A Trial of the Urine LAM Strip Test for TB Diagnosis Amongst Hospitalized HIV-infected Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial to Evaluate the Impact of Using a Point-of-care Urine LAM Strip Test for TB Diagnosis Amongst Hospitalized HIV-infected Patients in Resource-poor Settings

Conditions
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Tuberculosis

Intervention / Treatment
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* Device: Urine LAM strip test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infected (1x rapid HIV test positive) Considered TB suspect by attending doctor (must comprise at least 1 of the following: current fever or cough, drenching night sweats, self-reported LOW) Illness severity sufficient to warrant hospitalization ≥18 years old Provision of informed consent Exclusion Criteria: HIV-uninfected Patients receiving any anti-TB medication in the 60 days prior to testing Unable to provide 30mls urine Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAM plus standard care<br>Patients allocated to this study arm will receive urine LAM strip testing in addition to the standard TB diagnostic tools WHO approved and available at each site | Device: Urine LAM strip test<br>* 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<br>* Other names: Determine TB urine LAM Antigen strip test;|
| No Intervention: Standard care<br>Patients allocated to this study arm will receive standard TB diagnostics currently WHO approved and available at the study site | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality at 8-weeks after study enrollment | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TB-related morbidity score | Comparative change in TB score between baseline and 8 weeks after enrollment | Baseline and 8 weeks | 
| Change in Karnofsky performance index | Comparative changes in the Karnofsky performance index between baseline and 8 weeks following enrollment | 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. | 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 | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urine LAM strip test, diagnostics, tuberculosis