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

NCT05280392 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2023-05-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

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

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2023-03-30
Completion
2023-03-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05280392 on ClinicalTrials.gov