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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Benin
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut de Recherche pour le Developpement

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European and Developing Countries Clinical Trials Partnership (EDCTP)
Barcelona Institute for Global Health
Institut de Recherche Clinique du Benin
Ministère de la Santé - Bénin
Ministère de la Santé et de Hygiène Publique - Burkina Faso

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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