The Injection-Related InfectionS (IRIS) Program

NCT ID: NCT06169553

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Holistic injection-related injection treatment

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-
Minimum Eligible Age

16 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

HAMSMaRT

UNKNOWN

Sponsor Role collaborator

Keeping Six

UNKNOWN

Sponsor Role collaborator

YWCA Hamilton

UNKNOWN

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HAMSMaRT Clinic

Hamilton, Ontario, Canada

Site Status

David Braley Health Science Centre

Hamilton, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alisha Atri

Role: CONTACT

Phone: ‭(905) 525-9140

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nala Ismacil

Role: primary

Alisha Atri, MPH

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

https://keepingsix.org/about/

Keeping Six - collaborative organization

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HAH-23-012

Identifier Type: -

Identifier Source: org_study_id