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NCT Number: NCT06576648

Thailand HIV and Stigma Reduction Study

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).

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Key information

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of HIV Research and Innovation, Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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.

Primary outcomes

  1. Intervention Acceptability: System Usability Score (SUS)

    Time frame: Month 3, Month 6

    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.

  2. Intervention Acceptability: Exit Interview

    Time frame: Month 3

    Participants will be asked about their experiences using mHC and FRESH content and potential improvements.

  3. Intervention Feasibility: Participant retention

    Time frame: Baseline through Month 6

    Participant retention rate of over 85% at 6-month follow-up will be the minimum criterion for feasibility.

  4. Intervention Feasibility: Number of FRESH sessions viewed

    Time frame: Baseline through Month 6

    Intervention feasibility will be evaluated by the total number of FRESH sessions viewed.

  5. Intervention Feasibility: Number of mHC sessions completed

    Time frame: Baseline through Month 6

    Intervention feasibility will be evaluated by the number of completed intervention sessions.

  6. PrEP Uptake: Self-report

    Time frame: Month 3, Month 6

    PrEP uptake will be assessed using a self-report measure and confirmed via chart review and pharmacy records.

  7. PrEP Adherence: Visual analog scale

    Time frame: Baseline, Month 3, and Month 6

    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.

  8. PrEP Adherence: Self-Reported Adherence

    Time frame: Baseline, Month 3, and Month 6

    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.

  9. PrEP Adherence: DBS testing

    Time frame: Baseline, Month 3, and Month 6

    PrEP adherence will be evaluated by tenofovir concentrations in dried blood spots (DBS). The result will be triangulated with self-reports.

  10. HIV testing uptake: Self-report

    Time frame: Baseline, Month 3, and Month 6

    HIV testing uptake will be assessed via self-report and confirmed through chart review.

  11. Intersectional stigma

    Time frame: Baseline, Month 3, and Month 6

    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.

  12. Internalized stigma

    Time frame: Baseline, Month 3, and Month 6

    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.

  13. Perceived stigma

    Time frame: Baseline, Month 3, and Month 6

    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.

  14. Anticipated stigma

    Time frame: Baseline, Month 3, and Month 6

    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.

  15. Enacted stigma

    Time frame: Baseline, Month 3, and Month 6

    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.

  16. PrEP stigma

    Time frame: Baseline, Month 3, and Month 6

    PrEP stigma will be evaluated with a 10-item, 5-point Likert scale. Higher scores indicate a higher level of perceived stigma surrounding PrEP.

Secondary outcomes

  1. Empowerment

    Time frame: Baseline, Month 3, and Month 6

    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.

  2. Information: HIV Knowledge

    Time frame: Baseline, Month 3, and Month 6

    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.

  3. Information: PrEP Knowledge

    Time frame: Baseline, Month 3, and Month 6

    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.

  4. Motivation: Rollnick's Readiness Ruler

    Time frame: Baseline, Month 3, and Month 6

    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.

  5. Motivation: Decisional Balance for Problem Behavior

    Time frame: Baseline, Month 3, and Month 6

    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.

  6. Behavioral Skills

    Time frame: Baseline, Month 3, and Month 6

    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.

  7. HIV

    Time frame: Baseline, Month 3, and Month 6

    Fourth-generation HIV-1/2 antigen/antibody combi testing will be used to detect HIV infection.

  8. STI

    Time frame: Baseline and Month 6

    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.

  9. Sexual Risk

    Time frame: Baseline, Month 3, and Month 6

    Sexual risk will be assessed using a Timeline Followback interview via CASI for any risky sexual behavior over the past 30 days.

  10. Adaptive coping

    Time frame: Baseline, Month 3, and Month 6

    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.

  11. Resilience

    Time frame: Baseline, Month 3, and Month 6

    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.

  12. Substance use: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

    Time frame: Baseline, Month 3, and Month 6

    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.

  13. Substance use: Alcohol Use Disorder Identification Text (AUDIT-C)

    Time frame: Baseline, Month 3, and Month 6

    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.

  14. Mental health

    Time frame: Baseline, Month 3, and Month 6

    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.

  15. Perceived HIV risk

    Time frame: Baseline, Month 3, and Month 6

    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.

  16. Social support

    Time frame: Baseline, Month 3, and Month 6

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Deogwoon Kim, PhD

CONTACT

[email protected]

586-703-4899

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Institute of HIV Research and Innovation Foundation, Thailand
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Optimizing Mobile Interventions to Overcome Stigma and Promote HIV Prevention

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 29, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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