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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05866523
Other study ID # 5230236
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 16, 2023
Est. completion date August 1, 2025

Study information

Verified date October 2023
Source Loma Linda University
Contact Jennifer Veltman, MD
Phone 909 558 4000
Email jveltman@llu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Standard of Care
Subject admitted and seen by routine inpatient medical service.

Locations

Country Name City State
United States Loma Linda University Medical Center Loma Linda California

Sponsors (2)

Lead Sponsor Collaborator
Loma Linda University Gilead Sciences

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Up to 90 days post-study enrollment hospitalization discharge
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