Pre-Exposure ProphylaxisNCT05243030

Developing mHealth to Promote PrEP Use Among Thai Young Men Who Have Sex With Men

A study testing Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Motivational Interactive Text Messaging (MTM) 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 goal of this study is to develop and pilot test technology-based interventions to promote Pre-exposure Prophylaxis (PrEP) uptake and adherence among Thai young men who have sex with men (YMSM). Read more about this study

Who is it for?: Ages 16 to 25 years, men onlyHealthy volunteers can take part
Conditions the study is for: Pre-Exposure Prophylaxis
What is being tested?: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Motivational Interactive Text Messaging (MTM) 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: 119 participants
Where: 3 sitesThailand
Study dates: 23 Feb 2022to 17 Jul 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 25 years
Men only
Healthy volunteers accepted
Child, Adult

Who may be able to join

Age 16-25 years old
Men who report sex with men in the past 12 months
Confirmed HIV-negative status
Self-reported evidence of being at-risk for HIV acquisition, including one of the following in the past 6 months:
having a sex with an HIV-positive partner
having anal sex

Show all 11Show fewer

without using a condom
being diagnosed with an STI or
having any illicit drug use (e.g., Amphetamine type stimulants)
Able to understand, read and speak Thai
Either having not started PrEP (Group 1: PrEP naive) or currently on PrEP but not adherent to PrEP (taking ≤3 pills/week) in the past month (Group 2: PrEP users).

Who cannot join

In a mutually monogamous relationship of more than 6 months with a partner who recently tested HIV-negative
Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent
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: Adapting Effective mHealth Interventions to Improve Uptake and Adherence of the HIV Pre-exposure Prophylaxis (PrEP) in Thai Young Men Who Have Sex With Men (MSM).

The goal of this study is to develop and pilot test technology-based interventions to promote Pre-exposure Prophylaxis (PrEP) uptake and adherence among Thai young men who have sex with men (YMSM).

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). Motivational Interactive Text Messaging (MTM) will be integrated with MES-PrEP to provide ongoing support to maintain the individual's motivation for behavior change. Both interventions will be developed and refined based upon the inputs from YMSM through focus group discussion and youth advisory board.

The Investigators propose to pilot randomized controlled trial (RCT) to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention combining MES-PrEP and MTM to increase PrEP uptake and adherence among Thai YMSM. Eligible YMSM will be randomized to receive either the intervention plus the standard PrEP counseling or standard PrEP counseling, and followed for 6 months with assessments at baseline, month 1, 3 and 6.

Conditions: Pre-Exposure Prophylaxis
Being tested: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Motivational Interactive Text Messaging (MTM), Standard PrEP Counseling
Keywords: Pre-exposure Prophylaxis (PrEP), HIV Prevention, Mobile health (mHealth)

What participants receive

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

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.
Motivational Interactive Text Messaging (MTM)Behavioural
Participants will receive automated motivational text messages to promote PrEP initiation and adherence. These contents will be customized based on their readiness to change in regards to PrEP. The message content is individualized based on participant response to baseline survey. Those participants who indicate that they are "ready" to set the goal to take PrEP will receive text messages reminding them to take PrEP. Those who indicate that they are less than ready to take their PrEP can choose from a range of alternatives, such as taking on-demand PrEP or just think about taking PrEP. For those who are not ready to take PrEP, the content will be individualized based on the participant's choice, i.e., a daily message encouraging them to work toward their chosen goal. Participants who are currently not on PrEP will receive daily text messages regarding PrEP effectiveness, HIV risk and where to access PrEP.
Standard PrEP CounselingBehavioural
All participants will received one-on-one, face to face counseling from lay providers at baseline, months 1, 3 and 6. 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 NCT05243030
Study group	Role	What they receive
MES-PrEP and MTM	Experimental	Participants in this arm will receive standard PrEP counseling, followed by mHealth interventions to improve PrEP uptake and support PrEP adherence. Receives: Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP); Behavioral: Motivational Interactive Text Messaging (MTM); 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 Scale
System Usability Scale (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: 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 Feasibility: Number of Participants Who Responded to Text Messages
Intervention feasibility will be measured by the total number of participants who responded to text messages. Point estimates of >50% of participants responded to at least one text message are considered the minimum criteria for feasibility.
Measured: Baseline through Month 6
Intervention Feasibility: Number of Participants Who Completed the Intervention (MES-PrEP) Sessions
Intervention feasibility will be measured by participants who completed the MES-PrEP sessions. Point estimates of >50% of participants completed at least one MES-PrEP intervention session is considered as the minimum criteria for feasibility.
Measured: Baseline through Month 6
Intervention Feasibility: Participant Retention
Intervention Feasibility will be measured by participants retention rate at Month 6.
Measured: Baseline through Month 6
PrEP Uptake
PrEP uptake (initiation of a daily PrEP regimen) was measured by self-report.
Measured: Month 6
PrEP Adherence
PrEP adherence was measured by self-report and confirmed using dried blood spot test results (>= 700 fmol/3mm).
Measured: Month 6

Secondary outcomes (10)

HIV Knowledge (Score Difference: Month 6 - Baseline)
Knowledge of HIV was measured using a 15-item knowledge scale. Total scores ranged from 0 to 15, with higher scores indicating greater HIV knowledge. Change in knowledge scores was calculated by subtracting the baseline score from the Month 6 score.
Measured: Baseline to Month 6
Readiness for PrEP Use (Score Difference: Month 6 - Baseline)
Readiness for PrEP uptake and adherence was measured using the Contemplation Ladder for PrEP use, a 10-point Likert scale ranging from 1 (precontemplation) to 10 (maintenance). Change in readiness was calculated by subtracting the baseline score from the Month 6 score.
Measured: Baseline to Month 6
Attitudes Towards PrEP - Positive (Score Difference: Month 6 - Baseline)
Positive attitudes toward PrEP were measured using the perceived pros subscale of the 21-item Decisional Balance for PrEP Use scale. The subscale includes 12 items rated on a 5-point Likert scale from 0 to 4. Item scores were averaged to calculate the subscale score, resulting in a possible score range of 0 to 4, with higher scores indicating more positive attitudes toward PrEP. Change in attitudes was calculated by subtracting the baseline score from the Month 6 score, resulting in a possible change-score range of -4 to 4. Positive values indicated an increase in positive attitudes towards PrEP.
Measured: Baseline to Month 6
Attitudes Towards PrEP - Negative (Score Difference: Month 6 - Baseline)
Negative attitudes toward PrEP were measured using the perceived cons subscale of the 21-item Decisional Balance for PrEP Use scale. The subscale includes 9 items rated on a 5-point Likert scale from 0 to 4. Item scores were averaged to calculate the subscale score, resulting in a possible score range of 0 to 4, with higher scores indicating more negative attitudes toward PrEP. Change in attitudes was calculated by subtracting the baseline score from the Month 6 score, resulting in a possible change-score range of -4 to 4. Positive values indicated an increase in negative attitudes towards PrEP.
Measured: Baseline to Month 6
Behavioral Skill - PrEP Use (Score Difference: Month 6 - Baseline)
Behavioral skills for PrEP use were assessed using an item from an adapted version of the Self-Efficacy for Health Promotion and Risk Reduction Questionnaire. The item assessed confidence in taking PrEP as recommended on a scale from 1 to 10, with higher scores indicating greater confidence. Change in self-efficacy was calculated by subtracting the baseline score from the Month 6 score, resulting in a possible change-score range of -9 to +9, with positive values indicating increased self-efficacy.
Measured: Baseline to Month 6
Behavioral Skill - Risky Sex Reduction (Score Difference: Month 6 - Baseline)
Behavioral skills for risky sex reduction were assessed using an item from an adapted version of the Self-Efficacy for Health Promotion and Risk Reduction Questionnaire. The item assessed confidence in reducing condomless anal sex on a scale from 1 to 10, with higher scores indicating greater confidence. Change in self-efficacy was calculated by subtracting the baseline score from the Month 6 score, resulting in a possible change-score range of -9 to +9, with positive values indicating increased self-efficacy.
Measured: Baseline to Month 6
Behavioral Skill - Regular HIV Testing (Score Difference: Month 6 - Baseline)
Behavioral skills for regular HIV testing use were assessed using an item from an adapted version of the Self-Efficacy for Health Promotion and Risk Reduction Questionnaire. The item assessed confidence in taking HIV testing every 3-6 months on a scale from 1 to 10, with higher scores indicating greater confidence. Change in self-efficacy was calculated by subtracting the baseline score from the Month 6 score, resulting in a possible change-score range of -9 to +9, with positive values indicating increased self-efficacy.
Measured: Baseline to Month 6
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: Month 6
Sexual Risk (Score Difference: Month 6 - Baseline)
The sexual risk behavior score was calculated based on condomless sex, multiple sexual partners, having an HIV-positive partner, and anal sex. Scores ranged from 1 to 11, with higher scores indicating greater sexual risk. Change in sexual risk was calculated by subtracting the baseline score from the Month 6 score.
Measured: Baseline to Month 6
Number of Participants Who Tested Positive for HIV
HIV status was determined using the 4th generation HIV-1/2 antigen/antibody combo testing.
Measured: Baseline to Month 6

Timeline

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

23 Feb 202217 Jul 2025

First posted16 Feb 2022
Study start23 Feb 2022
Primary completion17 Jul 2025
Study completion17 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (21)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: Parallel groups
Model description: 2-arm RCT with 2:1 randomization to MES-PrEP+MTM or standard PrEP Counseling
Masking: None (open label)
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05243030
Sponsor's protocol ID: H00023523
Other IDs: 1R34MH124081-01A1
Status last verified: Oct 2026
First submitted: 18 Jan 2022
Last updated: 28 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All IPD collected during the study, after deidentification.

Publications

Colby D, Srithanaviboonchai K, Vanichseni S, Ongwandee S, Phanuphak N, Martin M, Choopanya K, Chariyalertsak S, van Griensven F. HIV pre-exposure prophylaxis and health and community systems in the Global South: Thailand case study. J Int AIDS Soc. 2015 Jul 20;18(4 Suppl 3):19953. doi: 10.7448/IAS.18.4.19953. eCollection 2015.
PubMed 26198342
Phanuphak N, Sungsing T, Jantarapakde J, Pengnonyang S, Trachunthong D, Mingkwanrungruang P, Sirisakyot W, Phiayura P, Seekaew P, Panpet P, Meekrua P, Praweprai N, Suwan F, Sangtong S, Brutrat P, Wongsri T, Na Nakorn PR, Mills S, Avery M, Vannakit R, Phanuphak P. Princess PrEP program: the first key population-led model to deliver pre-exposure prophylaxis to key populations by key populations in Thailand. Sex Health. 2018 Nov;15(6):542-555. doi: 10.1071/SH18065.
PubMed 30249317
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
Kolmodin MacDonell K, Naar S, Gibson-Scipio W, Lam P, Secord E. The Detroit Young Adult Asthma Project: Pilot of a Technology-Based Medication Adherence Intervention for African-American Emerging Adults. J Adolesc Health. 2016 Oct;59(4):465-71. doi: 10.1016/j.jadohealth.2016.05.016. Epub 2016 Jul 27.
PubMed 27475032
Horvath T, Azman H, Kennedy GE, Rutherford GW. Mobile phone text messaging for promoting adherence to antiretroviral therapy in patients with HIV infection. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009756. doi: 10.1002/14651858.CD009756.
PubMed 22419345
Thienkrua W, van Griensven F, Mock PA, Dunne EF, Raengsakulrach B, Wimonsate W, Howteerakul N, Ungsedhapand C, Chiwarakorn A, Holtz TH. Young Men Who Have Sex with Men at High Risk for HIV, Bangkok MSM Cohort Study, Thailand 2006-2014. AIDS Behav. 2018 Jul;22(7):2137-2146. doi: 10.1007/s10461-017-1963-7.
PubMed 29138981
Wheelock A, Eisingerich AB, Ananworanich J, Gomez GB, Hallett TB, Dybul MR, Piot P. Are Thai MSM willing to take PrEP for HIV prevention? An analysis of attitudes, preferences and acceptance. PLoS One. 2013;8(1):e54288. doi: 10.1371/journal.pone.0054288. Epub 2013 Jan 14.
PubMed 23342121
Seekaew P, Nguyen E, Sungsing T, Jantarapakde J, Pengnonyang S, Trachunthong D, Mingkwanrungruang P, Sirisakyot W, Phiayura P, Panpet P, Meekrua P, Praweprai N, Suwan F, Sangtong S, Brutrat P, Wongsri T, Nakorn PRN, Mills S, Avery M, Vannakit R, Phanuphak P, Phanuphak N. Correlates of nonadherence to key population-led HIV pre-exposure prophylaxis services among Thai men who have sex with men and transgender women. BMC Public Health. 2019 Mar 21;19(1):328. doi: 10.1186/s12889-019-6645-0.
PubMed 30898095
Beyrer C, Baral SD, van Griensven F, Goodreau SM, Chariyalertsak S, Wirtz AL, Brookmeyer R. Global epidemiology of HIV infection in men who have sex with men. Lancet. 2012 Jul 28;380(9839):367-77. doi: 10.1016/S0140-6736(12)60821-6. Epub 2012 Jul 20.
PubMed 22819660
Chan PA, Mena L, Patel R, Oldenburg CE, Beauchamps L, Perez-Brumer AG, Parker S, Mayer KH, Mimiaga MJ, Nunn A. Retention in care outcomes for HIV pre-exposure prophylaxis implementation programmes among men who have sex with men in three US cities. J Int AIDS Soc. 2016 Jun 13;19(1):20903. doi: 10.7448/IAS.19.1.20903. eCollection 2016.
PubMed 27302837
Schnall R, Travers J, Rojas M, Carballo-Dieguez A. eHealth interventions for HIV prevention in high-risk men who have sex with men: a systematic review. J Med Internet Res. 2014 May 26;16(5):e134. doi: 10.2196/jmir.3393.
PubMed 24862459
Parsons JT, Lelutiu-Weinberger C, Botsko M, Golub SA. A randomized controlled trial utilizing motivational interviewing to reduce HIV risk and drug use in young gay and bisexual men. J Consult Clin Psychol. 2014 Feb;82(1):9-18. doi: 10.1037/a0035311. Epub 2013 Dec 23.
PubMed 24364800
Naar-King S, Outlaw A, Green-Jones M, Wright K, Parsons JT. Motivational interviewing by peer outreach workers: a pilot randomized clinical trial to retain adolescents and young adults in HIV care. AIDS Care. 2009 Jul;21(7):868-73. doi: 10.1080/09540120802612824.
PubMed 20024744
Liu AY, Vittinghoff E, von Felten P, Rivet Amico K, Anderson PL, Lester R, Andrew E, Estes I, Serrano P, Brothers J, Buchbinder S, Hosek S, Fuchs JD. Randomized Controlled Trial of a Mobile Health Intervention to Promote Retention and Adherence to Preexposure Prophylaxis Among Young People at Risk for Human Immunodeficiency Virus: The EPIC Study. Clin Infect Dis. 2019 May 30;68(12):2010-2017. doi: 10.1093/cid/ciy810.
PubMed 30239620
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

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?

See locations

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RecruitingPhase 3
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
RecruitingPhase 4
Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP
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All Pre-Exposure Prophylaxis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adapting Effective mHealth Interventions to Improve Uptake and Adherence of the HIV Pre-exposure Prophylaxis (PrEP) in Thai Young Men Who Have Sex With Men (MSM).
ClinicalTrials.gov ID: NCT05243030
Acronym / sponsor ID: H00023523
Conditions: Pre-Exposure Prophylaxis
Keywords: Pre-exposure Prophylaxis (PrEP), HIV Prevention, Mobile health (mHealth)
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: University of Massachusetts, WorcesterUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH), Institute of HIV Research and Innovation Foundation, Thailand
Study start: 23 Feb 2022 (actual)
Primary completion: 17 Jul 2025 (actual)
Study completion: 17 Jul 2025 (actual)
First posted: 16 Feb 2022 (actual)
Results: Posted 28 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this study is to develop and pilot test technology-based interventions to promote Pre-exposure Prophylaxis (PrEP) uptake and adherence among Thai young men who have sex with men (YMSM).

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 2-arm RCT with 2:1 randomization to MES-PrEP+MTM or standard PrEP Counseling

Arm	Type	Receives
MES-PrEP and MTM	Experimental	Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Behavioral: Motivational Interactive Text Messaging (MTM), Behavioral: Standard PrEP CounselingParticipants in this arm will receive standard PrEP counseling, followed by mHealth interventions 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 25 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (11 listed)

Age 16-25 years old
Men who report sex with men in the past 12 months
Confirmed HIV-negative status
Self-reported evidence of being at-risk for HIV acquisition, including one of the following in the past 6 months:
Able to understand, read and speak Thai

Key exclusion criteria (3 listed)

In a mutually monogamous relationship of more than 6 months with a partner who recently tested HIV-negative
Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent
currently enrolled in another HIV intervention study

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
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	MES-PrEP and MTM
Motivational Interactive Text Messaging (MTM)Participants will receive automated motivational text messages to promote PrEP initiation and adherence. These contents will be customized based on their readiness to change in regards to PrEP. The message content is individualized based on participant response to baseline survey. Those participants who indicate that they are "ready" to set the goal to take PrEP will receive text messages reminding them to take PrEP. Those who indicate that they are less than ready to take their PrEP can choose from a range of alternatives, such as taking on-demand PrEP or just think about taking PrEP. For those who are not ready to take PrEP, the content will be individualized based on the participant's choice, i.e., a daily message encouraging them to work toward their chosen goal. Participants who are currently not on PrEP will receive daily text messages regarding PrEP effectiveness, HIV risk and where to access PrEP.	Behavioural	MES-PrEP and MTM
Standard PrEP CounselingAll participants will received one-on-one, face to face counseling from lay providers at baseline, months 1, 3 and 6. 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	MES-PrEP and MTM, Standard PrEP Counseling

Primary outcome

Intervention Acceptability: System Usability Scale
Time frame: Month 3
System Usability Scale (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 Feasibility: Number of Participants Who Responded to Text Messages
Time frame: Baseline through Month 6
Intervention feasibility will be measured by the total number of participants who responded to text messages. Point estimates of >50% of participants responded to at least one text message are considered the minimum criteria for feasibility.
Intervention Feasibility: Number of Participants Who Completed the Intervention (MES-PrEP) Sessions
Time frame: Baseline through Month 6
Intervention feasibility will be measured by participants who completed the MES-PrEP sessions. Point estimates of >50% of participants completed at least one MES-PrEP 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.
PrEP Uptake
Time frame: Month 6
PrEP uptake (initiation of a daily PrEP regimen) was measured by self-report.
PrEP Adherence
Time frame: Month 6
PrEP adherence was measured by self-report and confirmed using dried blood spot test results (>= 700 fmol/3mm).

