Point-of-Care Urine Lipoarabinomannan Testing to Guide Tuberculosis Treatment among Severely Ill Inpatients with Human Immunodeficiency Virus in Real-World Practice: a multi-center stepped wedge cluster-randomized trial from Ghana

Background: The lateral flow urine lipoarabinomannan assay, Determine TB LAM (Determine LAM), offers the potential for timely tuberculosis (TB) treatment among people with human immunodeficiency virus (PWH). Methods: In this cluster-randomized trial, Determine LAM was made available with staff training with performance feedback at 3 hospitals in Ghana. Newly admitted PWH with a positive World Health Organization four-symptom screening for TB, severe illness, or advanced HIV were enrolled. The primary outcome was days from enrollment to TB treatment initiation. We also reported the proportion of patients with a TB diagnosis, initiating TB treatment, all-cause mortality, and Determine LAM uptake at 8 weeks. Results: We enrolled 422 patients including 174 (41.2%) in the intervention group. The median CD4 count was 87 (interquartile range [IQR], 25-205) cells/μL, and 32.7% were on antiretroviral therapy. More patients were diagnosed with TB in the intervention compared with the control group: 59 (34.1%) versus 46 (18.7%) (P <. 001). Time to TB treatment remained constant, but patients were more likely to initiate TB treatment (adjusted hazard ratio, 2.19 [95% CI, 1.60-3.00]) during the intervention. Of patients with a Determine LAM test available, 41 (25.3%) tested positive. Of those, 19 (46.3%) initiated TB treatment. Overall, 118 patients had died (28.2%) at 8 weeks of follow-up. Conclusions: The Determine LAM intervention in real-world practice increased TB diagnosis and the probability of TB treatment but did not reduce time to treatment initiation. Despite high uptake, only half of the LAM-positive patients initiated TB treatment.