165 results on '"Linas BP"'
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2. Title: Keep It Up! 3.0: Study Protocol for a Type III Hybrid Implementation-Effectiveness Cluster-Randomized Trial
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Jones Jp, Dean A, Rana Saber, Macapagal K, Janulis P, Li Dh, Savinkina A, Smith Jd, Schackman Br, Swann G, Brown Ch, Linas Bp, Bettin E, Madkins Kl, Mustanski B, and Benbow N
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Protocol (science) ,Computer science ,Operating system ,Implementation effectiveness ,Cluster randomised controlled trial ,computer.software_genre ,computer - Abstract
BackgroundYoung men who have sex with men are disproportionately impacted by the HIV epidemic in the United States. Few rigorously tested HIV prevention interventions have been developed for young men who have sex with men; previous interventions have primarily focused on in-person programming, with high variability in fidelity. With nearly all young men who have sex with men going online daily, eHealth approaches to prevention may successfully bridge research and practice. Keep It Up! is an eHealth HIV Prevention program for young men who have sex with men. Previous research has demonstrated its effectiveness in reducing sexually transmitted infections and condomless anal sex and efficiency in delivering HIV prevention education. Aim 1 is to compare two strategies for implementing KIU—implementation in community-based organizations and a centralized direct-to-consumer recruitment arm. Aim 2 is to examine adoption characteristics which explain variability in implementation success. Our exploratory aim will develop recommendations and materials for sustainment of KIU after completion of the trial.MethodsThis is a Type III Hybrid Effectiveness-Implementation cluster randomized trial. Using estimates of young men who have sex with men per county in the United States, we identified 113 counties for our sample frame. Using an iterative process, we selected 66 counties to randomize 2:1 to our two strategies in Aim 1. The RE-AIM model for implementation science will be used to drive our outcome measurements in reach, effectiveness, implementation variability, and cost. Outcome measures will be collected from community-based organization staff participants, young men who have sex with men participants, and the technology provider. Our second aim will use mixed-methods research mapped onto the domains of the consolidated framework for implementation research. DiscussionThe trial has launched and is ongoing. This study is among the first to use a cluster randomized trial design in HIV implementation science. In comparing the community-based organization and direct to consumer models for recruitment and ongoing participant engagement, we are examining two strategies which have shown effectiveness in delivering health and technology interventions in the past, but with little base knowledge on their comparative advantages and disadvantages in implementation. The results of the trial will further understanding of the implementation of eHealth prevention interventions.Trial RegistrationNCT03896776, clinicaltrials.gov, 1 April 2019
- Published
- 2020
3. Isoniazid Preventive Therapy for People With HIV Who Are Heavy Alcohol Drinkers in High TB-/HIV-Burden Countries: A Risk-Benefit Analysis
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Freiman, JM, Jacobson, KR, Muyindike, WR, Horsburgh, CR, Eller, JJ, Hahn, JA, and Linas, BP
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Adult ,isoniazid ,Clinical Sciences ,Antitubercular Agents ,India ,HIV Infections ,Chemoprevention ,Young Adult ,prevention ,Models ,isoniazid preventive therapy ,Virology ,parasitic diseases ,Humans ,Tuberculosis ,Uganda ,alcohol ,HIV ,Statistical ,Survival Analysis ,Alcoholism ,Treatment Outcome ,Anti-Retroviral Agents ,Public Health and Health Services ,Female ,Liver Failure ,Brazil - Abstract
BACKGROUND:Isoniazid preventive therapy (IPT) reduces mortality among people living with HIV (PLHIV) and is recommended for those without active tuberculosis (TB) symptoms. Heavy alcohol use, however, is contraindicated for liver toxicity concerns. We evaluated the risks and benefits of IPT at antiretroviral therapy (ART) initiation to ART alone for PLHIV who are heavy drinkers in 3 high TB-/HIV-burden countries. METHODS:We developed a Markov simulation model to compare ART alone to ART with either 6 or 36 months of IPT for heavy drinking PLHIV enrolling in care in Brazil, India, and Uganda. Outcomes included nonfatal toxicity, fatal toxicity, life expectancy, TB cases, and TB death. RESULTS:In this simulation, 6 months of IPT + ART (IPT6) extended life expectancy over both ART alone and 36 months of IPT + ART (IPT36) in India and Uganda, but ART alone dominated in Brazil in 51.5% of simulations. Toxicity occurred in 160/1000 persons on IPT6 and 415/1000 persons on IPT36, with fatal toxicity in 8/1000 on IPT6 and 21/1000 on IPT36. Sensitivity analyses favored IPT6 in India and Uganda with high toxicity thresholds. CONCLUSIONS:The benefits of IPT for heavy drinkers outweighed its risks in India and Uganda when given for a 6-month course. The toxicity/efficacy trade-off was less in Brazil where TB incidence is lower. IPT6 resulted in fatal toxicity in 8/1000 people, whereas even higher toxicities of IPT36 negated its benefits in all countries. Data to better characterize IPT toxicity among HIV-infected drinkers are needed to improve guidance.
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- 2018
4. Evaluation of quality of life for diverse patient populations
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Linas Bp, Yabroff Kr, and Kevin A. Schulman
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Gerontology ,Clinical Trials as Topic ,Cancer Research ,medicine.medical_specialty ,education.field_of_study ,Cancer clinical trial ,business.industry ,Public health ,Population ,Clinical settings ,Objective analysis ,Cultural Diversity ,Patient preference ,Quality of life (healthcare) ,Oncology ,Evaluation Studies as Topic ,Neoplasms ,Cultural diversity ,Quality of Life ,medicine ,Humans ,education ,business - Abstract
Quality of life is used increasingly as a primary and secondary endpoint of clinical investigations of new therapies. Quality of life information may be especially useful for the assessment of cancer treatments, where increases in survival may be accompanied by detrimental side effects. The recognition of the importance of quality of life has led to the recent proliferation of cancer specific quality of life instruments. As more is understood about the heterogeneity of patient populations, however, we must assess how culturally defined factors may impact patient quality of life and its assessment. Quality of life instruments are diverse, ranging from those focusing on objective measures of functionality to those assessing subjective measures of patient preferences for their current health state. These instruments have been developed for use in the general population and for disease-specific populations. Assessment of the appropriateness of potential quality of life instruments in specific clinical settings, in addition to understanding the cultural diversity of the clinical population being studied, will guide the researcher in the choice of an appropriate quality of life instrument for cancer clinical trials.
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- 1996
5. Revisiting the Effectiveness of LTBI Screening in the U.S.
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Linas, BP, primary, Freedberg, KA, additional, and Horsburgh, CR, additional
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- 2009
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6. An economic analysis of the cost of mobile units for harm reduction, naloxone distribution, and medications for opioid use disorder.
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Castry M, Tin Y, Feder NM, Lewis N, Chatterjee A, Rudorf M, Samet JH, Beers D, Medley B, Gilbert L, Linas BP, and Barocas JA
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Background & Objective: Mobile substance use treatment units are effective approaches to increase treatment access and reduce barriers to opioid use disorder (OUD) care. However, little is known about the economic costs of maintaining and operating these units. This study aimed to estimate the economic costs of starting and maintaining mobile units providing harm reduction, overdose education and naloxone distribution (OEND), and medication for opioid use disorder (MOUD)., Methods: As part of the HEALing Communities Study, four communities in Massachusetts (Bourne/Sandwich, Brockton, Gloucester, Salem) implemented mobile units offering OEND and MOUD (buprenorphine and naltrexone only); each selected different services tailored to their community. All provided MOUD linkage via telehealth, but only one offered in-person MOUD prescribing on the unit. We retrospectively collected detailed resource utilization data from invoices to estimate the direct economic costs from August 2020 through June 2022. Cost components were categorized into start-up and operating costs. We calculated total economic cost over the study period and the average monthly operating cost., Results: Implementing a mobile unit offering OEND and MOUD required a one-time median start-up cost of $59,762 (range: $52,062-$113,671), with 80 % of those costs attributed to the vehicle purchase. The median monthly operating cost was $14,464. The largest cost category for all mobile units was personnel costs. The monthly ongoing costs varied by community settings and services: approximately $5000 for two urban communities offering OEND and MOUD linkage via telehealth (Gloucester, Salem), $28,000 for a rural community (Bourne/Sandwich), and $23,000 for an urban community also providing in-person MOUD prescribing on the unit (Brockton)., Conclusion: The economic costs of mobile substance use treatment and harm reduction units are substantial but vary by community settings and services offered. Our results provide valuable community-level economic data to stakeholders and policymakers considering establishing and/or expanding mobile units with OEND and MOUD services. Further exploration of cost-effectiveness and efficiency should be considered across different settings., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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7. Publisher Correction: Long COVID impacts: the voices and views of diverse Black and Latinx residents in Massachusetts.
