Status:
COMPLETED
DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence
Lead Sponsor:
Public Health Foundation Enterprises, Inc.
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
San Francisco Department of Public Health
Conditions:
Adherence, Medication
Risk Behavior
Eligibility:
All Genders
18-35 years
Phase:
PHASE4
Brief 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 th...
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 (Y...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03387462
Start Date
February 28 2018
End Date
August 30 2018
Last Update
October 27 2021
Active Locations (2)
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1
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, United States, 94102
2
Emory University, School of Public Health
Atlanta, Georgia, United States, 30322