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Spatial Repellents for Aedes-borne Virus Control in Sri Lanka (AEGIS ABV)

Primary Purpose

Arbovirus Infections

Status

Not yet recruiting

Phase

Not Applicable

Locations

Sri Lanka

Study Type

Interventional

Intervention

Transfluthrin

Placebo

About this trial

This is an interventional prevention trial for Arbovirus Infections focused on measuring Dengue, Zika, Chikungunya, Spatial Repellent, Transfluthrin, Vector-borne diseases, Mosquito vectors, Incidence

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

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

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.

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 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

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.

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

Inclusion Criteria:

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).

Exclusion Criteria:

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

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 drugs are sold, residents are always drunk or hostile).

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 drugs are sold, residents are always drunk or hostile).

Sites / Locations

Epidemiology Unit, Ministry of Health
Clinical Trials Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Spatial Repellent

Placebo

Arm Description

Transfluthrin

Inert ingredients

Outcomes

Primary Outcome Measures

Incidence of Aedes-borne virus (ABV) infection in the 'longitudinal cohort'.

The primary endpoint is the fraction of monotypic or seronegative individuals in the 'longitudinal cohort' 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 Outcome Measures

Clinically apparent cases of Aedes-borne virus (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.

Measured by comparing adult female Aedes aegypti indoor abundance in households using Procopak mosquito aspiration with active and placebo product receiving standard entomological surveillance and control procedures by the local Ministry of Health, 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.

Measured by comparing adult female Aedes aegypti blood fed rate in households with active and placebo product receiving standard entomological surveillance and control procedures by the local Ministry of Health, as an indicator for reduced mosquito human contact due to effect of product. Direct mosquito abdominal observation by microscopy from samples taken by Procopak aspiration during indoor mosquito collections in enrolled households once every 28 days during intervention.

Diversion of Aedes aegypti mosquitoes into untreated houses.

Measured by comparing 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 enrolled households once every 28 days during intervention.

Overall incidence of Aedes-borne virus (ABV) infection.

Measured by the seroconversion rates of all children enrolled in the trial, independent of order of infection (i.e., including tertiary and quaternary infections). Based on blood samples taken for longitudinal seroconversion and febrile surveillance from time of initial placement of intervention.

Full Information

NCT ID

NCT05452447

First Posted

July 6, 2022

Last Updated

March 21, 2023

Sponsor

University of Notre Dame

Collaborators

SC Johnson, A Family Company, fhiClinical, Ministry of Health, Sri Lanka, University of Sri Jayewardenepura, Sri Lanka, University of Washington, RemediumOne

1. Study Identification

Unique Protocol Identification Number

NCT05452447

Brief Title

Spatial Repellents for Aedes-borne Virus Control in Sri Lanka

Acronym

AEGIS ABV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 2023 (Anticipated)

Primary Completion Date

February 2025 (Anticipated)

Study Completion Date

February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Notre Dame

Collaborators

SC Johnson, A Family Company, fhiClinical, Ministry of Health, Sri Lanka, University of Sri Jayewardenepura, Sri Lanka, University of Washington, RemediumOne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arbovirus Infections

Keywords

Dengue, Zika, Chikungunya, Spatial Repellent, Transfluthrin, Vector-borne diseases, Mosquito vectors, Incidence

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

14430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Spatial Repellent

Arm Type

Experimental

Arm Description

Transfluthrin

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Inert ingredients

Intervention Type

Device

Intervention Name(s)

Transfluthrin

Intervention Description

Passive emanator with formulated transfluthrin

Intervention Type

Device

Intervention Name(s)

Placebo

Intervention Description

Passive emanator with formulated inert ingredients

Primary Outcome Measure Information:

Title

Incidence of Aedes-borne virus (ABV) infection in the 'longitudinal cohort'.

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Clinically apparent cases of Aedes-borne virus (ABV) disease.

Description

Time Frame

24 months

Title

Adult female Aedes aegypti indoor abundance.

Description

Time Frame

24 months

Title

Adult female Aedes aegypti blood fed rate.

Description

Time Frame

24 months

Title

Diversion of Aedes aegypti mosquitoes into untreated houses.

Description

Time Frame

24 months

Title

Overall incidence of Aedes-borne virus (ABV) infection.

Description

Time Frame

24 months

Other Pre-specified Outcome Measures:

Title

Adverse Events (AEs) and Serious Adverse Events (SAEs).

Description

Measured by solicited and unsolicited reports from both the longitudinal cohort and febrile surveillance cohort during the trial period. Mean, minimum and maximum frequency and percentage of AEs and SAEs across clusters among enrolled subjects will be summarized by treatment arm.

Time Frame

24 months

Title

Incidence of Aedes-borne virus (ABV) infection in subjects residing in households within treatment clusters but without SR product.

Description

Measured by comparing Aedes-borne virus infection rates between subjects residing in households with SR product in treatment clusters and subjects from the same clusters who did not agree to the SR application in their households but are receiving standard entomological surveillance and control procedures by the local ministry of health, as an indicator of community effect due to effect of product.

Time Frame

24 months

Title

Clinically apparent cases of Aedes-borne virus (ABV) disease in subjects residing in households within treatment clusters but without SR product.

Description

Measured by comparing Aedes-borne virus disease case rates between subjects residing in households with SR product in households in treatment clusters and individuals from the same clusters who did not agree to the SR application in their households but are receiving standard entomological surveillance and control procedures by the local ministry of health, as an indicator of community effect due to effect of product.

Time Frame

24 months

Title

Adult female Aedes aegypti indoor abundance using Procopak mosquito aspiration in households within treatment clusters but without SR product.

Description

Measured by comparing adult female Aedes aegypti indoor abundance in households with SR product in treatment clusters and households from the same clusters who did not agree to the SR application but are receiving standard entomological surveillance and control procedures by the local ministry of health, as an indicator of community effect to effect of product. Indoor mosquito collections in enrolled households once every 28 days during intervention

Time Frame

24 months

Title

Adult female Aedes aegypti blood fed rate using Procopak mosquito aspiration in households within treatment clusters but without SR product.

Description

Measured by comparing adult female Aedes aegypti blood fed rate in households with SR product in treatment clusters and households from the same clusters who did not agree to the SR application but are receiving standard entomological surveillance and control procedures by the local ministry of health, as an indicator of community effect to effect of product. Samples from indoor mosquito collections in enrolled households once every 28 days during intervention.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility 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) 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 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. 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 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 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. 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 Inclusion Criteria: 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). Exclusion Criteria: 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 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 drugs are sold, residents are always drunk or hostile). 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 drugs are sold, residents are always drunk or hostile).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

John P Grieco, Ph.D.

Phone

5743617572

jgrieco@nd.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Nicole L Achee, Ph.D.

Phone

5746311561

nachee@nd.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John P Grieco, Ph.D.

Organizational Affiliation

University of Notre Dame

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Korelege Hasitha Aravinda Tissera, M.D.

Organizational Affiliation

Epidemiology Unit, Ministry of Health, Sri Lanka

Official's Role

Principal Investigator

Facility Information:

Facility Name

Epidemiology Unit, Ministry of Health

City

Colombo

State/Province

West

ZIP/Postal Code

00100

Country

Sri Lanka

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hasitha Tisseara, Dr.

dr_korelege@yahoo.co.uk

Facility Name

Clinical Trials Unit

City

Ragama

State/Province

West

ZIP/Postal Code

01010

Country

Sri Lanka

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Asita de Silva, Prof.

asita@kln.ac.lk

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Analytical datasets will be anonymized and GPS tag-blurred to remove sensitive information prior to sharing.

IPD Sharing Time Frame

The data and supporting information will be made available 12 months following completion of data analysis and will remain open access in the public domain.

IPD Sharing Access Criteria

Open-access repository distributed under the terms of the Creative Commons Attribution (CC-BY) License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Spatial Repellents for Aedes-borne Virus Control in Sri Lanka

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