NCT05454579

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

December 2, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

July 1, 2022

Last Update Submit

March 25, 2026

Conditions

HIVSTIsHCV

Keywords

HIV

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

- 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* transgender woman or * transgender man

You may qualify if:

  • Thai/Vietnamese/Filipino nationality
  • Aged ≥ 18 years old
  • Self-identify as a transgender woman or transgender man
  • Have signed consent form

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Victoria by LoveYourself

Pasay, Manila, Philippines

Location

Rainbow Sky Association of Thailand (RSAT)

Bangkok, Bangkapi, 10240, Thailand

Location

Institute of HIV Research and Innovation

Pathum Wan, Bangkok, 10330, Thailand

Location

Tangerine Clinic, Institute of HIV Research and Innovation

Pathum Wan, Bangkok, 10330, Thailand

Location

Glink Clinics, Ho Chi Minh City (HCMC), Vietnam Glink Clinic HCMC1

Ho Chi Minh City, Thuong Kiet Street, Vietnam

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nittaya Phanuphak, MD,PhD.

    Institute of HIV Research and Innovation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 12, 2022

Study Start

December 2, 2022

Primary Completion

May 15, 2024

Study Completion

March 30, 2025

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

VN(1)PH(1)TH(3)