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Algorithm-guided empirical tuberculosis treatment for people with advanced HIV (TB Fast Track): An open-label, cluster-randomised trial

The Lancet HIV Jan 16, 2020

Grant AD, Charalambous S, Tlali M, et al. - As among HIV-positive people, often undiagnosed tuberculosis is identified to be the major cause of death, researchers examined if mortality could be reduced with the use of a clinical algorithm allowing the introduction of empirical tuberculosis treatment by nurses in primary health-care clinics compared with standard of care for adults with advanced HIV disease. They conducted an open-label cluster-randomized controlled trial recruiting 3,053 individuals from 24 primary health-care clinics in South Africa and randomizing the clinics (1:1) to provide either an intervention or routine care (control). Of these, 3,022 (1507 participants in the intervention group and 1,515 participants in the control group) were analyzed. Study nurses evaluated participants on the basis of tuberculosis symptoms, body-mass index, point-of-care haemoglobin concentrations, and urine lipoarabinomannan assay results in intervention clinics. Tuberculosis treatment was immediately initiated followed by antiretroviral therapy (ART) 2 weeks later among participants classified by a study algorithm as having high probability of tuberculosis (positive urine lipoarabinomannan assay, body-mass index < 18·5 kg/m 2, or haemoglobin concentration < 100 g/L); symptom-guided investigation was recommended for participants classified as medium probability (tuberculosis symptoms, no high probability criteria); and immediate ART initiation was recommended for participants classified as low probability (no tuberculosis symptoms or high probability criteria). In standard-of-care clinics, treatment to participants was provided in accordance with South African guidelines. In this high-risk population, a substantial increase in coverage of tuberculosis treatment was observed in correlation with the intervention but with no reduction in mortality.
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