Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06314386 | NOT YET RECRUITING | Tuberculosis

Systems Analysis and Improvement Approach to Prevent TB
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.

Condition or disease

Tuberculosis

TPT

TB - Tuberculosis

Intervention/treatment

Systems Analysis and Improvement Approach for TB (SAIA-TB)

Phase

NA

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
Estimated Enrollment : 19560 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : SAIA-TB: Using the Systems Analysis and Improvement Approach (SAIA) to Prevent TB in Rural South Africa
Actual Study Start Date : 2025-01-06
Estimated Primary Completion Date : 2028-02-29
Estimated Study Completion Date : 2029-02-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 0 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Systems Analysis and Improvement Approach to Prevent TB

Location Details

NCT06314386

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

South Africa,

Addo Clinic

Addo, South Africa,

Not yet recruiting

South Africa,

Lighting Clinic

Addo, South Africa,

Not yet recruiting

South Africa,

Kwa-Nonqubela Clinic

Alexandria, South Africa,

Not yet recruiting

South Africa,

Marselle Clinic

Boesmans river mouth, South Africa,

Not yet recruiting

South Africa,

Masakhane Clinic

Hankey, South Africa,

Not yet recruiting

South Africa,

Humansdorp Clinic

Humansdorp, South Africa,

Not yet recruiting

South Africa,

Pellsrus Clinic

Jeffrey's Bay, South Africa,

Not yet recruiting

South Africa,

Joubertina CHC

Jubertina, South Africa,

Not yet recruiting

South Africa,

Louterwater Clinic

Jubertina, South Africa,

Not yet recruiting

South Africa,

Twee Riviere Clinic

Jubertina, South Africa,

Not yet recruiting

South Africa,

Kareedouw Clinic

curry dew, South Africa,

Not yet recruiting

South Africa,

Kenton On Sea Clinic

Kenton on Sea, South Africa,

Not yet recruiting

South Africa,

Kirkwood Clinic

Kirkwood, South Africa,

Not yet recruiting

South Africa,

Moses Mabida Clinic

Kirkwood, South Africa,

Not yet recruiting

South Africa,

The Clinic's efforts

Patency, South Africa,

Not yet recruiting

South Africa,

Nkwezi Clinic

Port Alfred, South Africa,