NCT04418037

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-15
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2020-06-05
• Last updated: 2024-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study