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

NCT04418037 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-12-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Sara H Browne, MD MPH · UC San Diego

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04418037 on ClinicalTrials.gov