STREngthening COronavirus Disease 2019 (COVID-19) Surveillance in Africa

COVID-19 Clinical Trial

— STREESCO  

Official title:

STREngthening Epidemiological Surveillance in Benin and Burkina Faso for an Effective Response to COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06170320
• Other study ID #: RIA2020EF-2923
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: December 2023
• Source: Institut de Recherche pour le Developpement
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this observational study was to develop, with the intended users, an epidemic surveillance and response system that will be effective, sensitive, coordinated and appropriate. The STREESCO project aims to - Implement active epidemiological surveillance of suspected cases in Benin at strategic sites in accordance with the World Health Organization (WHO) protocol, in support of the national strategy for responding to the CoVID-19 virus. - To strengthen this national strategy by developing a clinico-epidemiological surveillance system in remote areas of Benin (health centre approach) and Burkina Faso (population survey approach). - To gain a better understanding of the dynamics of the epidemic and its parameters in Africa thanks to a modern biostatistical and geo-epidemiological analysis of the data collected as part of this project.

Description:

Within the framework of the health systems set up by the Benin health authorities, the project aims to develop, with the intended users, an epidemic surveillance and response system that will be effective, sensitive, coordinated and adapted to a context where resources are limited. Following the start of data collection on 01 March 2021, new reforms to the response strategy against CoVID-19 in Benin have led the investigators to opt for a new strategy in order to meet the objectives of the study. The epidemiological surveillance system will be adapted to the reforms, and data collected and processed prospectively on the dynamics of the epidemic will be collected in CoVID-19 screening centres and in public and private health centres. This is the scientific data needed to issue an early warning signal and enable the healthcare system to respond appropriately. The information system will be based on (i) epidemiological surveys in the field, (ii) virological, serological and antigenic tests, (iii) indicators that will enable action to be monitored, adaptation to the epidemic to be assessed and the response capacity of health structures to be controlled. Analysis (biostatistics, geo-epidemiology) of the data collected will provide useful knowledge for a better understanding of the dynamics of the epidemic. Finally, the project will encourage collaboration between African and European researchers and strengthen the capacity of African institutions to set up an epidemic surveillance system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7000
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All volunteering for COVID-19 screening in health units dedicated to COVID-19 activities.
• Having benefited from a COVID-19 test.
• Give free and informed consent to participate in the study.

Exclusion Criteria:

• Subjects who did not give free and informed consent to participate in the study.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Locations

Country	Name	City	State
Benin	Institut de Recherche Clinique du Bénin	Abomey Calavi	Atlantique

Sponsors (6)

Lead Sponsor	Collaborator
Institut de Recherche pour le Developpement	Barcelona Institute for Global Health, European and Developing Countries Clinical Trials Partnership (EDCTP), Institut de Recherche Clinique du Bénin, Ministère de la Santé - Bénin, Ministère de la Santé et de Hygiène Publique - Burkina Faso

Country where clinical trial is conducted

Benin, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by strategic sites (suspected cases, contact cases)	Total number of subjects with a positive COVID-19 test divided by the total number of volunteers tested in the study.	9 months
Primary	Average number of contact cases per person infected with SARS-CoV-2 across all the study sites was as follows	Identify the number of contact cases per subject testing positive for SARS-CoV-2 infection at each of the strategic sites.	9 months
Primary	Factors associated with SARS-CoV-2 infection in volunteers screened at 03 strategic sites	Multivariate logistic regression model on sociodemographic, anthropometric, clinical and environmental characteristics of volunteer subjects screened for SARS-CoV-2 infection	9 months
Primary	Clusters of cases in the area of each strategic site (radius, period, relative risk)	Analysis of the spatial distribution of positive cases of SARS-CoV-2 infection on each of the strategic sites	9 months
Primary	Intra-district incidence rate on the 03 strategic sites	Number of positive cases for SARS-CoV-2 infection divided by the total number of the population multiplied by 1000.	9 months
Primary	Environmental factors associated with incidence rates and hotspots	Binomial mixed generalized additive model (GAMM)	9 months
Primary	Basic reproduction number for each strategic site and overall	Bayesian approach to quantify transmissibility over time during the epidemic at each site and overall.	9 months
Primary	Proportion of health workers infected with SARS-CoV-2 by strategic sites	Total number of health workers with a positive COVID-19 test divided by the total number of health workers tested in the study.	9 months
Primary	Factors associated with SARS-CoV-2 infection in health workers at 03 strategic sites	Multivariate logistic regression model on sociodemographic, anthropometric, clinical and environmental characteristics, prevention and control measures among health workers for SARS-CoV-2 infection.	9 months
Primary	Seroprevalence of SARS-CoV-2 infection among pregnant women in the 3rd trimester in maternity wards of strategic study sites	Number of pregnant women with a positive Rapid Diagnostic Test (RDT) divided by the total number of pregnant women tested during the study.	3 months
Primary	Factors associated with SARS-CoV-2 sero-infection in pregnant women in the 3rd trimester at 03 strategic sites	Multivariate logistic regression model on sociodemographic, anthropometric, clinical, linked to the course of pregnancy and vaccination status characteristics in pregnant women in the 3rd trimester at 03 strategic sites	3 months