- *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
- 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
- *Primary objective*: To evaluate and compare safety of a [[FDC]] against [[Albendazole]] alone via [[MDA]] in two study areas in Kenya and [[Ghana]].
- To evaluate the effectiveness of one round of [[MDA]] with [[FDC]] vs [[Albendazole]] against [[STH]] (T. trichiura, A. lumbricoides, hookworms) [[by]] microscopy
- [[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