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Sprague Martinez L, Sharma N, John J, Battaglia TA, Linas BP, Clark CR, Hudson LB, Lobb R, Betz G, Ojala O'Neill SO, Lima A, Doty R, Rahman S, and Bassett IV
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- 2024
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8. Long COVID impacts: the voices and views of diverse Black and Latinx residents in Massachusetts.
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Sprague Martinez L, Sharma N, John J, Battaglia TA, Linas BP, Clark CR, Hudson LB, Lobb R, Betz G, Ojala O'Neill SO, Lima A, Doty R, Rahman S, and Bassett IV
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- Adult, Aged, Female, Humans, Male, Middle Aged, Focus Groups, Massachusetts, Black or African American psychology, COVID-19 ethnology, COVID-19 psychology, Hispanic or Latino psychology, Post-Acute COVID-19 Syndrome
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Objective: To understand how Long COVID is impacting the health and social conditions of the Black and Latinx communities., Background: Emerging research on Long COVID has identified three distinct characteristics, including multi-organ damage, persistent symptoms, and post-hospitalization complications. Given Black and Latinx communities experienced significantly higher COVID rates in the first phase of the pandemic they may be disproportionately impacted by Long COVID., Methods: Eleven focus groups were conducted in four languages with diverse Black and Latinx individuals (n = 99) experiencing prolonged symptoms of COVID-19 or caring for family members with prolonged COVID-19 symptoms. Data was analyzed thematically., Results: Most participants in non-English language groups reported they were unfamiliar with the diagnosis of long COVID, despite experiencing symptoms. Long COVID impacts spanned financial and housing stability to physical and mental health impacts. Participants reported challenging encounters with health care providers, a lack of support managing symptoms and difficulty performing activities of daily living including work., Conclusions: There is a need for multilingual, accessible information about Long COVID symptoms, improved outreach and healthcare delivery, and increased ease of enrollment in long-term disability and economic support programs., (© 2024. The Author(s).)
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- 2024
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9. Potential impact of curative and preventive interventions toward hepatitis C elimination in people who inject drugs-A network modeling study.
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Zhu L, Thompson WW, Hagan L, Randall LM, Rudolph AE, Young AM, Havens JR, Salomon JA, and Linas BP
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- Humans, United States epidemiology, Needle Sharing, Incidence, Prevalence, Models, Theoretical, Substance Abuse, Intravenous complications, Substance Abuse, Intravenous epidemiology, Hepatitis C prevention & control, Hepatitis C epidemiology, Antiviral Agents administration & dosage, Antiviral Agents therapeutic use
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Background: Injection-equipment-sharing networks play an important role in hepatitis C virus (HCV) transmission among people who inject drugs (PWID). Direct-acting antiviral (DAA) treatments for HCV infection and interventions to prevent HCV transmission are critical components of an overall hepatitis C elimination strategy, but how they contribute to the elimination outcomes in different PWID network settings are unclear., Methods: We developed an agent-based network model of HCV transmission through the sharing of injection equipment among PWID and parameterized and calibrated the model with rural PWID data in the United States. We modeled curative and preventive interventions at annual coverage levels of 12.5 %, 25 %, or 37.5 % (cumulative percentage of eligible individuals engaged), and two allocation approaches: random vs targeting PWID with more injection partners (hereafter 'degree-based'). We compared the impact of these intervention strategies on prevalence and incidence of HCV infections. We conducted sensitivity analysis on key parameters governing the effects of curative and preventive interventions and PWID network characteristics., Results: Combining curative and preventive interventions at 37.5 % annual coverage with degree-based allocation decreased prevalence and incidence of HCV infection by 67 % and 70 % over two years, respectively. Curative interventions decreased prevalence by six to 12 times more than preventive interventions, while curative and preventive interventions had comparable effectiveness on reducing incidence. Intervention impact increased with coverage almost linearly across all intervention strategies, and degree-based allocation was always more effective than random allocation, especially for preventive interventions. Results were sensitive to parameter values defining intervention effects and network mean degree., Conclusion: DAA treatments are effective in reducing both prevalence and incidence of HCV infection in PWID, but preventive interventions play a significant role in reducing incidence when intervention coverage is low. Increasing coverage, including efforts in reaching individuals with the most injection partners, preventing reinfection, and improving compliance and retention in preventive services can substantially improve the outcomes. PWID network characteristics should be considered when designing hepatitis C elimination programs., Competing Interests: Declaration of competing interest The authors declare there is no conflict of interests., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
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- 2024
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10. COVID-19 clinical trials: who is likely to participate and why?
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Fisher KA, Epstein MM, Nguyen N, Fouayzi H, Crawford S, Linas BP, and Mazor KM
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- Humans, Female, Male, Middle Aged, Adult, Massachusetts, Trust, Surveys and Questionnaires, Aged, SARS-CoV-2, Patient Participation statistics & numerical data, Young Adult, COVID-19, Clinical Trials as Topic
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Aim: To identify factors associated with willingness to participate in a COVID-19 clinical trial and reasons for and against participating. Materials & methods: We surveyed Massachusetts (MA, USA) residents online using the Dynata survey platform and via phone using random digit dialing between October and November 2021. Respondents were asked to imagine they were hospitalized with COVID-19 and invited to participate in a treatment trial. We assessed willingness to participate by asking, "Which way are you leaning" and why. We used multivariate logistic regression to model factors associated with leaning toward participation. Open-ended responses were analyzed using conventional content analysis. Results: Of 1071 respondents, 65.6% leaned toward participating. Multivariable analyses revealed college-education (OR: 1.59; 95% CI: 1.11, 2.27), trust in the healthcare system (OR: 1.32; 95% CI: 1.10, 1.58) and relying on doctors (OR: 1.77; 95% CI: 1.45, 2.17) and family or friends (OR: 1.31; 95% CI: 1.11, 1.54) to make health decisions were significantly associated with leaning toward participating. Respondents with lower health literacy (OR: 0.57; 95% CI: 0.36, 0.91) and who identify as Black (OR: 0.40; 95% CI: 0.24, 0.68), Hispanic (OR: 0.61; 95% CI: 0.38, 0.98), or republican (OR: 0.61; 95% CI: 0.38, 0.97) were significantly less likely to lean toward participating. Common reasons for participating included helping others, benefitting oneself and deeming the study low risk. Common reasons for leaning against were deeming the study high risk, disliking experimental treatments and not wanting to be a guinea pig. Conclusion: Our finding that vulnerable individuals and those with lower levels of trust in the healthcare system are less likely to be receptive to participating in a COVID-19 clinical trial highlights that work is needed to achieve a healthcare system that provides confidence to historically disadvantaged groups that their participation in research will benefit their community.
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- 2024
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11. The association between naloxone claims and proportion of independent versus chain pharmacies: A longitudinal analysis of naloxone claims in the United States.
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Freibott CE, Jalali A, Murphy SM, Walley AY, Linas BP, Jeng PJ, Bratberg J, Marshall BDL, Zang X, Green TC, and Morgan JR
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- Humans, United States, Longitudinal Studies, Drug Overdose drug therapy, Drug Overdose epidemiology, Community Pharmacy Services statistics & numerical data, Health Services Accessibility statistics & numerical data, Naloxone supply & distribution, Naloxone therapeutic use, Narcotic Antagonists supply & distribution, Narcotic Antagonists therapeutic use, Pharmacies statistics & numerical data
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Background: Expanding access to naloxone through pharmacies is an important policy goal. Our objective was to characterize national county-level naloxone dispensing of chain versus independent pharmacies., Methods: The primary exposure in our longitudinal analysis was the proportion of chain pharmacies in a county, identified through the U.S. Department of Homeland Security 2010 Infrastructure Foundation-Level Data. We defined counties as having "higher proportion" of chain pharmacies if at least 50% of pharmacies were large national chains. The primary outcome was quarter-year (2016Q1-2019Q2) rate of pharmacy naloxone claims per 100,000 persons from Symphony Health at the county level. We compared the naloxone dispensing rate between county types using 2-sample t tests. We estimated the association between county-level chain pharmacy proportion and rate of naloxone claims using a linear model with year-quarter fixed effects., Results: Nearly one-third of counties (n = 946) were higher proportion. Higher proportion counties had a significantly higher rate of naloxone claims across the study period, in 4 of 6 urban-rural classifications, and in counties with and without naloxone access laws (NALs). The linear model confirmed that higher proportion counties had a significantly higher rate of naloxone claims, adjusting for urban-rural designation, income, population characteristics, opioid mortality rate, coprescribing laws, and NALs., Conclusion: In this national study, we found an association between naloxone dispensing rates and the county-level proportion of chain (vs. independent) pharmacies. Incentivizing naloxone dispensing through educational, regulatory, or legal efforts may improve naloxone availability and dispensing rates-particularly in counties with proportionately high numbers of independent pharmacies., Competing Interests: Disclosure The authors declare no relevant conflicts of interest or financial relationships., (Copyright © 2024 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)
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- 2024
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12. Strategies for isoniazid preventive therapy in HIV-positive patients who consume alcohol.
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Savinkina A, Muyindike W, Hahn JA, Emenyonu NI, Fatch R, Ngabirano C, Adong J, Jacobson KR, and Linas BP
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- Humans, Uganda epidemiology, Male, Female, Adult, Markov Chains, Tuberculin Test, Tuberculosis prevention & control, Tuberculosis epidemiology, Chemical and Drug Induced Liver Injury prevention & control, Chemical and Drug Induced Liver Injury etiology, Chemical and Drug Induced Liver Injury epidemiology, Young Adult, Middle Aged, Isoniazid administration & dosage, Antitubercular Agents administration & dosage, Antitubercular Agents adverse effects, Latent Tuberculosis drug therapy, HIV Infections drug therapy, Alcohol Drinking adverse effects, Alcohol Drinking epidemiology
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BACKGROUND WHO guidance to defer isoniazid preventive therapy (IPT) among those with regular alcohol use because of hepatotoxicity concerns may exclude many people living with HIV (PLWH) at high TB risk in these settings.OBJECTIVE To evaluate hepatotoxicity during TB preventive therapy (TPT) in PLWH who report alcohol use in Uganda over 10 years.METHODS We developed a Markov model of latent TB infection, isoniazid preventive therapy (IPT - a type of TPT), and TB disease using data from the Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT) study. We modeled several treatment scenarios, including no IPT, IPT with liver enzyme monitoring (AST/ALT) during treatment, and IPT with pre-screening using the tuberculin skin test (TST).RESULTS The no IPT scenario had 230 TB deaths/100,000 population over 10 years, which is more than that seen in any IPT scenario. IPT, even with no monitoring, was preferred over no IPT when population TB disease incidence was >50 in 100,000. .CONCLUSIONS For PLWH who report alcohol use in high TB burden settings, IPT should be offered, ideally with regular AST/ALT monitoring. However, even if regular monitoring is not possible, IPT is still preferable to no IPT in almost every modeled scenario.- Published
- 2024
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13. Test characteristics for combining non-invasive liver fibrosis staging modalities in individuals with Hepatitis C virus.
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Epstein RL, Buzzee B, White LF, Feld JJ, Castera L, Sterling RK, Linas BP, and Taylor LE
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- Humans, Sensitivity and Specificity, Hepatitis C, Chronic complications, Hepatitis C, Chronic pathology, Predictive Value of Tests, Severity of Illness Index, Male, Female, Hepatitis C diagnosis, Hepatitis C complications, Middle Aged, Liver Cirrhosis diagnosis, Liver Cirrhosis pathology, Liver Cirrhosis virology, Elasticity Imaging Techniques methods
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Non-invasive methods have largely replaced biopsy to identify advanced fibrosis in hepatitis C virus (HCV). Guidelines vary regarding testing strategy to balance accuracy, costs and loss to follow-up. Although individual test characteristics are well-described, data comparing the accuracy of using two tests together are limited. We calculated combined test characteristics to determine the utility of combined strategies. This study synthesizes empirical data from fibrosis staging trials and the literature to estimate test characteristics for Fibrosis-4 (FIB4), APRI or a commercial serum panel (FibroSure®), followed by transient elastography (TE) or FibroSure®. We simulated two testing strategies: (1) second test only for those with intermediate first test results (staged approach), and (2) second test for all. We summarized empiric data with multinomial distributions and used this to estimate test characteristics of each strategy on a simulated population of 10,000 individuals with 4.2% cirrhosis prevalence. Negative predictive value (NPV) for cirrhosis from a single test ranged from 98.2% (95% CB 97.6-98.8%) for FIB-4 to 99.4% (95% CB 99.0-99.8%) for TE. Using a staged approach with TE second, sensitivity for cirrhosis rose to 93.3-96.9%, NPV to 99.7-99.8%, while PPV dropped to <32%. Using TE as a second test for all minimally changed estimated test characteristics compared with the staged approach. Combining two non-invasive fibrosis tests barely improves NPV and decreases or does not change PPV compared with a single test, challenging the utility of serial testing modalities. These calculated combined test characteristics can inform best methods to identify advanced fibrosis in various populations., (© 2024 John Wiley & Sons Ltd.)
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- 2024
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14. Long COVID awareness and receipt of medical care: a survey among populations at risk for disparities.
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Fisher KA, Mazor KM, Epstein MM, Goldthwait L, Abu Ghazaleh H, Zhou Y, Crawford S, Marathe J, and Linas BP
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- Adolescent, Adult, Aged, Female, Humans, Male, Middle Aged, Young Adult, Cross-Sectional Studies, Hispanic or Latino statistics & numerical data, SARS-CoV-2, Surveys and Questionnaires, United States, Black or African American, White, Post-Acute COVID-19 Syndrome, COVID-19 epidemiology, Health Knowledge, Attitudes, Practice, Healthcare Disparities statistics & numerical data
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Introduction: The COVID-19 pandemic has been characterized by disparities in disease burden and medical care provision. Whether these disparities extend to long COVID awareness and receipt of medical care is unknown. We aimed to characterize awareness of long COVID and receipt of medical care for long COVID symptoms among populations who experience disparities in the United States (US)., Methods: We conducted a cross-sectional survey among a national sample of US adults between January 26-February 5, 2023. We surveyed approximately 2,800 adults drawn from the Ipsos probability-based KnowledgePanel® who identify as White, Black, or Hispanic, with over-sampling of Black, Hispanic, and Spanish-proficient adults. Awareness of long COVID was assessed with the question, "Have you heard of long COVID? This is also referred to as post-COVID, Long-haul COVID, Post-acute COVID-19, or Chronic COVID." Respondents reporting COVID-19 symptoms lasting longer than 1 month were classified as having long COVID and asked about receipt of medical care., Results: Of the 2,828 respondents, the mean age was 50.4 years, 52.8% were female, 40.2% identified as Hispanic, 29.8% as Black, and 26.7% as White. 18% completed the survey in Spanish. Overall, 62.5% had heard of long COVID. On multivariate analysis, long COVID awareness was lower among respondents who identified as Black (OR 0.64; 95% CI 0.51, 0.81), Hispanic and completed the survey in English (OR 0.59; 95% CI 0.46, 0.76), and Hispanic and completed the survey in Spanish (OR 0.31, 95% C.I. 0.23, 0.41), compared to White respondents (overall p < 0.001). Long COVID awareness was also associated with educational attainment, higher income, having health insurance, prior history of COVID-19 infection, and COVID-19 vaccination. Among those reporting symptoms consistent with long COVID ( n = 272), 26.8% received medical care. Older age, longer symptom duration and greater symptom impact were associated with receipt of medical care for long COVID symptoms. Of those who received care, most (77.8%) rated it as less than excellent on a 5-point scale., Discussion: This survey reveals limited awareness of long COVID and marked disparities in awareness according to race, ethnicity, and language. Targeted public health campaigns are needed to raise awareness., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer RS declared a shared parent affiliation, with the authors JM and BL to the handling editor at the time of the review., (Copyright © 2024 Fisher, Mazor, Epstein, Goldthwait, Abu Ghazaleh, Zhou, Crawford, Marathe and Linas.)
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- 2024
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15. Challenges of COVID-19 Case Forecasting in the US, 2020-2021.
