Systems Analysis and Improvement Approach to Prevent TB

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.

Conditions

• Tuberculosis
• TPT
• TB - Tuberculosis

Interventions

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.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Boston University

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Medical Research Council, South Africa

  collaborator OTHER

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Boston College

  lead OTHER

Principal Investigators

• Brittney J van de Water, PhD · Boston College

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

0 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-06

Primary Completion

2028-02-29

Completion

2029-02-28

Countries

• South Africa

Study Locations