Trial Outcomes & Findings for DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men (NCT NCT03771638)
NCT ID: NCT03771638
Last Updated: 2025-07-03
Results Overview
Measurement of PrEP Adherence as measured by TFV-DP level \>=700 fmol/punch in DBS among young MSM initiating PrEP
COMPLETED
PHASE4
100 participants
24 weeks
2025-07-03
Participant Flow
Participants were recruited into the study using online recruitment techniques and outreach into venues frequented by men who have sex with men. The protocol opened on February 1, 2019 and study follow-up was complete on April 21, 2020. Participants were recruited from the Atlanta Metropolitan Area or the greater San Francisco Bay Area, with 50 participants recruited from each location.
Participants were screened for behavioral and medical eligibility. If they met study eligibility criteria and were willing to consent to participate, they were enrolled in the study.
Participant milestones
| Measure |
DOT Diary Intervention
DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet
DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities.
|
DOT Diary Control
Standard of care for Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
34
|
|
Overall Study
COMPLETED
|
60
|
29
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men
Baseline characteristics by cohort
| Measure |
DOT Diary Intervention
n=66 Participants
DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet
DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities.
|
DOT Diary Control
n=34 Participants
Standard of care for Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.0 years
n=99 Participants
|
25.9 years
n=107 Participants
|
26 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
19 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Latino
|
15 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=99 Participants
|
34 participants
n=107 Participants
|
100 participants
n=206 Participants
|
|
Sexual orientation
Bisexual
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sexual orientation
Gay
|
56 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Sexual orientation
Queer
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sexual orientation
Missing
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants who were retained at 24 weeks and had dried blood spot for TFV-DP levels
Measurement of PrEP Adherence as measured by TFV-DP level \>=700 fmol/punch in DBS among young MSM initiating PrEP
Outcome measures
| Measure |
DOT Diary Intervention
n=58 Participants
DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet
DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities.
|
DOT Diary Control
n=29 Participants
Standard of care for Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet
|
|---|---|---|
|
Effect of DOT Diary App on PrEP Adherence
|
39 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: 6, 12, 18, 24 weeksPopulation: DOT Diary Intervention arm with specimens collected at weeks 6, 12, 18, and 24.
As a measure of concordance between DBS measurements and aDOT-based assessments of PrEP adherence: Number of specimens with \< 700 fmol/punch or \>= 700 fmol/punch agreement with number of participants reporting PrEP use \< 4 days/week or 4-7 days/week at weeks 6, 12, 18, 24
Outcome measures
| Measure |
DOT Diary Intervention
n=66 Participants
DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet
DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities.
|
DOT Diary Control
Standard of care for Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet
|
|---|---|---|
|
Concordance of TFV-DP and FTC-TP in DBS With Adherence Measured by DOT Diary App
specimens < 700 fmol/punch and PrEP use reported < 4 days/week
|
34 number of measures by DBS and aDOT
|
—
|
|
Concordance of TFV-DP and FTC-TP in DBS With Adherence Measured by DOT Diary App
specimens < 700 fmol/punch and PrEP use reported 4-7 times/week
|
29 number of measures by DBS and aDOT
|
—
|
|
Concordance of TFV-DP and FTC-TP in DBS With Adherence Measured by DOT Diary App
specimens >=700 fmol/punch and PrEP use reported < 4 days/week
|
13 number of measures by DBS and aDOT
|
—
|
|
Concordance of TFV-DP and FTC-TP in DBS With Adherence Measured by DOT Diary App
specimens >= 700 fmol/punch and PrEP use reported 4-7 times/week
|
135 number of measures by DBS and aDOT
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants randomized to the DOT Diary Intervention arm who completed a system usability score measure at 24 weeks. Data are missing for 6 participants.
Combined descriptive analysis of key attributes of acceptability of DOT Diary over 24 weeks by YMSM on PrEP, in order to identify potential improvements to the app to maximize acceptability. This was measured using the System Usability Scale, with minmum value of 0 and maximum value of 100. This is a scale that uses a 10-item questionnaire with a 5-point Likert scale from strongly agree to strongly disagree. Scores are summed and the final score is multiplied by 2. Higher scores mean a better outcome.
Outcome measures
| Measure |
DOT Diary Intervention
n=60 Participants
DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet
DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities.
|
DOT Diary Control
Standard of care for Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet
|
|---|---|---|
|
DOT Diary Mobile App Acceptability
|
77.9 score on a scale
Standard Deviation 14.7
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants randomized to the DOT Diary Intervention arm who completed the usability question at week 24.
Descriptive analysis of key attribute of ease of use of DOT Diary over 24 weeks by YMSM on PrEP. Participants were asked if the DOT Diary app was easy to use and answered using a Likert Scale from 1= Strongly disagree, 2= Disagree, 3= Neutral, 4= Agree, 5= Strongly agree. A higher score indicates a better outcome.
Outcome measures
| Measure |
DOT Diary Intervention
n=60 Participants
DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet
DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities.
|
DOT Diary Control
Standard of care for Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet
|
|---|---|---|
|
DOT Diary Mobile App Ease of Use
|
4.3 score on a scale
Interval 1.0 to 5.0
|
—
|
SECONDARY outcome
Timeframe: 6, 12, 18, 24 weeksPopulation: Participants in the DOT Diary group who reported anal sex in their diary.
Percentage of total anal sex acts across the 30 participants covered by use of PrEP for 4-7 days prior to that sex act, as measured by a-DOT. This is only for the a-DOT arm of the study.
Outcome measures
| Measure |
DOT Diary Intervention
n=100 sex acts covered by PrEP
DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet
DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities.
|
DOT Diary Control
Standard of care for Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet
|
|---|---|---|
|
PrEP Coverage of Sexual Acts (Prevention-effectiveness Adherence) as Measured by DOT Diary
|
93 % ot 100 sex acts covered by PrEP
|
—
|
Adverse Events
DOT Diary Intervention Arm
DOT Diary Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Susan Buchbinder
Bridge HIV, San Francisco Department of Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place