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

NCT04418037 | Completed Phase 4 FDA Device

• 2 other identifiers: 182100R01MH110057
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• An accurate measure of medication taking adherence captured by the DHFS

  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 Outcomes (3)

• Achieving <90% adherence as detected by DHFS over the study intervention (weeks 0-16).

  16 weeks

• Percentage of participants who require adherence support to maintain adherence over 90% during weeks 0-16.

  16 weeks

• Satisfaction rating for DHFS use for HIV treatment as 'satisfactory' or higher.

  16 weeks

Study Arms (1)

Single arm using the Digital Health Feedback System

EXPERIMENTAL

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)

Interventions

Digital Health Feedback System(DHFS) DEVICE

We will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence.

Single arm using the Digital Health Feedback System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV seropositive status, as documented by positive licensed HIV antibody testing and a detectable viral load \> 1000 copies/ml.
• 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.
• Persons initiating or continuing treatment for HIV infection by their HIV provider, that includes either:
• Dolutegravir/Tenofovir alafenamide/Emtricitabine: IS-DTG/TAF/FTC (Tivicay® and Descovy®)
• Bictegravir/ Tenofovir alafenamide/Emtricitabine: IS-BIC /TAF/FTC (Biktarvy®)
• Darunavir/Cobistat/Emtricitabine/Tenofovir alafenamide: IS-DRV/C/F/TAF (Symtuza™)
• 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 ≥ 7.0 g/dL.
• Platelet count ≥ 50,000/mm3.
• AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 5 x ULN.
• Total bilirubin ≤ 3 x ULN and direct bilirubin.
• Estimated GFR by Cockcroft-Gault equation of greater than 30 ml/min.
• 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.

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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator
• Gilead Sciences: collaborator
• ViiV Healthcare: collaborator

Study Sites (1)

UCSD AntiViral Research Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sara H Browne, MD MPH

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: June 5, 2020
• Study Start: May 15, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 16, 2024

Record last verified: 2024-11

Locations

US (1)