Thailand Transgender Women Stigma Study
NCT Number: NCT06576648
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pre-Exposure Prophylaxis
Interventions: BEHAVIORAL: Mobile Healthy Choices (mHC)|BEHAVIORAL: Finding Respect and Ending Stigma around HIV (FRESH)|BEHAVIORAL: Standard PrEP Counseling
Sponsor: University of Massachusetts, Worcester
Collaborators: National Institute of Mental Health (NIMH)|Institute of HIV Research and Innovation Foundation, Thailand
Sex: MALE
Age: ADULT
Enrollment: 154
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-12-16
Completion Date: 2027-08-14
Locations: Institute of HIV Research and Innovation, Bangkok, Thailand|Rainbow Sky Association of Thailand, Bangkok, Thailand|SWING Foundation, Bangkok, Thailand

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, young transgender women (18-29 years).

Primary Outcome Measures: 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 an adapted version of the Transgender Stigma Scale. It is a 13-item, 4-point Likert scale, with a maximum score of 52. Higher scores indicate a higher level of perceived stigma associated with being a transgender woman., 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 Outcome Measures: 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