HIVNCT07122219
Enhancing Uptake of Needle and Syringe Programs in Canadian Federal Prisons
A study testing NIATx in people with HIV and Hepatitis C Virus (HCV), run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 9 sites in Canada.
Trial summary
This study is focused on improving the implementation of Prison Needle Exchange Programs (PNEPs) in Canadian federal prisons, with the goal of increasing the uptake of these programs among people who inject drugs in prison. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Hepatitis C Virus (HCV)
- What is being tested?
- NIATx
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 548 participants
- Where
- 9 sitesCanada
- Study dates
- 1 Oct 2024to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All people incarcerated at a study site during the intervention period
Who cannot join
- None (site level intervention)
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Canada9 sites, 9 recruiting
- Not yet recruiting
Fraser Valley Institution for Women
Abbotsford British Columbia, British Columbia, V2S 1A1
- Recruiting
Dorchester Medium
Dorchester, New Brunswick, E4K 2Y9
- Not yet recruiting
Edmonton Institution for Women
Edmonton, Alberta, T5S 2H9
- Not yet recruiting
Joliette Institution for Women
Joliette, Quebec, J6E 8W1
- Not yet recruiting
Joyceville Institution
Kingston, Ontario, K7L 4X9
- Not yet recruiting
Grand Valley Institution for Women
Kitchener, Ontario, N2P 2C5
- Not yet recruiting
Mission Institution
Mission, British Columbia, V2V 4L8
- Recruiting
Atlantic Institution
Smiths Crossing, New Brunswick, E9B 1T9
- Recruiting
Nova Institution for Women
Truro, Nova Scotia, B2N 6R8
About this study
This study is focused on improving the implementation of Prison Needle Exchange Programs (PNEPs) in Canadian federal prisons, with the goal of increasing the uptake of these programs among people who inject drugs in prison. The study is being conducted in nine federal prisons, including five women's prisons, where a higher proportion of incarcerated individuals report a history of injection drug use. This study aims to improve PNEP adoption and sustainability by identifying barriers and facilitators and implementing evidence-based strategies to enhance program engagement.
Read the detailed description
Using a step-wedge design, we will conduct a Type 2 hybrid implementation trial to assess the extent to which PNEP uptake is improved over 24 months of observation using the Network for the Improvement of Addiction Treatment (NIATx) implementation strategy bundle. Nine prisons were non-randomly* allocated to one of three groups, with the groups receiving the intervention (i.e., NIATx) over 24 months at staggered time intervals (every 6 months). This will be followed by an additional 12 month post-intervention period, when sustainability will be assessed.
*Originally randomized; allocation was modified due to logistical constraints
- Conditions
- HIV, Hepatitis C Virus (HCV)
- Being tested
- NIATx
- Keywords
- Needle-Exchange Programs, Prisons, Health Services for Prisoners, Blood-Borne Pathogens, HIV, Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIATxBehavioural
The Network for the Improvement of Addiction Treatment (NIATx) model uses a bundle of implementation tools that include expert facilitation (coaching) and quality process improvement specifically for behavioural healthcare settings to improve access and retention in treatment.
