Clinical trial NCT06698510: Introduction of Arpraziquantel Treatment for Schistosomiasis Control in Preschool-aged Children in Endemic Areas: a Small-scale Public Health Intervention Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schistosomiasis
Keywords: schistosomiasis
preschool-aged children
praziquantel
arpraziquantel
deworming
pediatric treatment
child health
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Technical University Munchen
name: Makerere University
name: African Institute for Health and Development, Kenya
name: Kenya Medical Research Institute
name: Kenya Ministry of Health
name: Ministry of Health, Uganda
name: Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle
name: Université Félix Hophouët-Boigny
name: Unlimit Health
First posted: 2024-11-21
Enrollment: 18500
Sex: ALL
Minimum age (years): 24
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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.

Brief 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 criteria: * 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

Primary outcomes:
measure: Platform performance for arPZQ distribution
timeFrame: Documentation from 3 months before up to 12 weeks after the drug distribution
Secondary outcomes:
measure: Effectiveness of social mobilization, communication and training
timeFrame: Documentation from 3 months before up to 12 weeks after the drug distribution
Other outcomes:
Locations:
city: Abidjan
country: Côte D'Ivoire
facility: 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)
city: Abidjan
country: Côte D'Ivoire
facility: Université Félix Hophouët-Boigny (UFHB), Département de sociologie
city: Abidjan
country: Côte D'Ivoire
facility: Université Félix Hophouët-Boigny (UFHB), UFR Biosciences
city: Nairobi
country: Kenya
facility: African Institute for Health and Development (AIHD)
city: Nairobi
country: Kenya
facility: Kenya Medical Research Institute (KEMRI), Eastern and Southern Africa Centre of International Parasite Control (ESACIPAC)
city: Kampala
country: Uganda
facility: Makerere University, Department of Sociology and Anthropology
city: Kampala
country: Uganda
facility: Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health
Study officials:
affiliation: Swiss Tropical & Public Health Institute
name: Peter Steinmann, PhD PD
role: PRINCIPAL_INVESTIGATOR
References: