| Registry | NCT07122219 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, sequential, masking: none, health services research |
| Enrollment | 548 (Estimated) |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre (Other); collaborators: Yale University, Burnet Institute, Kirby Institute |
| Conditions | HIV, Hepatitis C Virus (HCV) |
| Interventions | NIATx (Behavioral) |
| Dates | start 2024-10-01, primary completion 2028-02-29 (estimated), completion 2029-09-30 (estimated), first posted 2025-08-14, last updated 2025-12-29 |
| Locations | 9 sites in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for HIV All trials for Hepatitis C Virus (HCV) All trials of NIATx
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| NIATx group 1 | Experimental | Behavioral: NIATx | Control (month 1-6) then NIATx (month 7-30) then Maintenance (month 31-42) |
| NIATx group 2 | Experimental | Behavioral: NIATx | Control (month 7-12) then NIATx (month 13-36) then Maintenance (month 37-48) |
| NIATx group 3 | Experimental | Behavioral: NIATx | Control (month 13-18) then NIATx (month 19-42) then Maintenance (month 43-54) |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * All people incarcerated at a study site during the intervention period Exclusion Criteria: \- None (site level intervention)
| Facility | City | Country | Status |
|---|---|---|---|
| Edmonton Institution for Women | Edmonton, Alberta | Canada | Not yet recruiting |
| Fraser Valley Institution for Women | Abbotsford British Columbia, British Columbia | Canada | Not yet recruiting |
| Mission Institution | Mission, British Columbia | Canada | Not yet recruiting |
| Dorchester Medium | Dorchester, New Brunswick | Canada | Recruiting |
| Atlantic Institution | Smiths Crossing, New Brunswick | Canada | Recruiting |
| Nova Institution for Women | Truro, Nova Scotia | Canada | Recruiting |
| Joyceville Institution | Kingston, Ontario | Canada | Not yet recruiting |
| Grand Valley Institution for Women | Kitchener, Ontario | Canada | Not yet recruiting |
| Joliette Institution for Women | Joliette, Quebec | Canada | Not yet recruiting |