HIVPhase 4NCT02800655
Digital Health Feedback System for Longitudinal Measurement of Medication Adherence During Anti-Retroviral (ARV)Therapy
A Phase 4 study testing Digital Health Feedback System in people with HIV, run by University of California, San Diego at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Digital Health Feedback System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2016to Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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®
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- 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)
- Estimated GFR by Cockcroft-Gault equation of greater than 30 ml/min, if starting treatment with Genvoya®: Elvitegravir/Cobisistat/Tenofovir alafenamide/Emtricitabine (E/C/F/TAF), Biktarvy®(BIC/F/TAF), Odefsey®: Riplivirine/Tenofovir alafenamide/Emtricitabine (R/F/TAF), or with Tivicay®: Dolutegravir (DTG) PLUS Descovy®: Tenofovir alafenamide/Emtricitabine (F/TAF)
- HIV RNA value (viral load) ≤ 100,000 copies/mL, if starting treatment with Odefsey®: Riplivirine/Tenofovir alafenamide/Emtricitabine (R/F/TAF)
- Females of childbearing potential must agree to use an acceptable form of contraception throughout the protocol and for 6 weeks after stopping the IS-ARV medications.
- Men and women age ≥ 18 years.
- 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.
- Ability to use mobile device per investigator determination, and to wear PDH wearable sensor (i.e., no skin conditions precluding use).
- Ability and willingness of subject to give written informed consent.
- -
Who cannot join
- 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).
- Evidence of any major antiretroviral resistance associated mutation in genotypic testing at baseline, prior to study entry for subjects. Resistance testing results must be available for review by the site investigator and study protocol team prior to enrollment to ensure that no exclusionary resistance exists. All resistance testing results should be scanned and uploaded to the on-line data collecting system (https://cfar.ucsd.edu/intranet).
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- 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
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Family Health Centers of San Diego
San Diego, California, 92103
UCSD AntiViral Research Center
San Diego, California, 92103
About this study
Official title: A Prospective Single Arm Open Label Intervention Study Using the DHFS With HIV Infected Participants Initiating or Continuing HIV Treatment
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.
Read the detailed description
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.
- Conditions
- HIV
- Being tested
- Digital Health Feedback System
- Keywords
- ARV treatment, Medication Adherence, Digital Health Feedback System, Proteus Digital Health
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Digital Health Feedback System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 16 weeks
Secondary outcomes (3)
The persistence of sensor-enabled ingestions
Defined as the number of detected ingestion divided by the number of expected ingestions, over the duration of monitoring.
Measured: 16 weeks
Participants will be classified into groups according to the accurate measurement of adherence
High 95-100% adherence, Normal 90-95% adherence, At risk 80-90% taking adherence, Severe Risk <80%
Measured: 16 weeks
Medication behavior during IS-ARV use
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).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2021
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Gilead Sciences, ViiV Healthcare, GlaxoSmithKline, Proteus Digital Health, Inc.
- Responsible party
- Principal investigator, Sara H. Browne, MD, MPH, University of California, San Diego
- Investigators
- Sara H Browne, MD, MPH, Study chair, University of California, San Diego AntiViral Research CenterConstance A Benson, MD, Study chair, University of California, San Diego AntiViral Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800655
- Sponsor's protocol ID
- 160521
- Other IDs
- R01MH110057
- Status last verified
- Dec 2022
- First submitted
- 5 Apr 2016
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Arm Open Label Intervention Study Using the DHFS With HIV Infected Participants Initiating or Continuing HIV Treatment
- ClinicalTrials.gov ID
- NCT02800655
- Acronym / sponsor ID
- 160521
- Conditions
- HIV
- Keywords
- ARV treatment, Medication Adherence, Digital Health Feedback System, Proteus Digital Health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Gilead Sciences, ViiV Healthcare, GlaxoSmithKline, Proteus Digital Health, Inc.
- Study start
- Jun 2016
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DHFS with IS-ARV | Experimental | Device: Digital Health Feedback SystemDigital 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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:
- 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:
- Females of childbearing potential must agree to use an acceptable form of contraception throughout the protocol and for 6 weeks after stopping the IS-ARV medications.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health Feedback SystemThis 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 | Device | DHFS with IS-ARV |
Primary outcome
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).
3 secondary outcomes
The persistence of sensor-enabled ingestions
Time frame: 16 weeks
Participants will be classified into groups according to the accurate measurement of adherence
Time frame: 16 weeks
Medication behavior during IS-ARV use
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara H Browne, MD, MPH study chair
University of California, San Diego AntiViral Research Center
Constance A Benson, MD study chair
University of California, San Diego AntiViral Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Digital Health Feedback System in people with HIV, run by University of California, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication taking adherence (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.