| Study group | Role | What they receive |
|---|---|---|
| NIATx group 1 | Experimental | Control (month 1-6) then NIATx (month 7-30) then Maintenance (month 31-42) Receives: Behavioral: NIATx |
| NIATx group 2 | Experimental | Control (month 7-12) then NIATx (month 13-36) then Maintenance (month 37-48) Receives: Behavioral: NIATx |
| NIATx group 3 | Experimental | Control (month 13-18) then NIATx (month 19-42) then Maintenance (month 43-54) Receives: Behavioral: NIATx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
Number of participants on the PNEP
Measured: From start to end of intervention period (24 months)
Secondary outcomes (2)
Bloodborne virus cascade of care
Number of HIV and hepatitis C virus screenings/tests, diagnoses, and treatment initiations, among the total prison population
Measured: From start to end of intervention period (24 months)
Enrollment in opioid agonist therapy
The number of people who inject drugs who access opioid agonist therapy among the total prison population
Measured: From start to end of intervention period (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Oct 2024
- Primary completion29 Feb 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Hybrid type 2 stepped-wedge implementation trial. All sites will receive the intervention (NIATx); the order in which they receive the intervention was non-randomized\*. \*Originally randomized; allocation was modified due to logistical constraints
- Masking
- None (open label)
- Enrolment
- 548 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Burnet Institute, Kirby Institute
- Responsible party
- Principal investigator, Nadine Kronfli, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Nadine Kronfli, Principal investigator, Research Institute of the McGill University Health CentreFrederick L. Altice, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122219
- Sponsor's protocol ID
- 2023-9201
- Other IDs
- 195710
- Status last verified
- Dec 2025
- First submitted
- 7 Aug 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data requests can be made to Correctional Service Canada
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Uptake of Needle and Syringe Programs in Canadian Federal Prisons
- ClinicalTrials.gov ID
- NCT07122219
- Acronym / sponsor ID
- 2023-9201
- Conditions
- HIV, Hepatitis C Virus (HCV)
- Keywords
- Needle-Exchange Programs, Prisons, Health Services for Prisoners, Blood-Borne Pathogens, HIV, Hepatitis C
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 548 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Yale University, Burnet Institute, Kirby Institute
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 14 Aug 2025 (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.
This study is focused on improving the implementation of Prison Needle Exchange Programs (PNEPs) in Canadian federal prisons, with the goal of increasing the uptake of these programs among people who inject drugs in prison. The study is being conducted in nine federal prisons, including five women's prisons, where a higher proportion of incarcerated individuals report a history of injection drug use. This study aims to improve PNEP adoption and sustainability by identifying barriers and facilitators and implementing evidence-based strategies to enhance program engagement.
Detailed description
Using a step-wedge design, we will conduct a Type 2 hybrid implementation trial to assess the extent to which PNEP uptake is improved over 24 months of observation using the Network for the Improvement of Addiction Treatment (NIATx) implementation strategy bundle. Nine prisons were non-randomly* allocated to one of three groups, with the groups receiving the intervention (i.e., NIATx) over 24 months at staggered time intervals (every 6 months). This will be followed by an additional 12 month post-intervention period, when sustainability will be assessed.
*Originally randomized; allocation was modified due to logistical constraints
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Hybrid type 2 stepped-wedge implementation trial. All sites will receive the intervention (NIATx); the order in which they receive the intervention was non-randomized*. *Originally randomized; allocation was modified due to logistical constraints
| Arm | Type | Receives |
|---|---|---|
| NIATx group 1 | Experimental | Behavioral: NIATxControl (month 1-6) then NIATx (month 7-30) then Maintenance (month 31-42) |
| NIATx group 2 | Experimental | Behavioral: NIATxControl (month 7-12) then NIATx (month 13-36) then Maintenance (month 37-48) |
| NIATx group 3 | Experimental | Behavioral: NIATxControl (month 13-18) then NIATx (month 19-42) then Maintenance (month 43-54) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All people incarcerated at a study site during the intervention period
Key exclusion criteria (1 listed)
- None (site level intervention)
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 |
|---|---|---|
| NIATxThe Network for the Improvement of Addiction Treatment (NIATx) model uses a bundle of implementation tools that include expert facilitation (coaching) and quality process improvement specifically for behavioural healthcare settings to improve access and retention in treatment. | Behavioural | NIATx group 1, NIATx group 2, NIATx group 3 |
Primary outcome
Effectiveness
Time frame: From start to end of intervention period (24 months)
Number of participants on the PNEP
2 secondary outcomes
Bloodborne virus cascade of care
Time frame: From start to end of intervention period (24 months)
Enrollment in opioid agonist therapy
Time frame: From start to end of intervention period (24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No. Data requests can be made to Correctional Service Canada
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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.
Nadine Kronfli principal investigator
Research Institute of the McGill University Health Centre
Frederick L. Altice principal investigator
Yale University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIATx in people with HIV and Hepatitis C Virus (HCV), run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 9 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 1 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: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadine Kronfli (514-934-1934, nadine.kronfli@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: From start to end of intervention period (24 months)). 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 29 Dec 2025.