About this trial
The proposed small-scale pilot studies are public health intervention studies implemented through established routine programs and services in the frame of the mass drug administration (MDA) campaigns in Côte d'Ivoire, Kenya and Uganda. In each country two most promising health intervention platforms were selected for pilot distribution of arpraziquantel 150mg (arPZQ).
The aim of the small-scale pilot study is to assess the performance of different platforms for distributing arPZQ, a child-friendly formulation of praziquantel, to the target population (i.e., preschool-aged children (PSAC)) currently missed out in schistosomiasis treatment campaigns.
The specific objectives of the pilot study are:
* To assess the performance of different platforms for delivery of arPZQ to PSAC aged 24 to 59 months in terms of coverage, feasibility and acceptability * To determine social mobilization and training needs for effective delivery of arPZQ through different platforms
Preventive chemotherapy with arPZQ will be offered systematically to eligible PSAC aged 2 to below 5 years of consenting caregivers resident in the study area and reached through the selected platforms. Adverse events during MDA with arPZQ will be documented and reported by using existing tools and established reporting pathways aligned with standard pharmacovigilance and safety guidelines of the national drug authorities. Based on routine program processes and forms, variables pertaining to drug logistics, training, drug distribution, passive pharmacovigilance and supervision will be collected in order to measure and generate real-world data related to feasibility, coverage and acceptability of selected platforms and strategies to inform future scale-up to district levels.
Assessments will take place before (to capture social mobilization and training activities) during and after the drug distribution to document the implementation process and evaluate experiences made by the different stakeholders (e.g. children, parents, community members, health workers, programme staff).
Eligibility criteria
Qualifiers
Living in the designated implementation area since at least 6 months
Aged between 24 - 59 months
Informed consent available
No acute or chronic illness and/or inability to take oral medication
Disqualifiers
None
Trial design
Treatments tested in this trial
- Arpraziquantel 150mg dispersible tablet
Treatment groups
Sponsors and collaborators
Peter Steinmann
Lead sponsor
Swiss Tropical & Public Health Institute
Sponsor institution
Technical University Munchen
Collaborator
Makerere University
Collaborator
African Institute for Health and Development, Kenya
Collaborator
Kenya Medical Research Institute
Collaborator
Kenya Ministry of Health
Collaborator
Ministry of Health, Uganda
Collaborator
Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle
Collaborator
Université Félix Hophouët-Boigny
Collaborator
Unlimit Health
Collaborator