Digital Health Feedback System (DHFS) for Longitudinal Monitoring of ARVs Used in HIV Pre-exposure Prophylaxis (PrEP)

NCT03693040 | Unknown

• 2 other identifiers: 161618R01MH110057
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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 Pre-Exposure Prophylaxis (PrEP) medication for HIV prevention. 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 PrEP medication. The purpose of the study is to demonstrate that the DHFS is easy to use and acceptable to people taking PrEP; that patients will persist with its use; and that the system provides valid, accurate measures of adherence.

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (2)

• Medication Taking Adherence

  Medication taking adherence, defined as the number of doses ingested as captured by the DHFS over the number of doses prescribed, adjusted for Positive Detection Accuracy ( determined by the percentage of PrEP medication ingestion detected by the DHFS administered under witnessed observation).

  12 weeks

• The system positive detection accuracy (PDA) will be derived

  2\. PDA is determined by the percentage of HIV PrEP ingestion detected by the DHFS administered under witnessed observation, overall for all study subjects. PDA will be based upon proper DHFS use. The PDA will be calculated for a single tablet regimen.

  12 weeks

Secondary Outcomes (1)

• Determine the percentage of participants starting or continuing HIV PrEP who find the DHFS acceptable and easy to use.

  12 weeks

Study Arms (1)

DHFS with IS-Truvada

EXPERIMENTAL

Digital Health Feedback System (DHFS) with IS-Truvada 1 capsule daily for 12 weeks

Device: Digital Health Feedback System

Interventions

Digital Health Feedback System DEVICE

This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their PrEP medication. 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 provides information about when patients have taken their PrEP medication.

DHFS with IS-Truvada

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult non-pregnant HIV-seronegative participants who are starting or continuing HIV PrEP with IS-TDF/FTC (Truvada®), who are able to use the DHFS mobile device, and to tolerate a wearable sensor patch
• Laboratory values obtained by screening laboratories within 14 days of entry:
• Absolute neutrophil count (ANC) ≥ 1,000/mm3.
• Hemoglobin ≥ 9.0 g/dL.
• Platelet count ≥ 75,000/mm3.
• Aspartate aminotransferase (AST) , Alanine aminotransferase (ALT) , and alkaline phosphatase ≤ 3 x ULN.
• Estimated Glomerular Filtration Rate (GFR) by Cockcroft-Gault equation of \>50 ml/min, if starting treatment with Truvada®(TDF/FTC).
• HIV Ag/Ab test negative
• Hepatitis B serology negative
• Females of childbearing potential must agree to use an acceptable form of contraception throughout the protocol.
• Basic competency in understanding written and verbal information as it applies to DHFS use. English and Spanish will be used for study documents and communication.
• Willing to follow all protocol requirements.
• No symptoms or clinical suspicion of acute HIV infection.

You may not qualify if:

• Female who is pregnant, breast-feeding, or of childbearing potential and declines to use contraception throughout the study period.
• Use of any of the prohibited medications or other non-informed medications within 30 days of study entry (Day 0).
• Known allergy/sensitivity to any of the study drugs.
• Known sensitivity to skin adhesives.
• Serious medical (serious infection or acute therapy for other medical illness) or psychiatric illness requiring systemic treatment and/or hospitalization until participant either completes therapy or is clinically stable on therapy, in the opinion of the investigators, for at least 30 days prior to study entry (Day 0).
• Active drug or alcohol use, or dependence, or other conditions that, in the opinion of the site investigators, would significantly interfere with ability to follow to study requirements.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator
• Gilead Sciences: collaborator
• Proteus Digital Health, Inc.: collaborator

Study Sites (2)

UCSD AntiViral Research Center

San Diego, California, 92103, United States

Location

San Ysidro Health

San Diego, California, 92154, United States

Location

Study Officials

• Sara H Browne, MD MPH

  UCSD AntiViral Research Center

  STUDY CHAIR

• Constance A Benson, MD

  UCSD AntiViral Research Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: October 2, 2018
• Study Start: December 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

US (2)