Impact of Wolbachia Deployment on Arboviral Disease Incidence in Medellin and Bello, Colombia
NCT ID: NCT03631719
Last Updated: 2022-04-08
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
Total Enrollment
834 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-10-25
Study Completion Date
2021-12-31
Brief Summary
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Study setting: Medellin and Bello municipalities, Colombia Health condition(s) studied: Dengue, Zika and chikungunya virus infection Intervention: Deployment of Wolbachia-infected Aedes aegypti mosquitoes in Medellin and Bello.
Study design:
1. An interrupted time-series analysis utilising routine disease surveillance data collected by the Medellín and Bello Health Secretariats, which aims to compare incidence of dengue, chikungunya and Zika pre- and post-Wolbachia release.
2. A test-negative study using an incident case-control design, which aims to quantify the reduction in disease incidence among people living within a Wolbachia-treated zone compared with an untreated zone that has a similar dengue risk profile at baseline.
Study design:
1. An interrupted time-series analysis utilising routine disease surveillance data collected by the Medellín and Bello Health Secretariats, which aims to compare incidence of dengue, chikungunya and Zika pre- and post-Wolbachia release.
2. A test-negative study using an incident case-control design, which aims to quantify the reduction in disease incidence among people living within a Wolbachia-treated zone compared with an untreated zone that has a similar dengue risk profile at baseline.
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Detailed Description
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* Selection and enrolment of participants: Enrolment of patients will commence after completion of Wolbachia releases in the early zones. Study processes for enrolling patients presenting with febrile illness will be established at a network of primary health care facilities that serve the population who reside in the study area. Trained research staff will be employed to assist with study processes in each site. Participants will be enrolled from within the population of patients (aged ≥3 years old) presenting with undifferentiated fever of 1-4 days' duration. All patients meeting the inclusion criteria will be eligible for enrolment and will be asked to provide written informed consent before participating in the study.
* Recruitment procedures: All eligible participants meeting study inclusion criteria will be invited to enroll continuously throughout the study period. Recruitment will occur during normal clinic hours. Participants will be managed according to standard clinical practice by the attending physicians. Recruitment rates in each clinic and across the study site as a whole will be monitored weekly, including a review of the screening logs to identify the proportion of eligible participants who did not consent to participate. The field coordinator will make regular visits to low-enrolling clinics to identify clinic-based, patient-based or other causes for low recruitment, and put measures in place to address these.
* Screening: All patients presenting with febrile illness will be screened against the study inclusion criteria by trained staff. All eligible febrile individuals will be recorded in a screening log and invited to participate. Participation status (consent/decline) will be recorded against each participant in the log.
* Informed consent: Written informed consent will be sought from participants (or their guardian where the participant is a minor) by trained local staff, after explaining the study objectives, processes, data, and sample collection, and the participant has had an opportunity to ask questions. A verbal explanation of the written Explanatory Statement will be provided to all participants in the local language. In addition, participants aged between 7 and 17 years will be invited to sign an assent form indicating they understand the research and agree to participate. Data and sample collection procedures
* Data collection: A unique identifier will be assigned to each participant at enrollment. Basic demographic details, eligibility against the inclusion criteria and illness onset date will be recorded in a standardized case report form.
* Recruitment procedures: All eligible participants meeting study inclusion criteria will be invited to enroll continuously throughout the study period. Recruitment will occur during normal clinic hours. Participants will be managed according to standard clinical practice by the attending physicians. Recruitment rates in each clinic and across the study site as a whole will be monitored weekly, including a review of the screening logs to identify the proportion of eligible participants who did not consent to participate. The field coordinator will make regular visits to low-enrolling clinics to identify clinic-based, patient-based or other causes for low recruitment, and put measures in place to address these.
* Screening: All patients presenting with febrile illness will be screened against the study inclusion criteria by trained staff. All eligible febrile individuals will be recorded in a screening log and invited to participate. Participation status (consent/decline) will be recorded against each participant in the log.
* Informed consent: Written informed consent will be sought from participants (or their guardian where the participant is a minor) by trained local staff, after explaining the study objectives, processes, data, and sample collection, and the participant has had an opportunity to ask questions. A verbal explanation of the written Explanatory Statement will be provided to all participants in the local language. In addition, participants aged between 7 and 17 years will be invited to sign an assent form indicating they understand the research and agree to participate. Data and sample collection procedures
* Data collection: A unique identifier will be assigned to each participant at enrollment. Basic demographic details, eligibility against the inclusion criteria and illness onset date will be recorded in a standardized case report form.
Conditions
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Dengue
Chikungunya Virus Infection
Zika Virus Infection
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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Early-release
Resident in areas that receive early Wolbachia deployments.
Wolbachia-carrying Ae.aegypti mosquitoes
Intervention Type
BIOLOGICAL
Wolbachia-infected Ae. aegypti mosquito eggs and adults sequentially deployed into Medellin and Bello, Colombia. Deployments cease once Wolbachia prevalence has reached a predetermined frequency (usually ≥60%).
Late-release
Resident in areas that receive late Wolbachia deployments.
No interventions assigned to this group
Interventions
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Wolbachia-carrying Ae.aegypti mosquitoes
Wolbachia-infected Ae. aegypti mosquito eggs and adults sequentially deployed into Medellin and Bello, Colombia. Deployments cease once Wolbachia prevalence has reached a predetermined frequency (usually ≥60%).
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Inclusion Criteria
* Fever (either self-reported or objectively measured, e.g. axillary temperature ≥38oC, with a date of onset between 1-4 days prior to the day of presentation.
* Aged ≥3 years old.
* Lived (i.e. slept) in the study area every night (or day) for the 10 days preceding illness onset.
* Aged ≥3 years old.
* Lived (i.e. slept) in the study area every night (or day) for the 10 days preceding illness onset.
Exclusion Criteria
* Localising features suggestive of a specific diagnosis e.g. severe diarrhea, otitis, pneumonia
* Prior enrollment in the study within the previous 4 weeks.
* Prior enrollment in the study within the previous 4 weeks.
Minimum Eligible Age
3 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Monash University
OTHER
Sponsor Role
collaborator
United States Agency for International Development (USAID)
FED
Sponsor Role
collaborator
Bill and Melinda Gates Foundation
OTHER
Sponsor Role
collaborator
Wellcome Trust
OTHER
Sponsor Role
collaborator
Universidad de Antioquia
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Cameron Simmons, Prof.
Role: STUDY_DIRECTOR
Monash University
Locations
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Universidad de Antioquia
Medellín, Antioquia, Colombia
Site Status
Countries
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Colombia
References
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Velez ID, Tanamas SK, Arbelaez MP, Kutcher SC, Duque SL, Uribe A, Zuluaga L, Martinez L, Patino AC, Barajas J, Munoz E, Mejia Torres MC, Uribe S, Porras S, Almanza R, Pulido H, O'Neill SL, Santacruz-Sanmartin E, Gonzalez S, Ryan PA, Denton JA, Jewell NP, Dufault SM, Simmons CP, Anders KL. Reduced dengue incidence following city-wide wMel Wolbachia mosquito releases throughout three Colombian cities: Interrupted time series analysis and a prospective case-control study. PLoS Negl Trop Dis. 2023 Nov 30;17(11):e0011713. doi: 10.1371/journal.pntd.0011713. eCollection 2023 Nov.
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Velez ID, Santacruz E, Kutcher SC, Duque SL, Uribe A, Barajas J, Gonzalez S, Patino AC, Zuluaga L, Martinez L, Munoz E, Mejia MC, Arbelaez MP, Pulido H, Jewell NP, Dufault SM, O'Neill SL, Simmons CP, Anders KL, Tanamas SK. The impact of city-wide deployment of Wolbachia-carrying mosquitoes on arboviral disease incidence in Medellin and Bello, Colombia: study protocol for an interrupted time-series analysis and a test-negative design study. F1000Res. 2019 Aug 1;8:1327. doi: 10.12688/f1000research.19858.2. eCollection 2019.
Reference Type
DERIVED
Provided Documents
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Document Type: Statistical Analysis Plan
Related Links
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http://pecet-colombia.org/
PECET Web Page
Other Identifiers
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PECET-002
Identifier Type: REGISTRY
Identifier Source: secondary_id
PEC004_18
Identifier Type: -
Identifier Source: org_study_id
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Experimental Malaria Infection of Healthy Malaria-Naive Adults by Mosquito Bite With the Genetically Modified Plasmodium Falciparum NF54/iGP3 GAP
NCT06881732
NOT_YET_RECRUITING
PHASE1