NCT02800655

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4 hiv

Timeline
Completed

Started Jun 2016

Longer than P75 for phase_4 hiv

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

5.5 years

First QC Date

April 5, 2016

Last Update Submit

December 21, 2022

Conditions

HIV

Keywords

ARV treatmentMedication AdherenceDigital Health Feedback SystemProteus Digital Health

Outcome Measures

Primary Outcomes (1)

  • 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 HIV medication ingestion detected by the DHFS administered under witnessed observation).

    16 weeks

Secondary Outcomes (3)

  • The persistence of sensor-enabled ingestions

    16 weeks

  • Participants will be classified into groups according to the accurate measurement of adherence

    16 weeks

  • Medication behavior during IS-ARV use

    16 weeks

Study Arms (1)

DHFS with IS-ARV

EXPERIMENTAL

Digital Health Feedback System (DHFS) with either IS- Odefsey®, IS- Genvoya®, IS-Biktarvy®, IS- Tivicay® and Truvada® or IS- Tivicay® and Descovy ® (IS-co-encapsulated with ingestion sensor) -1 or 2 capsules daily (QD), depending on the treatment regimen, administered orally for 16 weeks.

Device: Digital Health Feedback System

Interventions

Digital Health Feedback SystemDEVICE

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 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 provides information about when patients have taken their ARV medications. Other Names: DHFS

DHFS with IS-ARV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV seropositive status, as documented by positive licensed HIV antibody testing AND either treatment naïve, defined as never having received ARVs in the past (excluding ARVs used as pre-exposure prophylaxis OR post-exposure prophylaxis) or continuing HIV treatment.
  • Persons ready to initiate first regimen treatment for HIV infection by their HIV provider, that includes either:
  • Biktarvy®
  • Genvoya®
  • Odefsey®
  • Tivicay® PLUS Truvada®
  • Tivicay®: PLUS Descovy®
  • Eligible for antiretroviral medications and in possession of prescriptions for above noted study eligible regimens.
  • Laboratory values obtained by screening laboratories within 30 days of entry:
  • Absolute neutrophil count (ANC) ≥ 1,000/mm3.
  • Hemoglobin ≥ 9.0 g/dL.
  • Platelet count ≥ 75,000/mm3.
  • AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 3 x ULN.
  • Total bilirubin ≤ 1.5 x ULN and direct bilirubin.
  • Estimated GFR by Cockcroft-Gault equation of greater than 50 ml/min, if starting treatment with Tivicay®: Dolutegravir (DTG) PLUS Truvada®: Tenofovir disoproxil fumarate/Emtiritabine (TDF/FTC)
  • +8 more criteria

You may not qualify if:

  • Female who is pregnant, breast-feeding, or of childbearing potential and disagrees to use contraception throughout the study period.
  • Use of any of the prohibited medications or other non-informed medications (Section 5.5.2) 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 subject 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).
  • NOTE: Subjects will be excluded if genotype shows presence of any HIV-associated resistance mutations listed per the International AIDS Society-USA mutation list (update lists can be found at: http://www.iasusa.org).
  • 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.
  • History of pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Family Health Centers of San Diego

San Diego, California, 92103, United States

Location

UCSD AntiViral Research Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sara H Browne, MD, MPH

    University of California, San Diego AntiViral Research Center

    STUDY CHAIR

  • Constance A Benson, MD

    University of California, San Diego AntiViral Research Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Research Associate

Study Record Dates

First Submitted

April 5, 2016

First Posted

June 15, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2023

Last Updated

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

Locations

US(2)