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

• Sponsor: University Hospital, Clermont-Ferrand (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05149001
• Collaborator: Poitiers University Hospital (Other), Poissy-Saint Germain Hospital (Other), Centre Hospitalier Universitaire Dijon (Other), Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (Other), Hopital Antoine Beclere (Other), Nantes University Hospital (Other), Hospital, La Roche sur Yon (Other), Hôpital Necker-Enfants Malades (Other), Centre Hospitalier de Bretagne Sud (Other), Reims University Hospital (Other), Groupe Hospitalier de la Rochelle Ré Aunis (Other), Hospital Laennec, Quimper (Other), University Hospital, Brest (Other), Hospital Cornouaille, Quimper (Other), Centre Hospitalier de Cholet (Other), University Hospital, Strasbourg (Other), CH Annecy Genevois (Other), Centre hospitalier de Perpignan (Other), Centre Hospitalier le Mans (Other), Centre Hospitalier VALENCIENNES (Other), Bicetre Hospital (Other), Centre Hospitalier Universitaire de Nice (Other), University Hospital, Marseille (Other), Jacques Lacarin Hospital Center (Other), L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône (Other), Centre Hospitalier Universitaire de Besancon (Other), Hospital, Vannes (Other), Moulins Hospital (Other), Hospital, Montluçon (Other), Centre Hospitalier de Niort (Other), Hôpital Edouard Herriot (Other), Hospital La Source, Orléans (Other), Centre Hospitalier du Pays d'Aix (Other), Hospital Andre Mignot, Le Chesnay (Other), Hôpital Raymond Poincaré (Other), University Hospital, Angers (Other), University Hospital, Pointe-à-Pitre (Other), Centre Hospitalier des Pays de Morlaix (Other), Hospital Foch, Suresnes (Other), Tenon Hospital, Paris (Other), University Hospital of Saint-Etienne (Other), Centre Hospitalier de Saint-Denis (Other), University Hospital, Mulhouse (Other)
• Enrollment: 600
• Locations: 43
• Anticipated Duration (Months): 5
• Patients Per Site: 14
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
HIV Infections

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Study Among People Living With HIV and Their Health Professionals of Associated Factors of Resilience to Self-stigma
• Actual Study Start Date: Jan 17, 2022
• Anticipated Primary Completion Date: Jun 17, 2022
• Anticipated Study Completion Date: Jun 17, 2022

Outcome Measures

Primary Outcome Measures

1. Self-stigma as experienced by PLHIV will be explored through 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]

   Percentage of patient with self-stigma

Secondary Outcome Measures

1. 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]

   multivariate analysis of factors associated with disparition of self-stigma

2. 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]

   Percentage of caregivers who perceive self-stigma and how they propose to their patients the way to surpass themselves

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier du Pays d'Aix	Aix-en-Provence		France
2	Chu Angers	Angers		France
3	CH Annecy Genevois	Annecy		France
4	Chru Besancon	Besançon		France
5	CHRU Brest	Brest		France
6	CH Cholet	Cholet		France
7	Hopital Antoine Beclere	Clamart		France
8	Clermont-Ferrand University Hospital	Clermont-Ferrand		France
9	Chu Dijon	Dijon		France
10	Hopital Raymond Poincaré	Garches		France
11	CHD Vendrée	La Roche-sur-Yon		France
12	Groupe Hospitalier de La rochelle-Ré-Aunis	La Rochelle		France
13	CH de Versailles	Le Chesnay		France
14	Hopital Bicetre Aphp	Le Kremlin-Bicêtre		France
15	Ch Le Mans	Le Mans		France
16	Centre Hospitalier Bretagne Sud	Lorient		France
17	CHU LYON	Lyon		France
18	CISIH	Marseille		France
19	Ch Montlucon	Montluçon		France
20	CH Morlaix	Morlaix		France
21	CH Moulins-Yzeure	Moulins		France
22	CHU de Mulhouse	Mulhouse		France
23	Chu Nantes	Nantes		France
24	CHU NICE	Nice		France
25	CH NIORT	Niort		France
26	CH Orléans	Orléans		France
27	Hopitel Necker	Paris		France
28	CH Perpignan	Perpignan		France
29	Chu Poissy	Poissy		France
30	CHU Poitiers	Poitiers		France
31	Centre Hospitalier Intercommunal de Cornouaille	Quimper		France
32	Pole Santé Publique - CH Laennec	Quimper		France
33	Chu Reims	Reims		France
34	CHU Nord	Saint-Étienne		France
35	CHU Strasbourg	Strasbourg		France
36	Hopital Tenon	Tenon		France
37	Chu Toulon	Toulon		France
38	Ch Valenciennes	Valenciennes		France
39	CHBA Vannes	Vannes		France
40	CH VICHY	Vichy		France
41	Hôpital Nord Ouest villefranche sur Saone	Villefranche-sur-Saône		France
42	CHU Pointe-à-Pitre	Pointe-à-Pitre		Guadeloupe
43	CHU Felix Guyon	Saint-Denis		Réunion

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Christine JACOMET, Dr, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Clermont-Ferrand
• ClinicalTrials.gov Identifier: NCT05149001
• Other Study ID Numbers: RNI 2021 JACOMET 2; 2021-A01588-33
• First Posted: Dec 8, 2021
• Last Update Posted: Mar 14, 2022
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Clermont-Ferrand: HIV; Stigmatization; Self-stigma
• Additional relevant MeSH terms: HIV Infections

Study Results

No Results Posted as of Mar 14, 2022