Study Among People Living With HIV and Their Health Professionals of Associated Factors of Resilience to Self-stigma (RESILSTIGMA)
April 28, 2023 updated by: University Hospital, Clermont-Ferrand
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
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
667
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aix-en-Provence, France
- Centre Hospitalier du Pays d'Aix
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Angers, France
- CHU Angers
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Annecy, France
- CH Annecy Genevois
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Besançon, France
- CHRU Besançon
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Brest, France
- CHRU Brest
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Cholet, France
- CH Cholet
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Clamart, France
- Hôpital Antoine Béclère
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Clermont-Ferrand, France
- Clermont-Ferrand University Hospital
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Dijon, France
- CHU Dijon
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Garches, France
- Hôpital Raymond Poincaré
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La Roche-sur-Yon, France
- CHD Vendrée
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La Rochelle, France
- Groupe Hospitalier de La Rochelle-Ré-Aunis
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Le Chesnay, France
- CH de Versailles
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Le Kremlin-Bicêtre, France
- Hôpital Bicêtre APHP
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Le Mans, France
- CH Le Mans
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Lorient, France
- Centre Hospitalier Bretagne Sud
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Lyon, France
- CHU Lyon
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Marseille, France
- CISIH
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Montluçon, France
- CH Montluçon
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Morlaix, France
- CH Morlaix
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Moulins, France
- CH Moulins-Yzeure
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Mulhouse, France
- CHU de Mulhouse
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Nantes, France
- CHU Nantes
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Nice, France
- CHU Nice
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Niort, France
- CH Niort
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Orléans, France
- CH Orléans
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Paris, France
- Hopitel Necker
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Perpignan, France
- CH Perpignan
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Poissy, France
- Chu Poissy
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Poitiers, France
- CHU Poitiers
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Quimper, France
- Centre Hospitalier Intercommunal de Cornouaille
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Quimper, France
- Pole Santé Publique - CH Laennec
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Reims, France
- CHU Reims
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Saint-Étienne, France
- CHU Nord
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Strasbourg, France
- CHU Strasbourg
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Tenon, France
- Hopital Tenon
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Toulon, France
- Chu Toulon
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Valenciennes, France
- Ch Valenciennes
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Vannes, France
- CHBA Vannes
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Vichy, France
- CH Vichy
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Villefranche-sur-Saône, France
- Hopital Nord Ouest Villefranche sur Saone
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Pointe-à-Pitre, Guadeloupe
- CHU Pointe-à-Pitre
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Saint-Denis, Réunion
- CHU Felix Guyon
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
people living with HIV
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-stigma as experienced by PLHIV will be explored through a custom questionnaire intended for the patient
Time Frame: 1 day during the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
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Percentage of patient with self-stigma
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1 day during the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The main explanatory variables will be studied by means of a custom questionnaire intended for the patient
Time Frame: 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
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1 day during the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
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Self-stigma of patients perceived by their caregivers
Time Frame: 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
|
1 day during the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Christine JACOMET, Dr, University Hospital, Clermont-Ferrand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2022
Primary Completion (Actual)
April 14, 2022
Study Completion (Actual)
April 14, 2022
Study Registration Dates
First Submitted
November 29, 2021
First Submitted That Met QC Criteria
December 7, 2021
First Posted (Actual)
December 8, 2021
Study Record Updates
Last Update Posted (Actual)
May 1, 2023
Last Update Submitted That Met QC Criteria
April 28, 2023
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNI 2021 JACOMET 2
- 2021-A01588-33 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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