Supporting, Mobilizing and Accelerating Research for Tuberculosis Elimination (SMART4TB) Technical Area 1: Diagnostics - Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT)

What this Trial Is About

Tuberculosis (TB) remains a major global health issue with over 3 million people undiagnosed each year and 1 million deaths. The ADAPT study aims to reduce this burden by evaluating new point-of-care TB diagnostic tests that are faster, simpler, and less costly. The study focuses on adolescents and adults with suspected TB symptoms or risk factors, assessing these novel tests in real-world outpatient settings in high TB burden countries. The study also evaluates the usability and acceptability of these tests by health workers. Participants will be involved in testing novel TB triage and diagnostic tools, including semi-automated or automated molecular assays based on tongue swabs. These tests will be compared against standard reference methods like sputum Xpert MTB/RIF Ultra and mycobacterial culture. The study plans to enroll about 450 participants per year at each of three sites to assess various diagnostic tests and 50 health workers to evaluate test usability. During the study, participants will undergo diagnostic testing and screening based on TB symptoms or risk factors. Health workers will be observed and surveyed regarding the ease of use and acceptance of the new tests. Researchers will track the proportion of positive and negative test results among participants with and without TB over two years. The study involves follow-up visits and consent, ensuring adherence and data collection, with the goal of improving rapid TB diagnosis and management worldwide.

Assessing Diagnostics At Point-of-care for Tuberculosis