Seroprevalence of Coronavirus Disease 2019 (COVID-19) Antibodies in a Vulnerable Neighbourhood, Buenos Aries Argentina
NCT ID: NCT04472078
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
873 participants
OBSERVATIONAL
2020-06-10
2020-12-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Methods Between June 10th and July 1st, a cross-sectional design was carried out on people over 14 years old, selected from a probabilistic sample of households. Finger prick puncture ELISA test
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Starter PAR team: researcher who developed the Elisa Test, virologist that perform the analysis of the test and physician that served as volunteer field epidemiologist at the surveillance system (DetectAr Barrio 31) offered technical cooperation to test people experiencing homelessness.
PAR-First step: A sample for convenience of homeless people was tested during 3 days in a popular dining room managed by a non-governmental organization. Samples were collected by a DetectAr nurse and a volunteer epidemiologist.
PAR-Second step: feasibility was determined by the DetectAr coordinators of the Community Health Division of the Ministry of Health and the 12 health community workers (HCWs) when two volunteer epidemiologists from a University Institute explained the field organization (sample technique, data collection and database entry) for obtaining a probabilistic sample of residents. The PAR process was a cornerstone for reaching the sample size.
PAR-Third step: A cross-sectional study for seroprevalence survey was carried out.
Sample size and sample method Sample size was calculated for a seroprevalence of 5% according to evidence. A two-stage random sampling method was applied. First level: sector of the slum, Second level: geographical areas determined by the Department of Statistic and Census. Thirty houses were selected at this level. People over 14 years old were tested at the front door of their houses.
Serological test An enzyme linked immunosorbent assay \[ELISA\] developed in Argentina, by a laboratory in Buenos Aires, Argentina, was used. Performance characteristics are a high specificity (\>95%) and a high sensibility (\>95%) for SARS-COV-2 IgG. The test detects antibodies against two viral antigens, trimeric spike and the receptor binding domain (RBD) of the spike. Viral proteins were expressed in human cells. This kit has obtained regulatory approval by Argentina's national drug regulatory agency (ANMAT, National Administration for Drugs, Food and Medical Devices)\[. Blood samples were collected in a capillary tube from a finger prick, taken at the front door of each house. All HCWs were trained and epidemiological data was entered in a database. Samples were processed and analyzed at the virology laboratory in a pediatric hospital of Buenos Aires.
Statistical analysis To obtain the weighted prevalence, sample dataset was expanded to that of the last census by 3 factors: at neighborhood level, at household level and at individual level. The calculation of expansion factors at the household level is the inverse of the joint probability of selecting the last sampling unit (a household). The expansion factors at the household level imply three types of adjustments. The first one is related with non-response (given that some households did not want to answer the survey); the second one corresponds to the projection of sample to the entire population, and the third one to calibration techniques with a final adjustment by groups of age and gender, using external information from population census. Therefore, calibration variables were people 14 year-old or more, grouped by sex and by intervals of age: 14-30; 31-45; 46-59; 60 and more.
Prevalence of IgG antibodies were adjusted using sampling weights and post-stratification to allow for differences in non-response rates based on age group, sex, and census-tract income.
As household members share exposure to COVID-19, thus the outcome (prevalence of COVID-19 IgG) should show some correlation within the household. To test clustering effect, a random effects logistic regression model (multilevel model) was applied as it includes the variation between clusters explicitly in the likelihood and therefore takes account of intracluster correlation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Serological Assay or IgG for SARS-CoV-2
Serological Assay for detection of IgG for SARS-CoV-2
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
14 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital de Niños R. Gutierrez de Buenos Aires
OTHER
Salud Comunitaria Ministerio de Salud GCBA
UNKNOWN
Hospital Italiano de Buenos Aires
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
ALICIA MISTCHENKO
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alicia Mistchenko, MD PHD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Niños Ricardo Gutierrez
Vanina L Pagotto, MD MG
Role: STUDY_CHAIR
Hospital Italiano de Buenos Aires
Silvana Figar, MD MG
Role: STUDY_CHAIR
Hospital Italiano de Buenos Aires
Andrea Gamarnik, PHD
Role: STUDY_CHAIR
National Council of Scientific and Technical Research, Argentina
Ana M Gomez Saldaño, MD MG
Role: STUDY_CHAIR
Salud Comunitaria Ministerio de Salud GCBA
Fernan Quiroz, MD MG
Role: STUDY_DIRECTOR
Ministerio de Salud GCBA
Lorena Luna, MG
Role: STUDY_CHAIR
Salud Comunitaria Ministerio de Salud GCBA
Magdalena Wagner Manslau
Role: STUDY_CHAIR
Salud Comunitaria Ministerio de Salud GCBA
Julieta Salto
Role: STUDY_CHAIR
Salud Comunitaria Ministerio de Salud GCBA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital de Niños Ricardo Gutierrez
Buenos Aires, Buenos Aires F.D., Argentina
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sood N, Simon P, Ebner P, Eichner D, Reynolds J, Bendavid E, Bhattacharya J. Seroprevalence of SARS-CoV-2-Specific Antibodies Among Adults in Los Angeles County, California, on April 10-11, 2020. JAMA. 2020 Jun 16;323(23):2425-2427. doi: 10.1001/jama.2020.8279.
Pereira RJ, Nascimento GNLD, Gratao LHA, Pimenta RS. The risk of COVID-19 transmission in favelas and slums in Brazil. Public Health. 2020 Jun;183:42-43. doi: 10.1016/j.puhe.2020.04.042. Epub 2020 May 8. No abstract available.
Corburn J, Vlahov D, Mberu B, Riley L, Caiaffa WT, Rashid SF, Ko A, Patel S, Jukur S, Martinez-Herrera E, Jayasinghe S, Agarwal S, Nguendo-Yongsi B, Weru J, Ouma S, Edmundo K, Oni T, Ayad H. Slum Health: Arresting COVID-19 and Improving Well-Being in Urban Informal Settlements. J Urban Health. 2020 Jun;97(3):348-357. doi: 10.1007/s11524-020-00438-6.
Moen EL, Fricano-Kugler CJ, Luikart BW, O'Malley AJ. Analyzing Clustered Data: Why and How to Account for Multiple Observations Nested within a Study Participant? PLoS One. 2016 Jan 14;11(1):e0146721. doi: 10.1371/journal.pone.0146721. eCollection 2016.
Galbraith S, Daniel JA, Vissel B. A study of clustered data and approaches to its analysis. J Neurosci. 2010 Aug 11;30(32):10601-8. doi: 10.1523/JNEUROSCI.0362-10.2010.
Aarts E, Verhage M, Veenvliet JV, Dolan CV, van der Sluis S. A solution to dependency: using multilevel analysis to accommodate nested data. Nat Neurosci. 2014 Apr;17(4):491-6. doi: 10.1038/nn.3648. Epub 2014 Mar 26.
Zhang CH, Schwartz GG. Spatial Disparities in Coronavirus Incidence and Mortality in the United States: An Ecological Analysis as of May 2020. J Rural Health. 2020 Jun;36(3):433-445. doi: 10.1111/jrh.12476. Epub 2020 Jun 16.
Theel ES, Slev P, Wheeler S, Couturier MR, Wong SJ, Kadkhoda K. The Role of Antibody Testing for SARS-CoV-2: Is There One? J Clin Microbiol. 2020 Jul 23;58(8):e00797-20. doi: 10.1128/JCM.00797-20. Print 2020 Jul 23.
Buckley RM. Targeting the World's Slums as Fat Tails in the Distribution of COVID-19 Cases. J Urban Health. 2020 Jun;97(3):358-364. doi: 10.1007/s11524-020-00450-w.
Related Links
Access external resources that provide additional context or updates about the study.
Studies on the processes of social and urban integration in three Buenos Aires slums
Participatory action research in health systems
Systemic Facilitation of Collective Processes: Supporting Creativity and Participative Processes in Groups, Communities and Networks
COVID-19 reagents
Household and population census: villas 31 and 31 bis, City of Buenos Aires 2009
The Color of Coronavirus: COVID-19 Deaths by Race and Ethnicity in the U.S.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1831
Identifier Type: -
Identifier Source: org_study_id