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LogseqFMS/pages/STOP2030___Web.md

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2024/02/19 Propuestas de cambios

- Hay que dejar claro que es un proyecto y ser mucho más concreto sobre los detalles del proyecto. No solo vaguedades.
- Hay que incluir
	- Objetivos generales y objetivos específicos del proyecto.
		- *Overall goal*: Support the achievement of the [[WHO]] 2030 NTD Roadmap for [[STH]] and beyond
		- *Project purpose*: Advance and accelerate an innovative pharmacological tool to support the elimination goals against [[STH]] species, specially those poorly responsive to current treatment regimens
		- *The intervention*: A single tablet, [[Fixed-Dose Combination]] of Ivermectin and [[Albendazole]]
		- *Specific objectives*:
			- Provide a tool to support the achievement of the [[WHO]] Roadmap goals for [[STH]]
			- Submission process of [[FDC]] to EMA & national agencies in [[Ghana]] and Kenya
			- Safety and effectiveness tailored to policy makers for the control of [[STH]], including [[Strongyloides stercolaris]] and integration with other NTDs
			- Acceptability, feasibility and adherence data added to the evidence package to support [[WHO]] guidance
			- Develop a model for sustainable supply and costing
			- Model the impact of different use cases and scenarios
			- Pilot antihelmintic resistance surveillance based on genetic epidemiology
	- Investigadores principales de cada uno de los partners
	- Timeline y milestones (cuáles se han cumplido?)
		- __Proposed safety and effectiveness study__
			- *Primary objective*: To evaluate and compare safety of a [[FDC]] against [[Albendazole]] alone via [[MDA]] in two study areas in Kenya and [[Ghana]].
			- *Secondary objectives*:
				- To evaluate the effectiveness of one round of [[MDA]] with [[FDC]] vs [[Albendazole]] against [[STH]] (T. trichiura, A. lumbricoides, hookworms) [[by]] microscopy
				- To evaluate the effectiveness of one round of [[MDA]] with [[FDC]] vs [[Albendazole]] against [[Strongyloides stercolaris]] [[by]] serology
			- *Primary goal*: Safety (incidence of SAEs)
			- *Secondary goals*: Effectiveness at 21 days and 1 [[year]]; Genomic resistance
			- *Sample size*: approx. 20k.
			- *Target population*: School based
			- *Epidemiologic conditions of the sites*: T. trichiura ongoing transmission areas
			- *Countries*: [[Ghana]] and [[Kenya]]
		- __Proposed acceptability and feasibility study__
			- *Primary goal*: Acceptability and feasibility
			- *Secondary goals*: Adherence (3-day regimen), fidelity
			- *Countries*: [[Ghana]] and [[Kenya]]
			- *Epidemiologic conditions of the sites*: Ongoing [[STH]] deworming activities
			-
	- Ideas generales importantes
		- Dosing strategies for Ivermectine are being revisited
		- The fix-dose coformulation of Albendazole/Ivermectine is [[due]] to enter regulatory agencies
		- Acceptability and safety studies are underway
		- The access plan is being developed
		- Integration across programs (these results have implications beyond STH)
		- Progress has been achieved through public-private partnerships but more partners are needed to reach the ultimate goal.
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