"To do so in a patient-centred way is not particularly lucrative": The effects of neoliberal health care on PrEP implementation and delivery.

BACKGROUND: HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention used by HIV-negative people to prevent HIV acquisition. Despite increased use of PrEP worldwide, several barriers to PrEP implementation have resulted in insufficient uptake, inadequate adherence, and frequent discontinuation. Our objective was to interrogate the social, political, and economic conditions shaping PrEP implementation and delivery among gay, bisexual, queer and other men who have sex with men (GBQM) in Ontario, Canada. METHODS: Six focus groups and three interviews with 20 stakeholders in Ontario (e.g., healthcare professionals, clinicians, community-based organization staff, and government staff) were conducted between July and October 2021. Participants were asked about the personal, workplace, and structural factors shaping PrEP delivery strategies for GBQM. Transcripts were analyzed using reflexive thematic analysis informed by the political economy of PrEP and employed a critique of neoliberalism. RESULTS: Participants critiqued the problematic arrangements of the current healthcare system in Canada. Neoliberal governmentality and policies have resulted in inequitable PrEP care by establishing funding structures prioritizing profit and requiring patients and providers to function as individual entrepreneurs. Consequently, healthcare disparities are compounded for marginalized peoples who lack the resources and capacity to navigate existing healthcare systems. Participants identified several pathways to improve the implementation of PrEP, including greater institutional and governmental supports for PrEP and healthcare, leveraging communities and collaboration, and moving beyond risk-based health frameworks. CONCLUSION: Socio-political-economic changes reflecting post-neoliberal principles are needed to overcome existing barriers to PrEP care, and sexual and reproductive healthcare more broadly.

Cost-effectiveness of remdesivir plus usual care versus usual care alone for hospitalized patients with COVID-19: an economic evaluation as part of the Canadian Treatments for COVID-19 (CATCO) randomized clinical trial.

BACKGROUND: The role of remdesivir in the treatment of hospitalized patients with COVID-19 remains ill-defined. We conducted a cost-effectiveness analysis alongside the Canadian Treatments for COVID-19 (CATCO) open-label, randomized clinical trial evaluating remdesivir. METHODS: Patients with COVID-19 in Canadian hospitals from Aug. 14, 2020, to Apr. 1, 2021, were randomly assigned to receive remdesivir plus usual care versus usual care alone. Taking a public health care payer's perspective, we collected in-hospital outcomes and health care resource utilization alongside estimated unit costs in 2020 Canadian dollars over a time horizon from randomization to hospital discharge or death. Data from 1281 adults admitted to 52 hospitals in 6 Canadian provinces were analyzed. RESULTS: The total mean cost per patient was $37 918 (standard deviation [SD] $42 413; 95% confidence interval [CI] $34 617 to $41 220) for patients randomly assigned to the remdesivir group and $38 026 (SD $46 021; 95% CI $34 480 to $41 573) for patients receiving usual care (incremental cost -$108 [95% CI -$4953 to $4737], p > 0.9). The difference in proportions of in-hospital deaths between remdesivir and usual care groups was -3.9% (18.7% v. 22.6%, 95% CI -8.3% to 1.0%, p = 0.09). The difference in proportions of incident invasive mechanical ventilation events between groups was -7.0% (8.0% v. 15.0%, 95% CI -10.6% to -3.4%, p = 0.006), whereas the difference in proportions of total mechanical ventilation events between groups was -5.7% (16.4% v. 22.1%, 95% CI -10.0% to -1.4%, p = 0.01). Remdesivir was the dominant intervention (but only marginally less costly, with mildly lower mortality) with an incalculable incremental cost effectiveness ratio; we report results of incremental costs and incremental effects separately. For willingness-to-pay thresholds of $0, $20 000, $50 000 and $100 000 per death averted, a strategy using remdesivir was cost-effective in 60%, 67%, 74% and 79% of simulations, respectively. The remdesivir costs were the fifth highest cost driver, offset by shorter lengths of stay and less mechanical ventilation. INTERPRETATION: From a health care payer perspective, treating patients hospitalized with COVID-19 with remdesivir and usual care appears to be preferrable to treating with usual care alone, albeit with marginal incremental cost and small clinical effects. The added cost of remdesivir was offset by shorter lengths of stay in the intensive care unit and less need for ventilation. STUDY REGISTRATION: ClinicalTrials. gov, no. NCT04330690.

Use of HIV pre-exposure prophylaxis among urban Canadian gay, bisexual and other men who have sex with men: a cross-sectional analysis of the Engage cohort study.

BACKGROUND: In Canada, gay, bisexual and other men who have sex with men (GBM) are disproportionately affected by HIV. Our objective was to describe access to HIV pre-exposure prophylaxis (PrEP) and identify factors associated with not using PrEP among self-reported HIV-negative or HIV-unknown GBM. METHODS: This was a cross-sectional analysis of the Engage study cohort. Between 2017 and 2019, sexually active GBM aged 16 years or more in Montréal, Toronto and Vancouver were recruited via respondent-driven sampling (RDS). Participation included testing for HIV and sexually transmitted and blood-borne infections, and completion of a questionnaire. We examined PrEP access using a health care services model and fit RDS-adjusted logistic regressions to determine correlates of not using PrEP among those for whom PrEP was clinically recommended and who were aware of the intervention. RESULTS: A total of 2449 GBM were recruited, of whom 2008 were HIV-negative or HIV-unknown; 1159 (511 in Montréal, 247 in Toronto and 401 in Vancouver) met clinical recommendations for PrEP. Of the 1159, 1100 were aware of PrEP (RDS-adjusted proportion: Montréal 84.6%, Toronto 94.2%, Vancouver 92.7%), 678 had felt the need for PrEP in the previous 6 months (RDS-adjusted proportion: Montréal 39.2%, Toronto 56.1%, Vancouver 49.0%), 406 had tried to access PrEP in the previous 6 months (RDS-adjusted proportion: Montréal 20.6%, Toronto 33.2%, Vancouver 29.6%) and 319 had used PrEP in the previous 6 months (RDS-adjusted proportion: Montréal 14.5%, Toronto 21.6%, Vancouver 21.8%). Not using PrEP was associated with several factors, including not feeling at high enough risk, viewing PrEP as not completely effective, not having a primary care provider and lacking medication insurance. INTERPRETATION: Although half of GBM met clinical recommendations for PrEP, less than a quarter of them reported use. Despite high levels of awareness, a programmatic response that addresses PrEP-related perceptions and health care system barriers is needed to scale up PrEP access among GBM in Canada.

The Need and Desire for Mental Health and Substance Use-Related Services Among Clients of Publicly Funded Sexually Transmitted Infection Clinics in Vancouver, Canada.

CONTEXT: Sexually transmitted infections (STI) and mental health and substance use (MHSU) disorders all occur at elevated rates in sexual and gender minorities. These overlapping epidemics, or syndemics, are exacerbated by challenges these same populations face in accessing sexual/gender minority-affirming services. Many publicly funded STI clinics are a low barrier and provide sexual minority-competent care. These sites therefore may be uniquely situated to address clients' MHSU-related needs. OBJECTIVE: We characterize the need and desire for MHSU services among STI clinic clients. DESIGN, SETTING, PARTICIPANTS: We conducted a waiting room survey at 6 STI clinics in Metro Vancouver, Canada. MAIN OUTCOME MEASURES: We calculated the proportion of clients with self-reported unmet MHSU needs in the previous 12 months and, among these clients, barriers to accessing MHSU services and desire for MHSU services within the STI clinic. We also examined social disparities in barriers to accessing MHSU services. RESULTS: Among 1115 respondents-65% of whom were sexual minorities-39% reported a recent need for MHSU-related care, most frequently in relation to anxiety (29%), depression (26%), substance use (10%), or suicide ideation (7%). Seventy-two percent of this group had not yet talked to a provider about their concern. Common barriers included shame (26%) and inability to afford the service (24%). Eighty-three percent of clients with unmet MHSU needs indicated that they were comfortable discussing MHSU concerns with an STI clinic provider, and 94% expressed desire to receive MHSU assessments, referrals, or counseling in the STI clinic. Sexual and gender minorities and those attending a suburban clinic were more likely to report barriers to accessing MHSU services. CONCLUSIONS: More than a quarter of STI clinic clients report unmet MHSU health care needs; moreover, these clients report high levels of comfort with and desire to discuss MHSU concerns with STI clinic providers. Sexually transmitted infections clinics are thus opportune sites for syndemic service integration.

Economic evaluation of HIV pre-exposure prophylaxis strategies: protocol for a methodological systematic review and quantitative synthesis.

BACKGROUND: Pre-exposure prophylaxis (PrEP) with antiretrovirals is an efficacious and effective intervention to decrease the risk of HIV (human immunodeficiency virus) acquisition. Yet drug and delivery costs prohibit access in many jurisdictions. In the absence of guidelines for the synthesis of economic evaluations, we developed a protocol for a systematic review of economic evaluation studies for PrEP by drawing on best practices in systematic reviews and the conduct and reporting of economic evaluations. We aim to estimate the incremental cost per health outcome of PrEP compared with placebo, no PrEP, or other HIV prevention strategies; assess the methodological variability in, and quality of, economic evaluations of PrEP; estimate the incremental cost per health outcome of different PrEP implementation strategies; and quantify the potential sources of heterogeneity in outcomes. METHODS: We will systematically search electronic databases (MEDLINE, Embase) and the gray literature. We will include economic evaluation studies that assess both costs and health outcomes of PrEP in HIV-uninfected individuals, without restricting language or year of publication. Two reviewers will independently screen studies using predefined inclusion criteria, extract data, and assess methodological quality using the Philips checklist, Second Panel on the Cost-effectiveness of Health and Medicines, and the International Society for Pharmacoeconomics and Outcomes Research recommendations. Outcomes of interest include incremental costs and outcomes in natural units or utilities, cost-effectiveness ratios, and net monetary benefit. We will perform descriptive and quantitative syntheses using sensitivity analyses of outcomes by population subgroups, HIV epidemic settings, study designs, baseline intervention contexts, key parameter inputs and assumptions, type of outcomes, economic perspectives, and willingness to pay values. DISCUSSION: Findings will guide future economic evaluation of PrEP strategies in terms of methodological and knowledge gaps, and will inform decisions on the efficient integration of PrEP into public health programs across epidemiologic and health system contexts. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016038440 .

Enhanced syphilis screening among HIV-positive men (ESSAHM): a study protocol for a clinic-randomized trial with stepped wedge design.

BACKGROUND: The current syphilis epidemic among urban men who have sex with men (MSM) has serious implications for those co-infected with human immunodeficiency virus (HIV). Routine and frequent syphilis screening has the potential to ensure early detection and treatment, minimize disease burden, and help control the ongoing spread of syphilis and HIV. We aim to enhance syphilis screening among HIV-positive men by conducting a clinic-based intervention that incorporates opt-out syphilis testing into routine HIV laboratory evaluation for this population. Trial objectives are to determine the degree to which the intervention (1) increases the detection rate of untreated syphilis, (2) increases screening coverage, (3) increases screening frequency, and (4) reaches men at highest risk according to sexual behaviors. METHODS/DESIGN: The trial is a pragmatic, stepped wedge cluster-randomized controlled trial that introduces the intervention stepwise across four urban HIV clinics in Ontario, Canada. The intervention includes standing orders for syphilis serological testing whenever a male in HIV care undergoes HIV viral load testing, which typically occurs every 3-6 months. The control condition is the maintenance of current, provider-initiated syphilis testing practice. Approximately 3100 HIV-positive men will be followed over 30 months. Test results will be obtained from the centralized provincial laboratory in Ontario and will be supplemented by a standardized clinical worksheet and medical chart review at the clinics. Detailed clinical, psychosocial, and behavioral data is available for a subset of men receiving HIV care who are also participants of the province-wide Ontario HIV Treatment Network Cohort Study. Process evaluation plans include audit and feedback of compliance of the participating centers to identify potential barriers to the introduction of this type of practice into routine care. Health economic components include evaluation of the impact and cost-effectiveness of the intervention. DISCUSSION: This trial will be the first of its kind in Canada and will provide evidence regarding the feasibility, clinical effectiveness, and cost-effectiveness of a clinic-based intervention to improve syphilis screening among HIV-positive men. Involvement of knowledge users in all stages of trial design, conduct, and analysis will facilitate scale-up should the intervention be effective. TRIAL REGISTRATION: ClinicalTrials.gov NCT02019043.