Background
The lateral flow urine lipoarabinomannan assay, Determine TB-LAM (Determine LAM), offers the potential for timely tuberculosis (TB) treatment among people living with HIV (PWH).
Methods
In this cluster-randomized trial, Determine LAM was made available with staff training with performance feedback at three hospitals in Ghana. Newly admitted PWH with a positive WHO four-symptom screen 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 cells/mm3 (IQR 25-205) and 138 patients (32.7%) were on antiretroviral therapy. More patients were diagnosed with TB in the intervention group compared with the control group, 59 (34.1%; 95%CI27.1-41.7) vs 46 (18.7%; 95%CI14.0-24.1), p <0.001. Time to TB treatment remained constant at a median of 3 days (IQR 1-8), but patients were more likely to initiate TB treatment, aHR 2.19 (95%CI1.60-3.00) 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%; 95%CI24.0-33.0) at 8 weeks 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.
This study indicates that FujiLAM testing performs equivalently on spot and early morning urine samples for detecting tuberculosis among people with HIV. Sensitivity could be increased with a two-sample strategy but at the risk of lower specificity. These data can inform future guidelines and clinical practice around FujiLAM.
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