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project:: [[STOP2030]]
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by:: [[Alejandro Krolewiecki]], [[Marina Gold]], [[Celia Olmos]], [[Alan Brooks]]
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date:: [[2023/12]]
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- Entre [[2023/12/10]] y [[2023/12/14]]
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- # Resumen de [[Alejandro Krolewiecki]]
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- Participants:
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- [[GHS]] : [[Abraham Oduro]] , [[Joseph Opare]] , [[Ivy Osei]] , [[Cornelius Debpuur]] , [[Edward Hervie]], Nicole.
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- [[Liconsa]] : [[Celia Olmos]] , [[Alejandro Krolewiecki]]
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- [[Mundo Sano]] : [[Marina Gold]]
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- [[Bridges for Development]] : [[Alan Brooks]]
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- To be discussed w ISGlobal and KEMRI
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- ### WP 2 – RDD/Dr Oduro lead from GHS
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- #### Dates
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- FDC – target Oct/Nov, 2024 (early dry season)
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- PZQ - Move to January/Feb 2025 (but at least 3 weeks after FDC)
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- Have FDC available after month 11 sample collection
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- #### Protocol
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- Protocol ideally finalized in January 2025
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- GHS will wait for detailed review until next version of the protocol
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- [[Dr. Oduro]]'s team leads review from GHS side
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- Target weeks 8-19 Jan (2 weeks) for review
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- Week 22-26 Jan to incorporate comments by [[ISGlobal]]
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- [[ISGlobal]] convene virtual discussion on protocol to address emerging/outstanding comments
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- IRB Submissions
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- ISGlobal responsible for submission of documents
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- Ghana submit by 1 Feb in advance of 7 Feb 2024 deadline (5 March as backup)
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- RDD will notify of supporting documents needed for the IRB
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- Training - R&D/ISGlobal
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- Good Clinical Practice (can be GFDA or from different organization as long as not expired)
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- Reference lab
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- 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.
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- Communication & Social mobilization - NTD Programme/RDD/Health Promotion/Mundo Sano
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- 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 clinical trial, building on and using MDA architecture as much as possible
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- GHS to review external communications plan – Tuesday 19th
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- All/Mundo Sano facilitate
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- Circulate and review materials from past MDA and/or relevant trials from communications/social mobilization (GHS has already circulated)
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- Align on targeted changes for Ghana and for Kenya (meeting with Kenya scheduled for December 19th with the Comms team)
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- Consdiera how to reflect non-STH diseases also addressed by the FDC (e.g. Onchocercosis, Limphatic Filariasis, Scabies). This was consulted with the Comms team an we are not sure it is a good idea. Perhaps we can think about doing posters and material to be left to the sites after the project, but not during the study |