Trial Outcomes & Findings for mHealth Technologies to Enhance PrEP Adherence Among Thai MSM (NCT NCT04413708)
NCT ID: NCT04413708
Last Updated: 2025-03-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Month 3
Results posted on
2025-03-12
Participant Flow
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.
60 individuals met the study inclusion criteria and were enrolled and randomized into the P3T arm or the Standard of Care arm.
Participant milestones
| Measure |
P3-T PrEP Adherence App
P3-T provided 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 included 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 included a user-selected avatar.
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.
Other Name: P3-T
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
P3-T PrEP Adherence App
P3-T provided 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 included 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 included a user-selected avatar.
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.
Other Name: P3-T
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
P3-T PrEP Adherence App
n=30 Participants
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.
|
Standard of Care
n=30 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21 years
n=30 Participants
|
22 years
n=30 Participants
|
21 years
n=60 Participants
|
|
Sex/Gender, Customized
Assigned male sex at birth
|
30 participants
n=30 Participants
|
30 participants
n=30 Participants
|
60 participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Thailand
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
60 Participants
n=60 Participants
|
|
Current sexual identity
Gay, homosexual, same gender loving
|
22 Participants
n=30 Participants
|
24 Participants
n=30 Participants
|
46 Participants
n=60 Participants
|
|
Current sexual identity
Bisexual
|
5 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
8 Participants
n=60 Participants
|
|
Current sexual identity
Queer
|
2 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
|
Current sexual identity
Other
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: Only applies to P3-T PrEP Adherence App group
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.
Outcome measures
| Measure |
P3-T PrEP Adherence App
n=30 Participants
P3-T provided 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 included 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 included a user-selected avatar.
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.
Other Name: P3-T
|
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.
|
|---|---|---|
|
Intervention Feasibility: Average Number of Days of Any App Use
|
68 days
Standard Deviation 29
|
—
|
PRIMARY outcome
Timeframe: Month 3Population: Only applies to P3-T PrEP Adherence App group
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.
Outcome measures
| Measure |
P3-T PrEP Adherence App
n=30 Participants
P3-T provided 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 included 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 included a user-selected avatar.
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.
Other Name: P3-T
|
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.
|
|---|---|---|
|
Intervention Feasibility: Average Number of Days of PrEP Medication Tracked Through App
|
60 Days
Standard Deviation 28
|
—
|
PRIMARY outcome
Timeframe: Month 3Population: Only applies to P3-T PrEP Adherence App group. Data not collected on 2 participants.
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).
Outcome measures
| Measure |
P3-T PrEP Adherence App
n=28 Participants
P3-T provided 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 included 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 included a user-selected avatar.
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.
Other Name: P3-T
|
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.
|
|---|---|---|
|
Intervention Acceptability: Mean Intervention Acceptability, Composite Score CSQ-8
|
25.18 score on a scale
Standard Deviation 4.11
|
—
|
SECONDARY outcome
Timeframe: Month 3Population: Data not collected on 4 participants.
The number of participants with protective levels of tenofovir-diphosphate (TFV-DP) at month 3 between the study arms.
Outcome measures
| Measure |
P3-T PrEP Adherence App
n=29 Participants
P3-T provided 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 included 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 included a user-selected avatar.
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.
Other Name: P3-T
|
Standard of Care
n=27 Participants
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.
|
|---|---|---|
|
Difference in PrEP Medication Adherence Between Study Arms at Month 3
|
27 count of participants
|
23 count of participants
|
SECONDARY outcome
Timeframe: Month 6Population: Data not collected on 5 participants
The number of participants with protective levels of TFV-DP at month 6 between the study arms.
Outcome measures
| Measure |
P3-T PrEP Adherence App
n=29 Participants
P3-T provided 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 included 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 included a user-selected avatar.
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.
Other Name: P3-T
|
Standard of Care
n=26 Participants
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.
|
|---|---|---|
|
Difference in PrEP Medication Adherence Between Study Arms at Month 6
|
21 Participants
|
18 Participants
|
Adverse Events
P3-T PrEP Adherence App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place