Pre-Exposure ProphylaxisNCT05262426

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

A study testing Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Enhanced YaCool and Standard PrEP Counseling in people with Pre-Exposure Prophylaxis, run by University of Massachusetts, Worcester at 3 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 16 to 29 years, men onlyHealthy volunteers can take part
Conditions the study is for: Pre-Exposure Prophylaxis
What is being tested?: Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Enhanced YaCool 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: 145 participants
Where: 3 sitesThailand
Study dates: 27 Dec 2021to 31 Jul 2026
Phase: Interventional
Are there results?: None posted in the registry

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 16 to 29 years
Men only
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Show all 15Show fewer

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).
Have at least 1-year experience working with HIV-negative transgender women, including providing PrEP prescription and counseling
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).

Who cannot join

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
None
Aim 2:

Show all 10Show fewer

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

Trial locations and contacts

3 sites in 1 country.

Thailand3 sites

Rainbow Sky Association of Thailand
Bangkok, Bangkok, 10240
Institute of HIV Research and Innovation
Bangkok, Bangkok, 10330
SWING Foundation
Bangkok, Bangkok, 10500

Other trials in Thailand

About this study

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

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.

Read the detailed description

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.

Conditions: Pre-Exposure Prophylaxis
Being tested: Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Enhanced YaCool, Standard PrEP Counseling
Keywords: Pre-exposure Prophylaxis (PrEP), HIV Prevention, mHealth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP)Behavioural
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.
Enhanced YaCoolBehavioural
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 CounselingBehavioural
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.

Study groups in NCT05262426
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Behavioral: Enhanced YaCool; Behavioral: Standard PrEP Counseling
Standard PrEP Counseling	Active comparator	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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 1 through Month 12

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Month 12
HIV Status
HIV status based on 4th generation HIV-1/2 antigen/antibody combo testing.
Measured: 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.
Measured: 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.
Measured: Baseline to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Dec 202131 Jul 2026

First posted2 Mar 2022
Study start27 Dec 2021
Primary completion31 Jan 2026
Study completion31 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Pre-Exposure ProphylaxisStudies of the same condition, open and under way.
More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
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: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05262426
Sponsor's protocol ID: H00023527
Other IDs: 1R21HD107988-01
Status last verified: Sep 2026
First submitted: 7 Feb 2022
Last updated: 8 Sep 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.

Publications

Baral SD, Poteat T, Stromdahl S, Wirtz AL, Guadamuz TE, Beyrer C. Worldwide burden of HIV in transgender women: a systematic review and meta-analysis. Lancet Infect Dis. 2013 Mar;13(3):214-22. doi: 10.1016/S1473-3099(12)70315-8. Epub 2012 Dec 21.
PubMed 23260128
Logie CH, Newman PA, Weaver J, Roungkraphon S, Tepjan S. HIV-Related Stigma and HIV Prevention Uptake Among Young Men Who Have Sex with Men and Transgender Women in Thailand. AIDS Patient Care STDS. 2016 Feb;30(2):92-100. doi: 10.1089/apc.2015.0197. Epub 2016 Jan 20.
PubMed 26788978
Ramautarsing RA, Meksena R, Sungsing T, Chinbunchorn T, Sangprasert T, Fungfoosri O, Meekrua D, Sumalu S, Pasansai T, Bunainso W, Wongsri T, Mainoy N, Colby D, Avery M, Mills S, Vannakit R, Phanuphak P, Phanuphak N. Evaluation of a pre-exposure prophylaxis programme for men who have sex with men and transgender women in Thailand: learning through the HIV prevention cascade lens. J Int AIDS Soc. 2020 Jun;23 Suppl 3(Suppl 3):e25540. doi: 10.1002/jia2.25540.
PubMed 32602660
Rael CT, Martinez M, Giguere R, Bockting W, MacCrate C, Mellman W, Valente P, Greene GJ, Sherman S, Footer KHA, D'Aquila RT, Carballo-Dieguez A. Barriers and Facilitators to Oral PrEP Use Among Transgender Women in New York City. AIDS Behav. 2018 Nov;22(11):3627-3636. doi: 10.1007/s10461-018-2102-9.
PubMed 29589137
Wood S, Gross R, Shea JA, Bauermeister JA, Franklin J, Petsis D, Swyryn M, Lalley-Chareczko L, Koenig HC, Dowshen N. Barriers and Facilitators of PrEP Adherence for Young Men and Transgender Women of Color. AIDS Behav. 2019 Oct;23(10):2719-2729. doi: 10.1007/s10461-019-02502-y.
PubMed 30993479
Fuchs JD, Stojanovski K, Vittinghoff E, McMahan VM, Hosek SG, Amico KR, Kouyate A, Gilmore HJ, Buchbinder SP, Lester RT, Grant RM, Liu AY. A Mobile Health Strategy to Support Adherence to Antiretroviral Preexposure Prophylaxis. AIDS Patient Care STDS. 2018 Mar;32(3):104-111. doi: 10.1089/apc.2017.0255.
PubMed 29565183
Songtaweesin WN, Kawichai S, Phanuphak N, Cressey TR, Wongharn P, Saisaengjan C, Chinbunchorn T, Janyam S, Linjongrat D, Puthanakit T; CE-PID - TRC Adolescent Study Team. Youth-friendly services and a mobile phone application to promote adherence to pre-exposure prophylaxis among adolescent men who have sex with men and transgender women at-risk for HIV in Thailand: a randomized control trial. J Int AIDS Soc. 2020 Sep;23 Suppl 5(Suppl 5):e25564. doi: 10.1002/jia2.25564.
PubMed 32869511
Naar-King S, Parsons JT, Johnson AM. Motivational interviewing targeting risk reduction for people with HIV: a systematic review. Curr HIV/AIDS Rep. 2012 Dec;9(4):335-43. doi: 10.1007/s11904-012-0132-x.
PubMed 22890780
Bonar EE, Wolfe JR, Drab R, Stephenson R, Sullivan PS, Chavanduka T, Hailu B, Guest JL, Bauermeister J. Training Young Adult Peers in a Mobile Motivational Interviewing-Based Mentoring Approach to Upstream HIV Prevention. Am J Community Psychol. 2021 Mar;67(1-2):237-248. doi: 10.1002/ajcp.12471. Epub 2020 Nov 2.
PubMed 33137221
Dale SK. Using Motivational Interviewing to Increase PrEP Uptake Among Black Women at Risk for HIV: an Open Pilot Trial of MI-PrEP. J Racial Ethn Health Disparities. 2020 Oct;7(5):913-927. doi: 10.1007/s40615-020-00715-9. Epub 2020 Feb 20.
PubMed 32078743
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.
PubMed 23359664
Dubov A, Altice FL, Fraenkel L. An Information-Motivation-Behavioral Skills Model of PrEP Uptake. AIDS Behav. 2018 Nov;22(11):3603-3616. doi: 10.1007/s10461-018-2095-4.
PubMed 29557540
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.
PubMed 30033644
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.
PubMed 38219741
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.
PubMed 35587370

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing an mHealth Intervention to Improve Uptake and Adherence of the HIV Pre-exposure Prophylaxis (PrEP) in Vulnerable Adolescents and Emerging Adults
ClinicalTrials.gov ID: NCT05262426
Acronym / sponsor ID: H00023527
Conditions: Pre-Exposure Prophylaxis
Keywords: Pre-exposure Prophylaxis (PrEP), HIV Prevention, mHealth
Study type: Interventional
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: University of Massachusetts, WorcesterUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Wayne State University, Institute of HIV Research and Innovation Foundation, Thailand
Study start: 27 Dec 2021 (actual)
Primary completion: 31 Jan 2026 (actual)
Study completion: 31 Jul 2026 (actual)
First posted: 2 Mar 2022 (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.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Standard PrEP Counseling, MES-PrEP and Enhanced YaCool	Experimental	Behavioral: Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Behavioral: Enhanced YaCool, Behavioral: Standard PrEP CounselingParticipants 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.
Standard PrEP Counseling and MES-PrEP	Experimental	Behavioral: Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Behavioral: Standard PrEP CounselingParticipants in this arm will receive standard PrEP counseling, followed by one mHealth intervention (MES-PrEP) to improve PrEP uptake and support PrEP adherence.
Standard PrEP Counseling and Enhanced YaCool	Experimental	Behavioral: Enhanced YaCool, Behavioral: Standard PrEP CounselingParticipants in this arm will receive standard PrEP counseling, followed by one mHealth intervention (Enhanced YaCool) to improve PrEP uptake and support PrEP adherence.
Standard PrEP Counseling	Active comparator	Behavioral: Standard PrEP CounselingParticipants in this arm will receive the standard PrEP counseling.

Who may qualify

Ages: 16 to 29 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (15 listed)

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

Key exclusion criteria (10 listed)

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
None

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
Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP)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.	Behavioural	Standard PrEP Counseling and MES-PrEP, Standard PrEP Counseling, MES-PrEP and Enhanced YaCool
Enhanced YaCoolEnhanced 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).	Behavioural	Standard PrEP Counseling and Enhanced YaCool, Standard PrEP Counseling, MES-PrEP and Enhanced YaCool
Standard PrEP CounselingAll 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.	Behavioural	Standard PrEP Counseling, Standard PrEP Counseling and Enhanced YaCool, Standard PrEP Counseling and MES-PrEP, Standard PrEP Counseling, MES-PrEP and Enhanced YaCool

Primary outcome

Intervention Acceptability: System Usability Score
Time frame: Month 3
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.
Intervention Acceptability: System Usability Score
Time frame: Month 6
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.
Intervention Acceptability: Client Satisfaction Questionnaire
Time frame: Month 3
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.
Intervention Acceptability: Client Satisfaction Questionnaire
Time frame: Month 6
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.
Intervention Acceptability: Exit Interview
Time frame: Month 1
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.
Intervention Feasibility: Number of responses to text messages
Time frame: Baseline through Month 12
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.
Intervention Feasibility: Number of intervention sessions completed
Time frame: Baseline through Month 12
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.
Intervention Feasibility: Participant retention
Time frame: Baseline through Month 6
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.
PrEP Adherence: Visual analog scale
Time frame: Baseline through Month 12
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.
PrEP Adherence: Self-reported adherence
Time frame: Baseline through Month 12
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.
PrEP Adherence: Dried blood spots
Time frame: Baseline through Month 12
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.
PrEP Uptake
Time frame: Month 1 through Month 12
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.

