NCT05688423|Active Not RecruitingDMC
Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients
CTN0121
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CTN0121
Sponsor study identifier
Secondary identifiers
NIH
interventional
480
1 country
6
Study Start
January 5, 2024
Actual (reported)Primary Completion
April 3, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 3, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to test the effectiveness of an integrated infectious disease/substance use disorder (SUD) clinical team intervention approach in patients hospitalized with severe injection-related infections (SIRI) who use drugs. The main question this study aims to answer is whether this intervention approach will be associated with lower mortality and fewer hospital readmissions. Participants will participate in the integrated SUD/ID care team intervention (SIRI Team). Researchers will compare this intervention to treatment as usual (TUA) to see if there are any differences in health outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 3, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 21, 2022
Actual (reported)January 18, 2023
Actual (reported)January 5, 2024
Actual (reported)April 3, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 3, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Mortality and Hospital Readmissions
Binary: A participant is alive with no hospital readmission 4 months post-randomization vs. a participant has died or been readmitted to the hospital within 4 months post-randomization
4 months post-randomization
Initiation of treatment before hospital discharge
Course of hospital visit (expected to be within 1 month of randomization)
Receipt of post-discharge treatment
This will be a repeated assessment at each of the follow-up times. The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.
Completion of planned antibiotic course for the index infection
Course of antibiotic treatment (Length varies by severity of infection); Assessed at the 4 month follow-up time
Patient-directed discharge from index hospitalization
Course of hospital visit (expected to be within 1 month of randomization)
Post-discharge hospital visits
This will be a repeated assessment at each of the follow-up times. The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.
The study intervention ("SIRI Team") consists of a hospital-based multidisciplinary (ID/SUD consult) team that will provide intensive, integrated care for participants' ID and SUD both during the hospital stay and post-discharge for up to four months post-randomization. The SIRI Team will provide low barrier access to medications and harm reduction services for SUD; streamline ID/SUD treatment; provide longitudinal care with familiar providers; leverage different areas of expertise between physicians, advance practice providers, and patient navigators; and create patient-centered treatment plans, tailored to the individual, and informed by each patient's social circumstances, substance use, and personal goals/desires.
Treatment as Usual (TAU) will consist of the current healthcare landscape at each participating hospital site.
Participants randomized to the intervention will receive integrated ID and SUD care (SIRI Team) both during the hospitalization and after hospital discharge for 4 months post-randomization. The intervention is based upon six general principles for treating PWID with infectious complications and is informed by harm reduction. 1. Medications for SUD as integral to management of infectious complications 2. Integration of ID and SUD care 3. Longitudinal care with familiar providers 4. Multidisciplinary care and care coordination 5. Tailored antibiotic options and care settings 6. Harm reduction
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Miami - Jackson Memorial Hospital
Miami, Florida, 33136, United States
Tampa General Hospital
Tampa, Florida, 33601, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87106, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Serota DP, Feaster DJ, Bartholomew TS, Kapadia SN, Gooden LK, Murphy SM, Malik S, Chueng TA, Hernandez S, Rodriguez AE, Alonso E, Horigian VE, Walker R, Matheson T, Moran LM, Nelson CM, Parish C, Tookes HE, Rio CD, Metsch LR. Integrated infectious disease and substance use disorder treatment for severe injection-related infections: protocol for the randomized controlled HI-SIRI trial. Addict Sci Clin Pract. 2026 Feb 21;21(1):28. doi: 10.1186/s13722-026-00654-6.
Lisa R Metsch, PhD
Columbia University
David P Serota, MD, MSc
University of Miami
Daniel J Feaster, PhD
University of Miami
Carlos del Rio, MD
Emory University
First Submitted
November 21, 2022
First Posted
January 18, 2023
Study Start
January 5, 2024
Written Exposure in Substance Treatment (WEST 3.0): Randomized Controlled Trial
Participants assigned to the TAU group will receive the standard treatment for their severe injection-related infection and substance use disorder at each hospital. While TAU may differ between sites, it is typically comprised of a patient being cared for primarily by a hospital medicine physician (hospitalist) with consultation by infectious diseases (ID) and either psychiatry or addiction medicine physician. If the ID or addiction teams believe post-hospitalization follow up is indicated, each service will follow local protocols for arranging post-discharge continuation of care.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
April 3, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 3, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 21, 2025
Record last verified: 2025-10
Information about the study and the de-identified study data will be available at https://datashare.nida.nih.gov/ within 18 months of the date the data are locked, as per the procedures of the National Drug Abuse Treatment Clinical Trials Network.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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