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NCT Number: NCT06698510

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

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).

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Key information

Age range

24 month–59 month

Sex eligibility

All sexes

Study type

Observational

Primary location

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), Abidjan, Côte d’Ivoire

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Platform performance for arPZQ distribution

    Time frame: Documentation from 3 months before up to 12 weeks after the drug 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.

Secondary outcomes

  1. Effectiveness of social mobilization, communication and training

    Time frame: Documentation from 3 months before up to 12 weeks after the drug distribution

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nora Monnier, Dr. med.

CONTACT

[email protected]

+41 61 284 82 29

Peter Steinmann, PhD PD

CONTACT

[email protected]

+41 61 284 82 18

Sponsors and collaborators

Lead sponsor

Peter Steinmann

Other

Collaborators

  • African Institute for Health and Development, Kenya
  • Kenya Medical Research Institute
  • Kenya Ministry of Health
  • Makerere University
  • Ministry of Health, Uganda
  • Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle
  • Technical University Munchen
  • Université Félix Hophouët-Boigny
  • Unlimit Health

Registry information

Official study 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

Acronym: ADOPTpilot

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 21, 2024
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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