Adherence, PatientP3-TNCT04413708
mHealth Technologies to Enhance PrEP Adherence Among Thai MSM
A study testing P3-T PrEP Adherence App in people with Adherence, Patient and Pre-Exposure Prophylaxis, run by Duke University at 1 site in Thailand.
Trial summary
This study aims to: 1) adapt the theory-based P3 (Prepared, Protected, emPowered) app designed to improve pre-exposure prophylaxis (PrEP) adherence, retention in PrEP clinical care, and PrEP persistence among young gay, bisexual, and other men who have sex with men (YMSM) in the United States for YMSM in Thailand, and… Read more about this study
- Who is it for?
- Ages 16 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adherence, Patient, Pre-Exposure Prophylaxis, HIV/AIDS
- What is being tested?
- P3-T PrEP Adherence App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 12 Jun 2020to 10 Aug 2021
- 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 24 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male sex at birth
- Gender identity is male
- Identify as a man who has sex with men
- Ages 16-24
- Plan to start PrEP in next 14 days
- Able to speak and read Thai
- Own an Android or iOS smartphone
Who cannot join
- Currently participating in another experimental PrEP adherence intervention
- Plan to move out of Bangkok in the next 6 months
- Unable to be consented due to an active substance use or psychological condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel mHealth Technologies to Enhance PrEP Adherence Among Thai MSM: Collaborative Adaptation and Evaluation
This study aims to: 1) adapt the theory-based P3 (Prepared, Protected, emPowered) app designed to improve pre-exposure prophylaxis (PrEP) adherence, retention in PrEP clinical care, and PrEP persistence among young gay, bisexual, and other men who have sex with men (YMSM) in the United States for YMSM in Thailand, and 2) conduct a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and potential impact of the adapted P3-Thailand (P3-T) app.
Read the detailed description
This R21 study, titled "Novel mHealth Technologies to Enhance PrEP Adherence among Thai MSM: Collaborative Adaptation and Evaluation" was designed to adapt and test a theory-based, PrEP adherence smartphone app, P3, to 1) improve PrEP adherence and thus protective PrEP drug levels, 2) to increase retention in PrEP clinical care, 3) support PrEP persistence among YMSM in the United States for YMSM in Thailand, and 4) conduct a pilot RCT to assess the feasibility and acceptability of the adapted P3-T app and to examine the potential impact of the app on PrEP adherence.
The study was a partnership between Duke University, Chulalongkorn University, Thai Red Cross AIDS Research Centre (TRC-ARC), and the University of North Carolina-Chapel Hill, and includes a robust plan to increase mHealth capacity at Chulalongkorn University and TRC-ARC.
P3 is a theory-based, comprehensive smartphone app platform for YMSM that utilizes social networking and game-based mechanics as well as evidenced-based features to improve PrEP medication adherence. P3 is a product born from the collaborative effort of researchers and health game developers working closely with members of the target population in the United States. Built on a successful, evidence-based platform designed by our collaborating technology partner, Ayogo, and tested by our study team, P3 is flexible, allowing for customization and adaptations for different cultural and linguistic contexts, and responsive to changes in technology.
The social networking features of P3 are designed to capitalize on social involvement as a means through which YMSM can receive information and social support, experience social norms and reflective appraisals, and feel a sense of connectedness to peers. Peers have been recognized as a highly important source of sexual health and HIV prevention information and support among Thai YMSM. The gaming features of P3 were goal-oriented and immersive and provided a challenging and motivating environment for behavior change. As a result, P3 is ideal for engaging YMSM in behavior change, by maintaining attention and avoiding boredom and attrition.
The pilot RCT of the adapted P3-T app was conducted with 60 YMSM newly starting PrEP in Bangkok, Thailand to 1) assess app feasibility and acceptability, and 2) explore the potential impact of the app on PrEP adherence.
In-depth interviews were conducted with 10 P3-T arm participants after the 3-month intervention period. The interview will ask participants about their experience and impressions of the app, how they used it, and how it may have impacted their behaviors during the 3-month intervention period.
- Conditions
- Adherence, Patient, Pre-Exposure Prophylaxis, HIV/AIDS
- Being tested
- P3-T PrEP Adherence App
- Keywords
- PrEP adherence, HIV, Young men who have sex with men, YMSM, Thailand, Mobile app, mHealth
- Medical subject headings
- Patient Compliance, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P3-T PrEP Adherence AppBehavioural
Also called P3-T
P3-T provides daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that includes daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that includes a user-selected avatar.
| Study group | Role | What they receive |
|---|---|---|
| P3-T PrEP adherence app | Experimental | Intended app use includes, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3 month intervention period.
Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit. Receives: Behavioral: P3-T PrEP Adherence App |
| Standard of Care | No intervention | Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility: Average Number of Days of Any App Use
The number of days of any app use among those assigned to the P3-T adherence arm during the 3-month intervention period as recorded by backend app metrics. Higher number of days indicates higher intervention feasibility.
Measured: Month 3
Intervention Feasibility: Average Number of Days of PrEP Medication Tracked Through App
The number of days of PrEP medication tracked through app during the 3-month intervention period among participants assigned to the P3-T adherence arm as recorded by backend app metrics. Higher number indicates higher intervention feasibility.
Measured: Month 3
Intervention Acceptability: Mean Intervention Acceptability, Composite Score CSQ-8
Intervention acceptability was assessed using the Client Satisfaction Questionnaire (CSQ-8), an 8-item validated scale measuring the construct of global intervention satisfaction, collected in the 3-month follow-up survey (intervention group only). The eight items (quality of app, kind of service received from app, app met needs, recommend app to a friend, amount of help received from app, the effectiveness of app for dealing with health issue (PrEP adherence), overall satisfaction, and willingness to use the app again) were assessed using a 4-point response scale with individually specified anchors. The mean composite score of the CSQ-8 was calculated with a total possible range of 8 (lowest acceptability, worst outcome) to 32 (highest acceptability, best outcome).
Measured: Month 3
Secondary outcomes (2)
Difference in PrEP Medication Adherence Between Study Arms at Month 3
The number of participants with protective levels of tenofovir-diphosphate (TFV-DP) at month 3 between the study arms.
Measured: Month 3
Difference in PrEP Medication Adherence Between Study Arms at Month 6
The number of participants with protective levels of TFV-DP at month 6 between the study arms.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start12 Jun 2020
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
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 (1)Papers the sponsor has linked to this study.
- Other trials for Adherence, PatientStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Chulalongkorn University, Thai Red Cross AIDS Research Centre, Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Sara LeGrand, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413708
- Sponsor's protocol ID
- 2020-0099
- Other IDs
- 1R21TW010965
- Acronym
- P3-T
- Status last verified
- Mar 2025
- First submitted
- 29 May 2020
- Last updated
- 12 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Songtaweesin WN, LeGrand S, Bandara S, Piccone C, Wongharn P, Moonwong J, Jupimai T, Saisaengjan C, Theerawit T, Muessig K, Hightow-Weidman L, Puthanakit T, Phanuphak N, Tangmunkongvorakul A. Adaptation of a Theory-Based Social Networking and Gamified App-Based Intervention to Improve Pre-Exposure Prophylaxis Adherence Among Young Men Who Have Sex With Men in Bangkok, Thailand: Qualitative Study. J Med Internet Res. 2021 Nov 4;23(11):e23852. doi: 10.2196/23852.
PubMed 34734828
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel mHealth Technologies to Enhance PrEP Adherence Among Thai MSM: Collaborative Adaptation and Evaluation
- ClinicalTrials.gov ID
- NCT04413708
- Acronym / sponsor ID
- P3-T / 2020-0099
- Conditions
- Adherence, Patient, Pre-Exposure Prophylaxis, HIV/AIDS
- Keywords
- PrEP adherence, HIV, Young men who have sex with men, YMSM, Thailand, Mobile app, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Chulalongkorn University, Thai Red Cross AIDS Research Centre, Fogarty International Center of the National Institute of Health
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 12 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to: 1) adapt the theory-based P3 (Prepared, Protected, emPowered) app designed to improve pre-exposure prophylaxis (PrEP) adherence, retention in PrEP clinical care, and PrEP persistence among young gay, bisexual, and other men who have sex with men (YMSM) in the United States for YMSM in Thailand, and 2) conduct a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and potential impact of the adapted P3-Thailand (P3-T) app.
Detailed description
This R21 study, titled "Novel mHealth Technologies to Enhance PrEP Adherence among Thai MSM: Collaborative Adaptation and Evaluation" was designed to adapt and test a theory-based, PrEP adherence smartphone app, P3, to 1) improve PrEP adherence and thus protective PrEP drug levels, 2) to increase retention in PrEP clinical care, 3) support PrEP persistence among YMSM in the United States for YMSM in Thailand, and 4) conduct a pilot RCT to assess the feasibility and acceptability of the adapted P3-T app and to examine the potential impact of the app on PrEP adherence.
The study was a partnership between Duke University, Chulalongkorn University, Thai Red Cross AIDS Research Centre (TRC-ARC), and the University of North Carolina-Chapel Hill, and includes a robust plan to increase mHealth capacity at Chulalongkorn University and TRC-ARC.
P3 is a theory-based, comprehensive smartphone app platform for YMSM that utilizes social networking and game-based mechanics as well as evidenced-based features to improve PrEP medication adherence. P3 is a product born from the collaborative effort of researchers and health game developers working closely with members of the target population in the United States. Built on a successful, evidence-based platform designed by our collaborating technology partner, Ayogo, and tested by our study team, P3 is flexible, allowing for customization and adaptations for different cultural and linguistic contexts, and responsive to changes in technology.
The social networking features of P3 are designed to capitalize on social involvement as a means through which YMSM can receive information and social support, experience social norms and reflective appraisals, and feel a sense of connectedness to peers. Peers have been recognized as a highly important source of sexual health and HIV prevention information and support among Thai YMSM. The gaming features of P3 were goal-oriented and immersive and provided a challenging and motivating environment for behavior change. As a result, P3 is ideal for engaging YMSM in behavior change, by maintaining attention and avoiding boredom and attrition.
The pilot RCT of the adapted P3-T app was conducted with 60 YMSM newly starting PrEP in Bangkok, Thailand to 1) assess app feasibility and acceptability, and 2) explore the potential impact of the app on PrEP adherence.
In-depth interviews were conducted with 10 P3-T arm participants after the 3-month intervention period. The interview will ask participants about their experience and impressions of the app, how they used it, and how it may have impacted their behaviors during the 3-month intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.
| Arm | Type | Receives |
|---|---|---|
| P3-T PrEP adherence app | Experimental | Behavioral: P3-T PrEP Adherence AppIntended app use includes, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3 month intervention period. Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit. |
| Standard of Care | No intervention | –Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Male sex at birth
- Gender identity is male
- Identify as a man who has sex with men
- Ages 16-24
- Plan to start PrEP in next 14 days
Key exclusion criteria (3 listed)
- Currently participating in another experimental PrEP adherence intervention
- Plan to move out of Bangkok in the next 6 months
- Unable to be consented due to an active substance use or psychological condition
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 |
|---|---|---|
| P3-T PrEP Adherence AppAlso: P3-TP3-T provides daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that includes daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that includes a user-selected avatar. | Behavioural | P3-T PrEP adherence app |
Primary outcome
Intervention Feasibility: Average Number of Days of Any App Use
Time frame: Month 3
The number of days of any app use among those assigned to the P3-T adherence arm during the 3-month intervention period as recorded by backend app metrics. Higher number of days indicates higher intervention feasibility.
Intervention Feasibility: Average Number of Days of PrEP Medication Tracked Through App
Time frame: Month 3
The number of days of PrEP medication tracked through app during the 3-month intervention period among participants assigned to the P3-T adherence arm as recorded by backend app metrics. Higher number indicates higher intervention feasibility.
Intervention Acceptability: Mean Intervention Acceptability, Composite Score CSQ-8
Time frame: Month 3
Intervention acceptability was assessed using the Client Satisfaction Questionnaire (CSQ-8), an 8-item validated scale measuring the construct of global intervention satisfaction, collected in the 3-month follow-up survey (intervention group only). The eight items (quality of app, kind of service received from app, app met needs, recommend app to a friend, amount of help received from app, the effectiveness of app for dealing with health issue (PrEP adherence), overall satisfaction, and willingness to use the app again) were assessed using a 4-point response scale with individually specified anchors. The mean composite score of the CSQ-8 was calculated with a total possible range of 8 (lowest acceptability, worst outcome) to 32 (highest acceptability, best outcome).
2 secondary outcomes
Difference in PrEP Medication Adherence Between Study Arms at Month 3
Time frame: Month 3
Difference in PrEP Medication Adherence Between Study Arms at Month 6
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34734828Songtaweesin WN, LeGrand S, Bandara S, Piccone C, Wongharn P, Moonwong J, Jupimai T, Saisaengjan C, Theerawit T, Muessig K, Hightow-Weidman L, Puthanakit T, Phanuphak N, Tangmunkongvorakul A. Adaptation of a Theory-Based Social Networking and Gamified App-Based Intervention to Improve Pre-Exposure Prophylaxis Adherence Among Young Men Who Have Sex With Men in Bangkok, Thailand: Qualitative Study. J Med Internet Res. 2021 Nov 4;23(11):e23852. doi: 10.2196/23852.
- Individual participant dataSharing planned: No
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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.
Sara LeGrand, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P3-T PrEP Adherence App in people with Adherence, Patient and Pre-Exposure Prophylaxis, run by Duke University at 1 site in Thailand.
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 7 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 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 12 Mar 2025). 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 Feasibility: Average Number of Days of Any App Use (time frame: Month 3). The study lists 3 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 NCT04413708, which also lists 1 linked publication.
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 12 Mar 2025.