結核を予防するためのシステム分析と改善アプローチ (SAIA-TB)
SAIA-TB: システム分析および改善アプローチ (SAIA) を使用した南アフリカ農村部の結核予防
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Addo、南アフリカ
- Addo Clinic
-
Addo、南アフリカ
- Lukhanyiso Clinic
-
Alexandria、南アフリカ
- Kwa-Nonqubela Clinic
-
Boesmansriviermond、南アフリカ
- Marselle Clinic
-
Hankey、南アフリカ
- Masakhane Clinic
-
Humansdorp、南アフリカ
- Humansdorp Clinic
-
Jeffrey's Bay、南アフリカ
- Pellsrus Clinic
-
Joubertina、南アフリカ
- Joubertina CHC
-
Joubertina、南アフリカ
- Louterwater Clinic
-
Joubertina、南アフリカ
- Twee Riviere Clinic
-
Kareedouw、南アフリカ
- Kareedouw Clinic
-
Kenton on Sea、南アフリカ
- Kenton On Sea Clinic
-
Kirkwood、南アフリカ
- Kirkwood Clinic
-
Kirkwood、南アフリカ
- Moses Mabida Clinic
-
Patensie、南アフリカ
- Imizamo Yetho Clinic
-
Port Alfred、南アフリカ
- Nkwenkwezi Clinic
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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. |
|
介入なし：Unexposed
Clinics are considered unexposed prior to the initiation of SAIA-TB in their clinic |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
TB Screening
時間枠：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
時間枠：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
時間枠：18 months
|
The proportion of individuals initiating TB preventive treatment among those with a negative diagnostic evaluation and eligible for TPT |
18 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Successful TB Prevention Treatment (TPT) Outcome
時間枠：18 months
|
The proportion of individuals who complete TB Prevention Treatment (TPT) among those who initiate TPT |
18 months
|
|
Successful TB Outcome
時間枠：18 months
|
The proportion of individuals cured or completing treatment for TB disease among those who initiate TB treatment |
18 months
|
|
TB Evaluation
時間枠：18 months
|
The proportion of individuals receiving a diagnostic evaluation among those with a positive screening |
18 months
|
|
TB Diagnosis
時間枠：18 months
|
The proportion of individuals diagnosed with TB among those who completed a diagnostic evaluation |
18 months
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Brittney J van de Water, PhD、Boston College
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 23.139.01
- R01NR020866 (米国 NIH グラント/契約)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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