- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06170320
STREngthening COronavirus Disease 2019 (COVID-19) Surveillance in Africa (STREESCO)
December 14, 2023 updated by: Institut de Recherche pour le Developpement
STREngthening Epidemiological Surveillance in Benin and Burkina Faso for an Effective Response to COVID-19
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
7000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Atlantique
-
Abomey Calavi, Atlantique, Benin, 04BP1114
- Institut de Recherche Clinique du Bénin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
This surveillance was carried out in 03 strategic sites: in Cotonou, the economic capital, in Allada, a town on the border of the cordon sanitaire set up in March 2020, and in Natitingou, a town in northern Benin outside the cordon sanitaire.
It was based in the health units involved in the response to COVID-19 at the 03 strategic sites.
Initially, we included volunteers for COVID-19 screening, contact cases of positive subjects, and health workers present in the centres.
Secondly, The study population consisted of pregnant women in the third trimester (≥ 28 weeks) of pregnancy seen for antenatal care (ANC) in the study maternity units of the 03 strategic sites were surveyed in order to describe their serological status with respect to SARS-CoV-2 infection.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average number of contact cases per person infected with SARS-CoV-2 across all the study sites was as follows
Time Frame: 9 months
|
Identify the number of contact cases per subject testing positive for SARS-CoV-2 infection at each of the strategic sites.
|
9 months
|
|
Factors associated with SARS-CoV-2 infection in volunteers screened at 03 strategic sites
Time Frame: 9 months
|
Multivariate logistic regression model on sociodemographic, anthropometric, clinical and environmental characteristics of volunteer subjects screened for SARS-CoV-2 infection
|
9 months
|
|
Clusters of cases in the area of each strategic site (radius, period, relative risk)
Time Frame: 9 months
|
Analysis of the spatial distribution of positive cases of SARS-CoV-2 infection on each of the strategic sites
|
9 months
|
|
Intra-district incidence rate on the 03 strategic sites
Time Frame: 9 months
|
Number of positive cases for SARS-CoV-2 infection divided by the total number of the population multiplied by 1000.
|
9 months
|
|
Basic reproduction number for each strategic site and overall
Time Frame: 9 months
|
Bayesian approach to quantify transmissibility over time during the epidemic at each site and overall.
|
9 months
|
|
Proportion of health workers infected with SARS-CoV-2 by strategic sites
Time Frame: 9 months
|
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
|
|
Factors associated with SARS-CoV-2 infection in health workers at 03 strategic sites
Time Frame: 9 months
|
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
|
|
Factors associated with SARS-CoV-2 sero-infection in pregnant women in the 3rd trimester at 03 strategic sites
Time Frame: 3 months
|
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
|
|
Proportion of subjects infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by strategic sites (suspected cases, contact cases)
Time Frame: 9 months
|
Total number of subjects with a positive COVID-19 test divided by the total number of volunteers tested in the study.
|
9 months
|
|
Environmental factors associated with incidence rates and hotspots
Time Frame: 9 months
|
Binomial mixed generalized additive model (GAMM)
|
9 months
|
|
Seroprevalence of SARS-CoV-2 infection among pregnant women in the 3rd trimester in maternity wards of strategic study sites
Time Frame: 3 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Achille MASSOUGBODJI, Institut de Recherche Clinique du Bénin
- Study Director: Gilles COTTRELL, Institut de Recherche pour le Développement - France
- Study Director: Raquel GONZALEZ, Fundación Privada Instituto de Salud Global Barcelona
- Study Chair: Anges YADOULETON, Ministère de la Santé - Bénin
- Study Chair: Boukary OUEDRAOGO, Ministère de la Santé - Burkina Faso
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
July 30, 2022
Study Completion (Actual)
July 30, 2022
Study Registration Dates
First Submitted
December 12, 2023
First Submitted That Met QC Criteria
December 12, 2023
First Posted (Actual)
December 14, 2023
Study Record Updates
Last Update Posted (Estimated)
December 21, 2023
Last Update Submitted That Met QC Criteria
December 14, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIA2020EF-2923
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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