Thailand Transgender Women Stigma Study
- Conditions
- Pre-Exposure Prophylaxis
- Interventions
- Behavioral: Mobile Healthy Choices (mHC)Behavioral: Finding Respect and Ending Stigma around HIV (FRESH)Behavioral: Standard PrEP Counseling
- Registration Number
- NCT06576648
- Lead Sponsor
- University of Massachusetts, Worcester
- 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, young transgender women (18-29 years).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 154
- 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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Standard PrEP counseling, mHC, and FRESH content Mobile Healthy Choices (mHC) 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. Standard PrEP counseling, mHC, and FRESH content Standard PrEP Counseling 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. Standard PrEP counseling Standard PrEP Counseling Participants in this arm will receive the standard PrEP counseling. Standard PrEP counseling, mHC, and FRESH content Finding Respect and Ending Stigma around HIV (FRESH) 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. Standard PrEP counseling and mHC Mobile Healthy Choices (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. Standard PrEP counseling and mHC Standard PrEP Counseling Participants 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 Finding Respect and Ending Stigma around HIV (FRESH) Participants 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 and FRESH content Standard PrEP Counseling Participants in this arm will receive standard PrEP counseling, followed by six FRESH sessions to reduce stigma and increase utilization of HIV prevention services.
- Primary Outcome Measures
Name Time Method Intervention Acceptability: System Usability Score (SUS) 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 Feasibility: Participant retention Baseline through Month 6 Participant retention rate of over 85% at 6-month follow-up will be the minimum criterion for feasibility.
Intervention Acceptability: Exit Interview Month 3 Participants will be asked about their experiences using mHC and FRESH content and potential improvements.
PrEP Uptake: Self-report Month 3, Month 6 PrEP uptake will be assessed using a self-report measure and confirmed via chart review and pharmacy records.
Internalized stigma 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.
Intervention Feasibility: Number of FRESH sessions viewed Baseline through Month 6 Intervention feasibility will be evaluated by the total number of FRESH sessions viewed.
Intervention Feasibility: Number of mHC sessions completed Baseline through Month 6 Intervention feasibility will be evaluated by the number of completed intervention sessions.
PrEP Adherence: Self-Reported Adherence 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 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.
Perceived stigma Baseline, Month 3, and Month 6 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.
Enacted stigma 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 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.
PrEP Adherence: Visual analog scale 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.
Intersectional stigma 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.
Anticipated stigma 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.
HIV testing uptake: Self-report Baseline, Month 3, and Month 6 HIV testing uptake will be assessed via self-report and confirmed through chart review.
- Secondary Outcome Measures
Name Time Method Information: HIV Knowledge 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.
Information: PrEP Knowledge 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.
Empowerment 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.
Motivation: Decisional Balance for Problem Behavior 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.
HIV Baseline, Month 3, and Month 6 Fourth-generation HIV-1/2 antigen/antibody combi testing will be used to detect HIV infection.
STI 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.
Sexual Risk 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.
Motivation: Rollnick's Readiness Ruler 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.
Behavioral Skills 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.
Adaptive coping 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.
Resilience 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.
Substance use: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) 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.
Substance use: Alcohol Use Disorder Identification Text (AUDIT-C) 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.
Perceived HIV risk 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.
Mental health 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.
Social support 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.
Trial Locations
- Locations (3)
Institute of HIV Research and Innovation
🇹🇭Bangkok, Thailand
Rainbow Sky Association of Thailand
🇹🇭Bangkok, Thailand
SWING Foundation
🇹🇭Bangkok, Thailand