Adoption of L-PZQ for Schistosomiasis by Endemic Counties - Social Science Research Study
NCT ID: NCT05350462
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
225 participants
OBSERVATIONAL
2021-12-01
2025-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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ECOLOGIC_OR_COMMUNITY
CROSS_SECTIONAL
Study Groups
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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)
Community pilot L-PZQ distribution - intervention is NOT part of this observational study
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.
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)
No interventions assigned to this group
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)
Community pilot L-PZQ distribution - intervention is NOT part of this observational study
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.
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)
Community pilot L-PZQ distribution - intervention is NOT part of this observational study
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.
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)
Community pilot L-PZQ distribution - intervention is NOT part of this observational study
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.
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)
Community pilot L-PZQ distribution - intervention is NOT part of this observational study
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.
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)
Community pilot L-PZQ distribution - intervention is NOT part of this observational study
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.
Interventions
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Community pilot L-PZQ distribution - intervention is NOT part of this observational study
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.
Eligibility Criteria
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Inclusion Criteria
* all key informant groups as described
* willing to participate voluntarily and to provide informed consent
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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African Institute for Health and Development
UNKNOWN
Makerere University
OTHER
European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
Global Health Innovative Technology Fund
OTHER
Stichting Lygature
UNKNOWN
Université Félix Houphouët-Boigny
UNKNOWN
Kenya Medical Research Institute
OTHER
Swiss Tropical & Public Health Institute
OTHER
SCI Foundation
UNKNOWN
Technical University of Munich
OTHER
Responsible Party
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Andrea Winkler
Prof. Dr. Dr.
Principal Investigators
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Mary Nyamongo, Dr.
Role: PRINCIPAL_INVESTIGATOR
African Institute for Health and Development
Stella Neema, Prof.
Role: PRINCIPAL_INVESTIGATOR
Makerere University - Social Science Department
Alain Toh, Prof.
Role: PRINCIPAL_INVESTIGATOR
Université Félix Houphouët-Boigny d'Abidjan-Cocody
Locations
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Université Félix Houphouët-Boigny
Abidjan, , Côte d’Ivoire
African Institute for Health and Development
Nairobi, , Kenya
Makerere University
Kampala, , Uganda
Countries
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Other Identifiers
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RIA2019IR-2895
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
G2020-102R1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
731/21 S
Identifier Type: -
Identifier Source: org_study_id