Systems Analysis and Improvement Approach to Prevent TB (SAIA-TB)

SAIA-TB: Using the Systems Analysis and Improvement Approach (SAIA) to Prevent TB in Rural South Africa

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Tuberculosis; TB - Tuberculosis; TPT
• Intervention / Treatment: Other: Systems Analysis and Improvement Approach for TB (SAIA-TB)

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.

• Study Type: Interventional
• Enrollment (Estimated): 19560
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Addo, South Africa
    • Addo Clinic
  • Addo, South Africa
    • Lukhanyiso Clinic
  • Alexandria, South Africa
    • Kwa-Nonqubela Clinic
  • Boesmansriviermond, South Africa
    • Marselle Clinic
  • Hankey, South Africa
    • Masakhane Clinic
  • Humansdorp, South Africa
    • Humansdorp Clinic
  • Jeffrey's Bay, South Africa
    • Pellsrus Clinic
  • Joubertina, South Africa
    • Joubertina CHC
  • Joubertina, South Africa
    • Louterwater Clinic
  • Joubertina, South Africa
    • Twee Riviere Clinic
  • Kareedouw, South Africa
    • Kareedouw Clinic
  • Kenton on Sea, South Africa
    • Kenton On Sea Clinic
  • Kirkwood, South Africa
    • Kirkwood Clinic
  • Kirkwood, South Africa
    • Moses Mabida Clinic
  • Patensie, South Africa
    • Imizamo Yetho Clinic
  • Port Alfred, South Africa
    • Nkwenkwezi Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Aim 1:

1. Inclusion Criteria for clinics:

   • Location in the municipalities of Dr. Beyers Naude, Blue Crane Route, Makana, Ndlambe, Sundays River Valley, Kou-Kamma, or Kouga within the Sarah Baartman district, Eastern Cape, South Africa
   • Within 2 hours' drive to Gqeberha, where the study office is located
   • Only one clinic per town/area/location to ensure a mix of rural, semi-rural, semi urban
   • Clinic capacity/Patient volume > 700 total outpatient attendees per month (8,400 patients per year)
   • Staff size of at least 5 employees with a mixture of at least 2 professional nurses, 1 or 2 pharmacist/pharmacy technicians, at least 1 data capturer, a social worker, and multiple community health workers who are clinic-based or part of ward-based outreach teams.
   • Must have an acting Clinic Manager

2. Exclusion Criteria for clinics:

   • Clinic managers and/or staff are unwilling to participate

Aim 2:

1. Inclusion Criteria:

   • 18 years and older
   • Frontline clinical and/or managerial staff, district-level TB management
   • Ability to provide informed consent

2. Exclusion Criteria:

   • Under age 18
   • Unwilling to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Exposed; Clinics are considered exposed after intensive SAIA-TB intervention, implementation phase, and maintenance phase.	Other: Systems Analysis and Improvement Approach for TB (SAIA-TB); 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.
No Intervention: Unexposed; Clinics are considered unexposed prior to the initiation of SAIA-TB in their clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TB Screening	The proportion of individuals screened with WHO TB symptom screen in the target population	18 months
Linkage to care for TB disease treatment	The proportion of individuals initiating TB disease treatment among those with a positive diagnostic evaluation	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	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TB Evaluation	The proportion of individuals receiving a diagnostic evaluation among those with a positive screening	18 months
TB Diagnosis	The proportion of individuals diagnosed with TB among those who completed a diagnostic evaluation	18 months
Successful TB Prevention Treatment (TPT) Outcome	The proportion of individuals who complete TB Prevention Treatment (TPT) among those who initiate TPT	18 months
Successful TB Outcome	The proportion of individuals cured or completing treatment for TB disease among those who initiate TB treatment	18 months

Collaborators and Investigators

• Sponsor: Boston College
• Collaborators: Boston University; National Institute of Nursing Research (NINR); National Institutes of Health (NIH); University of Washington; Medical Research Council, South Africa
• Investigators: Principal Investigator: Brittney J van de Water, PhD, Boston College

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2025
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: tuberculosis
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: 23.139.01; R01NR020866 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No