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

Официальное название

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

Обзор

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).

Вмешательства

• Препарат 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.

Первичные конечные точки

• Platform performance for arPZQ distribution [Срок оценки: Documentation from 3 months before up to 12 weeks after the drug distribution]

Вторичные конечные точки (1)

• Effectiveness of social mobilization, communication and training [Срок оценки: Documentation from 3 months before up to 12 weeks after the drug distribution]

Критерии участия

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Экологическое

Центры проведения

Côte d’Ivoire · 3 центра

• Programme National de Lutte Contre les Maladies Tropicales Négligées à Chimiothérapie Prév — Abidjan
• Université Félix Hophouët-Boigny (UFHB), Département de sociologie — Abidjan
• Université Félix Hophouët-Boigny (UFHB), UFR Biosciences — Abidjan

Kenya · 2 центра

• African Institute for Health and Development (AIHD) — Nairobi
• Kenya Medical Research Institute (KEMRI), Eastern and Southern Africa Centre of Internatio — Nairobi

Uganda · 2 центра

• Makerere University, Department of Sociology and Anthropology — Kampala
• Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health — Kampala

Идентификаторы

NCT: NCT06698510 · 2108p · RIA2019IR-2895; G2020-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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