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

HIV Seropositivity Clinical Trial

— Trans&VIH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04849767
• Other study ID #: ANRS 14056 TRANS&VIH
• Secondary ID: 20-694
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2021
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• transgender woman or transgender man

• living with HIV

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

Related Conditions & MeSH terms

• HIV Seropositivity

Intervention

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.

Locations

Country	Name	City	State
France	INSERM	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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