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NCT Number: NCT05454579

The South-East Asian Transgender Health Cohort

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.

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Key information

Conditions

HIV Communicable Diseases Disease Attributes Genital Diseases HCV Infections Pathologic Processes Pathological Conditions, Signs and Symptoms STIs Sexually Transmitted Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Victoria by LoveYourself, Pasay, Manila, Philippines

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. New cases of HIV infection in transgender people

    Time frame: 24 months

    Longitudinally evaluate medical conditions in physiology by using self-administered questionnaires (e.g. sexual behavioral risk assessment) and laboratory results of anti-HIV over 24 months of follow-up.

  2. Mental health status in transgender people

    Time frame: 24 months

    Longitudinally evaluate the mental health as well as gender violence, stigma, discrimination, substance use, etc. by using self-administered questionnaires (e.g. mental health assessment, psychosocial assessment) including gender affirmation in primary care (e.g., hormones and/or surgical interventions history).

  3. Structural factors and psychosocial factors that impact the physiology and mental health of transgender people

    Time frame: 24 months

    This is related to no.2 and will be collected by using the same questionnaires of self-administered. After collecting and grouping the data, we will know the structure and psychosocial problems that impact the health care system's access of transgender people.

Sponsors and collaborators

Lead sponsor

Institute of HIV Research and Innovation Foundation, Thailand

Other

Collaborators

  • amfAR, The Foundation for AIDS Research

Registry information

Acronym: SEATrans

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jul 12, 2022
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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