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

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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

Tracking Information
First Submitted Date October 7, 2021
First Posted Date October 13, 2021
Last Update Posted Date October 19, 2021
Estimated Study Start Date November 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 7, 2021)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Vaccination Coverage and Determinants of Success of the COVID-19 Vaccination Program Among Populations in Very Precarious Situations
Official Title PREVAC: Evaluation of Vaccination Coverage and Determinants of Success of the COVID-19
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.).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population migrants, homeless and travelling community
Condition COVID-19
Intervention Other: Vaccination coverage
proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population
Study Groups/Cohorts
  • Shelters Paris/93
    Intervention: Other: Vaccination coverage
  • Workers' hostels Paris/93
    Intervention: Other: Vaccination coverage
  • travelling community IDF(77/93/95)
    Intervention: Other: Vaccination coverage
  • Street/Camps Paris/93
    Intervention: Other: Vaccination coverage
  • Covid Homeless and migrants Marseille
    Intervention: Other: Vaccination coverage
  • Hostel Paris/93
    Intervention: Other: Vaccination coverage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: October 7, 2021)
3470
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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.).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
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
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT05075941
Other Study ID Numbers 2021-A01960-41
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Access Criteria: Study partners
Responsible Party Epicentre
Study Sponsor Epicentre
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
Investigators
Principal Investigator: Elisabeth POULET, MD Epicentre
PRS Account Epicentre
Verification Date October 2021