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| ID | Type | Description | Link |
|---|---|---|---|
| RIA2019IR-2895; G2020-102 | Other Grant/Funding Number | European and Developing Countries Clinical Trials Partnership (EDCTP); Global Healh Innovative Technology (GHIT) Fund |
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| Name | Class |
|---|---|
| Technical University Munchen | UNKNOWN |
| Makerere University | OTHER |
| African Institute for Health and Development, Kenya | UNKNOWN |
| Kenya Medical Research Institute |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arPZQ distributed through Platform 1 (NTD programmes) | 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. |
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| arPZQ distributed through Platform 2 (child health days/nutrition programmes) | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arpraziquantel 150mg dispersible tablet | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. | Documentation from 3 months before up to 12 weeks after the drug distribution |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Steinmann, PhD PD | Contact | +41 61 284 82 18 | peter.steinmann@swisstph.ch | |
| Nora Monnier, Dr. med. | Contact | +41 61 284 82 29 | nora.monnier@swisstph.ch |
| Name | Affiliation | Role |
|---|---|---|
| Peter Steinmann, PhD PD | Swiss Tropical & Public Health Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Programme National de Lutte Contre les Maladies Tropicales Négligées à Chimiothérapie Préventive (PNLMTN-CP), Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle (MSHPCMU) | Recruiting | Abidjan |
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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| OTHER |
| Kenya Ministry of Health | OTHER_GOV |
| Ministry of Health, Uganda | OTHER_GOV |
| Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle | UNKNOWN |
| Université Félix Hophouët-Boigny | UNKNOWN |
| Unlimit Health | UNKNOWN |
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| Documentation from 3 months before up to 12 weeks after the drug distribution |
| Côte d’Ivoire |
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| Université Félix Hophouët-Boigny (UFHB), Département de sociologie | Recruiting | Abidjan | Côte d’Ivoire |
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| Université Félix Hophouët-Boigny (UFHB), UFR Biosciences | Recruiting | Abidjan | Côte d’Ivoire |
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| African Institute for Health and Development (AIHD) | Not yet recruiting | Nairobi | Kenya |
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| Kenya Medical Research Institute (KEMRI), Eastern and Southern Africa Centre of International Parasite Control (ESACIPAC) | Not yet recruiting | Nairobi | Kenya |
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| Makerere University, Department of Sociology and Anthropology | Not yet recruiting | Kampala | Uganda |
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| Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health | Not yet recruiting | Kampala | Uganda |
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| ID | Term |
|---|---|
| D012552 | Schistosomiasis |
| ID | Term |
|---|---|
| D014201 | Trematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000079426 | Vector Borne Diseases |
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