Systemanalyse und Verbesserungsansatz zur Prävention von Tuberkulose (SAIA-TB)
SAIA-TB: Verwendung des Systems Analysis and Improvement Approach (SAIA) zur Prävention von Tuberkulose im ländlichen Südafrika
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
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Addo, Südafrika
- Addo Clinic
-
Addo, Südafrika
- Lukhanyiso Clinic
-
Alexandria, Südafrika
- Kwa-Nonqubela Clinic
-
Boesmansriviermond, Südafrika
- Marselle Clinic
-
Hankey, Südafrika
- Masakhane Clinic
-
Humansdorp, Südafrika
- Humansdorp Clinic
-
Jeffrey's Bay, Südafrika
- Pellsrus Clinic
-
Joubertina, Südafrika
- Joubertina CHC
-
Joubertina, Südafrika
- Louterwater Clinic
-
Joubertina, Südafrika
- Twee Riviere Clinic
-
Kareedouw, Südafrika
- Kareedouw Clinic
-
Kenton on Sea, Südafrika
- Kenton On Sea Clinic
-
Kirkwood, Südafrika
- Kirkwood Clinic
-
Kirkwood, Südafrika
- Moses Mabida Clinic
-
Patensie, Südafrika
- Imizamo Yetho Clinic
-
Port Alfred, Südafrika
- Nkwenkwezi Clinic
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: Exposed
Clinics are considered exposed after intensive SAIA-TB intervention, implementation phase, and maintenance phase. |
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. |
|
Kein Eingriff: Unexposed
Clinics are considered unexposed prior to the initiation of SAIA-TB in their clinic |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
TB Screening
Zeitfenster: 18 months
|
The proportion of individuals screened with WHO TB symptom screen in the target population |
18 months
|
|
Linkage to care for TB disease treatment
Zeitfenster: 18 months
|
The proportion of individuals initiating TB disease treatment among those with a positive diagnostic evaluation |
18 months
|
|
Linkage to care for TB preventive treatment
Zeitfenster: 18 months
|
The proportion of individuals initiating TB preventive treatment among those with a negative diagnostic evaluation and eligible for TPT |
18 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Successful TB Prevention Treatment (TPT) Outcome
Zeitfenster: 18 months
|
The proportion of individuals who complete TB Prevention Treatment (TPT) among those who initiate TPT |
18 months
|
|
Successful TB Outcome
Zeitfenster: 18 months
|
The proportion of individuals cured or completing treatment for TB disease among those who initiate TB treatment |
18 months
|
|
TB Evaluation
Zeitfenster: 18 months
|
The proportion of individuals receiving a diagnostic evaluation among those with a positive screening |
18 months
|
|
TB Diagnosis
Zeitfenster: 18 months
|
The proportion of individuals diagnosed with TB among those who completed a diagnostic evaluation |
18 months
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Brittney J van de Water, PhD, Boston College
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 23.139.01
- R01NR020866 (US NIH Stipendium/Vertrag)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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