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Table 4 Schedule of individual assessments

From: EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil

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

  
  1. aVisit will occur after the peak transmission season (Feb–June)
  2. bVisit will only be completed by a subset of participants enrolled in the Time Use Survey Sub-Study
  3. cTo be completed by the participant’s parent/legal guardian −60 to 0 days prior to the blood draw
  4. dIncludes confirmation of continuing study participation and collection of any significant health updates that would make the participant ineligible for study activities
  5. eTo be completed during parental contact