Pre-exposure Prophylaxis (PrEP) at Home

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.

Conditions

• HIV/AIDS

Interventions

BEHAVIORAL

PrEP@Home System

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.

OTHER

Standard of Care

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).

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Aaron Siegler, PhD · Emory University

• Kenneth Mayer, MD · Harvard Medical School (HMS and HSDM)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-04-26

Primary Completion

2023-04-15

Completion

2023-04-15

Countries

• United States

Study Locations