Systems Analysis and Improvement Approach to Prevent TB

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Systems Analysis and Improvement Approach for TB (SAIA-TB)
  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 tre

Первичные конечные точки

• TB Screening [Срок оценки: 18 months]
• Linkage to care for TB disease treatment [Срок оценки: 18 months]
• Linkage to care for TB preventive treatment [Срок оценки: 18 months]

Вторичные конечные точки (4)

• Successful TB Prevention Treatment (TPT) Outcome [Срок оценки: 18 months]
• Successful TB Outcome [Срок оценки: 18 months]
• TB Evaluation [Срок оценки: 18 months]
• TB Diagnosis [Срок оценки: 18 months]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

ЮАР · 16 центров

• Addo Clinic — Addo
• Lukhanyiso Clinic — Addo
• Kwa-Nonqubela Clinic — Alexandria
• Marselle Clinic — Boesmansriviermond
• Masakhane Clinic — Hankey
• Humansdorp Clinic — Humansdorp
• Pellsrus Clinic — Jeffrey's Bay
• Joubertina CHC — Joubertina
• … и ещё 8 центров

Публикации

• van de Water BJ, Brooks MB, Matji R, Ncanywa B, Dikgale F, Abuelezam NN, Mzileni B, Nokwe M, Moko S, Mvusi L, Loveday M, Gimbel S. Systems analysis and improvement approach to optimize tuberculosis (SAIA-TB) screening, treatment, and prevention in South Africa: a stepped-wedge cluster randomized trial. Implement Sci Commun. 2024 Apr 16;5(1):40. doi: 10.1186/s43058-024-00582-z. PMID 38627799

Идентификаторы

NCT: NCT06314386 · 23.139.01 · R01NR020866

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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