Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314386
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Brief Title:
Systems Analysis and Improvement Approach to Prevent TB
Sponsor:
Boston College
Organization:
Boston College
Study Overview
Official Title:
SAIA-TB Using the Systems Analysis and Improvement Approach SAIA to Prevent TB in Rural South Africa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAIA-TB
Brief Summary:
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
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NR020866 | NIH | None | httpsreporternihgovquickSearchR01NR020866 |