Back to resultsTeam-based Inpatient ARTAS (ARTAS)
Primary Purpose
HIV Infections, Inpatient Facility Diagnoses
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Team Based Inpatient ARTAS
Standard of Care
Sponsored by
About this trial
This is an interventional other trial for HIV Infections focused on measuring HIV, linkage to care, hospital readmission
Eligibility Criteria
Inclusion Criteria: 18 years of age or greater newly diagnosed HIV Known diagnosis of HIV not on ART within 30 days of admission Known HIV and not virally suppressed based on interview Known HIV and has not been under the care of an HIV specialist within the past 6 months Exclusion Criteria: All three criteria must be present for exclusion: virally suppressed actively taking ART are under active care of an HIV specialist within the last 6 months Less than 18 years of age (stand alone exclusion)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard of Care Historic Control
Team based inpatient ARTAS
Arm Description
Control group will get treatment as usual, which consists of medical care by primary admitting service
Eligible patients after the study consent process will receive Antiretroviral Treatment Access Study (ARTAS) intervention by social-worker and a medical consultation by an infectious disease physician
Outcomes
Primary Outcome Measures
Rate of linkage to HIV care post discharge
Subject had one visit with HIV specialist post hospital discharge. This will be determined per medical chart review and phone interview with subject
Secondary Outcome Measures
Readmission Rate after initial post-study hospitalization
Subject had one emergency room visit or one inpatient admission post hospital discharge. This will be determined per medical chart review and phone interview with subject.
Full Information
NCT ID
NCT05866523
First Posted
May 10, 2023
Last Updated
September 6, 2023
Sponsor
Loma Linda University
Collaborators
Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05866523
Brief Title
Team-based Inpatient ARTAS
Acronym
ARTAS
Official Title
Team-based Inpatient Anti-Retroviral Treatment and Access to Services (ARTAS)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
Collaborators
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Exploring the effect of team-based ARTAS intervention in an inpatient setting on HIV linkage to care and hospital readmission rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Inpatient Facility Diagnoses
Keywords
HIV, linkage to care, hospital readmission
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
This is a prospective, observational cohort study design with patients enrolled at Loma Linda University Medical Center (LLUMC), evaluating a multidisciplinary inpatient linkage to care program compared to historical control.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care Historic Control
Arm Type
Active Comparator
Arm Description
Control group will get treatment as usual, which consists of medical care by primary admitting service
Arm Title
Team based inpatient ARTAS
Arm Type
Active Comparator
Arm Description
Eligible patients after the study consent process will receive Antiretroviral Treatment Access Study (ARTAS) intervention by social-worker and a medical consultation by an infectious disease physician
Intervention Type
Behavioral
Intervention Name(s)
Team Based Inpatient ARTAS
Intervention Description
Infectious Disease Team will provide inpatient consultation. Social Work Team will provide 1 session of case management inpatient and up to 5 case management sessions within 90 days post discharge or until the client is linked to medical care as evidenced by visit with HIV specialist within 90 days post discharge.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
Subject admitted and seen by routine inpatient medical service.
Primary Outcome Measure Information:
Title
Rate of linkage to HIV care post discharge
Description
Subject had one visit with HIV specialist post hospital discharge. This will be determined per medical chart review and phone interview with subject
Time Frame
Up to 90 days post-study enrollment hospitalization discharge
Secondary Outcome Measure Information:
Title
Readmission Rate after initial post-study hospitalization
Description
Subject had one emergency room visit or one inpatient admission post hospital discharge. This will be determined per medical chart review and phone interview with subject.
Time Frame
Up to 90 days post-study enrollment hospitalization discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or greater
newly diagnosed HIV
Known diagnosis of HIV not on ART within 30 days of admission
Known HIV and not virally suppressed based on interview
Known HIV and has not been under the care of an HIV specialist within the past 6 months
Exclusion Criteria:
All three criteria must be present for exclusion:
virally suppressed
actively taking ART
are under active care of an HIV specialist within the last 6 months
Less than 18 years of age (stand alone exclusion)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Veltman, MD
Phone
909 558 4000
Ext
14912
Email
jveltman@llu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Team-based Inpatient ARTAS
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