AMEP-EHVA T02: Expectation, Motivation and Experience of HIV-patients Regarding Participation to an HIV Cure-related Clinical Trial

Sponsor
ANRS, Emerging Infectious Diseases (Other)
Overall Status
Recruiting
CT.gov ID
NCT05280392
Collaborator
(none)
69
1
32.3
2.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Self-administered questionnaires
  • Other: Semi-directive individual interviews
  • Other: Semi-directive individual interviews

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 Design

Study Type:
Observational
Anticipated Enrollment :
69 participants
Observational Model:
Other
Time Perspective:
Prospective
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)
Actual Study Start Date :
Jun 21, 2022
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
People living with HIV

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

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • people living with HIV

  • who were offered to participate in EHVA T02 clinical trial

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHUV Lausanne Switzerland

Sponsors and Collaborators

  • ANRS, Emerging Infectious Diseases

Investigators

  • Principal Investigator: Christel Protiere, Dr, Institut National de la Santé Et de la Recherche Médicale, UMR1252 SESSTIM, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier:
NCT05280392
Other Study ID Numbers:
  • ANRS 95052
First Posted:
Mar 15, 2022
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ANRS, Emerging Infectious Diseases
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 25, 2022