Health Condition 1: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Control Intervention1: Composite Reference Standard (CRS), i.e., the standard for
diagnosis of active TB disease, commonly called the ‘gold’ standard in
diagnostic accuracy studies, based on the NTEP
Sponsors
Abbott Diagnostics Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: HIV positive status and CD4 count = 200 cells/ mm3
Exclusion criteria
Exclusion criteria: Individual currently under anti-tuberculosis treatment (ATT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic performance evaluation of Determine TB LAM Ag TestTimepoint: This is approximately 12 months study for enrolling 330 patients which we expect to start from 1st of April 2024 and complete on or before Mar 2025 and result analysis will be done within Mar/Apr 2025 | — |
Secondary
| Measure | Time frame |
|---|---|
| A point-of-Care urinary LAM assay, for detection of active TB disease in people living with HIV (PLHIV) with CD4 counts less than or equal to 200 cells/mm in IndiaTimepoint: This is approximately 12 months study for enrolling 330 patients which we expect to start from 1st of April 2024 & complete on or before Mar 2025 & result analysis will be done within Mar/Apr 2025 | — |
Countries
India
Contacts
Public ContactDr Upasna Agarwal
National Institute Of Tuberculosis and Respiratory Diseases
Outcome results
None listed