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NCT06314386Enrolling by invitation

Systems Analysis and Improvement Approach to Prevent TB

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

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
19560 (estimated)
First submitted
11 Mar 2024
Start date
6 Feb 2025
Primary completion date
29 Feb 2028
Lead sponsor
Boston College
Diseases
Tuberculosis
NCT number
NCT06314386

What you commit to

  • Study type: Interventional
  • Planned participants: 19560
  • From 6 Feb 2025 to the primary completion date, 29 Feb 2028
  • 16 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Aim 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
  • Exclusion Criteria for clinics:
    • Clinic managers and/or staff are unwilling to participate
    • Aim 2:
  • Inclusion Criteria:
    • 18 years and older
    • Frontline clinical and/or managerial staff, district-level TB management
    • Ability to provide informed consent
  • Exclusion Criteria:
    • Under age 18
    • Unwilling to provide informed consent

Age in the registry: 0 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Lukhanyiso Clinic
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AddoSouth AfricaUnknown status
Addo Clinic
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AddoSouth AfricaUnknown status
Kwa-Nonqubela Clinic
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AlexandriaSouth AfricaUnknown status
Marselle Clinic
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BoesmansriviermondSouth AfricaUnknown status
Masakhane Clinic
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HankeySouth AfricaUnknown status
Humansdorp Clinic
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HumansdorpSouth AfricaUnknown status
Pellsrus Clinic
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Jeffrey's BaySouth AfricaUnknown status
Twee Riviere Clinic
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JoubertinaSouth AfricaUnknown status
Louterwater Clinic
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JoubertinaSouth AfricaUnknown status
Joubertina CHC
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JoubertinaSouth AfricaUnknown status
Kareedouw Clinic
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KareedouwSouth AfricaUnknown status
Kenton On Sea Clinic
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Kenton on SeaSouth AfricaUnknown status
Moses Mabida Clinic
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KirkwoodSouth AfricaUnknown status
Kirkwood Clinic
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KirkwoodSouth AfricaUnknown status
Imizamo Yetho Clinic
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PatensieSouth AfricaUnknown status
Nkwenkwezi Clinic
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Port AlfredSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.