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campaigns, remove prior authorization requirements and treatment limitations, and address the negative reputation of outdated HCV treatments.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.

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.

The urgent need to implement point-of-care RNA testing for hepatitis C virus to support elimination.

Hepatitis C virus (HCV) elimination is an important global public health goal. However, the United States (US) is not on track to meet the World Health Organization's 2030 targets for HCV elimination. Recently, the White House proposed an HCV elimination plan that includes point-of-care (POC) HCV RNA testing, which is currently in use in many countries, but is not approved in the US. POC HCV RNA testing is crucial for implementing community-based testing, and for enabling test-and-treat programs, assessing cure, and monitoring for reinfection.. In this commentary, we review the status of POC HCV RNA testing in the US, discuss factors that are needed for successful implementation, and issue specific public health and policy recommendations that would allow for the use of POC HCV RNA testing to support HCV elimination.

The effects of COVID-19 on New York State's Drug User Health Hubs and syringe service programs: a qualitative study.

BACKGROUND: Syringe service programs (SSPs) deliver critical harm reduction services to people who inject drugs (PWID). Some SSPs in New York State received enhanced funding to provide additional services to combat opioid overdose fatalities. These SSPs, known as Drug User Health Hubs, provide buprenorphine for the treatment of opioid use disorder and other health-related services in addition to their syringe services. While the COVID-19 pandemic posed widespread challenges to the delivery of health services nationwide, the effect of the pandemic on SSPs uniquely impacts PWID. This study examines the impact of COVID-19 on service delivery of Drug User Health Hubs and stand-alone SSPs in New York State. METHODS: Between July 2020 and September 2020, we performed eleven semi-structured virtual interviews with staff from three Health Hub SSPs and three stand-alone SSPs. The interviews explored the effect of the COVID-19 pandemic on SSPs and their clients as well as the changes implemented in response. Interviews were recorded and transcribed. We performed content analysis to identify emerging themes from the data. RESULTS: Due to the COVID-19 pandemic, some SSPs temporarily shut down while others limited their hours of operation. SSPs modified their service delivery to maintain syringe services and naloxone distribution over other services such as STI and HCV testing. They virtualized components of their services, including telemedicine for the provision of buprenorphine. While SSPs found virtualization to be important for maintaining their services, it negatively impacted the intimate nature of client interactions. Participants also described the impact of the pandemic on the well-being of PWID, including isolation, worsened mental health challenges, and increased drug overdoses. CONCLUSIONS: In response to the COVID-19 pandemic, SSPs demonstrated innovation, adaptability, and togetherness. Despite the challenges posed by the pandemic, SSPs continued to be key players in maintaining access to sterile supplies, buprenorphine, and other services for PWID. In addition to adapting to COVID-19 restrictions, they also responded to the dynamic needs of their clients. Sustainable funding and recognition of the critical role of SSPs in supporting PWID can help to improve outcomes for PWID.

"Treated like a Human Being": perspectives of people who inject drugs attending low-threshold HCV treatment at a syringe service program in New York City.

BACKGROUND: Hepatitis C virus (HCV) treatment can effectively cure HCV among people who inject drugs (PWID). Perspectives of PWID treated in innovative models can reveal program features that address barriers to treatment, and guide implementation of similar models. METHODS: We interviewed 29 participants in the intervention arm of a randomized trial. The trial enrolled PWID with HCV in New York City from 2017 to 2020 and tested the effectiveness of a low-threshold HCV treatment model at a syringe services program. Participants were purposively sampled and interviewed in English or Spanish. The interview guide focused on prior experiences with HCV testing and treatment, and experiences during the trial. Interviews were inductively coded and analyzed using thematic analysis. RESULTS: Before enrollment, participants reported being tested for HCV in settings such as prison, drug treatment, and emergency rooms. Treatment was delayed because of not being seen as urgent by providers. Participants reported low self-efficacy, competing priorities, and systemic barriers to treatment such as insurance, waiting lists, and criminal-legal interactions. Stigma was a major factor. Treatment during the trial was facilitated through respect from staff, which overcame stigma. The flexible care model (allowing walk-ins and missed appointments) helped mitigate logistical barriers. The willingness of the staff to address social determinants of health was highly valued. CONCLUSION: Our findings highlight the need for low-threshold programs with nonjudgmental behavior from program staff, and flexibility to adapt to participants' needs. Social determinants of health remain a significant barrier, but programs' efforts to address these factors can engender trust and facilitate treatment. Trial registration NCT03214679.

Responding to a surge in overdose deaths: perspectives from US syringe services programs.

BACKGROUND: US overdose deaths have reached a record high. Syringe services programs (SSPs) play a critical role in addressing this crisis by providing multiple services to people who use drugs (PWUD) that help prevent overdose death. This study examined the perspectives of leadership and staff from a geographically diverse sample of US SSPs on factors contributing to the overdose surge, their organization's response, and ongoing barriers to preventing overdose death. METHODS: From 2/11/2021 to 4/23/2021, we conducted semi-structured interviews with leadership and staff from 27 SSPs sampled from the North American Syringe Exchange Network directory. Interviews were transcribed and qualitatively analyzed using a Rapid Assessment Process. RESULTS: Respondents reported that increased intentional and unintentional fentanyl use (both alone and combined with other substances) was a major driver of the overdose surge. They also described how the COVID-19 pandemic increased solitary drug use and led to abrupt increases in use due to life disruptions and worsened mental health among PWUD. In response to this surge, SSPs have increased naloxone distribution, including providing more doses per person and expanding distribution to people using non-opioid drugs. They are also adapting overdose prevention education to increase awareness of fentanyl risks, including for people using non-opioid drugs. Some are distributing fentanyl test strips, though a few respondents expressed doubts about strips' effectiveness in reducing overdose harms. Some SSPs are expanding education and naloxone training/distribution in the broader community, beyond PWUD and their friends/family. Respondents described several ongoing barriers to preventing overdose death, including not reaching certain groups at risk of overdose (PWUD who do not inject, PWUD experiencing homelessness, and PWUD of color), an inconsistent naloxone supply and lack of access to intranasal naloxone in particular, inadequate funding, underestimates of overdoses, legal/policy barriers, and community stigma. CONCLUSIONS: SSPs remain essential in preventing overdose deaths amid record numbers likely driven by increased fentanyl use and COVID-19-related impacts. These findings can inform efforts to support SSPs in this work. In the face of ongoing barriers, support for SSPs-including increased resources, political support, and community partnership-is urgently needed to address the worsening overdose crisis.

The Experience of Implementing a Low-Threshold Buprenorphine Treatment Program in a Non-Urban Medical Practice.

BACKGROUND: To respond to the U.S. opioid crisis, new models of healthcare delivery for opioid use disorder treatment are essential. We used a qualitative approach to describe the implementation of a low-threshold buprenorphine treatment program in an independent, community-based medical practice in Ithaca, NY. METHODS: We conducted 17 semi-structured interviews with program staff, leadership, and external stakeholders. Then we analyzed these data using content analysis. We used purposeful sampling aiming for variation in job title for program staff, and in organizational affiliation for external stakeholders. RESULTS: We found that opening an independent medical practice allowed for low-threshold buprenorphine treatment with less regulatory oversight, but state-certification was ultimately required to ensure financial sustainability. Relying on health insurance reimbursement alone led to funding shortfalls and additional funding sources were also required. The practice's ability to build relationships with licensed substance use treatment programs, community organizations, the legal system, and government agencies in the region differed depending on how much these entities supported a harm reduction philosophy compared to abstinence-based treatment. Finally, expanding the practice to a second location in a different region, co-located with a syringe service program, required adapting to a new cultural and political environment. CONCLUSION: The results from this study provide insight about the challenges that independent medical practices might face in delivering low-threshold buprenorphine treatment. They support policy efforts to address the financial burdens associated with providing low-threshold buprenorphine therapy and inform the external relationships that other providers would need to consider when delivering novel treatment models.

Hepatitis C testing and treatment uptake among young people who use opioids in New York City: A cross-sectional study.

Young people who use drugs have a rising hepatitis C (HCV) incidence in the United States, but they may face barriers to testing and treatment adoption due to stigma. We conducted a cross-sectional study of New York City residents aged 18-29 years who reported non-medical prescription opioid and/or heroin use in the past 30 days. Participants were recruited from the community between 2014-2016 via respondent-driven sampling. Participants completed an in-person structured survey that included questions about HCV testing and treatment and received HCV antibody testing. There were 539 respondents: 353 people who inject drugs (PWID) and 186 non-PWID. For PWID, median age was 25 years, 65% were male and 73% non-Hispanic White. For non-PWID, median age was 23 years, 73% were male and 39% non-Hispanic White. 20% of PWID and 54% of non-PWID had never been tested for HCV (P < .001). Years since first injection (aOR 1.16, CI: 1.02-1.32, P = .02) and history of substance use treatment (aOR 3.17, CI: 1.53-6.61, P = .02) were associated with prior testing among PWID. The seroprevalence of HCV among PWID was 25%, adjusted for sampling weights. Of the 75 who were aware of their HCV-positive status, 53% had received HCV-related medical care, and 28% had initiated treatment. HCV prevalence among young PWID is high, and many have never been tested. Injection experience and treatment engagement is associated with testing. Interventions to increase testing earlier in injection careers, and to improve linkage to HCV treatment, will be critical for young PWID.

Hepatitis C Treatment by Nonspecialist Providers in the Direct-acting Antiviral Era.

BACKGROUND: Hepatitis C virus (HCV) remains under-treated in the United States and treatment by nonspecialist providers can expand access. We compare HCV treatment provision and treatment completion between nonspecialist and specialist providers. METHODS: This retrospective study used claims data from the Healthcare Cost Institute from 2013 to 2017. We identified providers who prescribed HCV therapy between 2013 and 2017, and patients enrolled in private insurance or Medicare Advantage who had pharmacy claims for HCV treatment. We measured HCV treatment completion, determined based on prescription fills for the minimum expected duration of the antiviral regimen. Using propensity score-weighted regression, we compared the likelihood of early treatment discontinuation by the type of treating provider. RESULTS: The number of providers prescribing HCV treatment peaked in 2015 and then declined. The majority were gastroenterologists, although the proportion of general medicine providers increased to 17% by 2017. Among the 23,463 patients analyzed, 1008 (4%) discontinued before the expected minimum duration. In the propensity score-weighted analysis, patients treated by general medicine physicians had similar odds of treatment discontinuation compared with those treated by gastroenterologists [odds ratio (OR)=1.00, 95% confidence interval (CI): 0.99-1.01, P=0.45]. Results were similar when comparing gastroenterologists to nonphysician providers (OR=1.00, 95% CI: 0.99-1.01, P=0.53) and infectious diseases specialists (OR=1.00, 95% CI: 0.99-1.01, P=0.71). CONCLUSIONS: HCV treatment providers remain primarily gastroenterologists, even in the current simplified treatment era. Patients receiving treatment from general medicine or nonphysician providers had a similar likelihood of treatment completion, suggesting that removing barriers to the scale-up of treatment by nonspecialists may help close treatment gaps for hepatitis C.

A Harm Reduction Approach to Treating Opioid Use Disorder in an Independent Primary Care Practice: a Qualitative Study.

BACKGROUND: Stigma is a barrier to the uptake of buprenorphine to treat opioid use disorder. Harm reduction treatment models intend to minimize this stigma by organizing care around non-judgmental interactions with people who use drugs. There are few examples of implementing buprenorphine treatment using a harm reduction approach in a primary care setting in the USA. METHODS: We conducted a qualitative study by interviewing leadership, staff, and external stakeholders at Respectful, Equitable Access to Compassionate Healthcare (REACH) Medical in Ithaca, NY. REACH is a freestanding medical practice that provides buprenorphine treatment for opioid use disorder since 2018. We conducted semi-structured interviews with 17 participants with the objective of describing REACH's model of care. We selected participants based on their position at REACH or in the community. Interviews were recorded, transcribed, and analyzed for themes using content analysis, guided by the CDC Evaluation Framework. RESULTS: REACH provided buprenorphine, primary care, and mental health services in a low-threshold model. We identified three themes related to delivery of buprenorphine treatment. First, an organizational mission to provide equitable and low-stigma healthcare, which was a key to organizational identity. Second, a low-threshold buprenorphine treatment approach that was critical, but caused concern about over-prescribing and presented logistical challenges. Third, creation and retention of a harm reduction-oriented workforce by offering value-based work and by removing administrative barriers providers may face elsewhere to providing buprenorphine treatment. CONCLUSIONS: A harm reduction primary care model can help reduce stigma for people who use drugs and engage in buprenorphine treatment. Further research is needed to evaluate whether this model leads to improved patient outcomes, can overcome community stakeholder concerns, and is sustainable.

