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

NCT05135689 | Unknown

• 1 other identifier: 2021-A01097-34
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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

Conditions

HIV-positive

Keywords

HIV-positive; Serophobia

Outcome Measures

Primary Outcomes (2)

• The number of past situations for the last 5 years before the implementation of the study - of elderly people living with HIV in Retirement Home (EHPAD), home nursing care departments (SSIAD) and extended care units (USLD) in Île-de-France.

  2 years

• The number of current situations for the last 5 years before the implementation of the study - of elderly people living with HIV in Retirement Home (EHPAD), home nursing care departments (SSIAD) and extended care units (USLD) in Île-de-France.

  2 years

Secondary Outcomes (10)

• Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale

  2 years

• Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale

  2 years

• Assessment of depression according MINI Geriatric depression scale (Mini-GDS)

  2 years

• Screening for undernutrition using Mini Nutritional Assessment (MNA)

  2 years

• Assessment of quality of life according WHOQOL-HIV-BREF SCORE

  2 years

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-positive patients in Paris region medico-social sector, their informal caregivers and health professionals in the medico-social sector.

You may qualify if:

• 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 :

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Gérond'if: lead

Study Sites (1)

Geriatric Department, Broca hospital

Paris, IIe-de-France, 75013, France

RECRUITING

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Olivier Hanon, MD PhD

  Geriatric Department, Broca hospital,

  STUDY CHAIR

Central Study Contacts

Isabelle Dufour

CONTACT

+33 (0)185781010; isabelle.dufour@gerondif.org

Adrien Besseivhe

CONTACT

+33 (0)185781010; adrien.besseiche@gerondif.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 26, 2021
• Study Start: September 22, 2021
• Primary Completion: November 1, 2023
• Study Completion: October 1, 2024
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

FR (1)