Table 4.
Evaluation | Screening Visit 00 |
Enrollment Visit 01 Year 1 |
Parental contact Visit 01Pd Year 2 |
Visit 02a Year 2 |
Time Use Surveyb | Parental contact Visit 02Pd Year 3 |
Visit 03a Year 3 |
Time Use Surveyb | Parental contact Visit 03Pd Year 4 |
Final visit Visit 04a Year 4 |
---|---|---|---|---|---|---|---|---|---|---|
Study timepoint | −60 to 0 prior to visit 01 |
Sep–Dec 2020 |
−60 to 0 day(s) prior to visit 02 |
Jun–Nov 2021 |
Feb–Jun 2022 |
−60 to 0 day(s) prior to visit 03 |
Jun–Nov 2022 |
Feb–Jun 2023 |
−60 to 0 day(s) prior to visit 04 |
Jun–Nov 2023 |
Signed consent formc | X | |||||||||
Minor assent form | X | |||||||||
Eligibility review | X | X | X | X | ||||||
Demographic surveyc | X | |||||||||
Collection of relevant medical conditionsc | X | |||||||||
Assessment of eligibility | X | X | ||||||||
Phlebotomy | X | X | X | X | ||||||
Parental contactd | X | X | X | |||||||
Knowledge of treatment arm surveyc, e | X | X | X | |||||||
Time Use Survey | X | X |
aVisit will occur after the peak transmission season (Feb–June)
bVisit will only be completed by a subset of participants enrolled in the Time Use Survey Sub-Study
cTo be completed by the participant’s parent/legal guardian −60 to 0 days prior to the blood draw
dIncludes confirmation of continuing study participation and collection of any significant health updates that would make the participant ineligible for study activities
eTo be completed during parental contact