Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
Tuberculosis
About this trial
This is an interventional diagnostic trial for Tuberculosis focused on measuring Lesotho, South Africa, community-based, tuberculosis, active case findings, cost-effectiveness, CAD4TB, POC-CRP, Xpert MTB/RIF Ultra, triage, screening
Eligibility Criteria
Inclusion Criteria:
- Willing and able to provide signed written consent or witnessed oral consent in the case of illiteracy, prior to undertaking any study-related procedure
- Adults (≥18 years)
Exclusion Criteria:
- Any condition for which participation in the study, as judged by the investigator or a designated staff member, could compromise the well-being of the subject or prevent, limit or confound protocol specified assessments
- Seriously ill person who needs immediate medical care
- Current anti-TB treatment
- Lesotho only: Pregnancy (self-reported)
Sites / Locations
- SolidarMedRecruiting
- Human Sciences Research CouncilRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Approach 1 - CAD4TB screening
Approach 2 - CAD4TB screening with POC-CRP triage testing
Participants with a CAD4TB version 7 (Delft Imaging, NL) score above the overall threshold (as defined for study approach 1) are eligible for Xpert MTB/RIF Ultra testing.
Participants with a CAD4TB version 7 (Delft Imaging, NL) score within the threshold window (between lower and upper limit threshold as defined for study approach 2), a POC-CRP LumiraDx (LumiraDx Limited, UK) test will follow as a triage test. If CRP is above the determined threshold as defined for approach 2, Xpert MTB/RIF Ultra will be performed. If the CAD4TB score is above the upper limit threshold as defined for approach 2, Xpert MTB/RIF Ultra will be performed (without further CRP testing).