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Lopez VK, Cramer EY, Pagano R, Drake JM, O'Dea EB, Adee M, Ayer T, Chhatwal J, Dalgic OO, Ladd MA, Linas BP, Mueller PP, Xiao J, Bracher J, Castro Rivadeneira AJ, Gerding A, Gneiting T, Huang Y, Jayawardena D, Kanji AH, Le K, Mühlemann A, Niemi J, Ray EL, Stark A, Wang Y, Wattanachit N, Zorn MW, Pei S, Shaman J, Yamana TK, Tarasewicz SR, Wilson DJ, Baccam S, Gurung H, Stage S, Suchoski B, Gao L, Gu Z, Kim M, Li X, Wang G, Wang L, Wang Y, Yu S, Gardner L, Jindal S, Marshall M, Nixon K, Dent J, Hill AL, Kaminsky J, Lee EC, Lemaitre JC, Lessler J, Smith CP, Truelove S, Kinsey M, Mullany LC, Rainwater-Lovett K, Shin L, Tallaksen K, Wilson S, Karlen D, Castro L, Fairchild G, Michaud I, Osthus D, Bian J, Cao W, Gao Z, Lavista Ferres J, Li C, Liu TY, Xie X, Zhang S, Zheng S, Chinazzi M, Davis JT, Mu K, Pastore Y Piontti A, Vespignani A, Xiong X, Walraven R, Chen J, Gu Q, Wang L, Xu P, Zhang W, Zou D, Gibson GC, Sheldon D, Srivastava A, Adiga A, Hurt B, Kaur G, Lewis B, Marathe M, Peddireddy AS, Porebski P, Venkatramanan S, Wang L, Prasad PV, Walker JW, Webber AE, Slayton RB, Biggerstaff M, Reich NG, and Johansson MA
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- Humans, United States epidemiology, Computational Biology, Models, Statistical, COVID-19 epidemiology, COVID-19 transmission, Forecasting methods, SARS-CoV-2, Pandemics statistics & numerical data
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During the COVID-19 pandemic, forecasting COVID-19 trends to support planning and response was a priority for scientists and decision makers alike. In the United States, COVID-19 forecasting was coordinated by a large group of universities, companies, and government entities led by the Centers for Disease Control and Prevention and the US COVID-19 Forecast Hub (https://covid19forecasthub.org). We evaluated approximately 9.7 million forecasts of weekly state-level COVID-19 cases for predictions 1-4 weeks into the future submitted by 24 teams from August 2020 to December 2021. We assessed coverage of central prediction intervals and weighted interval scores (WIS), adjusting for missing forecasts relative to a baseline forecast, and used a Gaussian generalized estimating equation (GEE) model to evaluate differences in skill across epidemic phases that were defined by the effective reproduction number. Overall, we found high variation in skill across individual models, with ensemble-based forecasts outperforming other approaches. Forecast skill relative to the baseline was generally higher for larger jurisdictions (e.g., states compared to counties). Over time, forecasts generally performed worst in periods of rapid changes in reported cases (either in increasing or decreasing epidemic phases) with 95% prediction interval coverage dropping below 50% during the growth phases of the winter 2020, Delta, and Omicron waves. Ideally, case forecasts could serve as a leading indicator of changes in transmission dynamics. However, while most COVID-19 case forecasts outperformed a naïve baseline model, even the most accurate case forecasts were unreliable in key phases. Further research could improve forecasts of leading indicators, like COVID-19 cases, by leveraging additional real-time data, addressing performance across phases, improving the characterization of forecast confidence, and ensuring that forecasts were coherent across spatial scales. In the meantime, it is critical for forecast users to appreciate current limitations and use a broad set of indicators to inform pandemic-related decision making., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: APP report grants from Metabiota Inc outside the submitted work. J.S. and Columbia University declare partial ownership of SK Analytics. No other authors have competing interests to declare., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)
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- 2024
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16. Cost-Effectiveness of Strategies for Treatment Timing for Perinatally Acquired Hepatitis C Virus.
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Curtis MR, Epstein RL, Pei P, Linas BP, and Ciaranello AL
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- Humans, Child, Child, Preschool, Female, Adolescent, Male, Infectious Disease Transmission, Vertical prevention & control, Pregnancy, United States epidemiology, Life Expectancy, Cost-Benefit Analysis, Antiviral Agents therapeutic use, Antiviral Agents economics, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic economics
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Importance: Prevalence of chronic hepatitis C virus (HCV) infection among pregnant people is increasing in the US. HCV is transmitted vertically in 7% to 8% of births. Direct-acting antiviral (DAA) therapy was recently approved for children with HCV who are 3 years or older. The clinical and economic impacts of early DAA therapy for young children with HCV, compared with treating at older ages, are unknown., Objective: To develop a state-transition model to project clinical and economic outcomes for children with perinatally acquired HCV to investigate the cost-effectiveness of treating at various ages., Design, Setting, and Participants: The study team modeled the natural history of perinatally acquired HCV to simulate disease progression and costs of a simulated a cohort of 1000 US children with HCV from 3 years old through death. Added data were analyzed January 5, 2021, through July 1, 2022., Interventions: The study compared strategies offering 8 weeks of DAA therapy at 3, 6, 12, or 18 years old, as well as a comparator of never treating HCV., Main Outcomes and Measures: Outcomes of interest include life expectancy from 3 years and average lifetime per-person health care costs. Other clinical outcomes include cases of cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma (HCC)., Results: The study team projected that treating HCV at 3 years old was associated with lower mean lifetime per-person health care costs ($148 162) than deferring treatment until 6 years old ($164 292), 12 years old ($171 909), or 18 years old ($195 374). Projected life expectancy was longest when treating at 3 years old (78.36 life years [LYs]) and decreased with treatment deferral until 6 years old (76.10 LYs), 12 years old (75.99 LYs), and 18 years old (75.46 LYs). In a cohort of 1000 children with perinatally acquired HCV, treating at 3 years old prevented 89 projected cases of cirrhosis, 27 cases of HCC, and 74 liver-related deaths compared with deferring treatment until 6 years old. In sensitivity analyses, increasing loss to follow-up led to even greater clinical benefits and cost savings with earlier treatment., Conclusions and Relevance: These study results showed that DAA therapy for 3-year-old children was projected to reduce health care costs and increase survival compared with deferral until age 6 years or older. Measures to increase DAA access for young children will be important to realizing these benefits.
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- 2024
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17. Evaluation of Strategies to Enhance Community-Based Naloxone Distribution Supported by an Opioid Settlement.
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Zang X, Skinner A, Krieger MS, Behrends CN, Park JN, Green TC, Walley AY, Morgan JR, Linas BP, Yedinak JL, Schackman BR, and Marshall BDL
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- Humans, Rhode Island, Analgesics, Opioid therapeutic use, Opioid-Related Disorders drug therapy, Drug Overdose drug therapy, Drug Overdose prevention & control, Drug Overdose mortality, Naloxone therapeutic use, Naloxone supply & distribution, Narcotic Antagonists therapeutic use, Opiate Overdose drug therapy
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Importance: Many US states are substantially increasing community-based naloxone distribution, supported in part through settlements from opioid manufacturers and distributors., Objectives: To evaluate the potential impact of increased naloxone availability on opioid overdose deaths (OODs) and explore strategies to enhance this impact by integrating interventions to address solitary drug use., Design, Setting, and Participants: This decision analytical modeling study used PROFOUND (Prevention and Rescue of Fentanyl and Other Opioid Overdoses Using Optimized Naloxone Distribution Strategies), a previously published simulation model, to forecast annual OODs between January 2023 and December 2025. The simulated study population included individuals from Rhode Island who misused opioids and stimulants and were at risk for opioid overdose., Exposures: The study modeled expanded naloxone distribution supported by the state's opioid settlement (50 000 naloxone nasal spray kits each year). Two approaches to expanding naloxone distribution were evaluated: one based on historical spatial patterns of naloxone distribution (supply-based approach) and one based on the spatial distribution of individuals at risk (demand-based approach). In addition, hypothetical interventions to enhance the likelihood of witnessed overdoses in private or semiprivate settings were considered., Main Outcomes and Measures: Annual number of OODs and ratio of fatal to nonfatal opioid overdoses., Results: Modeling results indicated that distributing more naloxone supported by the state's opioid settlement could reduce OODs by 6.3% (95% simulation interval [SI], 0.3%-13.7%) and 8.8% (95% SI, 1.8%-17.5%) in 2025 with the supply-based and demand-based approaches, respectively. However, increasing witnessed overdoses by 20% to 60% demonstrated greater potential for reducing OODs, ranging from 8.5% (95% SI, 0.0%-20.3%) to 24.1% (95% SI, 8.6%-39.3%). Notably, synergistic associations were observed when combining both interventions: increased naloxone distribution with the 2 approaches and a 60% increase in witnessed overdoses could reduce OODs in 2025 by 33.5% (95% SI, 17.1%-50.4%) and 37.4% (95% SI, 19.6%-56.3%), respectively., Conclusions and Relevance: These findings suggest that interventions to address solitary drug use are needed to maximize the impact of continued efforts to increase community-based naloxone distribution, which may be particularly important for jurisdictions that have strong community-based naloxone distribution programs.
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- 2024
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18. Cost of start-up activities to implement a community-level opioid overdose reduction intervention in the HEALing Communities Study.
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Montoya ID, Watson C, Aldridge A, Ryan D, Murphy SM, Amuchi B, McCollister KE, Schackman BR, Bush JL, Speer D, Harlow K, Orme S, Zarkin GA, Castry M, Seiber EE, Barocas JA, Linas BP, and Starbird LE
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- Humans, Delivery of Health Care, Massachusetts, Evidence-Based Practice, Opiate Overdose
- Abstract
Background: Communities That HEAL (CTH) is a novel, data-driven community-engaged intervention designed to reduce opioid overdose deaths by increasing community engagement, adoption of an integrated set of evidence-based practices, and delivering a communications campaign across healthcare, behavioral-health, criminal-legal, and other community-based settings. The implementation of such a complex initiative requires up-front investments of time and other expenditures (i.e., start-up costs). Despite the importance of these start-up costs in investment decisions to stakeholders, they are typically excluded from cost-effectiveness analyses. The objective of this study is to report a detailed analysis of CTH start-up costs pre-intervention implementation and to describe the relevance of these data for stakeholders to determine implementation feasibility., Methods: This study is guided by the community perspective, reflecting the investments that a real-world community would need to incur to implement the CTH intervention. We adopted an activity-based costing approach, in which resources related to hiring, training, purchasing, and community dashboard creation were identified through macro- and micro-costing techniques from 34 communities with high rates of fatal opioid overdoses, across four states-Kentucky, Massachusetts, New York, and Ohio. Resources were identified and assigned a unit cost using administrative and semi-structured-interview data. All cost estimates were reported in 2019 dollars., Results: State-level average and median start-up cost (representing 8-10 communities per state) were $268,657 and $175,683, respectively. Hiring and training represented 40%, equipment and infrastructure costs represented 24%, and dashboard creation represented 36% of the total average start-up cost. Comparatively, hiring and training represented 49%, purchasing costs represented 18%, and dashboard creation represented 34% of the total median start-up cost., Conclusion: We identified three distinct CTH hiring models that affected start-up costs: hospital-academic (Massachusetts), university-academic (Kentucky and Ohio), and community-leveraged (New York). Hiring, training, and purchasing start-up costs were lowest in New York due to existing local infrastructure. Community-based implementation similar to the New York model may have lower start-up costs due to leveraging of existing infrastructure, relationships, and support from local health departments., (© 2024. The Author(s).)
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- 2024
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19. Abatacept Pharmacokinetics and Exposure Response in Patients Hospitalized With COVID-19: A Secondary Analysis of the ACTIV-1 IM Randomized Clinical Trial.
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Balevic SJ, Benjamin DK Jr, Powderly WG, Smith PB, Gonzalez D, McCarthy MW, Shaw LK, Lindsell CJ, Bozzette S, Williams D, Linas BP, Blamoun J, Javeri H, and Hornik CP
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- Humans, Male, Female, Middle Aged, Aged, Hospitalization statistics & numerical data, Adult, Area Under Curve, Aged, 80 and over, Abatacept therapeutic use, Abatacept pharmacokinetics, COVID-19 mortality, SARS-CoV-2, COVID-19 Drug Treatment
- Abstract
Importance: The pharmacokinetics of abatacept and the association between abatacept exposure and outcomes in patients with severe COVID-19 are unknown., Objective: To characterize abatacept pharmacokinetics, relate drug exposure with clinical outcomes, and evaluate the need for dosage adjustments., Design, Setting, and Participants: This study is a secondary analysis of data from the ACTIV-1 (Accelerating COVID-19 Therapeutic Interventions and Vaccines) Immune Modulator (IM) randomized clinical trial conducted between October 16, 2020, and December 31, 2021. The trial included hospitalized adults who received abatacept in addition to standard of care for treatment of COVID-19 pneumonia. Data analysis was performed between September 2022 and February 2024., Exposure: Single intravenous infusion of abatacept (10 mg/kg with a maximum dose of 1000 mg)., Main Outcomes and Measures: Mortality at day 28 was the primary outcome of interest, and time to recovery at day 28 was the secondary outcome. Drug exposure was assessed using the projected area under the serum concentration time curve over 28 days (AUC0-28). Logistic regression modeling was used to analyze the association between drug exposure and 28-day mortality, adjusted for age, sex, and disease severity. The association between time to recovery and abatacept exposure was examined using Fine-Gray modeling with death as a competing risk, and was adjusted for age, sex, and disease severity., Results: Of the 509 patients who received abatacept, 395 patients with 848 serum samples were included in the population pharmacokinetic analysis. Their median age was 55 (range, 19-89) years and most (250 [63.3%]) were men. Abatacept clearance increased with body weight and more severe disease activity at baseline. Drug exposure was higher in patients who survived vs those who died, with a median AUC0-28 of 21 428 (range, 8462-43 378) mg × h/L vs 18 262 (range, 9628-27 507) mg × h/L (P < .001). Controlling for age, sex, and disease severity, an increase of 5000 units in AUC0-28 was associated with lower odds of mortality at day 28 (OR, 0.52 [95% CI, 0.35-0.79]; P = .002). For an AUC0-28 of 19 400 mg × h/L or less, there was a higher probability of recovery at day 28 (hazard ratio, 2.63 [95% CI, 1.70-4.08] for every 5000-unit increase; P < .001). Controlling for age, sex, and disease severity, every 5000-unit increase in AUC0-28 was also associated with lower odds of a composite safety event at 28 days (OR, 0.46 [95% CI, 0.33-0.63]; P < .001). Using the dosing regimen studied in the ACTIV-1 IM trial, 121 of the 395 patients (30.6%) would not achieve an abatacept exposure of at least 19 400 mg × h/L, particularly at the extremes of body weight. Using a modified, higher-dose regimen, only 12 patients (3.0%) would not achieve the hypothesized target abatacept exposure., Conclusions and Relevance: In this study, patients who were hospitalized with severe COVID-19 and achieved higher projected abatacept exposure had reduced mortality and a higher probability of recovery with fewer safety events. However, abatacept clearance was high in this population, and the current abatacept dosing (10 mg/kg intravenously with a maximum of 1000 mg) may not achieve optimal exposure in all patients., Trial Registration: ClinicalTrials.gov Identifier: NCT04593940.
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- 2024
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20. A Communications Campaign to Build Confidence in Covid-19 Vaccines: The Boston Medical Center Experience.
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Assoumou SA, Bonilla HV, Vautour L, White C, Read Newcomb A, Kibbe D, Goldie J, Merrill A, Monahan M, Linas BP, Drainoni ML, Pierre CM, and Graham R
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Health systems could play an important role in efforts to build vaccine confidence in communities that have been hardest hit by Covid-19. Boston Medical Center (BMC) health system, New England's largest safety-net hospital, along with its community partners, implemented a Covid Response Program aimed at building vaccine confidence. The program was supported by a multifaceted and multilingual communications campaign including: 1) traditional and social media channels with trusted messengers, 2) consistent and accessible core messaging, 3) transparent dialogue, and 4) partnership with state and local health government officials. Between December 2020 and June 2022, BMC disseminated 650 social media posts leading to 12 million impressions and more than 1.8 million post engagements. The campaign included a TikTok video later featured during the presidential inauguration, resulting in more than 3.7 million views. BMC's HealthCity digital publication released 20 articles gaining more than 73,000 views while the FAQ/vaccine scheduling site, translated into seven languages, reached 844,000 page visits. At six months into the vaccination program, 70% of BMC primary care patients 18 years or older had received at least one shot and 60% were fully vaccinated, having received either two mRNA doses or one adenovirus vaccine. The proportions rose to 82% with one dose and 75% fully vaccinated at 12 months. By 24 months into the program, 83% of BMC primary care patients had received at least one shot and 77% were fully vaccinated; however, notable differences existed by race/ethnicity. Seventy six percent of Black patients and 75% of Latino patients were fully vaccinated, compared with 85% of Asian and 81% White patients. Key lessons learned include the importance of a multilingual, multimedia campaign and the need for bidirectional communication that could quickly shift to address evolving issues.
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- 2024
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21. Establishing a Protocol for Determining the Costs of an Integrated Set of Evidence-based Practices Aimed at Reducing Opioid Overdose Deaths.
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Tin Y, Castry M, Bowers-Sword R, Shantharam S, Aldridge A, Zarkin GA, Starbird L, Linas BP, Barocas JA, and Morgan JR
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- Humans, Prospective Studies, Public Health, Evidence-Based Practice methods, Opiate Overdose, Drug Overdose prevention & control
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Objectives: In the midst of the opioid overdose crisis, local jurisdictions face a choice of public health interventions. A significant barrier when considering evidence-based practices (EBPs) is the lack of information regarding their implementation cost. This protocol paper provides the methodological foundation for the economic cost evaluations of community-wide strategies on the scale of a national study. It can serve as a resource for other communities, local policymakers, and stakeholders as they consider implementing possible public health strategies in their unique settings., Methods: We present a protocol that details (1) the process of identifying, reviewing, and analyzing individual strategies for study-funded and non-study-funded costs; (2) prospective costing tool designation, and; (3) data collection. To do this, we set up working groups with community stakeholders, reviewed financial invoices, and surveyed individuals with detailed knowledge of their community implementation., Discussion: There were 3 main challenges/limitations. The first was the lack of a standard structure for documenting nonfunded costs associated with each strategy. The second was the need for timely implementation of cost data. The third was generalizability because our study designed its strategies for selected communities due to their high opioid overdose mortality rates. Future steps include more tailored questions to ask during the categorization/filter process and establishing realistic expectations for organizations regarding documenting., Conclusions: Data collected will provide a critical methodological foundation for costing large community-based EBP strategies and provide clarity for stakeholders on the cost of implementing EBP strategies to reduce opioid overdose deaths., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 American Society of Addiction Medicine.)
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- 2024
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22. Changes to opioid overdose deaths and community naloxone access among Black, Hispanic and White people from 2016 to 2021 with the onset of the COVID-19 pandemic: An interrupted time-series analysis in Massachusetts, USA.
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Zang X, Walley AY, Chatterjee A, Kimmel SD, Morgan JR, Murphy SM, Linas BP, Nolen S, Reilly B, Urquhart C, Schackman BR, and Marshall BDL
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- Humans, Analgesics, Opioid adverse effects, Black People, Ethnicity, Massachusetts epidemiology, Minority Groups, Pandemics, White, Hispanic or Latino, Interrupted Time Series Analysis, Black or African American, COVID-19, Naloxone therapeutic use, Opiate Overdose mortality, Opiate Overdose prevention & control
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Background and Aims: The onset of the coronavirus disease 2019 (COVID-19) pandemic was associated with a surge in opioid overdose deaths in Massachusetts, particularly affecting racial and ethnic minority communities. We aimed to compare the impact of the pandemic on opioid overdose fatalities and naloxone distribution from community-based programs across racial and ethnic groups in Massachusetts., Design: Interrupted time-series., Setting and Cases: Opioid overdose deaths (OODs) among non-Hispanic White, non-Hispanic Black, Hispanic and non-Hispanic other race people in Massachusetts, USA (January 2016 to June 2021)., Measurements: Rate of OODs per 100 000 people, rate of naloxone kits distributed per 100 000 people and ratio of naloxone kits per opioid overdose death as a measure of naloxone availability. We applied five imputation strategies using complete data in different periods to account for missingness of race and ethnicity for naloxone data., Findings: Before COVID-19 (January 2016 to February 2020), the rate of OODs declined among non-Hispanic White people [0.2% monthly reduction (95% confidence interval = 0.0-0.4%)], yet was relatively constant among all other population groups. The rate of naloxone kits increased across all groups (0.8-1.2% monthly increase) and the ratio of naloxone kits per OOD death among non-Hispanic White was 1.1% (0.8-1.4%) and among Hispanic people was 1.0% (0.2-1.8%). After the onset of the pandemic (March 2020+), non-Hispanic Black people experienced an immediate increase in the rate of OODs [63.6% (16.4-130%)], whereas rates among other groups remained similar. Trends in naloxone rescue kit distribution did not substantively change among any groups, and the ratio of naloxone kits per OOD death for non-Hispanic Black people did not compensate for the surge in OODs deaths in this group., Conclusions: With the onset of the COVID-19 pandemic, there was a surge in opioid overdose deaths among non-Hispanic Black people in Massachusetts, USA with no compensatory increase in naloxone rescue kit distribution. For non-Hispanic White and Hispanic people, opioid overdose deaths remained stable and naloxone kit distribution continued to increase., (© 2023 Society for the Study of Addiction.)
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- 2023
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23. Trends in buprenorphine dosage and days supplied for new treatment episodes for opioid use disorder, 2010-2019.
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Tilhou AS, Murray E, Wang J, Linas BP, White L, Samet JH, and LaRochelle M
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- Humans, Adult, Opiate Substitution Treatment, Analgesics, Opioid therapeutic use, Retrospective Studies, Buprenorphine therapeutic use, Opioid-Related Disorders drug therapy, Opiate Overdose drug therapy
- Abstract
Background: Buprenorphine reduces risk of opioid overdose mortality. However, its benefits are limited by low retention, particularly in early treatment. Optimizing initial dosage may impact retention. However, little is known about the prescription characteristics of new buprenorphine treatment episodes., Methods: In a US sample of commercial and employer-sponsored pharmacy claims, we identified new buprenorphine treatment episodes (days 1-30) from individuals ≥16 years following 90 days without buprenorphine from 2010 to 2019. Outcomes included first prescription average days supplied, first prescription average daily dosage, and average dosage on days 2, 8, 15 and 30., Results: We identified 117,793 new episodes among 96,451 unique individuals. Episodes per 10,000 person-years decreased slightly over time. Stratifying by age, sex and region demonstrated decreasing episodes among individuals ≤34 years and increasing episodes among individuals ≥35 years. From 2010-2019, first prescription average days supplied and daily dosage decreased from 17.1 to 15.3 days and 13.6mg to 11.6mg, respectively. Simultaneously, the proportion of episodes without possession and with dosages <16mg increased across all days and years. By day 30, episodes without buprenorphine possession grew from 27.9% to 30.8% and episodes involving dosages of <16mg grew from 26.4% to 33.4%., Conclusions: We found that buprenorphine dosage and days supplied for new treatment episodes decreased from 2010 to 2019 while buprenorphine possession worsened. Further investigation examining the relationship between buprenorphine dosage and retention in the early treatment period is needed., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023. Published by Elsevier B.V.)
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- 2023
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24. Modeling as Visioning: Exploring the Impact of Criminal Justice Reform on Health of Populations with Substance Use Disorders.
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Martin NK, Beletsky L, Linas BP, Bayoumi A, Pollack H, and Larney S
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In the context of historic reckoning with the role of the criminal-legal system as a structural driver of health harms, there is mounting evidence that punitive drug policies have failed to prevent problematic drug use while fueling societal harms. In this explainer article, we discuss how simulation modeling provides a methodological framework to explore the potential outcomes (beneficial and harmful) of various drug policy alternatives, from incremental to radical. We discuss potential simulation modeling opportunities while calling for a more active role of simulation modeling in visioning and operationalizing transformative change., Highlights: This article discusses opportunities for simulation modeling in projecting health and economic impacts (beneficial and harmful) of drug-related criminal justice reforms.We call on modelers to explore radical interventions to reduce drug-related harm and model grand alternative futures in addition to more probable scenarios, with a goal of opening up policy discourse to these options., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. The authors disclosed receipt of the follo wing financial support for the research, authorship, and/or publication of this article: Financial support for this study was provided entirely by a grant from the National Institute on Drug Abuse, R13DA052198. The funding agreement ensured the authors’ independence in designing the study, interpreting the data, writing, and publishing the report., (© The Author(s) 2023.)
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- 2023
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25. A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs.
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Frimpong JA, Parish CL, Feaster DJ, Gooden LK, Nelson MC, Matheson T, Siegel K, Haynes L, Linas BP, Assoumou SA, Tross S, Kyle T, Liguori TK, Toussaint O, Annane D, and Metsch LR
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- Humans, Analgesics, Opioid, HIV Testing, Randomized Controlled Trials as Topic, HIV Infections diagnosis, HIV Infections drug therapy, HIV Infections epidemiology, Mentoring, Hepatitis C diagnosis, Hepatitis C drug therapy, Hepatitis C epidemiology, Opioid-Related Disorders diagnosis, Opioid-Related Disorders epidemiology, Opioid-Related Disorders therapy
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Background: People with substance use disorders are vulnerable to acquiring HIV. Testing is fundamental to diagnosis, treatment, and prevention; however, in the past decade, there has been a decline in the number of substance use disorder (SUD) treatment programs offering on-site HIV testing. Fewer than half of SUDs in the USA offer on-site HIV testing. In addition, nearly a quarter of newly diagnosed cases have AIDS at the time of diagnosis. Lack of testing is one of the main reasons that annual HIV incidences have remained constant over time. Integration of HIV testing with testing for HCV, an infection prevalent among persons vulnerable to HIV infection, and in settings where they receive health services, including opioid treatment programs (OTPs), is of great public health importance., Methods/design: In this 3-arm cluster-RCT of opioid use disorders treatment programs, we test the effect of two evidence-based "practice coaching" (PC) interventions on the provision and sustained implementation of on-site HIV testing, on-site HIV/HCV testing, and linkage to care. Using the National Survey of Substance Abuse Treatment Services data available from SAMHSA, 51 sites are randomly assigned to one of the three conditions: practice coach facilitated structured conversations around implementing change, with provision of resources and documents to support the implementation of (1) HIV testing only, or (2) HIV/HCV testing, and (3) a control condition that provides a package with information only. We collect quantitative (e.g., HIV and HCV testing at 6-month-long intervals) and qualitative site data near the time of randomization, and again approximately 7-12 months after randomization., Discussion: Innovative and comprehensive approaches that facilitate and promote the adoption and sustainability of HIV and HCV testing in opioid treatment programs are important for addressing and reducing HIV and HCV infection rates. This study is one of the first to test organizational approaches (practice coaching) to increase HIV and HIV/HCV testing and linkage to care among individuals receiving treatment for opioid use disorder. The study may provide valuable insight and knowledge on the multiple levels of intervention that, if integrated, may better position OTPs to improve and sustain testing practices and improve population health., Trial Registration: ClinicalTrials.gov NCT03135886. Registered on 2 May 2017., (© 2023. BioMed Central Ltd., part of Springer Nature.)
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- 2023
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26. Economic Evaluation of Extended-Release Buprenorphine for Persons With Opioid Use Disorder.
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Flam-Ross JM, Marsh E, Weitz M, Savinkina A, Schackman BR, Wang J, Madushani RWMA, Morgan JR, Barocas JA, Walley AY, Chrysanthopoulou SA, Linas BP, and Assoumou SA
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- Adult, Female, Humans, Male, Middle Aged, Cost-Benefit Analysis, Patient Acceptance of Health Care, United States, Buprenorphine therapeutic use, Opioid-Related Disorders drug therapy
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Importance: In 2017, the US Food and Drug Administration (FDA) approved a monthly injectable form of buprenorphine, extended-release buprenorphine; published data show that extended-release buprenorphine is effective compared with no treatment, but its current cost is higher and current retention is lower than that of transmucosal buprenorphine. Preliminary research suggests that extended-release buprenorphine may be an important addition to treatment options, but the cost-effectiveness of extended-release buprenorphine compared with transmucosal buprenorphine remains unclear., Objective: To evaluate the cost-effectiveness of extended-release buprenorphine compared with transmucosal buprenorphine., Design, Setting, and Participants: This economic evaluation used a state transition model starting in 2019 to simulate the lifetime of a closed cohort of individuals with OUD presenting for evaluation for opioid agonist treatment with buprenorphine. The data sources used to estimate model parameters included cohort studies, clinical trials, and administrative data. The model relied on pharmaceutical costs from the Federal Supply Schedule and health care utilization costs from published studies. Data were analyzed from September 2021 to January 2023., Interventions: No treatment, treatment with transmucosal buprenorphine, or treatment with extended-release buprenorphine., Main Outcomes and Measures: Mean lifetime costs per person, discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs)., Results: The simulated cohort included 100 000 patients with OUD receiving (61% male; mean [SD] age, 38 [11] years) or not receiving medication treatment (58% male, mean [SD] age, 48 [18] years). Compared with no medication treatment, treatment with transmucosal buprenorphine yielded an ICER of $19 740 per QALY. Compared with treatment with transmucosal buprenorphine, treatment with extended-release buprenorphine yielded lower effectiveness by 0.03 QALYs per person at higher cost, suggesting that treatment with extended-release buprenorphine was dominated and not preferred. In probabilistic sensitivity analyses, treatment with transmucosal buprenorphine was the preferred strategy 60% of the time. Treatment with extended-release buprenorphine was cost-effective compared with treatment with transmucosal buprenorphine at a $100 000 per QALY willingness-to-pay threshold only after substantial changes in key parameters., Conclusions and Relevance: In this economic evaluation of extended-release buprenorphine compared with transmucosal buprenorphine for the treatment of OUD, extended-release buprenorphine was not associated with efficient allocation of limited resources when transmucosal buprenorphine was available. Future initiatives should aim to improve retention rates or decrease costs associated with extended-release buprenorphine.
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- 2023
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27. Safety and tolerability of isoniazid preventive therapy for tuberculosis for persons with HIV with and without alcohol use.
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Hahn JA, Ngabirano C, Fatch R, Emenyonu NI, Cheng DM, Adong J, Tumwegamire A, Terrault NA, Linas BP, Jacobson KR, and Muyindike WR
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- Humans, Isoniazid adverse effects, Antitubercular Agents adverse effects, Prospective Studies, Alcohol Drinking, HIV Infections complications, HIV Infections drug therapy, Tuberculosis prevention & control, Tuberculosis drug therapy
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Objective: Isoniazid (INH) preventive therapy is recommended to prevent tuberculosis (TB) disease for persons with HIV (PWH), except for those with regular and heavy alcohol consumption, due to hepatotoxicity concerns. We aimed to quantify the incidence of severe INH-related toxicity among PWH with and without recent alcohol consumption., Design: A prospective study of PWH receiving INH., Methods: We included PWH in southwest Uganda with recent (prior 3 months) ( n = 200) or no (prior year) self-reported alcohol consumption ( n = 101), on antiretroviral therapy, TB infected (≥5 mm on tuberculin skin test), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2× or less the upper limit of normal (ULN). Grade 3+ INH-related toxicity was ALT or AST at least 5× the ULN or severe symptoms; we stopped IPT upon detection. Grade 2 INH-related toxicity was ALT or AST 2-5× the ULN or moderate symptoms., Results: The cumulative incidence of Grade 3+ INH-related toxicity was 8.3% [95% confidence interval (95% CI) 5.4-12.0]; all resolved after INH cessation. Incidence was 6.0% (95% CI 3.1-10.2) among those reporting recent alcohol use and 12.9% (95% CI 7.0-21.0) among those reporting no prior year alcohol use. We found no differences by baseline phosphatidylethanol-confirmed alcohol severity. The cumulative incidence of Grade 2 toxicities (without Grade 3+) was 21.7% (95% CI 17.0-27.1); 25.0% (95% CI 19.0-31.8) among those with recent alcohol use and 14.8% (95% CI 8.1-23.9) among those with no prior year alcohol use., Conclusion: Alcohol use does not appear to increase risk for serious INH-related toxicity among PWH without significant liver enzyme elevations at baseline (≤2x ULN)., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)
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- 2023
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28. At the intersection of trust and mistrust: A qualitative analysis of motivators and barriers to research participation at a safety-net hospital.
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Tamlyn AL, Tjilos M, Bosch NA, Barnett KG, Perkins RB, Walkey A, Assoumou SA, Linas BP, and Drainoni ML
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- Humans, Qualitative Research, Health Knowledge, Attitudes, Practice, Health Services Research, Safety-net Providers, Trust
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Introduction: The underrepresentation of Black, Indigenous, and People of Color (BIPOC) individuals in healthcare research limits generalizability and contributes to healthcare inequities. Existing barriers and attitudes toward research participation must be addressed to increase the representation of safety net and other underserved populations., Methods: We conducted semi-structured qualitative interviews with patients at an urban safety net hospital, focusing on facilitators, barriers, motivators, and preferences for research participation. We conducted direct content analysis guided by an implementation framework and used rapid analysis methods to generate final themes., Results: We completed 38 interviews and identified six major themes related to preferences for engagement in research participation: (1) wide variation in research recruitment preferences; (2) logistical complexity negatively impacts willingness to participate; (3) risk contributes to hesitation toward research participation; (4) personal/community benefit, interest in study topic, and compensation serve as motivators for research participation; (5) continued participation despite reported shortcomings of informed consent process; and (6) mistrust could be overcome by relationship or credibility of information sources., Conclusion: Despite barriers to participation in research studies among safety-net populations, there are also facilitators that can be implemented to increase knowledge and comprehension, ease of participation, and willingness to join research studies. Study teams should vary recruitment and participation methods to ensure equal access to research opportunities., Patient/public Contribution: Our analysis methods and study progress were presented to individuals within the Boston Medical Center healthcare system. Through this process community engagement specialists, clinical experts, research directors, and others with significant experience working with safety-net populations supported data interpretation and provided recommendations for action following the dissemination of data., (© 2023 The Authors. Health Expectations published by John Wiley & Sons Ltd.)
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- 2023
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29. Population-Level Health Effects of Involuntary Displacement of People Experiencing Unsheltered Homelessness Who Inject Drugs in US Cities.
