NCT04849767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
536

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 12, 2024

Status Verified

April 1, 2021

Enrollment Period

1.8 years

First QC Date

April 9, 2021

Last Update Submit

February 9, 2024

Conditions

Keywords

TransgenderCommunity-based researchMixt methods

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Transgender people living with HIV

Transgender person Living with HIV Followed in clinical service

Other: Questionnaire

Interventions

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
Transgender people living with HIV

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-define as transgender, or who present themselves with a gender different from the one they were assigned at birth (transgender woman or transgender man)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INSERM

Marseille, 13005, France

Location

Related Publications (2)

  • Van Huizen R, Annequin M, Mora M, Faye A, Fiorentino M, Bourrelly M, Maradan G, Berenger C, Michard F, Yazdanpanah Y, Freire Maresca A, Rouveix E, Cuenot L, Balhan L, Costa M, Michels D, Blanquart L, Rincon G, Protiere C, Spire B; ANRS-Trans&HIV study group. Socioeconomic marginalization, social exclusion, and engagement in transactional sex among transgender women living with HIV: the role of multidimensional gender affirmation. AIDS Care. 2025 Dec;37(12):2174-2191. doi: 10.1080/09540121.2025.2560094. Epub 2025 Sep 29.

  • 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.

MeSH Terms

Conditions

HIV Seropositivity

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Bruno SPIRE, Dr

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 19, 2021

Study Start

October 1, 2020

Primary Completion

July 31, 2022

Study Completion

December 31, 2023

Last Updated

February 12, 2024

Record last verified: 2021-04

Locations