SchistosomiasisADOPTpilotNCT06698510
Introduction of Arpraziquantel Treatment for Schistosomiasis Control in Preschool-aged Children in Endemic Areas: A Small-scale Public Health Intervention Study
An observational study of Schistosomiasis, run by Peter Steinmann at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis
- What is being tested?
- Arpraziquantel 150mg dispersible tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 18,500 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 25 Nov 2024to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
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
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
Côte d’Ivoire3 sites, 3 recruiting
- 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)
Abidjan
Alain-Claver Kouamin, Dr. med., +225 07 07 40 32 34, kouaminclaver@yahoo.fr
- Recruiting
Université Félix Hophouët-Boigny (UFHB), Département de sociologie
Abidjan
Alain Toh, Prof., +225 07 07 14 63 46, alain.toh.1@gmail.com
- Recruiting
Université Félix Hophouët-Boigny (UFHB), UFR Biosciences
Abidjan
Eliézer K. N'Goran, Prof., +225 01 03 48 88 83, eliezerngoran@yahoo.fr
Kenya2 sites, 2 recruiting
- Not yet recruiting
African Institute for Health and Development (AIHD)
Nairobi
Mary Amuyunzu-Nyamongo, Prof., +254 733-366229, mnyamongo@aihdint.org
- Not yet recruiting
Kenya Medical Research Institute (KEMRI), Eastern and Southern Africa Centre of International Parasite Control (ESACIPAC)
Nairobi
Sammy M. Njenga, Prof., +254 735-173372, SNjenga@kemri.go.ke
Uganda2 sites, 2 recruiting
- Not yet recruiting
Makerere University, Department of Sociology and Anthropology
Kampala
Stella Neema, Prof., +256 772457576, sheisim@yahoo.com
- Not yet recruiting
Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health
Kampala
Prudence Beinamaryo, Dr., +256-789-548-930, prudenceb13@gmail.com
About this study
Official title: 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.
Read more
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
- Being tested
- Arpraziquantel 150mg dispersible tablet
- Keywords
- schistosomiasis, preschool-aged children, praziquantel, arpraziquantel, deworming, pediatric treatment, child health
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arpraziquantel 150mg dispersible tabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Arpraziquantel 150mg dispersible tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Documentation from 3 months before up to 12 weeks after the drug distribution
Secondary outcomes (1)
Effectiveness of social mobilization, communication and training
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.
Measured: Documentation from 3 months before up to 12 weeks after the drug distribution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start25 Nov 2024
- Primary completionNov 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 18,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Steinmann
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University Munchen, Makerere University, African Institute for Health and Development, Kenya, Kenya Medical Research Institute, Kenya Ministry of Health, Ministry of Health, Uganda, Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle, Université Félix Houphouët-Boigny, Unlimit Health
- Responsible party
- Sponsor-investigator, Peter Steinmann, Swiss Tropical & Public Health Institute
- Investigators
- Peter Steinmann, PhD PD, Principal investigator, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698510
- Sponsor's protocol ID
- 2108p
- Other IDs
- RIA2019IR-2895; G2020-102
- Acronym
- ADOPTpilot
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are data sharing agreements (DTAs) between Swiss TPH, Côte d'Ivoire/Kenya/Uganda MoH, Felix Hophouët-Boigny University, Kenya Medical Research Institute and Makerere University in place. Likewise DTAs are in place between partners working on the social science study that is between Technical University München, the African Institute for Health \& Development, Makerere University and Felix Hophouët-Boigny University. Data may be shared with other researchers upon request.
Publications
Monnier N, Beinamaryo P, Wells M, Akoa A, Aritnaitwe M, Barth-Jaeggi T, Bassa FK, Burrill J, Coulibaly G, Diakite NR, Dje NN, Gnahore AD, Hattendorf J, Hurlimann E, Kouame RO, Kouamin AC, Kyarisiima H, Lange IL, Lavry SL, Nabatte B, Neema S, N'Goran EK, N'Goran HR, Ohouo U, Preston A, Roth LF, Sehi Bi TJ, Verhoeven D, Winkler AS, Toh A, Steinmann P, Ouattara M; Pediatric Praziquantel Consortium. Pragmatic weight estimation for dosing of a new paediatric treatment for schistosomiasis prevention and control in preschool-aged children: a feasibility study in Uganda and Cote d'Ivoire. Infect Dis Poverty. 2026 Oct 12;15(1):108. doi: 10.1186/s40249-026-01507-9.
