HIV InfectionsASPEGICNCT04846595
Aspects of Vulnerability of People Living with HIV in the Alpine Arc Region
A study testing self questionnaire in people with HIV Infections, run by Centre Hospitalier Annecy Genevois at 1 site in France.
Trial summary
HIV infection in France has become a chronic disease and treatment has allowed patients to increase their life expectancy. However, these promising results suffer from a very large variability within the socio-epidemiological subgroups, and life expectancy at 20 years of age is still one third lower than in the… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- self questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 595 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2021to 17 Oct 2022
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any person living with HIV presenting for consultation with their infectious disease referrer.
- Patient followed for at least 6 months for their HIV infection
- Patient with undetectable or detectable HIV viral load
- Patient of legal age at the time of the study
- Patient informed of the study and having expressed no objection to the collection of health data
Who cannot join
- Patient opposed or unable to express opposition to participation in the study
- Patient is a minor at the time of the study
- Patient taking antiretroviral therapy for less than 6 months
Trial locations and contacts
1 site in 1 country.
About this study
HIV infection in France has become a chronic disease and treatment has allowed patients to increase their life expectancy. However, these promising results suffer from a very large variability within the socio-epidemiological subgroups, and life expectancy at 20 years of age is still one third lower than in the general population. Few studies of metropolitan cohorts investigated precariousness as an independent risk factor for mortality. The investigators chose to consider the vulnerability of people living with HIV (PLWHA) through the measurement of a validated French quantitative score, called EPICES ("Évaluation de la précarité et des inégalités de santé dans les centres d'examens de santé ", Evaluation of precariousness and health inequalities in health examination centers).
Read the detailed description
HIV infection in France has become a chronic disease and treatment has allowed patients to increase their life expectancy. However, these promising results suffer from a very large variability within the socio-epidemiological subgroups, and life expectancy at 20 years of age is still one third lower than in the general population. Few studies of metropolitan cohorts investigated precariousness as an independent risk factor for mortality. The investigators chose to consider the vulnerability of people living with HIV (PLWHA) through the measurement of a validated French quantitative score, called EPICES (Evaluation of precariousness and health inequalities in health examination centers). Using a self-administered questionnaire administered during an annual follow-up visit to an infectious disease specialist, the investigators seek to define in the alpine arc region in france, socio-demographic data associated with greater precariousness among PLWHA.
- Conditions
- HIV Infections
- Being tested
- self questionnaire
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self questionnaireOther
Evaluate the demographic variables and medical characteristics of people living with HIV in the Alpine Arc region
| Study group | Role | What they receive |
|---|---|---|
| Self questionnaire | Other | The study will be offered to all patients who have been treated for HIV infection for at least 6 months, during a follow-up consultation. A self questionnaire will be administered only once per patient during the usual consultation, there is no follow-up planned. Receives: Other: self questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variables of vulnerability
Evaluation of the variables associated with a state of vulnerability according to the "EPICES" scale (at a threshold of 30.17/100), among the social, demographic and medical characteristics of people living with HIV in the Alpine Arc region characteristics of people living with HIV in the Alpine Arc region
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start16 Feb 2021
- Primary completion17 Oct 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846595
- Sponsor's protocol ID
- 20-16
- Acronym
- ASPEGIC
- Status last verified
- Feb 2025
- First submitted
- 7 Apr 2021
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspects of Vulnerability of People Living with HIV in the Alpine Arc Region
- ClinicalTrials.gov ID
- NCT04846595
- Acronym / sponsor ID
- ASPEGIC / 20-16
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 595 participants (actual)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 15 Apr 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.
HIV infection in France has become a chronic disease and treatment has allowed patients to increase their life expectancy. However, these promising results suffer from a very large variability within the socio-epidemiological subgroups, and life expectancy at 20 years of age is still one third lower than in the general population. Few studies of metropolitan cohorts investigated precariousness as an independent risk factor for mortality. The investigators chose to consider the vulnerability of people living with HIV (PLWHA) through the measurement of a validated French quantitative score, called EPICES ("Évaluation de la précarité et des inégalités de santé dans les centres d'examens de santé ", Evaluation of precariousness and health inequalities in health examination centers).
Detailed description
HIV infection in France has become a chronic disease and treatment has allowed patients to increase their life expectancy. However, these promising results suffer from a very large variability within the socio-epidemiological subgroups, and life expectancy at 20 years of age is still one third lower than in the general population. Few studies of metropolitan cohorts investigated precariousness as an independent risk factor for mortality. The investigators chose to consider the vulnerability of people living with HIV (PLWHA) through the measurement of a validated French quantitative score, called EPICES (Evaluation of precariousness and health inequalities in health examination centers). Using a self-administered questionnaire administered during an annual follow-up visit to an infectious disease specialist, the investigators seek to define in the alpine arc region in france, socio-demographic data associated with greater precariousness among PLWHA.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self questionnaire | Other | Other: self questionnaireThe study will be offered to all patients who have been treated for HIV infection for at least 6 months, during a follow-up consultation. A self questionnaire will be administered only once per patient during the usual consultation, there is no follow-up planned. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any person living with HIV presenting for consultation with their infectious disease referrer.
- Patient followed for at least 6 months for their HIV infection
- Patient with undetectable or detectable HIV viral load
- Patient of legal age at the time of the study
- Patient informed of the study and having expressed no objection to the collection of health data
Key exclusion criteria (3 listed)
- Patient opposed or unable to express opposition to participation in the study
- Patient is a minor at the time of the study
- Patient taking antiretroviral therapy for less than 6 months
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 |
|---|---|---|
| self questionnaireEvaluate the demographic variables and medical characteristics of people living with HIV in the Alpine Arc region | Other | Self questionnaire |
Primary outcome
Variables of vulnerability
Time frame: one day
Evaluation of the variables associated with a state of vulnerability according to the "EPICES" scale (at a threshold of 30.17/100), among the social, demographic and medical characteristics of people living with HIV in the Alpine Arc region characteristics of people living with HIV in the Alpine Arc region
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 13 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self questionnaire in people with HIV Infections, run by Centre Hospitalier Annecy Genevois 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 5 inclusion and 3 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 13 Feb 2025. 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?
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?
Variables of vulnerability (time frame: one day). 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 13 Feb 2025.