DHFS for Medication Adherence Support During Hospital Admissions for Person Living With HIV

December 10, 2024 updated by: Sara H. Browne, MD, MPH, University of California, San Diego

Digital Health Feedback System (DHFS) for Anti-Retroviral Therapy Medication Adherence and Transitions of Care Support During Hospital Admissions for Persons Living With HIV

This study is a prospective single arm open label intervention study over 16 weeks using the DHFS and a telemedicine platform with persons living with HIV who are not virologically suppressed, admitted to UCSD Hillcrest Medical Center and initiating or restarting anti-retroviral therapy (ARVs). This proof of concept study will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence. The Study intervention has an initiation phase of 2 weeks, a persistence phase of 14 weeks and a follow-up phase out to 48 weeks. Once study consent is obtained, the participant will receive a focused case navigation, psychiatric and substance abuse evaluation and will initiate digitized ARVs, either in hospital or at the AVRC within 14 days of hospital discharge, in collaboration with their providers. The study intervention will be considered to start from the point at which the DHFS is started. The study team will ensure the participants continue to utilize the DHFS both in hospital and after discharge. Following the 16 week intervention the study team will continue to follow participants to evaluate retention in care and viral suppression up to 48 weeks in collaboration with the outpatient care providers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • UCSD Antiviral Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. HIV seropositive status, as documented by positive licensed HIV antibody testing and a detectable viral load > 1000 copies/ml.
  2. Persons admitted to UCSD Hillcrest Medical Center with an HIV associated diagnosis and to receive HIV care through UCSD Owen Clinic, FHCSD HIV Clinic or San Ysidro Health HIV Clinic post hospital discharge.

  3. Persons initiating or continuing treatment for HIV infection by their HIV provider, that includes either:

    1. Dolutegravir/Tenofovir alafenamide/Emtricitabine: IS-DTG/TAF/FTC (Tivicay® and Descovy®)
    2. Bictegravir/ Tenofovir alafenamide/Emtricitabine: IS-BIC /TAF/FTC (Biktarvy®)
    3. Darunavir/Cobistat/Emtricitabine/Tenofovir alafenamide: IS-DRV/C/F/TAF (Symtuza™)
  4. Eligible for antiretroviral medications and in possession of prescriptions for above noted study eligible regimens.

  5. Laboratory values obtained by screening laboratories within 30 days of entry:

    1. Absolute neutrophil count (ANC) ≥ 1,000/mm3.
    2. Hemoglobin ≥ 7.0 g/dL.
    3. Platelet count ≥ 50,000/mm3.
    4. AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 5 x ULN.
    5. Total bilirubin ≤ 3 x ULN and direct bilirubin.
    6. Estimated GFR by Cockcroft-Gault equation of greater than 30 ml/min.

  6. Females of childbearing potential (defined as girls who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e. who have had menses within the preceding 24 months, or have not undergone surgical sterilization (e.g. hysterectomy, bilateral oophorectomy, or salpingotomy) must have a negative serum or urine pregnancy test performed within 72 hours prior to study entry.

    If participating in activity that could lead to pregnancy, the participant must use at least one of the following forms of contraception throughout the protocol and for 6 weeks after stopping the IS-ARV medications.

    • Condoms (male or female) with a spermicidal agent
    • Diaphragm or cervical cap with spermicide
    • IUD
    • Oral contraception. Condoms in addition to other methods are highly recommended because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.
  7. Men and women age ≥ 18 years.
  8. 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.
  9. Ability and willingness to follow all protocol requirements.
  10. Ability to use mobile device per investigator determination, and to wear PDH wearable sensor (i.e., no skin conditions precluding use).
  11. Ability and willingness of participant to give written informed consent.

Exclusion Criteria:

  1. Female who is pregnant, breast-feeding, or of childbearing potential and disagrees to use contraception throughout the study period.
  2. Use of any of the prohibited medications or other non-informed medications (Section 5.5.2) within 30 days of study entry (Day 0).
  3. Known allergy/sensitivity to any of the study drugs.
  4. Known sensitivity to skin adhesives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single arm using the Digital Health Feedback System
This protocol is designed to evaluate a novel technology that employs an ingestible sensor to detect medication ingestion for use by persons initiating or restarting antiretroviral (ARV) treatment for HIV infection during a hospital admission.
Device: Digital Health Feedback System(DHFS)
We will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
An accurate measure of medication taking adherence captured by the DHFS
Time Frame: 16 weeks
The number of doses ingested as captured by the DHFS over the number of doses prescribed, adjusted for positive detection accuracy (PDA). The system positive detection accuracy (PDA), based on prior studies, will allow an accurate measure of adherence with CI calculated.
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Achieving <90% adherence as detected by DHFS over the study intervention (weeks 0-16).
Time Frame: 16 weeks
Participants with <90% adherence as detected by DHFS over the study intervention will be identified.
16 weeks
Percentage of participants who require adherence support to maintain adherence over 90% during weeks 0-16.
Time Frame: 16 weeks
Percentage of participants who require adherence support to maintain adherence over 90% will be calculated.
16 weeks
Satisfaction rating for DHFS use for HIV treatment as 'satisfactory' or higher.
Time Frame: 16 weeks
Characterize participant responses to study questionnaires on usability and exit questionnaire and summarize information regarding patient experience with the DHFS.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Gilead Sciences
ViiV Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara H Browne, MD MPH, UC San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 182100
  • R01MH110057 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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