Pre-exposure Prophylaxis (PrEP) at Home

Summary

Participation Requirements

Description

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, acceptabl...

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.

Tracking Information