A Phase 4 interventional study of Emtricitabine / Tenofovir Disoproxil Oral Tablet and DOT Diary mobile app in Adherence, Medication, Risk Behavior and Pre-Exposure Prophylaxis, sponsored by Public Health Foundation Enterprises, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Public Health Foundation Enterprises, Inc. · Phase 4, Interventional, and Other
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.
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.
937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.
This study's enrollment of 100 is below the median of 120 across 768 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →Public Health Foundation Enterprises, Inc. is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Eligible to take PrEP
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet · Other: DOT Diary mobile app
Standard of care for Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet
Drug pages: Emtricitabine · Tenofovir
Open label daily emtricitabine/tenofovir disoproxil oral tablet
Also known as: Truvada
DOT Diary mobile application for tracking medication adherence and sexual activities.
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks
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.
Time frame: 6, 12, 18, 24 weeks
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.
| Milestone | DOT Diary Intervention | DOT Diary Control |
|---|---|---|
| Started | 66 | 34 |
| Completed | 60 | 29 |
| Not completed | 6 | 5 |
Measurement of PrEP Adherence as measured by TFV-DP level \>=700 fmol/punch in DBS among young MSM initiating PrEP
| Participants | DOT Diary Intervention | DOT Diary Control |
|---|---|---|
| Effect of DOT Diary App on PrEP Adherence | 39 | 19 |
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
| number of measures by DBS and aDOT | DOT Diary Intervention |
|---|---|
| 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 |
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.
| score on a scale | DOT Diary Intervention |
|---|---|
| DOT Diary Mobile App Acceptability | 77.9 ± 14.7 |
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.
| score on a scale | DOT Diary Intervention |
|---|---|
| DOT Diary Mobile App Ease of Use | 4.3 (1 to 5) |
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.
| % ot 100 sex acts covered by PrEP | DOT Diary Intervention |
|---|---|
| PrEP Coverage of Sexual Acts (Prevention-effectiveness Adherence) as Measured by DOT Diary | 93 |
Collected over 24 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DOT Diary Intervention Arm | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) |
| DOT Diary Control Arm | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
This is a cohort of HIV uninfected men who have sex with men who qualify for taking HIV pre-exposure prophylaxis.
| Age, Continuous(years) | DOT Diary Intervention | DOT Diary Control | Total |
|---|---|---|---|
| Mean | 26.0 (18 to 35) | 25.9 (18 to 35) | 26 (18 to 35) |
| Sex: Female, Male(Participants) | DOT Diary Intervention | DOT Diary Control | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 66 | 34 | 100 |
| Race/Ethnicity, Customized(Participants) | DOT Diary Intervention | DOT Diary Control | Total |
|---|---|---|---|
| Asian/Pacific Islander | 10 | 4 | 14 |
| Black/African American | 19 | 7 | 26 |
| Latino | 15 | 7 | 22 |
| White | 21 | 15 | 36 |
| Other | 1 | 1 | 2 |
| Region of Enrollment(participants) | DOT Diary Intervention | DOT Diary Control | Total |
|---|---|---|---|
| United States | 66 | 34 | 100 |
| Sexual orientation(Participants) | DOT Diary Intervention | DOT Diary Control | Total |
|---|---|---|---|
| Bisexual | 5 | 6 | 11 |
| Gay | 56 | 27 | 83 |
| Queer | 3 | 1 | 4 |
| Missing | 2 | 0 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Public Health Foundation Enterprises, Inc.