An interventional study of NIATx in HIV and Hepatitis C Virus (HCV), sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 9 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Health services research
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.
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
1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.
This study's planned enrollment of 548 is above the median of 72 across 1,223 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
- None (site level intervention)
Control (month 1-6) then NIATx (month 7-30) then Maintenance (month 31-42)
Behavioral: NIATx
Control (month 7-12) then NIATx (month 13-36) then Maintenance (month 37-48)
Behavioral: NIATx
Control (month 13-18) then NIATx (month 19-42) then Maintenance (month 43-54)
Behavioral: NIATx
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.
Effectiveness
Number of participants on the PNEP
Time frame: From start to end of intervention period (24 months)
Bloodborne virus cascade of care
Number of HIV and hepatitis C virus screenings/tests, diagnoses, and treatment initiations, among the total prison population
Time frame: 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
Time frame: From start to end of intervention period (24 months)
Plan to share: No — Data requests can be made to Correctional Service Canada
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Feb 2028, 40 months after the start.
Of 150 non-industry interventional studies with no phase under Hepatitis C, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's planned 40 months is above that.
Counting every sponsor, half of 153 studies reached it within 25 months; a quarter within 14 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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McGill University Health Centre/Research Institute of the McGill University Health Centre →