DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men

• Status: Completed
• Trial end date: 2020-04-21
• Target enrollment: 0
• Participant gender: All

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 assess the impact of the app on adherence to HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Public Health Foundation Enterprises, Inc.
• Collaborators: AiCure; Emory University; National Institute of Allergy and Infectious Diseases (NIAID); National Institute of Mental Health (NIMH); San Francisco Department of Public Health
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• Self-identifies as a man

• Age 18-35 at enrollment

• Reports having insertive or receptive anal sex with a man or trans woman in the past 12 months and one or more of the following criteria in the last 12 months:

• Any condomless anal sex outside of a mutually monogamous relationship with an HIV-negative partner

• Two or more anal sex partners

• Self-reported sexually transmitted infection (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

• Willing to initiate 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 app

• Meets local locator requirements

• Lives, works or plays in Atlanta Metropolitan Area, San Francisco, Alameda, Marin, Contra Costa, Santa Clara, or San Mateo Counties

Exclusion Criteria:

• PrEP use within the past 4 months (PrEP naive participants will be prioritized)

• 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

• Unable to commit to study participation for 24 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.