The South-East Asian Transgender Health Cohort

Study Overview
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Brief Summary
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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
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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.

Official Title
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The South-East Asian Transgender Health Cohort

Conditions
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HIV, STIs, HCV

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| - 150 HIV-positive participants, both who were diagnosed with HIV infection and new cases.<br>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.<br>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.<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV