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Enhancing Uptake of Needle and Syringe Programs in Canadian Federal Prisons

NCT ID: NCT07122219

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

548 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2029-09-30

Brief Summary

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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

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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

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HIV Hepatitis C Virus (HCV)

Keywords

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Needle-Exchange Programs Prisons Health Services for Prisoners Blood-Borne Pathogens HIV Hepatitis C

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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NIATx group 1

Control (month 1-6) then NIATx (month 7-30) then Maintenance (month 31-42)

Group Type EXPERIMENTAL

NIATx

Intervention Type 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.

NIATx group 2

Control (month 7-12) then NIATx (month 13-36) then Maintenance (month 37-48)

Group Type EXPERIMENTAL

NIATx

Intervention Type 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.

NIATx group 3

Control (month 13-18) then NIATx (month 19-42) then Maintenance (month 43-54)

Group Type EXPERIMENTAL

NIATx

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- None (site level intervention)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

Burnet Institute

OTHER

Sponsor Role collaborator

Kirby Institute

OTHER_GOV

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Nadine Kronfli

Nominated Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nadine Kronfli

Role: PRINCIPAL_INVESTIGATOR

Research Institute of the McGill University Health Centre

Frederick L. Altice

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Edmonton Institution for Women

Edmonton, Alberta, Canada

Site Status NOT_YET_RECRUITING

Fraser Valley Institution for Women

Abbotsford, British Columbia, Canada

Site Status NOT_YET_RECRUITING

Mission Institution

Mission, British Columbia, Canada

Site Status NOT_YET_RECRUITING

Dorchester Medium

Dorchester, New Brunswick, Canada

Site Status RECRUITING

Atlantic Institution

Smiths Crossing, New Brunswick, Canada

Site Status RECRUITING

Nova Institution for Women

Truro, Nova Scotia, Canada

Site Status RECRUITING

Joyceville Institution

Kingston, Ontario, Canada

Site Status NOT_YET_RECRUITING

Grand Valley Institution for Women

Kitchener, Ontario, Canada

Site Status NOT_YET_RECRUITING

Joliette Institution for Women

Joliette, Quebec, Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Central Contacts

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Nadine Kronfli

Role: CONTACT

Phone: 514-934-1934

Email: [email protected]

Other Identifiers

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195710

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-9201

Identifier Type: -

Identifier Source: org_study_id