A cluster randomized, placebo control trial to evaluate the efficacy of a spatial repellent (Mosquito ShieldTM) against Aedes-borne virus infection among children >= 4–16 years of age in the Gampaha District, Sri Lanka
- Conditions
- Aedes-borne Virus
- Registration Number
- SLCTR/2022/018
- Lead Sponsor
- niversity of Notre Dame
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
LONGITUDINAL SEROCONVERSION Individual Level
Inclusion Criteria:
>= 4 – 16 years of age
Plans to stay in residence and/or study area for a minimum of 24 months
Resident of household or frequent visitor (~20% of day hours in house / month)
FEBRILE SURVEILLANCE Household Level
Inclusion Criteria:
•Adult head of households agrees to census, health visits and logging resident symptoms when febrile (or in the case of suspected Zika in the absence of fever, presenting with rash, arthralgia, arthritis or non-purulent conjunctivitis).
•Individuals spend a minimum of 4hrs per week during the daytime hours or sleep in the house.
FEBRILE SURVEILLANCE Individual Level
Inclusion Criteria:
•>= 6mo of age.
•Fever at the time of presentation or report of feverishness within the previous 24 hours or presenting with a rash, arthralgia, arthritis or non-purulent conjunctivitis (suspicion of ZIKA determined by project physician)
•Individual who spends a minimum of 4 hours per week within the household or sleeps in the house.
ENTOMOLOGICAL MONITORING Household Level
Inclusion Criteria:
•Adult head of household agrees to surveys.
•Properties where study personnel do not identify a security risk (i.e., site where abusive substances are sold, residents are always drunk or hostile).
SPATIAL REPELLENT INTERVENTION Household Level
Inclusion Criteria:
•Adult head of households agrees to have intervention applied inside the home and to provide access to team member at 4-week intervals to change products.
•Properties where study personnel do not identify a security risk (i.e., site where abusive substances are sold, residents are always drunk or hostile).
LONGITUDINAL SEROCONVERSION Individual Level
Exclusion Criteria:
•< 4 and > 16 years of age
•Plans to leave residence and/or study area within next 24 months
•Temporary visitor to household (<20% of day hours in house/ month)
FEBRILE SURVEILLANCE Household Level
Exclusion Criteria:
•Adult head of households does not agree to census, health visits or logging symptoms of residents.
•Households where study personnel identify a security risk (i.e., site where abusive substances are sold, residents are always drunk or hostile).
•Sites where no residents spend time during the day (i.e. work 7d a week outside the home).
FEBRILE SURVEILLANCE Individual Level
Exclusion Criteria:
•< 6mo of age.
•No fever at time of presentation or report of feverishness within the previous 24 hours or not reporting with a rash, arthralgia, arthritis or non-purulent conjunctivitis
•Individuals who have spent less than 4 hours in the household during the week prior to illness.
ENTOMOLOGICAL MONITORING Household Level
Exclusion Criteria:
•Adult head of household does not agree to surveys.
•Properties where study personnel identify a security risk (i.e., site where abusive substances are sold, residents are always drunk or hostile).
SPATIAL REPELLENT INTERVENTION Household Level
Exclusion Criteria:
•Adult head of household does not agree to Mosquito ShieldTM deployment or study team access.
•Properties where study personnel identify a security risk (i.e., site where abusive substances are sold, residents are always drunk or hostile
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Aedes-borne virus (ABV) infection assessed by serologic testing of scheduled longitudinal blood samples<br><br>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. <br><br>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.]<br>
- Secondary Outcome Measures
Name Time Method