Aedes-borne Virus
Conditions
Interventions
The study will be conducted in clusters of households, who will be selected from three Medical Officer of Health (MOH) areas in the district of Gampaha: Negombo, Wattala and Kelaniya.
A total of 14,4
Sponsors
University of Notre Dame
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: LONGITUDINAL SEROCONVERSION Individual Level Exclusion Criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.] | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically apparent laboratory confirmed cases of Aedes-borne virus (ABV) disease. Compare laboratory confirmed Aedes-borne virus infection rates in subjects residing in households with active and placebo product, receiving standard entomological surveillance and control procedures by the Ministry of Health of Sri Lanka, as an indicator for ABV disease. Clinically apparent is defined as an acute infection that causes overt symptoms (fever, rash, etc.) indicating virus circulation in the blood. [For the longitudinal cohort participants, acute and convalescent blood sampling based on time of health facility visit when febrile throughout the intervention period. For other household members participating in febrile surveillance, case definition measured and reported whenever they visit designated health facilities throughout the intervention period.] Adult female Aedes aegypti indoor abundance. Compare adult female Aedes aegypti indoor abundance in households using Procopak mosquito aspiration with active and placebo product as an indicator for reduced mosquito house entry due to effect of product [Indoor mosquito collections in enrolled households once every 28 days during intervention] Adult female Aedes aegypti blood fed rate. Compare adult female Aedes aegypti blood fed rate in households using direct abdominal observation by microscopy from Procopak mosquito aspiration sample with active and placebo product as an indicator for reduced mosquito human contact due to effect of product. [Samples from indoor mosquito collections in enrolled households once every 28 days during intervention.] Diversion of Aedes aegypti mosquitoes into untreated houses. Compare adult female Aedes aegypti abundance using Procopak mosquito aspiration in untreated households adjacent to treatment clusters (with active product) to untreated households adjacent to placebo clusters as an indicator for mosquito diversion due to effect of product. [Indoor mosquito collections in enrol | — |
Countries
Sri Lanka
Contacts
Public ContactDr. Korelege Hasitha Aravinda Tissera
Consultant Epidemiologist
Outcome results
None listed