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:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT02239250
Eligibility Criteria:
Inclusion Criteria:
* For Sector-level study:
* All households shown on updated 2012 government registers to be members of ubudehe 1 and 2 in Western Province, Rwanda will be eligible to participate in the study.
* For nested village-level study:
* All villages from all sectors in Western province, according to official Government lists will be eligible for participation with the exception of those villages that were selected for participation in Phase 1.
* At the village-level, all households that are classified as ubudehe 1 \& 2 according to updated 2012 government registers, are part of the village, are able to provide informed consent, and that have at least one child under 4 years of age at the time of enrollment will be eligible for participation. Presence of a child under 4 years of age will be assessed by checking dates of birth or recorded age in months in the CHW register of children \<5 years (Igitabo Cy'Ibikorwa Byo Gukurikirana), which are maintained at the village by CHW (though occasionally these are transferred to health centers). If this data is missing will be assesses based on CHW's report. In those cases where a village has more than the required number of participating households (10 household), a random selection of 10 households will be drawn.
* For the assessment of personal exposure to HAP a stricter set of eligibility criteria will be applied. Households that comply with the following eligibility criteria will be eligible for the exposure to HAP sub-study.
* Have a child 1.5-4 year old,
* Have a child healthy enough to wear the monitoring equipment (as perceived by the mother),
* Have a non-smoking primary cook,
* Have a primary cook that is currently not pregnant (as far as she is aware of), and
* Have a primary cook that is in a healthy state to wear the monitoring equipment
* The first two households identified from a randomised list will be invited to participate.
* For the biomarker sub-studies, both the primary cook and the child under 4 years of age from households undergoing HAP exposure assessment will be eligible for the inflammatory cytokine biomarker study. For the enteric seroconversion study, all children aged 6 to 12 months will be eligible for participation.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
5 Years
Study:
NCT02239250
Study Brief:
Protocol Section:
NCT02239250