diff --git a/journals/2024_02_19.md b/journals/2024_02_19.md index 9e5fc056..468c6e44 100644 --- a/journals/2024_02_19.md +++ b/journals/2024_02_19.md @@ -30,5 +30,5 @@ - Timeline con los milestones que se cumplieron y con los que faltarían. - Donde están los partners, una lista de quién es el IP. Una o dos [[Personas]] de cada partner. Tenemos que hacer un email para preguntar quién quieren que figure en la página [[web]] (y enlazar a su LinkedIn o su página personal). Que me confirmes si tienes el proyecto y [[yo]] te paso esa presentación a la que alude Alejandro donde están los objetivos. - Cuando hables con [[Nerea]] o con quien sea les digas que necesitamos hacer una puesta al día y contenido más técnico y nos den cuánto van a tardar en hacer este tipo de agregados. las fotos pueden quedar, el texto, tal vez sacar algo de los textos más genéricos y empezar a poner textos más específicos. Nosotros lo armamos en su momento, pero ahora hay que empezar a alimentarlo un poco más. Pregúntales cómo hacen con las otras páginas ellos. Tienen alguna periodicidad, cada cuánto las ponen al día. Es un proyecto bastante dinámico y de vez en cuando nos gustaría revisar el contenido y que lo pongan en su calendario de trabajo. TE mando el audio de [[Ale]] ahora y te hago un PPT de esa presentación. Cualquier cosa me preguntas por audio. -- # Mensaje de [[Ale Krolewiecki]] sobre [[STOP2030/Web]] +- # Mensaje de [[Ale Krolewiecki]] sobre [[STOP2030/Web]] [[STOP2030/Web/Update 2024]] - [[Yo]] no lo veo como lo estás viendo vos. La página no dice nada. tiene un montón de frases que podrían pertenecer a nada. No se describe cuál es el objetivo del proyecto. está vacia. Son solo frases que dicen que hay especies, que vamos a implementar y se me quedó a mi clarísimo cuando a la vuelta de Ginebra abrí una colaboración con una ivnestigadora de MaLasia y le copié la página [[web]] y a partir de la página [[web]] no sabe cuál es el objetivo del estudio, no sabe cuáles son las acciones que vamso a hacer ni cuál es el obejtivo ni los objetivos generales ni específicos. No sabe de ninguna persona que va a participar dentro de las instituciones que se mencionan. Nosotros somos varias [[Personas]] y no alcanza a descubrir absolutamente nada. Hay un montón de cosas que ya se tenían que haber incorporado. Porque son fotos lindas y frases más de una agencia de publicidad y no de un proyecto de salud pública. Estoy de acuerdo con la estructura. Sí poner los los WP, sí quién es el IP de cada centro, sí pregunta ra cada centro qué [[Personas]] quieren que aparezcan. Sí poner cuáles son los objetivos generales y específicos del proyecto, qué llamado de [[EDCTP]] ganamos, cuál es la linea de tiempo, cua´les son los milestones que ya ganamos. [[Yo]] le copié la página [[web]] pero también le copié un ppt que llevamos a Ginebra porque con la [[web]] la mujer ni siquiera podía tener certeza de que [[yo]] formaba parte del proyecto. \ No newline at end of file diff --git a/pages/STOP2030___Web.md b/pages/STOP2030___Web.md index 7bd3a4d8..ca34c15f 100644 --- a/pages/STOP2030___Web.md +++ b/pages/STOP2030___Web.md @@ -1,67 +1,2 @@ - [[STOP2030/Web/Update 2024/02]] -- -- # Cambios 2024/02 - - Hay que incorporar mucha información técnica que permita a otros investigadores conocer los detalles del proyecto. La web no es solo para público general. - - Asuntos a 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 - - ## Basic facts del proyecto - - En qué call de EDCTP (Global Health EDCTP3) ha salido - - Project duration (36 months); cuando empieza y cuando acaba (20 junio 2026) - - Cuáles son los Work Packages y quién los lidera - - ## 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 - - ## Objetivos y logros de los proyectos STOP previos (en background) - - Qualification at EMA for art. 58 - - Safety of IVM up to 600μg/kg alone and in coformulation with albendazole - - Demonstrated efficacy agrainst T. trichiura in a pivotal trial in Sub-Saharan Africa - - No stopping rules were reached - - Safety was adequate - - Palatability results confirm adecuacy of size, taste and smell - - Superior efficacy against T. trichiura confirms a comprehensive spectrum against STH - - Los papers más relevantes que salieran de los previos STOP - - ## Otros facts - - FDC of ivm/alb has the lowest level of investment risk of all candidates for Combination for STH treatment (STH Drug Combinations Expert Meeting, BMGF, April 2016) - - 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. - - ## Investigadores principales de cada uno de los partners - - TODO Mandar un email y pedirles nombres para saber a quiénes citamos en la web y cómo quieren que los mostremos (Foto? enlace a LinkedIn? a página personal de su institución? crear una pequeña bio de cada uno en la web de stop2030?) - - ## Abstract del proyecto - - [[Soil-Transmitted Helminths]] (STH) remain a significant public health problem with recognized obstacles for control and elimination with the current benzimidazole regimens in [[Mass Drug Administration]] (MDA) campaigns. Renewed targets from [[WHO]] for 2030 include elimination of [[STH]] morbidity in pre-school and school age children (PSAC & SAC), increased country governance and financial support and a strongyloidiasis control program; 2030 has also been targeted by [[WHO]] for controlling NTDs to attain the Sustainable Development Goals. - - The current proposal aims at accelerating the implementation of an innovative [[health]] technology, a [[Fixed-Dose Combination]] (FDC) tablet of co-formulated [[albendazole]] and ivermectin, with adequate safety and significantly superior efficacy against T. trichiura in a registrational randomized clinical trial. This trial is being conducted in Ethiopia, [[Kenya]] and Mozambique with the guidance of EMA and sponsored [[by]] [[EDCTP]] (STOP projects) with a Phase II trial completed and a Phase III currently recruiting. - - This [[project]], [[STOP2030]], seeks to complement the results of the safety and efficacy trial with a field-based safety and effectiveness clinical study, acceptability studies in [[Ghana]] and [[Kenya]], modelling and cost-effectiveness exercises. The resulting information will be consolidated to build a multidisciplinary package for policy making and [[WHO]] guidance with the support of advocacy and communication activities to reach stakeholders and maximize the exploitation and impact of the [[FDC]] for [[STH]] control and elimination. - - The Consortium assembled to execute the [[STOP2030]] proposal combines expertise in complementary fields [[from]] program assessment and implementation through Ministries of [[Health]] in sub Saharan African countries, advocacy, state of the art technology, leadership in clinical research and a pharma that has shown commitment for generating access to drugs against NTDs and has recently obtained [[WHO]] prequalification for generic ivermectin #INFO - - - - \ No newline at end of file +- \ No newline at end of file diff --git a/pages/STOP2030___Web___Update 2024___02.md b/pages/STOP2030___Web___Update 2024___02.md new file mode 100644 index 00000000..1c03d66a --- /dev/null +++ b/pages/STOP2030___Web___Update 2024___02.md @@ -0,0 +1,66 @@ +# Cambios 2024/02 + - Hay que incorporar mucha información técnica que permita a otros investigadores conocer los detalles del proyecto. La web no es solo para público general. + - Asuntos a 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 + - ## Basic facts del proyecto + - En qué call de EDCTP (Global Health EDCTP3) ha salido + - Project duration (36 months); cuando empieza y cuando acaba (20 junio 2026) + - Cuáles son los Work Packages y quién los lidera + - ## 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 + - ## Objetivos y logros de los proyectos STOP previos (en background) + - Qualification at EMA for art. 58 + - Safety of IVM up to 600μg/kg alone and in coformulation with albendazole + - Demonstrated efficacy agrainst T. trichiura in a pivotal trial in Sub-Saharan Africa + - No stopping rules were reached + - Safety was adequate + - Palatability results confirm adecuacy of size, taste and smell + - Superior efficacy against T. trichiura confirms a comprehensive spectrum against STH + - Los papers más relevantes que salieran de los previos STOP + - ## Otros facts + - FDC of ivm/alb has the lowest level of investment risk of all candidates for Combination for STH treatment (STH Drug Combinations Expert Meeting, BMGF, April 2016) + - 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. + - ## Investigadores principales de cada uno de los partners + - TODO Mandar un email y pedirles nombres para saber a quiénes citamos en la web y cómo quieren que los mostremos (Foto? enlace a LinkedIn? a página personal de su institución? crear una pequeña bio de cada uno en la web de stop2030?) + - ## Abstract del proyecto + - [[Soil-Transmitted Helminths]] (STH) remain a significant public health problem with recognized obstacles for control and elimination with the current benzimidazole regimens in [[Mass Drug Administration]] (MDA) campaigns. Renewed targets from [[WHO]] for 2030 include elimination of [[STH]] morbidity in pre-school and school age children (PSAC & SAC), increased country governance and financial support and a strongyloidiasis control program; 2030 has also been targeted by [[WHO]] for controlling NTDs to attain the Sustainable Development Goals. + + The current proposal aims at accelerating the implementation of an innovative [[health]] technology, a [[Fixed-Dose Combination]] (FDC) tablet of co-formulated [[albendazole]] and ivermectin, with adequate safety and significantly superior efficacy against T. trichiura in a registrational randomized clinical trial. This trial is being conducted in Ethiopia, [[Kenya]] and Mozambique with the guidance of EMA and sponsored [[by]] [[EDCTP]] (STOP projects) with a Phase II trial completed and a Phase III currently recruiting. + + This [[project]], [[STOP2030]], seeks to complement the results of the safety and efficacy trial with a field-based safety and effectiveness clinical study, acceptability studies in [[Ghana]] and [[Kenya]], modelling and cost-effectiveness exercises. The resulting information will be consolidated to build a multidisciplinary package for policy making and [[WHO]] guidance with the support of advocacy and communication activities to reach stakeholders and maximize the exploitation and impact of the [[FDC]] for [[STH]] control and elimination. + + The Consortium assembled to execute the [[STOP2030]] proposal combines expertise in complementary fields [[from]] program assessment and implementation through Ministries of [[Health]] in sub Saharan African countries, advocacy, state of the art technology, leadership in clinical research and a pharma that has shown commitment for generating access to drugs against NTDs and has recently obtained [[WHO]] prequalification for generic ivermectin #INFO + - + - +- \ No newline at end of file