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

Sponsor

Epicentre (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05075941

Collaborator

SANTE PUBLIQUE FRANCE (Other), Medecins Sans Frontieres, Netherlands (Other), Médecins du Monde (Other), CROIX ROUGE FRANCAISE (Other), OBSERVATOIRE DU SAMU SOCIAL (Other), INTERLOGEMENT 93 (Other), Agence Regionale de Sante d'Ile de France (Other)

3,470

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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	Phase
COVID-19	Other: Vaccination coverage

Study Design

Study Type:

Observational

Anticipated 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

Anticipated Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	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

Primary Outcome Measures

Vaccination coverage among COVID-19 [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 [one month]
Promote interventions to encourage the use of COVID-19 vaccination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Locations

No locations specified.

Investigators

Principal Investigator: Elisabeth POULET, MD, Epicentre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Epicentre

ClinicalTrials.gov Identifier:

NCT05075941

Other Study ID Numbers:

2021-A01960-41

First Posted:

Oct 13, 2021

Last Update Posted:

Oct 19, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Epicentre

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Oct 19, 2021