Does a simplified algorithm and integrated HCV care model improve linkage to care, retention, and cure among people who inject drugs? A pragmatic quality improvement randomized controlled trial protocol.

BACKGROUND: As many as 2.4 million Americans are affected by chronic Hepatitis C Virus (HCV) in the United States.In 2018, the estimated number of adults with a history of HCV infection in San Diego County was 55,354 (95% CI: 25,411-93,329). This corresponded to a seroprevalence of 2.1% (95% CI: 2.1-3.4%). One-third of infections were among PWID. Published research has demonstrated that direct-acting antivirals (DAAs) have high efficacy and can now be used by primary care providers to treat HCV. In addition, limited evidence exists to support the effectiveness of simplified algorithms in clinical trial and real-world settings. Even with expanded access to HCV treatment in primary care settings, there are still groups, especially people who inject drugs (PWID) and people experiencing homelessness, who experience treatment disparities due to access and treatment barriers. The current study extends the simplified algorithm with a streetside 'one-stop-shop' approach with integrated care (including the offer of buprenorphine prescriptions and abscess care) using a mobile clinic situated adjacent to a syringe service program serving many homeless populations. Rates of HCV treatment initiation and retention will be compared between patients offered HCV care in a mobile clinic adjacent to a syringe services program (SSP) and homeless encampment versus those who are linked to a community clinic's current practice of usual care, which includes comprehensive patient navigation. METHODS: A quasi-experimental, prospective, interventional, comparative effectiveness trial with allocation of approximately 200 patients who inject drugs and have chronic HCV to the "simplified care" pathway (intervention group) or the "usual care" pathway (control group). Block randomization will be performed with a 1:1 randomization. DISCUSSION: Previous research has demonstrated acceptable outcomes for patients treated using simplified algorithms for DAAs and point-of-care testing in mobile medical clinics; however, there are opportunities to explore how these new, innovative systems of care impact treatment initiation rates or other HCV care cascade outcomes among PWID. TRIAL REGISTRATION: We have registered our study with ClinicalTrials.gov, a resource of the United States National Library of Medicine. This database contains research studies from United States and other countries around the world. Our study has not been previously published. The ClinicalTrials.gov registration identifier is NCT04741750.

Effectiveness of a Decentralized Hub and Spoke Model for the Treatment of Hepatitis C Virus in a Federally Qualified Health Center.

Hepatitis C virus (HCV) is a major cause of cirrhosis, liver cancer, and mortality in the United States. We assessed the effectiveness of decentralized HCV treatment delivered by nurse practitioners (NPs), primary care physicians (PMDs), or an infectious disease physician (ID MD) using direct-acting antivirals in a Federally Qualified Health Center (FQHC) in urban San Diego, CA. We conducted a cross-sectional analysis of 1,261 patients who received treatment from six NPs, 10 PMDs, and one ID MD practicing in 10 clinics between January 2014 and January 2020. Care was delivered based on the Extension for Community Healthcare Outcomes (Project ECHO) model with one hub and nine spokes. HCV was deemed cured if a patient had a sustained virologic response (SVR) after 12 weeks of treatment (SVR12). We evaluated differences in the prevalence of cure between provider types and hub or spoke status using Poisson regression. Patients were 34% Latino, 16% black, 63% were aged >50 years, and 59% were homeless; 53% had advanced fibrosis, 69% had genotype 1, and 5% were coinfected with human immunodeficiency virus. A total of 943 patients achieved SVR12 (96% per protocol and 73% intention to treat). Even after adjustment for demographics, resources, and disease characteristics, the prevalence of cure did not differ between the ID MD and PMDs (prevalence ratio [PR], 1.00; 95% confidence interval [CI], 0.95-1.04) or NPs (PR, 1.01; 95% CI, 0.96-1.05). Similarly, there were no differences between the hub and spokes (PR, 1.01; 95% CI, 0.98-1.04). Conclusion: Among a low-income and majority homeless cohort of patients at urban FQHC clinics, HCV treatment administered by nonspecialist providers was not inferior to that provided by a specialist.

Understanding health disparities affecting utilization of tobacco treatment in low-income patients in an urban health center in Southern California.

Tobacco use disproportionately affects low-income communities. Prevalence among patients in Federally Qualified Health Centers (FQHCs) is higher (29.3%) than the general population (20%). Little is known about the rates of referrals to cessation services and cessation pharmacotherapy practices in FQHCs. This study will examine referral and prescribing patterns based on patient characteristics at a large FQHC in Southern California. We conducted a retrospective analysis of EHR data from 2019. Patients who were ≥ 18 years old and had "tobacco use" as an active problem were included in analyses. We characterized the proportion of 1) those who were referred to California Smokers' Helpline (CSH), 2) referred to smoking cessation counseling (SCC) at the FQHC clinic, or 3) received pharmacotherapy. Associations of demographic characteristics and comorbidities with referral types and uptake of services were evaluated using mixed-effects multinomial and logistic regressions. Of the 20,119 tobacco users identified, 87% had some cessation intervention: 66% were advised to quit and given information to contact CSH, while 21% were referred to SCC. Patients were least likely to get referred to cessation services if they had more medical, psychiatric, or substance use comorbidities, were in the lowest income group, were uninsured or were Hispanic. Although EHR systems have enhanced the ease of screening, most patients do not receive more than brief advice to quit during a PCP visit. Most (70%) low-income smokers see their PCPs at least once a year, making FQHCs excellent settings to promote smoking cessation initiatives in low-income populations.

Response to the Coronavirus Disease 2019 Pandemic Among People Experiencing Homelessness in Congregant Living Settings in San Diego, California.

During April 2020-August 2020, a preemptive testing strategy combined with accessible isolation and symptom screening among people experiencing homelessness in congregant living settings in San Diego, California, contributed to a low incidence proportion of coronavirus disease 2019 (0.9%). Proactively addressing challenges specific to a vulnerable population may prove impactful.

LesionViewer: a tool for tracking cancer lesions over time.

Oncologists managing cancer patients use radiology imaging studies to evaluate changes in measurable cancer lesions. Currently, the textual radiology report summarizes the findings, but is disconnected from the primary image data. This makes it difficult for the physician to obtain a visual overview of the location and behavior of the disease. LesionViewer is a prototype software system designed to assist clinicians in comprehending and reviewing radiology imaging studies. The interface provides an Anatomical Summary View of the location of lesions identified in a series of studies, and direct navigation to the relevant primary image data. LesionViewer's Disease Summary View provides a temporal abstraction of the disease behavior between studies utilizing methods of the RECIST guideline. In a usability study, nine physicians used the system to accurately perform clinical tasks appropriate to the analysis of radiology reports and image data. All users reported they would use the system if available.