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4.1 KiB
4.1 KiB
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
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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 (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)
- GHS/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 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
- Protocol ideally finalized in 2025/01
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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)
- GHS RDD to consider options for inclusion of key costing data points
- Target protocol implementation: end 2024 or early 2025 (rainy season permitting) for implementation.