The South-East Asian Transgender Health Cohort

Recruiting

• Conditions: HIV; STIs; HCV

• Registration Number: NCT05454579
• Lead Sponsor: Institute of HIV Research and Innovation Foundation, Thailand

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Study Start: 2022-12-02
• Status Verified: 2024-09
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-05-15
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Structural factors and psychosocial factors that impact the physiology and mental health of transgender people	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.
Mental health status in transgender people	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).
New cases of HIV infection in transgender people	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.

Trial Locations

Locations (5)

Tangerine Clinic, Institute of HIV Research and Innovation; 🇹🇭 Pathum wan, Bangkok, Thailand

Victoria by LoveYourself; 🇵🇭 Pasay, Manila, Philippines

Rainbow Sky Association of Thailand (RSAT); 🇹🇭 Bangkok, Bangkapi, Thailand

Institute of HIV Research and Innovation; 🇹🇭 Pathum wan, Bangkok, Thailand

Glink Clinics, Ho Chi Minh City (HCMC), Vietnam Glink Clinic HCMC1; 🇻🇳 Ho Chi Minh, Thuong Kiet Street, Vietnam