Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System

The premise for the study is that a tailored approach for YMSM from rural and small town
areas, addressing known barriers of transportation, access to providers, and privacy, is most
likely to yield high levels of PrEP initiation and persistence in care. The study sites are
Georgia, North Carolina, and Mississippi.

Using a smartphone application (app), participants assigned to the intervention will receive
and maintain a PrEP prescription without needing to leave their home (excepting pharmacy
pick-up in some cases) - achieved through app-based surveys/screenings, telemedicine
consultations, and home specimen self-collection.

Inclusion Criteria:

- Assigned male at birth

- Age 18-24 (inclusive)

- Live in a rural or small town Zone Improvement Plan (ZIP) Code based on urbanicity
classification

- Able to provide informed consent and complete survey instruments in English

- Willing to provide complete contact information (including 2 alternate contacts)

- Able and willing to provide identification verification for viewing confirmation only

- Laboratory confirmed HIV negative

- Owns a smartphone capable of running the study app

- Male sex partners in past 6 months

- Behavioral/epidemiological indication for PrEP :

- History of inconsistent or no condom use with more than one partner

- History of inconsistent or no condom use with one partner who is not mutually
monogamous

- HIV-positive sexual partner

- Any sexually transmitted infection (STI) diagnosed in past 6 months

- Commercial sex work

- African American MSM reporting anal sex in the past 6 months

- Willing to take daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as
PrEP

- Willing to use study-provided PrEP navigation services

Exclusion Criteria:

- HIV positive (self-report or laboratory confirmed)

- Chronic Hepatitis B

- Currently enrolled in any HIV prevention trial (behavioral or biomedical)

- Currently taking emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as PrEP based
on self-report

- Creatinine clearance <60 ml/min based on the Cockcroft-Gault equation

- Symptoms of acute HIV infection within the prior 30 days

- Contraindications to taking emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)

- Personal diagnosis or family history of hemophilia

- Investigator discretion to exclude anyone whose best interest is not to participate

- Evidence of fraudulent participation, such as duplicate Internet Protocol (IP)
address, multiple screening attempts, duplicate emails, etc