protocolSection identificationModule nctId: NCT06314386, orgStudyIdInfo id: 23.139.01, secondaryIdInfos id: R01NR020866, type: NIH, link: https://reporter.nih.gov/quickSearch/R01NR020866, briefTitle: Systems Analysis and Improvement Approach to Prevent TB, acronym: SAIA-TB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-06, primaryCompletionDateStruct date: 2028-02-29, completionDateStruct date: 2029-02-28, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Boston College, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: Boston University, collaborators name: University of Washington, collaborators name: Medical Research Council, South Africa, collaborators name: National Institute of Nursing Research (NINR), descriptionModule briefSummary: 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 clinicsThe 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., conditionsModule conditions: Tuberculosis, conditions: TPT, conditions: TB - Tuberculosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Stepped Wedge Crossover Cluster, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 19560, type: ESTIMATED, armsInterventionsModule interventions name: Systems Analysis and Improvement Approach for TB (SAIA-TB), outcomesModule primaryOutcomes measure: TB Screening, primaryOutcomes measure: Linkage to care for TB disease treatment, primaryOutcomes measure: TB Evaluation, primaryOutcomes measure: TB Diagnosis, secondaryOutcomes measure: Successful TB Prevention Treatment (TPT) Outcome, secondaryOutcomes measure: Successful TB Outcome, eligibilityModule sex: ALL, minimumAge: 0 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Addo Clinic, city: Addo, country: South Africa, geoPoint lat: -33.54833, lon: 25.6899, locations facility: Lukhanyiso Clinic, city: Addo, country: South Africa, geoPoint lat: -33.54833, lon: 25.6899, locations facility: Kwa-Nonqubela Clinic, city: Alexandria, country: South Africa, locations facility: Marselle Clinic, city: Boesmansriviermond, country: South Africa, geoPoint lat: -33.6863, lon: 26.65604, locations facility: Masakhane Clinic, city: Hankey, country: South Africa, geoPoint lat: -33.83308, lon: 24.88359, locations facility: Humansdorp Clinic, city: Humansdorp, country: South Africa, geoPoint lat: -34.02903, lon: 24.76912, locations facility: Pellsrus Clinic, city: Jeffrey's Bay, country: South Africa, geoPoint lat: -34.05031, lon: 24.90762, locations facility: Joubertina CHC, city: Joubertina, country: South Africa, geoPoint lat: -33.82547, lon: 23.85618, locations facility: Louterwater Clinic, city: Joubertina, country: South Africa, geoPoint lat: -33.82547, lon: 23.85618, locations facility: Twee Riviere Clinic, city: Joubertina, country: South Africa, geoPoint lat: -33.82547, lon: 23.85618, locations facility: Kareedouw Clinic, city: Kareedouw, country: South Africa, geoPoint lat: -33.9528, lon: 24.29053, locations facility: Kenton On Sea Clinic, city: Kenton on Sea, country: South Africa, geoPoint lat: -33.68421, lon: 26.67036, locations facility: Kirkwood Clinic, city: Kirkwood, country: South Africa, geoPoint lat: -33.39829, lon: 25.44279, locations facility: Moses Mabida Clinic, city: Kirkwood, country: South Africa, geoPoint lat: -33.39829, lon: 25.44279, locations facility: Imizamo Yetho Clinic, city: Patensie, country: South Africa, geoPoint lat: -33.76007, lon: 24.81383, locations facility: Nkwenkwezi Clinic, city: Port Alfred, country: South Africa, geoPoint lat: -33.58601, lon: 26.88329, hasResults: False