Enhancing Uptake of Needle and Syringe Programs in Canadian Federal Prisons

NCT07122219 | Recruiting

• 2 other identifiers: 2023-9201195710
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

HIV; Hepatitis C Virus (HCV)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Effectiveness

  Number of participants on the PNEP

  From start to end of intervention period (24 months)

Secondary Outcomes (2)

• Bloodborne virus cascade of care

  From start to end of intervention period (24 months)

• Enrollment in opioid agonist therapy

  From start to end of intervention period (24 months)

Study Arms (3)

NIATx group 1

EXPERIMENTAL

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

Behavioral: NIATx

NIATx group 2

EXPERIMENTAL

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

Behavioral: NIATx

NIATx group 3

EXPERIMENTAL

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

Behavioral: NIATx

Interventions

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.

NIATx group 1; NIATx group 2; NIATx group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- None (site level intervention)

Sponsors & Collaborators

• Yale University: collaborator
• Burnet Institute: collaborator
• Kirby Institute: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (9)

Edmonton Institution for Women

Edmonton, Alberta, T5S 2H9, Canada

NOT YET RECRUITING

Fraser Valley Institution for Women

Abbotsford British Columbia, British Columbia, V2S 1A1, Canada

NOT YET RECRUITING

Mission Institution

Mission, British Columbia, V2V 4L8, Canada

NOT YET RECRUITING

Dorchester Medium

Dorchester, New Brunswick, E4K 2Y9, Canada

RECRUITING

Atlantic Institution

Smiths Crossing, New Brunswick, E9B 1T9, Canada

RECRUITING

Nova Institution for Women

Truro, Nova Scotia, B2N 6R8, Canada

RECRUITING

Joyceville Institution

Kingston, Ontario, K7L 4X9, Canada

NOT YET RECRUITING

Grand Valley Institution for Women

Kitchener, Ontario, N2P 2C5, Canada

NOT YET RECRUITING

Joliette Institution for Women

Joliette, Quebec, J6E 8W1, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Nadine Kronfli

  Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Frederick L. Altice

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadine Kronfli

CONTACT

514-934-1934; nadine.kronfli@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nominated Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9)