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Impact of Wolbachia Deployment on Arboviral Disease Incidence in Medellin and Bello, Colombia (WMP-COL)

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ClinicalTrials.gov Identifier: NCT03631719
Recruitment Status : Unknown
Verified July 2018 by Universidad de Antioquia.
Recruitment status was:  Recruiting
First Posted : August 15, 2018
Last Update Posted : February 25, 2019
Sponsor:
Collaborators:
Monash University
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Wellcome Trust
Information provided by (Responsible Party):
Universidad de Antioquia

Brief Summary:

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.

Condition or disease Intervention/treatment
Dengue Chikungunya Virus Infection Zika Virus Infection Biological: Wolbachia-carrying Ae.aegypti mosquitoes

Detailed Description:
  • 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: World Mosquito Program - Colombia (WMP-COLOMBIA): The Impact of City-wide Deployment of Wolbachia-infected Mosquitoes on Arboviral Disease Incidence in Medellin and Bello, Colombia
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Group/Cohort Intervention/treatment
Early-release
Resident in areas that receive early Wolbachia deployments.
Biological: 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%).

Late-release
Resident in areas that receive late Wolbachia deployments.



Primary Outcome Measures :
  1. Dengue cases notified to surveillance system [ Time Frame: 5 years ]
    Incidence of dengue cases (suspected, epidemiological link, and IgM positive for dengue) notified to the disease surveillance system

  2. Virologically-confirmed dengue [ Time Frame: 2 years ]
    Virologically-confirmed dengue virus infection in patients reporting febrile illness recruited from health clinics. Participants are classified as dengue cases if plasma samples collected 1-4 days after onset of fever test positive for dengue virus NS1 antigen or dengue virus nucleic acid by RT-qPCR.


Secondary Outcome Measures :
  1. IgM test positive for dengue [ Time Frame: 5 years ]
    Number of cases who were IgM test positive for dengue

  2. Severe dengue cases [ Time Frame: 5 years ]
    Incidence of severe dengue cases reported to the surveillance system, by release zone and overall.

  3. Zika cases notified to surveillance system [ Time Frame: 5 years ]
    Incidence of Zika cases reported to the surveillance system.

  4. Chikungunya cases notified to surveillance system [ Time Frame: 5 years ]
    Incidence of chikungunya cases reported to the surveillance system.

  5. Spatial analysis [ Time Frame: 5 years ]
    The spatial distribution of notified dengue cases with geolocated primary address available, before and after Wolbachia deployment

  6. Virologically-confirmed chikungunya infection [ Time Frame: 2 years ]
    Virologically-confirmed chikungunya virus infection in patients reporting febrile illness recruited from health clinics. Participants are classified as chikungunya cases if plasma samples collected 1-4 days after onset of fever test positive for chikungunya virus NS1 antigen or chikungunya virus nucleic acid by RT-qPCR.

  7. Virologically-confirmed Zika infection [ Time Frame: 2 years ]
    Virologically-confirmed Zika virus infection in patients reporting febrile illness recruited from health clinics. Participants are classified as Zika cases if plasma samples collected 1-4 days after onset of fever test positive for Zika virus NS1 antigen or Zika virus nucleic acid by RT-qPCR.


Biospecimen Retention:   Samples With DNA
6 ml venous blood sample for DENV, chikungunya virus (CHIKV), and Zika virus (ZIKV) diagnostic testing


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The case-control study area as a whole has a population of approximately 564,000, of which approximately half will be resident in areas that receive early Wolbachia deployments ('early-release') and half in areas that will receive late Wolbachia deployments ('late-release').

The study population for measurement of the efficacy endpoint is the population of patients who reside in the study area, presenting to the network of participating primary health care facility with febrile illness, and meeting the eligibility criteria.

Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631719


Contacts
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Contact: Ivan D Velez, Prof. +574 4808390 ext 101 idvelez@pecet-colombia.org
Contact: Patricia Arbelaez patricia.arbelaez@worldmosquito.org

Locations
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Colombia
Universidad de Antioquia Recruiting
Medellín, Antioquia, Colombia
Sponsors and Collaborators
Universidad de Antioquia
Monash University
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Wellcome Trust
Investigators
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Study Director: Cameron Simmons, Prof. Monash University
Additional Information:
Publications:
Dengue Vaccine Initiative. Dengue vaccine candidates in clinical development. (2016). Available at: http://www.denguevaccines.org/vaccine-development. (Accessed: 13th June 2016)
World Health Organization. WHO Director-General summarizes the outcome of the Emergency Committee regarding clusters of microcephaly and Guillain-Barré syndrome. 2016. Available at. see World Health Organization. Zika virus: Fact sheet. 2016.
World Health Organization. Mosquito (vector) control emergency response and preparedness for Zika virus. (2016). Available at: http://www.who.int/neglected_diseases/news/mosquito_vector_control_response/en/. (Accessed: 18th March 2016)
Republic of Colombia, B. of the R. (Bogotá). D. of E. R. Colombia: Overview of its economic structure. (Printing of the Bank of the Republic, 1992).
Republic of Colombia, N. C. for E. and S. P. Guidelines for the formulation of integral environmental health policy with emphasis on the components of air quality, water quality and chemical safety. (2008).
Medina ÁM. El Dengue en Colombia. Epidemiología de la Reemergencia a la Hiperendemia. Medicina. 2013 Mar 5;35(1):75-6.n Ltda. Bogotá).
National Institute of Health. Epidemiological bulletin: week 52/2016. (2016).
Organization, W. H. et al. Dengue: guidelines for diagnosis, treatment, prevention and control. (World Health Organization, 2009).

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Responsible Party: Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT03631719    
Other Study ID Numbers: PEC004_18
PECET-002 ( Registry Identifier: Impact Assessment of Wolbachia deployment )
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad de Antioquia:
Wolbachia
Colombia
Dengue
Zika
Chikungunya
Arboviral diseases
Disease surveillance
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Virus Diseases
Dengue
Chikungunya Fever
Zika Virus Infection
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Alphavirus Infections
Togaviridae Infections