Design details for overdose education and take-home naloxone kits: Codesign with family medicine, emergency department, addictions medicine and community.

INTRODUCTION: Overdose education and naloxone distribution (OEND) programmes equip and train people who are likely to witness an opioid overdose to respond with effective first aid interventions. Despite OEND expansion across North America, overdose rates are increasing, raising questions about how to improve OEND programmes. We conducted an iterative series of codesign stakeholder workshops to develop a prototype for take-home naloxone (THN)-kit (i.e., two doses of intranasal naloxone and training on how to administer it). METHODS: We recruited people who use opioids, frontline healthcare providers and public health representatives to participate in codesign workshops covering questions related to THN-kit prototypes, training on how to use it, and implementation, including refinement of design artefacts using personas and journey maps. Completed over 9 months, the workshops were audio-recorded and transcribed with visible results of the workshops (i.e., sticky notes, sketches) archived. We used thematic analyses of these materials to identify design requirements for THN-kits and training. RESULTS: We facilitated 13 codesign workshops to identify and address gaps in existing opioid overdose education training and THN-kits and emphasize timely response and stigma in future THN-kit design. Using an iterative process, we created 15 prototypes, 3 candidate prototypes and a final prototype THN-kit from the synthesis of the codesign workshops. CONCLUSION: The final prototype is available for a variety of implementation and evaluation processes. The THN-kit offers an integrated solution combining ultra-brief training animation and physical packaging of nasal naloxone to be distributed in family practice clinics, emergency departments, addiction medicine clinics and community settings. PATIENT OR PUBLIC CONTRIBUTION: The codesign process was deliberately structured to involve community members (the public), with multiple opportunities for public contribution. In addition, patient/public participation was a principle for the management and structuring of the research team.

Exploring COVID-19 vaccine uptake, confidence and hesitancy among people experiencing homelessness in Toronto, Canada: protocol for the Ku-gaa-gii pimitizi-win qualitative study.

INTRODUCTION: People experiencing homelessness are at high risk for COVID-19 and poor outcomes if infected. Vaccination offers protection against serious illness, and people experiencing homelessness have been prioritised in the vaccine roll-out in Toronto, Canada. Yet, current COVID-19 vaccination rates among people experiencing homelessness are lower than the general population. This study aims to characterise reasons for COVID-19 vaccine uptake and hesitancy among people experiencing homelessness, to identify strategies to overcome hesitancy and provide public health decision-makers with information to improve vaccine confidence and uptake in this priority population. METHODS AND ANALYSIS: The Ku-gaa-gii pimitizi-win qualitative study (formerly the COVENANT study) will recruit up to 40 participants in Toronto who are identified as experiencing homelessness at the time of recruitment. Semistructured interviews with participants will explore general experiences during the COVID-19 pandemic (eg, loss of housing, social connectedness), perceptions of the COVID-19 vaccine, factors shaping vaccine uptake and strategies for supporting enablers, addressing challenges and building vaccine confidence. ETHICS AND DISSEMINATION: Approval for this study was granted by Unity Health Toronto Research Ethics Board. Findings will be communicated to groups organising vaccination efforts in shelters, community groups and the City of Toronto to construct more targeted interventions that address reasons for vaccine hesitancy among people experiencing homelessness. Key outputs will include a community report, academic publications, presentations at conferences and a Town Hall that will bring together people with lived expertise of homelessness, shelter staff, leading scholars, community experts and public health partners.

Requiring help injecting among people who inject drugs in Toronto, Canada: Characterising the need to address sociodemographic disparities and substance-use specific patterns.

INTRODUCTION: Those requiring help injecting are at an elevated risk of injection-related injury and blood-borne infections and are thus a priority group for harm reduction programs. As supervised consumption services (SCS) are scaled-up across Canada, information on those who require help injecting is necessary to inform equitable service uptake. We characterised the sociodemographic, structural and drug use correlates of needing help injecting among a cohort of people who inject drugs in Toronto, Canada. METHODS: A cross-sectional baseline survey was administered between November 2018 and March 2020. Unadjusted and multivariable logistic regression models examined associations with requiring help injecting in the past 6 months. A gender-stratified sub-analysis described characteristics of receiving help among those requiring it. RESULTS: Of 701 participants (31.0% cisgender women), 294 (41.9%) needed recent help injecting. In unadjusted analyses, being a racialised, non-Indigenous person (odds ratio [OR] 1.79, 95% confidence interval [CI] 1.13-2.86) or a cisgender woman (OR 1.72, 95% CI 1.24-2.39) were associated with needing help. In multivariable analyses, requiring assistance was associated with needing frequent help preparing drugs (adjusted OR [AOR] 9.52, 95% CI 4.78-21.28), fewer years since first injection (AOR for 1 year increase: 0.97, 95% CI 0.95-0.99) and injecting stimulants. Among those who required help, cisgender women reported needing assistance more often than cisgender men (P = 0.009). DISCUSSION AND CONCLUSIONS: Over two-fifths of the sample required help injecting; requiring assistance was associated with sociodemographic indicators and substance use-specific patterns. Findings highlight the need to scale-up educational resources for those who receive or provide help injecting, as well as SCS that accommodate onsite injection assistance.

The Ontario Integrated Supervised Injection Services Cohort Study of People Who Inject Drugs in Toronto, Canada (OiSIS-Toronto): Cohort Profile.

The Ontario Integrated Supervised Injection Services cohort in Toronto, Canada (OiSIS-Toronto) is an open prospective cohort of people who inject drugs (PWID). OiSIS-Toronto was established to evaluate the impacts of supervised consumption services (SCS) integrated within three community health agencies on health status and service use. The cohort includes PWID who do and do not use SCS, recruited via self-referral, snowball sampling, and community/street outreach. From 5 November 2018 to 19 March 2020, we enrolled 701 eligible PWID aged 18+ who lived in Toronto. Participants complete interviewer-administered questionnaires at baseline and semi-annually thereafter and are asked to consent to linkages with provincial healthcare administrative databases (90.2% consented; of whom 82.4% were successfully linked) and SCS client databases. At baseline, 86.5% of participants (64.0% cisgender men, median ([IQR] age= 39 [33-49]) had used SCS in the previous 6 months, of whom most (69.7%) used SCS for <75% of their injections. A majority (56.8%) injected daily, and approximately half (48.0%) reported fentanyl as their most frequently injected drug. As of 23 April 2021, 291 (41.5%) participants had returned for follow-up. Administrative and self-report data are being used to (1) evaluate the impact of integrated SCS on healthcare use, uptake of community health agency services, and health outcomes; (2) identify barriers and facilitators to SCS use; and (3) identify potential enhancements to SCS delivery. Nested sub-studies include evaluation of "safer opioid supply" programs and impacts of COVID-19.

Supervised consumption service use and recent non-fatal overdose among people who inject drugs in Toronto, Canada.

BACKGROUND: Aiming to reducing overdose mortality, over 40 supervised drug consumption services (SCS) presently operate in Canada. Arguments against SCS include the potential for increased non-fatal overdoses mediated by risk compensation. This study estimates associations between SCS use and recent non-fatal overdose among people who inject drugs (PWID). METHODS: We analyzed cross-sectional baseline data collected between November 2018 and March 2020 from a cohort of adult PWID in Toronto, Canada. Recent non-fatal overdose was self-reported over the previous six months. The primary exposure was frequency of SCS use, self-reported as the proportion of injections performed at an SCS (all or most [75-100%], some [26-74%], few [≤25%], or none) in the previous six months. The prevalence of recent overdose was compared between all unique pairs of groups based on their frequency of SCS use and expressed as covariate-adjusted prevalence ratios (PR) estimated using modified Poisson regression. RESULTS: Among 701 PWID (median [IQR] age, 40 [33 to 49]; 64.3% cisgender men; 56.8% injecting daily), most reported SCS use (all/most, 26.2%; some, 30.9%; few, 29.4%) versus no use (13.5%), with 38.6% reporting a recent overdose. From adjusted regression analyses, more frequent SCS use was not statistically significantly associated with overdose when compared to either no SCS use or less frequent use. Associations between SCS use frequency and overdose were notably smaller among SCS clients compared to associations between SCS clients and non-users (e.g., all/most versus none: PR, 1.43 [95% CI, 0.93 to 2.21]; all/most versus some: PR, 0.94 [95% CI, 0.75 to 1.17]; all/most versus few: PR, 1.15 [95% CI, 0.89 to 1.48]). CONCLUSION: Findings did not indicate statistically significant associations between SCS use frequency and recent non-fatal overdose, particularly among SCS clients who may be more comparable. Nevertheless, overdose was common, underscoring the need to prevent non-fatal overdose and associated morbidity.

Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial.

INTRODUCTION: The surviving opioid overdose with naloxone education and resuscitation (SOONER) project uses co-design and trial methods to develop and evaluate a point-of-care overdose education and naloxone distribution (OEND) tool. We plan to conduct a randomised controlled trial to assess the effectiveness of our OEND tool in comparison with best available standard of care by observing participants' performance as a responder to a simulated overdose. Recruiting and retaining people at risk of or likely to witness opioid overdose raises scientific, logistical and bioethical challenges. A feasibility study is needed to establish the effectiveness of recruitment and retention strategies and acceptability of study procedures prior to launching the full trial. METHODS AND ANALYSIS: Strategies to enhance recruitment include candidate-driven recruitment, verbal informed consent, and attractive, destigmatising materials. Adults at risk of or likely to witness opioid overdose will be recruited through an urban emergency department, inpatient and ambulatory addiction medicine service, and outpatient family practice settings. Participants randomised to the intervention arm will receive our OEND intervention; those in the control arm will be referred to existing OEND programme. Retention procedures include participant reminders, flexible scheduling, cash and comfort compensation, and strategies to maintain a consistent relationship between individual study staff and participants. Within 2 weeks following recruitment, participants will engage as a responder to a manikin-simulated overdose, and complete overdose knowledge and attitudes questionnaires. The primary outcome is recruitment and retention feasibility, defined as the recruitment of 28 participants within 28 days of recruitment and <50% attrition at the overdose simulation. Staff and participant feedback will also be collected and considered. ETHICS AND DISSEMINATION: The study has been reviewed by ethics boards at St. Michael's Hospital, Toronto Public Health and the University of Toronto. Dissemination will occur through peer-reviewed publication and presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov registry (NCT03821649).