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

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ClinicalTrials.gov Identifier: NCT05280392
Recruitment Status : Terminated (EHVA T02/ANRS VRI07 clinical trial had been discontinued. Find relevant information on the EHVA website: https://ehv-a.eu/trials/ehva-t02)
First Posted : March 15, 2022
Last Update Posted : May 15, 2023
Sponsor:
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Study Description
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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
HIV Seropositivity Other: Self-administered questionnaires 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
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Study Type : Observational
Actual Enrollment : 6 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 : June 21, 2022
Actual Primary Completion Date : March 30, 2023
Actual Study Completion Date : March 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Proportion of patients satisfied with their participation and the associated factors [ Time Frame: 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 [ Time Frame: 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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • people living with HIV
  • who were offered to participate in EHVA T02 clinical trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05280392


Locations
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Switzerland
CHUV
Lausanne, Switzerland
Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
Investigators
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Principal Investigator: Christel Protiere, Dr Institut National de la Santé Et de la Recherche Médicale, UMR1252 SESSTIM, France
More Information
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Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT05280392    
Other Study ID Numbers: ANRS 95052
First Posted: March 15, 2022    Key Record Dates
Last Update Posted: May 15, 2023
Last Verified: May 2023

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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:
HIV cure-related clinical trials
Participants' expectations and experiences
Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases