An observational study in Schistosomiasis, sponsored by Peter Steinmann. Recruiting at 7 sites in 3 countries. Open to participants aged 24 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by Peter Steinmann · Observational
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:
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).
79 studies on the registry are indexed under Schistosomiasis; 14 are open to participants now.
This study's planned enrollment of 18,500 is above the median of 532 across 25 observational studies indexed under Schistosomiasis.
Browse Schistosomiasis studies →This is the only study on the registry with Peter Steinmann as lead sponsor.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Preschool-aged children (24 to 59 months of age) of villages preselected to receive a single oral dose of 50mg/kg or 60mg/kg (depending on country) arpraziquantel as part of the routine schistosomiasis mass drug administration campaigns led by the national NTD programmes.
Drug: Arpraziquantel 150mg dispersible tablet
Preschool-aged children (24 to 59 months of age) of villages preselected to receive a single oral dose of 50mg/kg or 60mg/kg (depending on country) arpraziquantel as part of the routine vitamin A distribution/child health days campaigns led by the national nutrition programmes.
Drug: Arpraziquantel 150mg dispersible tablet
Arpraziquantel 150mg dispersible tablets given as single oral dose of 50mg/kg (in Kenya and Uganda; for Schistosoma mansoni infection) or 60mg/kg (in Côte d'Ivoire; for mixed infections with S. mansoni / S. haematobium) using weight-based dosing tables as detailed in the summary of product characteristics.
Platform performance for arPZQ distribution
Platform performance will be combined measure based on the coverage and feasibility measured by the following parameters and implementation outcome indicators: * Platform reach: Program reach and therapeutic coverage * Platform feasibility: Extent of changes to established procedures and requirements in terms of resources for social mobilization, training, drug logistics and drug delivery Feasibility will be assessed through quantitative and qualitative data on operational aspects * Platform acceptability/suitability: quantitative and qualitative feedback by stakeholders (health system \& population perspective) assessed through Questionnaires \& FGDs with parents and community stakeholders, KIIs and transect walks with health workers and programmatic supervision/monitoring tools and review meetings of implementers For the analysis and selection of a platform, a prioritization matrix will be developed which enables a triangulation and weighing of the above mentioned indicators.
Time frame: Documentation from 3 months before up to 12 weeks after the drug distribution
Effectiveness of social mobilization, communication and training
The effectiveness of the advocacy, social mobilization and communication campaign will be measured as a combined measure by the following indicators: * Appropriateness of the tools (content, distribution channel, locations, timetable) * Acceptability of messages and motivation to access treatment * Coverage and scope of social mobilization * Feasibility in terms of equipment, personnel and timetable using questionnaires, FGDs, KIIs, non-participative observations through social scientists and routine monitoring and supervision tools as well as training knowledge assessment forms applied by the platforms and monitoring and evaluation teams. For the analysis and selection of a platform with regard to its social mobilization and communication effectiveness, a prioritization matrix will be developed which enables a triangulation and weighing of the above mentioned indicators.
Time frame: Documentation from 3 months before up to 12 weeks after the drug distribution
Plan to share: No — There are data sharing agreements (DTAs) between Swiss TPH, Côte d'Ivoire/Kenya/Uganda MoH, Felix Hophouët-Boigny University, Kenya Medical Research Institute and Makerere University in place. Likewise DTAs are in place between partners working on the social science study that is between Technical University München, the African Institute for Health \& Development, Makerere University and Felix Hophouët-Boigny University. Data may be shared with other researchers upon request.
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