Periodic Reporting for period 1 - STOP2030 (STOP 2030: TOWARDS THE INTERRUPTION OF TRANSMISSION OF SOIL-TRANSMITTED HELMINTHS: PROMOTING IMPLEMENTATION OF RESEARCH RESULTS OF A FIXED-DOSE COMBINATION OF CO-FORMULATED IVERMECTIN AND ALBENDAZOLE)
Reporting period: 2023-07-01 to 2024-12-31
Soil-Transmitted Helminths (STH) remain a significant public health problem with recognized obstacles for control with the current benzimidazole regimens.
General objective
The current STOP2030 project aims at accelerating the implementation of an innovative fixed-dose combination (FDC) tablet of co-formulated albendazole and ivermectin, with adequate safety and significantly superior efficacy against T. trichiura as shown in a pivotal clinical trial conducted in SSA that resulted in EMA´s positive opinion in accordance with Article 58 of Regulation (EC) No 726/2004 for the treatment of STH and lymphatic filariasis.
The overall goal is to provide expanded safety and efficacy data with a field-based study and evaluate the feasibility to implement in NTD control programs adopting the new FDC. 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 FDC.
Specific objectives
(1) To complete the submission process of FDC to national agencies in Ghana and Kenya.
(2) Provide evidence on safety and effectiveness tailored to policy makers for a FDC for the control of STH, including S. stercoralis, and potentially useful for integration with other neglected tropical diseases (NTDs).
(3) Provide acceptability, feasibility, and adherence indicators to the evidence package to support WHO guidance on the use of FDC.
(4) Develop a model for sustainable supply and costing appropriate for widespread use in endemic country settings.
(5) Upscale the capacity of partner research centres in SSA for clinical research and pharmacovigilance to pharma and regulatory standards.
(6) Model the impact of different use cases and scenarios to promote product introduction, national decision making, and donor support.
(7) Implementing a pilot antihelmintic resistance surveillance approach based on genetic epidemiology.
(8) Engage stakeholders including policy and decision makers as well as end-users to identify and overcome barriers for implementation.
General objective
The current STOP2030 project aims at accelerating the implementation of an innovative fixed-dose combination (FDC) tablet of co-formulated albendazole and ivermectin, with adequate safety and significantly superior efficacy against T. trichiura as shown in a pivotal clinical trial conducted in SSA that resulted in EMA´s positive opinion in accordance with Article 58 of Regulation (EC) No 726/2004 for the treatment of STH and lymphatic filariasis.
The overall goal is to provide expanded safety and efficacy data with a field-based study and evaluate the feasibility to implement in NTD control programs adopting the new FDC. 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 FDC.
Specific objectives
(1) To complete the submission process of FDC to national agencies in Ghana and Kenya.
(2) Provide evidence on safety and effectiveness tailored to policy makers for a FDC for the control of STH, including S. stercoralis, and potentially useful for integration with other neglected tropical diseases (NTDs).
(3) Provide acceptability, feasibility, and adherence indicators to the evidence package to support WHO guidance on the use of FDC.
(4) Develop a model for sustainable supply and costing appropriate for widespread use in endemic country settings.
(5) Upscale the capacity of partner research centres in SSA for clinical research and pharmacovigilance to pharma and regulatory standards.
(6) Model the impact of different use cases and scenarios to promote product introduction, national decision making, and donor support.
(7) Implementing a pilot antihelmintic resistance surveillance approach based on genetic epidemiology.
(8) Engage stakeholders including policy and decision makers as well as end-users to identify and overcome barriers for implementation.
The project has made significant progress in al WPs. Project may be slightly behind the schedule and some deliverables were deferred, primarily due to regulatory delays and continues to work towards achieving the objectives set for each work package while adapting to challenges.
WP#1: Project Management and Communication:
(1) Established effective communication channels among consortium members.
(2) Coordinated and executed all legal agreements
(3) Developed an Internal Communication Plan to streamline information sharing and established a SharePoint.
(4) Risk and Quality Management: (4.1) Continuous risk management was implemented, with regular assessments of activities.
(5) Reporting and Financial management: Implemented structured reporting templates and internal financial reporting every 6 months.
WP#2: Biomedical Studies:
(1) Design and implementation of a pragmatic clinical trial.
(2) Developed clinical trial documents in compliance with regulatory requirements.
(3) Site selection for study execution
(4) Data Management and Monitoring: (3.1) Established a Data and Safety Monitoring Board and (3.2) developed a clinical monitoring plan.
(5) Genomic Epidemiology Studies: to evaluate the impact of interventions on parasite diversity and resistance. Protocol completed.
WP#3: Data Management and Analysis
(1) Developed and drafted a data management plan.
WP#4: Acceptability and feasibility studies.
(1) Developed and executed protocols for the acceptability and feasibility studies in both Ghana and Kenya.
(2) Completed formative studies to guide the design of Acceptability-Feasibility-Adherence studies in both study sites.
WP5: Policy and Communication
(1) Completed an analysis of implementation scenarios for the FDC, contributing to the WHO NTD 2030 roadmap.
(2) Developed a white paper on sustainable supply and financing models.
(3) Created and executed an External Communications Plan, including the establishment of a website and social media channels.
(4) Held meetings with WHO
WP#1: Project Management and Communication:
(1) Established effective communication channels among consortium members.
(2) Coordinated and executed all legal agreements
(3) Developed an Internal Communication Plan to streamline information sharing and established a SharePoint.
(4) Risk and Quality Management: (4.1) Continuous risk management was implemented, with regular assessments of activities.
(5) Reporting and Financial management: Implemented structured reporting templates and internal financial reporting every 6 months.
WP#2: Biomedical Studies:
(1) Design and implementation of a pragmatic clinical trial.
(2) Developed clinical trial documents in compliance with regulatory requirements.
(3) Site selection for study execution
(4) Data Management and Monitoring: (3.1) Established a Data and Safety Monitoring Board and (3.2) developed a clinical monitoring plan.
(5) Genomic Epidemiology Studies: to evaluate the impact of interventions on parasite diversity and resistance. Protocol completed.
WP#3: Data Management and Analysis
(1) Developed and drafted a data management plan.
WP#4: Acceptability and feasibility studies.
(1) Developed and executed protocols for the acceptability and feasibility studies in both Ghana and Kenya.
(2) Completed formative studies to guide the design of Acceptability-Feasibility-Adherence studies in both study sites.
WP5: Policy and Communication
(1) Completed an analysis of implementation scenarios for the FDC, contributing to the WHO NTD 2030 roadmap.
(2) Developed a white paper on sustainable supply and financing models.
(3) Created and executed an External Communications Plan, including the establishment of a website and social media channels.
(4) Held meetings with WHO
The project has yielded significant results and potential impacts:
Results Achieved
(1) Modeling Global Impact: we are developing models to assess the broader impact and cost-effectiveness of the FDC.
(2) Data Management Systems: A comprehensive data management plan in compliance with regulatory requirements to support the collection and analysis of data.
(3) Acceptability and Feasibility Studies: Formative studies have been conducted to gather stakeholder opinions on the current management of STH and the proposed FDC.
(4) Community Engagement: Stakeholder engagement has highlighted the importance of community education and sensitization.
(5) Sustainable Supply and Financing Models: The project has explored options for sustainable supply and financing, addressing concerns about reliance on donations and ensuring long-term availability.
Potential Impacts
(1) Improved Health Outcomes: The introduction of FDC is expected to enhance treatment efficacy against STH.
(2) Policy Development: The evidence generated will support the development of WHO guidelines and national policies.
(3) Capacity Building: The project aims to strengthen local research capacities in SSA.
(4) Key Needs for Further Uptake and Success
(4.1) Further Research: to gather comprehensive data on the safety and effectiveness of FDC.
(4.2) Demonstration Projects: to demonstrate the feasibility of integrating the FDC into existing NTD programs.
(4.3) Access to Markets and Finance: Strategies to ensure access in endemic regions.
(4.4.) Commercialization and IPR Support: Support for the commercialization of the FDC, including intellectual property rights (IPR) considerations.
(4.5) Internationalization: Collaboration with organizations to facilitate global uptake.
(4.6) Supportive Regulatory Framework: To expedite approval processes.
(4.7) Standardization Framework: Establishing standards for the production and distribution of the FDC.
In summary, the project has made significant strides in addressing STH through innovative treatment approaches, but continued efforts in research, community engagement, and policy development are essential to maximize its impact and ensure sustainable health outcomes.
Results Achieved
(1) Modeling Global Impact: we are developing models to assess the broader impact and cost-effectiveness of the FDC.
(2) Data Management Systems: A comprehensive data management plan in compliance with regulatory requirements to support the collection and analysis of data.
(3) Acceptability and Feasibility Studies: Formative studies have been conducted to gather stakeholder opinions on the current management of STH and the proposed FDC.
(4) Community Engagement: Stakeholder engagement has highlighted the importance of community education and sensitization.
(5) Sustainable Supply and Financing Models: The project has explored options for sustainable supply and financing, addressing concerns about reliance on donations and ensuring long-term availability.
Potential Impacts
(1) Improved Health Outcomes: The introduction of FDC is expected to enhance treatment efficacy against STH.
(2) Policy Development: The evidence generated will support the development of WHO guidelines and national policies.
(3) Capacity Building: The project aims to strengthen local research capacities in SSA.
(4) Key Needs for Further Uptake and Success
(4.1) Further Research: to gather comprehensive data on the safety and effectiveness of FDC.
(4.2) Demonstration Projects: to demonstrate the feasibility of integrating the FDC into existing NTD programs.
(4.3) Access to Markets and Finance: Strategies to ensure access in endemic regions.
(4.4.) Commercialization and IPR Support: Support for the commercialization of the FDC, including intellectual property rights (IPR) considerations.
(4.5) Internationalization: Collaboration with organizations to facilitate global uptake.
(4.6) Supportive Regulatory Framework: To expedite approval processes.
(4.7) Standardization Framework: Establishing standards for the production and distribution of the FDC.
In summary, the project has made significant strides in addressing STH through innovative treatment approaches, but continued efforts in research, community engagement, and policy development are essential to maximize its impact and ensure sustainable health outcomes.