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NCT Number: NCT07122219

Enhancing Uptake of Needle and Syringe Programs in Canadian Federal Prisons

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edmonton Institution for Women, Edmonton, Alberta, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All people incarcerated at a study site during the intervention period

Exclusion criteria

  • None (site level intervention)

Treatment and study plan

NIATx

Behavioral

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.

Primary outcomes

  1. Effectiveness

    Time frame: From start to end of intervention period (24 months)

    Number of participants on the PNEP

Secondary outcomes

  1. Bloodborne virus cascade of care

    Time frame: From start to end of intervention period (24 months)

    Number of HIV and hepatitis C virus screenings/tests, diagnoses, and treatment initiations, among the total prison population

  2. Enrollment in opioid agonist therapy

    Time frame: From start to end of intervention period (24 months)

    The number of people who inject drugs who access opioid agonist therapy among the total prison population

Study contacts

Contact information is provided by the study sponsor or research team.

Nadine Kronfli

CONTACT

[email protected]

514-934-1934

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Collaborators

  • Burnet Institute
  • Kirby Institute
  • Yale University

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Aug 14, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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