- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04402684
Influenza Vaccination in Patients Living With HIV in the Northern Region (VACCIGRIPPE)
January 25, 2021 updated by: Tourcoing Hospital
Influenza Vaccination in Patients Living With HIV in the Northern Region: An Observational Monocentre Study of Blankets, Modalities, Drivers and Brakes
Anyone living with the Human Immunodeficiency Virus (HIV) has an indication for annual influenza vaccination.
(Vaccination schedule and vaccination recommendations 2019).
Influenza is a viral infection that has a significant impact on the health care system.
However, vaccination coverage in France is still insufficient with regard to the objectives set at 75% by the WHO and the European Commission.
For the 2019-2020 seasonal influenza vaccination campaign, flu vaccination by volunteer pharmacists has become possible throughout the country.
Studies that have estimated vaccination coverage among HIV-positive populations are rare and show very low rates.
Study Overview
Status
Completed
Conditions
Detailed Description
Cross-sectional study via a self-questionnaire given to all HIV-infected patients coming for a scheduled consultation as part of their HIV follow-up in the spring of 2020.
Non-opposition letter given to the patient.
Collection of data a posteriori from the medical file recorded in the eNadis patient file.
Study Type
Observational
Enrollment (Actual)
124
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tourcoing, France
- Ch Tourcoing
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Any adult person living with HIV presenting for a follow-up consultation in the spring of 2020
Description
Inclusion Criteria:
- Any adult person living with HIV presenting for a follow-up consultation in the spring of 2020
- People who do not read French may participate if they wish with the help of a medical or paramedical staff member.
- Patient did not object
Exclusion Criteria:
- Minor patients
- Major under guardianship, curatorship, protected person
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
questionnaire influenza vaccine coverage
Time Frame: through study completion, an average of 1 year
|
The objective of this questionnaire is to estimate the influenza vaccine coverage among PVVIH followed at the Tourcoing Hospital Center.
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
modalities of influenza vaccination
Time Frame: through study completion, an average of 1 year
|
To identify the modalities of influenza vaccination when it is carried out
|
through study completion, an average of 1 year
|
the drivers and disincentives to influenza vaccination
Time Frame: through study completion, an average of 1 year
|
Estimate from patient reports the drivers and disincentives to influenza vaccination in a specific risk population.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Macha TETART, MD, Ch Tourcoing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2020
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
December 30, 2020
Study Registration Dates
First Submitted
April 17, 2020
First Submitted That Met QC Criteria
May 20, 2020
First Posted (Actual)
May 27, 2020
Study Record Updates
Last Update Posted (Actual)
January 26, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- RIPH_2020_5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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