Adherence, Patient, HIV/AIDS, Pre-Exposure Prophylaxis
Conditions
Keywords
PrEP adherence, HIV, Young men who have sex with men, YMSM, Thailand, Mobile app, mHealth
Brief 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 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.
Interventions
BEHAVIORALP3-T PrEP Adherence App
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.
Sponsors
University of North Carolina, Chapel Hill
Chulalongkorn University
Thai Red Cross AIDS Research Centre
Fogarty International Center of the National Institute of Health
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
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Intervention model description
Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.
Eligibility
Sex/Gender
MALE
Age
16 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Feasibility: Average Number of Days of Any App Use | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in PrEP Medication Adherence Between Study Arms at Month 3 | Month 3 | The number of participants with protective levels of tenofovir-diphosphate (TFV-DP) at month 3 between the study arms. |
| Difference in PrEP Medication Adherence Between Study Arms at Month 6 | Month 6 | The number of participants with protective levels of TFV-DP at month 6 between the study arms. |
Countries
Thailand
Participant flow
Recruitment details
Individuals were recruited by study staff based on physician referral to the Chulalongkorn pre-exposure prophylaxis (PrEP) clinic in Bangkok, Thailand between June 12, 2020 and January 15, 2021.
Pre-assignment details
60 individuals met the study inclusion criteria and were enrolled and randomized into the P3T arm or the Standard of Care arm.
Participants by arm
| Arm | Count |
|---|---|
| P3-T PrEP Adherence App 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.
P3-T PrEP Adherence App: 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. | 30 |
| Standard of Care 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. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | P3-T PrEP Adherence App | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 21 years | 22 years | 21 years |
| Current sexual identity Bisexual | 5 Participants | 3 Participants | 8 Participants |
| Current sexual identity Gay, homosexual, same gender loving | 22 Participants | 24 Participants | 46 Participants |
| Current sexual identity Other | 1 Participants | 1 Participants | 2 Participants |
| Current sexual identity Queer | 2 Participants | 2 Participants | 4 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Thailand | 30 Participants | 30 Participants | 60 Participants |
| Sex/Gender, Customized Assigned male sex at birth | 30 participants | 30 participants | 60 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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).
Time frame: Month 3
Population: Only applies to P3-T PrEP Adherence App group. Data not collected on 2 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| P3-T PrEP Adherence App | Intervention Acceptability: Mean Intervention Acceptability, Composite Score CSQ-8 | 25.18 score on a scale | Standard Deviation 4.11 |
Primary
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.
Time frame: Month 3
Population: Only applies to P3-T PrEP Adherence App group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| P3-T PrEP Adherence App | Intervention Feasibility: Average Number of Days of Any App Use | 68 days | Standard Deviation 29 |
Primary
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.
Time frame: Month 3
Population: Only applies to P3-T PrEP Adherence App group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| P3-T PrEP Adherence App | Intervention Feasibility: Average Number of Days of PrEP Medication Tracked Through App | 60 Days | Standard Deviation 28 |
Secondary
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.
Time frame: Month 3
Population: Data not collected on 4 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| P3-T PrEP Adherence App | Difference in PrEP Medication Adherence Between Study Arms at Month 3 | 27 count of participants |
| Standard of Care | Difference in PrEP Medication Adherence Between Study Arms at Month 3 | 23 count of participants |
p-value: 0.4195% CI: [0.5, 5.17]Fisher Exact
Secondary
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.
Time frame: Month 6
Population: Data not collected on 5 participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| P3-T PrEP Adherence App | Difference in PrEP Medication Adherence Between Study Arms at Month 6 | 21 Participants |
| Standard of Care | Difference in PrEP Medication Adherence Between Study Arms at Month 6 | 18 Participants |
p-value: 195% CI: [0.61, 1.9]Fisher Exact