NCT05075941

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.).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,811

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2021

Completed
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

October 7, 2021

Last Update Submit

April 5, 2023

Conditions

COVID-19

Keywords

vaccination coveragemigrantshomelesstravelling community

Outcome Measures

Primary Outcomes (2)

  • Vaccination coverage among COVID-19

    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

    Promote interventions to encourage the use of COVID-19 vaccination

    one month

Study Arms (6)

Shelters Paris/93

Other: Vaccination coverage

Workers' hostels Paris/93

Other: Vaccination coverage

travelling community IDF(77/93/95)

Other: Vaccination coverage

Street/Camps Paris/93

Other: Vaccination coverage

Covid Homeless and migrants Marseille

Other: Vaccination coverage

Hostel Paris/93

Other: Vaccination coverage

Interventions

Vaccination coverageOTHER

proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population

Covid Homeless and migrants MarseilleHostel Paris/93Shelters Paris/93Street/Camps Paris/93Workers' hostels Paris/93travelling community IDF(77/93/95)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

migrants, homeless and travelling community

You may qualify if:

  • 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

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Marseille

Marseille, France

Location

Paris

Paris, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Vaccination Coverage

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

VaccinationImmunizationPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Elisabeth POULET, MD

    Epicentre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 13, 2021

Study Start

November 15, 2021

Primary Completion

December 22, 2021

Study Completion

December 22, 2021

Last Updated

April 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Access Criteria
Study partners

Locations

FR(2)