Evaluating New Rapid and Non-Invasive Tests for Tuberculosis Diagnosis in Children Under 15

What this Trial Is About

Researchers are evaluating new, faster, simpler, and less expensive diagnostic tests for tuberculosis TB in children under 15 years old. These studies, called Rapid Research in Diagnostics Development for TB Network R2D2 Kids and Assessing Diagnostics at Point-of-care for TB in Children ADAPT for Kids, aim to reduce childhood deaths caused by TB by addressing challenges in current diagnosis methods, especially the difficulty of obtaining sputum samples from children. The studies will assess how well these novel tests detect TB compared to established definitions and will also evaluate how easy and acceptable the tests are for health workers to use. The studies involve evaluating several novel TB diagnostic tests including oral swab molecular testing, automated cough sound analysis using mobile devices, automated lung sound analysis with digital stethoscopes, and chest X-ray computer-aided detection using artificial intelligence. These tests are non-invasive and designed for point-of-care use. The evaluation will be conducted among children suspected of having TB, enrolling about 250 participants per year at three different sites. Additionally, about 30 health workers will participate to assess the usability of these new tests. New tests will be evaluated as they become ready for field testing. Participants will be monitored to determine the proportion of positive and negative results from the new tests among children with and without TB over two years. The study includes collecting respiratory samples using swabs, recording cough and lung sounds, and performing chest X-rays analyzed by AI. Health workers experiences with the tests will be gathered through observations and surveys. The total participation time varies with follow-up visits planned to assess diagnostic accuracy and usability. Safety and consent procedures are in place to protect participants, and the studies continue until September 2026.

Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)