NCT05280392

Expectation, Motivation and Experience of HIV-patients Regarding Participation to an HIV Cure-related Clinical Trial

Expectation, Motivation and Experience of HIV-patients Regarding Participation to the EHVA T02/ANRS VRI 07 HIV Cure-related Clinical Trial (AMEP-EHVA T02)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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: 1. the evolution over time of expectations and motivations related to participation in the trial, 2. anticipation and understanding of risks and benefits related to participation, 3. evolution over time of participation experience and of satisfaction with the information delivered, 4. experience and perception of the ATI period and its impact on preventive behaviours and sexual quality of life, 5. 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

Interventions

Type	Name	Description
OTHER	Self-administered questionnaires	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)
OTHER	Semi-directive individual interviews	With EHVA T02 participants (n=10 to 15): at the end of the follow-up period of the clinical trial.
OTHER	Semi-directive individual interviews	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

Timeline

• Start date: 2022-06-21
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2022-03-15
• Last updated: 2023-05-15

Locations

1 site across 1 country: Switzerland