Transgender Persons
Conditions
Interventions
This is an open, longitudinal, observational study. We will enroll 350 transgender women to be followed during a two years. Procedures include questionnaire, hepatic ultrasound and blood collection. T
Sponsors
Insituto Nacional de Infectologia Evandro Chagas/Instituto de Pesquisa Clinica Evandro Chagas
Insituto Nacional de Infectologia Evandro Chagas/Instituto de Pesquisa Clinica Evandro Chagas
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: People assigned male sex at birth who identify as transgender women, transvestites, or a gender other than male; age 18 or older; documented Human Immunodeficiency Virus (HIV) infection; history of risky sexual behavior in the last 12 months, including: acquisition of a Sexually Transmitted Infection (STI); report of unprotected anal/neovaginal intercourse; difficulty negotiating condom use
Exclusion criteria
Exclusion criteria: Any condition of the volunteer that, in the opinion of the investigator, may make her participation unsafe, complicate the interpretation of the study data or interfere in the study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A high prevalence of non-alcoholic fatty liver disease is expected to be identified in transgender people and transgender women living with or at risk of HIV infection, as determined using the FibroScan method. Liver stiffness and steatosis index (CAP) parameters will be monitored to quantify the degree of fibrosis and fat accumulation in the liver. | — |
Secondary
| Measure | Time frame |
|---|---|
| A high prevalence of cardiovascular disease is expected to be identified in transvestites and transgender women living with or at risk of HIV infection, as determined by measurements of carotid intima-media thickness and brachial artery dilation (BAD). Carotid ultrasound, according to the Mannheim method, and flow-mediated dilation assessment will be used to assess parameters such as intima-media thickness and endothelial response, early indicators of atherosclerosis and vascular dysfunction. | — |
Countries
Brazil
Contacts
Public ContactBeatriz ;Emilia Grinsztejn;Jalil
Instituto Nacional de Infectologia Evandro Chagas;Insituto Nacional de Infectologia Evandro Chagas/Instituto de Pesquisa Clinica Evandro Chagas
Outcome results
None listed