WP1: Scientific Coordination and Management
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.
WP2: Capacity building
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.
WP3: Clinical Trial
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.
WP4: Use of molecular biology for clinical trials
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.
WP 5: Modelling epidemiological and economic impact
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.
WP6: Communication, advocacy and exploitation
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.