“Pre-exposure Prophylaxis (PrEP) at Home”
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.
Behavioral - PrEP@Home System
The PrEP@Home system includes a home care kit mailed quarterly to participants. The kit includes components for self-collection of urine, rectal swab, pharyngeal swab and microtube blood collection, and materials for return shipping. Biological tests routinely performed at PrEP follow-up visits will be conducted on the specimens. At months 6 and 12, the kit will include materials to assess for protective levels of TFV-DP. The system includes a study app through which participants may track the m ...read more on ClinicalTrials.org
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 D ...read more on ClinicalTrials.org
Making it Last: A Randomized, Controlled Trial of a Home Care System to Promote Persistence in PrEP Care