Schistosomiasis in ChildrenADOPTNCT05350462
Adoption of L-PZQ for Schistosomiasis by Endemic Counties - Social Science Research Study
An observational study of Schistosomiasis in Children and Social Acceptance, run by Technical University of Munich at 3 sites in 3 countries.
Trial summary
Knowledge, acceptability and perception of paediatric schistosomiasis and its treatment will be explored through a social science-driven mixed-methods approach within three endemic countries: Kenya, Uganda and Côte d'Ivoire. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Schistosomiasis in Children, Social Acceptance
- What is being tested?
- Community pilot L-PZQ distribution - intervention is NOT part of this observational study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 225 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Dec 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- Adult, Older adult
Study population: The study populations will consist of key informants, such as parents/guardians of PSAC, frontline health personnel, community and religious leaders, key healthcare workers, community health stakeholders and schistosomiasis control officials, in each study site in each of the three countries. Selection and recruitment of participants for qualitative interviews will be purposive.
Who may be able to join
- within the targeted communities
- all key informant groups as described
- willing to participate voluntarily and to provide informed consent
Who cannot join
- refusing to give informed consent, participating not voluntarily or their participation causing psycho-social distress or even harm to themselves or other community members
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: ADOPT - Community Intervention: Social Science Research Study to Support the Adoption of Levo-Praziquantel (L-PZQ) for the Treatment of Schistosomiasis in Pre-school Aged Children in Côte d'Ivoire, Kenya and Uganda
Knowledge, acceptability and perception of paediatric schistosomiasis and its treatment will be explored through a social science-driven mixed-methods approach within three endemic countries: Kenya, Uganda and Côte d'Ivoire.
Read the detailed description
In many African countries, the worm disease schistosomiasis, also known as bilharzia, is a serious problem that affects the health of many people. An estimated 50 million pre-school children in sub-Saharan Africa are affected, but are currently excluded from routine preventive chemotherapy with praziquantel because there is no suitable preparation for this age group. As a result, the public-private Pediatric Praziquantel Consortium, led by the pharmaceutical company Merck, has developed Levo-Praziquantel 150 mg, which is child-friendly in dosage as well as in tolerability and taste. The European \& Developing Countries Clinical Trials Partnership (EDCTP) programme, together with the Global Health Innovation Technology Fund (GHIT), is funding the conduct of an implementation study "ADOPT - Adoption of Levo-Praziquantel 150mg for Schistosomiasis by endemic countries" to prepare for the introduction of Levo-Praziquantel in the partner countries Kenya, Côte d'Ivoire and Uganda, where schistosomiasis is endemic.
This study protocol describes the social science research part of the implementation project (Work Package 1). It aims to provide important insights into local conditions as well as knowledge, perceptions and management of schistosomiasis among the population in each of the three study countries, particularly among parents of young children and health workers. In addition, possible factors influencing the introduction and acceptance of the new preparation will be identified, as well as ideal platforms for this. Furthermore, the implementation pilot study will be accompanied and its implementation investigated.
The mixed-methods study with a focus on qualitative research methods will be conducted in two different phases in the three partner countries: 1) before the intervention/pilot study; 2) during and after the implementation pilot study. In the first phase, semi-structured Key Informant Interviews (KIIs) will be conducted with health workers and stakeholders from the Neglected Tropical Diseases (NTD) sector and local health workers in the study regions. In addition, parents/families of young children will be interviewed through focus group interviews (FGD) and socio-demographic questionnaires. Study design, data collection and analysis as well as publication and dissemination are carried out jointly by the social science research team of the TUM Center for Global Health and the partners in the study countries.
The formative qualitative evaluation of the post-intervention part will be conducted after the community pilot Levo-Praziquantel distribution (which is not part of this observational study) with the same key informants as preADOPT intervention. This will entail documentation of implementation strategies on the ground through participant observations, semi-structured and in-depth interviews and FGDs to assess the realisation and acceptance of the different strategies. We will also add a new key informant group, i.e. community drug distributors, of which participants will be recruited into semi-structured and in-depth interviews as well as FGDs. For the post-intervention, the same methods as described above for preintervention will be applied. In addition, a postintervention simple questionnaire will be added to the parent/guardian group (designed on the basis of findings from the pre-intervention part) to assess the implementation process.
- Conditions
- Schistosomiasis in Children, Social Acceptance
- Being tested
- Community pilot L-PZQ distribution - intervention is NOT part of this observational study
- Keywords
- key informant interview, mixed methods, qualitative research, focus group discussion, neglected tropical diseases, community health, pre-school aged children, Sub-Saharan Africa, Kenya, Uganda, Ivory Coast, Public-private partnership, collaborative research, implementation study, social acceptance, levo-praziquantel, mass drug administration, Côte d'Ivoire, knowledge, health literacy
- Medical subject headings
- Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community pilot L-PZQ distribution - intervention is NOT part of this observational studyBehavioural
Data collection will occur at two main time points of the ADOPT-community intervention project: before (baseline assessment) and during/after the community pilot L-PZQ distribution, in order to inform the design and process of the implementation, including that of advocacy and mobilisation, of Levo-Praziquantel delivery to PSAC.
| Study group | Role | What they receive |
|---|---|---|
| Agboville, Côte d'Ivoire | Drug naive region
Parents/guardians of pre-school aged children Primary healthcare personnel Community stakeholders (e.g. political/administrative leaders, religious leaders, traditional healers, civil society, non-governmental organizations, key health system representatives, schistosomiasis control officers, community drug distributers) Receives: Behavioral: Community pilot L-PZQ distribution - intervention is NOT part of this observational study | |
| Bangolo, Côte d'Ivoire | Drug naive region Parents/guardians of pre-school aged children Primary healthcare personnel Community stakeholders (e.g. political/administrative leaders, religious leaders, traditional healers, civil society, non-governmental organizations, key health system representatives, schistosomiasis control officers, community drug distributers) | |
| Man, Côte d'Ivoire | was a phase III clinical trial site for Levo-Praziquantel in 2021
Parents/guardians of pre-school aged children Primary healthcare personnel Community stakeholders (e.g. political/administrative leaders, religious leaders, traditional healers, civil society, non-governmental organizations, key health system representatives, schistosomiasis control officers, community drug distributers) Receives: Behavioral: Community pilot L-PZQ distribution - intervention is NOT part of this observational study | |
| Homa Bay, Kenya | was a phase III clinical trial site for Levo-Praziquantel in 2021
Parents/guardians of pre-school aged children Primary healthcare personnel Community stakeholders (e.g. political/administrative leaders, religious leaders, traditional healers, civil society, non-governmental organizations, key health system representatives, schistosomiasis control officers, community drug distributers) Receives: Behavioral: Community pilot L-PZQ distribution - intervention is NOT part of this observational study | |
| Kwale, Kenya | Drug naive region
Parents/guardians of pre-school aged children Primary healthcare personnel Community stakeholders (e.g. political/administrative leaders, religious leaders, traditional healers, civil society, non-governmental organizations, key health system representatives, schistosomiasis control officers, community drug distributers) Receives: Behavioral: Community pilot L-PZQ distribution - intervention is NOT part of this observational study | |
| Hoima, Uganda | Drug naive region
Parents/guardians of pre-school aged children Primary healthcare personnel Community stakeholders (e.g. political/administrative leaders, religious leaders, traditional healers, civil society, non-governmental organizations, key health system representatives, schistosomiasis control officers, community drug distributers) Receives: Behavioral: Community pilot L-PZQ distribution - intervention is NOT part of this observational study | |
| Bugiri, Uganda | Drug naive region
Parents/guardians of pre-school aged children Primary healthcare personnel Community stakeholders (e.g. political/administrative leaders, religious leaders, traditional healers, civil society, non-governmental organizations, key health system representatives, schistosomiasis control officers, community drug distributers) Receives: Behavioral: Community pilot L-PZQ distribution - intervention is NOT part of this observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative data analysis including self-reported information on knowledge, perception, and experience of schistosomiasis (treatment) and child health within families (Micro, Meso and Macro level)
Qualitative data analysis using the "Thematic Analysis" approach. This approach helps to identify, analyse and interpret patterns of meaning in the form of emerging "themes" in the qualitative data. Important "themes" emerging from the focus group discussions and key informant interviews are explored.
In this way, important subjective factors of acceptance or non-acceptance as well as differences within opinions can be revealed. Topics on which the qualitative analysis will focus are:
- Characterization and summary of knowledge, experience and views of parents/guardians of PSAC as well as health care providers and health authorities about schistosomiasis and its treatment. Comparison across study sites and countries.
- Comparison of data, which is collected prior to the intervention, and data collected during/after the intervention.
Measured: 13.12.2021 -31.06.2022 + Second study wave in 2024
Semi-structured socio-demographic questionnaires (quantitative data) used to collect further data from parents/guardians of PSAC in the study (knowledge, perception and acceptability related to (pediatric) schistosomiasis)
The outcomes of the quantitative da will be triangulated with qualitative data (Outcome 1) and secondary data from a desk review.
Measured: 13.12.2021 -31.06.2022 + Second study wave in 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Dec 2021
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schistosomiasis in ChildrenStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- African Institute for Health and Development, Makerere University, European and Developing Countries Clinical Trials Partnership (EDCTP), Global Health Innovative Technology Fund, Stichting Lygature, Université Félix Houphouët-Boigny, Kenya Medical Research Institute, Swiss Tropical & Public Health Institute, SCI Foundation
- Responsible party
- Principal investigator, Andrea Winkler, Technical University of Munich
- Investigators
- Mary Nyamongo, Dr., Principal investigator, African Institute for Health and DevelopmentStella Neema, Prof., Principal investigator, Makerere University - Social Science DepartmentAlain Toh, Prof., Principal investigator, Université Félix Houphouët-Boigny d'Abidjan-Cocody
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350462
- Sponsor's protocol ID
- 731/21 S
- Other IDs
- RIA2019IR-2895, G2020-102R1
- Acronym
- ADOPT
- Status last verified
- Nov 2023
- First submitted
- 14 Apr 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers in order to protect their privacy. Anonymised data will be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADOPT - Community Intervention: Social Science Research Study to Support the Adoption of Levo-Praziquantel (L-PZQ) for the Treatment of Schistosomiasis in Pre-school Aged Children in Côte d'Ivoire, Kenya and Uganda
- ClinicalTrials.gov ID
- NCT05350462
- Acronym / sponsor ID
- ADOPT / 731/21 S
- Conditions
- Schistosomiasis in Children, Social Acceptance
- Keywords
- key informant interview, mixed methods, qualitative research, focus group discussion, neglected tropical diseases, community health, pre-school aged children, Sub-Saharan Africa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- African Institute for Health and Development, Makerere University, European and Developing Countries Clinical Trials Partnership (EDCTP), Global Health Innovative Technology Fund, Stichting Lygature, Université Félix Houphouët-Boigny, Kenya Medical Research Institute, Swiss Tropical & Public Health Institute, SCI Foundation
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Apr 2022 (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.
Knowledge, acceptability and perception of paediatric schistosomiasis and its treatment will be explored through a social science-driven mixed-methods approach within three endemic countries: Kenya, Uganda and Côte d'Ivoire.
Detailed description
In many African countries, the worm disease schistosomiasis, also known as bilharzia, is a serious problem that affects the health of many people. An estimated 50 million pre-school children in sub-Saharan Africa are affected, but are currently excluded from routine preventive chemotherapy with praziquantel because there is no suitable preparation for this age group. As a result, the public-private Pediatric Praziquantel Consortium, led by the pharmaceutical company Merck, has developed Levo-Praziquantel 150 mg, which is child-friendly in dosage as well as in tolerability and taste. The European \& Developing Countries Clinical Trials Partnership (EDCTP) programme, together with the Global Health Innovation Technology Fund (GHIT), is funding the conduct of an implementation study "ADOPT - Adoption of Levo-Praziquantel 150mg for Schistosomiasis by endemic countries" to prepare for the introduction of Levo-Praziquantel in the partner countries Kenya, Côte d'Ivoire and Uganda, where schistosomiasis is endemic.
This study protocol describes the social science research part of the implementation project (Work Package 1). It aims to provide important insights into local conditions as well as knowledge, perceptions and management of schistosomiasis among the population in each of the three study countries, particularly among parents of young children and health workers. In addition, possible factors influencing the introduction and acceptance of the new preparation will be identified, as well as ideal platforms for this. Furthermore, the implementation pilot study will be accompanied and its implementation investigated.
The mixed-methods study with a focus on qualitative research methods will be conducted in two different phases in the three partner countries: 1) before the intervention/pilot study; 2) during and after the implementation pilot study. In the first phase, semi-structured Key Informant Interviews (KIIs) will be conducted with health workers and stakeholders from the Neglected Tropical Diseases (NTD) sector and local health workers in the study regions. In addition, parents/families of young children will be interviewed through focus group interviews (FGD) and socio-demographic questionnaires. Study design, data collection and analysis as well as publication and dissemination are carried out jointly by the social science research team of the TUM Center for Global Health and the partners in the study countries.
The formative qualitative evaluation of the post-intervention part will be conducted after the community pilot Levo-Praziquantel distribution (which is not part of this observational study) with the same key informants as preADOPT intervention. This will entail documentation of implementation strategies on the ground through participant observations, semi-structured and in-depth interviews and FGDs to assess the realisation and acceptance of the different strategies. We will also add a new key informant group, i.e. community drug distributors, of which participants will be recruited into semi-structured and in-depth interviews as well as FGDs. For the post-intervention, the same methods as described above for preintervention will be applied. In addition, a postintervention simple questionnaire will be added to the parent/guardian group (designed on the basis of findings from the pre-intervention part) to assess the implementation process.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Agboville, Côte d'Ivoire | – | Behavioral: Community pilot L-PZQ distribution - intervention is NOT part of this observational studyDrug naive region Parents/guardians of pre-school aged children Primary healthcare personnel Community stakeholders (e.g. political/administrative leaders, religious leaders, traditional healers, civil society, non-governmental organizations, key health system representatives, schistosomiasis control officers, community drug distributers) |
| Bangolo, Côte d'Ivoire | – | –Drug naive region Parents/guardians of pre-school aged children Primary healthcare personnel Community stakeholders (e.g. political/administrative leaders, religious leaders, traditional healers, civil society, non-governmental organizations, key health system representatives, schistosomiasis control officers, community drug distributers) |
| Man, Côte d'Ivoire | – | Behavioral: Community pilot L-PZQ distribution - intervention is NOT part of this observational studywas a phase III clinical trial site for Levo-Praziquantel in 2021 Parents/guardians of pre-school aged children Primary healthcare personnel Community stakeholders (e.g. political/administrative leaders, religious leaders, traditional healers, civil society, non-governmental organizations, key health system representatives, schistosomiasis control officers, community drug distributers) |
| Homa Bay, Kenya | – | Behavioral: Community pilot L-PZQ distribution - intervention is NOT part of this observational studywas a phase III clinical trial site for Levo-Praziquantel in 2021 Parents/guardians of pre-school aged children Primary healthcare personnel Community stakeholders (e.g. political/administrative leaders, religious leaders, traditional healers, civil society, non-governmental organizations, key health system representatives, schistosomiasis control officers, community drug distributers) |
| Kwale, Kenya | – | Behavioral: Community pilot L-PZQ distribution - intervention is NOT part of this observational studyDrug naive region Parents/guardians of pre-school aged children Primary healthcare personnel Community stakeholders (e.g. political/administrative leaders, religious leaders, traditional healers, civil society, non-governmental organizations, key health system representatives, schistosomiasis control officers, community drug distributers) |
| Hoima, Uganda | – | Behavioral: Community pilot L-PZQ distribution - intervention is NOT part of this observational studyDrug naive region Parents/guardians of pre-school aged children Primary healthcare personnel Community stakeholders (e.g. political/administrative leaders, religious leaders, traditional healers, civil society, non-governmental organizations, key health system representatives, schistosomiasis control officers, community drug distributers) |
| Bugiri, Uganda | – | Behavioral: Community pilot L-PZQ distribution - intervention is NOT part of this observational studyDrug naive region Parents/guardians of pre-school aged children Primary healthcare personnel Community stakeholders (e.g. political/administrative leaders, religious leaders, traditional healers, civil society, non-governmental organizations, key health system representatives, schistosomiasis control officers, community drug distributers) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study populations will consist of key informants, such as parents/guardians of PSAC, frontline health personnel, community and religious leaders, key healthcare workers, community health stakeholders and schistosomiasis control officials, in each study site in each of the three countries. Selection and recruitment of participants for qualitative interviews will be purposive.
