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COVID-19STREESCONCT06170320

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

An observational study of COVID-19 and SARS CoV 2 Infection, run by Institut de Recherche pour le Developpement at 1 site in Benin.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
COVID-19, SARS CoV 2 Infection, COVID-19 Pandemic
How many people
7,000 participants
Where
1 siteBenin
Study dates
1 Mar 2021to 30 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Benin1 site

  • Institut de Recherche Clinique du Bénin

    Abomey-Calavi, Atlantique Department, 04BP1114

Other trials in Benin

About this study

Official title: 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.
Read the 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.

Keywords
COVID-19, Epidemiological surveillance, Benin, strategic sites, dynamics
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 9 months

  2. 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.

    Measured: 9 months

  3. 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

    Measured: 9 months

  4. 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

    Measured: 9 months

  5. 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.

    Measured: 9 months

  6. Environmental factors associated with incidence rates and hotspots

    Binomial mixed generalized additive model (GAMM)

    Measured: 9 months

  7. Basic reproduction number for each strategic site and overall

    Bayesian approach to quantify transmissibility over time during the epidemic at each site and overall.

    Measured: 9 months

  8. 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.

    Measured: 9 months

  9. 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.

    Measured: 9 months

  10. 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.

    Measured: 3 months

  11. 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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2023
  2. Study start1 Mar 2021
  3. Primary completion30 Jul 2022
  4. Study completion30 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
7,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06170320
Sponsor's protocol ID
RIA2020EF-2923
Acronym
STREESCO
Status last verified
Dec 2023
First submitted
12 Dec 2023
Last updated
21 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Atchade A, Yadouleton A, Fiogbe M, Abdoulaye Alfa D, Yovo E, Le Hesran JY, Hounsa S, Bationo C, Figueroa-Romero A, Gaudart J, Gonzalez R, Bonnet E, Massougbodji A, Cottrell G. Determinants of SARS-CoV-2 infection across three sentinels sites in Benin during 2021: A multicentric surveillance study. PLOS Glob Public Health. 2025 Feb 13;5(2):e0004227. doi: 10.1371/journal.pgph.0004227. eCollection 2025.

    PubMed 39946403

  • Figueroa-Romero A, Atchade A, Yadouleton A, Fiogbe M, Bonnet E, Yovo E, Accrombessi M, Hounsa S, Paper T, Dupont R, Gaudart J, Le Hesran JY, Massougbodji A, Cottrell G, Gonzalez R. SARS-CoV-2 seroprevalence among Beninese pregnant women in the third year of the pandemic. BMC Public Health. 2024 Jul 2;24(1):1762. doi: 10.1186/s12889-024-19087-4.

    PubMed 38956517

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and SARS CoV 2 Infection, run by Institut de Recherche pour le Developpement at 1 site in Benin.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Benin. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06170320, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.

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