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SEATrans: The South-East Asian Transgender Health Cohort

Sponsor
Institute of HIV Research and Innovation Foundation, Thailand (Other)
Overall Status
Recruiting
CT.gov ID
NCT05454579
Collaborator
amfAR, The Foundation for AIDS Research (Other)
450
Enrollment
4
Locations
48.5
Anticipated Duration (Months)
112.5
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    450 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The South-East Asian Transgender Health Cohort
    Actual Study Start Date :
    May 15, 2022
    Anticipated Primary Completion Date :
    May 15, 2025
    Anticipated Study Completion Date :
    May 30, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    - 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.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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).

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Victoria by LoveYourself Pasay Manila Philippines
    2 Rainbow Sky Association of Thailand (RSAT) Bangkok Bangkapi Thailand 10240
    3 Institute of HIV Research and Innovation Pathum wan Bangkok Thailand 10330
    4 Glink Clinic Hanoi Hanoi Minh Khai Street Vietnam

    Sponsors and Collaborators

    • Institute of HIV Research and Innovation Foundation, Thailand
    • amfAR, The Foundation for AIDS Research

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institute of HIV Research and Innovation Foundation, Thailand
    ClinicalTrials.gov Identifier:
    NCT05454579
    Other Study ID Numbers:
    • IHRI017
    First Posted:
    Jul 12, 2022
    Last Update Posted:
    Jul 13, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Institute of HIV Research and Innovation Foundation, Thailand
    HIV

    Study Results

    No Results Posted as of Jul 13, 2022