The Injection-Related InfectionS (IRIS) Program (IRIS)

The IRIS Program: A Novel Pathway to Optimize Treatment of Injection-related Infections for People Who Inject Drugs in Hamilton, Ontario

People who inject drugs are at risk of injection-related infections, like abscesses or infective endocarditis. The Injection-Related InfectionS (IRIS) program hopes to improve treatment for participants by providing a low-barrier, one-stop shop model for people who inject drugs who experience injection-related infections to access more holistic and compassionate care. IRIS is a non-randomized clinical trial, meaning that it offers a specific program to eligible patients. This program offers care for substance use and infectious disease with additional peer support and systems navigation, if interested. The investigators anticipate enrolling 80 participants in the intervention and will follow participants throughout the infection treatment period (estimated 6-12 weeks). The investigators will collect information at the time of enrolment, at the 6-month mark, and monthly via electronic medical chart review. The investigators will use an interrupted time series analysis to evaluate the impact of the intervention on rates of treatment completion, emergency department visits, hospitalizations, and death, before versus after the intervention.

Study Overview

• Status: Not yet recruiting
• Conditions: Infections; Peer Support; Injection-related Infections; People Who Infect Drugs (PWID)
• Intervention / Treatment: Other: Holistic injection-related injection treatment

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alisha Atri; Phone Number: 21572‬ ‭(905) 525-9140; Email: atria1@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8M 1J3
      • HAMSMaRT Clinic
      • Contact: Nala Ismacil; Phone Number: 1 1-833-426-7678; Email: clinics@hamsmart.ca
    • Hamilton, Ontario, Canada, L8P 1H6
      • David Braley Health Science Centre
      • Contact: Alisha Atri, MPH; Phone Number: 21572‬ ‭(905) 525-9140; Email: atria1@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 16 or older
• Able to provide informed consent
• Presenting with a confirmed or suspected injection-related infection (including skin and soft tissue infections, osteomyelitis, infective endocarditis, Hepatitis C, HIV, etc)
• History of injection drug use within 3 months of recruitment
• Lives in Hamilton, Ontario

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants in the IRIS program will be offered a one-stop, low-barrier combined care model to address their injection-related infections. Specific program components include: (1) Diagnosis and treatment of injection-related infections; (2) Substance use treatment (3) Peer support; and (4) Care coordination/systems navigation.	Other: Holistic injection-related injection treatment; Participants in the intervention group will be provided additional supports to address their social and medical needs, including infectious disease management, addictions medicine, peer support, and systems navigation. Each participant will receive individualized care depending on their unique needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of emergency department visits and hospital readmission	Within 30 days of initial hospital admission or program enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of intended course of treatment for the injection-related infection	Investigators will record whether or not participants have completed the intended course of treatment for their injection-related infection (e.g. completed course of antibiotics - YES or NO).	Within 6 months of initial hospital admission or program enrolment
Number of hospital readmissions specifically for the infection that was the primary reason for program enrolment		Within 90-days of hospital discharge or program enrolment
Number of emergency department visits		Within 90-days of hospital discharge or program enrolment
Number of new initiations or record of continuation of substance use treatment		Within 90-days of hospital discharge or program enrolment
Mortality rates		Within 6-months of hospital discharge or program enrolment
Rates of program drop-out and reasons for discontinuation		Within 6-months of hospital discharge or program enrolment

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: HAMSMaRT; Keeping Six; YWCA Hamilton

Publications and helpful links

Helpful Links

• Keeping Six - collaborative organization
• HAMSMaRT - collaborative organization

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Actual): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: HAH-23-012

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