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

See Contacts and Locations

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

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

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

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

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