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Sexual HealthTransGuyaneNCT04962997

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

An observational study of Sexual Health and Mental Health, run by Centre Hospitalier de Cayenne at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sexual Health, Mental Health
What is being tested?
Data collection
How many people
46 participants
Where
2 sitesin 2 countries
Study dates
6 Aug 2021to 6 Jan 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: Person identifying as a transgender woman consulting at Cayenne Hospital (French Guiana) or Bichat Hospital (Paris) between 07/2021 and 10/2022

Who may be able to join

  • 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…)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

France1 site

  • Centre Hopsitalier Uiversitaire de Bichat

    Paris, 75018

Other trials in France

French Guiana1 site

  • Centre Hospitalier de Cayenne

    Cayenne, Guyane Française, 97306

Other trials in French Guiana

About this study

Official title: 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.

Read the 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).

Being tested
Data collection
Keywords
Transgender women, Retention in care, Global health, French Guiana
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data collectionOther

    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.

Study groups in NCT04962997
Study groupRoleWhat they receive
Transgender womenMajor person identifying as a transgender women consulting at Cayenne Hospital (French Guiana) or Bichat Hospital (Paris) between 06/2021 and 10/2022
Receives: Other: Data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Describe the frequency of violence suffered by transgender women treated in Cayenne or Paris

    Frequency of psychological, physical and sexual violence suffered by transgender women

    Measured: Day 0

Secondary outcomes (3)

  1. Describe the state of health of transgender women in Cayenne and Paris

    Describe the state of health of transgender women based on the data collected

    Measured: Day 0

  2. Compare these results with those of the National Survey of Transgender Women Living with Human Immunodeficiency Virus

    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").

    Measured: 17 months

  3. Describe the state of health of transgender women in Cayenne and Paris

    Describe the state of health of transgender women based on the data collected

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2021
  2. Study start6 Aug 2021
  3. Primary completion19 Oct 2022
  4. Study completion6 Jan 2023

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04962997
Sponsor's protocol ID
TransGuyane
Acronym
TransGuyane
Status last verified
Jun 2021
First submitted
9 Jun 2021
Last updated
17 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baral SD, Poteat T, Stromdahl S, Wirtz AL, Guadamuz TE, Beyrer C. Worldwide burden of HIV in transgender women: a systematic review and meta-analysis. Lancet Infect Dis. 2013 Mar;13(3):214-22. doi: 10.1016/S1473-3099(12)70315-8. Epub 2012 Dec 21.

    PubMed 23260128

  • Grinsztejn B, Jalil EM, Monteiro L, Velasque L, Moreira RI, Garcia AC, Castro CV, Kruger A, Luz PM, Liu AY, McFarland W, Buchbinder S, Veloso VG, Wilson EC; Transcender Study Team. Unveiling of HIV dynamics among transgender women: a respondent-driven sampling study in Rio de Janeiro, Brazil. Lancet HIV. 2017 Apr;4(4):e169-e176. doi: 10.1016/S2352-3018(17)30015-2. Epub 2017 Feb 8.

    PubMed 28188030

  • Silva-Santisteban A, Eng S, de la Iglesia G, Falistocco C, Mazin R. HIV prevention among transgender women in Latin America: implementation, gaps and challenges. J Int AIDS Soc. 2016 Jul 17;19(3 Suppl 2):20799. doi: 10.7448/IAS.19.3.20799. eCollection 2016.

    PubMed 27431470

  • Baggaley RF, White RG, Boily MC. HIV transmission risk through anal intercourse: systematic review, meta-analysis and implications for HIV prevention. Int J Epidemiol. 2010 Aug;39(4):1048-63. doi: 10.1093/ije/dyq057. Epub 2010 Apr 20.

    PubMed 20406794

  • Operario D, Burton J, Underhill K, Sevelius J. Men who have sex with transgender women: challenges to category-based HIV prevention. AIDS Behav. 2008 Jan;12(1):18-26. doi: 10.1007/s10461-007-9303-y. Epub 2007 Aug 19.

    PubMed 17705095

  • Pinto RM, Melendez RM, Spector AY. Male-to-Female Transgender Individuals Building Social Support and Capital From Within a Gender-Focused Network. J Gay Lesbian Soc Serv. 2008 Sep 1;20(3):203-220. doi: 10.1080/10538720802235179.

    PubMed 20418965

  • Reisner SL, Poteat T, Keatley J, Cabral M, Mothopeng T, Dunham E, Holland CE, Max R, Baral SD. Global health burden and needs of transgender populations: a review. Lancet. 2016 Jul 23;388(10042):412-436. doi: 10.1016/S0140-6736(16)00684-X. Epub 2016 Jun 17.

    PubMed 27323919

  • Poteat T, Wirtz AL, Radix A, Borquez A, Silva-Santisteban A, Deutsch MB, Khan SI, Winter S, Operario D. HIV risk and preventive interventions in transgender women sex workers. Lancet. 2015 Jan 17;385(9964):274-86. doi: 10.1016/S0140-6736(14)60833-3. Epub 2014 Jul 22.

    PubMed 25059941

  • Operario D, Soma T, Underhill K. Sex work and HIV status among transgender women: systematic review and meta-analysis. J Acquir Immune Defic Syndr. 2008 May 1;48(1):97-103. doi: 10.1097/QAI.0b013e31816e3971.

    PubMed 18344875

  • Ferreira S Jr, Francisco PMSB, Nogueira PA. [Profile of transvestites and transgender women: tuberculosis and HIV/AIDS in the city of Sao Paulo]. Rev Panam Salud Publica. 2016 Dec;40(6):410-417. Portuguese.

    PubMed 28718489

  • Zoni AC, Gonzalez MA, Sjogren HW. Syphilis in the most at-risk populations in Latin America and the Caribbean: a systematic review. Int J Infect Dis. 2013 Feb;17(2):e84-92. doi: 10.1016/j.ijid.2012.07.021. Epub 2012 Oct 12.

    PubMed 23063547

  • Solomon MM, Mayer KH, Glidden DV, Liu AY, McMahan VM, Guanira JV, Chariyalertsak S, Fernandez T, Grant RM; iPrEx Study Team. Syphilis predicts HIV incidence among men and transgender women who have sex with men in a preexposure prophylaxis trial. Clin Infect Dis. 2014 Oct;59(7):1020-6. doi: 10.1093/cid/ciu450. Epub 2014 Jun 13.

    PubMed 24928295

  • Keshinro B, Crowell TA, Nowak RG, Adebajo S, Peel S, Gaydos CA, Rodriguez-Hart C, Baral SD, Walsh MJ, Njoku OS, Odeyemi S, Ngo-Ndomb T, Blattner WA, Robb ML, Charurat ME, Ake J; TRUST/RV368 Study Group. High prevalence of HIV, chlamydia and gonorrhoea among men who have sex with men and transgender women attending trusted community centres in Abuja and Lagos, Nigeria. J Int AIDS Soc. 2016 Dec 7;19(1):21270. doi: 10.7448/IAS.19.1.21270. eCollection 2016.

    PubMed 27931519

  • Wickersham JA, Gibson BA, Bazazi AR, Pillai V, Pedersen CJ, Meyer JP, El-Bassel N, Mayer KH, Kamarulzaman A, Altice FL. Prevalence of Human Immunodeficiency Virus and Sexually Transmitted Infections Among Cisgender and Transgender Women Sex Workers in Greater Kuala Lumpur, Malaysia: Results From a Respondent-Driven Sampling Study. Sex Transm Dis. 2017 Nov;44(11):663-670. doi: 10.1097/OLQ.0000000000000662.

    PubMed 28708696

  • Kojima N, Park H, Konda KA, Joseph Davey DL, Bristow CC, Brown B, Leon SR, Vargas SK, Calvo GM, Caceres CF, Klausner JD. The PICASSO Cohort: baseline characteristics of a cohort of men who have sex with men and male-to-female transgender women at high risk for syphilis infection in Lima, Peru. BMC Infect Dis. 2017 Apr 11;17(1):255. doi: 10.1186/s12879-017-2332-x.

    PubMed 28399798

Questions about this trial

What is this clinical trial studying?

An observational study of Sexual Health and Mental Health, run by Centre Hospitalier de Cayenne at 2 sites in 2 countries.

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 6 inclusion and 4 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 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France, French Guiana. 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?

Describe the frequency of violence suffered by transgender women treated in Cayenne or Paris (time frame: Day 0). 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 NCT04962997, which also lists 15 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 17 Oct 2023.

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