The ADAPT for Kids study will evaluate accuracy of non-sputum tuberculosis diagnostic tests in children
BALTIMORE, February 15, 2024 — The Assessing Diagnostics at Point-of Care for Tuberculosis (ADAPT) for Kids study has enrolled its first participants at Instituto Nacional de Saúde (INS), Mozambique. ADAPT for Kids is evaluating promising TB diagnostic tests for children to inform World Health Organization (WHO) policy and ultimately provide children better, more accurate tests. The first tests studies will be tongue swab tests in children under 15 years, including children living with HIV. The study is led by Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB) consortium.
TB is a leading cause of death in children, and almost all (96%) childhood TB deaths occur in children not on treatment due to missed diagnosis. Pediatric TB is underdiagnosed, in part because existing tests don’t work well in children. “Better tools for diagnosis at the point-of-care means a faster start to treatment, which is vital to ending these senseless TB deaths in children,” said Dr. Nilesh Bhatt, ADAPT for Kids investigator and global clinical research director at the Elizabeth Glaser Pediatric AIDS Foundation.
ADAPT for Kids will enroll children less than 15 years old with TB symptoms and risk factors, including children living with HIV. One of the first tests the study will evaluate utilizes tongue swabs to detect TB. Traditional TB tests rely on sputum, which is difficult for children to produce. “A tongue swab test would be a game changer, making TB diagnosis easier for both children and health systems to process and turn around,” said Dr. Celso Khosa, ADAPT for Kids investigator and director of the Centro de Investigação e Treino em Saúde da Polana Caniço (CISPOC) at Mozambique’s INS. ADAPT for Kids will generate critical evidence not just on test accuracy, but also on usability and acceptability among healthcare workers, critical components to ensuring effective tests are adopted by health systems and countries.
“Improving diagnostics is at the center of how we reach the ultimate goal of ending TB in Mozambique,” said Dr. Benedita Jose, the National TB program director in Mozambique. “We are excited to focus on children with this study and help get them access to the same cutting edge diagnostic technology that we look at for other populations.”
“SMART4TB is proud that the ADAPT for Kids study was developed and implemented in parallel and in collaboration with the ADAPT study in adults,” said Dr. Devan Jaganath, ADAPT for Kids investigator and assistant professor of Pediatrics at University of California, San Francisco. “Pediatric TB research too often lags behind, and SMART4TB is dedicated to closing research gaps for children by making sure we’re evaluating similar promising diagnostic technology in kids.” To further ensure standardized, high-quality evidence for children, ADAPT for Kids also is coordinating with the pediatric site with the U.S. National Institute of Allergy and Infectious Diseases-funded The Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network).
A second ADAPT for Kids site at Mulago National Referral Hospital in Uganda, will be launched in the first half of 2024. Each site anticipates enrollment of 200-250 children per year.
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The SMART4TB Consortium brings together experts in TB tools development, implementation science, capacity strengthening, civil society engagement, and policy translation. Led by Johns Hopkins University, consortium members include University of California, San Francisco, Elizabeth Glaser Pediatric AIDS Foundation, KNCV Tuberculosis Foundation, and Treatment Action Group. SMART4TB is a cooperative agreement with the United States Agency for International Development (USAID), made possible by the generosity of the American people.The findings in this publication do not necessarily represent the views of the U.S. Agency for International Development or the U.S. Government.