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

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 | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article 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study Anmol Desai, Lauren O’Neal, Kia Reinis, Cristal Brown, Michael Stefanowicz, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-2772126/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 17 Aug, 2023 Read the published version in Implementation Science Communications → Version 1 posted 5 You are reading this latest preprint version Abstract 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 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 Suitability 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. Hepatitis C homelessness intravenous drug use qualitative research human-centered design implementation research Figures Figure 1 Figure 2 Figure 3 Figure 4 Contributions to the Literature Global elimination of hepatitis C virus (HCV) requires expanding treatment and targeting vulnerable populations, including people experiencing homelessness (PEH) and people who inject drugs (PWID) Clinics serving PEH and PWID require simplified, site-specific HCV treatment protocols to improve patient HCV outcomes Obtaining a broad, multi-level perspective of barriers and facilitators to HCV treatment using qualitative methods grounded in an implementation science framework allows for design of site-specific HCV treatment protocols We offer a model for future implementation researchers to design contextualized care protocols for treating vulnerable populations in non-traditional clinic settings. Background Chronic hepatitis C virus (HCV) infection affects 58 million people globally and 2.1 million people in the United States (US) ( 1 ). HCV incidence in the US is rising and remains a significant driver of liver-related morbidity and mortality ( 2 ). Among people experiencing homelessness (PEH), estimated HCV prevalence is more than 30%, though estimates are often underreported ( 3 ). The prevalence of HCV is 31% among those seeking care at Health Care for the Homeless (HCH) clinics, and 70% among those seeking care at HCH clinics who inject drugs (PWID) ( 4 ). Despite direct acting antivirals (DAAs) and a simplified HCV treatment algorithm with a > 97% cure rate, only a minority of the total population living with chronic HCV, who are aware of their status, has access to care (43%) or has been prescribed HCV treatment (16%) ( 5 , 6 ). In particular, access to treatment among vulnerable populations remains low ( 1 , 7 , 8 ). Access to treatment is obstructed by patient-level and systemic barriers, including misconceptions about HCV treatment, a limited number of experienced HCV providers in primary care clinics, payor restrictions, and overly complex organizational workflows ( 7 , 9 , 10 ). To increase access to treatment among PEH and PWID, clinics that serve these vulnerable populations urgently need locally adapted and contextualized protocols that use DAAs and the simplified treatment algorithm, while addressing patient and systemic barriers to, and facilitators of, HCV care. The purpose of this first phase of the Erase Hep C study was to utilize qualitative research methods guided by an implementation science framework combined with human-centered design thinking, to develop site-specific HCV treatment protocols by identifying and reducing barriers and leveraging facilitators of HCV care. Methods Study design The Practical, Robust Implementation and Sustainability Model (PRISM) framework informed development of semi-structured qualitative interview guides to identify multi-level contextual barriers and facilitators to HCV treatment in our community health center (CHC) system’s high-risk, vulnerable patient population (Fig. 1) ( 11 ). [FIGURE 1 HERE] Figure 1: PRISM Implementation Science Framework Adapted to the Erase Hep C study We leveraged knowledge and experience from patients diagnosed with HCV, clinic staff and providers, our CHC system’s leadership, and community-based organizations providing HCV testing and linkage to care, to inform design and implementation of simplified, site-specific HCV treatment protocols. We chose interviews over focus groups to elicit individual level perspectives about organizational structures and identify tasks that individuals perform. Interviews allowed people to speak freely and independently, which would have been affected by power dynamics in a focus group setting. Setting Qualitative interviews were conducted in seven primary care clinics within our CHC’s HCH program and among external organizations that engage in the community to provide HCV testing and linkage to care. The clinics included: 1) a full-spectrum clinic located within the Austin Resource Center for the Homeless (ARCH) shelter (“the ARCH Clinic”); 2) a patient-centered brick-and-mortar clinic providing full-spectrum care for PEH as well as other medically complex and socially vulnerable patients following hospital discharge (“Care Connections”); 3) a clinic dedicated to providing Medication Assisted Therapy (MAT) to individuals with Opioid Use Disorder (“the MAT Clinic”); 4) a clinic located at Community First! Village (CFV), a permanent supportive housing community for individuals who were formerly chronically homeless (“the CFV Clinic”); 5) a clinic located at a state-sanctioned encampment for PEH that is becoming a transformational shelter complex (“the Esperanza Clinic”); 6) a full-spectrum clinic space set-up within Sunrise Church, providing care alongside other partners of the Sunrise Homeless Navigation Center non-profit that serves PEH in Austin (“Sunrise”); and 7) a street medicine team bringing care to PEH at homeless campsites and under bridges (“the Street Team”). The Mobile Team operates three of these HCH clinic sites: CFV, Esperanza, and Sunrise. These HCH clinics serve people currently or previously having experienced homelessness, or people who inject drugs (PWID), providing both primary care and connection to a variety of social resources. Participants We interviewed a total of 42 people, made up of 28 clinic staff and providers, 10 patients diagnosed with HCV, and 4 staff from external organizations that screen or link patients with HCV to care. A purposive, convenience sample was used to engage patients and clinic staff across all levels of our CHC. We asked providers and staff to recommend patients with HCV, from treatment naïve to having achieved cure, who would be willing to participate in our interviews. Data collection A trained research coordinator and research assistant conducted thirty to sixty-minute audio-recorded interviews in person and over Zoom. Interviews were conducted between September and November 2021. Participants were asked about the process to initiate HCV treatment, challenges to starting and completing treatment, and facilitators of treatment adherence and completion. Staff, providers, and leadership were also asked about their role in the process of HCV care for patients. If additional and relevant information surfaced, conversations progressed beyond the semi-structured interview guides. At the end of each interview, the participants were asked demographic questions. We conducted interviews until we reached thematic saturation of data and perspectives. Data collected from the interviews were supplemented with observations and discussions of clinic processes with clinic teams at each clinic site that were conducted in July 2021. Written consent was obtained from participants, either in person or digitally. Participants were compensated $ 10 worth for being interviewed. Signed consent forms, audio-recordings, and transcribed interviews were all stored on Box, a HIPAA-compliant cloud storage system. This study was approved by the Institutional Review Board at the University of Texas at Austin and the Research and Quality Improvement Committee at CommUnityCare community health centers. The research team consisted of a research coordinator with extensive experience in global health fieldwork conducting large-scale nationally representative population and public health surveys; a research assistant with experience in HCV, qualitative research, and implementation science research; Co-Primary Investigators with extensive qualitative, implementation science research, and field epidemiology experience; and a Co-Investigator who is a hepatologist, HCV expert, and health services researcher. The research team also included several CHC providers to provide context on treating vulnerable populations within these CHC clinic sites. This research was reported based on the Standards for Reporting Qualitative Research (SRQR) guidelines ( 12 ) (Additional File 1). Data analysis All 42 interviews were transcribed verbatim, using a combination of Zoom transcription services and manual transcription, and anonymized for thematic analysis using NVivo 1.5.1 (QSR International, Burlington, Massachusetts). A dual analytic approach was used. First, qualitative thematic descriptive and interpretive coding, informed by our PRISM framework, was used to ensure each level of the framework was addressed in analysis. Second, a human-centered design thinking approach was utilized, focusing on the utility of the multi-level perspective data to design site-specific, simplified HCV treatment protocols at primary care clinics within our CHC’s HCH program. Two coders iteratively collaborated to define codes, finalize the codebook, highlight themes and subthemes of the barriers and facilitators, and identify relationships between themes. Themes focused on HCV treatment access at both the patient and clinic level, clinic processes both external and internal to the CHC system (e.g., across departments and other healthcare systems), and characteristics of the external environment that impact HCV patient outcomes. The codebook development was a hierarchical process with constant comparison, refinement of codes, and merging of existing codes ( 13 , 14 ). Coders initially conducted deductive code development, starting with a list of initial codes we expected to see emerge, based on our observations and guided tours of the clinical sites ( 15 ). Coders entered the first round of coding with this initial codebook, in which they individually read and coded the same three transcripts. The coders came together to discuss, negotiate, and revise the codes. The coders then went on to code an additional five different transcripts and conducted a second round of discussion and revision. Transcripts coded in these first two rounds of coding were randomly selected to capture a wide scope of roles to develop the most representative codebook. The final code structure was developed by consensus after coding the remaining transcripts and by applying the perspectives and characteristics of the PRISM framework throughout ( 13 ). Design Workshops Findings from qualitative interviews were fed into iterative, site-specific design workshops held with clinic staff to adapt the simplified treatment algorithm into actionable, site-specific HCV protocols integrated within existing clinic workflows. A total of nine site-specific workshops were held over two iterations, with the Mobile Team discussing the three mobile sites as a collective (CFV, Esperanza, and Sunrise). The first iteration of workshops discussed findings from the qualitative interviews with respondent validation and prioritization of barriers to address and facilitators to leverage with the site-specific protocols. In preparation for the second iteration of workshops, providers and clinical leads simplified the HCV care cascade workflow (Fig. 2). Driven by the evidence-based simplified treatment algorithm, tasks no longer necessary were collapsed and removed, to define the HCV care cascade framework from diagnosis to cure. [FIGURE 2 HERE] Figure 2: Hep C Care Cascade Framework Colored squares represent actions that occur along each step of the care cascade: provider visits (light pink), labs (hot pink), medication pick-up (lavender), Medical Access Program (MAP) and Patient Assistance Program (PAP) processes (green), formal payor processes (turquoise), otherwise synonymous with traditional commercial payors, and other HCV actions (grey). In the second workshop, this care cascade framework was presented to and adapted for each site, considering their patient populations, non-traditional clinical environments, staffing ratios, and clinical workflows. Subsequently, the actionable solutions to mitigate the biggest barriers that were identified in the first workshop were layered onto the workflow. Clinic teams increased staff accountability by assigning ownership of each task to a role, with task sharing or role duplication to fit the flexibility and dynamic environment of each clinic. The actionable solutions addressed barriers and leveraged facilitators found across multiple PRISM perspectives and characteristics. Results Participant demographics Forty-two participants were interviewed. Twenty-eight were clinic staff and leadership, including front-line clinical staff from each clinical site, as well as representatives from the referrals department, pharmacy department, and social and financial services departments (Table 1). We also interviewed four providers and system-level staff from other organizations in Austin, Texas who screen and link people diagnosed with HCV and PEH to care. Ten patients were interviewed who were at different points along the HCV care cascade. Patients ranged from being treatment naïve to having been cured. Of those interviewed, 40% were currently experiencing homelessness and 80% reported having injected drugs. [TABLE 1 HERE] Table 1: Distribution of clinic and system-level staff interviewed Anchoring barriers and facilitators along the hepatitis C care cascade By identifying barriers and facilitators to HCV care, clinic teams were able to conceptualize actionable solutions to barriers and leverage existing facilitators when designing the site-specific HCV treatment protocols. Barriers and facilitators were identified considering patient, clinic, provider, system, and external environmental characteristics and perspectives. The barriers and facilitators were anchored to every step along the HCV care cascade they impact, from diagnosis to confirmation of cure by sustained virologic response 12 weeks post-treatment (SVR12) (Fig. 3). Some barriers and facilitators affected multiple steps along the HCV care cascade and others were unique to specific steps. [FIGURE 3 HERE] Figure 3: Barriers and Facilitators along the Hepatitis C Care Cascade The dots represent patient actions along the care cascade (blue), as also indicated in Fig. 2, for which patients need to come for clinic visits (light pink), get labs (hot pink), and pick-up medication (lavender). Common themes at the patient level centered around the nature of the PEH and PWID populations, including transience, being vulnerable to theft, low health literacy, and difficulty adhering to medication and returning to the clinic for follow up testing. Clinic and system level themes encompassed operational processes, including tracking patients who miss critical appointments, transporting medication to patients, enabling medication adherence, patient HCV knowledge, and failure to follow-up with patients for SVR12 laboratory tests confirming cure. Partnerships with external organizations facilitated the HCV treatment process by helping to find patients, aiding in building trust with the care team, taking medication out to patients, or drawing blood for laboratory tests. Table 2 provides illustrative excerpts of these themes, gathered from our interviews. [TABLE 2 HERE] Table 2: Themes of Barriers and Facilitators identified along the Hepatitis C Care Cascade, with Illustrative Excerpts from Staff and Patient Interviews A superscript B indicates a barrier and a superscript F indicates a facilitator. Given diagnosis and offered treatment Barriers Several barriers centered around providers’ own comfort level in treating HCV, or in assessing treating PEH and PWID, assuming either they would not be able to adhere to treatment or would get re-infected, assumptions stemming from the stigma surrounding PEH and PWID. Among providers who are comfortable treating HCV in this population, treatment may not be offered if they are experiencing provider overload, may not have sufficient time for educating patients, or may need to prioritize other acute medical needs. “In the patient population that I was serving, some of that preventative care, when you triage how important it was, it wasn't as important as keeping them alive and out of the hospital…if you're constantly putting out a fire it's hard to get to the preventative side of the care.” (Provider) Lack of access to easy, comfortable, and reliable transportation and inability to contact patients due to low phone ownership were the most commonly reported obstacles to care, beginning with receiving an HCV diagnosis, and at every stage of clinic-patient interaction. Low phone ownership results in patients not receiving appointment reminders or an inability to reschedule missed appointments. Missing clinic follow up visits are barriers to completing diagnostic laboratory tests or receiving an HCV diagnosis. Facilitators Among patients who do not have phones, clinics collaborate with case managers and Emergency Medical Services (EMS) Community Health Paramedics (CHPs) to locate patients to encourage them to keep their appointments and come to the clinic, so they can receive their diagnosis in a timely manner. Providers set the patient up for success by determining patient readiness prior to offering treatment. Operational facilitators include the use of an HCV group on the clinic’s HIPAA compliant communication platform, on which providers can message other providers who treat HCV and get timely answers to case-based questions or readily available consultations with hepatology specialists. Additionally, having on-site laboratory testing reduces the likelihood of patients leaving the clinic without getting the necessary labs drawn to offer treatment. Treatment accepted Barriers Several barriers to accepting treatment are a function of the nature of this population, such as patients not feeling ready, low health literacy, competing medical priorities, and living with untreated mental health conditions and/or substance use disorders, resulting in patients not returning to the clinic to accept treatment. Accepting treatment can be a common drop off point for patients who are asymptomatic and feel that they do not need treatment, or who have other competing psychosocial priorities, or face additional barriers to remaining engaged in care. Facilitators Strong social networks can move patients towards undergoing treatment in numerous ways, such as friends who encourage them to get treated, friends informing them that treatment is easy and within reach, a patient wanting to prove to family members they are taking responsibility for their health, watching loved ones with HCV suffer or die. “I said yeah, I got to look into this and get [my hepatitis C] cured. I’m not ready to die. (Patient who reached SVR12) Educating patients on the consequences of untreated HCV increases their motivation to get cured. Providers and care coordinators can make the treatment regimen more acceptable to patients by making it more manageable for them, breaking down the care cascade into discrete pieces, and working with patients to create a specific plan for treatment and medication storage. Getting funding for treatment Barriers The majority of patients treated at CHC HCH sites lack health insurance. Patients on the county-based Medical Access Program (MAP) for the uninsured, which includes many PEH and PWID, commonly experience unnoticed lapses in coverage, which interferes with completion of requisite medical appointments or laboratory tests prior to initiating treatment. For patients covered by MAP, their DAA medications must be covered by the prescription access program (PAP), which is through a separate application process from MAP. Completing necessary PAP paperwork can be cumbersome and confusing to some patients who may conflate one assistance program for another. Verifying information for this paperwork, such as getting a letter of no income or proof of residency, can be tough, given how difficult it is for this population to return to clinic, unreliable communication methods, and lack of necessary identification or income documentation. Additionally, the strict requirements of prescription assistance programs can impede access to funding for treatment. While patients on Medicare or Medicaid are not eligible for PAP, they do have access to DAAs under these programs. However, this access often requires prior authorization or other bureaucratic steps that are confusing and time-consuming for providers, and can delay access to treatment for patients. Facilitators Clinic staff make the funding paperwork process easier for patients by getting patients’ signatures and information at the time of treatment acceptance. Though MAP does not cover the cost of medication, it covers medical care and labs, and serves as a facilitator to medication access by guaranteeing patients’ DAAs are covered by prescription assistance programs. On the operational side, specifying which labs are required by each payor and ensuring this information is known and shared across clinic providers and clinic staff further streamlines the funding application process. Treatment initiated Barriers Once a diagnosis is received, low health literacy can impact a patient initiating treatment and adhering to medication. PEH and PWID often experience competing medical priorities, reducing the likelihood of sensing any urgency to undergo treatment for their HCV or pickup medication. Alternatively, patients who are motivated to initiate treatment face transportation and communication obstacles to get to clinic to pick up their medication. Facilitators Initiating treatment is facilitated by clinic staff collaborating with the pharmacy department and external partners to improve patient access, by either couriering medication to locations patients can readily access, for example, the clinic they prefer to go to, or through direct delivery to patients by members of the Street Team, Mobile Team, or Community Health Workers. Patient oriented care, here defined by active encouragement and support of patients by clinic staff, facilitates acceptance and initiation of treatment by building confidence and bolstering engagement in care throughout the care cascade. Co-locating HCV treatment with corollary care, such as medication assisted treatment with buprenorphine for opioid use disorder, or by co-locating clinics where psychosocial resources, which are perceived as more pressing needs such as free meals or applying for housing, are being provided, increases the likelihood of patients engaging with clinics, including picking up their HCV medication and getting labs drawn. End of first month Barriers Once a patient receives funding for treatment, clinic operations may raise barriers to patients’ ability to adhere to their medication regimen or get necessary labs drawn. For example, patients may be confused about where to pick up their medication, especially if they frequent more than one HCH clinics or the pick-up location is not their usual clinic, or they may not understand the importance of communicating with their provider about side effects or perceived side effects. Furthermore, the long wait times of the CHC’s centralized call center makes it hard for patients to connect directly with an individual clinic. As a result, patients may decide to stop taking their medication on their own if they experience side effects and if they cannot or do not connect with their medical team in a timely manner. Facilitators At the clinic level, staff and providers take many actions to facilitate patients reaching this point in the care cascade, including offering mid-way check-in appointments, giving patients the opportunity to start treatment when they are ready, and emphasizing the importance of medication adherence. Rapid replacement of lost or stolen medications through PAP programs provides additional external support to medication adherence. “I do also try to address one of the 2 or 3 contingencies that come up, namely, it’s very common with patients, especially at Care Connections, if you lose your medicines – if you do, please don’t wait until the next appointment to tell me, please come here right away and we’ll talk to the drug company and usually we’ll get you a new bottle. So, I talk about that contingency. I talk about if [their medication] gets lost or stolen.” (Clinic Staff) Additionally, strengthening the patient and provider relationship while continuously providing support may increase patient communication with the clinic. The consistency of the Mobile Team’s location schedule increases the likelihood of walk-ins to clinics that are walk-in based, since patients will know when and where the clinic will be, especially important for patients without phones. The HCH clinics’ flexibility with scheduling and lateness allows patients to feel comfortable calling or coming into clinic if they experience side effects before stopping medication. End of treatment Barriers Patient level barriers to completing treatment are centered around low health literacy, lapses in medication adherence, and failure to return to the clinic for end of treatment (EOT) labs. Additionally, lack of safe storage to prevent medication loss or theft, frequent jail or hospital stays, and late medication refills can result in adherence lapses or prevent patients from completing treatment. “They're experiencing homelessness, they lose their medication, their medication gets stolen.” (Clinic Staff) Facilitators The same facilitators to medication access and patient engagement in initiating treatment are leveraged by clinics and staff to help patients adhere to their medication and reach treatment completion. SVR12 Barriers The need for laboratory tests to assess SVR12 to determine cure is not always understood by patients with low health literacy, so they do not return to clinic to get the blood drawn for laboratory tests. Patients who do understand the importance of SVR12 labs, may not always remember to come back for labs. Additionally, some providers may not sufficiently emphasize the importance of the SVR12 labs, knowing there is a high correlation of earlier undetectable viral loads with cure. “But for people that have finished treatment, a lot of it has to do with the stability of their social setting. Because it’s hard to remember to come back 3 months after you’ve finished treatment to get labs drawn when you’re still out on the streets.” (Clinic Staff) Facilitators For some patients, motivation to verify HCV cure drives completion of SVR12 labs. For clinics, getting SVR12 labs is made easier by providers ordering SVR12 labs ahead of time, so they can be completed whenever the patient next comes into the clinic beyond three months of completing treatment. Staff celebration of patient wins such as HCV cure boosts morale of both patients and staff. Incorporating qualitative findings into site-specific protocol design workshops These qualitative findings were incorporated into the human-centered design workshops to design site-specific, simplified treatment protocols. Even though our HCV care cascade starts at diagnosis, once the patients is in the clinic after screening, diagnosis, and linkage to care, numerous barriers to getting the patient into the clinic, as well as linking them to care were identified in the first workshops. During the design workshops, clinic teams focused on operational clinic-level barriers they had the ability to modify. Not all barriers, such as a patient going to jail or being hospitalized while on treatment, and losing access to their medication as a result, could be modified by clinic staff. Existing facilitators informed actions to leverage and emphasize, while modifiable barriers invited opportunities to propose solutions to be incorporated into the site-specific treatment protocols. The protocol variations across sites were operational differences in how teams accomplish tasks and who takes ownership of the tasks along the care cascade, taking into consideration varying staffing ratios, physical spaces, team dynamics, and characteristics of the patients that frequent each site. Actionable solutions incorporated into each site-specific protocol pertained to patient education, tracking patients along the care cascade, improving medication access and adherence, and ensuring patients return for necessary labs (Fig. 4). The Mobile Team designed a singular protocol for all the three mobile sites (CFV, Esperanza, and Sunrise). [FIGURE 4 HERE] Figure 4: Themes of Site-Specific Tasks Added along the Hep C Care Cascade by Clinic Clinic teams incorporated medication adherence counseling by ensuring patient HCV education was woven into the workflows. Following patients along the HCV care cascade also aids in ensuring patients’ medication access and adherence, which was especially emphasized on the Mobile and Street Teams workflows. Clinics incorporated a variety of methods to start tracking patients after treatment has been accepted such as augmented existing staff roles to leverage existing facilitators and optimize patient access to medications. All the clinic teams, except the ARCH clinic which has a care coordinator, chose to leverage the pre-existing resource of the CHC’s Sexual Health Team’s patient navigators (SHNs) to support patients through prescription access programs to obtain medications for uninsured patients. Care coordination and education helps patients remain engaged in care with the single goal of being cured. Discussion This qualitative study identified barriers and facilitators to HCV treatment at primary care clinics within our local community health center’s HCH program to inform the design of simplified, site-specific HCV treatment protocols for serving vulnerable populations in Austin, Texas. Barriers and facilitators to each step along the care cascade were identified, in order to reduce their negative impact or leverage their positive contribution to care. Participants were interested in contributing as study goals melded with clinic objectives to improve care for people with HCV, especially among PEH and PWID. Barriers encountered at each step along the care cascade are a result of the vulnerabilities uniquely experienced by this population, such as competing priorities, untreated mental health conditions and/or substance use disorders, living environment, unreliable communication, and inability of mental capacity to sufficiently plan to seek care in the face of unreliable transportation, where patients experience stigmatizing behavior, as also demonstrated in other studies ( 7 , 8 , 10 , 16 ). All these characteristics of the population conspire to result in high “no show” rates amongst this population, that can compromise patient care when patients miss their appointments and do not receive an HCV diagnosis, pick up medications, or complete laboratory tests ( 1 , 7 , 10 ). Though studies have shown that 40% of people are unaware of their HCV status, our results demonstrate that patients often do know their HCV status but face a host of barriers that can result in patients not seeking care despite knowing their status including not knowing that treatment is available and accessible to them ( 7 , 10 , 16 – 18 ). Actionable solutions to further bolster engagement in treatment clustered around enhancing and streamlining patient education, facilitating medication access, and care coordination. Actionable solutions added to the care cascade spanned across all PRISM domains, from system-level collaboration with other departments within our community health center (e.g., SHNs) to working with external community partners (e.g., EMS) who are key stakeholders to facilitate medication access ( 10 , 18 ). Clinics without a dedicated care coordinator augmented existing clinic roles and incorporated utilizing SHNs into their protocols to help track and support patients throughout the care cascade. For some patients, high motivation for HCV treatment is a significant contributor to overcoming these barriers. Despite these barriers, social resources co-located with the clinics and corollary care (e.g., buprenorphine for opioid use disorder), compounded by the supportive clinical environment, motivate patients to return to clinic at all steps along the care cascade ( 18 – 20 ). Existing operational facilitators to creating a supportive care environment include being patient-oriented, teamwork, strong communication, and flexibility among and across clinics. Clinics do not turn away patients who are late, accept patients who walk-in and utilize a standby list, set up clinics at various locations around town, and collaborate with external organizations, such as the EMS CHPs, to not only be on the lookout for patients but also meet the patients where they are ( 10 , 18 , 19 ). Through interviews and human-centered workshops, we obtained a multi-level perspective across an expansive breadth of clinics not yet discussed together in literature. Anchoring the barriers and facilitators along the HCV care cascade allowed the clinic teams to identify actionable solutions to break down barriers. The end of the first month was noted as a critical point in the HCV care cascade where both barriers and facilitators were most quantifiably weighted. Several barriers that were frequently identified in interviews and workshops have been obviated by the simplified treatment algorithm itself, which removed some steps that had earlier been required and were often difficult for this population in particular to accomplish, such as requiring appointments and labs at the end of the first month of treatment ( 6 ). Stressing the importance of coming back to have SVR12 labs drawn to determine cure was emphasized in the workshops as an important step in the care cascade that could be facilitated by the support of clinic staff and availability of on-site laboratory testing ( 18 – 20 ). There was an identified need to increase HCV patient knowledge on the importance of SVR12 labs or calling the clinic when experiencing side effects before stopping medication to increase patients reaching cure ( 7 , 20 , 21 ). Increasing patient knowledge includes continuing to make each step as easy as possible for the patients by leveraging how providers break down medical care into bite size pieces for the patients to better understand treatment and the vital steps of the process since many patients are motivated by seeing they have been cured ( 7 ). Value of a human-centered design approach By taking a ground-up systematic approach, rather than a top-down approach across all sites, each clinic team and staff were empowered to provide input into designing their own site-specific protocols. Inviting staff across all roles to participate in their site-specific design workshops to co-design the simplified, site-specific protocols garnered buy-in and ownership of the protocols at each site. Buy-in was also garnered by the study team’s interest in observing and understanding clinic processes, and building relationships with clinic teams by their presence in clinic, in preparation for the second phase of the study. Limitations Our study has its limitations. There was the risk of clinic staff being hesitant to fully disclose and discuss operational barriers for fear that supervisors or teammates would prefer not to disclose some of the barriers. To encourage staff to be forthcoming, interviews were conducted in private spaces, out of ear shot of others, and staff were assured that information would be anonymized. Study staff spent time in clinic, to observe and learn clinic practices, build relationships, and communicate the intent of the study so clinic staff can be more comfortable engaging in more open and honest dialogue. Additionally, due to the COVID-19 pandemic, interviews required flexibility and participants were offered in-person or virtual interviews. As the gold standard, in-person interviews allow for a wider read of body language, which may be more limited in virtual interviews conducted over Zoom. On the other hand, offering remote interviews may have led to a higher response rate among those who preferred a remote interview. Despite some staff in non-provider roles attesting during interviews or design workshops to having limited or no knowledge of HCV and the HCV treatment process, they were usually able to draw on their experience with general treatment processes and caring for this particular patient population to offer information and perspectives that were applicable to the HCV treatment process as well. Conclusions Though HCV treatment by primary care providers has been proven effective, hesitancy to treat PEH and PWID remains a barrier to treating this population and eliminating HCV worldwide ( 7 , 8 ). The Erase Hep C study aims to minimize this barrier and make HCV treatment more accessible locally to high-risk, vulnerable patient populations, and easier to incorporate into busy, primary care provider workflows, including in non-traditional clinic settings. We describe a method to incorporate staff and patient knowledge and experience to design contextualized HCV protocols for treating vulnerable populations in non-traditional clinic settings. Through a collaborative approach, these protocols will be integrated into clinic workflows and providers will be trained on simplified HCV treatment. In the second phase of the Erase Hep C study, the site-specific protocols developed in the design workshops will be implemented and patients will be enrolled into our single-arm trial with the aim of at least 75% of our study participants achieving SVR12. Ultimately, this approach could serve as a model for future implementation research aiming to develop and implement contextualized treatment models for other conditions in vulnerable populations. Abbreviations CareCo: Care Connections Clinic CFV: Community First! Village CHC: community health center CHP: Community Health Paramedic CHW: Community Health Worker DAA: direct acting antivirals EMS: Emergency Medical Services EOT: end of treatment HCH: Health Care for the Homeless HCV: Hepatitis C virus LCSW: Licensed Clinical Social Worker MA: Medical Assistant MAC: Medical Administrative Clerk MAP: Medical Access Program MAT: Medication Assisted Therapy PAP: Patient Assistance Program PEH: people experiencing homelessness PRISM: Practical, Robust Implementation and Sustainability Model PWID: people who inject drugs RN: Registered Nurse SHN: Sexual Health Navigator SRQR: Standards for Reporting Qualitative Research US: United States Declarations Ethics approval and consent to participate This first phase of the Erase Hep C study was approved by the University of Texas at Austin’s Institutional Review Board, as well as CommUnityCare’s Research and Quality Improvement Committee. Written voluntary informed consent was obtained from study participants for the qualitative interviews. Consent for publication Not applicable. Availability of data and materials Qualitative interview guides can be made available upon request. Competing interests There are no financial or competing interests. Funding The Erase Hep C study is funded by an investigator sponsored research grant from Gilead Sciences, Inc. The content is solely the responsibility of the authors. The trial sponsor is The University of Texas at Austin Dell Medical School. Author’s contributions AD and KR conducted the interviews, qualitative analysis, and coordinated and facilitated design workshops. CB, MS, AK, and TM reviewed the HCV care cascade, as clinic leads. All authors contributed to the writing of this manuscript. All authors approved the final version. Acknowledgements We would like to thank CommUnityCare for their input as our clinical partner, as well as patients and staff. Author’s information Anmol Desai, MPH, Email: [email protected] Lauren O’Neal, MPH, Email: [email protected] Kia Reinis, PhD, Email: [email protected] Cristal Brown, MD, MHS, Email: [email protected] Michael Stefanowicz, DO, Email: [email protected] Audrey Kuang, MD, Email: [email protected] Deepak Agrawal, MD, MPH, MBA, Email: [email protected] Darlene Bhavnani, PhD, MPH, Email: [email protected] Tim Mercer, MD, MPH*, Email: [email protected] References World Health Organization. Hepatitis C. Geneva, Switzerland: WHO, 2022 [updated 24 June 2022]. Available from: https://www.who.int/en/news-room/fact-sheets/detail/hepatitis-c. Centers for Disease Control and Prevention. Hepatitis C Questions and Answers for Health Professionals. Atlanta, Georgia: CDC, 2020 [updated August 7, 2020]. Available from: https://www.cdc.gov/hepatitis/hcv/hcvfaq.htm#section1. Edlin BR, Eckhardt BJ, Shu MA, Holmberg SD, Swan T. Toward a more accurate estimate of the prevalence of hepatitis C in the United States. Hepatology. 2015;62(5):1353-63. Strehlow AJ, Robertson MJ, Zerger S, Rongey C, Arangua L, Farrell E, et al. Hepatitis C among clients of health care for the homeless primary care clinics. J Health Care Poor Underserved. 2012;23(2):811-33. Yehia BR, Schranz AJ, Umscheid CA, Lo Re V. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One. 2014;9(7):e101554. Dieterich DT. A Simplified Algorithm for the Management of Hepatitis C Infection. Gastroenterol Hepatol (N Y). 2019;15(5 Suppl 3):1-12. Paisi M, Crombag N, Burns L, Bogaerts A, Withers L, Bates L, et al. Barriers and facilitators to hepatitis C screening and treatment for people with lived experience of homelessness: A mixed-methods systematic review. Health Expect. 2022;25(1):48-60. Thompson VV, Ragland KE, Hall CS, Morgan M, Bangsberg DR. Provider assessment of eligibility for hepatitis C treatment in HIV-infected homeless and marginally housed persons. AIDS. 2005;19. Beiser M, Leon C, Gaeta JM. Needs Assessment of HCV-Infected Individuals Experiencing Homelessness and Implications. J Health Care Poor Underserved. 2017;28(1):596-606. Fokuo JK, Masson CL, Anderson A, Powell J, Bush D, Ricco M, et al. Recommendations for Implementing Hepatitis C Virus Care in Homeless Shelters: The Stakeholder Perspective. Hepatol Commun. 2020;4(5):646-56. Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008;34(4):228-43. O'Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: a synthesis of recommendations. Acad Med. 2014;89(9):1245-51. Yale University. Fundamentals of Qualitative Research Methods: a series of videos from Yale University. Global Health Social Science: The Global Health Network; 2016. Tracy SJ. Qualitative Research Methods: Collecting Evidence, Crafting Analysis, Communicating Impact. UK: John Wiley & Sons, Ltd; 2013. Padgett DK. Qualitative and Mixed Methods in Public Health. Thousand Oaks: SAGE Publications, Inc.; 2014. Masson CL, Fokuo JK, Anderson A, Powell J, Zevin B, Bush D, et al. Clients' perceptions of barriers and facilitators to implementing hepatitis C virus care in homeless shelters. BMC Infect Dis. 2020;20(1):386. U.S. Department of Health and Human Services. Hepatitis C Basic Information. Washington, DC: Office of Infectious Disease and HIV/AIDS Policy (OIDP), 2020. Available from: https://www.hhs.gov/hepatitis/learn-about-viral-hepatitis/hepatitis-c-basics/index.html. London Joint Working Group on Substance Use and Hepatitis C. Hepatitis C testing and treatment interventions for the homeless population in London during the Covid-19 pandemic: Outcomes and learning. London, UK: London Joint Working Group on Substance Use and Hepatitis C, 2020. Available at http://ljwg.org.uk/wp-content/uploads/2021/01/HCV-testing-in-temporary-accommodation-during-lockdown-December-2020.pdf. E. Williams B, Nelons D, Seaman A, Witkowska M, Ronan W, Wheelock H, et al. Life projects: the transformative potential of direct-acting antiviral treatment for hepatitis C among people who inject drugs. International Journal of Drug Policy. 2019;72:138-45. World Health Organization. Barriers and facilitators to hepatitis C treatment for people who inject drugs: A qualitative study. Geneva, Switzerland: WHO, 2012. Lambert JS, Murtagh R, Menezes D, O’Carroll A, Murphy C, Cullen W, et al. ‘HepCheck Dublin’: an intensified hepatitis C screening programme in a homeless population demonstrates the need for alternative models of care. Tables Table 1: Distribution of clinic and system-level staff interviewed Classification of clinic and system-level staff interviewed Number of staff interviewed Providers (Physicians (MD/DO), Nurse Practitioner (NP)) 7 Clinic-level staff (Registered Nurse (RN), Medical Assistant (MA), Medical Administrative Clerk (MAC)) 8 Clinic-level social services staff (Licensed Clinical Social Worker (LCSW), Community Health Worker (CHW)) 5 System-level staff (pharmacy, referrals, social/financial services) 5 System-level leadership (manager, supervisor) 3 Table 2: Themes of Barriers and Facilitators identified along the Hepatitis C Care Cascade, with Illustrative Excerpts from Staff and Patient Interviews Step in Hep C Care Cascade Illustrative excerpt Given diagnosis and offered treatment Competing priorities B “Sometimes with our patients, what you can do today is what you're going to get done” (Clinic Staff) “Once in a great while I have a patient who says ‘I have a lot going on right now, I don’t really think I’m ready for it’.” (Provider) Patient-Provider Relationship (waiting till patient can succeed) F “I always offer it, but if they’re not ready, I don’t push. Because a lot of it is engagement, and I don’t want to scare them. So, if they’re on the fence, I can usually say ‘yeah, this is really good, knowledge is power, you should know what’s going on’ so you see which direction they’re in. But if they’re not ready, that’s totally fine. (Provider) Treatment accepted Low health literacy B “I didn’t know what it was…I didn’t know if it was serious or not. I had no information as to what it was, or what it can do to you. I was in the dark about it, so I didn’t care either which way because I didn’t know what it would do to me. I had no knowledge of what it is, so, it didn’t bother me much, but I was worried about it.” (Patient) Patient motivation F “I like my life. I want to get treated as fast as possible. I don’t [want to] infect anybody else…I want to get it over with.” (Patient who had been a PWID) Breaking down the care cascade F “I’ll go and I’ll speak to them, and give them this packet, go over, we have a timeline, a breakdown of like, you sign papers this day, you get labs this day, your medication this day. Go over with them what the program looks like.” (Clinic Staff) Getting funding for treatment Cumbersome funding process B “I think one of the major delays still is the time required for the prescription assistance program to kick in.” (Clinic Staff) Medication coverage F “Once they get [MAP], their visits are covered and medication is covered through the pharmacy. So that definitely keeps them going…I have this coverage that's helping me get my medication, get my visits, so I'm here.” (Clinic Staff) Treatment initiated Characteristics of the PEH and PWID populations B “There's the obvious barriers with patients experiencing homelessness, a lot of times they have coexisting mental health issues, substance abuse issues...mak[ing] it harder to remember that you have an appointment or remember to take your meds or having somewhere to secure your medication. Their stuff gets stolen, they lose things, they don't have transportation, they don't have phones. All those things with the homeless population are a huge barrier.” (Clinic Staff) Medication replacement F “[The patient] lost some of his [medication]. But he showed up right away, and we were able to get the drug company to replace them quickly enough to where I don't think he missed very many days.” (Clinic Staff) Corollary care F “If you're on suboxone [buprenorphine]…you want to live longer…you want to stop hurting yourself. So, I think…a lot of people will say, I want to get clean and sober because I don't want to die or I want my body to be okay, I want my body to last. And so, I think it goes along with hep[atitis] C too. Like I want to take care of myself now.” (Patient) Care environment F “Everybody here, we have the same goals in mind for our patients, and really [want to] see them all succeed and get their treatment.” (Clinic Staff) End of first month Medication adherence B “…Reasons patients don't complete treatment and some do experience side effects and don't have anyone to talk to, or aren't willing to complete it and stop...” (Provider) “The reason that people miss doses, or just stop entirely, will be because of some sort of side effect. The majority of the time, they're not common side effects and I don't really know if they even are true side effects of the medication, or just kind of something that happened around the same time, and the patient is just saying that that's what it's from.” (Clinic Staff) Care coordination F “If we saw them…remember you got to come in this day for your appointment and for your hep[atitis] C meds, your second bottle’s due…if I ever saw them walk by I would always remind them.” (Clinic Staff) Patient-provider relationship F “Please call me, so that you don’t have to suffer alone.” (Clinic Staff) End of treatment Psychosocial resources F “At CareConnections clinic there’s more resources: a counselor, wound care nurse, a foot doctor…a social worker, and a community health worker.” (Provider) “For the access of everything that’s being offered on a day-to-day basis, food, social service, and any other specified services that one may need, on his medical situation, mental health.” (Patient at Sunrise) SVR12 Returning to the clinic for labs B “The single biggest reason for lack of SVR12 is the fact that patients don’t show up for the appointment. And I think that we as providers don’t do enough messaging on it, either. Most of us know that treatment completion labs, the last day of the treatment, portends treatment success, they’re highly correlated with SVR12.” (Provider) Patient motivation F “He tells me that I was cured. That I didn’t have [hepatitis C] anymore…That made me feel good! I achieved something…That’s the way I looked at it.” (Patient who achieved SVR12) A superscript B indicates a barrier and a superscript F indicates a facilitator. Supplementary Files AdditionalFile1.docx Cite Share Download PDF Status: Published Journal Publication published 17 Aug, 2023 Read the published version in Implementation Science Communications → Version 1 posted Editorial decision: Major revision 27 Jun, 2023 Reviewers agreed at journal 04 May, 2023 Reviewers invited by journal 01 May, 2023 Editor assigned by journal 04 Apr, 2023 First submitted to journal 03 Apr, 2023 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-2772126","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":196672935,"identity":"2704e0d8-c020-45b8-aba5-c15acc1009c6","order_by":0,"name":"Anmol 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15:06:39","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1010784,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003ePRISM Implementation Science Framework Adapted to the Erase Hep C study\u003c/em\u003e\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-2772126/v1/e958f746438063bee1aa8606.png"},{"id":36620100,"identity":"82304a4a-86c8-4dfd-a273-6651c3b7019b","added_by":"auto","created_at":"2023-05-04 15:06:39","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":1650462,"visible":true,"origin":"","legend":"\u003cp\u003eHep C Care Cascade Framework\u003c/p\u003e\n\u003cp\u003eColored squares represent actions that occur along each step of the care cascade: provider visits (light pink), labs (hot pink), medication pick-up (lavender), Medical Access Program (MAP) and Patient Assistance Program (PAP) processes (green), formal payor processes (turquoise), otherwise synonymous with traditional commercial payors, and other HCV actions (grey).\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-2772126/v1/714e9e83431d6c4b83eed7a4.png"},{"id":36620099,"identity":"295accbc-0ba3-4d4e-9ae0-6b283149bf99","added_by":"auto","created_at":"2023-05-04 15:06:39","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":857800,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eBarriers and Facilitators along the Hepatitis C Care Cascade\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eThe dots represent patient actions along the care cascade (blue), as also indicated in Figure 2, for which patients need to come for clinic visits (light pink), get labs (hot pink), and pick-up medication (lavender).\u003c/em\u003e\u003c/p\u003e","description":"","filename":"floatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-2772126/v1/42ec2c0a7059c416af273913.png"},{"id":36620324,"identity":"1a099abc-1263-4879-a2a5-e7a4c3a3f0f7","added_by":"auto","created_at":"2023-05-04 15:14:39","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":646396,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eThemes of Site-Specific Tasks Added along the Hep C Care Cascade by Clinic\u003c/em\u003e\u003c/p\u003e","description":"","filename":"floatimage4.png","url":"https://assets-eu.researchsquare.com/files/rs-2772126/v1/732e489517f2260fa2106afe.png"},{"id":44735713,"identity":"344fefda-45b6-4f39-be5a-971a01821f7b","added_by":"auto","created_at":"2023-10-16 22:27:03","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2906741,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-2772126/v1/4c9746d0-9c90-4b44-bd47-e425bf0b8889.pdf"},{"id":36620101,"identity":"827f2240-eeec-439f-97d8-7118c93262ed","added_by":"auto","created_at":"2023-05-04 15:06:41","extension":"docx","order_by":10,"title":"","display":"","copyAsset":false,"role":"supplement","size":22642,"visible":true,"origin":"","legend":"","description":"","filename":"AdditionalFile1.docx","url":"https://assets-eu.researchsquare.com/files/rs-2772126/v1/9b21cdc1e112c57f33840062.docx"}],"financialInterests":"","formattedTitle":"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","fulltext":[{"header":"Contributions to the Literature","content":"\u003cul\u003e\n \u003cli\u003eGlobal elimination of hepatitis C virus (HCV) requires expanding treatment and targeting vulnerable populations, including people experiencing homelessness (PEH) and people who inject drugs (PWID)\u003c/li\u003e\n \u003cli\u003eClinics serving PEH and PWID require simplified, site-specific HCV treatment protocols to improve patient HCV outcomes\u003c/li\u003e\n \u003cli\u003eObtaining a broad, multi-level perspective of barriers and facilitators to HCV treatment using qualitative methods grounded in an implementation science framework allows for design of site-specific HCV treatment protocols\u003c/li\u003e\n \u003cli\u003eWe offer a model for future implementation researchers to design contextualized care protocols for treating vulnerable populations in non-traditional clinic settings.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Background","content":"\u003cp\u003eChronic hepatitis C virus (HCV) infection affects 58\u0026nbsp;million people globally and 2.1\u0026nbsp;million people in the United States (US) (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). HCV incidence in the US is rising and remains a significant driver of liver-related morbidity and mortality (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). Among people experiencing homelessness (PEH), estimated HCV prevalence is more than 30%, though estimates are often underreported (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). The prevalence of HCV is 31% among those seeking care at Health Care for the Homeless (HCH) clinics, and 70% among those seeking care at HCH clinics who inject drugs (PWID) (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eDespite direct acting antivirals (DAAs) and a simplified HCV treatment algorithm with a\u0026thinsp;\u0026gt;\u0026thinsp;97% cure rate, only a minority of the total population living with chronic HCV, who are aware of their status, has access to care (43%) or has been prescribed HCV treatment (16%) (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). In particular, access to treatment among vulnerable populations remains low (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Access to treatment is obstructed by patient-level and systemic barriers, including misconceptions about HCV treatment, a limited number of experienced HCV providers in primary care clinics, payor restrictions, and overly complex organizational workflows (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eTo increase access to treatment among PEH and PWID, clinics that serve these vulnerable populations urgently need locally adapted and contextualized protocols that use DAAs and the simplified treatment algorithm, while addressing patient and systemic barriers to, and facilitators of, HCV care. The purpose of this first phase of the Erase Hep C study was to utilize qualitative research methods guided by an implementation science framework combined with human-centered design thinking, to develop site-specific HCV treatment protocols by identifying and reducing barriers and leveraging facilitators of HCV care.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003eThe Practical, Robust Implementation and Sustainability Model (PRISM) framework informed development of semi-structured qualitative interview guides to identify multi-level contextual barriers and facilitators to HCV treatment in our community health center (CHC) system\u0026rsquo;s high-risk, vulnerable patient population (Fig.\u0026nbsp;1) (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e).\u003c/p\u003e \u003cdiv id=\"Sec4\" class=\"Section3\"\u003e \u003ch2\u003e[FIGURE 1 HERE]\u003c/h2\u003e \u003cp\u003e \u003cem\u003eFigure 1: PRISM Implementation Science Framework Adapted to the Erase Hep C study\u003c/em\u003e \u003c/p\u003e \u003cp\u003eWe leveraged knowledge and experience from patients diagnosed with HCV, clinic staff and providers, our CHC system\u0026rsquo;s leadership, and community-based organizations providing HCV testing and linkage to care, to inform design and implementation of simplified, site-specific HCV treatment protocols. We chose interviews over focus groups to elicit individual level perspectives about organizational structures and identify tasks that individuals perform. Interviews allowed people to speak freely and independently, which would have been affected by power dynamics in a focus group setting.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eSetting\u003c/h2\u003e \u003cp\u003eQualitative interviews were conducted in seven primary care clinics within our CHC\u0026rsquo;s HCH program and among external organizations that engage in the community to provide HCV testing and linkage to care. The clinics included: 1) a full-spectrum clinic located within the Austin Resource Center for the Homeless (ARCH) shelter (\u0026ldquo;the ARCH Clinic\u0026rdquo;); 2) a patient-centered brick-and-mortar clinic providing full-spectrum care for PEH as well as other medically complex and socially vulnerable patients following hospital discharge (\u0026ldquo;Care Connections\u0026rdquo;); 3) a clinic dedicated to providing Medication Assisted Therapy (MAT) to individuals with Opioid Use Disorder (\u0026ldquo;the MAT Clinic\u0026rdquo;); 4) a clinic located at Community First! Village (CFV), a permanent supportive housing community for individuals who were formerly chronically homeless (\u0026ldquo;the CFV Clinic\u0026rdquo;); 5) a clinic located at a state-sanctioned encampment for PEH that is becoming a transformational shelter complex (\u0026ldquo;the Esperanza Clinic\u0026rdquo;); 6) a full-spectrum clinic space set-up within Sunrise Church, providing care alongside other partners of the Sunrise Homeless Navigation Center non-profit that serves PEH in Austin (\u0026ldquo;Sunrise\u0026rdquo;); and 7) a street medicine team bringing care to PEH at homeless campsites and under bridges (\u0026ldquo;the Street Team\u0026rdquo;). The Mobile Team operates three of these HCH clinic sites: CFV, Esperanza, and Sunrise. These HCH clinics serve people currently or previously having experienced homelessness, or people who inject drugs (PWID), providing both primary care and connection to a variety of social resources.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eParticipants\u003c/h2\u003e \u003cp\u003eWe interviewed a total of 42 people, made up of 28 clinic staff and providers, 10 patients diagnosed with HCV, and 4 staff from external organizations that screen or link patients with HCV to care. A purposive, convenience sample was used to engage patients and clinic staff across all levels of our CHC. We asked providers and staff to recommend patients with HCV, from treatment na\u0026iuml;ve to having achieved cure, who would be willing to participate in our interviews.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eA trained research coordinator and research assistant conducted thirty to sixty-minute audio-recorded interviews in person and over Zoom. Interviews were conducted between September and November 2021. Participants were asked about the process to initiate HCV treatment, challenges to starting and completing treatment, and facilitators of treatment adherence and completion. Staff, providers, and leadership were also asked about their role in the process of HCV care for patients. If additional and relevant information surfaced, conversations progressed beyond the semi-structured interview guides. At the end of each interview, the participants were asked demographic questions. We conducted interviews until we reached thematic saturation of data and perspectives. Data collected from the interviews were supplemented with observations and discussions of clinic processes with clinic teams at each clinic site that were conducted in July 2021.\u003c/p\u003e \u003cp\u003e Written consent was obtained from participants, either in person or digitally. Participants were compensated \u003cspan\u003e$\u003c/span\u003e10 worth for being interviewed. Signed consent forms, audio-recordings, and transcribed interviews were all stored on Box, a HIPAA-compliant cloud storage system. This study was approved by the Institutional Review Board at the University of Texas at Austin and the Research and Quality Improvement Committee at CommUnityCare community health centers.\u003c/p\u003e \u003cp\u003eThe research team consisted of a research coordinator with extensive experience in global health fieldwork conducting large-scale nationally representative population and public health surveys; a research assistant with experience in HCV, qualitative research, and implementation science research; Co-Primary Investigators with extensive qualitative, implementation science research, and field epidemiology experience; and a Co-Investigator who is a hepatologist, HCV expert, and health services researcher. The research team also included several CHC providers to provide context on treating vulnerable populations within these CHC clinic sites. This research was reported based on the Standards for Reporting Qualitative Research (SRQR) guidelines (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e) (Additional File 1).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eData analysis\u003c/h2\u003e \u003cp\u003eAll 42 interviews were transcribed verbatim, using a combination of Zoom transcription services and manual transcription, and anonymized for thematic analysis using NVivo 1.5.1 (QSR International, Burlington, Massachusetts). A dual analytic approach was used. First, qualitative thematic descriptive and interpretive coding, informed by our PRISM framework, was used to ensure each level of the framework was addressed in analysis. Second, a human-centered design thinking approach was utilized, focusing on the utility of the multi-level perspective data to design site-specific, simplified HCV treatment protocols at primary care clinics within our CHC\u0026rsquo;s HCH program.\u003c/p\u003e \u003cp\u003eTwo coders iteratively collaborated to define codes, finalize the codebook, highlight themes and subthemes of the barriers and facilitators, and identify relationships between themes. Themes focused on HCV treatment access at both the patient and clinic level, clinic processes both external and internal to the CHC system (e.g., across departments and other healthcare systems), and characteristics of the external environment that impact HCV patient outcomes. The codebook development was a hierarchical process with constant comparison, refinement of codes, and merging of existing codes (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Coders initially conducted deductive code development, starting with a list of initial codes we expected to see emerge, based on our observations and guided tours of the clinical sites (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). Coders entered the first round of coding with this initial codebook, in which they individually read and coded the same three transcripts. The coders came together to discuss, negotiate, and revise the codes. The coders then went on to code an additional five different transcripts and conducted a second round of discussion and revision. Transcripts coded in these first two rounds of coding were randomly selected to capture a wide scope of roles to develop the most representative codebook. The final code structure was developed by consensus after coding the remaining transcripts and by applying the perspectives and characteristics of the PRISM framework throughout (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eDesign Workshops\u003c/h2\u003e \u003cp\u003eFindings from qualitative interviews were fed into iterative, site-specific design workshops held with clinic staff to adapt the simplified treatment algorithm into actionable, site-specific HCV protocols integrated within existing clinic workflows. A total of nine site-specific workshops were held over two iterations, with the Mobile Team discussing the three mobile sites as a collective (CFV, Esperanza, and Sunrise).\u003c/p\u003e \u003cp\u003eThe first iteration of workshops discussed findings from the qualitative interviews with respondent validation and prioritization of barriers to address and facilitators to leverage with the site-specific protocols. In preparation for the second iteration of workshops, providers and clinical leads simplified the HCV care cascade workflow (Fig.\u0026nbsp;2). Driven by the evidence-based simplified treatment algorithm, tasks no longer necessary were collapsed and removed, to define the HCV care cascade framework from diagnosis to cure.\u003c/p\u003e \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e \u003ch2\u003e[FIGURE 2 HERE]\u003c/h2\u003e \u003cp\u003e \u003cem\u003eFigure 2: Hep C Care Cascade Framework\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003eColored squares represent actions that occur along each step of the care cascade: provider visits (light pink), labs (hot pink), medication pick-up (lavender), Medical Access Program (MAP) and Patient Assistance Program (PAP) processes (green), formal payor processes (turquoise), otherwise synonymous with traditional commercial payors, and other HCV actions (grey).\u003c/em\u003e \u003c/p\u003e \u003cp\u003e In the second workshop, this care cascade framework was presented to and adapted for each site, considering their patient populations, non-traditional clinical environments, staffing ratios, and clinical workflows. Subsequently, the actionable solutions to mitigate the biggest barriers that were identified in the first workshop were layered onto the workflow. Clinic teams increased staff accountability by assigning ownership of each task to a role, with task sharing or role duplication to fit the flexibility and dynamic environment of each clinic. The actionable solutions addressed barriers and leveraged facilitators found across multiple PRISM perspectives and characteristics.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eParticipant demographics\u003c/h2\u003e \u003cp\u003eForty-two participants were interviewed. Twenty-eight were clinic staff and leadership, including front-line clinical staff from each clinical site, as well as representatives from the referrals department, pharmacy department, and social and financial services departments (Table\u0026nbsp;1). We also interviewed four providers and system-level staff from other organizations in Austin, Texas who screen and link people diagnosed with HCV and PEH to care. Ten patients were interviewed who were at different points along the HCV care cascade. Patients ranged from being treatment na\u0026iuml;ve to having been cured. Of those interviewed, 40% were currently experiencing homelessness and 80% reported having injected drugs.\u003c/p\u003e \u003cdiv id=\"Sec13\" class=\"Section3\"\u003e \u003ch2\u003e[TABLE 1 HERE]\u003c/h2\u003e \u003cp\u003e \u003cem\u003eTable\u0026nbsp;1: Distribution of clinic and system-level staff interviewed\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eAnchoring barriers and facilitators along the hepatitis C care cascade\u003c/h2\u003e \u003cp\u003eBy identifying barriers and facilitators to HCV care, clinic teams were able to conceptualize actionable solutions to barriers and leverage existing facilitators when designing the site-specific HCV treatment protocols. Barriers and facilitators were identified considering patient, clinic, provider, system, and external environmental characteristics and perspectives. The barriers and facilitators were anchored to every step along the HCV care cascade they impact, from diagnosis to confirmation of cure by sustained virologic response 12 weeks post-treatment (SVR12) (Fig.\u0026nbsp;3). Some barriers and facilitators affected multiple steps along the HCV care cascade and others were unique to specific steps.\u003c/p\u003e \u003cdiv id=\"Sec15\" class=\"Section3\"\u003e \u003ch2\u003e[FIGURE 3 HERE]\u003c/h2\u003e \u003cp\u003e \u003cem\u003eFigure 3: Barriers and Facilitators along the Hepatitis C Care Cascade\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003eThe dots represent patient actions along the care cascade (blue), as also indicated in Fig.\u0026nbsp;2, for which patients need to come for clinic visits (light pink), get labs (hot pink), and pick-up medication (lavender).\u003c/em\u003e \u003c/p\u003e \u003cp\u003eCommon themes at the patient level centered around the nature of the PEH and PWID populations, including transience, being vulnerable to theft, low health literacy, and difficulty adhering to medication and returning to the clinic for follow up testing. Clinic and system level themes encompassed operational processes, including tracking patients who miss critical appointments, transporting medication to patients, enabling medication adherence, patient HCV knowledge, and failure to follow-up with patients for SVR12 laboratory tests confirming cure. Partnerships with external organizations facilitated the HCV treatment process by helping to find patients, aiding in building trust with the care team, taking medication out to patients, or drawing blood for laboratory tests. Table\u0026nbsp;2 provides illustrative excerpts of these themes, gathered from our interviews.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section3\"\u003e \u003ch2\u003e[TABLE 2 HERE]\u003c/h2\u003e \u003cp\u003e \u003cem\u003eTable\u0026nbsp;2: Themes of Barriers and Facilitators identified along the Hepatitis C Care Cascade, with Illustrative Excerpts from Staff and Patient Interviews\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003eA superscript\u003c/em\u003e \u003csup\u003e \u003cem\u003eB\u003c/em\u003e \u003c/sup\u003e \u003cem\u003eindicates a barrier and a superscript\u003c/em\u003e \u003csup\u003e \u003cem\u003eF\u003c/em\u003e \u003c/sup\u003e \u003cem\u003eindicates a facilitator.\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eGiven diagnosis and offered treatment\u003c/h2\u003e \u003cdiv id=\"Sec18\" class=\"Section3\"\u003e \u003ch2\u003eBarriers\u003c/h2\u003e \u003cp\u003eSeveral barriers centered around providers\u0026rsquo; own comfort level in treating HCV, or in assessing treating PEH and PWID, assuming either they would not be able to adhere to treatment or would get re-infected, assumptions stemming from the stigma surrounding PEH and PWID. Among providers who are comfortable treating HCV in this population, treatment may not be offered if they are experiencing provider overload, may not have sufficient time for educating patients, or may need to prioritize other acute medical needs.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;In the patient population that I was serving, some of that preventative care, when you triage how important it was, it wasn't as important as keeping them alive and out of the hospital\u0026hellip;if you're constantly putting out a fire it's hard to get to the preventative side of the care.\u0026rdquo; (Provider)\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eLack of access to easy, comfortable, and reliable transportation and inability to contact patients due to low phone ownership were the most commonly reported obstacles to care, beginning with receiving an HCV diagnosis, and at every stage of clinic-patient interaction. Low phone ownership results in patients not receiving appointment reminders or an inability to reschedule missed appointments. Missing clinic follow up visits are barriers to completing diagnostic laboratory tests or receiving an HCV diagnosis.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section3\"\u003e \u003ch2\u003eFacilitators\u003c/h2\u003e \u003cp\u003eAmong patients who do not have phones, clinics collaborate with case managers and Emergency Medical Services (EMS) Community Health Paramedics (CHPs) to locate patients to encourage them to keep their appointments and come to the clinic, so they can receive their diagnosis in a timely manner. Providers set the patient up for success by determining patient readiness prior to offering treatment.\u003c/p\u003e \u003cp\u003eOperational facilitators include the use of an HCV group on the clinic\u0026rsquo;s HIPAA compliant communication platform, on which providers can message other providers who treat HCV and get timely answers to case-based questions or readily available consultations with hepatology specialists. Additionally, having on-site laboratory testing reduces the likelihood of patients leaving the clinic without getting the necessary labs drawn to offer treatment.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eTreatment accepted\u003c/h2\u003e \u003cdiv id=\"Sec21\" class=\"Section3\"\u003e \u003ch2\u003eBarriers\u003c/h2\u003e \u003cp\u003eSeveral barriers to accepting treatment are a function of the nature of this population, such as patients not feeling ready, low health literacy, competing medical priorities, and living with untreated mental health conditions and/or substance use disorders, resulting in patients not returning to the clinic to accept treatment. Accepting treatment can be a common drop off point for patients who are asymptomatic and feel that they do not need treatment, or who have other competing psychosocial priorities, or face additional barriers to remaining engaged in care.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section3\"\u003e \u003ch2\u003eFacilitators\u003c/h2\u003e \u003cp\u003eStrong social networks can move patients towards undergoing treatment in numerous ways, such as friends who encourage them to get treated, friends informing them that treatment is easy and within reach, a patient wanting to prove to family members they are taking responsibility for their health, watching loved ones with HCV suffer or die.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;I said yeah, I got to look into this and get [my hepatitis C] cured. I\u0026rsquo;m not ready to die. (Patient who reached SVR12)\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eEducating patients on the consequences of untreated HCV increases their motivation to get cured. Providers and care coordinators can make the treatment regimen more acceptable to patients by making it more manageable for them, breaking down the care cascade into discrete pieces, and working with patients to create a specific plan for treatment and medication storage.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec23\" class=\"Section2\"\u003e \u003ch2\u003eGetting funding for treatment\u003c/h2\u003e \u003cdiv id=\"Sec24\" class=\"Section3\"\u003e \u003ch2\u003eBarriers\u003c/h2\u003e \u003cp\u003eThe majority of patients treated at CHC HCH sites lack health insurance. Patients on the county-based Medical Access Program (MAP) for the uninsured, which includes many PEH and PWID, commonly experience unnoticed lapses in coverage, which interferes with completion of requisite medical appointments or laboratory tests prior to initiating treatment. For patients covered by MAP, their DAA medications must be covered by the prescription access program (PAP), which is through a separate application process from MAP. Completing necessary PAP paperwork can be cumbersome and confusing to some patients who may conflate one assistance program for another. Verifying information for this paperwork, such as getting a letter of no income or proof of residency, can be tough, given how difficult it is for this population to return to clinic, unreliable communication methods, and lack of necessary identification or income documentation. Additionally, the strict requirements of prescription assistance programs can impede access to funding for treatment. While patients on Medicare or Medicaid are not eligible for PAP, they do have access to DAAs under these programs. However, this access often requires prior authorization or other bureaucratic steps that are confusing and time-consuming for providers, and can delay access to treatment for patients.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec25\" class=\"Section3\"\u003e \u003ch2\u003eFacilitators\u003c/h2\u003e \u003cp\u003eClinic staff make the funding paperwork process easier for patients by getting patients\u0026rsquo; signatures and information at the time of treatment acceptance. Though MAP does not cover the cost of medication, it covers medical care and labs, and serves as a facilitator to medication access by guaranteeing patients\u0026rsquo; DAAs are covered by prescription assistance programs. On the operational side, specifying which labs are required by each payor and ensuring this information is known and shared across clinic providers and clinic staff further streamlines the funding application process.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec26\" class=\"Section2\"\u003e \u003ch2\u003eTreatment initiated\u003c/h2\u003e \u003cdiv id=\"Sec27\" class=\"Section3\"\u003e \u003ch2\u003eBarriers\u003c/h2\u003e \u003cp\u003eOnce a diagnosis is received, low health literacy can impact a patient initiating treatment and adhering to medication. PEH and PWID often experience competing medical priorities, reducing the likelihood of sensing any urgency to undergo treatment for their HCV or pickup medication. Alternatively, patients who are motivated to initiate treatment face transportation and communication obstacles to get to clinic to pick up their medication.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec28\" class=\"Section3\"\u003e \u003ch2\u003eFacilitators\u003c/h2\u003e \u003cp\u003eInitiating treatment is facilitated by clinic staff collaborating with the pharmacy department and external partners to improve patient access, by either couriering medication to locations patients can readily access, for example, the clinic they prefer to go to, or through direct delivery to patients by members of the Street Team, Mobile Team, or Community Health Workers.\u003c/p\u003e \u003cp\u003ePatient oriented care, here defined by active encouragement and support of patients by clinic staff, facilitates acceptance and initiation of treatment by building confidence and bolstering engagement in care throughout the care cascade. Co-locating HCV treatment with corollary care, such as medication assisted treatment with buprenorphine for opioid use disorder, or by co-locating clinics where psychosocial resources, which are perceived as more pressing needs such as free meals or applying for housing, are being provided, increases the likelihood of patients engaging with clinics, including picking up their HCV medication and getting labs drawn.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec29\" class=\"Section2\"\u003e \u003ch2\u003eEnd of first month\u003c/h2\u003e \u003cdiv id=\"Sec30\" class=\"Section3\"\u003e \u003ch2\u003eBarriers\u003c/h2\u003e \u003cp\u003eOnce a patient receives funding for treatment, clinic operations may raise barriers to patients\u0026rsquo; ability to adhere to their medication regimen or get necessary labs drawn. For example, patients may be confused about where to pick up their medication, especially if they frequent more than one HCH clinics or the pick-up location is not their usual clinic, or they may not understand the importance of communicating with their provider about side effects or perceived side effects. Furthermore, the long wait times of the CHC\u0026rsquo;s centralized call center makes it hard for patients to connect directly with an individual clinic. As a result, patients may decide to stop taking their medication on their own if they experience side effects and if they cannot or do not connect with their medical team in a timely manner.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec31\" class=\"Section3\"\u003e \u003ch2\u003eFacilitators\u003c/h2\u003e \u003cp\u003eAt the clinic level, staff and providers take many actions to facilitate patients reaching this point in the care cascade, including offering mid-way check-in appointments, giving patients the opportunity to start treatment when they are ready, and emphasizing the importance of medication adherence. Rapid replacement of lost or stolen medications through PAP programs provides additional external support to medication adherence.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;I do also try to address one of the 2 or 3 contingencies that come up, namely, it\u0026rsquo;s very common with patients, especially at Care Connections, if you lose your medicines \u0026ndash; if you do, please don\u0026rsquo;t wait until the next appointment to tell me, please come here right away and we\u0026rsquo;ll talk to the drug company and usually we\u0026rsquo;ll get you a new bottle. So, I talk about that contingency. I talk about if [their medication] gets lost or stolen.\u0026rdquo; (Clinic Staff)\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eAdditionally, strengthening the patient and provider relationship while continuously providing support may increase patient communication with the clinic. The consistency of the Mobile Team\u0026rsquo;s location schedule increases the likelihood of walk-ins to clinics that are walk-in based, since patients will know when and where the clinic will be, especially important for patients without phones. The HCH clinics\u0026rsquo; flexibility with scheduling and lateness allows patients to feel comfortable calling or coming into clinic if they experience side effects before stopping medication.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec32\" class=\"Section2\"\u003e \u003ch2\u003eEnd of treatment\u003c/h2\u003e \u003cdiv id=\"Sec33\" class=\"Section3\"\u003e \u003ch2\u003eBarriers\u003c/h2\u003e \u003cp\u003ePatient level barriers to completing treatment are centered around low health literacy, lapses in medication adherence, and failure to return to the clinic for end of treatment (EOT) labs. Additionally, lack of safe storage to prevent medication loss or theft, frequent jail or hospital stays, and late medication refills can result in adherence lapses or prevent patients from completing treatment.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;They're experiencing homelessness, they lose their medication, their medication gets stolen.\u0026rdquo; (Clinic Staff)\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec34\" class=\"Section3\"\u003e \u003ch2\u003eFacilitators\u003c/h2\u003e \u003cp\u003eThe same facilitators to medication access and patient engagement in initiating treatment are leveraged by clinics and staff to help patients adhere to their medication and reach treatment completion.\u003c/p\u003e \u003cdiv id=\"Sec35\" class=\"Section4\"\u003e \u003ch2\u003eSVR12\u003c/h2\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec36\" class=\"Section3\"\u003e \u003ch2\u003eBarriers\u003c/h2\u003e \u003cp\u003eThe need for laboratory tests to assess SVR12 to determine cure is not always understood by patients with low health literacy, so they do not return to clinic to get the blood drawn for laboratory tests. Patients who do understand the importance of SVR12 labs, may not always remember to come back for labs. Additionally, some providers may not sufficiently emphasize the importance of the SVR12 labs, knowing there is a high correlation of earlier undetectable viral loads with cure.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;But for people that have finished treatment, a lot of it has to do with the stability of their social setting. Because it\u0026rsquo;s hard to remember to come back 3 months after you\u0026rsquo;ve finished treatment to get labs drawn when you\u0026rsquo;re still out on the streets.\u0026rdquo; (Clinic Staff)\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec37\" class=\"Section3\"\u003e \u003ch2\u003eFacilitators\u003c/h2\u003e \u003cp\u003eFor some patients, motivation to verify HCV cure drives completion of SVR12 labs. For clinics, getting SVR12 labs is made easier by providers ordering SVR12 labs ahead of time, so they can be completed whenever the patient next comes into the clinic beyond three months of completing treatment. Staff celebration of patient wins such as HCV cure boosts morale of both patients and staff.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec38\" class=\"Section2\"\u003e \u003ch2\u003eIncorporating qualitative findings into site-specific protocol design workshops\u003c/h2\u003e \u003cp\u003eThese qualitative findings were incorporated into the human-centered design workshops to design site-specific, simplified treatment protocols. Even though our HCV care cascade starts at diagnosis, once the patients is in the clinic after screening, diagnosis, and linkage to care, numerous barriers to getting the patient into the clinic, as well as linking them to care were identified in the first workshops. During the design workshops, clinic teams focused on operational clinic-level barriers they had the ability to modify. Not all barriers, such as a patient going to jail or being hospitalized while on treatment, and losing access to their medication as a result, could be modified by clinic staff. Existing facilitators informed actions to leverage and emphasize, while modifiable barriers invited opportunities to propose solutions to be incorporated into the site-specific treatment protocols.\u003c/p\u003e \u003cp\u003eThe protocol variations across sites were operational differences in how teams accomplish tasks and who takes ownership of the tasks along the care cascade, taking into consideration varying staffing ratios, physical spaces, team dynamics, and characteristics of the patients that frequent each site. Actionable solutions incorporated into each site-specific protocol pertained to patient education, tracking patients along the care cascade, improving medication access and adherence, and ensuring patients return for necessary labs (Fig.\u0026nbsp;4). The Mobile Team designed a singular protocol for all the three mobile sites (CFV, Esperanza, and Sunrise).\u003c/p\u003e \u003cdiv id=\"Sec39\" class=\"Section3\"\u003e \u003ch2\u003e[FIGURE 4 HERE]\u003c/h2\u003e \u003cp\u003e \u003cem\u003eFigure 4: Themes of Site-Specific Tasks Added along the Hep C Care Cascade by Clinic\u003c/em\u003e \u003c/p\u003e \u003cp\u003eClinic teams incorporated medication adherence counseling by ensuring patient HCV education was woven into the workflows. Following patients along the HCV care cascade also aids in ensuring patients\u0026rsquo; medication access and adherence, which was especially emphasized on the Mobile and Street Teams workflows. Clinics incorporated a variety of methods to start tracking patients after treatment has been accepted such as augmented existing staff roles to leverage existing facilitators and optimize patient access to medications. All the clinic teams, except the ARCH clinic which has a care coordinator, chose to leverage the pre-existing resource of the CHC\u0026rsquo;s Sexual Health Team\u0026rsquo;s patient navigators (SHNs) to support patients through prescription access programs to obtain medications for uninsured patients. Care coordination and education helps patients remain engaged in care with the single goal of being cured.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003e This qualitative study identified barriers and facilitators to HCV treatment at primary care clinics within our local community health center\u0026rsquo;s HCH program to inform the design of simplified, site-specific HCV treatment protocols for serving vulnerable populations in Austin, Texas. Barriers and facilitators to each step along the care cascade were identified, in order to reduce their negative impact or leverage their positive contribution to care. Participants were interested in contributing as study goals melded with clinic objectives to improve care for people with HCV, especially among PEH and PWID.\u003c/p\u003e \u003cp\u003eBarriers encountered at each step along the care cascade are a result of the vulnerabilities uniquely experienced by this population, such as competing priorities, untreated mental health conditions and/or substance use disorders, living environment, unreliable communication, and inability of mental capacity to sufficiently plan to seek care in the face of unreliable transportation, where patients experience stigmatizing behavior, as also demonstrated in other studies (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). All these characteristics of the population conspire to result in high \u0026ldquo;no show\u0026rdquo; rates amongst this population, that can compromise patient care when patients miss their appointments and do not receive an HCV diagnosis, pick up medications, or complete laboratory tests (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThough studies have shown that 40% of people are unaware of their HCV status, our results demonstrate that patients often do know their HCV status but face a host of barriers that can result in patients not seeking care despite knowing their status including not knowing that treatment is available and accessible to them (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan additionalcitationids=\"CR17\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). Actionable solutions to further bolster engagement in treatment clustered around enhancing and streamlining patient education, facilitating medication access, and care coordination. Actionable solutions added to the care cascade spanned across all PRISM domains, from system-level collaboration with other departments within our community health center (e.g., SHNs) to working with external community partners (e.g., EMS) who are key stakeholders to facilitate medication access (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). Clinics without a dedicated care coordinator augmented existing clinic roles and incorporated utilizing SHNs into their protocols to help track and support patients throughout the care cascade. For some patients, high motivation for HCV treatment is a significant contributor to overcoming these barriers.\u003c/p\u003e \u003cp\u003eDespite these barriers, social resources co-located with the clinics and corollary care (e.g., buprenorphine for opioid use disorder), compounded by the supportive clinical environment, motivate patients to return to clinic at all steps along the care cascade (\u003cspan additionalcitationids=\"CR19\" citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). Existing operational facilitators to creating a supportive care environment include being patient-oriented, teamwork, strong communication, and flexibility among and across clinics. Clinics do not turn away patients who are late, accept patients who walk-in and utilize a standby list, set up clinics at various locations around town, and collaborate with external organizations, such as the EMS CHPs, to not only be on the lookout for patients but also meet the patients where they are (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThrough interviews and human-centered workshops, we obtained a multi-level perspective across an expansive breadth of clinics not yet discussed together in literature. Anchoring the barriers and facilitators along the HCV care cascade allowed the clinic teams to identify actionable solutions to break down barriers. The end of the first month was noted as a critical point in the HCV care cascade where both barriers and facilitators were most quantifiably weighted. Several barriers that were frequently identified in interviews and workshops have been obviated by the simplified treatment algorithm itself, which removed some steps that had earlier been required and were often difficult for this population in particular to accomplish, such as requiring appointments and labs at the end of the first month of treatment (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eStressing the importance of coming back to have SVR12 labs drawn to determine cure was emphasized in the workshops as an important step in the care cascade that could be facilitated by the support of clinic staff and availability of on-site laboratory testing (\u003cspan additionalcitationids=\"CR19\" citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). There was an identified need to increase HCV patient knowledge on the importance of SVR12 labs or calling the clinic when experiencing side effects before stopping medication to increase patients reaching cure (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). Increasing patient knowledge includes continuing to make each step as easy as possible for the patients by leveraging how providers break down medical care into bite size pieces for the patients to better understand treatment and the vital steps of the process since many patients are motivated by seeing they have been cured (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e).\u003c/p\u003e \u003cdiv id=\"Sec41\" class=\"Section2\"\u003e \u003ch2\u003eValue of a human-centered design approach\u003c/h2\u003e \u003cp\u003eBy taking a ground-up systematic approach, rather than a top-down approach across all sites, each clinic team and staff were empowered to provide input into designing their own site-specific protocols. Inviting staff across all roles to participate in their site-specific design workshops to co-design the simplified, site-specific protocols garnered buy-in and ownership of the protocols at each site. Buy-in was also garnered by the study team\u0026rsquo;s interest in observing and understanding clinic processes, and building relationships with clinic teams by their presence in clinic, in preparation for the second phase of the study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec42\" class=\"Section2\"\u003e \u003ch2\u003eLimitations\u003c/h2\u003e \u003cp\u003eOur study has its limitations. There was the risk of clinic staff being hesitant to fully disclose and discuss operational barriers for fear that supervisors or teammates would prefer not to disclose some of the barriers. To encourage staff to be forthcoming, interviews were conducted in private spaces, out of ear shot of others, and staff were assured that information would be anonymized. Study staff spent time in clinic, to observe and learn clinic practices, build relationships, and communicate the intent of the study so clinic staff can be more comfortable engaging in more open and honest dialogue. Additionally, due to the COVID-19 pandemic, interviews required flexibility and participants were offered in-person or virtual interviews. As the gold standard, in-person interviews allow for a wider read of body language, which may be more limited in virtual interviews conducted over Zoom. On the other hand, offering remote interviews may have led to a higher response rate among those who preferred a remote interview. Despite some staff in non-provider roles attesting during interviews or design workshops to having limited or no knowledge of HCV and the HCV treatment process, they were usually able to draw on their experience with general treatment processes and caring for this particular patient population to offer information and perspectives that were applicable to the HCV treatment process as well.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusions","content":"\u003cp\u003eThough HCV treatment by primary care providers has been proven effective, hesitancy to treat PEH and PWID remains a barrier to treating this population and eliminating HCV worldwide (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). The Erase Hep C study aims to minimize this barrier and make HCV treatment more accessible locally to high-risk, vulnerable patient populations, and easier to incorporate into busy, primary care provider workflows, including in non-traditional clinic settings. We describe a method to incorporate staff and patient knowledge and experience to design contextualized HCV protocols for treating vulnerable populations in non-traditional clinic settings. Through a collaborative approach, these protocols will be integrated into clinic workflows and providers will be trained on simplified HCV treatment. In the second phase of the Erase Hep C study, the site-specific protocols developed in the design workshops will be implemented and patients will be enrolled into our single-arm trial with the aim of at least 75% of our study participants achieving SVR12. Ultimately, this approach could serve as a model for future implementation research aiming to develop and implement contextualized treatment models for other conditions in vulnerable populations.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eCareCo: Care Connections Clinic\u003c/p\u003e\n\u003cp\u003eCFV: Community First! Village\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCHC: community health center\u003c/p\u003e\n\u003cp\u003eCHP: Community Health Paramedic\u003c/p\u003e\n\u003cp\u003eCHW: Community Health Worker\u003c/p\u003e\n\u003cp\u003eDAA: direct acting antivirals\u003c/p\u003e\n\u003cp\u003eEMS: Emergency Medical Services\u003c/p\u003e\n\u003cp\u003eEOT: end of treatment\u003c/p\u003e\n\u003cp\u003eHCH: Health Care for the Homeless\u003c/p\u003e\n\u003cp\u003eHCV: Hepatitis C virus\u003c/p\u003e\n\u003cp\u003eLCSW: Licensed Clinical Social Worker\u003c/p\u003e\n\u003cp\u003eMA: Medical Assistant\u003c/p\u003e\n\u003cp\u003eMAC: Medical Administrative Clerk\u003c/p\u003e\n\u003cp\u003eMAP: Medical Access Program\u003c/p\u003e\n\u003cp\u003eMAT: Medication Assisted Therapy\u003c/p\u003e\n\u003cp\u003ePAP: Patient Assistance Program\u003c/p\u003e\n\u003cp\u003ePEH: people experiencing homelessness\u003c/p\u003e\n\u003cp\u003ePRISM: Practical, Robust Implementation and Sustainability Model\u003c/p\u003e\n\u003cp\u003ePWID: people who inject drugs\u003c/p\u003e\n\u003cp\u003eRN: Registered Nurse\u003c/p\u003e\n\u003cp\u003eSHN: Sexual Health Navigator\u003c/p\u003e\n\u003cp\u003eSRQR: Standards for Reporting Qualitative Research\u003c/p\u003e\n\u003cp\u003eUS: United States\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis first phase of the Erase Hep C study was approved by the University of Texas at Austin\u0026rsquo;s Institutional Review Board, as well as CommUnityCare\u0026rsquo;s Research and Quality Improvement Committee. Written voluntary informed consent was obtained from study participants for the qualitative interviews.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eQualitative interview guides can be made available upon request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThere are no financial or competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe Erase Hep C study is funded by an investigator sponsored research grant from Gilead Sciences, Inc. The content is solely the responsibility of the authors. The trial sponsor is The University of Texas at Austin Dell Medical School.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor\u0026rsquo;s contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAD and KR conducted the interviews, qualitative analysis, and coordinated and facilitated design workshops. CB, MS, AK, and TM reviewed the HCV care cascade, as clinic leads. All authors contributed to the writing of this manuscript. All authors approved the final version.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank CommUnityCare for their input as our clinical partner, as well as patients and staff.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor\u0026rsquo;s information\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAnmol Desai, MPH, Email: [email protected] \u003c/p\u003e\n\u003cp\u003eLauren O\u0026rsquo;Neal, MPH, Email: [email protected] \u003c/p\u003e\n\u003cp\u003eKia Reinis, PhD, Email: [email protected] \u003c/p\u003e\n\u003cp\u003eCristal Brown, MD, MHS, Email: [email protected] \u003c/p\u003e\n\u003cp\u003eMichael Stefanowicz, DO, Email: [email protected] \u003c/p\u003e\n\u003cp\u003eAudrey Kuang, MD, Email: [email protected] \u003c/p\u003e\n\u003cp\u003eDeepak Agrawal, MD, MPH, MBA, Email: [email protected] \u003c/p\u003e\n\u003cp\u003eDarlene Bhavnani, PhD, MPH, Email: [email protected] \u003c/p\u003e\n\u003cp\u003eTim Mercer, MD, MPH*, Email: [email protected] \u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eWorld Health Organization. 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Qualitative Research Methods: Collecting Evidence, Crafting Analysis, Communicating Impact. UK: John Wiley \u0026amp; Sons, Ltd; 2013.\u003c/li\u003e\n\u003cli\u003ePadgett DK. Qualitative and Mixed Methods in Public Health. Thousand Oaks: SAGE Publications, Inc.; 2014.\u003c/li\u003e\n\u003cli\u003eMasson CL, Fokuo JK, Anderson A, Powell J, Zevin B, Bush D, et al. Clients\u0026apos; perceptions of barriers and facilitators to implementing hepatitis C virus care in homeless shelters. BMC Infect Dis. 2020;20(1):386.\u003c/li\u003e\n\u003cli\u003eU.S. Department of Health and Human Services. Hepatitis C Basic Information. Washington, DC: Office of Infectious Disease and HIV/AIDS Policy (OIDP), 2020. Available from: https://www.hhs.gov/hepatitis/learn-about-viral-hepatitis/hepatitis-c-basics/index.html.\u003c/li\u003e\n\u003cli\u003eLondon Joint Working Group on Substance Use and Hepatitis C. Hepatitis C testing and treatment interventions for the homeless population in London during the Covid-19 pandemic: Outcomes and learning. London, UK: London Joint Working Group on Substance Use and Hepatitis C, 2020. Available at http://ljwg.org.uk/wp-content/uploads/2021/01/HCV-testing-in-temporary-accommodation-during-lockdown-December-2020.pdf.\u003c/li\u003e\n\u003cli\u003eE. Williams B, Nelons D, Seaman A, Witkowska M, Ronan W, Wheelock H, et al. Life projects: the transformative potential of direct-acting antiviral treatment for hepatitis C among people who inject drugs. International Journal of Drug Policy. 2019;72:138-45.\u003c/li\u003e\n\u003cli\u003eWorld Health Organization. Barriers and facilitators to hepatitis C treatment for people who inject drugs: A qualitative study. Geneva, Switzerland: WHO, 2012.\u003c/li\u003e\n\u003cli\u003eLambert JS, Murtagh R, Menezes D, O\u0026rsquo;Carroll A, Murphy C, Cullen W, et al. \u0026lsquo;HepCheck Dublin\u0026rsquo;: an intensified hepatitis C screening programme in a homeless population demonstrates the need for alternative models of care.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1: Distribution of clinic and system-level staff interviewed\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"69.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eClassification of clinic and system-level staff interviewed\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eNumber of staff interviewed\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"69.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003eProviders (Physicians (MD/DO), Nurse Practitioner (NP))\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"69.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003eClinic-level staff (Registered Nurse (RN), Medical Assistant (MA), Medical Administrative Clerk (MAC))\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"69.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003eClinic-level social services staff (Licensed Clinical Social Worker (LCSW), Community Health Worker (CHW))\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"69.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003eSystem-level staff (pharmacy, referrals, social/financial services)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"69.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003eSystem-level leadership (manager, supervisor)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTable 2: Themes of Barriers and Facilitators identified along the Hepatitis C Care Cascade, with Illustrative Excerpts from Staff and Patient Interviews\u003c/em\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"100%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eStep in Hep C Care Cascade\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eIllustrative excerpt\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eGiven diagnosis and offered treatment\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eCompeting priorities \u003csup\u003eB\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;Sometimes with our patients, what you can do today is what you\u0026apos;re going to get done\u0026rdquo; (Clinic Staff)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;Once in a great while I have a patient who says \u0026lsquo;I have a lot going on right now, I don\u0026rsquo;t really think I\u0026rsquo;m ready for it\u0026rsquo;.\u0026rdquo; (Provider)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePatient-Provider Relationship (waiting till patient can succeed) \u003csup\u003eF\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;I always offer it, but if they\u0026rsquo;re not ready, I don\u0026rsquo;t push. Because a lot of it is engagement, and I don\u0026rsquo;t want to scare them. So, if they\u0026rsquo;re on the fence, I can usually say \u0026lsquo;yeah, this is really good, knowledge is power, you should know what\u0026rsquo;s going on\u0026rsquo; so you see which direction they\u0026rsquo;re in. But if they\u0026rsquo;re not ready, that\u0026rsquo;s totally fine. (Provider)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eTreatment accepted\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eLow health literacy \u003csup\u003eB\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;I didn\u0026rsquo;t know what it was\u0026hellip;I didn\u0026rsquo;t know if it was serious or not. I had no information as to what it was, or what it can do to you. I was in the dark about it, so I didn\u0026rsquo;t care either which way because I didn\u0026rsquo;t know what it would do to me. I had no knowledge of what it is, so, it didn\u0026rsquo;t bother me much, but I was worried about it.\u0026rdquo; (Patient)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePatient motivation \u003csup\u003eF\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;I like my life. I want to get treated as fast as possible. I don\u0026rsquo;t [want to] infect anybody else\u0026hellip;I want to get it over with.\u0026rdquo; (Patient who had been a PWID)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eBreaking down the care cascade \u003csup\u003eF\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;I\u0026rsquo;ll go and I\u0026rsquo;ll speak to them, and give them this packet, go over, we have a timeline, a breakdown of like, you sign papers this day, you get labs this day, your medication this day. Go over with them what the program looks like.\u0026rdquo; (Clinic Staff)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eGetting funding for treatment\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eCumbersome funding process \u003csup\u003eB\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;I think one of the major delays still is the time required for the prescription assistance program to kick in.\u0026rdquo; (Clinic Staff)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eMedication coverage \u003csup\u003eF\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;Once they get [MAP], their visits are covered and medication is covered through the pharmacy. So that definitely keeps them going\u0026hellip;I have this coverage that\u0026apos;s helping me get my medication, get my visits, so I\u0026apos;m here.\u0026rdquo; (Clinic Staff)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eTreatment initiated\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eCharacteristics of the PEH and PWID populations \u003csup\u003eB\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;There\u0026apos;s the obvious barriers with patients experiencing homelessness, a lot of times they have coexisting mental health issues, substance abuse issues...mak[ing] it harder to remember that you have an appointment or remember to take your meds or having somewhere to secure your medication. Their stuff gets stolen, they lose things, they don\u0026apos;t have transportation, they don\u0026apos;t have phones. All those things with the homeless population are a huge barrier.\u0026rdquo; (Clinic Staff)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eMedication replacement \u003csup\u003eF\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;[The patient] lost some of his [medication]. But he showed up right away, and we were able to get the drug company to replace them quickly enough to where I don\u0026apos;t think he missed very many days.\u0026rdquo; (Clinic Staff)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eCorollary care \u003csup\u003eF\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;If you\u0026apos;re on suboxone [buprenorphine]\u0026hellip;you want to live longer\u0026hellip;you want to stop hurting yourself. So, I think\u0026hellip;a lot of people will say, I want to get clean and sober because I don\u0026apos;t want to die or I want my body to be okay, I want my body to last. And so, I think it goes along with hep[atitis] C too. Like I want to take care of myself now.\u0026rdquo; (Patient)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eCare environment \u003csup\u003eF\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;Everybody here, we have the same goals in mind for our patients, and really [want to] see them all succeed and get their treatment.\u0026rdquo; (Clinic Staff)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eEnd of first month\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eMedication adherence \u003csup\u003eB\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;\u0026hellip;Reasons patients don\u0026apos;t complete treatment and some do experience side effects and don\u0026apos;t have anyone to talk to, or aren\u0026apos;t willing to complete it and stop...\u0026rdquo; (Provider)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;The reason that people miss doses, or just stop entirely, will be because of some sort of side effect. The majority of the time, they\u0026apos;re not common side effects and I don\u0026apos;t really know if they even are true side effects of the medication, or just kind of something that happened around the same time, and the patient is just saying that that\u0026apos;s what it\u0026apos;s from.\u0026rdquo; (Clinic Staff)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eCare coordination \u003csup\u003eF\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;If we saw them\u0026hellip;remember you got to come in this day for your appointment and for your hep[atitis] C meds, your second bottle\u0026rsquo;s due\u0026hellip;if I ever saw them walk by I would always remind them.\u0026rdquo; (Clinic Staff)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePatient-provider relationship \u003csup\u003eF\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;Please call me, so that you don\u0026rsquo;t have to suffer alone.\u0026rdquo; (Clinic Staff)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eEnd of treatment\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePsychosocial resources \u003csup\u003eF\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;At CareConnections clinic there\u0026rsquo;s more resources: a counselor, wound care nurse, a foot doctor\u0026hellip;a social worker, and a community health worker.\u0026rdquo; (Provider)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;For the access of everything that\u0026rsquo;s being offered on a day-to-day basis, food, social service, and any other specified services that one may need, on his medical situation, mental health.\u0026rdquo; (Patient at Sunrise)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSVR12\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eReturning to the clinic for labs \u003csup\u003eB\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;The single biggest reason for lack of SVR12 is the fact that patients don\u0026rsquo;t show up for the appointment. And I think that we as providers don\u0026rsquo;t do enough messaging on it, either. Most of us know that treatment completion labs, the last day of the treatment, portends treatment success, they\u0026rsquo;re highly correlated with SVR12.\u0026rdquo; (Provider)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.262626262626263%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePatient motivation \u003csup\u003eF\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"73.73737373737374%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ldquo;He tells me that I was cured. That I didn\u0026rsquo;t have [hepatitis C] anymore\u0026hellip;That made me feel good! I achieved something\u0026hellip;That\u0026rsquo;s the way I looked at it.\u0026rdquo; (Patient who achieved SVR12)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cem\u003eA superscript \u003csup\u003eB\u003c/sup\u003e indicates a barrier and a superscript \u003csup\u003eF\u003c/sup\u003e indicates a facilitator.\u003c/em\u003e\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"implementation-science-communications","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"iscm","sideBox":"Learn more about [Implementation Science Communications](https://implementationsciencecomms.biomedcentral.com)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ISCM/default.aspx","title":"Implementation Science Communications","twitterHandle":"@ImplementSci","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Hepatitis C, homelessness, intravenous drug use, qualitative research, human-centered design, implementation research ","lastPublishedDoi":"10.21203/rs.3.rs-2772126/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-2772126/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eBackground\u003c/b\u003e\u003c/p\u003e \u003cp\u003eHepatitis 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 Erase Hep C study aimed to identify barriers and facilitators specific to these vulnerable populations to design the site-specific, simplified treatment protocols.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethods\u003c/b\u003e\u003c/p\u003e \u003cp\u003e Forty-two semi-structured qualitative interviews, guided by the Practical, Robust Implementation and Suitability 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\u0026rsquo;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.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThe 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.\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusions\u003c/b\u003e\u003c/p\u003e \u003cp\u003eClinic 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.\u003c/p\u003e","manuscriptTitle":"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","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2023-05-04 15:06:34","doi":"10.21203/rs.3.rs-2772126/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2023-06-27T13:07:00+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2023-05-04T07:54:43+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2023-05-01T23:03:53+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2023-04-04T10:01:10+00:00","index":"","fulltext":""},{"type":"submitted","content":"Implementation Science Communications","date":"2023-04-03T09:58:47+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"implementation-science-communications","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"iscm","sideBox":"Learn more about [Implementation Science Communications](https://implementationsciencecomms.biomedcentral.com)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ISCM/default.aspx","title":"Implementation Science Communications","twitterHandle":"@ImplementSci","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"56f1e1c3-7db0-443b-99cf-955faa398fd0","owner":[],"postedDate":"May 4th, 2023","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2023-10-16T22:13:41+00:00","versionOfRecord":{"articleIdentity":"rs-2772126","link":"https://doi.org/10.1186/s43058-023-00484-6","journal":{"identity":"implementation-science-communications","isVorOnly":false,"title":"Implementation Science Communications"},"publishedOn":"2023-08-17 22:00:48","publishedOnDateReadable":"August 17th, 2023"},"versionCreatedAt":"2023-05-04 15:06:34","video":"","vorDoi":"10.1186/s43058-023-00484-6","vorDoiUrl":"https://doi.org/10.1186/s43058-023-00484-6","workflowStages":[]},"version":"v1","identity":"rs-2772126","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-2772126","identity":"rs-2772126","version":["v1"]},"buildId":"WrCJVZZCHTDjtuVLN7oU0","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}