PubMed 42864684
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06698510
- Acronym / sponsor ID
- ADOPTpilot / 2108p
- Conditions
- Schistosomiasis
- Keywords
- schistosomiasis, preschool-aged children, praziquantel, arpraziquantel, deworming, pediatric treatment, child health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 18,500 participants (estimated)
- Lead sponsor
- Peter SteinmannUniversity, hospital or other
- Collaborators
- Technical University Munchen, Makerere University, African Institute for Health and Development, Kenya, Kenya Medical Research Institute, Kenya Ministry of Health, Ministry of Health, Uganda, Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle, Université Félix Houphouët-Boigny, Unlimit Health
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arPZQ distributed through Platform 1 (NTD programmes) | – | Drug: Arpraziquantel 150mg dispersible tabletPreschool-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) | – | Drug: Arpraziquantel 150mg dispersible tabletPreschool-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. |
Who may qualify
- Ages
- 24 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arpraziquantel 150mg dispersible tabletArpraziquantel 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. | Drug | arPZQ distributed through Platform 1 (NTD programmes), arPZQ distributed through Platform 2 (child health days/nutrition programmes) |
Primary outcome
Platform performance for arPZQ distribution
Time frame: 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.
1 secondary outcome
Effectiveness of social mobilization, communication and training
Time frame: Documentation from 3 months before up to 12 weeks after the drug distribution
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Derived from this study: PubMed 42864684Monnier N, Beinamaryo P, Wells M, Akoa A, Aritnaitwe M, Barth-Jaeggi T, Bassa FK, Burrill J, Coulibaly G, Diakite NR, Dje NN, Gnahore AD, Hattendorf J, Hurlimann E, Kouame RO, Kouamin AC, Kyarisiima H, Lange IL, Lavry SL, Nabatte B, Neema S, N'Goran EK, N'Goran HR, Ohouo U, Preston A, Roth LF, Sehi Bi TJ, Verhoeven D, Winkler AS, Toh A, Steinmann P, Ouattara M; Pediatric Praziquantel Consortium. Pragmatic weight estimation for dosing of a new paediatric treatment for schistosomiasis prevention and control in preschool-aged children: a feasibility study in Uganda and Cote d'Ivoire. Infect Dis Poverty. 2026 Oct 12;15(1):108. doi: 10.1186/s40249-026-01507-9.
- Individual participant dataSharing planned: No. There are data sharing agreements (DTAs) between Swiss TPH, Côte d'Ivoire/Kenya/Uganda MoH, Felix Hophouët-Boigny University, Kenya Medical Research Institute and Makerere University in place. Likewise DTAs are in place between partners working on the social science study that is between Technical University München, the African Institute for Health \& Development, Makerere University and Felix Hophouët-Boigny University. Data may be shared with other researchers upon request.
Related trials for Schistosomiasis
Not yet recruitingPhase 3
A Phase III Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs in Addition to Praziquantel in Girls and Women With Female Genital Schistosomiasis
Female Genital Schistosomiasis
Not yet recruitingPhase 2/3
Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis
Schistosomiasis, Schistosoma Mansoni
Not yet recruiting
Assessment of Right Ventricular-Pulmonary Arterial Coupling in Schistosomiasis-Associated Pulmonary Arterial Hypertension
Schistosomiasis
Recruiting
Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations
Onchocerciasis (River Blindness), Schistosomiasis
Not yet recruitingObservational study
Nanobody-based Schistosomiasis Urine Test Kit Research
Schistosomiasis Haematobia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Steinmann, PhD PD principal investigator
Swiss Tropical & Public Health Institute
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schistosomiasis, run by Peter Steinmann at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Côte d’Ivoire, Kenya, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Steinmann, PhD PD (+41 61 284 82 18, peter.steinmann@swisstph.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platform performance for arPZQ distribution (time frame: Documentation from 3 months before up to 12 weeks after the drug distribution). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06698510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.