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

Recruiting

• Conditions: Schistosomiasis
• Interventions: Drug: Arpraziquantel 150mg dispersible tablet

• Registration Number: NCT06698510
• Lead Sponsor: Peter Steinmann

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-17
• Study First Posted: 2024-11-21
• Study Start: 2024-11-25
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-06
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
arPZQ distributed through Platform 1 (NTD programmes)	Arpraziquantel 150mg dispersible tablet	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)	Arpraziquantel 150mg dispersible tablet	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.

Primary Outcome Measures

Name	Time	Method
Platform performance for arPZQ distribution	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 Outcome Measures

Name	Time	Method
Effectiveness of social mobilization, communication and training	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.

Trial Locations

Locations (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

Université Félix Hophouët-Boigny (UFHB), Département de sociologie; 🇨🇮 Abidjan, Côte D'Ivoire

Université Félix Hophouët-Boigny (UFHB), UFR Biosciences; 🇨🇮 Abidjan, Côte D'Ivoire

African Institute for Health and Development (AIHD); 🇰🇪 Nairobi, Kenya

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

Makerere University, Department of Sociology and Anthropology; 🇺🇬 Kampala, Uganda

Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health; 🇺🇬 Kampala, Uganda