HIVNCT06741319
Behavioral and Psychosocial Characteristics of Clients Accessing Services at IHRI
An observational study of HIV, run by Institute of HIV Research and Innovation Foundation, Thailand at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Demographic characteristics, Social and sexual behaviors and Psychosocial characteristics
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300,000 participants
- Where
- 1 siteThailand
- Study dates
- 2 Jul 2013to 2 Jul 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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:
- 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
Show all 10Show fewer
- In SRS- and post-SRS cases2
- Verbal informed consent or signed informed consent on file
- No exclusionary medical conditions
- Approved by physician
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Tangerine Clinic, Institute of HIV Research and Innovation
Pathum Wan, Bangkok, 10330
Nittaya Phanuphak, MD.,Ph.D., +66 2 1605371, nittaya.p@ihri.org
Rena Janamnuaysook, MBA, +66 2 1605371, rena.j@ihri.org
About this study
Official title: The Institute of HIV Research and Innovation (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.
Read the detailed description
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
- Conditions
- HIV
- Being tested
- Demographic characteristics, Social and sexual behaviors, Psychosocial characteristics, Clinical characteristics, Referral and linkage to care for HIV-positive clients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demographic characteristicsBehavioural
- Gender identity
- Sex assigned at birth
- Age
- Address
- History of study enrollment(s)
Social and sexual behaviorsBehavioural
- 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 characteristicsBehavioural
- 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 characteristicsBehavioural
- 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 clientsBehavioural
- Health insurance scheme
- Initiation and continuation of antiretroviral treatment
Characteristics associated with service implementationBehavioural
- Facilitators, barriers, feasibility and acceptability of and satisfaction with service implementation as identified by clients and healthcare providers
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
- Demographic characteristics
- Social and sexual behaviors
- Psychosocial characteristics
- Clinical characteristics
- Referral and linkage to care for HIV-positive clients
- Characteristics associated with service implementation
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start2 Jul 2013
- Primary completion2 Jul 2030 (estimated)
- Study completion2 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siriporn Nonenoy, BNH,MPH, Study chair, Institute of HIV Research and Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741319
- Sponsor's protocol ID
- IHRI009
- Status last verified
- Mar 2026
- First submitted
- 12 Dec 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Institute of HIV Research and Innovation (IHRI)
- ClinicalTrials.gov ID
- NCT06741319
- Acronym / sponsor ID
- IHRI009
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300,000 participants (estimated)
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, ThailandUniversity, hospital or other
- Study start
- 2 Jul 2013 (actual)
- Primary completion
- 2 Jul 2030 (estimated)
- Study completion
- 2 Jul 2035 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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:
- Verbal informed consent or signed informed consent on file
- No exclusionary medical conditions
- Approved by physician
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Demographic characteristics* Gender identity * Sex assigned at birth * Age * Address * History of study enrollment(s) | Behavioural | – |
| Social and sexual behaviors* 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 | Behavioural | – |
| Psychosocial characteristics* 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 | Behavioural | – |
| Clinical characteristics* 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 | Behavioural | – |
| Referral and linkage to care for HIV-positive clients* Health insurance scheme * Initiation and continuation of antiretroviral treatment | Behavioural | – |
| Characteristics associated with service implementation- Facilitators, barriers, feasibility and acceptability of and satisfaction with service implementation as identified by clients and healthcare providers | Behavioural | – |
Primary outcome
Primary Outcome Measure
Time frame: 20 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Siriporn Nonenoy, BNH,MPH study chair
Institute of HIV Research and Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Institute of HIV Research and Innovation Foundation, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nittaya Phanuphak, MD.,PhD (6681 825 3544, nittaya.p@ihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.