NCT03771638

DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men

Completed Phase 4 Results posted Last updated 3 July 2025

What this trial tests

Phase 4 trial testing Emtricitabine / Tenofovir Disoproxil Oral Tablet in Adherence, Medication in 100 participants. Completed in 21 April 2020.

Timeline

1 February 2019

Primary endpoint
21 April 2020

21 April 2020

Quick facts

Lead sponsor	Public Health Foundation Enterprises, Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	100
Start date	1 February 2019
Primary completion	21 April 2020
Estimated completion	21 April 2020
Sites	2 locations across United States

Drugs / interventions tested

• Emtricitabine / Tenofovir Disoproxil Oral Tablet — full drug profile →
• DOT Diary mobile app

Conditions studied

• Adherence, Medication — all drugs for Adherence, Medication →
• Risk Behavior — all drugs for Risk Behavior →
• Pre-Exposure Prophylaxis — all drugs for Pre-Exposure Prophylaxis →
• HIV Prevention — all drugs for HIV Prevention →

Sponsor

Public Health Foundation Enterprises, Inc.

Who can join

Adults 18 to 35, any sex, with Adherence, Medication or Risk Behavior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Effect of DOT Diary App on PrEP Adherence Primary · 24 weeks

Measurement of PrEP Adherence as measured by TFV-DP level \>=700 fmol/punch in DBS among young MSM initiating PrEP

Group	Value	95% CI
DOT Diary Intervention	39
DOT Diary Control	19

Concordance of TFV-DP and FTC-TP in DBS With Adherence Measured by DOT Diary App Primary · 6, 12, 18, 24 weeks

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

specimens < 700 fmol/punch and PrEP use reported < 4 days/week

Group	Value	95% CI
DOT Diary Intervention	34

specimens < 700 fmol/punch and PrEP use reported 4-7 times/week

Group	Value	95% CI
DOT Diary Intervention	29

specimens >=700 fmol/punch and PrEP use reported < 4 days/week

Group	Value	95% CI
DOT Diary Intervention	13

specimens >= 700 fmol/punch and PrEP use reported 4-7 times/week

Group	Value	95% CI
DOT Diary Intervention	135

DOT Diary Mobile App Acceptability Primary · 24 weeks

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.

Group	Value	95% CI
DOT Diary Intervention	77.9	± 14.7

DOT Diary Mobile App Ease of Use Primary · 24 weeks

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.

Group	Value	95% CI
DOT Diary Intervention	4.3	1 – 5

PrEP Coverage of Sexual Acts (Prevention-effectiveness Adherence) as Measured by DOT Diary Secondary · 6, 12, 18, 24 weeks

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.

Group	Value	95% CI
DOT Diary Intervention	93

Sponsor's own description

The researchers are working with a technology company, AiCure, to develop a smartphone app, DOT Diary, which combines two drug adherence strategies. DOT Diary reminds people when it is time to take their medication, and uses motion-sensing technology to visually and automatically confirm the pill was swallowed. The goal of this study is to assess the impact of the app on adherence to HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. DOT Diary: Developing a Novel Mobile App Using Artificial Intelligence and an Electronic Sexual Diary to Measure and Support PrEP Adherence Among Young Men Who Have Sex with Men.
   Liu AY, Laborde ND, Coleman K, Vittinghoff E, et al · · 2021 · cited 31× · PMID 33044687 · DOI 10.1007/s10461-020-03054-2
2. Randomized Controlled Trial of Automated Directly Observed Therapy for Measurement and Support of PrEP Adherence Among Young Men Who have Sex with Men.
   Buchbinder SP, Siegler AJ, Coleman K, Vittinghoff E, et al · · 2023 · cited 13× · PMID 35984607 · DOI 10.1007/s10461-022-03805-3
3. Acceptability of an automated directly observed therapy (DOT) application for PrEP adherence support among young men who have sex with men: a qualitative exploration.
   Velloza J, Liu AY, Katz AWK, van der Straten A, et al · · 2024 · cited 1× · PMID 39222964 · DOI 10.1080/09540121.2024.2397133