10 secondary outcomes

HIV Knowledge (Score Difference: Month 6 - Baseline)
Time frame: Baseline to Month 6
Readiness for PrEP Use (Score Difference: Month 6 - Baseline)
Time frame: Baseline to Month 6
Attitudes Towards PrEP - Positive (Score Difference: Month 6 - Baseline)
Time frame: Baseline to Month 6
Attitudes Towards PrEP - Negative (Score Difference: Month 6 - Baseline)
Time frame: Baseline to Month 6
Behavioral Skill - PrEP Use (Score Difference: Month 6 - Baseline)
Time frame: Baseline to Month 6
Behavioral Skill - Risky Sex Reduction (Score Difference: Month 6 - Baseline)
Time frame: Baseline to Month 6
Behavioral Skill - Regular HIV Testing (Score Difference: Month 6 - Baseline)
Time frame: Baseline to Month 6
Sexually Transmitted Infections (STIs) Diagnosis
Time frame: Month 6
Sexual Risk (Score Difference: Month 6 - Baseline)
Time frame: Baseline to Month 6
Number of Participants Who Tested Positive for HIV
Time frame: Baseline to Month 6

Results and safety

Results posted to the registry on 28 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MES-PrEP and MTM	79	68
Standard PrEP Counseling	40	35

Primary outcome: Intervention Acceptability: System Usability Scale

Time frame: Month 3. Mean (Standard Deviation). Unit: Scores on a scale

Measure	MES-PrEP and MTM n = 15	Standard PrEP Counseling n = 0
Value	80.5 (13.07)	–

Population analysed: The System Usability Scale was administered only to participants in the intervention group who participated in exit interviews to quantitatively capture their experience with the intervention.

Primary outcome: Intervention Acceptability: Client Satisfaction Questionnaire

Time frame: Month 3. Mean (Standard Deviation). Unit: Scores on a scale

Measure	MES-PrEP and MTM n = 15	Standard PrEP Counseling n = 0
Value	28.2 (3.37)	–

Population analysed: The Client Satisfaction Questionnaire was administered only to participants in the intervention group who participated in exit interviews to quantitatively capture their experience with the intervention.

Primary outcome: Intervention Feasibility: Number of Participants Who Responded to Text Messages

Time frame: Baseline through Month 6. Count of participants. Unit: Participants

Measure	MES-PrEP and MTM n = 79	Standard PrEP Counseling n = 0
Value	36	–

Population analysed: The data were obtained only from participants who participated in the intervention.

Primary outcome: Intervention Feasibility: Number of Participants Who Completed the Intervention (MES-PrEP) Sessions

