NCT05149001

Brief Summary

This study is perform to study the effect of psychological and psychosocial factors associated with resilience to the self-stigmatization of people living with HIV

Trial Health

90
On Track

Trial Health Score

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

Enrollment
667

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
3 countries

43 active sites

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

First Submitted

Initial submission to the registry

November 29, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2022

Completed
Last Updated

May 1, 2023

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

November 29, 2021

Last Update Submit

April 28, 2023

Conditions

HIV Infections

Keywords

HIVStigmatizationSelf-stigma

Outcome Measures

Primary Outcomes (1)

  • Self-stigma as experienced by PLHIV will be explored through a custom questionnaire intended for the patient

    Percentage of patient with self-stigma

    1 day during the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand

Secondary Outcomes (2)

  • The main explanatory variables will be studied by means of a custom questionnaire intended for the patient

    1 day during the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand

  • Self-stigma of patients perceived by their caregivers

    1 day during the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand

Eligibility Criteria

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

people living with HIV

You may qualify if:

  • For patients: adult patient, male or female, infected with HIV medically monitored in a hospital department involved in the investigation.
  • Affiliation to a Social Security scheme For caregivers:Caregiver caring for people living with HIV as part of a hospital service involved in the survey (doctor, IDE, psychologist, other ...).

You may not qualify if:

  • Minor patient
  • Refusal of participation
  • Persons under guardianship, guardianship or legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (43)

Centre Hospitalier du Pays d'Aix

Aix-en-Provence, France

Location

Chu Angers

Angers, France

Location

CH Annecy Genevois

Annecy, France

Location

Chru Besancon

Besançon, France

Location

CHRU Brest

Brest, France

Location

CH Cholet

Cholet, France

Location

Hopital Antoine Beclere

Clamart, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, France

Location

Chu Dijon

Dijon, France

Location

Hopital Raymond Poincaré

Garches, France

Location

CHD Vendrée

La Roche-sur-Yon, France

Location

Groupe Hospitalier de La rochelle-Ré-Aunis

La Rochelle, France

Location

CH de Versailles

Le Chesnay, France

Location

Hopital Bicetre Aphp

Le Kremlin-Bicêtre, France

Location

Ch Le Mans

Le Mans, France

Location

Centre Hospitalier Bretagne Sud

Lorient, France

Location

CHU LYON

Lyon, France

Location

CISIH

Marseille, France

Location

Ch Montlucon

Montluçon, France

Location

CH Morlaix

Morlaix, France

Location

CH Moulins-Yzeure

Moulins, France

Location

CHU de Mulhouse

Mulhouse, France

Location

Chu Nantes

Nantes, France

Location

CHU NICE

Nice, France

Location

CH NIORT

Niort, France

Location

CH Orléans

Orléans, France

Location

Hopitel Necker

Paris, France

Location

CH Perpignan

Perpignan, France

Location

Chu Poissy

Poissy, France

Location

CHU Poitiers

Poitiers, France

Location

Centre Hospitalier Intercommunal de Cornouaille

Quimper, France

Location

Pole Santé Publique - CH Laennec

Quimper, France

Location

Chu Reims

Reims, France

Location

CHU Nord

Saint-Etienne, France

Location

CHU Strasbourg

Strasbourg, France

Location

Hopital Tenon

Thenon, France

Location

Chu Toulon

Toulon, France

Location

Ch Valenciennes

Valenciennes, France

Location

CHBA Vannes

Vannes, France

Location

CH VICHY

Vichy, France

Location

Hôpital Nord Ouest villefranche sur Saone

Villefranche-sur-Saône, France

Location

CHU Pointe-à-Pitre

Pointe-à-Pitre, Guadeloupe

Location

CHU Felix Guyon

Saint-Denis, Reunion

Location

MeSH Terms

Conditions

HIV InfectionsStereotyping

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christine JACOMET, Dr

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 8, 2021

Study Start

January 17, 2022

Primary Completion

April 14, 2022

Study Completion

April 14, 2022

Last Updated

May 1, 2023

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

RE(1)FR(41)GU(1)