Arpraziquantel for Schistosomiasis Control in Preschool-aged Children in Endemic Areas in Kenya and Côte d'Ivoire: A Small-scale Public Health Intervention Study Arpraziquantel for Schistosomiasis Control in Preschool-aged Children in Endemic Areas in Uganda, With Special Consideration of Dose Determination Methods: a Small-scale Public Health Intervention Study in Hoima and Bugiri Districts

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 4
Healthy Volunteers: t
View:

• 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

• No reported history of seizures

• No known allergic response to praziquantel

Locations
Other Locations
Kenya
African Institute for Health and Development (AIHD)
NOT_YET_RECRUITING
Nairobi
Kenya Medical Research Institute (KEMRI), Eastern and Southern Africa Centre of International Parasite Control (ESACIPAC)
NOT_YET_RECRUITING
Nairobi
Uganda
Makerere University, Department of Sociology and Anthropology
NOT_YET_RECRUITING
Kampala
Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health
NOT_YET_RECRUITING
Kampala
Contact Information
Primary
Peter Steinmann, PhD PD
peter.steinmann@swisstph.ch
+41 61 284 82 18
Backup
Nora Monnier, Dr. med.
nora.monnier@swisstph.ch
+41 61 284 82 29
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2026-03
Participants
Target number of participants: 18500
Treatments
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.
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.
Sponsors
Leads: Peter Steinmann
Collaborators: Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle, Makerere University, Technical University Munchen, African Institute for Health and Development, Kenya, Kenya Medical Research Institute, Ministry of Health, Uganda, Université Félix Hophouët-Boigny, Kenya Ministry of Health, Unlimit Health

This content was sourced from clinicaltrials.gov