DHFS for Medication Adherence Support During Hospital Admissions for Person Living With HIV
NCT ID: NCT04418037
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
16 participants
INTERVENTIONAL
2019-05-15
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Digital Health Feedback System(DHFS)
We will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence.
Interventions
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Digital Health Feedback System(DHFS)
We will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Gilead Sciences
INDUSTRY
ViiV Healthcare
INDUSTRY
University of California, San Diego
OTHER
Responsible Party
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Sara H. Browne, MD, MPH
Professor
Principal Investigators
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Sara H Browne, MD MPH
Role: PRINCIPAL_INVESTIGATOR
UC San Diego
Locations
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UCSD AntiViral Research Center
San Diego, California, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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182100
Identifier Type: -
Identifier Source: org_study_id