Pre-exposure Prophylaxis (PrEP) at Home
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      This study is a randomized clinical trial of PrEP@Home, a home care system for Human
      Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP). Individuals entering into PrEP
      care at an initial in-person study visit will be randomized to the PrEP@Home system for
      home-based PrEP care follow-up visits or to the control standard of care for clinic-based
      follow-up visits. The primary aim of this study is to assess protective levels of PrEP
      medication for the intervention arm compared to the control arm.
    

Detailed 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 the
      persistence of patients in PrEP care. Preliminary data indicate that a home-based care system
      for PrEP is feasible, and 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 in 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 participants' 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.
    

Intervention name(s): PrEP@Home System; Standard of Care
Intervention type(s): Behavioral; Other
Intervention description(s): The PrEP@Home system includes a home care kit mailed quarterly to participants. The kit has components for self-collection of urine, rectal and pharyngeal swabs, microtube blood collection, and materials for return shipping. Biological tests routinely performed at PrEP follow-up (FU) visits will be done on the specimens. At months 6 and 12, the kit will include materials to assess for protective levels of emtricitabine triphosphate (FTC-TP).
The system includes a study app through which participants may track the mailing of home testing kits, access quarterly surveys, and communicate with study clinicians. The surveys will include domains that physicians assess at PrEP care quarterly FU visits (sexual risk, illicit substance use, PrEP adherence, side effects).
Study Clinicians will review Lab and survey results and if the results show no contraindications for PrEP continuation, the clinician may renew a participant's PrEP prescription. Telemedicine visits will be scheduled as needed.; Control participants will receive clinic-based PrEP follow-up. After the baseline assessment, control participants will receive active linkage to standard, clinic-based PrEP care for their next PrEP care follow-up visit. Participants will also download the control version of the study app, which will contain only research elements pertinent to their participation in the control arm of the study including quarterly surveys. At months 6 and 12, control arm participants will be sent materials for DBS self-collection and return shipping to allow for measurement of the study outcome, emtricitabine triphosphate (FTC-TP).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This trial will include 396 participants with 2:1 allocation for the intervention (264) and control (132) conditions. The sample of 396 will target inclusion of 50% Black and 50% younger (aged 18-34) participants.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pre-exposure prophylaxis (PrEP); Home-based monitoring