HIV SeropositivityAMEP-EHVA T02NCT05280392
Expectation, Motivation and Experience of HIV-patients Regarding Participation to an HIV Cure-related Clinical Trial
An observational study of HIV Seropositivity, run by ANRS, Emerging Infectious Diseases at 1 site in Switzerland.
Trial summary
Following the ANRS-APSEC survey, AMEP-EHVA T02 is a longitudinal social science study that will explore the experience of people living with HIV (PLWH) who were offered to participate in the European randomized phase II placebo-controlled trial of vedolizumab with or without therapeutic HIV MVA vaccine including… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Seropositivity
- What is being tested?
- Self-administered questionnaires and Semi-directive individual interviews
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Jun 2022to 30 Mar 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The quantitative survey will be proposed to all the PLWH included in the EHVA T02/ANRS VRI07 trial (except in germany where the center estimates to include less than 5 participants)(n = 69 max), the inclusion criteria being those defined by the clinical protocol. Participants to the qualitative survey will be recruted in the three EHVA T02/ANRS VRI07 French centers.
Who may be able to join
- people living with HIV
- who were offered to participate in EHVA T02 clinical trial
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expectation, Motivation and Experience of HIV-patients Regarding Participation to the EHVA T02/ANRS VRI 07 HIV Cure-related Clinical Trial (AMEP-EHVA T02)
Following the ANRS-APSEC survey, AMEP-EHVA T02 is a longitudinal social science study that will explore the experience of people living with HIV (PLWH) who were offered to participate in the European randomized phase II placebo-controlled trial of vedolizumab with or without therapeutic HIV MVA vaccine including antiretroviral treatment interruption (EHVA T02/ANRS VRI07).
Read the detailed description
Moving towards the discovery of an HIV cure is of major public health interest, not only for people living with HIV (PLWH) who currently must take lifelong antiretroviral treatment (ART), with its associated side effects and comorbidities, but also for the community as a whole. An HIV cure will end the virus transmission, lead to global care-related savings and decrease in HIV-related stigma.
The present longitudinal social science study concerns the experience of PLWH who were offered to participate in the European randomized phase II placebo-controlled trial of vedolizumab with or without therapeutic HIV MVA vaccine including ART treatment interruption (EHVA T02/ANRS VRI07).
The objectives are to document:
- the evolution over time of expectations and motivations related to participation in the trial,
- anticipation and understanding of risks and benefits related to participation,
- evolution over time of participation experience and of satisfaction with the information delivered,
- experience and perception of the ATI period and its impact on preventive behaviours and sexual quality of life,
- motivations and experience related to refusal of participation, or if any, related to non-inclusion because of negative screening results.
This international multicentre longitudinal study will be nested within the EHVA T02/ANRS VRI07 trial, and will comprise two components. A quantitative component designed to answer to the four first objectives, and a qualitative one that will retrospectively deepen the trial participation experience and will also document the motivation for participation refusal and the experience of participants not included because of negative screening results (objective 5). The quantitative survey will be conducted within participating centres that estimate to include at least 5 participants, and the qualitative one only in France for feasibility purpose.
- Conditions
- HIV Seropositivity
- Being tested
- Self-administered questionnaires, Semi-directive individual interviews
- Keywords
- HIV cure-related clinical trials, Participants' expectations and experiences
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered questionnairesOther
4 self-questionnaires given to EHVA T02 participants: at inclusion (Q1, week 0), at the beginning of the ATI period (Q2, week 18), at the end of the ATI period (Q3, date depending on the participant) and at the end of the follow-up period of the clinical trial (Q4, week 54 at the latest)
Semi-directive individual interviewsOther
With EHVA T02 participants (n=10 to 15): at the end of the follow-up period of the clinical trial.
Semi-directive individual interviewsOther
With patients who refused to participate to EHVA T02 or patients not included because of negative screening results (n=10 to 15): within 21 days after the refusal or the results of the screening
| Study group | Role | What they receive |
|---|---|---|
| People living with HIV | PLWH who were offered to participate in the EHVA T02/ANRS VRI07 clinical trial Receives: Other: Self-administered questionnaires; Other: Semi-directive individual interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients satisfied with their participation and the associated factors
Through statistical analyses of some self-administered questionnaires items we will highlight the participants' satisfaction and experience of the participation.
Measured: through study completion, an average of 1 year
Impact of the participation in the trial on participant quality of life and quality of sexual life
Through statistical analyses of some self-administered questionnaires items (in particular the SF12.v2 scale for quality of life) and thematic analyses of semi-directive individual interviews we will highlight the impact of the participation in the trial.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start21 Jun 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Why it stopped: EHVA T02/ANRS VRI07 clinical trial had been discontinued. Find relevant information on the EHVA website: https://ehv-a.eu/trials/ehva-t02
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Christel Protiere, Dr, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, UMR1252 SESSTIM, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280392
- Sponsor's protocol ID
- ANRS 95052
- Acronym
- AMEP-EHVA T02
- Status last verified
- May 2023
- First submitted
- 11 Feb 2022
- Last updated
- 15 May 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 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expectation, Motivation and Experience of HIV-patients Regarding Participation to the EHVA T02/ANRS VRI 07 HIV Cure-related Clinical Trial (AMEP-EHVA T02)
- ClinicalTrials.gov ID
- NCT05280392
- Acronym / sponsor ID
- AMEP-EHVA T02 / ANRS 95052
- Conditions
- HIV Seropositivity
- Keywords
- HIV cure-related clinical trials, Participants' expectations and experiences
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: EHVA T02/ANRS VRI07 clinical trial had been discontinued. Find relevant information on the EHVA website: https://ehv-a.eu/trials/ehva-t02
- Enrolment
- 6 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 15 Mar 2022 (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.
Following the ANRS-APSEC survey, AMEP-EHVA T02 is a longitudinal social science study that will explore the experience of people living with HIV (PLWH) who were offered to participate in the European randomized phase II placebo-controlled trial of vedolizumab with or without therapeutic HIV MVA vaccine including antiretroviral treatment interruption (EHVA T02/ANRS VRI07).
Detailed description
Moving towards the discovery of an HIV cure is of major public health interest, not only for people living with HIV (PLWH) who currently must take lifelong antiretroviral treatment (ART), with its associated side effects and comorbidities, but also for the community as a whole. An HIV cure will end the virus transmission, lead to global care-related savings and decrease in HIV-related stigma.
The present longitudinal social science study concerns the experience of PLWH who were offered to participate in the European randomized phase II placebo-controlled trial of vedolizumab with or without therapeutic HIV MVA vaccine including ART treatment interruption (EHVA T02/ANRS VRI07).
The objectives are to document:
- the evolution over time of expectations and motivations related to participation in the trial,
- anticipation and understanding of risks and benefits related to participation,
- evolution over time of participation experience and of satisfaction with the information delivered,
- experience and perception of the ATI period and its impact on preventive behaviours and sexual quality of life,
- motivations and experience related to refusal of participation, or if any, related to non-inclusion because of negative screening results.
This international multicentre longitudinal study will be nested within the EHVA T02/ANRS VRI07 trial, and will comprise two components. A quantitative component designed to answer to the four first objectives, and a qualitative one that will retrospectively deepen the trial participation experience and will also document the motivation for participation refusal and the experience of participants not included because of negative screening results (objective 5). The quantitative survey will be conducted within participating centres that estimate to include at least 5 participants, and the qualitative one only in France for feasibility purpose.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People living with HIV | – | Other: Self-administered questionnaires, Other: Semi-directive individual interviewsPLWH who were offered to participate in the EHVA T02/ANRS VRI07 clinical trial |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The quantitative survey will be proposed to all the PLWH included in the EHVA T02/ANRS VRI07 trial (except in germany where the center estimates to include less than 5 participants)(n = 69 max), the inclusion criteria being those defined by the clinical protocol. Participants to the qualitative survey will be recruted in the three EHVA T02/ANRS VRI07 French centers.
Key inclusion criteria (2 listed)
- people living with HIV
- who were offered to participate in EHVA T02 clinical trial
Key exclusion criteria (0 listed)
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-administered questionnaires4 self-questionnaires given to EHVA T02 participants: at inclusion (Q1, week 0), at the beginning of the ATI period (Q2, week 18), at the end of the ATI period (Q3, date depending on the participant) and at the end of the follow-up period of the clinical trial (Q4, week 54 at the latest) | Other | People living with HIV |
| Semi-directive individual interviewsWith EHVA T02 participants (n=10 to 15): at the end of the follow-up period of the clinical trial. | Other | People living with HIV |
| Semi-directive individual interviewsWith patients who refused to participate to EHVA T02 or patients not included because of negative screening results (n=10 to 15): within 21 days after the refusal or the results of the screening | Other | People living with HIV |
Primary outcome
Proportion of patients satisfied with their participation and the associated factors
Time frame: through study completion, an average of 1 year
Through statistical analyses of some self-administered questionnaires items we will highlight the participants' satisfaction and experience of the participation.
Impact of the participation in the trial on participant quality of life and quality of sexual life
Time frame: through study completion, an average of 1 year
Through statistical analyses of some self-administered questionnaires items (in particular the SF12.v2 scale for quality of life) and thematic analyses of semi-directive individual interviews we will highlight the impact of the participation in the trial.
Results and safety
The study was stopped early (reason given: EHVA T02/ANRS VRI07 clinical trial had been discontinued. Find relevant information on the EHVA website: https://ehv-a.eu/trials/ehva-t02). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 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.
Christel Protiere, Dr principal investigator
Institut National de la Santé Et de la Recherche Médicale, UMR1252 SESSTIM, France
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 Seropositivity, run by ANRS, Emerging Infectious Diseases at 1 site in Switzerland.
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 0 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: stopped early, as of the sponsor's last update on 15 May 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 Switzerland. 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 was stopped early (reason given: EHVA T02/ANRS VRI07 clinical trial had been discontinued. Find relevant information on the EHVA website: https://ehv-a.eu/trials/ehva-t02). Results are not available in the source record.
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?
Proportion of patients satisfied with their participation and the associated factors (time frame: through study completion, an average of 1 year). 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 15 May 2023.