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

Mental Health Clinical Trial

— TransGuyane  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04962997
• Other study ID #: TransGuyane
• Status: Completed
• Start date: August 6, 2021
• Est. completion date: January 6, 2023

Study information

• Verified date: June 2021
• Source: Centre Hospitalier de Cayenne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 6, 2023
• Est. primary completion date: October 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health
• Sexual Health

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hopsitalier Uiversitaire de Bichat	Paris
French Guiana	Centre Hospitalier de Cayenne	Cayenne	Guyane Française

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier de Cayenne	Bichat Hospital

Countries where clinical trial is conducted

France,  French Guiana, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 0
Secondary	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	Day 0
Secondary	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").	17 months
Secondary	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	Day 1