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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:
    • 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
          • 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/ GHS/RDD/Health Promotion/ Mundo Sano
          • Frame messaging on why doing clinical trial as based on Trichuris trichiura burden – evidence for clinical trial most clear as albendazole is less effective and we have decent burden data; Reinforce messaging that it 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 KEMRI scheduled for 2024/12/19 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 and 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)