Health Status of Transgender Women in French Guiana and Paris (TransGuyane) (TransGuyane)

October 16, 2023 updated by: Centre Hospitalier de Cayenne

Health Status of Transgender Women in French Guiana and Paris: a Cross-sectional View (TransGuyane)

Assessing and comparing the life and health status of transgender or trans women in French Guiana and Paris. Conducting a questionnaire on physical, mental and sexual health, migration history, transition, and STI screening.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Transgender or trans women in French Guiana are not known to the hospital environment and rarely seek care: only about fifteen patients are followed up in the Infectious and Tropical Diseases Unit (UMIT) and the Adult Day Hospital (HDJA) of the Cayenne Hospital Center for Human Immunodeficiency Virus (HIV) infection. There is therefore a lack of knowledge of this population, of their health needs (physical, sexual and mental) but also a lack of assistance in the transition process. However, the violence suffered and the risks of infection are high among transgender women who frequently resort to sex work. In fact, they are said to carry the highest burden of HIV in the world, particularly in South America. The need for HIV prevention among transgender women in South America is great.

There is no bibliography of published works concerning transgender women in French Guiana, whereas there are more and more publications from countries that are geographically close (Brazil, Peru, United States), or even from metropolitan France. It is therefore necessary to address this issue in French Guiana. The population of transgender women followed up at the Bichat Hospital (for HIV infection or as part of a sexual health follow-up) represents one of the largest active files of transgender women in France and offers the opportunity to look at these two populations from a cross-sectional perspective.

The study will be cross-sectional and multicentric (Cayenne in French Guiana, Paris) and will include transgender women who have reached the age of majority and who agree to answer a questionnaire concerning their living and socio-economic conditions, their migration, their physical, sexual and mental health, and their transition process. Data relating to the search for Sexually Transmitted Infection STIs check-up as well as dermatological examination will be studied in particular with the agreement of the participants.

Data relating to the second consultation will be studied in particular (report of results) without systematic follow-up.

Non-interventional research (RIPH category 3). Cross-sectional observational multicentric study: at the CHC (Cayenne, French Guiana) and at Bichat Hospital (Paris).

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75018
        • Centre Hopsitalier Uiversitaire de Bichat
  • French Guiana
    • Guyane Française
      • Cayenne, Guyane Française, French Guiana, 97306
        • Centre Hospitalier de Cayenne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Person identifying as a transgender woman consulting at Cayenne Hospital (French Guiana) or Bichat Hospital (Paris) between 07/2021 and 10/2022

Description

Inclusion Criteria:

  • Person identifying as a transgender woman
  • Consulting at Cayenne Hospital (French Guiana) or Bichat Hospital (Paris)
  • Between 07/2021 and 10/2022
  • Major
  • No opposition to the study
  • Absence of neurological or psychiatric disorders that prevented understanding of the study and free participation (sequelae of cerebral toxoplasmosis with aphasia, deaf and mute person, active neuro-meningeal opportunistic infections with cognitive impairment…)

Exclusion Criteria:

  • Minor
  • Refusal to participate and/or neurological or psychiatric disorder preventing understanding of the study
  • Not be able to answer questions in languages mastered by principal investigator (French, English, Spanish or Portuguese)
  • Person under guardianship or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transgender women
Major person identifying as a transgender women consulting at Cayenne Hospital (French Guiana) or Bichat Hospital (Paris) between 06/2021 and 10/2022
Other: Data collection

Investigator will ensure the completion of a hetero-administered questionnaire which will be carried out in French, English, Portuguese or Spanish depending on the language spoken by the participant, including informations related to Demography and socio-economic conditions, Addictions, Work and studies, Housing, Health coverage, Gender and sexuality, Vulnerabilities and violence, Recourse to care, State of physical health, Mental Health, Prevention and Sexually Transmitted Infections (STIs), Checkup, Transition path and clinical complications and Dermatological problems.

Investigator will collect the data relating to the clinical examination, dermatological examination and the search for STIs (blood and / or urine) carried out in the routine care of the participant in a case report form (CRF).

The estimated duration of the interviews and the consultation is approximately 1 hour and 30 minutes per patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the frequency of violence suffered by transgender women treated in Cayenne or Paris
Time Frame: Day 0
Frequency of psychological, physical and sexual violence suffered by transgender women
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the state of health of transgender women in Cayenne and Paris
Time Frame: Day 0
Describe the state of health of transgender women based on the data collected
Day 0
Compare these results with those of the National Survey of Transgender Women Living with Human Immunodeficiency Virus
Time Frame: 17 months
Compare these results with those of the National Survey of Transgender Women Living with Human Immunodeficiency Virus (Dr. Spire's Metropolitan Study on "Trans identity and Human Immunodeficiency Virus").
17 months
Describe the state of health of transgender women in Cayenne and Paris
Time Frame: Day 1
Describe the state of health of transgender women based on the data collected
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Cayenne

Collaborators

Bichat Hospital

Investigators

  • Principal Investigator: Chloé BERTIN, Centre Hospitalier de Cayenne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2021

Primary Completion (Actual)

October 19, 2022

Study Completion (Actual)

January 6, 2023

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TransGuyane

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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