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CompletedNCT04849767Trans&VIHUpdated Feb 12, 2024

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

An observational study in HIV Seropositivity, sponsored by ANRS, Emerging Infectious Diseases. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-12.

Sponsored by ANRS, Emerging Infectious Diseases · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
536
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • HIV Seropositivity

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Keywords

  • Transgender
  • Community-based research
  • Mixt methods
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In context

HIV Seropositivity

210 studies on the registry are indexed under HIV Seropositivity; 10 are open to participants now.

This study's enrollment of 536 is above the median of 223 across 62 observational studies indexed under HIV Seropositivity.

Browse HIV Seropositivity studies →

Lead sponsor

ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

People who self-define as transgender, or who present themselves with a gender different from the one they were assigned at birth (transgender woman or transgender man), living with HIV (TRHIV), and followed in hospitals in metropolitan France and the country's overseas territories.

TRHIV frequenting hospital-based HIV services in France. In 2018, an exploratory survey in 258 such hospital services, allowed the estimation of the study population: 852 TRHIV women and 5 TRHIV men. Given the small size of the active patient file, we decided to survey all the TRHIV who agreed to participate in ANRS Trans \& HIV, in order to highlight possible disparities in HIV and transition care.

Eligibility criteria

Inclusion Criteria:

  • transgender woman or transgender man
  • living with HIV
  • followed in hospitals in metropolitan France and the country's overseas territories
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
536 participants (actual)
Patient registry
No

Groups and cohorts

  • Transgender people living with HIV

    Transgender person Living with HIV Followed in clinical service

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

    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.

    Also known as: interview

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What researchers measure

Primary outcomes

  1. Statistical analyses of trends in the personal and social situations of vulnerability in TRHIV

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

    Time frame: 12 months

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

    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.

    Time frame: 12 months

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Study locations

1 site
  • INSERM
    Marseille, 13005, France
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References and documents

Publications

  • Mora M, Rincon G, Bourrelly M, Maradan G, Freire Maresca A, Michard F, Rouveix E, Pannetier J, Leriche D, Alain T, Yazdanpanah Y, Michels D, Spire B. Living conditions, HIV and gender affirmation care pathways of transgender people living with HIV in France: a nationwide, comprehensive, cross-sectional, community-based research protocol (ANRS Trans&HIV). BMJ Open. 2021 Dec 16;11(12):e052691. doi: 10.1136/bmjopen-2021-052691. PubMed 34916316 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04849767
Lead sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Apr 19, 2021
Start date
Oct 1, 2020
Primary completion
Jul 31, 2022
Completion
Dec 31, 2023
Last update
Feb 12, 2024

Study contacts

Bruno SPIRE, Dr
principal investigator · Institut National de la Santé Et de la Recherche Médicale, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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