An interventional study of Systems Analysis and Improvement Approach for TB (SAIA-TB) in Tuberculosis, TPT and TB - Tuberculosis, sponsored by Boston College. Enrolling by invitation at 16 sites in South Africa. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Boston College · Not applicable, Interventional, and Health services research
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:
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.
This four-wave stepped wedge crossover cluster randomized trial will assess the effectiveness of the SAIA-TB intervention (Aim 1). A total of 16 clinics in four municipalities within the Sarah Baartman-district, Eastern Cape, South Africa will be included. The SAIA-TB intervention will be implemented at the clinic level. Public sector clinic staff and clinic managers, supported by study personnel, will deliver the intervention over an 18-month implementation phase, followed by a 12-month maintenance phase led by clinic managers without additional study personnel support, to provide evidence on intervention impact under ideal circumstances, as well as sustained effect over time. Aim 2 will consist of interviews and using the organization readiness for implementing change (ORIC) with facilities early in SAIA-TB implementation (within 3 months of initiating the intervention) to identify clinic-level attributes that affect intervention adoption. Additionally, the Consolidated Framework for Implementation Research (CFIR) will guide data collection and interpretation related to implementation, assess fidelity to intervention protocol, describe intervention adaptations when integrated into routine management systems, and identify clinic-level determinants of successful SAIA-TB implementation. Recurrent measurement of structural readiness and implementation dose (as a function of quality and quantity) at the clinic level will inform guidance on essential structural needs to implement SAIA-TB. The trial will culminate in a dissemination package, summarizing results and providing implementation guidance to support scale-up.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 19,560 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Boston College is the lead sponsor of 38 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Aim 1:
Inclusion Criteria for clinics:
Exclusion Criteria for clinics:
Aim 2:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinics are considered exposed after intensive SAIA-TB intervention, implementation phase, and maintenance phase.
Other: Systems Analysis and Improvement Approach for TB (SAIA-TB)
Clinics are considered unexposed prior to the initiation of SAIA-TB in their clinic
The Systems Analysis and Improvement Approach for TB (SAIA-TB) is a five-step systems analysis and iterative improvement cycle intervention which will be implemented by clinic staff with support from study personnel in intervention clinics. Components of the intervention include TB cascade analysis, patient flow mapping and continuous quality improvement, aimed to incrementally optimize TB screening, evaluation, diagnosis, TB preventive therapy and TB disease treatment initiation, successful treatment, and TB-free survival among the population at the intervention clinics.
TB Screening
The proportion of individuals screened with WHO TB symptom screen in the target population
Time frame: 18 months
Linkage to care for TB disease treatment
The proportion of individuals initiating TB disease treatment among those with a positive diagnostic evaluation
Time frame: 18 months
Linkage to care for TB preventive treatment
The proportion of individuals initiating TB preventive treatment among those with a negative diagnostic evaluation and eligible for TPT
Time frame: 18 months
Successful TB Prevention Treatment (TPT) Outcome
The proportion of individuals who complete TB Prevention Treatment (TPT) among those who initiate TPT
Time frame: 18 months
Successful TB Outcome
The proportion of individuals cured or completing treatment for TB disease among those who initiate TB treatment
Time frame: 18 months
TB Evaluation
The proportion of individuals receiving a diagnostic evaluation among those with a positive screening
Time frame: 18 months
TB Diagnosis
The proportion of individuals diagnosed with TB among those who completed a diagnostic evaluation
Time frame: 18 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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