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NCT05149001 Clinical Trial

Study Among People Living With HIV and Their Health Professionals of Associated Factors of Resilience to Self-stigma

HIV Infections Clinical Trial

— RESILSTIGMA  

Official title:
Study Among People Living With HIV and Their Health Professionals of Associated Factors of Resilience to Self-stigma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05149001
Other study ID # RNI 2021 JACOMET 2
Secondary ID 2021-A01588-33
Status Completed
Phase
First received
Last updated
Start date January 17, 2022
Est. completion date April 14, 2022

Study information
Verified date November 2021
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Description:

Epidemiological and sociological survey carried out with patients and their caregivers in the CHUs and CHGs of France via the COREVIH from 01/17/2022 to 02/17/2022. Primary endpoint: Self-stigmatization as experienced by PLWHA will be explored through a patient questionnaire Secondary endpoints:The main explanatory variables will be studied by means of a custom questionnaire intended for the patient and covering psychological flexibility, social provisions, avoidance and fusion mechanisms, quality of life, anxiety and depression. The socio-demographic explanatory variables will be collected by questionnaire, covering the following areas: sex, age, geographical origin, insecurity, drug use, sexuality, family context, employment, leisure, care environment. A questionnaire intended for caregivers will study the self-stigmatization perception of the people they care for and the means implemented to fight against self-stigmatization. Anonymous data will be reported in Redcap. The population will be described by numbers and percentages for categorical variables and by the mean ± standard deviation or the median [interquartile range] for the quantitative variables, with regard to their statistical distribution. Normality will be studied by the Shapiro-Wilk test and / or by histogram. As far as possible, graphical representations will be associated with the analyzes.

Recruitment information / eligibility
Status Completed
Enrollment 667
Est. completion date April 14, 2022
Est. primary completion date April 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 ...). Exclusion Criteria: - Minor patient - Refusal of participation - Persons under guardianship, guardianship or legal protection

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre Hospitalier du Pays d'Aix Aix-en-Provence
France Chu Angers Angers
France CH Annecy Genevois Annecy
France Chru Besancon Besançon
France CHRU Brest Brest
France CH Cholet Cholet
France Hopital Antoine Beclere Clamart
France Clermont-Ferrand University Hospital Clermont-Ferrand
France Chu Dijon Dijon
France Hopital Raymond Poincaré Garches
France CHD Vendrée La Roche-sur-Yon
France Groupe Hospitalier de La rochelle-Ré-Aunis La Rochelle
France CH de Versailles Le Chesnay
France Hopital Bicetre Aphp Le Kremlin-Bicêtre
France Ch Le Mans Le Mans
France Centre Hospitalier Bretagne Sud Lorient
France CHU LYON Lyon
France CISIH Marseille
France Ch Montlucon Montluçon
France CH Morlaix Morlaix
France CH Moulins-Yzeure Moulins
France CHU de Mulhouse Mulhouse
France Chu Nantes Nantes
France CHU NICE Nice
France CH NIORT Niort
France CH Orléans Orléans
France Hopitel Necker Paris
France CH Perpignan Perpignan
France Chu Poissy Poissy
France CHU Poitiers Poitiers
France Centre Hospitalier Intercommunal de Cornouaille Quimper
France Pole Santé Publique - CH Laennec Quimper
France Chu Reims Reims
France CHU Nord Saint-Étienne
France CHU Strasbourg Strasbourg
France Hopital Tenon Tenon
France Chu Toulon Toulon
France Ch Valenciennes Valenciennes
France CHBA Vannes Vannes
France CH VICHY Vichy
France Hôpital Nord Ouest villefranche sur Saone Villefranche-sur-Saône
Guadeloupe CHU Pointe-à-Pitre Pointe-à-Pitre
Réunion CHU Felix Guyon Saint-Denis

Sponsors (44)
Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Bicetre Hospital, Centre Hospitalier de Bretagne Sud, Centre Hospitalier de Cholet, Centre Hospitalier de Niort, Centre hospitalier de Perpignan, Centre Hospitalier de Saint-Denis, Centre Hospitalier des Pays de Morlaix, Centre Hospitalier du Pays d'Aix, Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Centre Hospitalier le Mans, Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire de Nice, Centre Hospitalier Universitaire Dijon, Centre Hospitalier VALENCIENNES, CH Annecy Genevois, Groupe Hospitalier de la Rochelle Ré Aunis, Hopital Antoine Beclere, Hôpital Edouard Herriot, Hôpital Necker-Enfants Malades, Hôpital Raymond Poincaré, Hospital Andre Mignot, Le Chesnay, Hospital Cornouaille, Quimper, Hospital Foch, Suresnes, Hospital La Source, Orléans, Hospital Laennec, Quimper, Hospital, La Roche sur Yon, Hospital, Montluçon, Hospital, Vannes, Jacques Lacarin Hospital Center, L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône, Moulins Hospital, Nantes University Hospital, Poissy-Saint Germain Hospital, Poitiers University Hospital, Reims University Hospital, Tenon Hospital, Paris, University Hospital of Saint-Etienne, University Hospital, Angers, University Hospital, Brest, University Hospital, Marseille, University Hospital, Mulhouse, University Hospital, Pointe-à-Pitre, University Hospital, Strasbourg

Countries where clinical trial is conducted

France,  Guadeloupe,  Réunion, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 The main explanatory variables will be studied by means of a custom questionnaire intended for the patient multivariate analysis of factors associated with disparition of self-stigma 1 day during the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
Secondary Self-stigma of patients perceived by their caregivers Percentage of caregivers who perceive self-stigma and how they propose to their patients the way to surpass themselves 1 day during the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
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