# [[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 -