Time frame: Baseline through Month 6. Count of participants. Unit: Participants

Measure	MES-PrEP and MTM n = 79	Standard PrEP Counseling n = 0
Value	79	–

Population analysed: Data were obtained only from participants who were assigned to the intervention group.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment to Month 6. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MES-PrEP and MTM	0 of 79 (0%)	0 of 79 (0%)	0 of 79
Standard PrEP Counseling	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26198342Colby D, Srithanaviboonchai K, Vanichseni S, Ongwandee S, Phanuphak N, Martin M, Choopanya K, Chariyalertsak S, van Griensven F. HIV pre-exposure prophylaxis and health and community systems in the Global South: Thailand case study. J Int AIDS Soc. 2015 Jul 20;18(4 Suppl 3):19953. doi: 10.7448/IAS.18.4.19953. eCollection 2015.
Background: PubMed 30249317Phanuphak N, Sungsing T, Jantarapakde J, Pengnonyang S, Trachunthong D, Mingkwanrungruang P, Sirisakyot W, Phiayura P, Seekaew P, Panpet P, Meekrua P, Praweprai N, Suwan F, Sangtong S, Brutrat P, Wongsri T, Na Nakorn PR, Mills S, Avery M, Vannakit R, Phanuphak P. Princess PrEP program: the first key population-led model to deliver pre-exposure prophylaxis to key populations by key populations in Thailand. Sex Health. 2018 Nov;15(6):542-555. doi: 10.1071/SH18065.
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 27475032Kolmodin MacDonell K, Naar S, Gibson-Scipio W, Lam P, Secord E. The Detroit Young Adult Asthma Project: Pilot of a Technology-Based Medication Adherence Intervention for African-American Emerging Adults. J Adolesc Health. 2016 Oct;59(4):465-71. doi: 10.1016/j.jadohealth.2016.05.016. Epub 2016 Jul 27.
Background: PubMed 22419345Horvath T, Azman H, Kennedy GE, Rutherford GW. Mobile phone text messaging for promoting adherence to antiretroviral therapy in patients with HIV infection. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009756. doi: 10.1002/14651858.CD009756.
Background: PubMed 29138981Thienkrua W, van Griensven F, Mock PA, Dunne EF, Raengsakulrach B, Wimonsate W, Howteerakul N, Ungsedhapand C, Chiwarakorn A, Holtz TH. Young Men Who Have Sex with Men at High Risk for HIV, Bangkok MSM Cohort Study, Thailand 2006-2014. AIDS Behav. 2018 Jul;22(7):2137-2146. doi: 10.1007/s10461-017-1963-7.
Background: PubMed 23342121Wheelock A, Eisingerich AB, Ananworanich J, Gomez GB, Hallett TB, Dybul MR, Piot P. Are Thai MSM willing to take PrEP for HIV prevention? An analysis of attitudes, preferences and acceptance. PLoS One. 2013;8(1):e54288. doi: 10.1371/journal.pone.0054288. Epub 2013 Jan 14.
Background: PubMed 30898095Seekaew P, Nguyen E, Sungsing T, Jantarapakde J, Pengnonyang S, Trachunthong D, Mingkwanrungruang P, Sirisakyot W, Phiayura P, Panpet P, Meekrua P, Praweprai N, Suwan F, Sangtong S, Brutrat P, Wongsri T, Nakorn PRN, Mills S, Avery M, Vannakit R, Phanuphak P, Phanuphak N. Correlates of nonadherence to key population-led HIV pre-exposure prophylaxis services among Thai men who have sex with men and transgender women. BMC Public Health. 2019 Mar 21;19(1):328. doi: 10.1186/s12889-019-6645-0.
Background: PubMed 22819660Beyrer C, Baral SD, van Griensven F, Goodreau SM, Chariyalertsak S, Wirtz AL, Brookmeyer R. Global epidemiology of HIV infection in men who have sex with men. Lancet. 2012 Jul 28;380(9839):367-77. doi: 10.1016/S0140-6736(12)60821-6. Epub 2012 Jul 20.
Background: PubMed 27302837Chan PA, Mena L, Patel R, Oldenburg CE, Beauchamps L, Perez-Brumer AG, Parker S, Mayer KH, Mimiaga MJ, Nunn A. Retention in care outcomes for HIV pre-exposure prophylaxis implementation programmes among men who have sex with men in three US cities. J Int AIDS Soc. 2016 Jun 13;19(1):20903. doi: 10.7448/IAS.19.1.20903. eCollection 2016.
Background: PubMed 24862459Schnall R, Travers J, Rojas M, Carballo-Dieguez A. eHealth interventions for HIV prevention in high-risk men who have sex with men: a systematic review. J Med Internet Res. 2014 May 26;16(5):e134. doi: 10.2196/jmir.3393.
Background: PubMed 24364800Parsons JT, Lelutiu-Weinberger C, Botsko M, Golub SA. A randomized controlled trial utilizing motivational interviewing to reduce HIV risk and drug use in young gay and bisexual men. J Consult Clin Psychol. 2014 Feb;82(1):9-18. doi: 10.1037/a0035311. Epub 2013 Dec 23.
Individual participant dataSharing planned: Yes. All IPD collected during the study, 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, PhD 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 11 inclusion and 3 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 28 Oct 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?

Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Scale (time frame: Month 3). The study lists 7 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 NCT05243030, which also lists 21 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 28 Oct 2026.