Evaluation of Vaccination Coverage and Determinants of Success of the COVID-19 Vaccination Program Among Populations in Very Precarious Situations (PREVAC)

April 5, 2023 updated by: Epicentre

PREVAC: Evaluation of Vaccination Coverage and Determinants of Success of the COVID-19

The main objective of the study is to assess the level of vaccination coverage (VC) against COVID-19 among migrants, homeless and travelling community, according to their living conditions and housing.

The secondary objectives are :

  • to compare the estimated level of vaccination coverage in the different sites and strata (emergency shelters/hotels, camps, workers' hostels, on the street) with the estimated level in the general population of the same territory obtained from the French Health Insurance data (SIVAC).
  • identify the obstacles and leverage of vaccination (i.e. mobile team) according to living conditions and habitat (socio-demographic factors, personal health history, vaccine adherence, local health policies, etc.).

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.
3811

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Marseille, France
        • Marseille
      • Paris, France
        • Paris

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

migrants, homeless and travelling community

Description

Inclusion Criteria:

  • Adult (18 years and older)
  • People considered as homeless (homeless, living in a camp or squat) or
  • Living in adapted housing (migrant workers' hostel) or
  • Housed in residences of the National System or
  • Housed in a social residence such as a 115 hotel or a social housing centre
  • Freely and voluntarily consenting to participate

Exclusion Criteria:

  • Refusal to participate in the study (non-consent).
  • Language barrier with no in-person or telephone translation available.
  • Impossibility to give free and informed consent (comprehension barrier, cognitive and/or psychiatric and/or addictive disorders, external pressure from family and friends, persons under guardianship, etc.).

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Shelters Paris/93
Other: Vaccination coverage
proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population
Workers' hostels Paris/93
Other: Vaccination coverage
proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population
travelling community IDF(77/93/95)
Other: Vaccination coverage
proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population
Street/Camps Paris/93
Other: Vaccination coverage
proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population
Covid Homeless and migrants Marseille
Other: Vaccination coverage
proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population
Hostel Paris/93
Other: Vaccination coverage
proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population

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
Vaccination coverage among COVID-19
Time Frame: one month
Assess the proportion of people declaring to have received at least one dose of vaccination against COVID-19 among migrants, homeless and travelling community, according to their living conditions and housing
one month
Identify the most appropriate conditions for the use of vaccination against COVID-19
Time Frame: one month
Promote interventions to encourage the use of COVID-19 vaccination
one month

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.
Epicentre

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.
Agence Regionale de Sante d'Ile de France
Medecins Sans Frontieres, Netherlands
Institut de Recherche en Santé Publique, France
Médecins du Monde
CROIX ROUGE FRANCAISE
OBSERVATOIRE DU SAMU SOCIAL
INTERLOGEMENT 93

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: Elisabeth POULET, MD, Epicentre

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.
November 15, 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.
December 22, 2021

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.
December 22, 2021

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).
October 7, 2021

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.
October 7, 2021

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.
October 13, 2021

Study Record Updates

Last Update Posted (Actual)

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.
April 6, 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.
April 5, 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.
April 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.
  • 2021-A01960-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results will be presented in a report to the Ministry of Health, the Haute Autorité de Santé and the various partners. The main findings of this study could potentially be compared with the findings of other ongoing studies, once they are completed. An abstract of the findings will be submitted for presentation at a scientific conference, and at least one manuscript will be submitted for publication in a peer-reviewed scientific journal.

IPD Sharing Access Criteria

Study partners

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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