Clinical trial NCT06741319: Behavioral and Psychosocial Characteristics of Clients Accessing Services at IHRI
Official title: The Institute of HIV Research and Innovation (IHRI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Lead sponsor: Institute of HIV Research and Innovation Foundation, Thailand
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 300000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pathum wan
country: Thailand
facility: Tangerine Clinic, Institute of HIV Research and Innovation
state: Bangkok
Study officials:
affiliation: Institute of HIV Research and Innovation
name: Siriporn Nonenoy, BNH,MPH
role: STUDY_CHAIR
References: