결핵 예방을 위한 시스템 분석 및 개선 접근 방식 (SAIA-TB)
SAIA-TB: 남아프리카 시골 지역의 결핵 예방을 위한 시스템 분석 및 개선 접근법(SAIA) 사용
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Addo, 남아프리카
- Addo Clinic
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Addo, 남아프리카
- Lukhanyiso Clinic
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Alexandria, 남아프리카
- Kwa-Nonqubela Clinic
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Boesmansriviermond, 남아프리카
- Marselle Clinic
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Hankey, 남아프리카
- Masakhane Clinic
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Humansdorp, 남아프리카
- Humansdorp Clinic
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Jeffrey's Bay, 남아프리카
- Pellsrus Clinic
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Joubertina, 남아프리카
- Joubertina CHC
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Joubertina, 남아프리카
- Louterwater Clinic
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Joubertina, 남아프리카
- Twee Riviere Clinic
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Kareedouw, 남아프리카
- Kareedouw Clinic
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Kenton on Sea, 남아프리카
- Kenton On Sea Clinic
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Kirkwood, 남아프리카
- Kirkwood Clinic
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Kirkwood, 남아프리카
- Moses Mabida Clinic
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Patensie, 남아프리카
- Imizamo Yetho Clinic
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Port Alfred, 남아프리카
- Nkwenkwezi Clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Aim 1:
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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
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Exclusion Criteria for clinics:
- Clinic managers and/or staff are unwilling to participate
Aim 2:
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Inclusion Criteria:
- 18 years and older
- Frontline clinical and/or managerial staff, district-level TB management
- Ability to provide informed consent
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Exclusion Criteria:
- Under age 18
- Unwilling to provide informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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. |
|
간섭 없음: Unexposed
Clinics are considered unexposed prior to the initiation of SAIA-TB in their clinic |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
TB Screening
기간: 18 months
|
The proportion of individuals screened with WHO TB symptom screen in the target population |
18 months
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Linkage to care for TB disease treatment
기간: 18 months
|
The proportion of individuals initiating TB disease treatment among those with a positive diagnostic evaluation |
18 months
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Linkage to care for TB preventive treatment
기간: 18 months
|
The proportion of individuals initiating TB preventive treatment among those with a negative diagnostic evaluation and eligible for TPT |
18 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Successful TB Prevention Treatment (TPT) Outcome
기간: 18 months
|
The proportion of individuals who complete TB Prevention Treatment (TPT) among those who initiate TPT |
18 months
|
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Successful TB Outcome
기간: 18 months
|
The proportion of individuals cured or completing treatment for TB disease among those who initiate TB treatment |
18 months
|
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TB Evaluation
기간: 18 months
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The proportion of individuals receiving a diagnostic evaluation among those with a positive screening |
18 months
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TB Diagnosis
기간: 18 months
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The proportion of individuals diagnosed with TB among those who completed a diagnostic evaluation |
18 months
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공동 작업자 및 조사자
스폰서
협력자
수사관
- 수석 연구원: Brittney J van de Water, PhD, Boston College
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 23.139.01
- R01NR020866 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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