HIV InfectionsRESILSTIGMANCT05149001
Study Among People Living With HIV and Their Health Professionals of Associated Factors of Resilience to Self-stigma
An observational study of HIV Infections, run by University Hospital, Clermont-Ferrand at 43 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 667 participants
- Where
- 43 sitesin 3 countries
- Study dates
- 17 Jan 2022to 14 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people living with HIV
Who may be able to join
- 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 ...).
Who cannot join
- Minor patient
- Refusal of participation
- Persons under guardianship, guardianship or legal protection
Trial locations and contacts
43 sites in 3 countries.
43 sites in 3 countries
France41 sites
Centre Hospitalier du Pays d'Aix
Aix-en-Provence
Chu Angers
Angers
CH Annecy Genevois
Annecy
Chru Besancon
Besançon
CHRU Brest
Brest
CH Cholet
Cholet
Hopital Antoine Beclere
Clamart
Clermont-Ferrand University Hospital
Clermont-Ferrand
Chu Dijon
Dijon
Hopital Raymond Poincaré
Garches
CHD Vendrée
La Roche-sur-Yon
Groupe Hospitalier de La rochelle-Ré-Aunis
La Rochelle
CH de Versailles
Le Chesnay
Hopital Bicetre Aphp
Le Kremlin-Bicêtre
Ch Le Mans
Le Mans
Centre Hospitalier Bretagne Sud
Lorient
CHU LYON
Lyon
CISIH
Marseille
Ch Montlucon
Montluçon
CH Morlaix
Morlaix
CH Moulins-Yzeure
Moulins
CHU de Mulhouse
Mulhouse
Chu Nantes
Nantes
CHU NICE
Nice
CH NIORT
Niort
CH Orléans
Orléans
Hopitel Necker
Paris
CH Perpignan
Perpignan
Chu Poissy
Poissy
CHU Poitiers
Poitiers
Centre Hospitalier Intercommunal de Cornouaille
Quimper
Pole Santé Publique - CH Laennec
Quimper
Chu Reims
Reims
CHU Nord
Saint-Etienne
CHU Strasbourg
Strasbourg
Hopital Tenon
Thenon
Chu Toulon
Toulon
Ch Valenciennes
Valenciennes
CHBA Vannes
Vannes
CH VICHY
Vichy
Hôpital Nord Ouest villefranche sur Saone
Villefranche-sur-Saône
About this study
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
Read the 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.
- Conditions
- HIV Infections
- Keywords
- HIV, Stigmatization, Self-stigma
- Medical subject headings
- HIV Infections, Stereotyping
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-stigma as experienced by PLHIV will be explored through a custom questionnaire intended for the patient
Percentage of patient with self-stigma
Measured: 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
multivariate analysis of factors associated with disparition of self-stigma
Measured: 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
Percentage of caregivers who perceive self-stigma and how they propose to their patients the way to surpass themselves
Measured: 1 day during the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start17 Jan 2022
- Primary completion14 Apr 2022
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- 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, Centre Hospitalier Departemental Vendee, 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, Perpignan Hospital Center, 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
- Responsible party
- Sponsor
- Investigators
- Christine JACOMET, Dr, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149001
- Sponsor's protocol ID
- RNI 2021 JACOMET 2
- Other IDs
- 2021-A01588-33
- Acronym
- RESILSTIGMA
- Status last verified
- Aug 2026
- First submitted
- 29 Nov 2021
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacomet C, Miele C, Goncalves E, Lambert C, Belletier C, Linard F, Phalip-Le Besnerais J, Dellamonica P, Dambrun M. RESILSTIGMA. Resilience to self-stigmatization experienced by people living with HIV: Which self-reported factors improve awareness among health workers? PLoS One. 2025 Feb 6;20(2):e0311776. doi: 10.1371/journal.pone.0311776. eCollection 2025.
PubMed 39913414
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Among People Living With HIV and Their Health Professionals of Associated Factors of Resilience to Self-stigma
- ClinicalTrials.gov ID
- NCT05149001
- Acronym / sponsor ID
- RESILSTIGMA / RNI 2021 JACOMET 2
- Conditions
- HIV Infections
- Keywords
- HIV, Stigmatization, Self-stigma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- 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, Centre Hospitalier Departemental Vendee, 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, Perpignan Hospital Center, 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
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 14 Apr 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people living with HIV
Key inclusion criteria (2 listed)
- 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 ...).
Key exclusion criteria (3 listed)
- Minor patient
- Refusal of participation
- Persons under guardianship, guardianship or legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Percentage of patient with self-stigma
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 39913414Jacomet C, Miele C, Goncalves E, Lambert C, Belletier C, Linard F, Phalip-Le Besnerais J, Dellamonica P, Dambrun M. RESILSTIGMA. Resilience to self-stigmatization experienced by people living with HIV: Which self-reported factors improve awareness among health workers? PLoS One. 2025 Feb 6;20(2):e0311776. doi: 10.1371/journal.pone.0311776. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine JACOMET, Dr principal investigator
University Hospital, Clermont-Ferrand
43 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University Hospital, Clermont-Ferrand at 43 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in France, Guadeloupe, Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05149001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.