Trans&VIH: National Survey About Trajectory and Life Conditions of HIV Trans People in France

Sponsor
ANRS, Emerging Infectious Diseases (Other)
Overall Status
Recruiting
CT.gov ID
NCT04849767
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other)
850
1
35.9
23.6

Study Details

Study Description

Brief Summary

TRANS&VIH is a national survey that will explore condition of vulnerability and trajectory of transgender people living with HIV. To fulfill this purpose, clinical data from medical registry and socio-behavioral information collected through questionnaire, will help to explore this questions about vulnerability and condition of transgender people living with HIV.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

Detailed Description

In France, transgender still a taboo subject, and is poorly documented. There are no precise data on the number of transgender people in France or on their socio-demographic characteristics. The absence of such data reinforces their invisibility in social life and contributes to their stigmatization. Transgender people faces many social barriers in our society. These barriers accumulate in HIV seropositive transgender people (TRHIV), and most likely increase the burden of HIV infection. The main objective of ANRS TRANS&VIH - the community-based research study presented here - is to identify personal and social situations of vulnerability for TRHIV in France, the obstacles for receiving medical care, and their healthcare needs.

ANRS TRANS&VIH is an ongoing national, exhaustive, cross-sectional survey of all TRHIV currently followed up in HIV services in France. It is a mixed-methods study, the quantitative and qualitative components includ TRHIV women and men, respectively. Socio-behavioral and medical data are collected (start date January 2021) by community-based interviewers in participating hospital-based HIV structures in order to explore patient care pathways and living conditions of the TRHIV population with regard to transitioning and HIV. This is the first study in France to collect such data. The statistical techniques used for the data analyses will reflect the study's objectives and will be adapted to the type of data collection used: cross-sectional (questionnaires) and longitudinal (life history). Several types of analyses will be performed, including: (i) a description of the individual characteristics of transgender female TRHIV; (ii) comparative analyses between different groups of stakeholders (e.g., differences between the Ile de France region (which covers Paris and the surrounding area) and other regions); (iii) analysis of life and HIV trajectories; (iv) structural analyses using structural data collected for participating HIV structures (v) qualitative analysis of data from interviews with participating TRHIV men.

ANRS TRANS&VIH results will be used to make recommendations to health authorities to ensure that a comprehensive healthcare package will be offered to TRHIV which takes into account this population's specific background and problems.

Study Design

Study Type:
Observational
Anticipated Enrollment :
850 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Trans&VIH: National Survey About Trajectory and Life Conditions of HIV Trans People in France
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Transgender people living with HIV

Transgender person Living with HIV Followed in clinical service

Other: Questionnaire
Questionnaire about socio-behavioral items and conditions of vulnerability. interview with female to male transgender person will be about life conditions, trajectory of the medical transition from female to male and actual medical following of the transition, migration trajectory and condition of HIV acquisition.
Other Names:
  • interview
  • Outcome Measures

    Primary Outcome Measures

    1. Statistical analyses of trends in the personal and social situations of vulnerability in TRHIV [12 months]

      Through statistical analyses of some questionnaire items, we will highlight the situations of vulnerability of transgender people.

    2. Statistical analyses of trends in obstacles that TRHV encounter in terms of medical care and their healthcare needs [12 months]

      The results, of the analyses of questionnaire data, will point trends in the medical needs of the study population and the factors that hamper the satisfiction of these needs.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • transgender woman or transgender man

    • living with HIV

    • followed in hospitals in metropolitan France and the country's overseas territories

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 INSERM Marseille France 13005

    Sponsors and Collaborators

    • ANRS, Emerging Infectious Diseases
    • Institut National de la Santé Et de la Recherche Médicale, France

    Investigators

    • Principal Investigator: Bruno SPIRE, Dr, Institut National de la Santé Et de la Recherche Médicale, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ANRS, Emerging Infectious Diseases
    ClinicalTrials.gov Identifier:
    NCT04849767
    Other Study ID Numbers:
    • ANRS 14056 TRANS&VIH
    • 20-694
    First Posted:
    Apr 19, 2021
    Last Update Posted:
    Apr 21, 2021
    Last Verified:
    Apr 1, 2021
    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 Apr 21, 2021