Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05075941
Recruitment Status : Not yet recruiting
First Posted : October 13, 2021
Last Update Posted : October 19, 2021
Sponsor:
Collaborators:
SANTE PUBLIQUE FRANCE
Medecins Sans Frontieres, Netherlands
Médecins du Monde
CROIX ROUGE FRANCAISE
OBSERVATOIRE DU SAMU SOCIAL
INTERLOGEMENT 93
Agence Regionale de Sante d'Ile de France
Information provided by (Responsible Party):
Epicentre

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.).

Condition or disease Intervention/treatment
COVID-19 Other: Vaccination coverage

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 3470 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: PREVAC: Evaluation of Vaccination Coverage and Determinants of Success of the COVID-19
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
migrants, homeless and travelling community
Criteria

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.).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05075941


Contacts
Layout table for location contacts
Contact: Thomas ROEDERER +33 1 40 21 55 55 thomas.roederer@epicentre.msf.org
Contact: Jessica SAYYAD +33 1 40 21 55 55 jessica.sayyad@epicentre.msf.org

Sponsors and Collaborators
Epicentre
SANTE PUBLIQUE FRANCE
Medecins Sans Frontieres, Netherlands
Médecins du Monde
CROIX ROUGE FRANCAISE
OBSERVATOIRE DU SAMU SOCIAL
INTERLOGEMENT 93
Agence Regionale de Sante d'Ile de France
Investigators
Layout table for investigator information
Principal Investigator: Elisabeth POULET, MD Epicentre
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT05075941    
Other Study ID Numbers: 2021-A01960-41
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: Study partners

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Epicentre:
vaccination coverage
migrants
homeless
travelling community
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs