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project:: STOP2030 by:: Alejandro Krolewiecki, Marina Gold, Celia Olmos, Alan Brooks date:: 2023/12
- Entre 2023/12/10 y 2023/12/14
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Resumen de Alejandro Krolewiecki
- Participants:
- To be discussed w ISGlobal and KEMRI
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WP 2 – RDD/Dr Oduro lead from GHS
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Dates
- FDC – target Oct/Nov, 2024 (early dry season)
- PZQ - Move to January/Feb 2025 (but at least 3 weeks after FDC)
- Have FDC available after month 11 sample collection
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Protocol
- Protocol ideally finalized in January 2025
- GHS will wait for detailed review until next version of the protocol
- Dr. Oduro's team leads review from GHS side
- Target weeks 8-19 Jan (2 weeks) for review
- Week 22-26 Jan to incorporate comments by ISGlobal
- ISGlobal convene virtual discussion on protocol to address emerging/outstanding comments
- IRB Submissions
- ISGlobal responsible for submission of documents
- Ghana submit by 1 Feb in advance of 7 Feb 2024 deadline (5 March as backup)
- RDD will notify of supporting documents needed for the IRB
- GHS will wait for detailed review until next version of the protocol
- Training - R&D/ISGlobal
- Good Clinical Practice (can be GFDA or from different organization as long as not expired)
- Reference lab
- Samples should be run on site (Kato Katz in the schools) and others in-country (ELISA dried blood spots for Strongyloides), with a lab in Accra still to be identified.
- Communication & Social mobilization - NTD Programme/RDD/Health Promotion/Mundo Sano
- Frame messaging on why doing clinical trial as based on Trichuris burden – evidence for clinical trial most clear as albendazole is less effective and we have decent burden data; Reinforce messaging that will be a
- Protocol ideally finalized in January 2025
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