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| ID | Type | Description | Link |
|---|---|---|---|
| UG1DA013720 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Miami | OTHER |
| Emory University | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
| The Emmes Company, LLC |
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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.
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. The SIRI Team intervention will be grounded in a harm reduction approach. The intervention duration is approximately 4 months. Participants will complete follow-up visits at 4-, 8-, and 12-months post-randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIRI Team | Experimental | 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. |
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| Treatment as Usual | Active Comparator | Treatment as Usual (TAU) will consist of the current healthcare landscape at each participating hospital site. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIRI Team | Behavioral | 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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Initiation of treatment before hospital discharge | Binary: If patient initiated any of the treatments listed in protocol vs. if they did not engage | Course of hospital visit (expected to be within 1 month of randomization) |
| Receipt of post-discharge treatment |
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Inclusion Criteria:
Exclusion Criteria:
All individuals meeting any of the exclusion criteria will be excluded from study participation. Specifically, individuals will be excluded from participation if they:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa R Metsch, PhD | Columbia University | Principal Investigator |
| David P Serota, MD, MSc | University of Miami | Principal Investigator |
| Daniel J Feaster, PhD | University of Miami | Principal Investigator |
| Carlos del Rio, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Miami - Jackson Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41723493 | Derived | 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. |
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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.
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Within 18 months
Information will be de-identified.
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| INDUSTRY |
The study will recruit patients at bedside in the hospital setting at approximately six hospitals and randomly assign approximately 480 inpatients in 1:1 ratio to the SIRI Team vs. TAU. Randomization will be stratified by 1) hospital site, 2) primary drug (opioid versus non-opioid), and 3) admission to intensive care unit (ICU) as part of the index hospitalization (ICU versus non-ICU) as a proxy for severity of infection.
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| Treatment as Usual | Behavioral | 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. |
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Binary: If patient initiated any of the treatments listed in protocol vs. if they did not engage |
| 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 | Binary: If patient completed planned antibiotic course for the index infection vs. if they did not complete antibiotic course | Course of antibiotic treatment (Length varies by severity of infection); Assessed at the 4 month follow-up time |
| Patient-directed discharge from index hospitalization | Binary: Patient discharges themselves from the hospital prior to the attending physician's orders to discharge vs. does not discharge themselves | Course of hospital visit (expected to be within 1 month of randomization) |
| Post-discharge hospital visits | Count: # of post-discharge hospital visits using repeated measures across all 3 follow-up 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. |
| New or recurrent acute bacterial or fungal infection post-index hospitalization | Binary: Participant has a recurrent or persistent acute bacterial or fungal infection during the period of assessment vs. does not have a recurrent or persistent acute bacterial or fungal infection | 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. |
| Substance use severity | Continuous: Assessed via Drug Abuse Screening Test (DAST-10) scale; Range of scores [0 - 10], higher scores indicate worse outcome | 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. |
| Alcohol use severity | Continuous: Assessed via Alcohol Use Disorders Identification Test (AUDIT) scale; Range of scores [0 - 40], higher scores indicate worse outcome | 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. |
| All-cause mortality | Binary: Mortality from all causes at any of the follow-up timepoints vs. alive at all timepoints | At each of the follow-up times (4, 8 and 12 months) |
| 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 |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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