Systems Analysis and Improvement Approach to Prevent TB

Tuberculosis Clinical Trial

— SAIA-TB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06314386
• Other study ID #: 23.139.01
• Secondary ID: R01NR020866
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 6, 2025
• Est. completion date: February 28, 2029

Study information

• Verified date: March 2024
• Source: Boston College
• Contact: Brittney J van de Water, PhD
• Phone: 617-552-8718
• Email: sulligst[@]bc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 19560
• Est. completion date: February 28, 2029
• Est. primary completion date: February 29, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

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

Related Conditions & MeSH terms

• TB - Tuberculosis
• Tuberculosis

Intervention

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.

Locations

Country	Name	City	State
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	Humansdorp Clinic	Humansdorp
South Africa	Pellsrus Clinic	Jeffrey's Bay
South Africa	Joubertina CHC	Joubertina
South Africa	Louterwater Clinic	Joubertina
South Africa	Twee Riviere Clinic	Joubertina
South Africa	Kareedouw Clinic	Kareedouw
South Africa	Kenton On Sea Clinic	Kenton on Sea
South Africa	Kirkwood Clinic	Kirkwood
South Africa	Moses Mabida Clinic	Kirkwood
South Africa	Imizamo Yetho Clinic	Patensie
South Africa	Nkwenkwezi Clinic	Port Alfred

Sponsors (6)

Lead Sponsor	Collaborator
Boston College	Boston University, Medical Research Council, South Africa, National Institute of Nursing Research (NINR), National Institutes of Health (NIH), University of Washington

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TB Screening	The proportion of individuals screened with WHO TB symptom screen in the target population	18 months
Primary	Linkage to care for TB disease treatment	The proportion of individuals initiating TB disease treatment among those with a positive diagnostic evaluation	18 months
Primary	TB Evaluation	The proportion of individuals receiving a diagnostic evaluation among those with a positive screening	18 months
Primary	TB Diagnosis	The proportion of individuals diagnosed with TB among those who completed a diagnostic evaluation	18 months
Secondary	Successful TB Prevention Treatment (TPT) Outcome	The proportion of individuals who complete TB Prevention Treatment (TPT) among those who initiate TPT	18 months
Secondary	Successful TB Outcome	The proportion of individuals cured or completing treatment for TB disease among those who initiate TB treatment	18 months