Pre-Exposure ProphylaxisNCT06576648
Thailand HIV and Stigma Reduction Study
A study testing Mobile Healthy Choices (mHC), Finding Respect and Ending Stigma around HIV (FRESH) and Standard PrEP Counseling in people with Pre-Exposure Prophylaxis, run by University of Massachusetts, Worcester at 3 sites in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Exposure Prophylaxis
- What is being tested?
- Mobile Healthy Choices (mHC), Finding Respect and Ending Stigma around HIV (FRESH) and Standard PrEP Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 3 sitesThailand
- Study dates
- 20 Feb 2025to 14 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand3 sites, 3 recruiting
- Recruiting
Institute of HIV Research and Innovation
Bangkok
Nittaya Phanuphak, 6621605371, nittaya.p@ihri.org
Nittaya Phanuphak
- Recruiting
Rainbow Sky Association of Thailand
Bangkok
Phubet Panpet, phubet.p@rsat.info
- Recruiting
SWING Foundation
Bangkok
Surang Janyam, 6602632950, director.swingfoundation@gmail.com
About this study
Official title: 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).
- Conditions
- Pre-Exposure Prophylaxis
- Being tested
- Mobile Healthy Choices (mHC), Finding Respect and Ending Stigma around HIV (FRESH), Standard PrEP Counseling
- Keywords
- Pre-Exposure Prophylaxis, HIV Prevention, mHealth, Stigma
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Healthy Choices (mHC)Behavioural
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)Behavioural
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 CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Standard PrEP Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 3, Month 6
Intervention Acceptability: Exit Interview
Participants will be asked about their experiences using mHC and FRESH content and potential improvements.
Measured: Month 3
Intervention Feasibility: Participant retention
Participant retention rate of over 85% at 6-month follow-up will be the minimum criterion for feasibility.
Measured: Baseline through Month 6
Intervention Feasibility: Number of FRESH sessions viewed
Intervention feasibility will be evaluated by the total number of FRESH sessions viewed.
Measured: Baseline through Month 6
Intervention Feasibility: Number of mHC sessions completed
Intervention feasibility will be evaluated by the number of completed intervention sessions.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3, and Month 6
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3, and Month 6
HIV
Fourth-generation HIV-1/2 antigen/antibody combi testing will be used to detect HIV infection.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start20 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion14 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Exposure ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Institute of HIV Research and Innovation Foundation, Thailand
- Responsible party
- Principal investigator, Bo Wang, University of Massachusetts, Worcester
- Investigators
- Bo Wang, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576648
- Sponsor's protocol ID
- STUDY00001982
- Other IDs
- R34MH134682-01A1
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Mobile Interventions to Overcome Stigma and Promote HIV Prevention
- ClinicalTrials.gov ID
- NCT06576648
- Acronym / sponsor ID
- STUDY00001982
- Conditions
- Pre-Exposure Prophylaxis
- Keywords
- Pre-Exposure Prophylaxis, HIV Prevention, mHealth, Stigma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Institute of HIV Research and Innovation Foundation, Thailand
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 14 Aug 2027 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard PrEP counseling, mHC, and FRESH content | Experimental | Behavioral: Mobile Healthy Choices (mHC), Behavioral: Finding Respect and Ending Stigma around HIV (FRESH), Behavioral: Standard PrEP CounselingParticipants 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. |
| Standard PrEP counseling and mHC | Experimental | Behavioral: Mobile Healthy Choices (mHC), Behavioral: Standard PrEP CounselingParticipants in this arm will receive standard PrEP counseling, followed by four mHC sessions to reduce stigma and increase utilization of HIV prevention services. |
| Standard PrEP counseling and FRESH content | Experimental | Behavioral: Finding Respect and Ending Stigma around HIV (FRESH), Behavioral: Standard PrEP CounselingParticipants in this arm will receive standard PrEP counseling, followed by six FRESH sessions to reduce stigma and increase utilization of HIV prevention services. |
| Standard PrEP counseling | Experimental | Behavioral: Standard PrEP CounselingParticipants in this arm will receive the standard PrEP counseling. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Standard PrEP counseling and mHC, Standard PrEP counseling, mHC, and FRESH content |
| 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. | Behavioural | Standard PrEP counseling and FRESH content, Standard PrEP counseling, mHC, and FRESH content |
| Standard PrEP CounselingAll 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. | Behavioural | Standard PrEP counseling, Standard PrEP counseling and FRESH content, Standard PrEP counseling and mHC, Standard PrEP counseling, mHC, and FRESH content |
Primary outcome
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.
Intervention Acceptability: Exit Interview
Time frame: Month 3
Participants will be asked about their experiences using mHC and FRESH content and potential improvements.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
16 secondary outcomes
Empowerment
Time frame: Baseline, Month 3, and Month 6
Information: HIV Knowledge
Time frame: Baseline, Month 3, and Month 6
Information: PrEP Knowledge
Time frame: Baseline, Month 3, and Month 6
Motivation: Rollnick's Readiness Ruler
Time frame: Baseline, Month 3, and Month 6
Motivation: Decisional Balance for Problem Behavior
Time frame: Baseline, Month 3, and Month 6
Behavioral Skills
Time frame: Baseline, Month 3, and Month 6
HIV
Time frame: Baseline, Month 3, and Month 6
STI
Time frame: Baseline and Month 6
Sexual Risk
Time frame: Baseline, Month 3, and Month 6
Adaptive coping
Time frame: Baseline, Month 3, and Month 6
Resilience
Time frame: Baseline, Month 3, and Month 6
Substance use: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Time frame: Baseline, Month 3, and Month 6
Substance use: Alcohol Use Disorder Identification Text (AUDIT-C)
Time frame: Baseline, Month 3, and Month 6
Mental health
Time frame: Baseline, Month 3, and Month 6
Perceived HIV risk
Time frame: Baseline, Month 3, and Month 6
Social support
Time frame: Baseline, Month 3, and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes. All IPD collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bo Wang, PhD principal investigator
University of Massachusetts, Worcester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Healthy Choices (mHC), Finding Respect and Ending Stigma around HIV (FRESH) and Standard PrEP Counseling in people with Pre-Exposure Prophylaxis, run by University of Massachusetts, Worcester at 3 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deogwoon Kim, PhD (586-703-4899, Deogwoon.Kim13@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Acceptability: System Usability Score (SUS) (time frame: Month 3, Month 6). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.