Clinical trial NCT05280392: Expectation, Motivation and Experience of HIV-patients Regarding Participation to an HIV Cure-related Clinical Trial
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HIV Seropositivity
Keywords: HIV cure-related clinical trials
Participants' expectations and experiences
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2022-03-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Proportion of patients satisfied with their participation and the associated factors
timeFrame: through study completion, an average of 1 year
measure: Impact of the participation in the trial on participant quality of life and quality of sexual life
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, UMR1252 SESSTIM, France
name: Christel Protiere, Dr
role: PRINCIPAL_INVESTIGATOR
References: