Introduction of Arpraziquantel Treatment for Schistosomiasis Control in Preschool-aged Children in Endemic Areas: A Small-scale Public Health Intervention Study

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).

Conditions

• Schistosomiasis

Interventions

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.

Sponsors & Collaborators

• Technical University Munchen

  collaborator UNKNOWN

• Makerere University

  collaborator OTHER

• African Institute for Health and Development, Kenya

  collaborator UNKNOWN

• Kenya Medical Research Institute

  collaborator OTHER

• Kenya Ministry of Health

  collaborator OTHER_GOV

• Ministry of Health, Uganda

  collaborator OTHER_GOV

• Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle

  collaborator UNKNOWN

• Université Félix Hophouët-Boigny

  collaborator UNKNOWN

• Unlimit Health

  collaborator UNKNOWN

• Peter Steinmann

  lead OTHER

Principal Investigators

• Peter Steinmann, PhD PD · Swiss Tropical & Public Health Institute

Eligibility

Min Age

24 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-25

Primary Completion

2025-11-30

Completion

2026-03-31

Countries

• Côte d’Ivoire
• Kenya
• Uganda

Study Locations