Addressing Barriers to On-site HIV and HCV Testing Services in Methadone Maintenance Treatment Programs in the United States: Findings From a National Multisite Qualitative Study.

CONTEXT: Few substance use disorder (SUD) treatment programs provide on-site human immunodeficiency virus (HIV) and/or hepatitis C virus (HCV) testing, despite evidence that these tests are cost-effective. OBJECTIVE: To understand how methadone maintenance treatment (MMT) programs that offer on-site HIV/HCV testing have integrated testing services, and the challenges related to offering on-site HIV/HCV testing. DESIGN: We used the 2014 National Drug Abuse Treatment System Survey to identify outpatient SUD treatment programs that reported offering on-site HIV/HCV testing to 75% or more of their clients. We stratified the sample to identify programs based on combinations of funding source, type of drug treatment offered, and Medicaid-managed care arrangements. We conducted semi-structured qualitative interviews with leadership and staff in 2017-2018 using a directed content analysis approach to identify dominant themes. SETTING: Seven MMT programs located in 6 states in the United States. PARTICIPANTS: Fifteen leadership and staff from 7 MMT programs with on-site HIV/HCV testing. MAIN OUTCOME MEASURE: Themes related to integration of on-site HIV/HCV testing. RESULTS: Methadone maintenance treatment programs identified 3 domains related to the integration of HIV/HCV testing on-site at MMT programs: (1) payment and billing, (2) internal and external stakeholders, and (3) medical and SUD treatment coordination. Programs identified the absence of state policies that facilitate medical billing and inconsistent grant funding as major barriers. Testing availability was limited by the frequency at which external organizations could provide services on-site, the reliability of those external relationships, and MMT staffing. Poor electronic health record systems and privacy policies that prevent medical information sharing between medical and SUD treatment providers also limited effective care coordination. CONCLUSION: Effective and sustainable integration of on-site HIV/HCV testing by MMT programs in the United States will require more consistent funding, improved billing options, technical assistance, electronic health record system enhancement and coordination, and policy changes related to privacy.

State Opioid Limits and Volume of Opioid Prescriptions Received by Medicaid Patients.

BACKGROUND: Since early 2016, an increasing number of states passed legislations that limit the duration and/or dosage of initial opioid prescriptions or opioids for acute pain. OBJECTIVE: The objective of this study was to assess changes in the number of opioid prescriptions covered by Medicaid and received by Medicaid patients associated with state implementation of legislative limits on initial opioid prescriptions. RESEARCH DESIGN: We explored the natural experiment resulting from the staggered implementation of state legislative limits. The analysis adopted a Difference-in-Differences framework and controlled for other major state policies bearing implications for prescription opioid use. The main analysis included 26 states that implemented limits from early 2016 to late 2018. A secondary analysis included all 50 states and the District of Columbia. MEASURES: Population-adjusted state-quarter level counts of Schedule II and III opioid prescriptions received by Medicaid patients, based on data from the Medicaid State Drug Utilization Data and state Medicaid enrollment reports for 2013-2018. RESULTS: Implementation of legislative limits on initial opioid prescriptions was associated with a 7% reduction in the number of opioid prescriptions per 100 Medicaid enrollees. Such reduction was largely attributable to a reduction in Schedule II opioid prescriptions. Secondary analysis by including all jurisdictions and sensitivity checks supported the robustness of results. CONCLUSION: The recent implementation of state legislative limits on initial opioid prescriptions was associated with meaningful reductions in the volume of Schedule II opioid prescriptions received by Medicaid patients.

Strategies for Improving Hepatitis C Treatment Access in the United States: State Officials Address High Drug Prices, Stigma, and Building Treatment Capacity.

CONTEXT: Curative treatments for hepatitis C virus (HCV) can alter the course of a devastating epidemic, but high drug prices have contributed to restrictions on HCV treatment access. OBJECTIVE: We aimed to learn how state health agencies have responded to the challenges of treatment access for HCV. DESIGN: Qualitative study using semistructured key informant interviews focused on aspects of HCV treatment access between June 2016 and March 2017. Content analysis was used to identify dominant themes. SETTING: United States. PARTICIPANTS: Eighteen health officials and treatment advocates across 6 states selected using purposive sampling. RESULTS: Drug pricing is the most important barrier to access, encouraging restrictive authorization criteria from payers that in turn discourage providers from offering treatment. However, payers have not experienced the budget impact that was initially feared. Although authorization criteria are being lifted for fee-for-service Medicaid programs, ensuring that managed care organizations follow suit remains a challenge. The effect of stigma, a shortage of treating providers, and lack of political motivation are additional challenges to expanding treatment. The response to the human immunodeficiency virus epidemic can augment or inform strategies for HCV treatment delivery, but this is limited by the absence of dedicated funding. CONCLUSIONS: While treatment eligibility criteria for HCV treatment are improving, many other barriers remain to achieving the scale-up needed to end the epidemic. Political disinterest, stigma, and a lack of specialty providers are continued barriers in some jurisdictions. States may need to invest in strategies to overcome these barriers, such as engaging in public and provider education and ensuring that treatment by primary care providers is reimbursed. Despite uncertainty about how federal policy changes to Medicaid may affect states' ability to respond, states can identify opportunities to improve access.

State Medicaid Hepatitis C Treatment Eligibility Criteria and Use of Direct-Acting Antivirals.

Medicaid program criteria for accessing hepatitis C treatment are changing. Medicaid drug utilization data from 2014 to 2016 show that programs that have relaxed their criteria have seen significant increases in treatment utilization, as have states with Medicaid expansions.

The Expanding Role of Antimicrobial Stewardship Programs in Hospitals in the United States: Lessons Learned from a Multisite Qualitative Study.

BACKGROUND: Misuse of antibiotics can lead to the development of antibiotic resistance, which adversely affects morbidity, mortality, length of stay, and cost. To combat the threat of antimicrobial resistance, The Joint Commission and the Centers for Medicare & Medicaid Services have initiated or proposed requirements for hospitals to have antimicrobial stewardship programs (ASPs), but implementation remains challenging. A key-informant interview study was conducted to describe the characteristics and innovative strategies of leading ASPs. METHODS: Semistructured interviews were conducted with 12 program leaders at four ASPs in the United States, chosen by purposive sampling on the basis of national reputation, scholarship, and geography. Questions focused on ASP implementation, program structure, strengths, weaknesses, lessons learned, and future directions. Content analysis was used to identify dominant themes. RESULTS: Three major themes were identified. The first was evolution of ASPs from a top-down structure to a more diffuse approach involving unit-based pharmacists, multidisciplinary staff, and shared responsibility for antimicrobial prescribing under the ASPs' leadership. The second theme was integration of information technology (IT) systems, which enabled real-time interventions to optimize antimicrobial therapy and patient management. The third was barriers to technology integration, including limited resources for data analysis and poor interoperability between software systems. CONCLUSION: The study provides valuable insights on program implementation at a sample of leading ASPs across the United States. These ASPs used expansion of personnel to amplify the ASP's impact and integrated IT resources into daily work flow to improve efficiency. These findings can be used to guide implementation at other hospitals and aid in future policy development.

Association between claims-based setting of diagnosis and treatment initiation among Medicare patients with hepatitis C.

OBJECTIVE: To develop a claims-based algorithm to determine the setting of a disease diagnosis. DATA SOURCES AND STUDY SETTING: Medicare enrollment and claims data from 2014 to 2019. STUDY DESIGN: We developed a claims-based algorithm using facility indicators, revenue center codes, and place of service codes to identify settings where HCV diagnosis first appeared. When the first appearance was in a laboratory, we attempted to associate HCV diagnoses with subsequent clinical visits. Face validity was assessed by examining association of claims-based diagnostic settings with treatment initiation. DATA COLLECTION/EXTRACTION METHODS: Patients newly diagnosed with HCV and continuously enrolled in traditional Medicare Parts A, B, and D (12 months before and 6 months after index diagnosis) were included. PRINCIPAL FINDINGS: Among 104,454 patients aged 18-64 and 66,726 aged ≥65, 70.1% and 69%, respectively, were diagnosed in outpatient settings, and 20.2% and 22.7%, respectively in laboratory or unknown settings. Logistic regression revealed significantly lower odds of treatment initiation after diagnosis in emergency departments/urgent cares, hospitals, laboratories, or unclassified settings, than in outpatient visits. CONCLUSIONS: The algorithm identified the setting of HCV diagnosis in most cases, and found significant associations with treatment initiation, suggesting an approach that can be adapted for future claims-based studies.