Clinical trial NCT05149001: Study Among People Living With HIV and Their Health Professionals of Associated Factors of Resilience to Self-stigma
Official title: Study Among People Living With HIV and Their Health Professionals of Associated Factors of Resilience to Self-stigma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
Stigmatization
Self-stigma
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Poitiers University Hospital
name: Poissy-Saint Germain Hospital
name: Centre Hospitalier Universitaire Dijon
name: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
name: Hopital Antoine Beclere
name: Nantes University Hospital
name: Hospital, La Roche sur Yon
name: Hôpital Necker-Enfants Malades
name: Centre Hospitalier de Bretagne Sud
name: Reims University hospital
name: Groupe Hospitalier de la Rochelle Ré Aunis
name: Hospital Laennec, Quimper
name: University Hospital, Brest
name: Hospital Cornouaille, Quimper
name: Centre Hospitalier de Cholet
name: University Hospital, Strasbourg
name: CH Annecy Genevois
name: Centre hospitalier de Perpignan
name: Centre Hospitalier le Mans
name: Centre Hospitalier VALENCIENNES
name: Bicetre Hospital
name: Centre Hospitalier Universitaire de Nice
name: University Hospital, Marseille
name: Jacques Lacarin Hospital Center
name: L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône
name: Centre Hospitalier Universitaire de Besancon
name: Hospital, Vannes
name: Moulins Hospital
name: Hospital, Montluçon
name: Centre Hospitalier de Niort
name: Hôpital Edouard Herriot
name: Hospital La Source, Orléans
name: Centre Hospitalier du Pays d'Aix
name: Hospital Andre Mignot, Le Chesnay
name: Hôpital Raymond Poincaré
name: University Hospital, Angers
name: University Hospital, Pointe-à-Pitre
name: Centre Hospitalier des Pays de Morlaix
name: Hospital Foch, Suresnes
name: Tenon Hospital, Paris
name: University Hospital of Saint-Etienne
name: Centre Hospitalier de Saint-Denis
name: University Hospital, Mulhouse
First posted: 2021-12-08
Enrollment: 667
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: people living with HIV

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-stigma as experienced by PLHIV will be explored through a custom questionnaire intended for the patient
timeFrame: 1 day during the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
Secondary outcomes:
measure: The main explanatory variables will be studied by means of a custom questionnaire intended for the patient
timeFrame: 1 day during the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
measure: Self-stigma of patients perceived by their caregivers
timeFrame: 1 day during the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Centre Hospitalier du Pays d'Aix
city: Angers
country: France
facility: Chu Angers
city: Annecy
country: France
facility: CH Annecy Genevois
city: Besançon
country: France
facility: Chru Besancon
city: Brest
country: France
facility: CHRU Brest
city: Cholet
country: France
facility: CH Cholet
city: Clamart
country: France
facility: Hopital Antoine Beclere
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
city: Dijon
country: France
facility: Chu Dijon
city: Garches
country: France
facility: Hopital Raymond Poincaré
city: La Roche-sur-Yon
country: France
facility: CHD Vendrée
city: La Rochelle
country: France
facility: Groupe Hospitalier de La rochelle-Ré-Aunis
city: Le Chesnay
country: France
facility: CH de Versailles
city: Le Kremlin-Bicêtre
country: France
facility: Hopital Bicetre Aphp
city: Le Mans
country: France
facility: Ch Le Mans
city: Lorient
country: France
facility: Centre Hospitalier Bretagne Sud
city: Lyon
country: France
facility: CHU LYON
city: Marseille
country: France
facility: CISIH
city: Montluçon
country: France
facility: Ch Montlucon
city: Morlaix
country: France
facility: CH Morlaix
city: Moulins
country: France
facility: CH Moulins-Yzeure
city: Mulhouse
country: France
facility: CHU de Mulhouse
city: Nantes
country: France
facility: Chu Nantes
city: Nice
country: France
facility: CHU NICE
city: Niort
country: France
facility: CH NIORT
city: Orléans
country: France
facility: CH Orléans
city: Paris
country: France
facility: Hopitel Necker
city: Perpignan
country: France
facility: CH Perpignan
city: Poissy
country: France
facility: Chu Poissy
city: Poitiers
country: France
facility: CHU Poitiers
city: Quimper
country: France
facility: Centre Hospitalier Intercommunal de Cornouaille
city: Quimper
country: France
facility: Pole Santé Publique - CH Laennec
city: Reims
country: France
facility: Chu Reims
city: Saint-Étienne
country: France
facility: CHU Nord
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Tenon
country: France
facility: Hopital Tenon
city: Toulon
country: France
facility: Chu Toulon
city: Valenciennes
country: France
facility: Ch Valenciennes
city: Vannes
country: France
facility: CHBA Vannes
city: Vichy
country: France
facility: CH VICHY
city: Villefranche-sur-Saône
country: France
facility: Hôpital Nord Ouest villefranche sur Saone
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU Pointe-à-Pitre
city: Saint-Denis
country: Réunion
facility: CHU Felix Guyon
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Christine JACOMET, Dr
role: PRINCIPAL_INVESTIGATOR
References: