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

NCT ID: NCT05280392

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-21
• Study Completion Date: 2023-03-30

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.

Conditions

HIV Seropositivity

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

People living with HIV

PLWH who were offered to participate in the EHVA T02/ANRS VRI07 clinical trial

Self-administered questionnaires

Intervention Type: 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)

Semi-directive individual interviews

Intervention Type: 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

Intervention Type: 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

Interventions

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)

Intervention Type: 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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christel Protiere, Dr

Role: PRINCIPAL_INVESTIGATOR

Institut National de la Santé Et de la Recherche Médicale, UMR1252 SESSTIM, France

Locations

CHUV

Lausanne, , Switzerland

Countries

Switzerland

Other Identifiers

ANRS 95052

Identifier Type: -

Identifier Source: org_study_id