NCT04962997

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

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

First Submitted

Initial submission to the registry

June 9, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

August 6, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2023

Completed
Last Updated

October 17, 2023

Status Verified

June 1, 2021

Enrollment Period

1.2 years

First QC Date

June 9, 2021

Last Update Submit

October 16, 2023

Conditions

Keywords

Transgender womenRetention in careGlobal healthFrench Guiana

Outcome Measures

Primary Outcomes (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

    Day 0

Secondary Outcomes (3)

  • Describe the state of health of transgender women in Cayenne and Paris

    Day 0

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

    17 months

  • Describe the state of health of transgender women in Cayenne and Paris

    Day 1

Study Arms (1)

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

Interventions

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.

Transgender women

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTransgender women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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…)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hopsitalier Uiversitaire de Bichat

Paris, 75018, France

Location

Centre Hospitalier de Cayenne

Cayenne, Guyane Française, 97306, French Guiana

Location

Related Publications (15)

  • 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.

    PMID: 23260128BACKGROUND
  • 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.

    PMID: 28188030BACKGROUND
  • 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.

    PMID: 27431470BACKGROUND
  • 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.

    PMID: 20406794BACKGROUND
  • 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.

    PMID: 17705095BACKGROUND
  • 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.

    PMID: 20418965BACKGROUND
  • 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.

    PMID: 27323919BACKGROUND
  • 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.

    PMID: 25059941BACKGROUND
  • 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.

    PMID: 18344875BACKGROUND
  • 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.

    PMID: 28718489BACKGROUND
  • 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.

    PMID: 23063547BACKGROUND
  • 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.

    PMID: 24928295BACKGROUND
  • 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.

    PMID: 27931519BACKGROUND
  • 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.

    PMID: 28708696BACKGROUND
  • 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.

    PMID: 28399798BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Chloé BERTIN

    Centre Hospitalier de Cayenne

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 9, 2021

First Posted

July 15, 2021

Study Start

August 6, 2021

Primary Completion

October 19, 2022

Study Completion

January 6, 2023

Last Updated

October 17, 2023

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations