HIV SeropositivityTrans&VIHNCT04849767
National Survey About Trajectory and Life Conditions of HIV Trans People in France
An observational study of HIV Seropositivity, run by ANRS, Emerging Infectious Diseases at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Seropositivity
- What is being tested?
- Questionnaire
- How many people
- 536 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- transgender woman or transgender man
- living with HIV
- followed in hospitals in metropolitan France and the country's overseas territories
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- HIV Seropositivity
- Being tested
- Questionnaire
- Keywords
- Transgender, Community-based research, Mixt methods
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called interview
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.
| Study group | Role | What they receive |
|---|---|---|
| Transgender people living with HIV | Transgender person Living with HIV Followed in clinical service Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Oct 2020
- Primary completion31 Jul 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Bruno SPIRE, Dr, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849767
- Sponsor's protocol ID
- ANRS 14056 TRANS&VIH
- Other IDs
- 20-694
- Acronym
- Trans&VIH
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fiorentino M, Annequin M, Faye A, Mora M, Van-Huizen R, Bourrelly M, Maradan G, Berenger C, Michard F, Yazdanpanah Y, Freire Maresca A, Rouveix E, Balhan L, Costa M, Michels D, Blanquart L, Rincon G, Spire B; and the ANRS-Trans&HIV study group; Members of the ANRS-Trans Scientific Committee. Past-year violence experienced by transgender women living with HIV with or without recent involvement in transactional sex: the French national cross-sectional ANRS-Trans&HIV study. BMJ Open. 2026 Oct 1;16(10):e111751. doi: 10.1136/bmjopen-2025-111751.
PubMed 42823115Van Huizen R, Annequin M, Mora M, Faye A, Fiorentino M, Bourrelly M, Maradan G, Berenger C, Michard F, Yazdanpanah Y, Maresca AF, Rouveix E, Balhan L, Costa M, Michels D, Blanquart L, Rincon G, Spire B, Protiere C; and the ANRS-Trans&HIV study group. Beyond the Individual: The Weight of Social and Structural Determinants of Depression Among Transgender Women Living with HIV in France (ANRS-Trans&HIV). AIDS Behav. 2026 Jun 5. doi: 10.1007/s10461-026-05176-5. Online ahead of print.
PubMed 42249232Van 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.
PubMed 41024590Mora 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans&VIH: National Survey About Trajectory and Life Conditions of HIV Trans People in France
- ClinicalTrials.gov ID
- NCT04849767
- Acronym / sponsor ID
- Trans&VIH / ANRS 14056 TRANS&VIH
- Conditions
- HIV Seropositivity
- Keywords
- Transgender, Community-based research, Mixt methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transgender people living with HIV | – | Other: QuestionnaireTransgender person Living with HIV Followed in clinical service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- transgender woman or transgender man
- living with HIV
- followed in hospitals in metropolitan France and the country's overseas territories
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: interviewQuestionnaire 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 | Transgender people living with HIV |
Primary outcome
Statistical analyses of trends in the personal and social situations of vulnerability in TRHIV
Time frame: 12 months
Through statistical analyses of some questionnaire items, we will highlight the situations of vulnerability of transgender people.
Statistical analyses of trends in obstacles that TRHV encounter in terms of medical care and their healthcare needs
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Derived from this study: PubMed 42823115Fiorentino M, Annequin M, Faye A, Mora M, Van-Huizen R, Bourrelly M, Maradan G, Berenger C, Michard F, Yazdanpanah Y, Freire Maresca A, Rouveix E, Balhan L, Costa M, Michels D, Blanquart L, Rincon G, Spire B; and the ANRS-Trans&HIV study group; Members of the ANRS-Trans Scientific Committee. Past-year violence experienced by transgender women living with HIV with or without recent involvement in transactional sex: the French national cross-sectional ANRS-Trans&HIV study. BMJ Open. 2026 Oct 1;16(10):e111751. doi: 10.1136/bmjopen-2025-111751.
- Derived from this study: PubMed 42249232Van Huizen R, Annequin M, Mora M, Faye A, Fiorentino M, Bourrelly M, Maradan G, Berenger C, Michard F, Yazdanpanah Y, Maresca AF, Rouveix E, Balhan L, Costa M, Michels D, Blanquart L, Rincon G, Spire B, Protiere C; and the ANRS-Trans&HIV study group. Beyond the Individual: The Weight of Social and Structural Determinants of Depression Among Transgender Women Living with HIV in France (ANRS-Trans&HIV). AIDS Behav. 2026 Jun 5. doi: 10.1007/s10461-026-05176-5. Online ahead of print.
- Derived from this study: PubMed 41024590Van 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.
- Derived from this study: PubMed 34916316Mora 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.
Related trials for HIV Seropositivity
Active, not recruitingPhase 2
Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
Idiopathic CD4 T Cell Lymphocytopenia
RecruitingObservational study
Thinking and Memory Problems in People With HIV
HIV Positive
Recruiting
Immuno-virological Evaluation of Persons Living With HIV (PLWH)
HIV-1-infection, HIV Seropositivity
Enrolling by invitation
A Multilevel, Multiphase Optimization Strategy for PrEP (MOST:PrEP)
HIV Seropositivity
RecruitingObservational study
Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection
HIV, Seroconversion, HIV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno SPIRE, Dr principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Seropositivity, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistical analyses of trends in the personal and social situations of vulnerability in TRHIV (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04849767, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.