Enfoque de análisis y mejora de sistemas para prevenir la tuberculosis (SAIA-TB)
SAIA-TB: Uso del enfoque de análisis y mejora de sistemas (SAIA) para prevenir la tuberculosis en las zonas rurales de Sudáfrica
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Addo, Sudáfrica
- Addo Clinic
-
Addo, Sudáfrica
- Lukhanyiso Clinic
-
Alexandria, Sudáfrica
- Kwa-Nonqubela Clinic
-
Boesmansriviermond, Sudáfrica
- Marselle Clinic
-
Hankey, Sudáfrica
- Masakhane Clinic
-
Humansdorp, Sudáfrica
- Humansdorp Clinic
-
Jeffrey's Bay, Sudáfrica
- Pellsrus Clinic
-
Joubertina, Sudáfrica
- Joubertina CHC
-
Joubertina, Sudáfrica
- Louterwater Clinic
-
Joubertina, Sudáfrica
- Twee Riviere Clinic
-
Kareedouw, Sudáfrica
- Kareedouw Clinic
-
Kenton on Sea, Sudáfrica
- Kenton On Sea Clinic
-
Kirkwood, Sudáfrica
- Kirkwood Clinic
-
Kirkwood, Sudáfrica
- Moses Mabida Clinic
-
Patensie, Sudáfrica
- Imizamo Yetho Clinic
-
Port Alfred, Sudáfrica
- Nkwenkwezi Clinic
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: 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. |
|
Sin intervención: Unexposed
Clinics are considered unexposed prior to the initiation of SAIA-TB in their clinic |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
TB Screening
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 18 months
|
The proportion of individuals initiating TB preventive treatment among those with a negative diagnostic evaluation and eligible for TPT |
18 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Successful TB Prevention Treatment (TPT) Outcome
Periodo de tiempo: 18 months
|
The proportion of individuals who complete TB Prevention Treatment (TPT) among those who initiate TPT |
18 months
|
|
Successful TB Outcome
Periodo de tiempo: 18 months
|
The proportion of individuals cured or completing treatment for TB disease among those who initiate TB treatment |
18 months
|
|
TB Evaluation
Periodo de tiempo: 18 months
|
The proportion of individuals receiving a diagnostic evaluation among those with a positive screening |
18 months
|
|
TB Diagnosis
Periodo de tiempo: 18 months
|
The proportion of individuals diagnosed with TB among those who completed a diagnostic evaluation |
18 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Brittney J van de Water, PhD, Boston College
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 23.139.01
- R01NR020866 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .