COVID-19PREVACNCT05075941
Evaluation of Vaccination Coverage and Determinants of Success of the COVID-19 Vaccination Program Among Populations in Very Precarious Situations
An observational study of COVID-19, run by Epicentre at 2 sites in France.
Trial 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. Read more about this study
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: migrants, homeless and travelling community
Who may be able to join
- 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
Who cannot join
- 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.).
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: PREVAC: Evaluation of Vaccination Coverage and Determinants of Success of the COVID-19
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.).
- Conditions
- COVID-19
- Being tested
- Vaccination coverage
- Keywords
- vaccination coverage, migrants, homeless, travelling community
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination coverageOther
proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population
| Study group | Role | What they receive |
|---|---|---|
| Shelters Paris/93 | Not described Receives: Other: Vaccination coverage | |
| Workers' hostels Paris/93 | Not described Receives: Other: Vaccination coverage | |
| travelling community IDF(77/93/95) | Not described Receives: Other: Vaccination coverage | |
| Street/Camps Paris/93 | Not described Receives: Other: Vaccination coverage | |
| Covid Homeless and migrants Marseille | Not described Receives: Other: Vaccination coverage | |
| Hostel Paris/93 | Not described Receives: Other: Vaccination coverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start15 Nov 2021
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3,811 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Santé 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
- Responsible party
- Sponsor
- Investigators
- Elisabeth POULET, MD, Principal investigator, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075941
- Sponsor's protocol ID
- 2021-A01960-41
- Acronym
- PREVAC
- Status last verified
- Apr 2023
- First submitted
- 7 Oct 2021
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVAC: Evaluation of Vaccination Coverage and Determinants of Success of the COVID-19
- ClinicalTrials.gov ID
- NCT05075941
- Acronym / sponsor ID
- PREVAC / 2021-A01960-41
- Conditions
- COVID-19
- Keywords
- vaccination coverage, migrants, homeless, travelling community
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,811 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Institut de Recherche en Santé 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
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- migrants, homeless and travelling community
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccination coverageproportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population | Other | Covid Homeless and migrants Marseille, Hostel Paris/93, Shelters Paris/93, Street/Camps Paris/93, Workers' hostels Paris/93, travelling community IDF(77/93/95) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth POULET, MD principal investigator
Epicentre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Epicentre at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination coverage among COVID-19 (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.