Enhancing uptake of the Canadian Prison Needle Exchange Program using a non-randomized stepped-wedge cluster type 1 hybrid implementation trial: The NEXUS study protocol

Background: Prison needle exchange programs (PNEPs) are evidence-based harm reduction interventions that decrease bloodborne virus transmission by reducing the sharing of injection equipment. Canada introduced PNEPs in nine of its 43 federal prisons in 2018-2019; however, uptake is low. This implementation gap undermines program effectiveness, jeopardising individual- and population-level benefits of the program. This stepped-wedge cluster non-randomised type 1 hybrid implementation trial will evaluate whether the Network for the Improvement of Addiction Treatment (NIATx) bundle of implementation strategies and tools increases PNEP uptake. Methods: All nine prisons were allocated non-randomly to three sequences; each sequence is activated at six-month intervals. Over 24 months, each prison will use NIATx tools to address site-specific barriers to PNEP determined during preliminary work. Stepped implementation will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework of the Practical Robust Implementation and Sustainability Model (PRISM). The primary effectiveness outcome is PNEP uptake (i.e., number of participants enrolled on the program). Secondary effectiveness outcomes include number of kits distributed (evidencing active participation) and individuals tested and diagnosed with bloodborne virus infections, including HIV and hepatitis B and C virus (to assess harm reduction impact). Staff surveys and focus groups during and post-implementation, respectively, will explore individual- and organisational-level factors influencing implementation and maintenance. Discussion: We anticipate that NIATx tools will improve uptake of PNEPs among people who inject drugs in Canadian federal prisons. Findings are expected to inform scale-up across remaining Canadian prisons, support long-term sustainability, and inform global advocacy for prison needle and syringe programs.