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LogseqFMS/pages/STOP2030___Viaje a Ghana 20...

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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]]
- # Resumen de [[Alejandro Krolewiecki]]
- Participants:
- [[GHS]] : [[Abraham Oduro]] , [[Joseph Opare]] , [[Ivy Osei]] , [[Cornelius Debpuur]] , [[Edward Hervie]], Nicole.
- [[Liconsa]] : [[Celia Olmos]] , [[Alejandro Krolewiecki]]
- [[Mundo Sano]] : [[Marina Gold]]
- [[Bridges for Development]] : [[Alan Brooks]]
- To be discussed w ISGlobal and KEMRI
- ### WP 2 RDD/Dr Oduro lead from GHS
- #### Dates
- FDC target [[2024/10]]/[[2024/11]] (early dry season)
- PZQ - Move to [[2025/01]]/[[2025/02]] (but at least 3 weeks after FDC)
- Have FDC available after month 11 sample collection
- #### Protocol
- Protocol ideally finalized in [[2025/01]]
- [[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, 2024, (2 weeks) for review
- Week 22-26 Jan, 2024, 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)
- [[GHS/RDD]] will notify of supporting documents needed for the IRB
- 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 clinical trial, building on and using MDA architecture as much as possible
- GHS to review external communications plan Tuesday 19th
- All/Mundo Sano facilitate
- Circulate and review materials from past MDA and/or relevant trials from communications/social mobilization (GHS has already circulated)
- Align on targeted changes for Ghana and for Kenya (meeting with Kenya scheduled for December 19th with the Comms team)
- Consider 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, to avoid confussion.
- Materials for Ghana (posters on STH) will be developed in collaboration with GHS to be used in awareness campaigns before the study.
- Develop timeline/work plan for activities up to the trial
- Ghana
- Kenya
- ### WP 4 - Acceptability & adherence & feasability - Ivy leads
- Target protocol implementation: end 2024 or early 2025 (rainy season permitting) for implementation.
- Standalone; not part of the Safety and Effectiveness clinical trial
- Protocol
- January: Draft primary and secondary research questions aligned to government/programme decision requirements
- Full draft protocol Q1 2024 (after formative research)
- 3 dose regimen
- Continue to include potential to inform future MDA design and improved effectiveness/cost effectiveness of MDAs, improved clinical management
- Alejandro to share potential protocol/design for salivary testing of [[Albendazol]] (e.g. 48 hours after dose 3) to complement reported coverage data.
- Economics Contributes also to WP3 (KEMRI)
- GHS RDD to consider options for inclusion of key costing data points
- Discuss with GHS economist
- Discuss with KEMRI (e.g. [[Stella Kepha]])
- Can be informed by ongoing work at [[London School of Hygiene & Tropical Medicine]] for the ALIVE trial (draft anticipated in [[2024/01]])