Thailand HIV and Stigma Reduction Study

NCT06576648 | Recruiting DMC

• 2 other identifiers: STUDY00001982R34MH134682-01A1
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Pre-Exposure Prophylaxis

Keywords

Pre-Exposure Prophylaxis; HIV Prevention; mHealth; Stigma

Outcome Measures

Primary Outcomes (16)

• 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

• 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

• 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

Secondary Outcomes (16)

• Empowerment

  Baseline, Month 3, and Month 6

• Information: HIV Knowledge

  Baseline, Month 3, and Month 6

• Information: PrEP Knowledge

  Baseline, Month 3, and Month 6

• Motivation: Rollnick's Readiness Ruler

  Baseline, Month 3, and Month 6

• Motivation: Decisional Balance for Problem Behavior

  Baseline, Month 3, and Month 6

Study Arms (4)

Standard PrEP counseling, mHC, and FRESH content

EXPERIMENTAL

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); Behavioral: Finding Respect and Ending Stigma around HIV (FRESH); Behavioral: Standard PrEP Counseling

Standard PrEP counseling and mHC

EXPERIMENTAL

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); Behavioral: Standard PrEP Counseling

Standard PrEP counseling and FRESH content

EXPERIMENTAL

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); Behavioral: Standard PrEP Counseling

Standard PrEP counseling

EXPERIMENTAL

Participants in this arm will receive the standard PrEP counseling.

Behavioral: Standard PrEP Counseling

Interventions

Mobile Healthy Choices (mHC) BEHAVIORAL

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.

Standard PrEP counseling and mHC; Standard PrEP counseling, mHC, and FRESH content

Finding Respect and Ending Stigma around HIV (FRESH) BEHAVIORAL

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.

Standard PrEP counseling and FRESH content; Standard PrEP counseling, mHC, and FRESH content

Standard PrEP Counseling BEHAVIORAL

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.

Standard PrEP counseling; Standard PrEP counseling and FRESH content; Standard PrEP counseling and mHC; Standard PrEP counseling, mHC, and FRESH content

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: Transgender women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Age 18 or above
• None
• 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.
• 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)

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute of Mental Health (NIMH): collaborator
• Institute of HIV Research and Innovation Foundation, Thailand: collaborator

Study Sites (3)

Institute of HIV Research and Innovation

Bangkok, Thailand

RECRUITING

Rainbow Sky Association of Thailand

Bangkok, Thailand

RECRUITING

SWING Foundation

Bangkok, Thailand

RECRUITING

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Bo Wang, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deogwoon Kim, PhD

CONTACT

586-703-4899; Deogwoon.Kim13@umassmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 14, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

TH (3)