8 secondary outcomes

PrEP Knowledge
Time frame: Baseline to Month 12
HIV Knowledge
Time frame: Baseline to Month 12
Motivation: Rollnick's Readiness Ruler
Time frame: Baseline to Month 12
Motivation: Decisional Balance for PrEP Use
Time frame: Baseline to Month 12
Behavior skills
Time frame: Baseline to Month 12
HIV Status
Time frame: Baseline to Month 12
Sexually Transmitted Infections (STIs) Diagnosis
Time frame: Baseline to Month 12
Sexual Risk
Time frame: Baseline to Month 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
Background: PubMed 23260128Baral SD, Poteat T, Stromdahl S, Wirtz AL, Guadamuz TE, Beyrer C. Worldwide burden of HIV in transgender women: a systematic review and meta-analysis. Lancet Infect Dis. 2013 Mar;13(3):214-22. doi: 10.1016/S1473-3099(12)70315-8. Epub 2012 Dec 21.
Background: PubMed 26788978Logie CH, Newman PA, Weaver J, Roungkraphon S, Tepjan S. HIV-Related Stigma and HIV Prevention Uptake Among Young Men Who Have Sex with Men and Transgender Women in Thailand. AIDS Patient Care STDS. 2016 Feb;30(2):92-100. doi: 10.1089/apc.2015.0197. Epub 2016 Jan 20.
Background: PubMed 32602660Ramautarsing RA, Meksena R, Sungsing T, Chinbunchorn T, Sangprasert T, Fungfoosri O, Meekrua D, Sumalu S, Pasansai T, Bunainso W, Wongsri T, Mainoy N, Colby D, Avery M, Mills S, Vannakit R, Phanuphak P, Phanuphak N. Evaluation of a pre-exposure prophylaxis programme for men who have sex with men and transgender women in Thailand: learning through the HIV prevention cascade lens. J Int AIDS Soc. 2020 Jun;23 Suppl 3(Suppl 3):e25540. doi: 10.1002/jia2.25540.
Background: PubMed 29589137Rael CT, Martinez M, Giguere R, Bockting W, MacCrate C, Mellman W, Valente P, Greene GJ, Sherman S, Footer KHA, D'Aquila RT, Carballo-Dieguez A. Barriers and Facilitators to Oral PrEP Use Among Transgender Women in New York City. AIDS Behav. 2018 Nov;22(11):3627-3636. doi: 10.1007/s10461-018-2102-9.
Background: PubMed 30993479Wood S, Gross R, Shea JA, Bauermeister JA, Franklin J, Petsis D, Swyryn M, Lalley-Chareczko L, Koenig HC, Dowshen N. Barriers and Facilitators of PrEP Adherence for Young Men and Transgender Women of Color. AIDS Behav. 2019 Oct;23(10):2719-2729. doi: 10.1007/s10461-019-02502-y.
Background: PubMed 29565183Fuchs JD, Stojanovski K, Vittinghoff E, McMahan VM, Hosek SG, Amico KR, Kouyate A, Gilmore HJ, Buchbinder SP, Lester RT, Grant RM, Liu AY. A Mobile Health Strategy to Support Adherence to Antiretroviral Preexposure Prophylaxis. AIDS Patient Care STDS. 2018 Mar;32(3):104-111. doi: 10.1089/apc.2017.0255.
Background: PubMed 32869511Songtaweesin WN, Kawichai S, Phanuphak N, Cressey TR, Wongharn P, Saisaengjan C, Chinbunchorn T, Janyam S, Linjongrat D, Puthanakit T; CE-PID - TRC Adolescent Study Team. Youth-friendly services and a mobile phone application to promote adherence to pre-exposure prophylaxis among adolescent men who have sex with men and transgender women at-risk for HIV in Thailand: a randomized control trial. J Int AIDS Soc. 2020 Sep;23 Suppl 5(Suppl 5):e25564. doi: 10.1002/jia2.25564.
Background: PubMed 22890780Naar-King S, Parsons JT, Johnson AM. Motivational interviewing targeting risk reduction for people with HIV: a systematic review. Curr HIV/AIDS Rep. 2012 Dec;9(4):335-43. doi: 10.1007/s11904-012-0132-x.
Background: PubMed 33137221Bonar EE, Wolfe JR, Drab R, Stephenson R, Sullivan PS, Chavanduka T, Hailu B, Guest JL, Bauermeister J. Training Young Adult Peers in a Mobile Motivational Interviewing-Based Mentoring Approach to Upstream HIV Prevention. Am J Community Psychol. 2021 Mar;67(1-2):237-248. doi: 10.1002/ajcp.12471. Epub 2020 Nov 2.
Background: PubMed 32078743Dale SK. Using Motivational Interviewing to Increase PrEP Uptake Among Black Women at Risk for HIV: an Open Pilot Trial of MI-PrEP. J Racial Ethn Health Disparities. 2020 Oct;7(5):913-927. doi: 10.1007/s40615-020-00715-9. Epub 2020 Feb 20.
Background: PubMed 23359664Naar-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.
Background: PubMed 29557540Dubov A, Altice FL, Fraenkel L. An Information-Motivation-Behavioral Skills Model of PrEP Uptake. AIDS Behav. 2018 Nov;22(11):3603-3616. doi: 10.1007/s10461-018-2095-4.
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. This study is not recruiting at the moment.

Bo Wang 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?

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 15 inclusion and 10 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: finished, as of the sponsor's last update on 8 Sep 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention Acceptability: System Usability Score (time frame: Month 3). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05262426, which also lists 15 linked publications.

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 8 Sep 2026.