Digital Health Feedback System for Longitudinal Measurement of Medication Adherence During Anti-Retroviral (ARV)Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02800655|
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : September 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV||Device: Digital Health Feedback System||Phase 4|
This study is a prospective single arm open label intervention study over 16 weeks using the DHFS with ARV-naive subjects initiating HIV treatment. The study intervention has an initiation (Phase 1), persistence (Phase 2) and follow-up period up to 96 weeks. In phase 1 Subjects will use the DHFS with close follow-up incorporating visits with directly observed ingestions. In Phase 2 the Subjects utilize the DHFS in their natural setting with sporadic study visits until 16 weeks. Eligible HIV seropositive subjects who are at least 18 years of age, are HIV treatment naïve, and are initiating antiretroviral therapy prescribed by their HIV practitioner will receive an ingestible sensor enabled oral Anti-Retroviral or IS-ARV either IS-R/F/TAF (Odefsey®), IS-EC/F/TAF (Genvoya®), IS-BIC/F/TAF (Biktarvy®), IS-DTG/TDF/FTC (Tivicay® and Truvada®) or IS-DTG/TAF/FTC (Tivicay® and Descovy ®). The study will be conducted at the UCSD AVRC. Subjects will be recruited from UCSD AVRC, UCSD Owen Clinic, related or affiliated UCSD HIV primary care programs or community HIV primary care clinics. Following the 16 week intervention HIV plasma viral load and continuation in HIV care are followed for up to 96 weeks. The primary outcome will be an accurate measure of adherence i.e. the number of doses of selected IS-ARVs ingested, as captured by the DHFS, over the number of doses prescribed, adjusted for PDA. The investigators will also assess the acceptability and feasibility of longitudinal monitoring in real time of the ingestion rate utilizing the DHFS. In addition the investigators will evaluate the ability of the DHFS to identify subjects whose longitudinal medication taking and timing patterns in the first 16 weeks of ARV treatment puts them at risk for detectable HIV RNA levels as far out as 96 weeks from start of treatment.
PHARMACOKINETIC (PK) SUBSTUDY
A subset of 15 participants prescribed an IS-Dolutegravir regimen will be enrolled in a PK sub-study to generate a projected time-course of drug concentrations across the entire study period. On Day 14 of treatment sub-study participants will have a detailed PK profile for Dolutegravir obtained over a single dosing interval.
Participants will also have random plasma Dolutegravir levels measured at 4, 8, 12, and 16 weeks during the DHFS monitoring.Plasma HIV-1 RNA and CD4+ T-cell count will be measured at study entry.
At the start of the IS-Tivicay, participants included in the PK study will undergo intensive monitoring of viral decay dynamics with plasma HIV-1 RNA measured at baseline and Days 2, 7, 10 and 14, as well as at Weeks 4, 8, 12, and 16 to provide the dynamic range of virologic suppression relative to drug exposure profiles generated from the intensive PK sampling on Day 14 and the DHFS dosing history.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Single Arm Open Label Intervention Study Using the DHFS With HIV Infected Participants Initiating or Continuing HIV Treatment|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: DHFS with IS-ARV
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
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.
- Medication taking adherence [ Time Frame: 16 weeks ]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).
- The persistence of sensor-enabled ingestions [ Time Frame: 16 weeks ]Defined as the number of detected ingestion divided by the number of expected ingestions, over the duration of monitoring.
- Participants will be classified into groups according to the accurate measurement of adherence [ Time Frame: 16 weeks ]High 95-100% adherence, Normal 90-95% adherence, At risk 80-90% taking adherence, Severe Risk <80%
- Medication behavior during IS-ARV use [ Time Frame: 16 weeks ]Defined as the overall number of doses taken divided by the number of expected doses and by patterns of medication behavior (timing of dose, patterns of skipped doses, doses related to physiological parameters).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800655
|Contact: Sara H Browne, MD, MPH||+1 760 -email@example.com|
|Contact: Amanda J Tucker Maytom, MDfirstname.lastname@example.org|
|United States, California|
|Family Health Centers of San Diego||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Paloma Mohn email@example.com|
|Principal Investigator: Sarah Rojas, MD, MAS|
|UCSD AntiViral Research Center||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Bianca Ramirez 619-543-2689 firstname.lastname@example.org|
|Principal Investigator: Sara H Browne, MD, MPH|
|Principal Investigator: Constance A Benson, MD|
|Study Chair:||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|