Adoption of L-PZQ for Schistosomiasis by Endemic Counties - Social Science Research Study

NCT05350462 | Unknown

• 3 other identifiers: 731/21 SRIA2019IR-2895G2020-102R1
• Study Type: observational
• Target: 225
• Locations: 3 countries
• Sites: 3

Brief 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.

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; Kenya; Uganda; Ivory Coast; Public-private partnership; collaborative research; implementation study; social acceptance; levo-praziquantel; mass drug administration; Côte d'Ivoire; knowledge; health literacy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  13.12.2021 -31.06.2022 + Second study wave in 2024

Study Arms (7)

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)

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)

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)

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)

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)

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)

Behavioral: Community pilot L-PZQ distribution - intervention is NOT part of this observational study

Interventions

Community pilot L-PZQ distribution - intervention is NOT part of this observational study BEHAVIORAL

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.

Agboville, Côte d'Ivoire; Bugiri, Uganda; Hoima, Uganda; Homa Bay, Kenya; Kwale, Kenya; Man, Côte d'Ivoire

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• within the targeted communities
• all key informant groups as described
• willing to participate voluntarily and to provide informed consent

You may not qualify if:

• \- refusing to give informed consent, participating not voluntarily or their participation causing psycho-social distress or even harm to themselves or other community members

Sponsors & Collaborators

• Technical University of Munich: lead
• African Institute for Health and Development: collaborator
• Makerere University: collaborator
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator
• Global Health Innovative Technology Fund: collaborator
• Stichting Lygature: collaborator
• Université Félix Houphouët-Boigny: collaborator
• Kenya Medical Research Institute: collaborator
• Swiss Tropical & Public Health Institute: collaborator
• SCI Foundation: collaborator

Study Sites (3)

Université Félix Houphouët-Boigny

Abidjan, Côte d’Ivoire

Location

African Institute for Health and Development

Nairobi, Kenya

Location

Makerere University

Kampala, Uganda

Location

MeSH Terms

Conditions

Neglected Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary Nyamongo, Dr.

  African Institute for Health and Development

  PRINCIPAL INVESTIGATOR

• Stella Neema, Prof.

  Makerere University - Social Science Department

  PRINCIPAL INVESTIGATOR

• Alain Toh, Prof.

  Université Félix Houphouët-Boigny d'Abidjan-Cocody

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 28, 2022
• Study Start: December 1, 2021
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1); UG (1); CÔ (1)