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 @ 12:30 AM
Ignite Modification Date:
2025-12-25 @ 12:30 AM
NCT ID:
NCT03824067
Eligibility Criteria:
Inclusion Criteria:
* Any infant who receives an EID test, either conventional or POC, for the 4-6 week EID indication at one of the study sites (which were randomly selected from project sites in country)
* HEI under 12 weeks of age or their parents/caregivers
* Some methods will only include HEI who test positive (medical chart extraction and longitudinal follow up)
* Purposively selected caregivers of HEI for in-depth interviews
* Focus groups with community members will not require participants to have sought testing for EID
Exclusion Criteria:
* Participants not at selected study sites
* For some methods (medical chart extraction and longitudinal follow-up), HEI who test negative
* For qualitative component, excluded if unable to consent due to age, competence, or inability to speak any of the study languages
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03824067
Study Brief:
Protocol Section:
NCT03824067