Key inclusion criteria (3 listed)
- within the targeted communities
- all key informant groups as described
- willing to participate voluntarily and to provide informed consent
Key exclusion criteria (1 listed)
- refusing to give informed consent, participating not voluntarily or their participation causing psycho-social distress or even harm to themselves or other community members
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 |
|---|---|---|
| Community pilot L-PZQ distribution - intervention is NOT part of this observational studyData collection will occur at two main time points of the ADOPT-community intervention project: before (baseline assessment) and during/after the community pilot L-PZQ distribution, in order to inform the design and process of the implementation, including that of advocacy and mobilisation, of Levo-Praziquantel delivery to PSAC. | Behavioural | Agboville, Côte d'Ivoire, Bugiri, Uganda, Hoima, Uganda, Homa Bay, Kenya, Kwale, Kenya, Man, Côte d'Ivoire |
Primary outcome
Qualitative data analysis including self-reported information on knowledge, perception, and experience of schistosomiasis (treatment) and child health within families (Micro, Meso and Macro level)
Time frame: 13.12.2021 -31.06.2022 + Second study wave in 2024
Qualitative data analysis using the "Thematic Analysis" approach. This approach helps to identify, analyse and interpret patterns of meaning in the form of emerging "themes" in the qualitative data. Important "themes" emerging from the focus group discussions and key informant interviews are explored. In this way, important subjective factors of acceptance or non-acceptance as well as differences within opinions can be revealed. Topics on which the qualitative analysis will focus are: * Characterization and summary of knowledge, experience and views of parents/guardians of PSAC as well as health care providers and health authorities about schistosomiasis and its treatment. Comparison across study sites and countries. * Comparison of data, which is collected prior to the intervention, and data collected during/after the intervention.
Semi-structured socio-demographic questionnaires (quantitative data) used to collect further data from parents/guardians of PSAC in the study (knowledge, perception and acceptability related to (pediatric) schistosomiasis)
Time frame: 13.12.2021 -31.06.2022 + Second study wave in 2024
The outcomes of the quantitative da will be triangulated with qualitative data (Outcome 1) and secondary data from a desk review.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers in order to protect their privacy. Anonymised data will be available upon request.
Related trials for Schistosomiasis in Children
RecruitingObservational study
Introduction of Arpraziquantel Treatment for Schistosomiasis Control in Preschool-aged Children in Endemic Areas: A Small-scale Public Health Intervention Study
Schistosomiasis
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. This study is not recruiting at the moment.
Mary Nyamongo, Dr. principal investigator
African Institute for Health and Development
Stella Neema, Prof. principal investigator
Makerere University - Social Science Department
Alain Toh, Prof. principal investigator
Université Félix Houphouët-Boigny d'Abidjan-Cocody
3 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 in Children and Social Acceptance, run by Technical University of Munich at 3 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?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative data analysis including self-reported information on knowledge, perception, and experience of schistosomiasis (treatment) and child health within families (Micro, Meso and Macro level) (time frame: 13.12.2021 -31.06.2022 + Second study wave in 2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2023.