Systems Analysis and Improvement Approach to Prevent TB
- Conditions
- TuberculosisTPTTB - Tuberculosis
- Interventions
- Other: Systems Analysis and Improvement Approach for TB (SAIA-TB)
- Registration Number
- NCT06314386
- Lead Sponsor
- Boston College
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 19560
- 18 years and older
- Frontline clinical and/or managerial staff, district-level TB management
- Ability to provide informed consent
- Under age 18
- Unwilling to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Exposed Systems Analysis and Improvement Approach for TB (SAIA-TB) Clinics are considered exposed after intensive SAIA-TB intervention, implementation phase, and maintenance phase.
- Primary Outcome Measures
Name Time Method TB Screening 18 months The proportion of individuals screened with WHO TB symptom screen in the target population
Linkage to care for TB disease treatment 18 months The proportion of individuals initiating TB disease treatment among those with a positive diagnostic evaluation
Linkage to care for TB preventive treatment 18 months The proportion of individuals initiating TB preventive treatment among those with a negative diagnostic evaluation and eligible for TPT
- Secondary Outcome Measures
Name Time Method Successful TB Prevention Treatment (TPT) Outcome 18 months The proportion of individuals who complete TB Prevention Treatment (TPT) among those who initiate TPT
TB Evaluation 18 months The proportion of individuals receiving a diagnostic evaluation among those with a positive screening
TB Diagnosis 18 months The proportion of individuals diagnosed with TB among those who completed a diagnostic evaluation
Successful TB Outcome 18 months The proportion of individuals cured or completing treatment for TB disease among those who initiate TB treatment
Trial Locations
- Locations (16)
Nkwenkwezi Clinic
🇿🇦Port Alfred, South Africa
Twee Riviere Clinic
🇿🇦Joubertina, South Africa
Imizamo Yetho Clinic
🇿🇦Patensie, South Africa
Kareedouw Clinic
🇿🇦Kareedouw, South Africa
Kenton On Sea Clinic
🇿🇦Kenton on Sea, South Africa
Moses Mabida Clinic
🇿🇦Kirkwood, South Africa
Kirkwood Clinic
🇿🇦Kirkwood, South Africa
Humansdorp Clinic
🇿🇦Humansdorp, South Africa
Pellsrus Clinic
🇿🇦Jeffrey's Bay, South Africa
Joubertina CHC
🇿🇦Joubertina, South Africa
Louterwater Clinic
🇿🇦Joubertina, South Africa
Addo Clinic
🇿🇦Addo, South Africa
Lukhanyiso Clinic
🇿🇦Addo, South Africa
Kwa-Nonqubela Clinic
🇿🇦Alexandria, South Africa
Marselle Clinic
🇿🇦Boesmansriviermond, South Africa
Masakhane Clinic
🇿🇦Hankey, South Africa