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The Injection-Related InfectionS (IRIS) Program

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06169553
Acronym
IRIS
Enrollment
80
Registered
2023-12-13
Start date
2024-01-31
Completion date
2025-12-31
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERHolistic 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.

Sponsors

HAMSMaRT
CollaboratorUNKNOWN
Keeping Six
CollaboratorUNKNOWN
YWCA Hamilton
CollaboratorUNKNOWN
McMaster University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 105 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frame
Number of emergency department visits and hospital readmissionWithin 30 days of initial hospital admission or program enrolment

Secondary

MeasureTime frameDescription
Number of hospital readmissions specifically for the infection that was the primary reason for program enrolmentWithin 90-days of hospital discharge or program enrolment
Number of emergency department visitsWithin 90-days of hospital discharge or program enrolment
Completion of intended course of treatment for the injection-related infectionWithin 6 months of initial hospital admission or program enrolmentInvestigators 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).
Mortality ratesWithin 6-months of hospital discharge or program enrolment
Rates of program drop-out and reasons for discontinuationWithin 6-months of hospital discharge or program enrolment
Number of new initiations or record of continuation of substance use treatmentWithin 90-days of hospital discharge or program enrolment

Countries

Canada

Contacts

Primary ContactAlisha Atri
atria1@mcmaster.ca‭(905) 525-9140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026