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

HIV Seropositivity Clinical Trial

— AMEP-EHVA T02  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05280392
• Other study ID #: ANRS 95052
• Status: Terminated
• Start date: June 21, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: May 2023
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 antiretroviral treatment interruption (EHVA T02/ANRS VRI07).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• people living with HIV

• who were offered to participate in EHVA T02 clinical trial

Related Conditions & MeSH terms

• HIV Seropositivity

Intervention

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)
• Semi-directive individual interviews
With EHVA T02 participants (n=10 to 15): at the end of the follow-up period of the clinical trial.
• 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

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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