Introduction of Arpraziquantel Treatment for Schistosomiasis Control in Preschool-aged Children in Endemic Areas: A Small-scale Public Health Intervention Study (ADOPTpilot)
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
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Peter Steinmann, PhD PD
- Phone Number: +41 61 284 82 18
- Email: peter.steinmann@swisstph.ch
Study Contact Backup
- Name: Nora Monnier, Dr. med.
- Phone Number: +41 61 284 82 29
- Email: nora.monnier@swisstph.ch
Study Locations
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Abidjan, Côte d’Ivoire
- Recruiting
- 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)
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Contact:
- Alain-Claver Kouamin, Dr. med.
- Phone Number: +225 07 07 40 32 34
- Email: kouaminclaver@yahoo.fr
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Abidjan, Côte d’Ivoire
- Recruiting
- Université Félix Hophouët-Boigny (UFHB), Département de sociologie
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Contact:
- Alain Toh, Prof.
- Phone Number: +225 07 07 14 63 46
- Email: alain.toh.1@gmail.com
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Abidjan, Côte d’Ivoire
- Recruiting
- Université Félix Hophouët-Boigny (UFHB), UFR Biosciences
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Contact:
- Eliézer K. N'Goran, Prof.
- Phone Number: +225 01 03 48 88 83
- Email: eliezerngoran@yahoo.fr
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Nairobi, Kenya
- Not yet recruiting
- African Institute for Health and Development (AIHD)
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Contact:
- Mary Amuyunzu-Nyamongo, Prof.
- Phone Number: +254 733-366229
- Email: mnyamongo@aihdint.org
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Nairobi, Kenya
- Not yet recruiting
- Kenya Medical Research Institute (KEMRI), Eastern and Southern Africa Centre of International Parasite Control (ESACIPAC)
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Contact:
- Sammy M. Njenga, Prof.
- Phone Number: +254 735-173372
- Email: SNjenga@kemri.go.ke
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Kampala, Uganda
- Not yet recruiting
- Makerere University, Department of Sociology and Anthropology
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Contact:
- Stella Neema, Prof.
- Phone Number: +256 772457576
- Email: sheisim@yahoo.com
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Kampala, Uganda
- Not yet recruiting
- Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health
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Contact:
- Prudence Beinamaryo, Dr.
- Phone Number: +256-789-548-930
- Email: prudenceb13@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
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.
Description
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
|
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 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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Platform performance for arPZQ distribution
Time Frame: Documentation from 3 months before up to 12 weeks after the drug distribution
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Platform performance will be combined measure based on the coverage and feasibility measured by the following parameters and implementation outcome indicators:
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
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. |
Documentation from 3 months before up to 12 weeks after the drug distribution
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Steinmann, PhD PD, Swiss Tropical & Public Health Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2108p
- RIA2019IR-2895; G2020-102 (Other Grant/Funding Number: European and Developing Countries Clinical Trials Partnership (EDCTP); Global Healh Innovative Technology (GHIT) Fund)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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