DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence (NCT03387462) | Clinical Trial Compass
CompletedPhase 4
DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence
United States20 participantsStarted 2018-02-28
Plain-language 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. 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.
Who can participate
Age range
18 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
DOT Diary Mobile App Acceptability
Timeframe: 8 weeks
2
DOT Diary Mobile App Ease of Use
Timeframe: 8 weeks
3
Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP