Lead: ISGlobal, Spain
The goal of this WP is to:
- Provide overall scientific coordination of the project and ensure that the work complies with the highest quality levels.
- Ensure an efficient operational management and an appropriate liaison with EDCTP.
- Support the coordinator in organising and monitoring the work plan.
- Ensure deliverables are completed on time, with high quality standards and within costs.
- Enable the appropriate communication and work dynamics to help drive the consortium towards the successful completion of the project.
Lead: Bahir dar University, Ethiopia
The objectives of this WP are to:
- Strengthen local capacities to conduct trials in NTDs under Good Clinical Practice (ICH-GCP) Standards.
- Upgrade existing infrastructure to foster state-of-the-art clinical trials on NTDs.
- Support project regions in training for good clinical practice and good laboratory practice.
- Develop training materials.
- Promote African leadership in the field of NTDs and trial management.
The main goal of this WP is to evaluate the efficacy of a fixed-dose combination (FDC) of ivermectin and albendazole, as single or three-dose regimen, compared to single dose albendazole, in a multicentre randomised phase III clinical trial, for the treatment of STH (with endpoints for Trichuris trichiura, hookworms and Strongyloides stercoralis).
This WP will also:
- Evaluate the safety of the FDC as a single or three-dose regimen compared to ALB.
- Evaluate the efficacy of the FDC against A. lumbricoides.
- Evaluate the performance of qPCR in calculating the primary outcome measurement (efficacy) compared to an egg counting method (Kato-Katz).
- Evaluate the prevalence of phenotypic and genotypic resistance to ALB in STH in the three treatment arms before and after treatment.
- Increase community sensitization and investigate barriers and facilitators for MDA uptake.
- Evaluate the efficacy of the FDC in the prevalence of itching/scabies compared to single dose ALB.
The main goals of this WP are to:
- Set up a quality control system for molecular and parasitological diagnostics.
- Evaluate qPCR as marker of treatment response to ALB and correlate with parasitological results.
- Assess the prevalence of alleles in the beta tubulin gene related to ALB resistance, before and after treatment.
The overall goal of this WP is to develop a model-based approach to support the evaluation of treatment efficacy and cost-effectiveness of new anthelmintic regimens. The specific objectives are
- To develop a novel transmission model for Strongyloides stercoralis infection.
- To develop a framework for evaluating treatment efficacy in different epidemiological settings.
- To model the economic and epidemiological impact of the FDC in each of the three trial settings.
The overall goal of this WP is to maximise the impact of the project by:
- Developing communication tools and materials.
- Disseminating STOP’s aims and results throughout the entire course of the project to the scientific community, the wider STH community, affected populations, and the general public.
- Engaging relevant stakeholders and decision makers at the local, national and international level to ensure the results are translated into evidence-based policies.