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

NCT05262426 | Active Not Recruiting DMC

• 2 other identifiers: H000235271R21HD107988-01
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pre-Exposure Prophylaxis

Keywords

Pre-exposure Prophylaxis (PrEP); HIV Prevention; mHealth

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (8)

• PrEP Knowledge

  Baseline to Month 12

• HIV Knowledge

  Baseline to Month 12

• Motivation: Rollnick's Readiness Ruler

  Baseline to Month 12

• Motivation: Decisional Balance for PrEP Use

  Baseline to Month 12

• Behavior skills

  Baseline to Month 12

Other Outcomes (6)

• Drug/Alcohol Use: ASSIST

  Baseline to Month 12

• Drug/Alcohol Use: AUDIT-C

  Baseline to Month 12

• Mental Health

  Baseline to Month 12

Study Arms (4)

Standard PrEP Counseling, MES-PrEP and Enhanced YaCool

EXPERIMENTAL

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); Behavioral: Enhanced YaCool; Behavioral: Standard PrEP Counseling

Standard PrEP Counseling and MES-PrEP

EXPERIMENTAL

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); Behavioral: Standard PrEP Counseling

Standard PrEP Counseling and Enhanced YaCool

EXPERIMENTAL

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; Behavioral: Standard PrEP Counseling

Standard PrEP Counseling

ACTIVE COMPARATOR

Participants in this arm will receive the standard PrEP counseling.

Behavioral: Standard PrEP Counseling

Interventions

Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP) BEHAVIORAL

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.

Standard PrEP Counseling and MES-PrEP; Standard PrEP Counseling, MES-PrEP and Enhanced YaCool

Standard PrEP Counseling BEHAVIORAL

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.

Standard PrEP Counseling; Standard PrEP Counseling and Enhanced YaCool; Standard PrEP Counseling and MES-PrEP; Standard PrEP Counseling, MES-PrEP and Enhanced YaCool

Enhanced YaCool BEHAVIORAL

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).

Standard PrEP Counseling and Enhanced YaCool; Standard PrEP Counseling, MES-PrEP and Enhanced YaCool

Eligibility Criteria

• Age: 16 Years - 29 Years
• Gender Eligibility Details: Transgender Women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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
• Have at least 1-year experience working with HIV-negative transgender women, including providing PrEP prescription and counseling
• None
• Aim 2:
• 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).
• Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Wayne State University: collaborator
• Institute of HIV Research and Innovation Foundation, Thailand: collaborator
• University of Massachusetts, Worcester: lead

Study Sites (3)

Rainbow Sky Association of Thailand

Bangkok, Bangkok, 10240, Thailand

Location

Institute of HIV Research and Innovation

Bangkok, Bangkok, 10330, Thailand

Location

SWING Foundation

Bangkok, Bangkok, 10500, Thailand

Location

Related Publications (15)

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• Naar-King S, Outlaw AY, Sarr M, Parsons JT, Belzer M, Macdonell K, Tanney M, Ondersma SJ; Adolescent Medicine Network for HIV/AIDS Interventions. Motivational Enhancement System for Adherence (MESA): pilot randomized trial of a brief computer-delivered prevention intervention for youth initiating antiretroviral treatment. J Pediatr Psychol. 2013 Jul;38(6):638-48. doi: 10.1093/jpepsy/jss132. Epub 2013 Jan 28.

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  PMID: 29557540 BACKGROUND

• Phanuphak N, Anand T, Jantarapakde J, Nitpolprasert C, Himmad K, Sungsing T, Trachunthong D, Phomthong S, Phoseeta P, Tongmuang S, Mingkwanrungruang P, Meekrua D, Sukthongsa S, Hongwiangchan S, Upanun N, Barisri J, Pankam T, Phanuphak P. What would you choose: Online or Offline or Mixed services? Feasibility of online HIV counselling and testing among Thai men who have sex with men and transgender women and factors associated with service uptake. J Int AIDS Soc. 2018 Jul;21 Suppl 5(Suppl Suppl 5):e25118. doi: 10.1002/jia2.25118.

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• Janamnuaysook R, Guo Y, Yu YJ, Phanuphak N, Kawichai S, MacDonell K, Jupimai T, Rongkavilit C, Wang B. Lived experiences with pre-exposure prophylaxis uptake and adherence among transgender women in Thailand: a qualitative study. Sex Health. 2024 Jan;21:SH23102. doi: 10.1071/SH23102.

  PMID: 38219741 RESULT

• MacDonell KK, Wang B, Phanuphak N, Janamnuaysook R, Srimanus P, Rongkavilit C, Naar S. Optimizing an mHealth Intervention to Improve Uptake and Adherence to HIV Pre-exposure Prophylaxis in Young Transgender Women: Protocol for a Multi-Phase Trial. JMIR Res Protoc. 2022 May 19;11(5):e37659. doi: 10.2196/37659.

  PMID: 35587370 DERIVED

Study Officials

• Bo Wang

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 2, 2022
• Study Start: December 27, 2021
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wises to access the data.

Locations

TH (3)