NCT06741319

Brief Summary

This protocol describes a 20-year prospective cohort study, gathering behavioral and psychosocial information on clients who access services of the Institute of HIV Research and Innovation (IHRI) and the Thai Red Cross AIDS Research Centre through the Thai Red Cross Anonymous Clinic, the Thai Red Cross Mobile Clinics, Affiliated Health Clinics, The gender and immunity clinic and Pribta Tangerine Polyclinic. Services provided through these sites include VCT, STD screening and treatment, anal and cervical Pap smears, general health checkups, sexual health education, and sexual health communication, gender-affirmative hormone therapy (GAHT) and risk-reduction via web boards and chat rooms. Behavioral and psychosocial information will be collected using validated questionnaires and from data collection forms routinely used when providing services in different service sites of IHRI and the TRC-ARC. The information will be collected anonymously at baseline and at follow-up visits, according to type of services each client receives. Clients at the Thai Red Cross Anonymous Clinic, Thai Red Cross Mobile Health Clinics, Affiliated Health Clinics and Pribta Tangerine Polyclinic will be given an identification number. Qualitative methods, including focus group discussions (FGD) and in-depth interviews (IDI) will be conducted with clients and healthcare providers to examine the facilitators, barriers, feasibility and acceptability of service implementation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300,000

participants targeted

Target at P75+ for all trials

Timeline
112mo left

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Jul 2013Jul 2035

Study Start

First participant enrolled

July 2, 2013

Completed
11.5 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2035

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

17 years

First QC Date

December 12, 2024

Last Update Submit

March 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    1. Demographic characteristics 2. Social and sexual behaviors 3. Psychosocial characteristics 4. Clinical characteristics 5. Referral and linkage to care for HIV-positive clients 6. Characteristics associated with service implementation

    20 years

Interventions

* Gender identity * Sex assigned at birth * Age * Address * History of study enrollment(s)

* Places where clients go for shopping, dining out, exercise, entertainment * Places where clients meet their sexual partner(s) * Places where clients obtain condoms and lubricants * Social networking and other online services clients regularly use and purposes of using * Lifetime and current sexual practices and condom use * Number and types of sexual partners * Self-perceived HIV risk level * Disclosure of HIV or sexual orientation status

* Sexual orientation * Educational level * Occupation and income * Attitude towards and use of HIV testing and sexual health services * Use of injecting drugs, recreational drugs, and alcohol

* Medical history, including gender dysphoria and hormone therapy * HIV counseling and testing * Diagnosis and treatment of sexually transmitted diseases (STD) * Sample collection information * Laboratory results * Gender dysphoria and mental health history * Body hair pattern * Bridging therapy * Fertility and reproductive issues * Gender transition effects

* Health insurance scheme * Initiation and continuation of antiretroviral treatment

\- Facilitators, barriers, feasibility and acceptability of and satisfaction with service implementation as identified by clients and healthcare providers

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population: Clients accessing services of the Pribta Tangerine Polyclinic, the Thai Red Cross Anonymous Clinic, the Thai Red Cross Mobile Clinics and Affiliated Health Clinics.

You may qualify if:

  • years or 16 and 17 years of age with parental or guardian consent In non- or pre-SRS cases
  • Recommendation1 by counsellor based on:
  • A) Presence of GD history B) Understanding of risks and benefits of GAHT D) Practice and readiness for gender transition E) Availability of social support F) Ability to take hormones as instructed
  • Verbal informed consent or signed informed consent on file
  • Approved by physician
  • In SRS- and post-SRS cases2
  • Verbal informed consent or signed informed consent on file
  • Approved by physician

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangerine Clinic, Institute of HIV Research and Innovation

Pathum Wan, Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Interventions

SexReferral and Consultation

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaProfessional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Siriporn Nonenoy, BNH,MPH

    Institute of HIV Research and Innovation

    STUDY CHAIR

Central Study Contacts

Nittaya Phanuphak, MD.,PhD

CONTACT

Rena Janamnuaysook, MBA

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 18, 2024

Study Start

July 2, 2013

Primary Completion (Estimated)

July 2, 2030

Study Completion (Estimated)

July 2, 2035

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations