- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04846595
Aspects of Vulnerability of People Living with HIV in the Alpine Arc Region (ASPEGIC)
February 11, 2025 updated by: Centre Hospitalier Annecy Genevois
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).
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
595
Phase
- Not Applicable
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
-
-
Haute-Savoie
-
Pringy, Haute-Savoie, France, 74374
- CH Annecy Genevois
-
-
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 to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
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
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Self questionnaire
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.
|
Evaluate the demographic variables and medical characteristics of people living with HIV in the Alpine Arc region
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Variables of vulnerability
Time Frame: one day
|
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
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
February 16, 2021
Primary Completion (Actual)
October 17, 2022
Study Completion (Actual)
October 17, 2022
Study Registration Dates
First Submitted
April 7, 2021
First Submitted That Met QC Criteria
April 13, 2021
First Posted (Actual)
April 15, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 11, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- HIV Infections
Other Study ID Numbers
- 20-16
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
product manufactured in and exported from the U.S.
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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