NCT04846595

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
595

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Feb 2021

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

February 16, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2022

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

April 7, 2021

Last Update Submit

February 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    one day

Study Arms (1)

Self questionnaire

OTHER

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.

Other: self questionnaire

Interventions

Evaluate the demographic variables and medical characteristics of people living with HIV in the Alpine Arc region

Self questionnaire

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ch Annecy Genevois

Pringy, Haute-Savoie, 74374, France

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 15, 2021

Study Start

February 16, 2021

Primary Completion

October 17, 2022

Study Completion

October 17, 2022

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations