The State of Hepatitis C Elimination from the Front Lines: A Qualitative Study of Provider-Perceived Gaps to Treatment Initiation.

BACKGROUND: Hepatitis C (HCV) is a curable chronic infection, but lack of treatment uptake contributes to ongoing morbidity and mortality. State and national strategies for HCV elimination emphasize the pressing need for people with HCV to receive treatment. OBJECTIVE: To identify provider-perceived barriers that hinder the initiation of curative HCV treatment and elimination of HCV in the USA. APPROACH: Qualitative semi-structured interviews with 36 healthcare providers who have evaluated patients with HCV in New York City, Western/Central New York, and Alabama. Interviews, conducted between 9/2021 and 9/2022, explored providers' experiences, perceptions, and approaches to HCV treatment initiation. Transcripts were analyzed using hybrid inductive and deductive thematic analysis informed by established health services and implementation frameworks. KEY RESULTS: We revealed four major themes: (1) Providers encounter professional challenges with treatment provision, including limited experience with treatment and perceptions that it is beyond their scope, but are also motivated to learn to provide treatment; (2) providers work toward building streamlined and inclusive practice settings-leveraging partnerships with experts, optimizing efficiency through increased access, adopting inclusive cultures, and advocating for integrated care; (3) although at times overwhelmed by patients facing socioeconomic adversity, increases in public awareness and improvements in treatment policies create a favorable context for providers to treat; and (4) providers are familiar with the relative advantages of improved HCV treatments, but the reputation of past treatments continues to deter elimination. CONCLUSIONS: To address the remaining barriers and facilitators providers experience in initiating HCV treatment, strategies will need to expand educational initiatives for primary care providers, further support local infrastructures and integrated care systems, promote public awareness campaigns, remove prior authorization requirements and treatment limitations, and address the negative reputation of outdated HCV treatments. Addressing these issues should be considered priorities for HCV elimination approaches at the state and national levels.

Care Integration for Hepatitis C Virus Treatment Through Facilitated Telemedicine Within Opioid Treatment Programs: Qualitative Study.

BACKGROUND: Telemedicine has the potential to remove geographic and temporal obstacles to health care access. Whether and how telemedicine can increase health care access for underserved populations remains an open question. To address this issue, we integrated facilitated telemedicine encounters for the management of hepatitis C virus (HCV), a highly prevalent condition among people with opioid use disorder (OUD), into opioid treatment programs (OTPs). In New York State, OTPs are methadone-dispensing centers that provide patient-centered, evidence-based treatment for OUD. We investigated the integration and impact of facilitated telemedicine into OTP workflows in these settings. OBJECTIVE: This study aims to understand OTP staff experiences with integrating facilitated telemedicine for HCV treatment into OTPs, including best practices and lessons learned. METHODS: We conducted semistructured interviews with 45 OTP staff members (13 clinical, 12 administrative, 6 physicians, and 14 support staff members) at least one year after the implementation of facilitated telemedicine for HCV management. We used hermeneutic phenomenological analysis to understand OTP staff experiences. RESULTS: We identified 4 overarching themes illustrating the successful integration of facilitated telemedicine for HCV care into OTPs. First, integration requires an understanding of the challenges, goals, and values of the OTP. As OTP staff learned about new, highly effective HCV therapies, they valued an HCV cure as a "win" for their patients and were excited about the potential to eliminate a highly prevalent infectious disease. Second, the integration of facilitated telemedicine into OTPs fosters social support and reinforces relationships between patients and OTP staff. OTP staff appreciated the ability to have "eyes on" patients during telemedicine encounters to assess body language, a necessary component of OUD management. Third, participants described high levels of interprofessional collaboration as a care team that included the blurring of lines between disciplines working toward a common goal of improving patient care. Study case managers were integrated into OTP workflows and established communication channels to improve patient outcomes. Fourth, administrators endorsed the sustained and future expansion of facilitated telemedicine to address comorbidities. CONCLUSIONS: OTP staff were highly enthusiastic about facilitated telemedicine for an underserved population. They described high levels of collaboration and integration comparable to relevant integrative frameworks. When situated within OTPs, facilitated telemedicine is a high-value application of telemedicine that provides support for underserved populations necessary for high-quality health care. These experiences support sustaining and scaling facilitated telemedicine in comparable settings and evaluating its ability to address other comorbidities. TRIAL REGISTRATION: ClinicalTrials.gov NCT02933970; https://clinicaltrials.gov/study/NCT02933970.

Hepatitis C Virus Elimination Programs in Louisiana and Washington: Importance of Screening and Surveillance Systems.

The US government has established a national goal of hepatitis C virus (HCV) elimination by 2030. To date, most HCV elimination planning and activity have been at the state level. Fifteen states presently have publicly available HCV elimination plans. In 2019, Louisiana and Washington were the first states to initiate 5-year funded HCV elimination programs. These states differ on motivation for pursuing HCV elimination and ranking on several indicators. Simultaneously, however, they have emphasized several similar elimination components including HCV screening promotion through public awareness, screening expansion, surveillance enhancement (including electronic reporting and task force development), and harm reduction. The 13 other states with published elimination plans have proposed the majority of the elements identified by Louisiana and Washington, but several have notable gaps. Louisiana's and Washington's comprehensive plans, funding approaches, and programs provide a useful framework that can move states and the nation toward HCV elimination.

Facilitated telemedicine for hepatitis C virus: Addressing challenges for improving health and life for people with opioid use disorder.

BACKGROUND: People who use drugs (PWUD) frequently delay or avoid obtaining medical care in traditional healthcare settings. Through a randomized controlled trial, we investigated facilitated telemedicine for hepatitis C virus (HCV) integrated into opioid treatment programmes. We sought to understand the experiences and meanings of facilitated telemedicine and an HCV cure among PWUD. METHODS: We utilized purposive sampling to interview 25 participants, 6-40 months after achieving an HCV cure. We interpreted and explicated common meanings of participants' experiences of an HCV cure obtained through facilitated telemedicine. RESULTS: Participants embraced facilitated telemedicine integrated into opioid treatment programmes as patient-centred care delivered in 'safe spaces' (Theme 1). Participants elucidated their experiences of substance use and HCV while committing to treatment for both entities. Facilitated telemedicine integrated into opioid treatment programmes enabled participants to avoid stigma encountered in conventional healthcare settings (Theme 2). Participants conveyed facing negative perceptions of HCV and substance use disorder. Improved self-awareness, acquired through HCV and substance use treatment, enabled participants to develop strategies to address shame and stigma (Theme 3). An HCV cure, considered by PWUD as a victory over a lethal infectious disease, promotes self-confidence, enabling participants to improve their health and lives (Theme 4). CONCLUSIONS: Integrating facilitated telemedicine into opioid treatment programmes addresses several healthcare barriers for PWUD. Similarly, obtaining an HCV cure increases their self-confidence, permissive to positive lifestyle changes and mitigating the negative consequences of substance use. PATIENT AND PUBLIC CONTRIBUTION: In this study of patient involvement, we interviewed patient-participants to understand the meaning of an HCV cure through facilitated telemedicine. Participants from a facilitated telemedicine pilot study provided essential input on the design and outcomes of a randomized controlled trial. Pilot study participants endorsed facilitated telemedicine in a testimonial video. They attended site initiation meetings to guide trial implementation. A Patient Advisory Committee (PAC) ensured that patient participants were active members of the research team. The PAC represented patients' voices through feedback on study procedures. A Sustainability Committee supported public involvement in the research process, including educational opportunities, feedback on implementation, and future sustainability considerations.

Scaling and Sustaining Facilitated Telemedicine to Expand Treatment Access Among Underserved Populations: A Qualitative Study.

Background: Opioid treatment programs are an essential component of the management of opioid use disorder (OUD). They have also been proposed as "medical homes" to expand health care access for underserved populations. We utilized telemedicine as a method to increase access for hepatitis C virus (HCV) care among people with OUD. Methods: We interviewed 30 staff and 15 administrators regarding the integration of facilitated telemedicine for HCV into opioid treatment programs. Participants provided feedback and insight for sustaining and scaling facilitated telemedicine for people with OUD. We utilized hermeneutic phenomenology to develop themes related to telemedicine sustainability in opioid treatment programs. Results: Three themes emerged on sustaining the facilitated telemedicine model: (1) Telemedicine as a Technical Innovation in Opioid Treatment Programs, (2) Technology Transcending Space and Time, and (3) COVID-19 Disrupting the Status Quo. Participants identified skilled staff, ongoing training, technology infrastructure and support, and an effective marketing campaign as key to maintaining the facilitated telemedicine model. Participants highlighted the study-supported case manager's role in managing the technology to transcend temporal and geographical challenges for HCV treatment access for people with OUD. COVID-19 fueled changes in health care delivery, including facilitated telemedicine, to expand the opioid treatment program's mission as a medical home for people with OUD. Conclusions: Opioid treatment programs can sustain facilitated telemedicine to increase health care access for underserved populations. COVID-19-induced disruptions promoted innovation and policy changes recognizing telemedicine's role in expanding health care access to underserved populations. ClinicalTrials.gov Identifier: NCT02933970.

Social determinants of health derived from people with opioid use disorder: Improving data collection, integration and use with cross-domain collaboration and reproducible, data-centric, notebook-style workflows.

Deriving social determinants of health from underserved populations is an important step in the process of improving the well-being of these populations and in driving policy improvements to facilitate positive change in health outcomes. Collection, integration, and effective use of clinical data for this purpose presents a variety of specific challenges. We assert that combining expertise from three distinct domains, specifically, medical, statistical, and computer and data science can be applied along with provenance-aware, self-documenting workflow tools. This combination permits data integration and facilitates the creation of reproducible workflows and usable (reproducible) results from the sensitive and disparate sources of clinical data that exist for underserved populations.

Engaging people who use drugs in clinical research: integrating facilitated telemedicine for HCV into substance use treatment.

BACKGROUND: People who use drugs (PWUD) have difficulty participating in clinical research. We evaluated approaches to engage PWUD in clinical research, using facilitated telemedicine for hepatitis C virus (HCV) care as an example. METHODS: We analyzed stakeholder interview transcripts and study-related data (i.e., progress reports, meeting minutes) from interrelated studies to understand engagement experiences at the patient, site, and organizational levels. Stakeholders include patient-participants, opioid treatment program (OTP) staff and administrators, and research team members involved in HCV management through facilitated telemedicine integrated into OTPs. RESULTS: Three themes emerged. Initially, the research team sought understanding of the unique culture and community of each OTP (Theme 1). The team built trusting relationships through education, communication, and feedback (Theme 2). Finally, the research team enhanced collaborative care and incorporated the patients' voice to improve health outcomes (Theme 3). Patient-participants and OTP staff endorsed the integrated HCV care approach. Engagement practices are summarized as the CREATE framework (C = culture, R = respect, E = educate, A = advantage, T = trust, E = endorse). CONCLUSIONS: PWUD engagement in clinical research is maximized by building trusting relationships with open communication channels. Understanding the community, demonstrating respect, and augmenting knowledge are foundational for engaging PWUD in clinical research. These practices are transferable to engagement of PWUD in clinical research broadly.

People who use drugs rarely join clinical research studies for many reasons including mistrust of researchers and lack of access to healthcare. Their joining, however, is critical to understand how to address issues affecting their communities. For ten years, we have studied telemedicine (doctor visit through a computer) to increase healthcare access for people who use drugs with hepatitis C virus (HCV). HCV infection occurs commonly in people who use drugs and is curable in almost everyone who takes treatment. We place HCV treatment through facilitated telemedicine into drug treatment programs. A case manager who is familiar to patients oversees the telemedicine encounter with the doctor. We developed themes from interviews with patients, staff, and other involved people as well as from study documents. As a first step, researchers need to understand the culture and community of the drug treatment program. Knowing the culture permits researchers to connect the goals of the study with those of the drug treatment program. It also helps researchers build trust with the program staff. We have seen that trust between the researchers and the staff in the drug treatment program permits individuals with different jobs to work together to deliver HCV treatment resulting in a cure. During the entire process, a patient advisory committee made sure the patients were partners in the research. Based upon these results, we have developed a new approach, CREATE (C = Culture, R = respect, E = educate, A = advantage, T = trust, E = endorse), that explains each step in the process.

Hepatitis C Treatment Initiation Among US Medicaid Enrollees.

Importance: Direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) infection is highly effective but remains underused. Understanding disparities in the delivery of DAAs is important for HCV elimination planning and designing interventions to promote equitable treatment. Objective: To examine variations in the receipt of DAA in the 6 months following a new HCV diagnosis. Design, Setting, and Participants: This retrospective cohort study used national Medicaid claims from 2017 to 2019 from 50 states, Washington DC, and Puerto Rico. Individuals aged 18 to 64 years with a new diagnosis of HCV in 2018 were included. A new diagnosis was defined as a claim for an HCV RNA test followed by an International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) diagnosis code, after a 1-year lookback period. Main Outcomes and Measures: Outcome was receipt of a DAA prescription within 6 months of diagnosis. Logistic regression was used to examine demographic factors and ICD-10-identified comorbidities associated with treatment initiation. Results: Among 87 652 individuals, 43 078 (49%) were females, 12 355 (14%) were age 18 to 29 years, 35 181 (40%) age 30 to 49, 51 282 (46%) were non-Hispanic White, and 48 840 (49%) had an injection drug use diagnosis. Of these individuals, 17 927 (20%) received DAAs within 6 months of their first HCV diagnosis. In the regression analyses, male sex was associated with increased treatment initiation (OR, 1.24; 95% CI, 1.16-1.33). Being age 18 to 29 years (OR, 0.65; 95% CI, 0.50-0.85) and injection drug use (OR, 0.84; 95% CI, 0.75-0.94) were associated with decreased treatment initiation. After adjustment for state fixed effects, Asian race (OR, 0.50; 95% CI, 0.40-0.64), American Indian or Alaska Native race (OR, 0.68; 95% CI, 0.55-0.84), and Hispanic ethnicity (OR, 0.81; 95% CI, 0.71-0.93) were associated with decreased treatment initiation. Adjustment for state Medicaid policy did not attenuate the racial or ethnic disparities. Conclusions: In this retrospective cohort study, HCV treatment initiation was low among Medicaid beneficiaries and varied by demographic characteristics and comorbidities. Interventions are needed to increase HCV treatment uptake among Medicaid beneficiaries and to address disparities in treatment among key populations, including younger individuals, females, individuals from minoritized racial and ethnic groups, and people who inject drugs.

Facilitating engagement of persons with opioid use disorder in treatment for hepatitis C virus infection via telemedicine: Stories of onsite case managers.

Although hepatitis C virus (HCV) infection has high prevalence and incidence in persons with opioid use disorder (PWOUD), their engagement in HCV care has been limited due to a variety of factors. In an ongoing multisite study at 12 opioid treatment programs (OTPs) throughout New York State (NYS), we have been evaluating telemedicine accompanied by onsite administration of direct acting antiviral (DAA) medications compared with usual care including offsite referral to a liver specialist for HCV management. Each site has a case manager (CM) who is responsible for all study-related activities including participant recruitment, facilitating telemedicine interactions, retention in care, and data collection. Our overall objective is to analyze CM experiences of clients' stories and events to understand how the telemedicine model facilitates HCV treatment. Hermeneutic phenomenology was used to interpret and to explicate common meanings and shared practices of the phenomena of case management, and a focus group with CMs was conducted to reinforce and expand on key themes identified from the CMs' stories. We identified three themes: (1) building trust, (2) identification of multiple competing priorities, and (3) development of personalized care approaches. Our results illustrate that trust is a fundamental pillar on which the telemedicine system can be based. Participants' experiences at the OTP can reinforce trust. Understanding the specific competing priorities and routinizing dedicated personalized approaches to overcome them are key to increasing participation in HCV care among PWOUD.

Toward precision prescribing for methadone: Determinants of methadone deposition.

BACKGROUND: Despite the World Health Organization listing methadone as an essential medication, effective dose selection is challenging, especially in racial and ethnic minority populations. Subtherapeutic doses can result in withdrawal symptoms while supratherapeutic doses can result in overdose and death. Although CYP3A4 was conventionally considered the principal methadone metabolizing enzyme, more recent data have identified CYP2B6 as the principal enzyme. CYP2B6 has ethnically-associated polymorphisms that affect the metabolic rate. Our objective was to investigate the effects of genetic and nongenetic factors on methadone metabolism. METHODS: We measured trough plasma methadone levels in 100 participants with opioid use disorder. We assessed methadone metabolism by calculating the metabolite ratio (major metabolite: 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine [EDDP] divided by methadone concentration). We assessed hepatic fibrosis and steatosis by transient elastography and CYP2B6 alleles, principally responsible for methadone metabolism. Mixed effects models modeled the data in 97 participants. RESULTS: Participants were largely male (58%), minority (61% African American) and non-Hispanic (68%). Forty percent were HCV mono-infected, 40% were uninfected, and 20% were HCV/HIV co-infected. Female sex had significant effects on (R)- and (S)-methadone metabolism (p = 0.016 and p = 0.044, respectively). CYP2B6 loss of function (LOF) alleles significantly affected (S)-methadone metabolism (p = 0.012). Body mass index (BMI) significantly affected (R)-methadone metabolism (p = 0.034). Methadone metabolism appeared to be lower in males, in individuals with LOF alleles, and elevated BMI. CONCLUSIONS: Genetic analysis, especially in minority populations, is essential to delivering individualized treatments. Although the principal methadone metabolizing enzyme remains controversial, our results suggest that sex, CYP2B6 genotype, and BMI should be incorporated into multivariate models to create methadone dosing algorithms. Methadone dosing algorithms should facilitate medication delivery, improve patient satisfaction, and diminish overdose potential.