Adherence, MedicationPhase 4NCT03771638

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

A Phase 4 study testing Emtricitabine / Tenofovir Disoproxil Oral Tablet and DOT Diary mobile app in people with Adherence, Medication and Risk Behavior, run by Public Health Foundation Enterprises, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Adherence, Medication, Risk Behavior, Pre-Exposure Prophylaxis
What is being tested?: Emtricitabine / Tenofovir Disoproxil Oral Tablet and DOT Diary mobile app
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 2 sitesUnited States
Study dates: 1 Feb 2019to 21 Apr 2020
Phase: Phase 4
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 18 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Self-identifies as a man
Age 18-35 at enrollment
Reports having insertive or receptive anal sex with a man or trans woman in the past 12 months and one or more of the following criteria in the last 12 months:
Any condomless anal sex outside of a mutually monogamous relationship with an HIV-negative partner
Two or more anal sex partners
Self-reported sexually transmitted infection (STI; gonorrhea, chlamydia, syphilis)

Show all 17Show fewer

Having a known HIV-positive sexual partner
HIV-negative as determined by a negative 4th generation HIV test at screening and negative rapid 4th generation test at enrollment
Willing to initiate PrEP
Eligible to take PrEP
Creatinine clearance ≥60 ml/min as estimated by Cockcroft-Gault equation at screening
Hepatitis B surface antigen (HBsAg) negative
Willing and able to provide written informed consent
Able to read and speak English
Smartphone ownership compatible with DOT Diary app
Meets local locator requirements
Lives, works or plays in Atlanta Metropolitan Area, San Francisco, Alameda, Marin, Contra Costa, Santa Clara, or San Mateo Counties

Who cannot join

PrEP use within the past 4 months (PrEP naive participants will be prioritized)
Any reactive HIV test at screening or enrollment
Signs or symptoms of acute HIV infection at screening or enrollment
History of pathological bone fracture not related to trauma
Taking nephrotoxic medications
History of participation in the active arm of an HIV vaccine trial

Show all 9Show fewer

In a mutually monogamous sexual relationship with an HIV-negative partner for the past 12 months
Unable to commit to study participation for 24 weeks
Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Emory University, School of Public Health
Atlanta, Georgia, 30322
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, 94102

Other trials in United States

About this study

Official title: DOT Diary Longitudinal Pilot: A Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men

Read the detailed description

In the DOT Diary research project, the AiCure automated directly observed therapy (aDOT) smartphone app has been adapted for use in monitoring and supporting HIV pre-exposure prophylaxis (PrEP) use among young men who have sex with men (YMSM). The aDOT app uses automated directly observed therapy (DOT) that use the smartphone camera and artificial intelligence software to confirm that the right person is taking the right medication at the right time. A sexual diary has been integrated into the aDOT app to assist YMSM in understanding whether they are receiving protection from PrEP for individual sexual episodes, and when it is particularly important to take PrEP (e.g. after a sexual episode). Specifically, the sexual diary allows participants to track sexual encounters, sexual behaviors that occurred in each encounter, and rating characteristics of partners. The app provides a calendar displaying all days in which PrEP medication was taken, and all days in which sexual activity occurred, allowing participants to see coverage of sexual encounters with PrEP. Based on pharmacokinetic and pharmacodynamic data from prior PrEP trials, the app will also indicate the estimated level of protection achieved from PrEP (e.g. low, medium, high), and also provide personalized messages on the additional numbers of doses needed to maximize protection.

In the next stage of app development and assessment, the researchers will conduct the DOT Diary Longitudinal Pilot to assess the impact of the app on PrEP adherence as measured by pharmacokinetic measures of PrEP use (tenofovir diphosphate [TFV-DP] and emtricitabine triphosphate [FTC-TP] levels in dried blood spots [DBS]). The researchers will also assess the concordance of TFV-DP and FTC-TP in DBS with adherence measured by DOT Diary, and the acceptability and ease of use of the app over a longer (24-week) period. This pilot study will allow evaluation and further refinement of the app in preparation for testing in a larger efficacy trial among YMSM at risk for HIV acquisition. The researchers will conduct this pilot protocol among YMSM in Atlanta and San Francisco Bay Area, two metropolitan regions heavily impacted by HIV, yet differing in sociodemographics, as well as in the availability and uptake of HIV prevention services, including PrEP. These diverse research locations will allow collection of data to inform app development among a broad group of YMSM.

