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The South-East Asian Transgender Health Cohort (SEATrans)

I

Institute of HIV Research and Innovation Foundation, Thailand

Status

Enrolling

Conditions

HIV
HCV
STIs

Study type

Observational

Funder types

Other

Identifiers

NCT05454579
IHRI017

Details and patient eligibility

About

This is a prospective observational cohort study that will enroll 300 HIV-negative transgender people and 150 transgender people living with HIV from 4 community health centers in Thailand, Vietnam, and the Philippines. Each participant will be followed-up until the completion of 24 months.

Full description

This prospective observational cohort study will longitudinally track physical (e.g. HIV/STI, sexual risk behavior, gender affirmation, clinical information, cardiovascular health, medical history) and mental health (e.g. stigma and discrimination, gender-based violence, anxiety, depression); identify biomedical, structural, and psychosocial factors impacting physical and mental health among transgender people; describe the structural barriers to healthcare experienced by transgender people as well as develop the guidance on holistic healthcare policies for transgender people.

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Thai/Vietnamese/Filipino nationality
  • Aged ≥ 18 years old
  • Self-identify as a transgender woman or transgender man
  • Have signed consent form

Exclusion criteria

  • None

Trial design

450 participants in 3 patient groups

- 150 HIV-positive participants, both who were diagnosed with HIV infection and new cases.
Description:
Newly diagnosed HIV-infected participants will be linked to care to start ART. Known HIV-positive participants will be linked to care if they are not in care already. All HIV-positive participants will undergo viral load and CD4 testing at screening/baseline, and be invited back every 6 months for assessment of adherence, viral load testing, STI testing, FBS and lipid profile. A CD4 count will be repeated at Month 12 and Month 24.
- 150 HIV-negative participants who are already receiving PrEP or who will accept PrEP.
Description:
HIV-negative participants will be offered PrEP. Those who accept PrEP will enroll in the PrEP program in each country, undergo creatinine testing at screening/baseline and be invited back at Month 1, Month 3, and every three months thereafter for HIV testing and assessment of adherence. STI testing, FBS, creatinine and lipid profile will be repeated every 6 months.
- 150 HIV-negative participants who will refuse PrEP.
Description:
HIV-negative participants who do not wish to start PrEP will be invited back at every three months for HIV-testing. STI-testing, FBS and lipid profile will be repeated every 6 months.

Trial contacts and locations

5

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Central trial contact

Rena Janamnuaysook, MBA; Nittaya Phanuphak, MD,PhD.

Data sourced from clinicaltrials.gov

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