Validation of Artificial Intelligence Enabled TB Screening and Diagnosis in Zambia

Sponsor
Centre for Infectious Disease Research in Zambia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05139940
Collaborator
(none)
2,432
3
12.3
810.7
66.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2432 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Validation of Artificial Intelligence Enabled TB Screening and Diagnosis in Zambia
    Actual Study Start Date :
    Nov 22, 2021
    Anticipated Primary Completion Date :
    Sep 30, 2022
    Anticipated Study Completion Date :
    Nov 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Pilot Group to calibrate the operating points for AI algorithms (Estimated Enrollment up to 500)

    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)

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Pilot Group to calibrate the operating points for AI algorithms [2 months]

      1. Operating point selection for TB AI algorithm and Abnormal/Normal AI algorithm on CXRs for outcomes listed in Main Cross Sectional Group.

    2. Main Cross Sectional Group [7 months]

      1. TB AI algorithm sensitivity and specificity in detecting active TB on CXR compared to panel of radiologists

    Secondary Outcome Measures

    1. Main Cross Sectional Group: [7 months]

      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

    2. Main Cross Sectional Group [7 months]

      2. Abnormal/Normal AI algorithm sensitivity and specificity compared to 90% sensitivity and 50% specificity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chainda South Health Facility Lusaka Zambia 10101
    2 Chawama first level hospital Lusaka Zambia 10101
    3 Kanyama level 1 Lusaka Zambia 10101

    Sponsors and Collaborators

    • Centre for Infectious Disease Research in Zambia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre for Infectious Disease Research in Zambia
    ClinicalTrials.gov Identifier:
    NCT05139940
    Other Study ID Numbers:
    • Google AI
    First Posted:
    Dec 1, 2021
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre for Infectious Disease Research in Zambia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 8, 2022