The novel urine LAM point-of-care strip test offers potential clinical utility to improve TB diagnosis in HIV co-infected patients. Urine LAM strip test performance improves with increasing illness severity and more advanced immunosuppression, thus offering the greatest potential utility in hospitalised HIV-infected patients with advanced immunosuppression (CD4 cell count less than 200). However, in the context of high rates of empiric treatment and the availability of other novel TB diagnostics, the clinical impact of the urine LAM strip test is unknown. This study will investigate the impact of the urine LAM strip test. The study hypothesis is that the urine LAM strip test, when combined with standard TB diagnostics (smear microscopy and culture) will significantly improve TB treatment-related outcomes (TB-related mortality, morbidity and length of hospital stay) in HIV-infected hospitalized patients when compared to standard TB diagnostics alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
2,618
This is a point-of-care lateral flow strip test to detect the presence of lipoarabinomannan (LAM) in patient urine samples. Only patients with a grade 2-5 visual band intensity will be considered positive and commenced on treatment
University of Cape Town
Cape Town, Western Cape, South Africa
Mbeya Medical Research Programme
Mbeya, Tanzania
University Teaching Hospital
Lusaka, Zambia
University of Zimbabwe
Harare, Zimbabwe
All-cause mortality
All-cause mortality at 8-weeks after study enrollment
Time frame: 8 weeks
Change in TB-related morbidity score
Comparative change in TB score between baseline and 8 weeks after enrollment
Time frame: Baseline and 8 weeks
Change in Karnofsky performance index
Comparative changes in the Karnofsky performance index between baseline and 8 weeks following enrollment
Time frame: Baseline and 8 week
Hospital length of stay
This is the number of days of hospital admission for enrolled patients up to a maximum of 8 weeks post enrollment.
Time frame: Date of hospital discharge (max 8 weeks) minus date of admission
Diagnostic accuracy of urine LAM strip test
Diagnostic accuracy (sensitivity, specificity, predictive values and likelihood ratios) of the urine LAM strip test using TB culture as the diagnostic reference standard
Time frame: 8 weeks
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