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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH109320-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| San Francisco Department of Public Health | OTHER_GOV |
| Emory University | OTHER |
| AiCure |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOT Diary Optimization Intervention | Experimental | DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emtricitabine / Tenofovir Disoproxil Oral Tablet | Drug | Open label daily emtricitabine/tenofovir disoproxil oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 weeks |
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Inclusion Criteria:
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
Eligible to take PrEP
Willing and able to provide written informed consent
Able to read and speak English
Smartphone ownership compatible with DOT Diary
Meets local locator requirements
Exclusion Criteria:
Self-identify as a man
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| Name | Affiliation | Role |
|---|---|---|
| Susan Buchbinder, MD | Bridge HIV, San Francisco Department of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridge HIV, San Francisco Department of Public Health | San Francisco | California | 94102 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33044687 | Result | 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. |
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If requested, will share summary participant data with all identifying information removed.
Data are available from publication of the primary results through 3 years.
Must have IRB approval.
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Participants were recruited online and via social media, as well as through in-person community outreach.
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| ID | Title | Description |
|---|---|---|
| FG000 | DOT Diary Optimization Intervention | DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2018 |
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| INDUSTRY |
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| DOT Diary mobile app | Other | DOT Diary mobile application for tracking medication adherence and sexual activities. |
|
| Emory University, School of Public Health |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| 4 Weeks |
|
| 8 Weeks |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
18-35 years old, eligible, and willing to take PrEP
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| ID | Title | Description |
|---|---|---|
| BG000 | DOT Diary Optimization Intervention | DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | MSM eligible for or taking PrEP | Posted | Mean | Standard Deviation | Score on scale | 8 weeks |
|
|
| |||||||||||||||||||||||||
| Primary | 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. | Participants answering the ease of use question at 8 weeks. | Posted | Median | Inter-Quartile Range | Score on a scale (Likert) | 8 weeks |
|
| ||||||||||||||||||||||||||
| Primary | 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 | MSM eligible for or taking PrEP | Posted | Number | Percentage of doses taken | 8 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | MSM eligible for or taking PrEP | Posted | Number | Count of participants for each reason | 8 weeks |
|
|
8 weeks
As daily oral FTC/TDF for PrEP is a licensed medication, the study focused assessment of AEs on the known toxicity profile of the medication, including creatinine elevations / decreases in creatinine clearance, bone fractures / toxicity, and symptoms associated with a start-up syndrome (e.g. diarrhea, nausea, headache, abdominal gas). A targeted symptom review was performed at each visit using a symptom checklist focused on symptoms associated with FTC/TDF.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DOT Diary Optimization Intervention | DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities. | 0 | 20 | 0 | 20 | 0 | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Buchbinder | Bridge HIV, San Francisco Department of Public Health | 628-217-7479 | susan.buchbinder@sfdph.org |
| Dec 19, 2019 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 12, 2018 | Dec 19, 2019 | ICF_001.pdf |
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D012309 | Risk-Taking |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|