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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Adherence, Medication, Risk Behavior, Pre-Exposure Prophylaxis, HIV Prevention

Intervention / Treatment
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* Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet
* Other: DOT Diary mobile app


Participation Criteria
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Eligibility Criteria
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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: 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) 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 Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DOT Diary Optimization Intervention<br>DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet | Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet<br>* Open label daily emtricitabine/tenofovir disoproxil oral tablet<br>* Other names: Truvada;Other: DOT Diary mobile app<br>* DOT Diary mobile application for tracking medication adherence and sexual activities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, PrEP, HIV Prevention, Truvada, HIV Risk Reduction, Mobile App