HIV-positiveVIAGENCT05135689
Medico-social Description of Seniors Living With HIV, Associated With a Qualitative Survey on Their Care in the Paris Region Structures
An observational study of HIV-positive, run by Gérond'if at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-positive
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2021to Oct 2024
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-positive patients in Paris region medico-social sector, their informal caregivers and health professionals in the medico-social sector.
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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,
- Patient with a legal protection measure (guardianship and others), and at least 1 of the inclusion criteria for patients is not met.
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Geriatric Department, Broca hospital
Paris, IIe-de-France, 75013
Olivier Hanon, MD PhD, D +33(0)144083503, olivier.hanon@aphp.fr
About this study
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
Read the 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
- Keywords
- HIV-positive, Serophobia
- Medical subject headings
- HIV Seropositivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Secondary outcomes (10)
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
This is a measurement of the subject's ability to perform activities of daily living independently. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. A high score (6) indicates full function (patient independent). 2 or less score, indicates severe functional impairment.(patient very dependent)
Measured: 2 years
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
The measure is calculated by summing the point values for each question. The maximum score of 8 indicates that all activities can be performed independently. A minimum score of 0 indicates that the measured activites of daily living can only be performed partially or not at all.
Measured: 2 years
Assessment of depression according MINI Geriatric depression scale (Mini-GDS)
If the score is greater than or equal to 1: high probability of depression. If the score is 0: high probability of no depression.
Measured: 2 years
Screening for undernutrition using Mini Nutritional Assessment (MNA)
Measured: 2 years
Assessment of quality of life according WHOQOL-HIV-BREF SCORE
Measured: 2 years
Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score
The maximum score for the MMSE is 30. A score of 25 or higher is classed as normal. If the score is below 25, the result is usually considered to be abnormal (indicating possible cognitive impairment).
Measured: 2 years
Assessment of somatic-comorbidities according Charlson scale
Measured: 2 years
Assessment of the degree of autonomy according AGGIR score
Measured: 2 years
Assessment of level of fargility according FREAD scale
5 is the best value, 0 is the worst value
Measured: 2 years
Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start22 Sep 2021
- Primary completionNov 2023 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-positiveStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Hanon, MD PhD, Study chair, Geriatric Department, Broca hospital,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135689
- Sponsor's protocol ID
- 2021-A01097-34
- Acronym
- VIAGE
- Status last verified
- Jan 2023
- First submitted
- 15 Nov 2021
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-social Description of Seniors Living With HIV, Associated With a Qualitative Survey on Their Care in the Paris Region Structures
- ClinicalTrials.gov ID
- NCT05135689
- Acronym / sponsor ID
- VIAGE / 2021-A01097-34
- Conditions
- HIV-positive
- Keywords
- HIV-positive, Serophobia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 26 Nov 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 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-positive patients in Paris region medico-social sector, their informal caregivers and health professionals in the medico-social sector.
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (13 listed)
- 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,
- Patient with a legal protection measure (guardianship and others), and at least 1 of the inclusion criteria for patients is not met.
- 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,
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
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.
Time frame: 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.
Time frame: 2 years
10 secondary outcomes
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Time frame: 2 years
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time frame: 2 years
Assessment of depression according MINI Geriatric depression scale (Mini-GDS)
Time frame: 2 years
Screening for undernutrition using Mini Nutritional Assessment (MNA)
Time frame: 2 years
Assessment of quality of life according WHOQOL-HIV-BREF SCORE
Time frame: 2 years
Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score
Time frame: 2 years
Assessment of somatic-comorbidities according Charlson scale
Time frame: 2 years
Assessment of the degree of autonomy according AGGIR score
Time frame: 2 years
Assessment of level of fargility according FREAD scale
Time frame: 2 years
Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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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.
Olivier Hanon, MD PhD study chair
Geriatric Department, Broca hospital,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-positive, run by Gérond'if at 1 site in France.
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 17 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Dufour (+33 (0)185781010, isabelle.dufour@gerondif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2023.