Clinical trial NCT06170320: STREngthening COronavirus Disease 2019 (COVID-19) Surveillance in Africa
Official title: STREngthening Epidemiological Surveillance in Benin and Burkina Faso for an Effective Response to COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS CoV 2 Infection
COVID-19 Pandemic
Keywords: COVID-19
Epidemiological surveillance
Benin
strategic sites
dynamics
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: European and Developing Countries Clinical Trials Partnership (EDCTP)
name: Institut de Recherche Clinique du Bénin
name: Barcelona Institute for Global Health
name: Ministère de la Santé - Bénin
name: Ministère de la Santé et de Hygiène Publique - Burkina Faso
First posted: 2023-12-14
Enrollment: 7000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by strategic sites (suspected cases, contact cases)
timeFrame: 9 months
measure: Average number of contact cases per person infected with SARS-CoV-2 across all the study sites was as follows
timeFrame: 9 months
measure: Factors associated with SARS-CoV-2 infection in volunteers screened at 03 strategic sites
timeFrame: 9 months
measure: Clusters of cases in the area of each strategic site (radius, period, relative risk)
timeFrame: 9 months
measure: Intra-district incidence rate on the 03 strategic sites
timeFrame: 9 months
measure: Environmental factors associated with incidence rates and hotspots
timeFrame: 9 months
measure: Basic reproduction number for each strategic site and overall
timeFrame: 9 months
measure: Proportion of health workers infected with SARS-CoV-2 by strategic sites
timeFrame: 9 months
measure: Factors associated with SARS-CoV-2 infection in health workers at 03 strategic sites
timeFrame: 9 months
measure: Seroprevalence of SARS-CoV-2 infection among pregnant women in the 3rd trimester in maternity wards of strategic study sites
timeFrame: 3 months
measure: Factors associated with SARS-CoV-2 sero-infection in pregnant women in the 3rd trimester at 03 strategic sites
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abomey Calavi
country: Benin
facility: Institut de Recherche Clinique du Bénin
state: Atlantique
Study officials:
affiliation: Institut de Recherche Clinique du Bénin
name: Achille MASSOUGBODJI
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Recherche pour le Développement - France
name: Gilles COTTRELL
role: STUDY_DIRECTOR
affiliation: Fundación Privada Instituto de Salud Global Barcelona
name: Raquel GONZALEZ
role: STUDY_DIRECTOR
affiliation: Ministère de la Santé - Bénin
name: Anges YADOULETON
role: STUDY_CHAIR
affiliation: Ministère de la Santé - Burkina Faso
name: Boukary OUEDRAOGO
role: STUDY_CHAIR
References: