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NCT04418037 · ClinicalTrials.gov registry record · Phase 4
DHFS for Medication Adherence Support During Hospital Admissions for Person Living With HIV
A Phase 4 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT04418037 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 16 participants.
The verdict
NCT04418037, a Phase 4 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
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.
Interventions
- DEVICE Digital Health Feedback System(DHFS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-05-15 |
| Est. Completion | 2021-12-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04418037
The ClinicalTrials.gov registry entry for NCT04418037 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Digital Health Feedback System(DHFS) is the first listed.
NCT04418037 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04418037 about?
NCT04418037 is a clinical study titled "DHFS for Medication Adherence Support During Hospital Admissions for Person 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...
What is the current status of trial NCT04418037?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2019-05-15. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT04418037?
The interventions under investigation include: Digital Health Feedback System(DHFS) (DEVICE).
Who is sponsoring clinical trial NCT04418037?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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