject Area: Clinical Infectiology and Tropical Medicine
• Term: since 2023
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 511057927

Accurate and timely diagnostics give a patient the best opportunity for a good health outcome since clinical decisions will follow an understanding of the patient's health problem. However, 47% of the global population has little to no access to diagnostics, particularly in low- and middle-income countries (LMICs). Tuberculosis (TB) is a leading cause of death from an infectious disease in LMICs, with about 1.5 million deaths every year, partly due to delayed or missed diagnosis. To achieve Sustainable Development Goals and reduce TB-related morbidity and mortality, novel diagnostic tests are urgently needed. Our project seeks to address this urgent need by improving case finding in resource-limited, high TB burden settings through the validation of innovative, digital TB triage tools that provide individualized TB disease risk predictions to guide next steps of care. The project will capitalize on scientific innovations and digitization of the health care workforce driven by the COVID-19 pandemic. The overall goal of the project is to establish the effectiveness and added value of two novel digital triage tools (digital app-based triage test and portable chest-X-ray with an artificial-intelligence supported digital interpretation tool) and identify the critical aspects to achieve large-scale adoption. The project is organized along the following objectives: (1) Establish diagnostic accuracy of two novel triage tools in a cross-sectional study in TB high-burden countries within a hybrid effectiveness-implementation study; (2) Quantify the added value of two novel triage tools on case finding with the hybrid effectiveness implementation study that assesses the novel tools within established algorithms for TB care in high-burden countries (compared to the standard of care); (3) Identify critical aspects to achieve large-scale adoption and impact of these tools in the intended TB high-burden settings using a mixed methods approach, involving patients and other stakeholders; (4) Predict the economic value and benefits of implementation at scale of the novel digital triage tests using analyses of cost-effectiveness, extended cost-effectiveness and benefit-incidence. The findings generated across the four objectives will maximize impact through identification of the most appropriate implementation strategies that enable equitable access, maximize value, and ultimately benefit TB control. In addition to publications arising from the work, the data will be summarized in a dossier for policy makers (incl. the World Health Organization). This proposal is an integral part of a Heisenberg Programme Proposal that aims to secure an independent scientific position in Global Health diagnostics research. The projects proposed leverage long-standing partnership with investigators in the LMICs. Funding from the German Alliance for Global Health Research is supporting the development of the app-based screening tool.

• DFG Programme: Research Grants
• International Connection: USA
• Cooperation Partners: Professor Adithya Cattamanchi; Professor Payam Nahid