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Aspects of Vulnerability of People Living With HIV in the Alpine Arc Region (ASPEGIC)

Primary Purpose

HIV Infections

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
self questionnaire
Sponsored by
Centre Hospitalier Annecy Genevois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV Infections

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any person living with HIV presenting for consultation with their infectious disease referrer.
  • Patient followed for at least 6 months for their HIV infection
  • Patient with undetectable or detectable HIV viral load
  • Patient of legal age at the time of the study
  • Patient informed of the study and having expressed no objection to the collection of health data

Exclusion Criteria:

  • Patient opposed or unable to express opposition to participation in the study
  • Patient is a minor at the time of the study
  • Patient taking antiretroviral therapy for less than 6 months

Sites / Locations

  • Ch Annecy GenevoisRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Self questionnaire

Arm Description

The study will be offered to all patients who have been treated for HIV infection for at least 6 months, during a follow-up consultation. A self questionnaire will be administered only once per patient during the usual consultation, there is no follow-up planned.

Outcomes

Primary Outcome Measures

Variables of vulnerability
Evaluation of the variables associated with a state of vulnerability according to the "EPICES" scale (at a threshold of 30.17/100), among the social, demographic and medical characteristics of people living with HIV in the Alpine Arc region characteristics of people living with HIV in the Alpine Arc region

Secondary Outcome Measures

Full Information

First Posted
April 7, 2021
Last Updated
July 19, 2022
Sponsor
Centre Hospitalier Annecy Genevois
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1. Study Identification

Unique Protocol Identification Number
NCT04846595
Brief Title
Aspects of Vulnerability of People Living With HIV in the Alpine Arc Region
Acronym
ASPEGIC
Official Title
Aspects of Vulnerability of People Living With HIV in the Alpine Arc Region
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Annecy Genevois

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
HIV infection in France has become a chronic disease and treatment has allowed patients to increase their life expectancy. However, these promising results suffer from a very large variability within the socio-epidemiological subgroups, and life expectancy at 20 years of age is still one third lower than in the general population. Few studies of metropolitan cohorts investigated precariousness as an independent risk factor for mortality. The investigators chose to consider the vulnerability of people living with HIV (PLWHA) through the measurement of a validated French quantitative score, called EPICES ("Évaluation de la précarité et des inégalités de santé dans les centres d'examens de santé ", Evaluation of precariousness and health inequalities in health examination centers).
Detailed Description
HIV infection in France has become a chronic disease and treatment has allowed patients to increase their life expectancy. However, these promising results suffer from a very large variability within the socio-epidemiological subgroups, and life expectancy at 20 years of age is still one third lower than in the general population. Few studies of metropolitan cohorts investigated precariousness as an independent risk factor for mortality. The investigators chose to consider the vulnerability of people living with HIV (PLWHA) through the measurement of a validated French quantitative score, called EPICES (Evaluation of precariousness and health inequalities in health examination centers). Using a self-administered questionnaire administered during an annual follow-up visit to an infectious disease specialist, the investigators seek to define in the alpine arc region in france, socio-demographic data associated with greater precariousness among PLWHA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self questionnaire
Arm Type
Other
Arm Description
The study will be offered to all patients who have been treated for HIV infection for at least 6 months, during a follow-up consultation. A self questionnaire will be administered only once per patient during the usual consultation, there is no follow-up planned.
Intervention Type
Other
Intervention Name(s)
self questionnaire
Intervention Description
Evaluate the demographic variables and medical characteristics of people living with HIV in the Alpine Arc region
Primary Outcome Measure Information:
Title
Variables of vulnerability
Description
Evaluation of the variables associated with a state of vulnerability according to the "EPICES" scale (at a threshold of 30.17/100), among the social, demographic and medical characteristics of people living with HIV in the Alpine Arc region characteristics of people living with HIV in the Alpine Arc region
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any person living with HIV presenting for consultation with their infectious disease referrer. Patient followed for at least 6 months for their HIV infection Patient with undetectable or detectable HIV viral load Patient of legal age at the time of the study Patient informed of the study and having expressed no objection to the collection of health data Exclusion Criteria: Patient opposed or unable to express opposition to participation in the study Patient is a minor at the time of the study Patient taking antiretroviral therapy for less than 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janssen Cécile, Dr
Phone
+3350636618
Email
cjanssen@ch-annecygenevois.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Lejeune Stéphanie
Phone
+33450636958
Email
slejeune1@ch-annecygenevois.fr
Facility Information:
Facility Name
Ch Annecy Genevois
City
Pringy
State/Province
Haute-Savoie
ZIP/Postal Code
74374
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janssen Cécile, Dr
Phone
+33450636618
Email
cjanssen@ch-annecygenevois.fr
First Name & Middle Initial & Last Name & Degree
Lejeune Stéphanie
Phone
+33450636958
Email
slejeune1@ch-annecygenevois.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Aspects of Vulnerability of People Living With HIV in the Alpine Arc Region

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