NCT05866523

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
7mo left

Started Oct 2023

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Oct 2023Dec 2026

First Submitted

Initial submission to the registry

May 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 16, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

May 10, 2023

Last Update Submit

February 25, 2026

Conditions

Keywords

HIV, linkage to care, hospital readmission

Outcome Measures

Primary Outcomes (1)

  • 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

    Up to 90 days post-study enrollment hospitalization discharge

Secondary Outcomes (1)

  • Readmission Rate after initial post-study hospitalization

    Up to 90 days post-study enrollment hospitalization discharge

Study Arms (2)

Standard of Care Historic Control

ACTIVE COMPARATOR

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

Behavioral: Standard of Care

Team based inpatient ARTAS

ACTIVE COMPARATOR

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

Interventions

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.

Team based inpatient ARTAS

Subject admitted and seen by routine inpatient medical service.

Standard of Care Historic Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • virally suppressed
  • actively taking ART
  • are under active care of an HIV specialist within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

RECRUITING

Related Publications (3)

  • Craw JA, Gardner LI, Marks G, Rapp RC, Bosshart J, Duffus WA, Rossman A, Coughlin SL, Gruber D, Safford LA, Overton J, Schmitt K. Brief strengths-based case management promotes entry into HIV medical care: results of the antiretroviral treatment access study-II. J Acquir Immune Defic Syndr. 2008 Apr 15;47(5):597-606. doi: 10.1097/QAI.0b013e3181684c51.

    PMID: 18285714BACKGROUND
  • Gardner LI, Metsch LR, Anderson-Mahoney P, Loughlin AM, del Rio C, Strathdee S, Sansom SL, Siegal HA, Greenberg AE, Holmberg SD; Antiretroviral Treatment and Access Study Study Group. Efficacy of a brief case management intervention to link recently diagnosed HIV-infected persons to care. AIDS. 2005 Mar 4;19(4):423-31. doi: 10.1097/01.aids.0000161772.51900.eb.

    PMID: 15750396BACKGROUND
  • Gardner LI, Marks G, Craw J, Metsch L, Strathdee S, Anderson-Mahoney P, del Rio C; Antiretroviral Treatment Access Study Group. Demographic, psychological, and behavioral modifiers of the Antiretroviral Treatment Access Study (ARTAS) intervention. AIDS Patient Care STDS. 2009 Sep;23(9):735-42. doi: 10.1089/apc.2008.0262.

    PMID: 19645619BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Jennifer Veltman, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 19, 2023

Study Start

October 16, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations