Thailand HIV and Stigma Reduction Study

Optimizing Mobile Interventions to Overcome Stigma and Promote HIV Prevention

This project will develop a multi-component, technology-delivered intervention designed to reduce HIV and intersectional stigma and improve the use of HIV pre-exposure prophylaxis (PrEP) among HIV-negative Thai vulnerable emerging adults (18-29 years).

Study Overview

• Status: Recruiting
• Conditions: Pre-Exposure Prophylaxis
• Intervention / Treatment: Behavioral: Mobile Healthy Choices (mHC); Behavioral: Finding Respect and Ending Stigma around HIV (FRESH); Behavioral: Standard PrEP Counseling

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deogwoon Kim, PhD; Phone Number: 586-703-4899; Email: Deogwoon.Kim13@umassmed.edu

Study Locations

• Thailand
  • Bangkok, Thailand
    • Recruiting
    • Institute of HIV Research and Innovation
    • Principal Investigator: Nittaya Phanuphak
    • Contact: Nittaya Phanuphak; Phone Number: 6621605371; Email: nittaya.p@ihri.org
    • Sub-Investigator: Rena Janamnuaysook
  • Bangkok, Thailand
    • Recruiting
    • Rainbow Sky Association of Thailand
    • Contact: Phubet Panpet; Email: phubet.p@rsat.info
  • Bangkok, Thailand
    • Recruiting
    • SWING Foundation
    • Contact: Surang Janyam; Phone Number: 6602632950; Email: director.swingfoundation@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Aim 1 (Formative Research and Beta-Testing) Transgender women

Inclusion Criteria:

• Ages between 18 and 29 years
• Male sex at birth
• Self-identifies as women, transgender women or culturally identifies with the female spectrum
• Laboratory-confirmed HIV-negative status
• Self-reported recent history of condomless sex
• Able to understand, read and speak Thai
• Either not started PrEP or currently on PrEP but not adherent (taking ≤3 pills/week) in the past month.

Exclusion Criteria:

• Have a serious cognitive or psychiatric problem compromising ability to provide informed consent
• Have active suicidal ideation or major mental illness at the time of interview (these patients will be referred for treatment)
• Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreased creatinine clearance)
• Currently enrolled in another HIV intervention study.

Healthcare providers Inclusion criteria

• Age 18 or above
• Has provided HIV prevention or treatment services for TGW for at least one year Exclusion criteria
• None

Aim 2 (Pilot RCT) Transgender women Inclusion criteria

• Ages between 18 and 29 years
• Male sex at birth
• Self-identifies as women, transgender women or culturally identifies with the female spectrum
• Laboratory-confirmed HIV-negative status
• Self-reported recent history of condomless sex
• Able to understand, read and speak Thai
• Either not started PrEP or currently on PrEP but not adherent (taking ≤3 pills/week) in the past month.

Exclusion criteria

• Have a serious cognitive or psychiatric problem compromising ability to provide informed consent
• Have active suicidal ideation or major mental illness at the time of interview (these patients will be referred for treatment)
• Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreased creatinine clearance)
• Currently enrolled in another HIV intervention study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard PrEP counseling, mHC, and FRESH content; Participants in this arm will receive standard PrEP counseling, followed by four mHC sessions and six FRESH sessions to reduce stigma and increase utilization of HIV prevention services.	Behavioral: Mobile Healthy Choices (mHC); mHC is a four-session, 20-minute, motivational interviewing-based intervention, which will be delivered on the CIAS platform. It will be tailored to participants' responses given during the interaction in the intervention. In the first two sessions, the (virtual) counselor will motivate participants to overcome stigma and utilize HIV prevention services by using tailored motivational interviewing strategies, develop an individualized change goal based on their readiness, and provide cognitive behavioral strategies. In the last two sessions, the counselor will review the change plan, monitor progress, and provide support for sustained behavioral change. The sessions will occur within three months after baseline.; Behavioral: Finding Respect and Ending Stigma around HIV (FRESH); FRESH content includes six 10-15 minute sessions with interactive, culturally sensitive multimedia modules, which will be delivered on the CIAS platform. The content will aim to improve self-efficacy, reduce intersectional stigmas and promote HIV preventative behaviors. The sessions will occur within three months after baseline.; Behavioral: Standard PrEP Counseling; All participants will receive one-on-one, face to face counseling from focusing on sexual and behavioral risk assessment for HIV/STIs, risk reduction, and HIV prevention. For those not on PrEP, the sessions will focus on risk perception, awareness of PrEP, and facilitators and barriers to PrEP access. For those on PrEP, the sessions will focus on adherence. The counseling will be provided at baseline, 3 months, and 6 months.
Experimental: Standard PrEP counseling and mHC; Participants in this arm will receive standard PrEP counseling, followed by four mHC sessions to reduce stigma and increase utilization of HIV prevention services.	Behavioral: Mobile Healthy Choices (mHC); mHC is a four-session, 20-minute, motivational interviewing-based intervention, which will be delivered on the CIAS platform. It will be tailored to participants' responses given during the interaction in the intervention. In the first two sessions, the (virtual) counselor will motivate participants to overcome stigma and utilize HIV prevention services by using tailored motivational interviewing strategies, develop an individualized change goal based on their readiness, and provide cognitive behavioral strategies. In the last two sessions, the counselor will review the change plan, monitor progress, and provide support for sustained behavioral change. The sessions will occur within three months after baseline.; Behavioral: Standard PrEP Counseling; All participants will receive one-on-one, face to face counseling from focusing on sexual and behavioral risk assessment for HIV/STIs, risk reduction, and HIV prevention. For those not on PrEP, the sessions will focus on risk perception, awareness of PrEP, and facilitators and barriers to PrEP access. For those on PrEP, the sessions will focus on adherence. The counseling will be provided at baseline, 3 months, and 6 months.
Experimental: Standard PrEP counseling and FRESH content; Participants in this arm will receive standard PrEP counseling, followed by six FRESH sessions to reduce stigma and increase utilization of HIV prevention services.	Behavioral: Finding Respect and Ending Stigma around HIV (FRESH); FRESH content includes six 10-15 minute sessions with interactive, culturally sensitive multimedia modules, which will be delivered on the CIAS platform. The content will aim to improve self-efficacy, reduce intersectional stigmas and promote HIV preventative behaviors. The sessions will occur within three months after baseline.; Behavioral: Standard PrEP Counseling; All participants will receive one-on-one, face to face counseling from focusing on sexual and behavioral risk assessment for HIV/STIs, risk reduction, and HIV prevention. For those not on PrEP, the sessions will focus on risk perception, awareness of PrEP, and facilitators and barriers to PrEP access. For those on PrEP, the sessions will focus on adherence. The counseling will be provided at baseline, 3 months, and 6 months.
Experimental: Standard PrEP counseling; Participants in this arm will receive the standard PrEP counseling.	Behavioral: Standard PrEP Counseling; All participants will receive one-on-one, face to face counseling from focusing on sexual and behavioral risk assessment for HIV/STIs, risk reduction, and HIV prevention. For those not on PrEP, the sessions will focus on risk perception, awareness of PrEP, and facilitators and barriers to PrEP access. For those on PrEP, the sessions will focus on adherence. The counseling will be provided at baseline, 3 months, and 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Acceptability: System Usability Score (SUS)	The SUS is a 10-item, 5-point Likert scale for evaluating subjective usability. Each item is scored from 1 to 5, with the calculation involving either subtracting 1 from the user response or the user response from 5 depending on the item. The scores are then summed and multiplied by 2.5 to obtain a total score ranging from 0 to 100. A score above 80 indicates that the intervention is acceptable.	Month 3, Month 6
Intervention Acceptability: Exit Interview	Participants will be asked about their experiences using mHC and FRESH content and potential improvements.	Month 3
Intervention Feasibility: Participant retention	Participant retention rate of over 85% at 6-month follow-up will be the minimum criterion for feasibility.	Baseline through Month 6
Intervention Feasibility: Number of FRESH sessions viewed	Intervention feasibility will be evaluated by the total number of FRESH sessions viewed.	Baseline through Month 6
Intervention Feasibility: Number of mHC sessions completed	Intervention feasibility will be evaluated by the number of completed intervention sessions.	Baseline through Month 6
PrEP Uptake: Self-report	PrEP uptake will be assessed using a self-report measure and confirmed via chart review and pharmacy records.	Month 3, Month 6
PrEP Adherence: Visual analog scale	PrEP adherence will be assessed through the Young Adult Adherence Interview, which contains a visual analog scale (VAS) ranging from 0 to 100. Higher percentages on the VAS indicate greater adherence to ART.	Baseline, Month 3, and Month 6
PrEP Adherence: Self-Reported Adherence	PrEP adherence will be evaluated through self-reported adherence over the past four weeks. Participants will rate their adherence on a scale ranging from 0 to 100%, with higher percentages indicating better adherence to PrEP. The result will be triangulated with DBS reports.	Baseline, Month 3, and Month 6
PrEP Adherence: DBS testing	PrEP adherence will be evaluated by tenofovir concentrations in dried blood spots (DBS). The result will be triangulated with self-reports.	Baseline, Month 3, and Month 6
HIV testing uptake: Self-report	HIV testing uptake will be assessed via self-report and confirmed through chart review.	Baseline, Month 3, and Month 6
Intersectional stigma	Intersectional stigma will be assessed using the Intersectional Discrimination Index, which includes three subsets: anticipated, day-to-day, and major discrimination. The anticipated and day-to-day discrimination measures each consist of 9 items, while the major discrimination measure includes 13 items. The anticipated discrimination score is calculated as a mean ranging from 0 to 4. The day-to-day discrimination score is based on frequency and can range from 0-9 (lifetime) or 0-18 (past-year). The major discrimination score is based on frequency and can range from 0-26 (lifetime) or 0-13 (past-year). For all three measures, higher scores indicate a greater level of anticipated discrimination or experienced discrimination.	Baseline, Month 3, and Month 6
Internalized stigma	Internalized stigma will be evaluated using the Internalized AIDS-related Stigma Scale, a 6-item scale. Scores range from 0 to 6, with higher scores indicating greater internalized stigma.	Baseline, Month 3, and Month 6
Anticipated stigma	Anticipated stigma will be evaluated from three different sources (friends and family, neighbors, and others in the community, and healthcare workers) using a 9-item, 5-Likert scale. Scores can reach up to 45, with higher scores indicating a greater expectation of experiencing stigma in the future.	Baseline, Month 3, and Month 6
Enacted stigma	Enacted stigma will be evaluated with an 8-item, 4-point Likert scale enacted stigma scale. The total score can reach up to 32, with higher scores indicating having more stigma experiences.	Baseline, Month 3, and Month 6
PrEP stigma	PrEP stigma will be evaluated with a 10-item, 5-point Likert scale. Higher scores indicate a higher level of perceived stigma surrounding PrEP.	Baseline, Month 3, and Month 6
Perceived stigma	Perceived stigma will be evaluated using a 13-item, 4-point Likert scale, with a maximum score of 52. Higher scores indicate a higher level of perceived stigma.	Baseline, Month 3, and Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Empowerment	Empowerment will be assessed using the Healthcare Empowerment Inventory. It's an 8-item, 5-point Likert scale, with total scores ranging from 8 to 40. Higher scores indicate a greater sense of empowerment in her health care.	Baseline, Month 3, and Month 6
Information: HIV Knowledge	HIV transmission risk awareness will be assessed through an 18-item HIV Knowledge Questionnaire. The total scores can range from 0 to 18, with higher scores indicating a higher level of HIV knowledge.	Baseline, Month 3, and Month 6
Information: PrEP Knowledge	PrEP knowledge will be assessed through a 13-item PrEP Knowledge Scale. The total score can range from 0 to 13, with higher scores indicating a higher level of PrEP knowledge.	Baseline, Month 3, and Month 6
Motivation: Rollnick's Readiness Ruler	Motivation will be evaluated using the 5-item Rollnick's Readiness Ruler. Each item ranges from 0 to 10, with higher scores indicating a greater readiness for change in HIV prevention and risk behaviors.	Baseline, Month 3, and Month 6
Motivation: Decisional Balance for Problem Behavior	Motivation will be assessed using the Decisional Balance for Problem Behavior scale. This 36-item, 5-point Likert scale evaluates the perceived pros and cons of using PrEP.	Baseline, Month 3, and Month 6
Behavioral Skills	Behavioral skills will be assessed using an adapted version of the Self-Efficacy for Health Promotion and Risk Reduction Questionnaire. This 8-item, 5-point Likert scale measures confidence levels in HIV prevention behaviors, including condom use and adherence to the PrEP schedule. Higher scores indicate a greater confidence in health promotion and HIV prevention.	Baseline, Month 3, and Month 6
HIV	Fourth-generation HIV-1/2 antigen/antibody combi testing will be used to detect HIV infection.	Baseline, Month 3, and Month 6
STI	Treponemal test with rapid plasma reagin (RPR) will be used for syphilis, while urine, oropharyngeal, and rectal swabs will be used for gonorrhea and chlamydia.	Baseline and Month 6
Sexual Risk	Sexual risk will be assessed using a Timeline Followback interview via CASI for any risky sexual behavior over the past 30 days.	Baseline, Month 3, and Month 6
Adaptive coping	Adaptive coping will be assessed by the Brief Resilient Coping Scale, a four-item, 5-point Likert scale questionnaire. Higher scores indicate greater resilient coping.	Baseline, Month 3, and Month 6
Resilience	Resilience will be assessed by the Connor-Davidson Resilience Scale. It is a 10-item, 5-point Likert scale questionnaire, with scores ranging from 0 to 40. Higher scores indicate a greater ability to cope with challenges.	Baseline, Month 3, and Month 6
Substance use: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)	Substance use will be assessed with ASSIST, an 8-item questionnaire that measures the use of ten substances, including alcohol, smoking, cannabis, and other drugs. Each item is scored from 0 to 12, resulting in a risk score for each ranging from 0 to 31 for tobacco and 0 to 39 for alcohol and other drugs. Higher scores indicate a higher risk of substance use disorder.	Baseline, Month 3, and Month 6
Substance use: Alcohol Use Disorder Identification Text (AUDIT-C)	Substance use, specifically alcohol use disorder, will be assessed by using AUDIT-C. Each item is scored from 0 to 4, with 0 indicating no alcohol consumption and 4 indicating more hazardous drinking habits. The total score can range up to 12, with higher scores suggesting greater risks of hazardous alcohol consumption.	Baseline, Month 3, and Month 6
Mental health	Mental health will be evaluated using the Thai General Health Questionnaire. The questionnaire has 12 4-point Likert scale items that assess psychological distress, including depression and anxiety. Scores range up to 48, with higher scores indicating a higher level of psychological distress.	Baseline, Month 3, and Month 6
Perceived HIV risk	Perceived HIV risk will be assessed using the Perceived Risk of HIV Scale (8 item, 4-point Likert scale). The score ranges up to 40-, with higher scores indicating a high level of perception in HIV risk.	Baseline, Month 3, and Month 6
Social support	Social support will be assessed using the Social Provision Scale (13-item, 5-point Likert scale). The survey assesses the availability of five forms of social supportsd: attachment, guidance, social integration, reliable alliance, and reassurance of worth. Scores range from 13 to 65, with higher scores indicating receiving a higher level of social support.	Baseline, Month 3, and Month 6

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Institute of Mental Health (NIMH); Institute of HIV Research and Innovation Foundation, Thailand
• Investigators: Principal Investigator: Bo Wang, PhD, University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 14, 2027

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: mHealth; HIV Prevention; Stigma; Pre-Exposure Prophylaxis
• Additional Relevant MeSH Terms: Behavior; Social Behavior; Social Stigma
• Other Study ID Numbers: STUDY00001982; R34MH134682-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Anyone who wishes to access the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No