Impact of Migration History and Social Conditions on the Immuno-virological Control of HIV in Migrants in France (PrimoAVIH)

July 2, 2026 updated by: University Hospital, Clermont-Ferrand

Migrants living with HIV - whether the infection was diagnosed in their country of origin or in France- frequently experience vulnerabilities related to their migration trajectories and often face socioeconomic and administrative instability upon arrival .

The primary outcome of this study is to compare the immunovirological efficacy of antiretroviral therapy among migrants living with HIV patients according to their social and administrative status.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • France
      • Clermont-Ferrand, France, France, 63000
        • Clermont-Ferrand University Hospital
        • Principal Investigator:
          • Aida ZAGHDOUDI, Medical Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adults patients living with HIV and receiving care at Clermont-Ferrand Univeristy Hospital between 2010 and 2022

Description

Inclusion Criteria:

  • Adults (≥18 years of age);
  • Migrant patients (i.e., individuals who entered France for the first time from another country) receiving care at Clermont-Ferrand University Hospital between January 1, 2010, and December 31, 2022, whose HIV infection was either known at the time of their arrival in France or diagnosed within 12 months after their arrival in France.

Non-inclusion Criteria:

  • Patients who declined to participate in the study;
  • Patients who do not speak French and for whom no interpretere was available
  • Adults subject to a legal protection measure (i.e., under guardianship, curatorship, or judicial protection)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV immuno-virological status
Time Frame: Submission to the Research Ethics Committee (REC): February 2026 REC approval: May 2026 Study initiation : July 2026 Recruitment period: 18 months Total study duration: 30 months Estimated study completed : january 2029
To compare the immuno-virological efficacy of antiretroviral therapy according to the social and administrative status of HIV-infected migrants
Submission to the Research Ethics Committee (REC): February 2026 REC approval: May 2026 Study initiation : July 2026 Recruitment period: 18 months Total study duration: 30 months Estimated study completed : january 2029

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Aida ZAGHDOUDI, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2026

Primary Completion (Estimated)

February 15, 2029

Study Completion (Estimated)

February 15, 2030

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI 2025 ZAGHDOUDI
  • ANSM (Other Identifier: 2017-A03433-50)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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