Medico-social Description of Seniors Living With HIV, Associated With a Qualitative Survey on Their Care in the Paris Region Structures

NCT ID: NCT05135689

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-22
• Study Completion Date: 2024-10-31

Brief Summary

This study is part of a national vision to fight against serophobia and support society towards more ethical and benevolent practices vis-à-vis aging and specific populations.

The main objective of this study is to assess over the past five years the prevalence of people living with the Human Immunodeficiency Virus (HIV) aged 60 years and over and its evolution within the Paris Region medico-social structures

Detailed Description

The aim objective of this study is to identify patients living with the Human Immunodeficiency Virus (HIV) in medical and social strutures in Île-de-France, in order to question them, in particular about their life courses and how they are treated and supported now. This study also query family caregivers of seropositive seniors and profiessional caregivers.

This trial is designed in two parts:

• The one consists to quantify and describe patient's clinical and social profil: Age, sex, authonomy level, medical data related to HIV infoection, Chronic deseases, social and economic data will be collected at 5 and 3 years before inclusion, at inclusion, at 1 and 2 yeans after inclusion
• Then a second qualitative part which allow to query seropositive patients about their fagility and comorbidities, and to identify the impact of these on their life and social relation.

Conditions

HIV-positive

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

For patients:

• HIV-positive, regardless of strain or age of infection,
• Orally expressing his non-opposition to his participation in the study and documented in the medical file by investigator,
• Follow-up, placed and / or treated in one of the centers concerned by the scope of the study in Paris Region.
• Since informal caregivers can be included in the study by being linked to a previously included patient, the patient must agree to share the status with informal caregiver, or have previously shared their status with informal caregiver.
• Patients with legal protection may participate only if:
• They clearly agree that their legal representative should be consulted on participation in the study,
• They accept that this person is aware of their HIV status ,
• After having been consulted, this person (legally responsible) does not object to the participation of the person for whom he is responsible.

For informal caregiver:

• Person having a caring activity, before and during the study (such as the spouse, a child, a parent, neighbor, support person, etc.), for his close patient participating in the study,
• Authorized by the patient to be offered the study; the patient's agreement to approach the informal caregiver will have been sought beforehand in order to prevent the lack of medical confidentiality,
• Person expressing orally his non-opposition to his participation in the study and documented in the medical file of the patient to whom he is helping,
• Person capable of understanding the questionnaires and assessments of the study and able to answer them without the assistance of a third party.

For health professionals :

• Professional (health worker, nurse, coordinating physician, or other professions listed in the protocol), male or female, working in one of the study establishments recruited in Île-de-France (Nursing Home, Nurses home care services or Long-term care facilities), welcoming or having received people living with the Human Immunodeficiency Virus (HIV) ,
• Professional volunteer to participate in the study after having been informed with the information note intended for healthcare professionals.

For informal caregivers:

• Person not having a helping activity or exercising his role of helping for remuneration, or exercising his role of helping a loved one not included in the study,
• Person who exercises his role of helping in the context of a voluntary or associative activity,
• Person expressing orally his opposition to his participation in the study and documented in the medical file of the patient to whom he is helping,
• Person unable to understand the questionnaires and evaluations of the study and who is not able to answer them without the help of a third party,
• Person having the status of legal representative of the patient as part of a legal protection measure (guardianship and others).

For health professionals :

• Health professional working in the non-Francilians health or medico-social sector,
• Health professional opposing participation in the study.

Exclusion Criteria

For patients:

• Patient expressing his opposition to his participation in the study,
• Patient who - according to the investigator - is unable to understand the study or answer the study questionnaires,

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gérond'if

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier Hanon, MD PhD

Role: STUDY_CHAIR

Geriatric Department, Broca hospital,

Locations

Geriatric Department, Broca hospital

Paris, IIe-de-France, France

Site Status: RECRUITING

Countries

France

Central Contacts

Isabelle Dufour

Role: CONTACT

isabelle.dufour@gerondif.org

+33 (0)185781010

Adrien Besseivhe

Role: CONTACT

adrien.besseiche@gerondif.org

+33 (0)185781010

Facility Contacts

Olivier Hanon, MD PhD

Role: primary

olivier.hanon@aphp.fr

D +33(0)144083503

Other Identifiers

2021-A01097-34

Identifier Type: -

Identifier Source: org_study_id