Clinical Trial: Digital Health Feedback System for Longitudinal Measurement of Medication Adherence During Initial ARV Therapy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional




Official Title: A Prospective Single Arm Open Label Intervention Study Using the Digital Health Feedback System (DHFS) With Antiretroviral(ARV)-Naive Subjects Initiating HIV Treatment

Brief Summary:

This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their ARV medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which gives healthcare providers information about when patients have taken their ARV medications.

The purpose of the study is to demonstrate that the DHFS is easy to use and acceptable to the HIV patient population; that patients will persist with its use; and that the system provides valid, accurate measures of adherence.