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

Terminated

• Conditions: HIV Seropositivity
• Interventions: Other: Self-administered questionnaires; Other: Semi-directive individual interviews

• Registration Number: NCT05280392
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief 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.

Study Timeline

• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-15
• Study Start: 2022-06-21
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• people living with HIV
• who were offered to participate in EHVA T02 clinical trial

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
People living with HIV	Semi-directive individual interviews	PLWH who were offered to participate in the EHVA T02/ANRS VRI07 clinical trial
People living with HIV	Self-administered questionnaires	PLWH who were offered to participate in the EHVA T02/ANRS VRI07 clinical trial

Primary Outcome Measures

Name	Time	Method
Impact of the participation in the trial on participant quality of life and quality of sexual life	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.
Proportion of patients satisfied with their participation and the associated factors	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.

Trial Locations

Locations (1)

CHUV; 🇨🇭 Lausanne, Switzerland