Adherence, MedicationPhase 4NCT03387462

DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence

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: 20 participants
Where: 2 sitesUnited States
Study dates: 28 Feb 2018to 30 Aug 2018
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 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:
Any condomless anal sex (not in a mutually monogamous relationship with an HIV-negative partner)
Two or more anal sex partners
Self-reported STI (gonorrhea, chlamydia, syphilis)

Show all 16Show 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
Currently taking PrEP or interested in initiating 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
Meets local locator requirements

Who cannot join

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
In a mutually monogamous sexual relationship with an HIV-negative partner for the past 12 months

Show all 9Show fewer

Does not live, work or play in Atlanta Metropolitan Area, San Francisco, Alameda, Marin, Contra Costa, Santa Clara, or San Mateo Counties
Unable to commit to study participation for 8 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 (D2): Developing a Mobile App With Combined Automated DOT and Daily Sexual Diary for Monitoring and Improving PrEP Adherence: DOT Diary Optimization Pilot

Read the detailed description

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.

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 NCT03387462
Study group	Role	What they receive
DOT Diary Optimization Intervention	Experimental	DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet Receives: Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet; Other: DOT Diary mobile app

What is being measured

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

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.
Measured: 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.
Measured: 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
Measured: 8 weeks

Secondary outcomes (1)

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
Measured: 8 weeks

Timeline

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

28 Feb 201830 Aug 2018

First posted2 Jan 2018
Study start28 Feb 2018
Primary completion30 Aug 2018
Study completion30 Aug 2018

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03387462
Sponsor's protocol ID: 17-22864
Other IDs: 1R01MH109320-01
Status last verified: Oct 2021
First submitted: 1 Dec 2017
Last updated: 27 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: If requested, will share summary participant data with all identifying information removed.

Publications

Liu AY, Laborde ND, Coleman K, Vittinghoff E, Gonzalez R, Wilde G, Thorne AL, Ikeguchi E, Shafner L, Sunshine L, van der Straten A, Siegler AJ, Buchbinder S. 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. AIDS Behav. 2021 Apr;25(4):1001-1012. doi: 10.1007/s10461-020-03054-2. Epub 2020 Oct 12.
PubMed 33044687

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DOT Diary (D2): Developing a Mobile App With Combined Automated DOT and Daily Sexual Diary for Monitoring and Improving PrEP Adherence: DOT Diary Optimization Pilot
ClinicalTrials.gov ID: NCT03387462
Acronym / sponsor ID: 17-22864
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: 20 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: 28 Feb 2018 (actual)
Primary completion: 30 Aug 2018 (actual)
Study completion: 30 Aug 2018 (actual)
First posted: 2 Jan 2018 (actual)
Results: Posted 19 Feb 2020

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DOT Diary Optimization Intervention	Experimental	Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet, Other: DOT Diary mobile appDOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet

Who may qualify

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

Key inclusion criteria (16 listed)

Self-identifies as a man
Age 18-35 at enrollment
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:
HIV-negative as determined by a negative 4th generation HIV test at screening and negative rapid 4th generation test at enrollment
Currently taking PrEP or interested in initiating PrEP

Key exclusion criteria (9 listed)

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

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 Optimization Intervention
DOT Diary mobile appDOT Diary mobile application for tracking medication adherence and sexual activities.	Other	DOT Diary Optimization Intervention

Primary outcome

DOT Diary Mobile App Acceptability
Time frame: 8 weeks
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.
DOT Diary Mobile App Ease of Use
Time frame: 8 weeks
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.
Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young 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 is measured by the percentage of doses taken with visual confirmation of pill ingestion

1 secondary outcome

Assessment of Situations and Reasons for Sub-optimal Use of the App
Time frame: 8 weeks

Results and safety

Results posted to the registry on 19 Feb 2020, 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 Optimization Intervention	20	19

Primary outcome: DOT Diary Mobile App Acceptability

Time frame: 8 weeks. Mean (Standard Deviation). Unit: Score on scale

Measure	DOT Diary Optimization Intervention n = 19
Value	79.8 (15.0)

Population analysed: MSM eligible for or taking PrEP

Primary outcome: DOT Diary Mobile App Ease of Use

Time frame: 8 weeks. Median (Inter-Quartile Range). Unit: Score on a scale (Likert)

Measure	DOT Diary Optimization Intervention n = 19
Value	4 (4 to 5)

Population analysed: Participants answering the ease of use question at 8 weeks.

Primary outcome: Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP

Time frame: 8 weeks. Number. Unit: Percentage of doses taken

Measure	DOT Diary Optimization Intervention n = 19
Value	93

Population analysed: MSM eligible for or taking PrEP

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DOT Diary Optimization Intervention	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33044687Liu AY, Laborde ND, Coleman K, Vittinghoff E, Gonzalez R, Wilde G, Thorne AL, Ikeguchi E, Shafner L, Sunshine L, van der Straten A, Siegler AJ, Buchbinder S. 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. AIDS Behav. 2021 Apr;25(4):1001-1012. doi: 10.1007/s10461-020-03054-2. Epub 2020 Oct 12.
Individual participant dataSharing planned: Yes. If requested, will share summary participant data with all identifying information removed.

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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 16 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 27 Oct 2021. 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 19 Feb 2020). 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?

DOT Diary Mobile App Acceptability (time frame: 8 weeks). The study lists 3 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 NCT03387462, 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 27 Oct 2021.