The Injection-Related InfectionS (IRIS) Program

NCT06169553 | Unknown

• 1 other identifier: HAH-23-012
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Peer Support; Injection-related Infections; Infections; People Who Infect Drugs (PWID)

Outcome Measures

Primary Outcomes (1)

• Number of emergency department visits and hospital readmission

  Within 30 days of initial hospital admission or program enrolment

Secondary Outcomes (6)

• Completion of intended course of treatment for the injection-related infection

  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

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

Holistic injection-related injection treatment OTHER

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.

Intervention group

Eligibility Criteria

• Age: 16 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• HAMSMaRT: collaborator
• Keeping Six: collaborator
• YWCA Hamilton: collaborator

Study Sites (2)

HAMSMaRT Clinic

Hamilton, Ontario, L8M 1J3, Canada

Location

David Braley Health Science Centre

Hamilton, Ontario, L8P 1H6, Canada

Location

Related Links

• Keeping Six - collaborative organization

MeSH Terms

Conditions

Infections

Central Study Contacts

Alisha Atri

CONTACT

‭(905) 525-9140; atria1@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 13, 2023
• Study Start: January 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)