Conditions: Adherence, Medication, Risk Behavior, Pre-Exposure Prophylaxis, HIV Prevention
Being tested: Emtricitabine / Tenofovir Disoproxil Oral Tablet, DOT Diary mobile app
Keywords: Adherence, PrEP, HIV Prevention, Truvada, HIV Risk Reduction, Mobile App
Medical subject headings: Medication Adherence, Risk-Taking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Emtricitabine / Tenofovir Disoproxil Oral TabletDrug
Also called Truvada
Open label daily emtricitabine/tenofovir disoproxil oral tablet
DOT Diary mobile appOther
DOT Diary mobile application for tracking medication adherence and sexual activities.

Study groups in NCT03771638
Study group	Role	What they receive
DOT Diary Intervention	Experimental	DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily) Receives: Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet; Other: DOT Diary mobile app
DOT Diary Control	Other	Standard of care for Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily) Receives: Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of DOT Diary App on PrEP Adherence
Measurement of PrEP Adherence as measured by TFV-DP level >=700 fmol/punch in DBS among young MSM initiating PrEP
Measured: 24 weeks
Concordance of TFV-DP and FTC-TP in DBS With Adherence Measured by DOT Diary App
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
Measured: 6, 12, 18, 24 weeks
DOT Diary Mobile App Acceptability
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.
Measured: 24 weeks
DOT Diary Mobile App Ease of Use
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.
Measured: 24 weeks

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201921 Apr 2020

First posted11 Dec 2018
Study start1 Feb 2019
Primary completion21 Apr 2020
Study completion21 Apr 2020

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, MedicationStudies of the same condition, open and under way.
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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, controlled study
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03771638
Sponsor's protocol ID: 18-25821
Other IDs: 1R01MH109320-01
Status last verified: Jul 2025
First submitted: 3 Dec 2018
Last updated: 3 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Velloza J, Liu AY, Katz AWK, van der Straten A, Siegler AJ, Scott H, Wilde G, Lockard A, Christie RH, Buchbinder SP. Acceptability of an automated directly observed therapy (DOT) application for PrEP adherence support among young men who have sex with men: a qualitative exploration. AIDS Care. 2024 Nov;36(11):1704-1718. doi: 10.1080/09540121.2024.2397133. Epub 2024 Sep 2.
PubMed 39222964

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DOT Diary Longitudinal Pilot: A Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men
ClinicalTrials.gov ID: NCT03771638
Acronym / sponsor ID: 18-25821
Conditions: Adherence, Medication, Risk Behavior, Pre-Exposure Prophylaxis, HIV Prevention
Keywords: Adherence, PrEP, HIV Prevention, Truvada, HIV Risk Reduction, Mobile App
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Public Health Foundation Enterprises, Inc.University, hospital or other
Collaborators: National Institute of Mental Health (NIMH), San Francisco Department of Public Health, Emory University, AiCure
Study start: 1 Feb 2019 (actual)
Primary completion: 21 Apr 2020 (actual)
Study completion: 21 Apr 2020 (actual)
First posted: 11 Dec 2018 (actual)
Results: Posted 3 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized, controlled study

Arm	Type	Receives
DOT Diary Intervention	Experimental	Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet, Other: DOT Diary mobile appDOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
DOT Diary Control	Other	Drug: Emtricitabine / Tenofovir Disoproxil Oral TabletStandard of care for Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (17 listed)

Self-identifies as a man
Age 18-35 at enrollment
Reports having insertive or receptive anal sex with a man or trans woman in the past 12 months and one or more of the following criteria in the last 12 months:
HIV-negative as determined by a negative 4th generation HIV test at screening and negative rapid 4th generation test at enrollment
Willing to initiate PrEP

Key exclusion criteria (9 listed)

PrEP use within the past 4 months (PrEP naive participants will be prioritized)
Any reactive HIV test at screening or enrollment
Signs or symptoms of acute HIV infection at screening or enrollment
History of pathological bone fracture not related to trauma
Taking nephrotoxic medications

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
Emtricitabine / Tenofovir Disoproxil Oral TabletAlso: TruvadaOpen label daily emtricitabine/tenofovir disoproxil oral tablet	Drug	DOT Diary Control, DOT Diary Intervention
DOT Diary mobile appDOT Diary mobile application for tracking medication adherence and sexual activities.	Other	DOT Diary Intervention

Primary outcome

Effect of DOT Diary App on PrEP Adherence
Time frame: 24 weeks
Measurement of PrEP Adherence as measured by TFV-DP level >=700 fmol/punch in DBS among young MSM initiating PrEP
Concordance of TFV-DP and FTC-TP in DBS With Adherence Measured by DOT Diary App
Time frame: 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
DOT Diary Mobile App Acceptability
Time frame: 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.
DOT Diary Mobile App Ease of Use
Time frame: 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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 3 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DOT Diary Intervention	66	60
DOT Diary Control	34	29

Primary outcome: Effect of DOT Diary App on PrEP Adherence

Time frame: 24 weeks. Count of participants. Unit: Participants

Measure	DOT Diary Intervention n = 58	DOT Diary Control n = 29
Value	39	19

DOT Diary Intervention vs DOT Diary Control: Risk Ratio (RR): 1.01 (95% CI 0.75 to 1.36), p = 0.94, GEE Poisson models

Population analysed: Participants who were retained at 24 weeks and had dried blood spot for TFV-DP levels

Primary outcome: Concordance of TFV-DP and FTC-TP in DBS With Adherence Measured by DOT Diary App

Time frame: 6, 12, 18, 24 weeks. Number. Unit: number of measures by DBS and aDOT

Measure	DOT Diary Intervention n = 66
specimens < 700 fmol/punch and PrEP use reported < 4 days/week	34
specimens < 700 fmol/punch and PrEP use reported 4-7 times/week	29
specimens >=700 fmol/punch and PrEP use reported < 4 days/week	13
specimens >= 700 fmol/punch and PrEP use reported 4-7 times/week	135

DOT Diary Intervention: Kappa statistic: 0.49 (95% CI 0.36 to 0.62), Kappa

Population analysed: DOT Diary Intervention arm with specimens collected at weeks 6, 12, 18, and 24.

Primary outcome: DOT Diary Mobile App Acceptability

Time frame: 24 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	DOT Diary Intervention n = 60
Value	77.9 (14.7)

Population analysed: Participants randomized to the DOT Diary Intervention arm who completed a system usability score measure at 24 weeks. Data are missing for 6 participants.

Primary outcome: DOT Diary Mobile App Ease of Use

Time frame: 24 weeks. Mean (Full Range). Unit: score on a scale

Measure	DOT Diary Intervention n = 60
Value	4.3 (1 to 5)

Population analysed: Participants randomized to the DOT Diary Intervention arm who completed the usability question at week 24.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DOT Diary Intervention Arm	0 of 66 (0%)	0 of 66 (0%)	0 of 66
DOT Diary Control Arm	0 of 34 (0%)	0 of 34 (0%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39222964Velloza J, Liu AY, Katz AWK, van der Straten A, Siegler AJ, Scott H, Wilde G, Lockard A, Christie RH, Buchbinder SP. Acceptability of an automated directly observed therapy (DOT) application for PrEP adherence support among young men who have sex with men: a qualitative exploration. AIDS Care. 2024 Nov;36(11):1704-1718. doi: 10.1080/09540121.2024.2397133. Epub 2024 Sep 2.
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.

Susan Buchbinder, MD principal investigator

Bridge HIV, San Francisco Department of Public Health

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 17 inclusion and 9 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 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 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?

Effect of DOT Diary App on PrEP Adherence (time frame: 24 weeks). The study lists 4 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 NCT03771638, 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 3 Jul 2025.