Identifying barriers and facilitators along the hepatitis C care cascade to inform human-centered design of contextualized treatment protocols for vulnerable populations in Austin, Texas: a qualitative study.

BACKGROUND: Hepatitis C virus (HCV) is a leading cause of liver-related mortality and morbidity. Despite effective direct acting antivirals and a simplified treatment algorithm, limited access to HCV treatment in vulnerable populations, including people experiencing homelessness (PEH) and people who inject drugs (PWID), hinders global elimination. Adapting the evidence-based, simplified HCV treatment algorithm to the organizational and contextual realities of non-traditional clinic settings serving vulnerable populations can help overcome specific barriers to HCV care. The first phase of the Erase Hep C study aimed to identify barriers and facilitators specific to these vulnerable populations to design the site-specific, simplified treatment protocols. METHODS: Forty-two semi-structured qualitative interviews, guided by the Practical, Robust Implementation and Sustainability Model (PRISM) framework, were conducted with clinic staff, community-based organizations providing screening and linkage to care, and patients diagnosed with HCV, to identify contextual barriers and facilitators to treatment at a local community health center's Health Care for the Homeless program in Austin, Texas. Audio-recorded interviews were systematically analyzed using thematic analysis informed by the PRISM framework and design thinking, to anchor barriers and facilitators along the HCV care cascade. Findings were fed into human-centered design workshops to co-design, with clinic staff, site-specific, simplified HCV treatment protocols. RESULTS: The specific needs of PEH and PWID patient populations informed barriers and facilitators of HCV care. Barriers included tracking patients who miss critical appointments or labs, medication access and adherence, and patient HCV knowledge. Clinical teams leveraged existing facilitators and incorporated solutions to barriers into clinic workflows to improve care coordination and medication access. Actionable solutions included augmenting existing staff roles, employing HCV care navigation throughout the cascade, and standardizing medication adherence counseling. CONCLUSIONS: Clinic staff identified HCV care facilitators to leverage, and designed actionable solutions to address barriers, to incorporate into site-specific treatment protocols to improve patient HCV outcomes. Methods used to incorporate staff and patient experiential knowledge into the design of contextualized treatment protocols in non-traditional clinic settings could serve as a model for future implementation research. The next phase of the study is protocol implementation and patient enrollment into a single-arm trial to achieve HCV cure.

Development, implementation, and feasibility of site-specific hepatitis C virus treatment workflows for treating vulnerable, high-risk populations: protocol of the Erase Hep C study - a prospective single-arm intervention trial.

BACKGROUND: Hepatitis C virus (HCV) is the leading indication for liver transplantation and liver-related mortality. The development of direct-acting antivirals (DAA) and a simplified treatment algorithm with a > 97% cure rate should make global elimination of HCV an achievable goal. Yet, vulnerable populations with high rates of HCV still have limited access to treatment. By designing locally contextualized site-specific HCV treatment workflows, we aim to cure HCV in vulnerable, high-risk populations, including people experiencing homelessness (PEH) and people who inject drugs (PWID), in Austin, TX, USA. METHODS: Our implementation science study will utilize a qualitative and design thinking approach to characterize patient and systemic barriers and facilitators to HCV treatment in vulnerable, high-risk populations seeking care across seven diverse primary care clinics serving PEHs and PWIDs. Qualitative interviews guided by the Practical, Robust Implementation and Sustainability Model (PRISM) framework will identify barriers and facilitators by leveraging knowledge and experience from both clinic staff and patients. Data synthesized using thematic analysis and design thinking will feed into workshops with clinic stakeholders for idea generation to design site-specific HCV treatment workflows. Providers will be trained on the use of a simplified HCV treatment algorithm with DAAs and clinic staff on the new site-specific HCV treatment workflows. These workflows will be implemented by the seven diverse primary care clinics serving vulnerable, high-risk populations. Implementation and clinical outcomes will be measured using data collected through interviews with staff as well as through medical chart review. DISCUSSION: Our study provides a model of how to contextualize and implement site-specific HCV treatment workflows targeting vulnerable, high-risk populations in other geographic locations. This model can be adopted for future implementation research programs aiming to develop and implement site-specific treatment workflows for vulnerable, high-risk populations and in primary care clinical settings for other disease states beyond just HCV. TRIAL REGISTRATION: Registered on ClinicalTrials.gov on July, 14, 2022. Identifier: NCT05460130 .

Protecting providers and patients: results of an Internet survey of health care workers' risk perceptions and ethical concerns during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic has generated worldwide scarcity of critical resources to protect against and treat disease. Shortages of face masks and other protective equipment place health workers, already on the frontline of the disease, at higher risk. Moral distress from making difficult decisions about allocating scarce resources and care to patients ill with COVID-19 can further add to burdens health workers face. This study investigates clinical health workers' risk perceptions and concerns about the ethics of their clinical decision-making, the actions of their institutions to address resource scarcity concerns during the COVID-19 pandemic, and their ability to voice safety concerns, as well as their own views on how scarce resources should be allocated. METHODS: An online survey was open to health care workers who provide clinical care to patients, with no specialty training or geographic location requirements, from May 19 to June 30, 2020. Participants were recruited through purposive sampling using medical association and institutional email lists, and by snowball sampling. RESULTS: Of 839 participants, a majority were physicians (540, 69.4%) working in academic medical centers (270, 35.2%) or private health systems in the community (234, 30.5%) in the USA (760, 90.7%). Most reported being concerned about their own health (494, 73.6%) and about the possibility of spreading COVID-19 to family and friends (534, 85.9%) during the pandemic. All respondents reported shortages or rationing of at least one type of medical resource (e.g., sanitizing supplies and personal protective equipment). More than half of respondents (351, 53.9%) did not feel they received sufficient training in how to allocate scarce resources in the pandemic. Many felt moral distress related to conflicts between institutional constraints and what they believed was right (459, 66.5%). Though a majority (459, 67.7%) reported feeling "comfortable" internally communicating with their administration about safety issues, far fewer reported feeling "confident" speaking publicly about safety issues without retaliation from their institution (255, 37.3%). CONCLUSIONS: In the face of limited resources, surveyed health care workers reported concern about their own and their families' health from exposure. Securing adequate protective equipment must be a high priority for pandemic management. In addition, more governmental and facility-level ethical guidance is required for allocation of resources given ongoing scarcity, and facilities must create conditions so health care workers can speak openly about safety issues without fear of retaliation.

Community-Acquired Antimicrobial Resistant Enterobacteriaceae in Central America: A One Health Systematic Review.

Community-acquired antimicrobial resistant Enterobacteriaceae (CA-ARE) are an increasingly important issue around the world. Characterizing the distribution of regionally specific patterns of resistance is important to contextualize and develop locally relevant interventions. This systematic review adopts a One Health framework considering the health of humans, animals, and the environment to describe CA-ARE in Central America. Twenty studies were identified that focused on antimicrobial resistance (AMR) in Enterobacteriaceae. Studies on CA-ARE in Central America characterized resistance from diverse sources, including humans (n = 12), animals (n = 4), the environment (n = 2), and combinations of these categories (n = 2). A limited number of studies assessed prevalence of clinically important AMR, including carbapenem resistance (n = 3), third generation cephalosporin resistance (n = 7), colistin resistance (n = 2), extended spectrum beta-lactamase (ESBL) production (n = 4), or multidrug resistance (n = 4). This review highlights significant gaps in our current understanding of CA-ARE in Central America, most notably a general dearth of research, which requires increased investment and research on CA-ARE as well as AMR more broadly.