The South-East Asian Transgender Health Cohort

HIV Clinical Trial

— SEATrans  

Official title:

The South-East Asian Transgender Health Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05454579
• Other study ID #: IHRI017
• Status: Recruiting
• Start date: May 15, 2022
• Est. completion date: May 30, 2026

Study information

• Verified date: September 2023
• Source: Institute of HIV Research and Innovation Foundation, Thailand
• Contact: Nittaya Phanuphak, MD,PhD.
• Phone: 6681 825 3544
• Email: nittaya.p[@]ihri.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: May 30, 2026
• Est. primary completion date: May 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HCV
• HIV

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Institute of HIV Research and Innovation Foundation, Thailand	amfAR, The Foundation for AIDS Research

Countries where clinical trial is conducted

Philippines,  Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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