The South-East Asian Transgender Health Cohort (SEATrans)

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.

Study Overview

• Status: Completed
• Conditions: HIV; HCV; STIs

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 450

Contacts and Locations

Study Locations

• Philippines
  • Manila
    • Pasay, Manila, Philippines
      • Victoria by LoveYourself
• Thailand
  • Bangkapi
    • Bangkok, Bangkapi, Thailand, 10240
      • Rainbow Sky Association of Thailand (RSAT)
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Institute of HIV Research and Innovation
    • Pathum Wan, Bangkok, Thailand, 10330
      • Tangerine Clinic, Institute of HIV Research and Innovation
• Vietnam
  • Thuong Kiet Street
    • Ho Chi Minh City, Thuong Kiet Street, Vietnam
      • Glink Clinics, Ho Chi Minh City (HCMC), Vietnam Glink Clinic HCMC1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

• transgender woman or
• transgender man

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
- 150 HIV-positive participants, both who were diagnosed with HIV infection and new cases.; 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New cases of HIV infection in transgender people	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.	24 months
Mental health status in transgender people	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).	24 months
Structural factors and psychosocial factors that impact the physiology and mental health of transgender people	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.	24 months

Collaborators and Investigators

• Sponsor: Institute of HIV Research and Innovation Foundation, Thailand
• Collaborators: amfAR, The Foundation for AIDS Research
• Investigators: Principal Investigator: Nittaya Phanuphak, MD,PhD., Institute of HIV Research and Innovation

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2022
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HIV
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases
• Other Study ID Numbers: IHRI017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No