Trace+ South Africa Cohort

Nearly 11 million people developed tuberculosis (TB) disease in 2023 and TB remains a leading infectious cause of death, largely due to diagnostic delays and poor healthcare access. Much of that TB went undiagnosed, and just 62% of TB diagnoses were bacteriologically confirmed —a critical step for ensuring accurate diagnosis and effective treatment initiation. Trace+ is a prospective, observational cohort study of adults who received a ‘Trace’ result on expectorated sputum Xpert Ultra tests conducted as part of routine clinical care. Patients were recruited from seven health facilities in Kampala, Uganda, between February 2021 to December 2024, and from 35 outpatient clinics in the catchment area of Harry Gwala Regional Hospital in Pietermaritzburg, South Africa, between November 2022 to June 2024. Patients were eligible for recruitment if they were aged >=16 years, had not yet initiated TB treatment at the time of the enrollment (“baseline”) visit, did not require hospitalization, and had not received any TB treatment within the previous three months.