Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT04529434
Eligibility Criteria:
Inclusion Criteria
Main study
* Children, aged under 13 years old, male or female
* Residing in a study village for at least 3 years
* Parents/guardian is willing and able to give written informed consent for the child to participate in the baseline and end-of study evaluation and the surveillance for malaria, respiratory tract infection and diarrhoeal disease.
* Additionally, children 10, 11, and 12 years of age provide assent to participate.
Ancillary studies
* Head of a household or other family member of a household that is taking part in the main study
* 18 years and above
* Consent to take part in the main study
* Residing and live in the village for 3 years or more
* Live in the intervention or comparison houses or a trusted community member (community leaders, medical officer and community health worker)
Exclusion criteria
Main study
* Any participant who refuses, or in the case of children whose parents/guardian refuses, to participate in the study.
* Any child who is between 10 and 12 years who refuses to provide assent
* If the family plans for moving to other village during the study period
* Parents/guardians have mental health problems
Ancillary studies
* Under 18 years
* Not provide consent
* Not living in the study village for 3 years or more
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
12 Years
Study:
NCT04529434
Study Brief:
Protocol Section:
NCT04529434