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

Active, not recruiting

• Conditions: Schistosomiasis in Children; Social Acceptance
• Interventions: Behavioral: Community pilot L-PZQ distribution - intervention is NOT part of this observational study

• Registration Number: NCT05350462
• Lead Sponsor: Technical University of Munich

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.

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 Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01
• Primary Completion: 2025-03-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kwale, Kenya	Community pilot L-PZQ distribution - intervention is NOT part of this observational study	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)
Agboville, Côte d'Ivoire	Community pilot L-PZQ distribution - intervention is NOT part of this observational study	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)
Homa Bay, Kenya	Community pilot L-PZQ distribution - intervention is NOT part of this observational study	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)
Man, Côte d'Ivoire	Community pilot L-PZQ distribution - intervention is NOT part of this observational study	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)
Bugiri, Uganda	Community pilot L-PZQ distribution - intervention is NOT part of this observational study	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)
Hoima, Uganda	Community pilot L-PZQ distribution - intervention is NOT part of this observational study	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)

Primary Outcome Measures

Name	Time	Method
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)	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)	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.

Trial Locations

Locations (3)

African Institute for Health and Development; 🇰🇪 Nairobi, Kenya

Makerere University; 🇺🇬 Kampala, Uganda

Université Félix Houphouët-Boigny; 🇨🇮 Abidjan, Côte D'Ivoire