Not provided
Not provided
Not provided
Not provided
Not provided
EHVA T02/ANRS VRI07 clinical trial had been discontinued. Find relevant information on the EHVA website: https://ehv-a.eu/trials/ehva-t02
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People living with HIV | PLWH who were offered to participate in the EHVA T02/ANRS VRI07 clinical trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-administered questionnaires | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | through study completion, an average of 1 year |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christel Protiere, Dr | Institut National de la Santé Et de la Recherche Médicale, UMR1252 SESSTIM, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUV | Lausanne | Switzerland |
Not provided
Not provided
Not provided
Not provided
|
| Semi-directive individual interviews | Other | With EHVA T02 participants (n=10 to 15): at the end of the follow-up period of the clinical trial. |
|
| Semi-directive individual interviews | Other | 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 |
|
| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided