预防结核病的系统分析和改进方法 (SAIA-TB)
SAIA-TB：使用系统分析和改进方法 (SAIA) 预防南非农村地区的结核病
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Addo、南非
- Addo Clinic
-
Addo、南非
- Lukhanyiso Clinic
-
Alexandria、南非
- Kwa-Nonqubela Clinic
-
Boesmansriviermond、南非
- Marselle Clinic
-
Hankey、南非
- Masakhane Clinic
-
Humansdorp、南非
- Humansdorp Clinic
-
Jeffrey's Bay、南非
- Pellsrus Clinic
-
Joubertina、南非
- Joubertina CHC
-
Joubertina、南非
- Louterwater Clinic
-
Joubertina、南非
- Twee Riviere Clinic
-
Kareedouw、南非
- Kareedouw Clinic
-
Kenton on Sea、南非
- Kenton On Sea Clinic
-
Kirkwood、南非
- Kirkwood Clinic
-
Kirkwood、南非
- Moses Mabida Clinic
-
Patensie、南非
- Imizamo Yetho Clinic
-
Port Alfred、南非
- Nkwenkwezi Clinic
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：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. |
|
无干预：Unexposed
Clinics are considered unexposed prior to the initiation of SAIA-TB in their clinic |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
TB Screening
大体时间：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
大体时间：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
大体时间：18 months
|
The proportion of individuals initiating TB preventive treatment among those with a negative diagnostic evaluation and eligible for TPT |
18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Successful TB Prevention Treatment (TPT) Outcome
大体时间：18 months
|
The proportion of individuals who complete TB Prevention Treatment (TPT) among those who initiate TPT |
18 months
|
|
Successful TB Outcome
大体时间：18 months
|
The proportion of individuals cured or completing treatment for TB disease among those who initiate TB treatment |
18 months
|
|
TB Evaluation
大体时间：18 months
|
The proportion of individuals receiving a diagnostic evaluation among those with a positive screening |
18 months
|
|
TB Diagnosis
大体时间：18 months
|
The proportion of individuals diagnosed with TB among those who completed a diagnostic evaluation |
18 months
|
合作者和调查者
合作者
调查人员
- 首席研究员：Brittney J van de Water, PhD、Boston College
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.