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 2021-10-27.
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 understand people's experiences using this new app while taking HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.
In the DOT Diary research project, the AiCure 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).
In the next stage of app development, the researchers are conducting this study to identify areas of the app that require refinement to maximize the acceptability and ease of use of the DOT adherence monitoring app. The researchers will assess overall acceptability and ease of use of the integrated DOT Diary (D2) app over an 8 week period.The goal of this pilot study will be to refine and optimize the app for further testing in a larger and longer pilot study 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 20 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.
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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 anal sex with a man or trans woman in the past 12 months and one or more of the following criteria in the past 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
Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet · Other: DOT Diary mobile app
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.
DOT Diary Mobile App Acceptability
System Usability Scale (SUS) is a 10 item questionnaire with 5 response options: strongly disagree to strongly agree. These are scored 0-4. The scores are then summed up (making sure all positive responses -- increased usability -- are given the higher scores). The final score is multiplied by 2.5 Possible scores are from 0-100, with maximal usability achieving the higher score. Although the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.
Time frame: 8 weeks
DOT Diary Mobile App Ease of Use
5-point Likert scale (1=strongly disagree that app is easy to use; 5=strongly agree that app is easy to use) on a single question of the key attribute of ease of use of DOT Diary over 8 weeks by MSM on PrEP.
Time frame: 8 weeks
Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP
Adherence and Persistence of use of the DOT and sexual diary components of DOT Diary by young MSM on PrEP is measured by the percentage of doses taken with visual confirmation of pill ingestion
Time frame: 8 weeks
Assessment of Situations and Reasons for Sub-optimal Use of the App
Combined analysis of situations and reasons for sub-optimal use of the app, for the purpose of app optimization
Time frame: 8 weeks
Participants were recruited online and via social media, as well as through in-person community outreach.
| Milestone | DOT Diary Optimization Intervention |
|---|---|
| Started | 20 |
| 4 weeks | 20 |
| 8 weeks | 19 |
| Completed | 19 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
System Usability Scale (SUS) is a 10 item questionnaire with 5 response options: strongly disagree to strongly agree. These are scored 0-4. The scores are then summed up (making sure all positive responses -- increased usability -- are given the higher scores). The final score is multiplied by 2.5 Possible scores are from 0-100, with maximal usability achieving the higher score. Although the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.
| Score on scale | DOT Diary Optimization Intervention |
|---|---|
| DOT Diary Mobile App Acceptability | 79.8 ± 15.0 |
5-point Likert scale (1=strongly disagree that app is easy to use; 5=strongly agree that app is easy to use) on a single question of the key attribute of ease of use of DOT Diary over 8 weeks by MSM on PrEP.
| Score on a scale (Likert) | DOT Diary Optimization Intervention |
|---|---|
| DOT Diary Mobile App Ease of Use | 4 (4 to 5) |
Adherence and Persistence of use of the DOT and sexual diary components of DOT Diary by young MSM on PrEP is measured by the percentage of doses taken with visual confirmation of pill ingestion
| Percentage of doses taken | DOT Diary Optimization Intervention |
|---|---|
| Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP | 93 |
Combined analysis of situations and reasons for sub-optimal use of the app, for the purpose of app optimization
| Count of participants for each reason | DOT Diary Optimization Intervention |
|---|---|
| Technical problems | 8 |
| Away from home | 6 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DOT Diary Optimization Intervention | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
18-35 years old, eligible, and willing to take PrEP
| Age, Continuous(years) | DOT Diary Optimization Intervention |
|---|---|
| Mean | 27.4 ± 3.3 |
| Sex: Female, Male(Participants) | DOT Diary Optimization Intervention |
|---|---|
| Female | 0 |
| Male | 20 |
| Ethnicity (NIH/OMB)(Participants) | DOT Diary Optimization Intervention |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | DOT Diary Optimization Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 15 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — If requested, will share summary participant data with all identifying information removed.
Supporting information: Study protocol, Informed consent form
Time frame: Data are available from publication of the primary results through 3 years.
Access criteria: Must have IRB approval.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Emtricitabine · Tenofovir
Public Health Foundation Enterprises, Inc.