The Injection-Related InfectionS (IRIS) Program

Infections Clinical Trial

— IRIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06169553
• Other study ID #: HAH-23-012
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: McMaster University
• Contact: Alisha Atri
• Phone: ?(905) 525-9140
• Email: atria1[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 105 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Peer Support

Intervention

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.

Locations

Country	Name	City	State
Canada	David Braley Health Science Centre	Hamilton	Ontario
Canada	HAMSMaRT Clinic	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	HAMSMaRT, Keeping Six, YWCA Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of emergency department visits and hospital readmission		Within 30 days of initial hospital admission or program enrolment
Secondary	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
Secondary	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
Secondary	Number of emergency department visits		Within 90-days of hospital discharge or program enrolment
Secondary	Number of new initiations or record of continuation of substance use treatment		Within 90-days of hospital discharge or program enrolment
Secondary	Mortality rates		Within 6-months of hospital discharge or program enrolment
Secondary	Rates of program drop-out and reasons for discontinuation		Within 6-months of hospital discharge or program enrolment

External Links

•   HAMSMaRT - collaborative organization
•   Keeping Six - collaborative organization