Life Experience of People Aged 60 and Over Living with HIV | NCT05083273

Studies
Life Experience of People Aged 60 and Over Living with HIV

NCT05083273

Sponsor

Hôpital NOVO

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

225Actual

Phase

Not provided

Conditions

Virus-HIV

Interventions

Cohorte

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 18, 2021Actual

Primary Completion Date

Jun 24, 2021Actual

Completion Date

Jun 24, 2021Actual

First Submitted Date

Jun 1, 2021

First Submission Date that Met QC Criteria

Oct 6, 2021

First Posted Date

Oct 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to Assess the impact of HIV on the life course of patients aged 60 and over.

Detailed Description

COREVIH IDF Nord and CERMES3 conducted a first qualitative survey of 32 HIV patients aged 60 and over. The study, in the form of an individual interview, aimed to identify the difficulties that PLWHIV may encounter in their life course, to question their future and the impact that HIV could have.

From this study, a questionnaire was drawn up covering the points raised by the qualitative study. The questionnaire was designed by doctors of the four hospitals that participated in the first study and a sociologist from CERMES3.

After patient's oral agreement obtained, the study questionnaire "Sociological study PVHIV ≥ 60 years" will be given to the patient for completion.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

225Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cohorte	Other	Completion of a socio-demographic, professional, medical and personal questionnaire		Questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine the impact of HIV in the life cours of people aged 60 and over and the questioning of the future.	People aged 60 and over will answer to a sociological questionnaire to identify the impact of HIV in their life cours and the questioning of the future, directly or indirectly linked to HIV.	Through study completion, an average of 6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria :

People aged 60 and over living with HIV and view in consultation

Patient participation agreement obtained

Exclusion criteria :

People living with HIV less than 60 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

People aged 60 and over living with HIV

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laurent Blum, Dr	Hôpital NOVO	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Beaujon, Clichy / Médecine Interne		Clichy		92110	France
Université Paris Descartes - CERMES3

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided