Peer SupportIRISNCT06169553
The Injection-Related InfectionS (IRIS) Program
A study testing Holistic injection-related injection treatment in people with Peer Support and Injection-related Infections, run by McMaster University at 2 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 16 to 105 years
- Conditions the study is for
- Peer Support, Injection-related Infections, Infections
- What is being tested?
- Holistic injection-related injection treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 105 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
HAMSMaRT Clinic
Hamilton, Ontario, L8M 1J3
Nala Ismacil, 1-833-426-7678 ext. 1, clinics@hamsmart.ca
David Braley Health Science Centre
Hamilton, Ontario, L8P 1H6
Alisha Atri, MPH, (905) 525-9140 ext. 21572, atria1@mcmaster.ca
About this study
Official title: 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.
- Being tested
- Holistic injection-related injection treatment
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holistic injection-related injection treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Holistic injection-related injection treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of emergency department visits and hospital readmission
Measured: Within 30 days of initial hospital admission or program enrolment
Secondary outcomes (6)
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).
Measured: 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
Measured: Within 90-days of hospital discharge or program enrolment
Number of emergency department visits
Measured: Within 90-days of hospital discharge or program enrolment
Number of new initiations or record of continuation of substance use treatment
Measured: Within 90-days of hospital discharge or program enrolment
Mortality rates
Measured: Within 6-months of hospital discharge or program enrolment
Rates of program drop-out and reasons for discontinuation
Measured: Within 6-months of hospital discharge or program enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peer SupportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- HAMSMaRT, Keeping Six, YWCA Hamilton
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169553
- Sponsor's protocol ID
- HAH-23-012
- Acronym
- IRIS
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IRIS Program: A Novel Pathway to Optimize Treatment of Injection-related Infections for People Who Inject Drugs in Hamilton, Ontario
- ClinicalTrials.gov ID
- NCT06169553
- Acronym / sponsor ID
- IRIS / HAH-23-012
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- HAMSMaRT, Keeping Six, YWCA Hamilton
- Study start
- Jan 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Holistic injection-related injection treatmentParticipants 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. |
Who may qualify
- Ages
- 16 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holistic injection-related injection treatmentParticipants 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. | Other | Intervention group |
Primary outcome
Number of emergency department visits and hospital readmission
Time frame: Within 30 days of initial hospital admission or program enrolment
6 secondary outcomes
Completion of intended course of treatment for the injection-related infection
Time frame: 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
Time frame: Within 90-days of hospital discharge or program enrolment
Number of emergency department visits
Time frame: Within 90-days of hospital discharge or program enrolment
Number of new initiations or record of continuation of substance use treatment
Time frame: Within 90-days of hospital discharge or program enrolment
Mortality rates
Time frame: Within 6-months of hospital discharge or program enrolment
Rates of program drop-out and reasons for discontinuation
Time frame: Within 6-months of hospital discharge or program enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Keeping Six - collaborative organizationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holistic injection-related injection treatment in people with Peer Support and Injection-related Infections, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alisha Atri ((905) 525-9140 ext. 21572, atria1@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of emergency department visits and hospital readmission (time frame: Within 30 days of initial hospital admission or program enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.