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
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.
- 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.
- 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|
- 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|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|
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%).
Resident in areas that receive late Wolbachia deployments.
- 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
- 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.
- IgM test positive for dengue [ Time Frame: 5 years ]Number of cases who were IgM test positive for dengue
- Severe dengue cases [ Time Frame: 5 years ]Incidence of severe dengue cases reported to the surveillance system, by release zone and overall.
- Zika cases notified to surveillance system [ Time Frame: 5 years ]Incidence of Zika cases reported to the surveillance system.
- Chikungunya cases notified to surveillance system [ Time Frame: 5 years ]Incidence of chikungunya cases reported to the surveillance system.
- Spatial analysis [ Time Frame: 5 years ]The spatial distribution of notified dengue cases with geolocated primary address available, before and after Wolbachia deployment
- 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.
- 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
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
|Contact: Ivan D Velez, Prof.||+574 4808390 ext email@example.com|
|Contact: Patricia Arbelaezfirstname.lastname@example.org|
|Universidad de Antioquia||Recruiting|
|Medellín, Antioquia, Colombia|
|Study Director:||Cameron Simmons, Prof.||Monash University|