Clinical trial NCT05350462: Adoption of L-PZQ for Schistosomiasis by Endemic Counties - Social Science Research 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: African Institute for Health and Development
name: Makerere University
name: European and Developing Countries Clinical Trials Partnership (EDCTP)
name: Global Health Innovative Technology Fund
name: Stichting Lygature
name: Université Félix Houphouët-Boigny
name: Kenya Medical Research Institute
name: Swiss Tropical & Public Health Institute
name: SCI Foundation
First posted: 2022-04-28
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
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)
timeFrame: 13.12.2021 -31.06.2022 + Second study wave in 2024
measure: 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)
timeFrame: 13.12.2021 -31.06.2022 + Second study wave in 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Abidjan
country: Côte D'Ivoire
facility: Université Félix Houphouët-Boigny
city: Nairobi
country: Kenya
facility: African Institute for Health and Development
city: Kampala
country: Uganda
facility: Makerere University
Study officials:
affiliation: African Institute for Health and Development
name: Mary Nyamongo, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University - Social Science Department
name: Stella Neema, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Université Félix Houphouët-Boigny d'Abidjan-Cocody
name: Alain Toh, Prof.
role: PRINCIPAL_INVESTIGATOR
References: