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Evaluating the Impact of Computer-assisted X-ray Diagnosis and Other Triage Tools to Optimise Xpert Orientated Community-based Active Case Finding for TB and COVID-19

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 8, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion date: Aug 15, 2025 to Jun 30, 2026
    • Study completion date: Dec 2025 to Dec 30, 2026
    v6
  2. Notable Primary completion date changed from estimate of Jan 2025 to Aug 15, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Mar 2025 to Dec 2025
    • Site details revised at 3 of 3 sites
    v5
  3. Minor Site details revised at 2 of 3 sitesv4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2022 to Feb 23, 2022
    • Secondary endpoints revised (15)
    • Site details revised at 3 of 3 sites
    v3
  5. Minor Secondary endpoints revised (15)
    • Study description expanded, about 5 words
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Tuberculosis (TB) is now the commonest cause of death in many African countries. Globally, \~35% (almost 1 in 3) of TB cases are 'missed' (remain undiagnosed or undetected). In sub-Saharan Africa, 40-50% of the TB case burden remains undiagnosed within the community. These 'missed' TB cases (at primary care level) serve as a reservoir, which severely undermines TB control. With rapid advances in the development of TB screening tests, the investigators aim to determine the pragmatic utility of computer-assisted x-ray diagnosis (CAD). Recent data suggest that CAD performs on par with experienced radiologists to identify potential TB cases, hereby reducing the frequency at which Xpert tests are requested and helps to focus limited resources on the relevant cases. In addition, the investigators aim to test nascent screening technologies for TB diagnosis such as evaluating urine-based TB screening biosignatures. The COVID-19 pandemic has ravaged African peri-urban communities where TB is also common. With the pressing need to improve screening and diagnosis of COVID-19, the investigators plan to explore the potential for urine- and blood-based COVID-19 screening assays. Symptoms of COVID-19 and TB overlap, and limited affordability, as well as the stigma associated with both diseases, severely limits testing. Data are now urgently needed about the feasibility of co-screening and testing for TB and COVID-19. The utility of such an approach, if any, has not been studied in African communities.
Trial Details
NCT Number NCT05220163
Lead Sponsor University of Cape Town
Collaborators: European and Developing Countries Clinical Trials Partnership (EDCTP), Zambart, Biomedical Research and Training Institute, Ospedale San Raffaele, Radboud University Medical Center, Foundation for Innovative New Diagnostics, Switzerland, University of Stellenbosch
Conditions
(from sponsor)
Tuberculosis, COVID-19, HIV Infections
Related terms COVID-19, HIV Infections, Tuberculosis
Enrollment 26,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov