Developing mHealth to Promote PrEP Use Among Thai Young Vulnerable Adolescents and Emerging Adults

Study Overview
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Brief Summary
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The main aim of this study is to develop technology-based interventions to improve HIV pre-exposure prophylaxis (PrEP) uptake and adherence among Thai young transgender women.

Detailed Description
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Motivational Enhancement System for Adherence (MESA) is a computer-based motivation invention, based on the Information-Motivation-Behavioral Skills (IMB) model and Motivational Interviewing (MI) principles, used to promote adherence among HIV-positive youth initiating antiretroviral treatment. In this study, the team will adapt and develop MESA to focus on PrEP uptake and adherence, which will be called Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). YaCool is a mobile application developed to support transgender women self-management of gender and sexual health, including PrEP use. In Aim 1, the investigators will begin with needs assessment to evaluate intervention efficacy by exploring the barriers and facilitators of PrEP uptake and adherence through in-depth interviews with transgender women and community health workers. The two interventions will be developed and refined based upon the inputs from transgender women through focus group discussion and community advisory board. In Aim 2, the investigators will conduct a Multiphase Optimization Strategy (MOST) design-based trial to evaluate the feasibility, acceptability, and preliminary efficacy of MES-PrEP and Enhanced YaCool and to determine whether MES-PrEP works better when combined with Enhanced YaCool to improve PrEP use. Eligible transgender women will be randomized to one of the four experimental conditions, and followed for 12 months with assessments at baseline, month 1, 3, 6, 9 and 12.

Official Title
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Optimizing an mHealth Intervention to Improve Uptake and Adherence of the HIV Pre-exposure Prophylaxis (PrEP) in Vulnerable Adolescents and Emerging Adults

Conditions
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Pre-Exposure Prophylaxis

Intervention / Treatment
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* Behavioral: Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP)
* Behavioral: Enhanced YaCool
* Behavioral: Standard PrEP Counseling


Participation Criteria
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Eligibility Criteria
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Aim 1: Transgender women participants Inclusion Criteria: Age 16-29 years old Male sex at birth Self-identifies as woman or transgender women or culturally identifies with the female spectrum Confirmed HIV-negative status Self-reported recent history of condomless sex in the past 6 months Able to understand, read and speak Thai Either having not started PrEP (Group 1: PrEP naive), currently on PrEP but not adherent to PrEP (taking ≤3 pills/week) in the past month (Group 2: PrEP users) or currently on PrEP with good adherence (Group 3: PrEP users with good adherence). Exclusion Criteria: Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent Have active suicidal ideation or major mental illness (e.g., untreated psychosis or mania) at the time of interview (patients will be referred for treatment) Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreased creatinine clearance) Healthcare providers Inclusion Criteria: Have at least 1-year experience working with HIV-negative transgender women, including providing PrEP prescription and counseling Exclusion Criteria: None Aim 2: Inclusion Criteria: Age 16-29 years old Male sex at birth Self-identifies as woman or transgender women or culturally identifies with the female spectrum Confirmed HIV-negative status Self-reported recent history of condomless sex in the past 6 months Able to understand, read and speak Thai Either having not started PrEP (Group 1: PrEP naive), currently on PrEP but not adherent to PrEP (taking ≤3 pills/week) in the past month (Group 2: PrEP users). Exclusion Criteria: Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent Have active suicidal ideation or major mental illness (e.g., untreated psychosis or mania) at the time of interview (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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard PrEP Counseling, MES-PrEP and Enhanced YaCool<br>Participants in this arm will receive standard PrEP counseling, followed by two mHealth interventions (MES-PrEP and Enhanced YaCool) to improve PrEP uptake and support PrEP adherence. | Behavioral: Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP)<br>* MES-PrEP is a two-session computer-delivered intervention based on IMB model. The intervention is tailored based on the person's ratings of perceived importance and confidence of initiating PrEP and sustaining adherence to PrEP. Participants are routed to different intervention content based on their assessment of their importance and confidence. Youth are provided with feedback on scores on the knowledge assessment followed by information about protective effect that can result from improved PrEP adherence. Finally, participants are asked to set a goal: obtain PrEP prescription, optimal adherence, practice steps, or thinking about it more, and they form plans for overcoming barriers. In the second session, branches are based on whether the youth felt they met the goal, partially met the goal, or did not meet the goal. Sessions of MES-PrEP will occur at baseline and month 1.<br>Behavioral: Enhanced YaCool<br>* Enhanced YaCool is mobile application developed to support transgender women self-management of their gender and sexual health, including PrEP use. YaCool is a passcode-protected app that allows users to personalized text messaged reminders to take PrEP and/or clinic appointments, record PrEP adherence and sexual activity, and track lab tests. The application is set up to provide personalized recommendations for PrEP regimen, confirmed by clinic healthcare staff. Participants will be asked to download Enhanced YaCool to support PrEP use and gender/sexual health self-management between MES-PrEP sessions for 30 days, and thereafter until the end of Month 12 (if desired).<br>Behavioral: Standard PrEP Counseling<br>* All participants will received one-on-one, face to face counseling from lay providers at baseline, months 1, 3, 6, 9 and 12. Standard PrEP counseling includes sexual and behavioral risk assessment for HIV/STIs and risk reduction. For those not on PrEP, the sessions will focus on risk perception, awareness of PrEP/post-exposure prophylaxis (PEP) and facilitators and barriers of accessing PrEP. For those on PrEP, the sessions will focus on adherence. Standard counseling sessions will be nonjudgmental, non-discriminatory and client-centered.<br>|
| Experimental: Standard PrEP Counseling and MES-PrEP<br>Participants in this arm will receive standard PrEP counseling, followed by one mHealth intervention (MES-PrEP) to improve PrEP uptake and support PrEP adherence. | Behavioral: Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP)<br>* MES-PrEP is a two-session computer-delivered intervention based on IMB model. The intervention is tailored based on the person's ratings of perceived importance and confidence of initiating PrEP and sustaining adherence to PrEP. Participants are routed to different intervention content based on their assessment of their importance and confidence. Youth are provided with feedback on scores on the knowledge assessment followed by information about protective effect that can result from improved PrEP adherence. Finally, participants are asked to set a goal: obtain PrEP prescription, optimal adherence, practice steps, or thinking about it more, and they form plans for overcoming barriers. In the second session, branches are based on whether the youth felt they met the goal, partially met the goal, or did not meet the goal. Sessions of MES-PrEP will occur at baseline and month 1.<br>Behavioral: Standard PrEP Counseling<br>* All participants will received one-on-one, face to face counseling from lay providers at baseline, months 1, 3, 6, 9 and 12. Standard PrEP counseling includes sexual and behavioral risk assessment for HIV/STIs and risk reduction. For those not on PrEP, the sessions will focus on risk perception, awareness of PrEP/post-exposure prophylaxis (PEP) and facilitators and barriers of accessing PrEP. For those on PrEP, the sessions will focus on adherence. Standard counseling sessions will be nonjudgmental, non-discriminatory and client-centered.<br>|
| Experimental: Standard PrEP Counseling and Enhanced YaCool<br>Participants in this arm will receive standard PrEP counseling, followed by one mHealth intervention (Enhanced YaCool) to improve PrEP uptake and support PrEP adherence. | Behavioral: Enhanced YaCool<br>* Enhanced YaCool is mobile application developed to support transgender women self-management of their gender and sexual health, including PrEP use. YaCool is a passcode-protected app that allows users to personalized text messaged reminders to take PrEP and/or clinic appointments, record PrEP adherence and sexual activity, and track lab tests. The application is set up to provide personalized recommendations for PrEP regimen, confirmed by clinic healthcare staff. Participants will be asked to download Enhanced YaCool to support PrEP use and gender/sexual health self-management between MES-PrEP sessions for 30 days, and thereafter until the end of Month 12 (if desired).<br>Behavioral: Standard PrEP Counseling<br>* All participants will received one-on-one, face to face counseling from lay providers at baseline, months 1, 3, 6, 9 and 12. Standard PrEP counseling includes sexual and behavioral risk assessment for HIV/STIs and risk reduction. For those not on PrEP, the sessions will focus on risk perception, awareness of PrEP/post-exposure prophylaxis (PEP) and facilitators and barriers of accessing PrEP. For those on PrEP, the sessions will focus on adherence. Standard counseling sessions will be nonjudgmental, non-discriminatory and client-centered.<br>|
| Active Comparator: Standard PrEP Counseling<br>Participants in this arm will receive the standard PrEP counseling. | Behavioral: Standard PrEP Counseling<br>* All participants will received one-on-one, face to face counseling from lay providers at baseline, months 1, 3, 6, 9 and 12. Standard PrEP counseling includes sexual and behavioral risk assessment for HIV/STIs and risk reduction. For those not on PrEP, the sessions will focus on risk perception, awareness of PrEP/post-exposure prophylaxis (PEP) and facilitators and barriers of accessing PrEP. For those on PrEP, the sessions will focus on adherence. Standard counseling sessions will be nonjudgmental, non-discriminatory and client-centered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Acceptability: System Usability Score | System Usability Score (SUS) is a 10-item, Likert scale used to calculate intervention usability. Each item ranges from 0 to 4 (with 4 being the most positive response). For odd-numbered items, the score is calculated by subtracting one from the user response. For even-numbered items, the score is calculated by subtracting the user response from 5. Then sum the total score and multiply that by 2.5. The overall SUS scores range from 0 to 100. A score of > 50 indicates that the technology-based interventions are acceptable. | Month 3 | 
| Intervention Acceptability: System Usability Score | System Usability Score (SUS) is a 10-item, Likert scale used to calculate intervention usability. Each item ranges from 0 to 4 (with 4 being the most positive response). For odd-numbered items, the score is calculated by subtracting one from the user response. For even-numbered items, the score is calculated by subtracting the user response from 5. Then sum the total score and multiply that by 2.5. The overall SUS scores range from 0 to 100. A score of > 50 indicates that the technology-based interventions are acceptable. | Month 6 | 
| Intervention Acceptability: Client Satisfaction Questionnaire | Client Satisfaction Questionnaire (CSQ-8) is an 8-items, Likert scale measuring the construct of global intervention satisfaction. The total possible composite score range from 8 to 32, with higher scores indicating a greater degree of acceptability. | Month 3 | 
| Intervention Acceptability: Client Satisfaction Questionnaire | Client Satisfaction Questionnaire (CSQ-8) is an 8-items, Likert scale measuring the construct of global intervention satisfaction. The total possible composite score range from 8 to 32, with higher scores indicating a greater degree of acceptability. | Month 6 | 
| Intervention Acceptability: Exit Interview | Intervention acceptability will be assess by the number of positive responses based on the exit interviews administered at month 1. Participants will be asked to provide feedback on experiences using MES-PrEP and enhanced YaCool, acceptability and ease of use, suggestions for improvement, role in PrEP uptake and adherence, and interest in continued intervention use, as well as experiences following a PrEP regimen, reasons for discontinuation of PrEP, and additional tools that would assist them in taking PrEP. | Month 1 | 
| Intervention Feasibility: Number of responses to text messages | Intervention feasibility will be measured by total number of responses to and frequency of usage of Enhanced YaCool. Point estimates of >50% of participants responded to Enhanced YaCool at least once is considered as the minimum criteria for feasibility. | Baseline through Month 12 | 
| Intervention Feasibility: Number of intervention sessions completed | Intervention feasibility will be measured by number of intervention sessions completed. Point estimates of >50% of participants completed at least one intervention session is considered as the minimum criteria for feasibility. | Baseline through Month 12 | 
| Intervention Feasibility: Participant retention | Intervention Feasibility will be measured by participants retention rate at Month 6. Retention rate of >85% at month 6 is considered as the minimum criteria for feasibility. | Baseline through Month 6 | 
| PrEP Adherence: Visual analog scale | PrEP adherence will be measured from Young Adult Adherence Interview via computer-assisted self-interview (CASI) survey which contains a visual analog scale (VAS). VAS ranges from 0 to 100, with higher percentage indicating greater adherence to PrEP. | Baseline through Month 12 | 
| PrEP Adherence: Self-reported adherence | PrEP adherence will be measured from self-reported adherence to PrEP in the past 4 weeks via CASI survey. The scale ranges from 0 to 100%, with higher percentage indicating greater adherence to PrEP. The result of this self-reported adherence will be triangulated with the results of dried blood spots testing. | Baseline through Month 12 | 
| PrEP Adherence: Dried blood spots | PrEP adherence will be measured by the level of tenofovir in dried blood spots (DBS). DBS report on 80% Truvada adherence after at least three weeks of regular adherence. | Baseline through Month 12 | 
| PrEP Uptake | PrEP uptake will be measured by the number of PrEP prescription, using a self-report measure (participants reporting if they left the clinic with PrEP) and confirming with clinic records. | Month 1 through Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Knowledge | Knowledge of PrEP will be measured using the 13-item PrEP knowledge scale. The total possible score is 13, with higher scores indicating a greater degree of PrEP knowledge. | Baseline to Month 12 | 
| HIV Knowledge | Knowledge of HIV transmission risk will be assessed using am 18-item HIV Knowledge Questionnaire. The total possible composite score range from 0 to 18, with higher scores indicating a greater degree of HIV knowledge. | Baseline to Month 12 | 
| Motivation: Rollnick's Readiness Ruler | Behavioral intentions will be measured using 5-item Rollnick's Readiness Ruler, which correspond to PrEP uptake and adherence. Each item ranges from 0 to 10, with higher numbers indicate greater readiness for change. | Baseline to Month 12 | 
| Motivation: Decisional Balance for PrEP Use | Attitude towards PrEP will be measured using 36-item Decisional Balance for PrEP Use. The 5-point Likert scale assesses the pros and cons of PrEP use and is helpful in understanding cognitive and motivational aspects of decision making. | Baseline to Month 12 | 
| Behavior skills | Behavior skills will be assessed using the 8-item adapted version of Self-Efficacy for Health Promotion and Risk Reduction Questionnaire. The 5-point Likert scale assesses the confidence in using a condom, taking PrEP as recommended and getting PrEP refills. The total possible score is 40, with higher scores indicating a greater confidence for each item. | Baseline to Month 12 | 
| HIV Status | HIV status based on 4th generation HIV-1/2 antigen/antibody combo testing. | Baseline to Month 12 | 
| Sexually Transmitted Infections (STIs) Diagnosis | STI diagnosis based on treponemal test with rapid plasma reagin (RPR) confirmation for syphilis. Pooled urine, oropharyngeal and rectal swabs for gonorrhea and chlamydia nucleic acid amplification test (NAAT) testing. | Baseline to Month 12 | 
| Sexual Risk | Sexual risk will be assessed through Timeline Followback via CASI, which collects sexual behavior in the past 30 days, including questions about condom use and number of sexual partners. | Baseline to Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-exposure Prophylaxis (PrEP), HIV Prevention, mHealth