Tuberculosis Clinical Trial
— SAIA-TBOfficial title:
SAIA-TB: Using the Systems Analysis and Improvement Approach (SAIA) to Prevent TB in Rural South Africa
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 | 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 |
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 |
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 |
South Africa,
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 |
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