Impact of an Accelerated Pretreatment Evaluation on Linkage-to-Care for Hepatitis C-infected Persons Who Inject Drugs.

Background: Historically, hepatitis C virus (HCV) pretreatment evaluation has required multiple visits, frequently resulting in loss to follow-up and a delayed initiation of treatment. New technologies can accelerate this process. We investigated the feasibility of a single-day evaluation program and its impact on evaluation completion, treatment eligibility awareness, and treatment initiation among people who inject drugs (PWIDs). Methods: HCV-infected PWID who were unaware if they were eligible for treatment were recruited in a prospective evaluation of an accelerated model of care between 2017 and 2019 and compared to a historical cohort. The patients underwent a medical evaluation, rapid HCV viral load testing, and transient elastography during a single visit, at the end of which they were informed whether they were eligible for treatment. A historical cohort of patients fulfilling the same inclusion criteria and evaluated with the usual standard of care spanning several visits who were examined at the addiction medicine clinic from 2014 to 2016 served as the comparison group. Results: The accelerated and historical cohorts included 99 and 76 patients, respectively. The cohorts did not differ significantly by age and gender, but more patients in the historical cohort were undergoing opioid agonist therapy, while more patients in the accelerated cohort injected drugs in the last month. An accelerated evaluation resulted in a higher rate of evaluation completion (100% vs 67.1%; P < .001). Among those eligible for treatment, the proportion of those initiating treatment was similar between the groups (51/64 (79.7%) vs. 26/37 (70.3%); P = .28). The delay in the initiation of treatment was shorter in the accelerated cohort than in the historical cohort (69 (IQR: 49-106) days vs. 219 (IQR: 141-416) days; P < .001). Conclusions: Accelerated evaluation enhanced the awareness of eligibility and reduced the time to initiation among eligible patients. Trial Registration: This study is registered on www.clinicaltrials.gov (NCT02755402).

The changing landscape of pharmaceutical alternatives to the unregulated drug supply during COVID-19.

BACKGROUND: The dual COVID-19 and overdose emergencies amplified strain on healthcare systems tasked with responding to both. One downstream consequence of the pandemic in the USA and Canada was a surge in drug overdoses resulting from public health-restricted access to services and an increasingly toxic unregulated drug supply. This study aimed to describe changes implemented by programs prescribing pharmaceutical alternatives to the drug supply during the early stages of the COVID-19 pandemic. METHODS: An environmental scan used surveys and qualitative interviews with service providers across Canada to examine pharmaceutical alternative prescribing practices and programs before and during the pandemic. This study summarized the nature, frequency, and reasons for pandemic-driven service delivery changes using directed content analysis, counts, and thematic analysis. RESULTS: Eighty-two of the 103 participating sites reported 1193 unique changes in physical space (368), client protocols (347), program operations (342), ancillary services (127), and staffing (90). Four qualitative themes describing the reasons for these changes emerged, namely (1) decreasing risk of COVID-19 infection; (2) decreasing risk of overdose; (3) prioritizing acute care of COVID-19 patients; and (4) improving client access to treatment. CONCLUSIONS: While most changes were aimed at decreasing risk of COVID-19 infection, some were found to be at odds with the measures needed to combat the overdose crisis; others met dual objectives of decreased risk of both overdose and infection. Further research should examine which changes should be kept or reversed once COVID-19-related public health measures are lifted.

"COVID just kind of opened a can of whoop-ass": The rapid growth of safer supply prescribing during the pandemic documented through an environmental scan of addiction and harm reduction services in Canada.

OBJECTIVES: In the context of the ongoing overdose crisis, a stark increase in toxic drug deaths from the unregulated street supply accompanied the onset of the COVID-19 pandemic. Injectable opioid agonist treatment (iOAT - hydromorphone or medical-grade heroin), tablet-based iOAT (TiOAT), and safer supply prescribing are emerging interventions used to address this crisis in Canada. Given rapid clinical guidance and policy change to enable their local adoption, our objectives were to describe the state of these interventions before the pandemic, and to document and explain changes in implementation during the early pandemic response (March-May 2020). METHODS: Surveys and interviews with healthcare providers comprised this mixed methods national environmental scan of iOAT, TiOAT, and safer supply across Canada at two time points. Quantitative data were summarized using descriptive statistics; interview data were coded and analyzed thematically. RESULTS: 103 sites in 6 Canadian provinces included 19 iOAT, 3 TiOAT and 21 safer supply sites on March 1, 2020; 60 new safer supply sites by May 1 represented a 285% increase. Most common substances were opioids, available at all sites; most common settings were addiction treatment programs and primary care clinics, and onsite pharmacies models. 79% of safer supply services were unfunded. Diversity in service delivery models demonstrated broad adaptability. Qualitative data reinforced the COVID-19 pandemic as the driving force behind scale-up. DISCUSSION: Data confirmed the capacity for rapid scale-up of flexible, community-based safer supply prescribing during dual public health emergencies. Geographical, client demographic, and funding gaps highlight the need to target barriers to implementation, service delivery and sustainability.

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.

Service delivery models for injectable opioid agonist treatment in Canada: 2 sequential environmental scans.

BACKGROUND: Injectable opioid agonist treatment (iOAT) is an emerging evidence-based option in the continuum of care for opioid use disorder in parts of Canada. Our study objective was to identify and describe iOAT programs operating during the ongoing opioid overdose crisis. METHODS: We conducted 2 sequential environmental scans. Programs were eligible to participate if they were in operation as of Sept. 1, 2018, and Mar. 1, 2019. Information was collected over 2-3 months for each scan (September-October 2018, March-May 2019). Programs that participated in the first scan and newly established programs were invited to participate in the second scan. The scans included questions about location, service delivery model, clinical and operational characteristics, numbers and demographic characteristics of clients, and program barriers and facilitators. Descriptive analysis was performed. RESULTS: We identified 14 unique programs across the 2 scans. Eleven programs located in urban centres in British Columbia and Ontario participated in the first scan. At the time of the second scan, 2 of these programs were on hold and 2 of 3 newly established programs were in Alberta. The total capacity of all participating programs was 420 clients at most. Four service delivery models were identified; iOAT was most commonly integrated within existing health and social services. All programs offered hydromorphone, and 1 program also offered diacetylmorphine. In the first scan, 73% of clients (133/183) were male; the mean age of clients was 47 years. Limited capacity, pharmacy operations and lack of diacetylmorphine access were among the most frequently reported barriers. The most commonly reported facilitators included client-centred care, client relationships and access to other health and social support. INTERPRETATION: Evidence indicates that iOAT can be successfully implemented using diverse service delivery models. Future work should facilitate scale-up of this evidence-based treatment where gaps persist in high-risk communities.