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Systems Analysis and Improvement Approach to Prevent TB

Study acronym: SAIA-TB
StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria expanded, about 16 words
    • Publications: details revised at 1 of 1 entry
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Primary endpoints: 4 to 3
    • Start date changed from estimate of Jan 6, 2025 to Feb 6, 2025
    • Secondary endpoints: 2 to 4
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This randomized trial uses the evidence-based Systems Analysis and Improvement Approach (SAIA) adapted for tuberculosis (SAIA-TB) to assess the comprehensive tuberculosis (TB) care cascade across 16 clinics in rural Eastern Cape, South Africa to improve patient outcomes. The aims of this study are to: * Evaluate the effectiveness of SAIA-TB use in clinics on TB cascade outcomes for TB patients and with high-risk contacts * Determine the drivers of SAIA-TB implementation success or failure across clinics The investigators hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period.
Trial Details
NCT Number NCT06314386
Lead Sponsor Boston College
Collaborators: National Institutes of Health (NIH), Boston University, University of Washington, Medical Research Council, South Africa, National Institute of Nursing Research (NINR)
Conditions
(from sponsor)		 Tuberculosis, TPT, TB - Tuberculosis
Related terms Latent Tuberculosis, Tuberculosis
Enrollment 19,560 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov