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Trials - SLCTR/2022/018

Protocol Change

Date

2022-09-14


Protocol

Protocol changed


Item Changed

Primary outcome(s)


Previous Version

1.Incidence of Aedes-borne virus (ABV) infection assessed by serologic testing of scheduled longitudinal blood samples Seroconversion to dengue from baseline (pre-intervention) and follow-up (post-intervention) samples as well as ABV active disease rates will be compared between active intervention and placebo (control) clusters. The primary endpoint is the fraction of monotypic or seronegative individuals who seroconvert to an arbovirus during the follow-up period post randomization with intervention. Here, the intervention follow-up period is 2 years after initial deployment of SR or placebo. [There will be 3 blood samplings from longitudinal cohort participants for measure of seroconversion: one for baseline serostatus characterization (T0), a second at 12 months (T1) and a third at 24 months (T2) from time of initial placement of intervention.]


Next Version

1.Incidence of Aedes-borne virus (ABV) infection assessed by serologic testing of scheduled longitudinal blood samples Seroconversion to dengue from baseline (pre-intervention) and follow-up (post-intervention) samples as well as ABV active disease rates will be compared between active intervention and placebo (control) clusters. The primary endpoint is the fraction of monotypic or seronegative individuals who seroconvert to an arbovirus during the follow-up period post randomization with intervention. Here, the intervention follow-up period is 2 years after initial deployment of SR or placebo. [There will be 3 blood samplings from longitudinal cohort participants for measure of seroconversion: one for baseline serostatus characterization (T0), a second at 12 months (T1) and a third at 24 months (T2) from time of initial placement of intervention.]