Pre-exposure Prophylaxis (PrEP) at Home

Clinical guidance calls for quarterly follow-up visits for individuals taking PrEP. Yet these
visits impose burdens on the healthcare system and on patients that could hinder persistence
of patients in PrEP care. Preliminary data indicate that a home-based care system for PrEP is
feasible, acceptable, and may increase patient willingness to remain in care.

This study explores the effect of a home-based PrEP support system on maintenance in PrEP
care. The study will enroll 396 participants into a stratified randomized, controlled trial
comparing the PrEP@Home intervention arm to the standard of care control arm. The study seeks
to explore intervention performance among highly impacted groups, and therefore will target a
sample that is 50% Black and 50% aged 18-34 years.

Individuals in the intervention and control arms will have a baseline study visit, in which
patients will be prescribed PrEP. Participants randomized to the intervention arm will
receive home care for PrEP at months 3, 6, 9, and 12. Home care will include a mailed package
with materials for HIV/sexually transmitted infection (STI)/creatinine specimen
self-collection, materials for return shipping, and a link to an electronic, self-report
behavioral assessment. Home care will also include access to the intervention version of the
study app to facilitate patient-provider and patient-system interactions. Study clinicians
will monitor patients in home care, and renew prescriptions as indicated. Control arm
participants will be linked to a local PrEP provider, where they will be seen for quarterly
clinic visits per standard of care. Control participants will have access to the control
version of the study app that contains only research elements pertinent to their
participation in the control arm of the study.

At months 6 and 12, all participants will be mailed materials for dried blood spot (DBS)
self-collection to allow for measurement of tenofovir diphosphate (TFV-DP) levels. The
primary outcome is a comparison of the levels of TFV-DP, a measure that provides information
regarding protective levels of PrEP, for the intervention relative to the control arm.

Inclusion Criteria:

- Male at birth

- Report anal sex with a man in the past 6 months

- Are able to complete survey instruments in English

- Live in the metropolitan area of a study site

- Are willing to provide at least 2 means of alternate contact

- Willing to not enroll in another HIV prevention trial

- HIV-negative (self-reported and lab confirmed)

- Own and willing to use a smart phone for the duration of the study

- Willing to download study app

- Willing to take a photo of a PrEP prescription label

- Behaviorally indicated for PrEP (per Centers for Disease Control and Prevention (CDC)
guidance) or African American men who have sex with men (MSM) who report anal sex in
the last six months

- PrEP naïve or has initiated PrEP within the last three months

- Willing to take PrEP, including adherence to daily dosing

- Willing to use, as needed, study-provided PrEP navigation services to obtain coverage
for PrEP medication

- Able to work with study site to develop a plan to cover financial cost of PrEP if not
covered through insurance or Gilead financial assistance

- Willing to use a home kit that will include self-administered collection of urine,
rectal and pharyngeal swabs, and finger prick blood.

Exclusion Criteria:

- Reports having genital reassignment surgery

- <18 or ≥ 50 years of age

- Currently enrolled in another HIV prevention trial

- Symptoms of acute HIV infection, or being evaluated for acute infection because of
recent high risk exposure

- Has taken Post Exposure Prophylaxis (PEP) in the last 3 months

- Has ever taken PrEP for ≥ 3 months

- Creatinine clearance <60 ml/min

- Hepatitis B surface antigen (HBsAg) positive

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

- History of hemophilia

- Unable to conduct finger prick at study site