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NCT Number: NCT06741319

Behavioral and Psychosocial Characteristics of Clients Accessing Services at IHRI

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.

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Key information

Conditions

HIV

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

STUDY OBJECTIVES

  • To describe behavioral and psychosocial characteristics of clients who access services.
  • To understand the effectiveness of the HIV prevention package offered to clients who access services in terms of cost and infections averted
  • To study changes in behavioral and psychosocial characteristics among clients over time
  • To study differences in behavioral and psychosocial characteristics among clients by gender identity, sexual orientation, HIV status, and service sites
  • To assess behavioral and psychosocial factors that influence the willingness to participate in study trials
  • To assess the facilitators, barriers, feasibility and acceptability of and satisfaction with service implementation among clients and healthcare providers under IHRI and TRCARC

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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
  • No exclusionary medical conditions
  • Approved by physician

In SRS- and post-SRS cases2

  • Verbal informed consent or signed informed consent on file
  • No exclusionary medical conditions
  • Approved by physician

Exclusion criteria

None

Treatment and study plan

Demographic characteristics

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

Social and sexual behaviors

Behavioral
  • 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

Psychosocial characteristics

Behavioral
  • 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

Clinical characteristics

Behavioral
  • 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

Referral and linkage to care for HIV-positive clients

Behavioral
  • Health insurance scheme
  • Initiation and continuation of antiretroviral treatment

Characteristics associated with service implementation

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

Primary outcomes

  1. Primary Outcome Measure

    Time frame: 20 years

    • Demographic characteristics
    • Social and sexual behaviors
    • Psychosocial characteristics
    • Clinical characteristics
    • Referral and linkage to care for HIV-positive clients
    • Characteristics associated with service implementation

Study contacts

Contact information is provided by the study sponsor or research team.

Nittaya Phanuphak, MD.,PhD

CONTACT

[email protected]

6681 825 3544

Rena Janamnuaysook, MBA

CONTACT

[email protected]

6698 516 4562

Sponsors and collaborators

Lead sponsor

Institute of HIV Research and Innovation Foundation, Thailand

Other

Registry information

Official study title

The Institute of HIV Research and Innovation (IHRI)

Important dates

Study start
2013
Primary completion
2030
Study completion
2035
First posted
Dec 18, 2024
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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