Changes in supervised consumption site use and emergency interventions in Montréal, Canada in the first twelve months of the COVID-19 pandemic: An interrupted time series study.

BACKGROUND: The COVID-19 pandemic has impacted supervised consumption site (SCS) operations in Montréal, Canada, potentially including changes in SCS visits, on-site emergency interventions, injection of specific drugs, and distribution of harm reduction materials. METHOD: We used administrative data from all four Montréal SCS from 1 March 2018 - 28 February 2021 to conduct an interrupted time series study with 13 March 2020 as the intervention point. We employed segmented regression using generalised least squares fit by maximum likelihood. We analysed monthly SCS visits and materials distributed as counts, and emergency interventions and drugs injected as proportions of visits. RESULTS: SCS visits (level change = -1,286; 95% CI [-1,642, -931]) and the proportion of visits requiring emergency intervention (level = -0.27% [-0.47%, -0.06%]) decreased immediately in March 2020, followed by an increasing trend in emergency interventions (slope change = 0.12% [0.10%, 0.14%]) over the ensuing 12 months. Over the same period, the proportion of injections involving opioids increased (slope = 0.05% [0.03%, 0.07%]), driven by increasing pharmaceutical opioid and novel synthetic opioid injections. Novel synthetic opioids were the drugs most often injected prior to overdose. The proportion of injections involving unregulated amphetamines increased immediately (level = 7.83% [2.93%, 12.73%]), then decreased over the next 12 months (slope = -1.86% [-2.51%, -1.21%]). There was an immediate increase in needle/syringe distribution (level = 16,552.81 [2,373, 30,732]), followed by a decreasing trend (slope = -2,398 [-4,218, -578]). There were no changes in pre-existing increasing trends in naloxone or fentanyl test strip distribution. CONCLUSION: Reduced SCS use and increasing emergency interventions at SCS are cause for serious concern. Findings suggest increased availability of novel synthetic opioids in Montréal, heightening overdose risk.

M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID.

BACKGROUND: Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes. METHODS: The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial (M2HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated. DISCUSSION: The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings. TRIAL REGISTRATION: Clinicaltrials.gov NCT03981445 . Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201.