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
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lukhanyiso Clinic Coordinator of this site? Confirm its status | Addo | South Africa | Unknown status |
| Addo Clinic Coordinator of this site? Confirm its status | Addo | South Africa | Unknown status |
| Kwa-Nonqubela Clinic Coordinator of this site? Confirm its status | Alexandria | South Africa | Unknown status |
| Marselle Clinic Coordinator of this site? Confirm its status | Boesmansriviermond | South Africa | Unknown status |
| Masakhane Clinic Coordinator of this site? Confirm its status | Hankey | South Africa | Unknown status |
| Humansdorp Clinic Coordinator of this site? Confirm its status | Humansdorp | South Africa | Unknown status |
| Pellsrus Clinic Coordinator of this site? Confirm its status | Jeffrey's Bay | South Africa | Unknown status |
| Twee Riviere Clinic Coordinator of this site? Confirm its status | Joubertina | South Africa | Unknown status |
| Louterwater Clinic Coordinator of this site? Confirm its status | Joubertina | South Africa | Unknown status |
| Joubertina CHC Coordinator of this site? Confirm its status | Joubertina | South Africa | Unknown status |
| Kareedouw Clinic Coordinator of this site? Confirm its status | Kareedouw | South Africa | Unknown status |
| Kenton On Sea Clinic Coordinator of this site? Confirm its status | Kenton on Sea | South Africa | Unknown status |
| Moses Mabida Clinic Coordinator of this site? Confirm its status | Kirkwood | South Africa | Unknown status |
| Kirkwood Clinic Coordinator of this site? Confirm its status | Kirkwood | South Africa | Unknown status |
| Imizamo Yetho Clinic Coordinator of this site? Confirm its status | Patensie | South Africa | Unknown status |
| Nkwenkwezi Clinic Coordinator of this site? Confirm its status | Port Alfred | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.