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

Peter Steinmann

Status: Not yet enrolling

Conditions: Schistosomiasis

Treatments: Drug: Arpraziquantel 150mg dispersible tablet

Study type: Observational

Funder types: Other

Identifiers

NCT06698510

RIA2019IR-2895 ( G2020-102;Other Grant/Funding Number)

2108p

Details and patient eligibility

About

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).

Enrollment: 18,500 estimated patients

Sex: All

Ages: 24 to 59 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

18,500 participants in 2 patient groups

arPZQ distributed through Platform 1 (NTD programmes)

Description:

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.

Treatment:

Drug: Arpraziquantel 150mg dispersible tablet

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

Description:

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.

Treatment:

Drug: Arpraziquantel 150mg dispersible tablet