Background: The clinical burden of Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and other post-infectious fatiguing illnesses (PIFI) is increasing. There is a critical need to advance understanding of the effectiveness and sustainability of innovative approaches to clinical care of patients having these conditions. Methods: We aim to assess the effectiveness of a Long COVID and Fatiguing Illness Recovery Program (LC&FIRP) in a two-arm, single-blind, pragmatic, quality improvement, professional cluster, randomized controlled trial in which 20 consenting clinicians across primary care clinics in a Federally Qualified Health Center system in San Diego, CA, will be randomized at a ratio of 1:1 to either participate in (1) weekly multi-disciplinary team-based case consultation and peer-to-peer sharing of emerging best practices (i.e., teleECHO (Extension for Community Healthcare Outcomes)) with monthly interactive webinars and quarterly short courses or (2) monthly interactive webinars and quarterly short courses alone (a control group); 856 patients will be assigned to participating clinicians (42 patients per clinician). Patient outcomes will be evaluated according to the study arm of their respective clinicians. Quantitative and qualitative outcomes will be measured at 3- and 6-months post-baseline for clinicians and every 3-months post assignment to a participating clinician for patients. The primary patient outcome is change in physical function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29. Analyses of differences in outcomes at both the patient and clinician levels will include a linear mixed model to compare change in outcomes from baseline to each post-baseline assessment between the randomized study arms. A concurrent prospective cohort study will compare the LC&FIRP patient population to the population enrolled in a university health system. Longitudinal data analysis approaches will allow us to examine differences in outcomes between cohorts. Discussion: We hypothesize that weekly teleECHO sessions with monthly interactive webinars and quarterly short courses will significantly improve clinician- and patient-level outcomes compared to the control group. This study will provide much needed evidence on the effectiveness of a technology-enabled multi-disciplinary team-based care model for the management of Long COVID, ME/CFS, and other PIFI within a federally qualified health center. Trial registration: ClinicalTrials.gov, NCT05167227. Registered on December 22, 2021.

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.

Background: Hepatitis C virus (HCV) infection disproportionately affects people who inject drugs (PWID), particularly people experiencing homelessness, who face significant barriers to testing and treatment. Simplified testing and treatment algorithms, including the use of mobile medical units (MMUs), may improve access to care for this population. This study evaluated the effectiveness of a simplified HCV testing and treatment algorithm with integrated care delivered via MMU to unhoused PWID in an urban United States setting. Methods: This pragmatic, randomized controlled trial compared a simplified MMU care model with usual care among 201 PWID who tested positive for HCV antibody. Patients were randomized into simplified MMU or usual care. The primary outcome was treatment initiation within 6 months. Secondary outcomes included treatment completion, sustained virologic response at 12 weeks (SVR12), and initiation of medication-assisted treatment for opioid use disorder. Results: Of 98 patients with confirmed HCV RNA, 33% in the MMU group initiated treatment compared to 24% in the usual care group (P = .4). Treatment completion and SVR12 rates were higher in the usual care group (16% vs 10% and 12% vs 4%, respectively), but differences were not statistically significant. MMUs facilitated faster treatment initiation but encountered challenges with patient retention and follow-up. Conclusions: While the MMU model demonstrated potential for improving rapid access to HCV treatment, overall treatment initiation, retention, and cure rates remained low. A critical need remains to develop approaches that more closely approximate a test-and-treat model to increase treatment initiation and completion and achieve elimination in unhoused PWID. Clinical Trials Registration: NCT04741750.

In 2020, the Eliminate Hepatitis C Initiative in the county of San Diego (COSD) was launched, a private–public joint endeavor between the COSD and the American Liver Foundation. We use epidemic modeling to assess whether the COSD is on track to reach its elimination targets (80% reduction in incidence, 65% reduction in hepatitis C virus (HCV)-related mortality by 2030 compared to 2015) and what intervention scale-up may be required. We adapted a previously developed dynamic, deterministic model of HCV transmission and disease progression among adults in the COSD, stratified by risk, age, gender, and human immunodeficiency virus (HIV) status. The model is calibrated to detailed historical epidemiological data on HCV burden, treatment, and mortality in the COSD. We project HCV infections and mortality under status quo HCV treatment (65%/year among people coinfected with HCV and HIV, 0–5%/year among others) and determine what treatment scale-up among those without HIV is required to achieve HCV elimination, with or without concomitant reductions in injection transmission risk from 2024 onward. We project an increase in new HCV infections in the COSD to 2213 [95% C.I.: 1069–3763] in 2030, a mean 91% relative increase between 2015 and 2030. HCV-related deaths are expected to decrease to 246 [95% C.I.: 180–295] in 2030, a mean relative decrease of 14% compared to 2015. The incidence elimination target could be achieved through increasing HCV treatment among those without HIV to a mean of 60%/year, similar to the level achieved among people coinfected with HCV and HIV. Combination interventions reduce the treatment needed; if injecting risk is reduced by 25%, then treating 48%/year could achieve elimination. The COSD is likely not on track to reach the incidence or mortality targets, but achieving the incidence target is possible if treatment rates overall are scaled-up to rates that have been achieved among people coinfected with HCV and HIV. Elimination is achievable but requires committed funding and expansion of comprehensive testing, linkage, and treatment programs alongside harm reduction initiatives.

Sofosbuvir/velpatasvir/voxilaprevir is recommended for hepatitis C virus (HCV) retreatment in those who fail initial treatment but is unavailable in resource-limited settings. We describe a government sofosbuvir/velpatasvir + ribavirin (SOF/VEL + RBV) × 24 weeks retreatment program in Rwanda (November 2021–October 2022). Of 231 participants, 174 were cured (75.3% intention-to-treat analysis). SOF/VEL + RBV may be considered for HCV retreatment in resource-limited settings.

Background: Monoclonal antibody (mAb) treatment for COVID-19 is associated with improved clinical outcomes. However, there is limited information regarding the impact of treatment on symptoms and the prevalence of post-COVID Conditions (PCC). Understanding of the association between time to mAb infusion and the development of PCC is also limited. Methods: This longitudinal study was conducted among patients with COVID-19 who received mAb infusions at a Federally Qualified Health Center in San Diego, CA. A series of telephone interviews were conducted at baseline and follow-up (14 days and 28+ days). A comprehensive symptom inventory was completed and physical and mental health status were measured using PROMIS-29 and PHQ-2. Pearson’s Chi-squared tests and independent two-sample t-tests were performed to test for association between time to mAb infusion and outcomes at follow-up. A Poisson regression model was used to analyze whether time to mAb infusion predicts risk of developing PCC. Results: Participants (N = 411) were 53% female, ranged in age from 16 to 92 years (mean 50), and a majority (56%) were Latino/Hispanic. Cross-sectional findings revealed a high symptom burden at baseline (70% of patients had cough, 50% had fever, and 44% had headache). The prevalence of many symptoms decreased substantially by the final follow-up survey (29% of patients had cough, 3% had fever, and 28% had headache). Longitudinal findings indicated that 10 symptoms decreased in prevalence from baseline to final follow-up, 2 remained the same, and 14 increased. The severity of symptoms and most patient-reported physical and mental health measure scores decreased over time. The prevalence of PCC was 69% when PCC was defined as ≥ 1 symptom at final follow-up. Time to mAb infusion was not significantly associated with any outcome at follow-up. Time to infusion was not associated with PCC status at final follow-up in the crude or adjusted Poisson regression models. Conclusions: The prevalence of PCC was high among this patient population following COVID-19 mAb treatment. Time to mAb infusion did not predict the development of PCC. Further research in these areas is essential to answer urgent clinical questions about effective treatments of COVID-19.