Behavioral and Psychosocial Characteristics of Clients Accessing Services at IHRI

NCT ID: NCT06741319

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-02

Study Completion Date

2030-07-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

STUDY OBJECTIVES

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Demographic characteristics

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Referral and linkage to care for HIV-positive clients

* Health insurance scheme
* Initiation and continuation of antiretroviral treatment

Intervention Type BEHAVIORAL

Characteristics associated with service implementation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 18 years or 16 and 17 years of age with parental or guardian consent In non- or pre-SRS cases
2. 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
3. Verbal informed consent or signed informed consent on file
4. No exclusionary medical conditions
5. Approved by physician

In SRS- and post-SRS cases2

1. Verbal informed consent or signed informed consent on file
2. No exclusionary medical conditions
3. Approved by physician

Exclusion Criteria

None
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institute of HIV Research and Innovation Foundation, Thailand

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Siriporn Nonenoy, BNH,MPH

Role: STUDY_CHAIR

Institute of HIV Research and Innovation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tangerine Clinic, Institute of HIV Research and Innovation

Pathum Wan, Bangkok, Thailand

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nittaya Phanuphak, MD.,PhD

Role: CONTACT

Phone: 6681 825 3544

Email: [email protected]

Rena Janamnuaysook, MBA

Role: CONTACT

Phone: 6698 516 4562

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nittaya Phanuphak, MD.,Ph.D.

Role: primary

Rena Janamnuaysook, MBA

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IHRI009

Identifier Type: -

Identifier Source: org_study_id