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UnknownNCT05919277

A Dengue Sero-prevalence Study in the Metropolitan Area of Buenos Aires

Status
Unknown
Phase
Study type
Observational
Enrollment
1,487 (estimated)
Sponsor
Fundacion GESICA · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

Summary

The objective of this observational study of dengue seroprevalence in the metropolitan area of Buenos Aires is to know what percentage of the population has antibodies against dengue in persons 18 years of age or older who are residents of the city of Buenos Aires or its metropolitan area. The main questions to be answered are: * What is the seroprevalence of antibodies against dengue measured by Immunoglobulin G determination by ELISA * Characterize the different dengue serotypes in the affected population. Participants will undergo a small blood draw to determine the presence of Immunoglobulin G antibodies against dengue. * Tests will also be performed to determine infection by flaviviruses other than dengue virus.

Detailed description

A two-stage stratified design will be used. The primary sampling units will be mostly defined as the census sections of the 2010 National Census of Population, Households and Dwellings. It has 5 strata, constructed through a functional relationship between the income quintiles obtained in the Annual Household Survey (AHS) and the variables that were surveyed in the census. Stratum 1 corresponds to the lowest income population, while stratum 5 corresponds to the highest. The first stage of sampling in this framework will consist of about 100 to 300 primary sampling units, called primary units areas, selected with a probability proportional to size, the measure of size being the total number of dwellings. A sample of 1,487 dwellings is proposed. In each primary unit area, a number of dwellings will be selected to be visited by enumerators, who will make a list of all members residing in the dwelling (regardless of whether they are from the same household) and select a member aged ≥18 years to proceed with the survey. This last selection is a 3rd and final sampling stage that will define the sample of 1487 participants to be tested. The sample size was calculated based on the estimated probability of pre-infection for each of the municipalities and localities participating in the survey.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTDengue Immunoglobulin G antibodies performed with ELISAAll participants who agree to participate by signing an informed consent form will undergo a finger prick for the determination of Immunoglobulin G antibodies measured by ELISA. In a subgroup of persons who test positive, they will be invited to have blood drawn for neutralization determination in order to study serotypes and the presence of other flaviviruses.

Timeline

Start date
2023-09-11
Primary completion
2023-12-01
Completion
2024-09-01
First posted
2023-06-26
Last updated
2023-09-13

Locations

1 site across 1 country: Argentina

Source: ClinicalTrials.gov record NCT05919277. Inclusion in this directory is not an endorsement.