Validation of Artificial Intelligence Enabled TB Screening and Diagnosis in Zambia

Study Overview
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Brief Summary
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Tuberculosis (TB) is a global epidemic and for many years has remained a major cause of death throughout the developing world. Zambia is among the top 30 TB/HIV high burden countries. Chest X-ray (CXR) is recommended as a triaging test for TB, and a diagnostic aid when available. However, many high-burden settings lack access to experienced radiologists capable of interpreting these images, resulting in mixed sensitivity, poor specificity, and large inter-observer variation. In recognition of this challenge, the World Health Organization has recommended the use of automated systems that utilize artificial intelligence (AI) to read CXRs for screening and triaging for TB. In this study, we primarily evaluate the performance of our AI algorithm for TB, and secondarily for Abnormal/Normal.

Official Title
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Validation of Artificial Intelligence Enabled TB Screening and Diagnosis in Zambia

Conditions
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Tuberculosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are 18 years and older with a known HIV status or are willing to undergo HIV testing if unknown HIV status and meet the following criteria will be included in the study: Presumptive TB patients defined as having any of the following: ○ Cough, Weight loss, Night sweats, Fever Household /close TB contacts regardless of symptoms Newly diagnosed HIV regardless of symptoms. Exclusion Criteria: Individuals who do meet the above inclusion criteria will be excluded. In addition, individuals with history of TB treatment within 365 days prior to enrolment will be excluded.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pilot Group to calibrate the operating points for AI algorithms (Estimated Enrollment up to 500)<br>Diagnostic Test: TB AI algorithm performance in detecting active TB. Diagnostic Test: TB diagnosis from sputum and urine (Smear microscopy, Xpert MTB RIF/ultra, Lipoarabinomannan (LAM) and mycobacterial culture) Diagnostic Test: Abnormal/Normal AI algorithm to detect abnormal/normal CXRs. Diagnostic Test: Radiologist evaluation of CXRs for active TB, abnormal/normal. Diagnostic Test: Labs: Hemoglobin level, HIV status, CD4 count. | |
| Main Cross Sectional Group (Estimated Enrollment 1932 minus the volume in pilot)<br>Diagnostic Test: TB AI algorithm performance in detecting active TB. Diagnostic Test: TB diagnosis from sputum and urine (Smear microscopy, Xpert MTB RIF/ultra, Lipoarabinomannan (LAM) and mycobacterial culture) Diagnostic Test: Abnormal/Normal AI algorithm to detect abnormal/normal CXRs. Diagnostic Test: Radiologist evaluation of CXRs for active TB, abnormal/normal. Diagnostic Test: Labs: Hemoglobin level, HIV status, CD4 count. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pilot Group to calibrate the operating points for AI algorithms | 1. Operating point selection for TB AI algorithm and Abnormal/Normal AI algorithm on CXRs for outcomes listed in Main Cross Sectional Group. | 2 months | 
| Main Cross Sectional Group | 1. TB AI algorithm sensitivity and specificity in detecting active TB on CXR compared to panel of radiologists | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main Cross Sectional Group: | 1. TB AI algorithm sensitivity and specificity in detecting active TB compared to World Health Organisation (WHO) performance guidelines of 90% sensitivity and 70% specificity | 7 months | 
| Main Cross Sectional Group | 2. Abnormal/Normal AI algorithm sensitivity and specificity compared to 90% sensitivity and 50% specificity. | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Diagnosis, Artificial Intelligence, Chest X-ray