Virus-HIVPVVIHNCT05083273
Life Experience of People Aged 60 and Over Living with HIV
An observational study of Virus-HIV, run by Hôpital NOVO at 6 sites in France.
Trial summary
The purpose of this study is to Assess the impact of HIV on the life course of patients aged 60 and over. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virus-HIV
- What is being tested?
- Cohorte
- How many people
- 225 participants
- Where
- 6 sitesFrance
- Study dates
- 18 May 2021to 24 Jun 2021
- 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 aged 60 and over living with HIV
Who may be able to join
- People aged 60 and over living with HIV and view in consultation
- Patient participation agreement obtained
Who cannot join
- People living with HIV less than 60 years old
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hospital Beaujon, Clichy / Médecine Interne
Clichy, 92110
Université Paris Descartes - CERMES3
Paris, 75006
Hôpital Bichat Claude-Bernard - Service de Maladies Infectieuses et Tropicales
Paris, 75018
Hôpital Bichat Claude-Bernard -COREVIH Ile de France Nord
Paris, 75018
Centre Hospitalier René Dubos
Pontoise, 95300
Hospital Delafontaine, Saint-Denis / Maladie infectieuse
Saint-Denis, 93200
About this study
Official title: Life Experience of People Aged 60 and Over Living with HIV: Quantitative Sociological Study
The purpose of this study is to Assess the impact of HIV on the life course of patients aged 60 and over.
Read the 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.
- Conditions
- Virus-HIV
- Being tested
- Cohorte
- Keywords
- VIH, Living with HIV, 60 years old and over
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CohorteOther
Also called Questionnaire
Completion of a socio-demographic, professional, medical and personal questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start18 May 2021
- Primary completion24 Jun 2021
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virus-HIVStudies 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
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Blum, Dr, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083273
- Sponsor's protocol ID
- CHRD1321
- Acronym
- PVVIH
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Experience of People Aged 60 and Over Living with HIV: Quantitative Sociological Study
- ClinicalTrials.gov ID
- NCT05083273
- Acronym / sponsor ID
- PVVIH / CHRD1321
- Conditions
- Virus-HIV
- Keywords
- VIH, Living with HIV, 60 years old and over
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 19 Oct 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.
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.
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 aged 60 and over living with HIV
Key inclusion criteria (2 listed)
- People aged 60 and over living with HIV and view in consultation
- Patient participation agreement obtained
Key exclusion criteria (1 listed)
- People living with HIV less than 60 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CohorteAlso: QuestionnaireCompletion of a socio-demographic, professional, medical and personal questionnaire | Other | – |
Primary outcome
Determine the impact of HIV in the life cours of people aged 60 and over and the questioning of the future.
Time frame: Through study completion, an average of 6 month
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.
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 19 Sep 2024.
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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.
Laurent Blum, Dr principal investigator
Hôpital NOVO
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Virus-HIV, run by Hôpital NOVO at 6 sites 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 2 inclusion and 1 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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?
Determine the impact of HIV in the life cours of people aged 60 and over and the questioning of the future. (time frame: Through study completion, an average of 6 month). 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 19 Sep 2024.