Team-based Inpatient ARTAS

Sponsor

Loma Linda University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05866523

Collaborator

Gilead Sciences (Industry)

300

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Inpatient Facility Diagnoses	Behavioral: Team Based Inpatient ARTAS Behavioral: Standard of Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention 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.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)

Primary Purpose:

Other

Official Title:

Team-based Inpatient Anti-Retroviral Treatment and Access to Services (ARTAS)

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of Care Historic Control Control group will get treatment as usual, which consists of medical care by primary admitting service	Behavioral: Standard of Care Subject admitted and seen by routine inpatient medical service.
Active Comparator: Team based inpatient ARTAS 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	Behavioral: Team Based Inpatient ARTAS 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.

Arm

Intervention/Treatment

Active Comparator: Standard of Care Historic Control

Control group will get treatment as usual, which consists of medical care by primary admitting service

Behavioral: Standard of Care

Subject admitted and seen by routine inpatient medical service.

Active Comparator: Team based inpatient ARTAS

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

Behavioral: Team Based Inpatient ARTAS

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.

Outcome Measures

Primary Outcome Measures

Rate of linkage to HIV care post discharge [Up to 90 days post-study enrollment hospitalization 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 [Up to 90 days post-study enrollment hospitalization discharge]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Loma Linda University
Gilead Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Veltman, Associate Professor of Medicine, Loma Linda University

ClinicalTrials.gov Identifier:

NCT05866523

Other Study ID Numbers:

jv123jv

First Posted:

May 19, 2023

Last Update Posted:

May 19, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jennifer Veltman, Associate Professor of Medicine, Loma Linda University

HIV, linkage to care, hospital readmission

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of May 19, 2023