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

NCT05280392 | Terminated

• 1 other identifier: ANRS 95052
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Seropositivity

Keywords

HIV cure-related clinical trials; Participants' expectations and experiences

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

People living with HIV

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

Other: Self-administered questionnaires; Other: Semi-directive individual interviews

Interventions

Self-administered questionnaires 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)

People living with HIV

Semi-directive individual interviews OTHER

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

People living with HIV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (1)

CHUV

Lausanne, Switzerland

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Christel Protiere, Dr

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 15, 2022
• Study Start: June 21, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

CH (1)