Teamwork Makes the Dream Work (ARTAS)

October 27, 2023 updated by: Jennifer Veltman, Loma Linda University

Teamwork Makes the Dream Work: Team-based Inpatient Anti-Retroviral Treatment and Access to Services (ARTAS)

Exploring the effect of team-based ARTAS intervention in an inpatient setting on HIV linkage to care and hospital readmission rates.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jennifer Veltman, MD
  • Phone Number: 14912 909 558 4000
  • Email: jveltman@llu.edu

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of linkage to HIV care post discharge
Time Frame: 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
Up to 90 days post-study enrollment hospitalization discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission Rate after initial post-study hospitalization
Time Frame: 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.
Up to 90 days post-study enrollment hospitalization discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Collaborators

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5230236

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Standard of Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe