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

NCT06698510 | Recruiting

• 2 other identifiers: 2108pRIA2019IR-2895; G2020-102
• Study Type: observational
• Target: 18,500
• Locations: 3 countries
• Sites: 7

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).

Conditions

Schistosomiasis

Keywords

schistosomiasis; preschool-aged children; praziquantel; arpraziquantel; deworming; pediatric treatment; child health

Outcome Measures

Primary Outcomes (1)

• 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: * 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.

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

Secondary Outcomes (1)

• Effectiveness of social mobilization, communication and training

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

Study Arms (2)

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.

Drug: Arpraziquantel 150mg dispersible tablet

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.

Drug: Arpraziquantel 150mg dispersible tablet

Interventions

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.

arPZQ distributed through Platform 1 (NTD programmes); arPZQ distributed through Platform 2 (child health days/nutrition programmes)

Eligibility Criteria

• Age: 24 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (7)

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

RECRUITING

Université Félix Hophouët-Boigny (UFHB), Département de sociologie

Abidjan, Côte d’Ivoire

RECRUITING

Université Félix Hophouët-Boigny (UFHB), UFR Biosciences

Abidjan, Côte d’Ivoire

RECRUITING

African Institute for Health and Development (AIHD)

Nairobi, Kenya

NOT YET RECRUITING

Kenya Medical Research Institute (KEMRI), Eastern and Southern Africa Centre of International Parasite Control (ESACIPAC)

Nairobi, Kenya

NOT YET RECRUITING

Makerere University, Department of Sociology and Anthropology

Kampala, Uganda

NOT YET RECRUITING

Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health

Kampala, Uganda

NOT YET RECRUITING

MeSH Terms

Conditions

Schistosomiasis

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Peter Steinmann, PhD PD

  Swiss Tropical & Public Health Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Unit Head

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 21, 2024
• Study Start: November 25, 2024
• Primary Completion: November 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CÔ (3); KE (2); UG (2)