- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04846595
Aspects of Vulnerability of People Living With HIV in the Alpine Arc Region (ASPEGIC)
19. juli 2022 opdateret af: 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).
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
600
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Janssen Cécile, Dr
- Telefonnummer: +3350636618
- E-mail: cjanssen@ch-annecygenevois.fr
Undersøgelse Kontakt Backup
- Navn: Lejeune Stéphanie
- Telefonnummer: +33450636958
- E-mail: slejeune1@ch-annecygenevois.fr
Studiesteder
-
-
Haute-Savoie
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Pringy, Haute-Savoie, Frankrig, 74374
- Rekruttering
- Ch Annecy Genevois
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Kontakt:
- Lejeune Stéphanie
- Telefonnummer: +33450636958
- E-mail: slejeune1@ch-annecygenevois.fr
-
Kontakt:
- Janssen Cécile, Dr
- Telefonnummer: +33450636618
- E-mail: cjanssen@ch-annecygenevois.fr
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 99 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: 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.
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Evaluate the demographic variables and medical characteristics of people living with HIV in the Alpine Arc region
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Variables of vulnerability
Tidsramme: 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
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one day
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. februar 2021
Primær færdiggørelse (Forventet)
31. december 2022
Studieafslutning (Forventet)
31. december 2022
Datoer for studieregistrering
Først indsendt
7. april 2021
Først indsendt, der opfyldte QC-kriterier
13. april 2021
Først opslået (Faktiske)
15. april 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. juli 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. juli 2022
Sidst verificeret
1. juli 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20-16
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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