Spatial Repellents for Aedes-borne Virus Control in Sri Lanka
NCT ID: NCT05452447
Last Updated: 2025-09-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
6949 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-03-02
Study Completion Date
2025-06-30
Brief Summary
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The primary objective of the study is to demonstrate and quantify the protective efficacy (PE) of a single SR product, in reducing DENV infection and active Aedes-borne virus (ABV) disease in human cohorts. The study design will be a prospective, cluster randomized controlled trial (cRCT). Although not a specific objective of this project, an overall goal is to allow for official recommendations (or not) from the World Health Organization (WHO) for the use of SRs in public health. A WHO global policy recommendation will establish evaluation systems of SR products to regulate efficacy evaluations, thereby increasing quality, overall use and a consequent reduction in disease.
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Detailed Description
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The study will be a prospective, cRCT, participant and observer-blinded, placebo-controlled trial in a site endemic for ABV to measure the impact of a SR product on new ABV virus infections. Clusters of households, each cluster containing 110-120 residents testing negative for antibodies against DENV (seronegative) or positive to a single DENV infection (monotypic), will be selected from three MOH areas in the district of Gampaha: Negambo, Wattala, Kelaniya. All participating houses in each cluster will be monitored entomologically for adult Aedes aegypti surveys for 3 months before deployment of the SR intervention and monthly after the intervention is in place. Entomological surveys will include monitoring of indoor Ae. aegypti adult population densities and blood-fed status. DENV infection in study participants will be assessed by serologic testing of scheduled longitudinal blood samples (primary outcome) and passively by monitoring febrile persons for acute Dengue illness (secondary outcome). Seroconversion to DENV 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. Testing and confirmation of Zika virus (ZIKV) and Chikungunya virus (CHIKV) infection at baseline and during the intervention phase of the trial will be dependent on circulation history/detection in study area during study period.
The spatial repellent (SR) will be a new formulation of transfluthrin. This active ingredient (AI) is widely used in mosquito coils and other household pest control products worldwide. The new formulation is a passive emanator that will release the AI over a period of up to four weeks, Mosquito ShieldTM. The emanator will consist of a pre-treated piece of cellulose acetate or other medium, which will be positioned within consenting households according to manufacturer specifications of 2 units/9m2. A placebo product of matched design with inert ingredients will be applied similarly. The Mosquito ShieldTM and placebo products for this study will be designed and provided by S.C. Johnson, INC. A Family Company.
The spatial repellent (SR) will be a new formulation of transfluthrin. This active ingredient (AI) is widely used in mosquito coils and other household pest control products worldwide. The new formulation is a passive emanator that will release the AI over a period of up to four weeks, Mosquito ShieldTM. The emanator will consist of a pre-treated piece of cellulose acetate or other medium, which will be positioned within consenting households according to manufacturer specifications of 2 units/9m2. A placebo product of matched design with inert ingredients will be applied similarly. The Mosquito ShieldTM and placebo products for this study will be designed and provided by S.C. Johnson, INC. A Family Company.
Conditions
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Arbovirus Infections
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Spatial Repellent
Transfluthrin
Group Type
EXPERIMENTAL
Transfluthrin
Intervention Type
DEVICE
Passive emanator with formulated transfluthrin
Placebo
Inert ingredients
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DEVICE
Passive emanator with formulated inert ingredients
Interventions
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Transfluthrin
Passive emanator with formulated transfluthrin
Intervention Type
DEVICE
Placebo
Passive emanator with formulated inert ingredients
Intervention Type
DEVICE
Eligibility Criteria
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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)
* 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.
* ≥ 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.
* Adult head of household agrees to surveys.
* Properties where study personnel do not identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile).
* 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 drugs are sold, residents are always drunk or hostile).
* 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)
* 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.
* ≥ 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.
* Adult head of household agrees to surveys.
* Properties where study personnel do not identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile).
* 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 drugs are sold, residents are always drunk or hostile).
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
* 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 drugs 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
* \< 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
* Adult head of household does not agree to surveys.
* Properties where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile).
SPATIAL REPELLENT INTERVENTION Household Level
* 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 drugs are sold, residents are always drunk or hostile).
* 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
* 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 drugs 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
* \< 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
* Adult head of household does not agree to surveys.
* Properties where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile).
SPATIAL REPELLENT INTERVENTION Household Level
* 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 drugs are sold, residents are always drunk or hostile).
Minimum Eligible Age
6 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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S.C. Johnson & Son, Inc.
INDUSTRY
Sponsor Role
collaborator
fhiClinical
UNKNOWN
Sponsor Role
collaborator
Ministry of Health, Sri Lanka
OTHER_GOV
Sponsor Role
collaborator
University of Sri Jayewardenepura, Sri Lanka
UNKNOWN
Sponsor Role
collaborator
University of Washington
OTHER
Sponsor Role
collaborator
RemediumOne
UNKNOWN
Sponsor Role
collaborator
University of Notre Dame
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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John P Grieco, Ph.D.
Role: STUDY_DIRECTOR
University of Notre Dame
Korelege Hasitha Aravinda Tissera, M.D.
Role: PRINCIPAL_INVESTIGATOR
Epidemiology Unit, Ministry of Health, Sri Lanka
Locations
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Epidemiology Unit, Ministry of Health
Colombo, West, Sri Lanka
Site Status
Clinical Trials Unit
Ragama, West, Sri Lanka
Site Status
Countries
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Sri Lanka
References
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Morrison AC, Astete H, Chapilliquen F, Ramirez-Prada C, Diaz G, Getis A, Gray K, Scott TW. Evaluation of a sampling methodology for rapid assessment of Aedes aegypti infestation levels in Iquitos, Peru. J Med Entomol. 2004 May;41(3):502-10. doi: 10.1603/0022-2585-41.3.502.
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Ogoma SB, Moore SJ, Maia MF. A systematic review of mosquito coils and passive emanators: defining recommendations for spatial repellency testing methodologies. Parasit Vectors. 2012 Dec 7;5:287. doi: 10.1186/1756-3305-5-287.
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Syafruddin D, Bangs MJ, Sidik D, Elyazar I, Asih PB, Chan K, Nurleila S, Nixon C, Hendarto J, Wahid I, Ishak H, Bogh C, Grieco JP, Achee NL, Baird JK. Impact of a spatial repellent on malaria incidence in two villages in Sumba, Indonesia. Am J Trop Med Hyg. 2014 Dec;91(6):1079-87. doi: 10.4269/ajtmh.13-0735. Epub 2014 Oct 13.
Reference Type
BACKGROUND
Other Identifiers
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21-05-6629
Identifier Type: -
Identifier Source: org_study_id
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