NCT04402684

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 10, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

April 17, 2020

Last Update Submit

January 25, 2021

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

  • questionnaire influenza vaccine coverage

    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 Outcomes (2)

  • modalities of influenza vaccination

    through study completion, an average of 1 year

  • the drivers and disincentives to influenza vaccination

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Any adult person living with HIV presenting for a follow-up consultation in the spring of 2020

You may qualify if:

  • 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

You may not qualify if:

  • Minor patients
  • Major under guardianship, curatorship, protected person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Tourcoing

Tourcoing, France

Location

Study Officials

  • Macha TETART, MD

    CH TOURCOING

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

May 27, 2020

Study Start

April 10, 2020

Primary Completion

September 30, 2020

Study Completion

December 30, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)