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Healthcare WorkersNCT04844515

The ESPERES Prospective Cohort of Healthcare Workers in France: Study on COVID-19 Vaccine and the COVID-19 Pandemic (ESPERES_COVID19)

An observational study of Healthcare Workers and COVID-19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is the first study performed within the ESPERES cohort, related to prevention against COVID-19, in particular vaccination against COVID-19 and more broadly on the COVID-19 pandemic. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Healthcare Workers, COVID-19
How many people
15,000 participants
Where
1 siteFrance
Study dates
9 Apr 2021to 23 Apr 2023
How long will I take part?
24 Months
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 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population will be made up of HCWs. For the purposes of this study, a "healthcare worker" is defined as an individual who currently works in a setting where individuals receive healthcare (i.e. individuals do not have to work directly with patients, but may have any role within a setting where individuals receive healthcare, such as administrative office, housekeeping, food service, etc.). ESPERES_COVID-19 will be offered to all the HCWs of the Assistance Publique - Hôpitaux de Paris (AP-HP) establishments and to other public or private health establishments (lucrative or not) in the Ile-De-France region and to establishments in other French regions, in order to diversify the contexts.

Who may be able to join

  • Legal age
  • Healthcare workers defined as individuals who currently work in a setting where individuals receive healthcare (i.e. individuals do not have to work directly with patients, but may have any role within a setting where individuals receive healthcare, such as administrative office, housekeeping, food service, etc.)
  • Agreeing to participate (digital consent)

Who cannot join

  • No internet access

Trial locations and contacts

1 site in 1 country.

Florence Tubach, MD, PHD contact

01 42 16 05 88

florence.tubach@aphp.fr

Sandra Fournier, MD contact

sandra.fournier@aphp.fr

France1 site, 1 recruiting
  • Pitié-Salpêtrière - Charles Foix, AP-HP

    Paris, 75013

    Emmanuelle Liegey, Clinical PM, 01 44 84 17 63, emmanuelle.liegey@aphp.fr

    Sarra Pochon, Clinical PM, 01 42 16 75 74, sarra.pochon@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: The ESPERES Prospective Cohort of Healthcare Workers in France: Study on COVID-19 Vaccine and the COVID-19 Pandemic

This is the first study performed within the ESPERES cohort, related to prevention against COVID-19, in particular vaccination against COVID-19 and more broadly on the COVID-19 pandemic.

ESPERES is a national prospective e-cohort study providing a resource for collecting information on healthcare workers (HCWs) currently working in France. The overall goal of ESPERES is to develop the infrastructure necessary to create and engage a community of HCWs who may be eligible for participation in future research studies. ESPERES is set up to answer research questions, in the field of prevention for HCWs, prevention for their own health, that of their relatives, their colleagues, and users of the hospital. These research questions will be carried out in the context of specific subsequent studies.

Read the detailed description

Most countries face the issue of vaccine hesitancy, with sizeable fractions, or sometimes the majority, of the public opposing some vaccines. The problem is particularly acute in the case of COVID-19 vaccination: first, a high uptake of COVID-19 vaccines is necessary to reach and sustain herd immunity; second, and to the best of our knowledge, no country is currently planning on making COVID-19 vaccination mandatory, making public approval essential. Unfortunately, hesitancy towards COVID-19 vaccines is high in many countries.

Vaccine hesitancy also concerns healthcare workers (HCWs) who are at the frontline of the COVID-19 pandemic and identified as a priority target group for COVID-19 vaccines. Furthermore, HCWs can be relays of information concerning vaccination and thus play a key role as mediator in the promotion (or not) of this vaccination. However, vaccine intentions against COVID-19 are not fully known among different categories of HCWs and are likely to evolve with knowledge about the safety and efficacy of vaccines as well as the evolution of the epidemic. Consequently, it is crucial to understand the evolution of these vaccine intentions and their determinants in HCWs in order to better target interventions to promote this vaccination, in a context where scientific data are themselves evolving quickly.

The study population will be made up of HCWs. For the purposes of this study, a "healthcare worker" is defined as an individual who currently works in a setting where individuals receive healthcare (i.e. individuals do not have to work directly with patients, but may have any role within a setting where individuals receive healthcare, such as administrative office, housekeeping, food service, etc.). ESPERES_COVID-19 will be offered to all the HCWs of the Assistance Publique - Hôpitaux de Paris (AP-HP) establishments and to other public or private health establishments (lucrative or not) in the Ile-De-France region and to establishments in other French regions, in order to diversify the contexts.

Each participant is self-included and collects his own data via a web interface. This cohort is open, meaning that eligible people can be included until the end of the study (no limited inclusion period). This cohort will start in 2021 and is scheduled for an initial duration of 24 months but may be extended as part of amendments.

Participants will be regularly asked to answer online questionnaires lasting at most 20 minutes. The frequency of these questionnaires will not exceed one questionnaire every 2 weeks (and will generally be more spaced out). During their follow-up in the cohort, participants may be asked, depending on their characteristics, to participate in studies nested in the cohort.

All data from ESPERES_COVID-19 will be gathered in a health data repository. The statistical analyses planned in the research protocol will be performed by the pharmaco-epidemiology center (CEPHEPI), under the responsibility of Dr Candice ESTELLAT and Pr Florence TUBACH. The CEPHEPI is backed by the public health department of the hospital group Pitié-Salpêtrière - Charles Foix, AP-HP.

A calculation of the sample size is not justified for this study as it aims to answer several research questions in a cohort. However, a number about 15,000 participants in ESPERES_COVID-19 are expected.

Keywords
Healthcare workers, Preventive measures, Attitudes, COVID-19
Medical subject headings
COVID-19, Behavior

What is being measured

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

  1. The COVID-19 vaccine intention with the question: "Do you intend to get vaccinated against COVID-19?" : I am already vaccinated / Yes, as soon as possible / Yes, but I prefer to wait before getting vaccinated / No, I don't think I'm gonna get vaccinated

    Measured: Up to 24 months

Secondary outcomes (17)
  1. The COVID-19 vaccine intention in HCWs participants according to the characteristics of the vaccines (country of the manufacturer, technology used, number of doses, etc.) and of the HCWs

    Measured: Up to 24 months

  2. Potential individual sociocognitive factors in the acceptance of COVID-19 vaccination, based on models developed for vaccine hesitation (5C psychological antecedents of vaccination adapted for COVID-19 vaccination and HCWs). (eleven points-Likert scales)

    Measured: Up to 24 months

  3. The perceptions of participants regarding the strategies for managing the pandemic and the progress of the health crisis and the pandemic (eleven points-Likert scales)

    Measured: Up to 24 months

  4. The healthy behaviors in other contexts (especially influenza vaccination over the last years)

    Measured: Up to 24 months

  5. The methods and sources of information concerning questions relating to health: media (website, social networks, television, radio or written press), nature (mainstream, classic or alternative media), etc.

    Measured: Up to 24 months

  6. Frequency of searches for information on COVID-19 or COVID-19 vaccines

    Measured: Up to 24 months

  7. Socio-demographic and professional characteristics, lifestyles: age, gender, profession and place of practice

    Measured: Up to 24 months

  8. The percentages of participants with history of COVID-19 and risk factors for severe forms of COVID-19 (perception of being at risk for severe forms)

    Measured: Up to 24 months

  9. The impact of the epidemic on the participants in their professional and personal life (closed-ended questions)

    Measured: Up to 24 months

  10. Contextual determinants: characteristic of living (density and constitution of the household) and work (type of hospital, working hours, time and mode of travel to workplace) places

    Measured: Up to 24 months

  11. Other health behaviors related to the COVID-19 pandemic: adherence to protective measures in professionnal and personal life during the last 14 days (eleven points-Likert scale)

    Measured: Up to 24 months

  12. The self-reported COVID-19 vaccine rate (dates, number of doses, type of vaccine, satisfaction)

    Measured: Up to 24 months

  13. Incidence of SARS-COV-2 infection (date, severity, mode of diagnosis, etc.)

    Measured: Up to 24 months

  14. The attitude of HCWs participants regarding the advice they give or not to patients, relatives and colleagues regarding the vaccination against COVID-19 (closed-ended questions)

    Measured: Up to 24 months

  15. Behavioral risk factors during the last 14 days before the SARS-COV-2 infection (closed-ended questions)

    Measured: Up to 24 months

  16. Other health behaviors related to the COVID-19 pandemic: the frequency of carrying out diagnostic tests for the infection to SARS-COV-2

    Measured: Up to 24 months

  17. The perceptions of participants in general regarding to the COVID-19 vaccination (eleven points-Likert scales)

    Measured: Up to 24 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 Apr 2021
  2. Study start9 Apr 2021
  3. Primary completion1 Oct 2022 (estimated)
  4. Study completion23 Apr 2023 (estimated)

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
Cohort
Time perspective
Prospective
Enrolment
15,000 participants (estimated)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04844515
Sponsor's protocol ID
APHP210173.1
Status last verified
Jun 2022
First submitted
13 Apr 2021
Last updated
21 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Healthcare Workers and COVID-19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. 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 France. 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?

Results are not available in the source record.

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

Contact Florence Tubach, MD, PHD (01 42 16 05 88, florence.tubach@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The COVID-19 vaccine intention with the question: "Do you intend to get vaccinated against COVID-19?" : I am already vaccinated / Yes, as soon as possible / Yes, but I prefer to wait before getting vaccinated / No, I don't think I'm gonna get vaccinated (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Jun 2022.

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