Clinical Trial

Systems Analysis and Improvement Approach to Prevent TB

Study acronym: SAIA-TB
Enrolling by Invitation
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-03-15.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-05-02
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 Tuberculosis, TPT, TB - Tuberculosis
Enrollment 19,560 participants
Start Date 2025-02-06
Primary Completion 2028-02-29 (estimated)
Study Completion 2029-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-05-06