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).
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
None
* Study population receiving intervention: All eligible preschool-aged children (2-5 years) from pre-selected study areas for small-scale implementation present at the day of the treatment campaign, will be accessed and treated with arpraziquantel by one of the two selected platforms depending on the assignment of the area. * Study population of post-distribution social science study: Subsamples of parents of preschool-aged children of the respective implementation areas, community stakeholders involved in social mobilization and distribution, health workers and programmatic staff involved in training, social mobilization and distribution.
Ecologic or community
Prospective
Arpraziquantel 150mg dispersible tablet
DrugArpraziquantel 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.
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.
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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
