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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Seropositivity
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 536

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • INSERM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Transgender; Community-based research; Mixt methods
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Urogenital Diseases; Genital Diseases; HIV Seropositivity
• Other Study ID Numbers: ANRS 14056 TRANS&VIH; 20-694 (Other Identifier: The Inserm Ethics Evaluation Committee IRB00003888)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No