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Barocas JA, Nall SK, Axelrath S, Pladsen C, Boyer A, Kral AH, Meehan AA, Savinkina A, Peery D, Bien M, Agnew-Brune C, Goldshear J, Chiang J, Linas BP, Gonsalves G, Bluthenthal RN, and Mosites E
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- Humans, Cities, Housing, Ill-Housed Persons, Substance-Related Disorders epidemiology, Drug Overdose epidemiology
- Abstract
Importance: At least 500 000 people in the US experience homelessness nightly. More than 30% of people experiencing homelessness also have a substance use disorder. Involuntary displacement is a common practice in responding to unsheltered people experiencing homelessness. Understanding the health implications of displacement (eg, "sweeps," "clearings," "cleanups") is important, especially as they relate to key substance use disorder outcomes., Objective: To estimate the long-term health effects of involuntary displacement of people experiencing homelessness who inject drugs in 23 US cities., Design, Setting, and Participants: A closed cohort microsimulation model that simulates the natural history of injection drug use and health outcomes among people experiencing homelessness who inject drugs in 23 US cities. The model was populated with city-level data from the Centers for Disease Control and Prevention's National HIV Behavioral Surveillance system and published data to make representative cohorts of people experiencing homelessness who inject drugs in those cities., Main Outcomes and Measures: Projected outcomes included overdose mortality, serious injection-related infections and mortality related to serious injection-related infections, hospitalizations, initiations of medications for opioid use disorder, and life-years lived over a 10-year period for 2 scenarios: "no displacement" and "continual involuntary displacement." The population-attributable fraction of continual displacement to mortality was estimated among this population., Results: Models estimated between 974 and 2175 additional overdose deaths per 10 000 people experiencing homelessness at 10 years in scenarios in which people experiencing homelessness who inject drugs were continually involuntarily displaced compared with no displacement. Between 611 and 1360 additional people experiencing homelessness who inject drugs per 10 000 people were estimated to be hospitalized with continual involuntary displacement, and there will be an estimated 3140 to 8812 fewer initiations of medications for opioid use disorder per 10 000 people. Continual involuntary displacement may contribute to between 15.6% and 24.4% of additional deaths among unsheltered people experiencing homelessness who inject drugs over a 10-year period., Conclusion and Relevance: Involuntary displacement of people experiencing homelessness may substantially increase drug-related morbidity and mortality. These findings have implications for the practice of involuntary displacement, as well as policies such as access to housing and supportive services, that could mitigate these harms.
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- 2023
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30. Estimated Costs and Outcomes Associated With Use and Nonuse of Medications for Opioid Use Disorder During Incarceration and at Release in Massachusetts.
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Chatterjee A, Weitz M, Savinkina A, Macmadu A, Madushani RWMA, Potee RA, Ryan D, Murphy SM, Walley AY, and Linas BP
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- Humans, Naltrexone therapeutic use, Analgesics, Opioid therapeutic use, Massachusetts epidemiology, Opioid-Related Disorders drug therapy, Opioid-Related Disorders epidemiology, Buprenorphine therapeutic use, Drug Overdose drug therapy, Drug Overdose epidemiology
- Abstract
Importance: Most prisons and jails in the US discontinue medications for opioid use disorder (MOUD) upon incarceration and do not initiate MOUD prior to release., Objective: To model the association of MOUD access during incarceration and at release with population-level overdose mortality and OUD-related treatment costs in Massachusetts., Design, Setting, and Participants: This economic evaluation used simulation modeling and cost-effectiveness with costs and quality-adjusted life-years (QALYs) discounted at 3% to compare MOUD treatment strategies in a corrections cohort and an open cohort representing individuals with OUD in Massachusetts. Data were analyzed between July 1, 2021, and September 30, 2022., Exposures: Three strategies were compared: (1) no MOUD provided during incarceration or at release, (2) extended-release (XR) naltrexone offered only at release from incarceration, and (3) all 3 MOUDs (naltrexone, buprenorphine, and methadone) offered at intake., Main Outcomes and Measures: Treatment starts and retention, fatal overdoses, life-years and QALYs, costs, and incremental cost-effectiveness ratios (ICERs)., Results: Among 30 000 simulated incarcerated individuals with OUD, offering no MOUD was associated with 40 927 (95% uncertainty interval [UI], 39 001-42 082) MOUD treatment starts over a 5-year period and 1259 (95% UI, 1130-1323) overdose deaths after 5 years. Over 5 years, offering XR-naltrexone at release led to 10 466 (95% UI, 8515-12 201) additional treatment starts, 40 (95% UI, 16-50) fewer overdose deaths, and 0.08 (95% UI, 0.05-0.11) QALYs gained per person, at an incremental cost of $2723 (95% UI, $141-$5244) per person. In comparison, offering all 3 MOUDs at intake led to 11 923 (95% UI, 10 861-12 911) additional treatment starts, compared with offering no MOUD, 83 (95% UI, 72-91) fewer overdose deaths, and 0.12 (95% UI, 0.10-0.17) QALYs per person gained, at an incremental cost of $852 (95% UI, $14-$1703) per person. Thus, XR-naltrexone only was a dominated strategy (both less effective and more costly) and the ICER of all 3 MOUDs compared with no MOUD was $7252 (95% UI, $140-$10 018) per QALY. Among everyone with OUD in Massachusetts, XR-naltrexone only averted 95 overdose deaths over 5 years (95% UI, 85-169)-a 0.9% decrease in state-level overdose mortality-while the all-MOUD strategy averted 192 overdose deaths (95% UI, 156-200)-a 1.8% decrease., Conclusions and Relevance: The findings of this simulation-modeling economic study suggest that offering any MOUD to incarcerated individuals with OUD would prevent overdose deaths and that offering all 3 MOUDs would prevent more deaths and save money compared with an XR-naltrexone-only strategy.
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- 2023
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31. Estimated Clinical Outcomes and Cost-effectiveness Associated With Provision of Addiction Treatment in US Primary Care Clinics.
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Jawa R, Tin Y, Nall S, Calcaterra SL, Savinkina A, Marks LR, Kimmel SD, Linas BP, and Barocas JA
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- Humans, Cost-Benefit Analysis, Life Expectancy, Primary Health Care, Analgesics, Opioid therapeutic use, Buprenorphine therapeutic use
- Abstract
Importance: US primary care practitioners (PCPs) are the largest clinical workforce, but few provide addiction care. Primary care is a practical place to expand addiction services, including buprenorphine and harm reduction kits, yet the clinical outcomes and health care sector costs are unknown., Objective: To estimate the long-term clinical outcomes, costs, and cost-effectiveness of integrated buprenorphine and harm reduction kits in primary care for people who inject opioids., Design, Setting, and Participants: In this modeling study, the Reducing Infections Related to Drug Use Cost-Effectiveness (REDUCE) microsimulation model, which tracks serious injection-related infections, overdose, hospitalization, and death, was used to examine the following treatment strategies: (1) PCP services with external referral to addiction care (status quo), (2) PCP services plus onsite buprenorphine prescribing with referral to offsite harm reduction kits (BUP), and (3) PCP services plus onsite buprenorphine prescribing and harm reduction kits (BUP plus HR). Model inputs were derived from clinical trials and observational cohorts, and costs were discounted annually at 3%. The cost-effectiveness was evaluated over a lifetime from the modified health care sector perspective, and sensitivity analyses were performed to address uncertainty. Model simulation began January 1, 2021, and ran for the entire lifetime of the cohort., Main Outcomes and Measures: Life-years (LYs), hospitalizations, mortality from sequelae (overdose, severe skin and soft tissue infections, and endocarditis), costs, and incremental cost-effectiveness ratios (ICERs)., Results: The simulated cohort included 2.25 million people and reflected the age and gender of US persons who inject opioids. Status quo resulted in 6.56 discounted LYs at a discounted cost of $203 500 per person (95% credible interval, $203 000-$222 000). Each strategy extended discounted life expectancy: BUP by 0.16 years and BUP plus HR by 0.17 years. Compared with status quo, BUP plus HR reduced sequelae-related mortality by 33%. The mean discounted lifetime cost per person of BUP and BUP plus HR were more than that of the status quo strategy. The dominating strategy was BUP plus HR. Compared with status quo, BUP plus HR was cost-effective (ICER, $34 400 per LY). During a 5-year time horizon, BUP plus HR cost an individual PCP practice approximately $13 000., Conclusions and Relevance: This modeling study of integrated addiction service in primary care found improved clinical outcomes and modestly increased costs. The integration of addiction service into primary care practices should be a health care system priority.
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- 2023
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32. Keep It Up! 3.0: Study protocol for a type III hybrid implementation-effectiveness cluster-randomized trial.
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Mustanski B, Saber R, Jones JP, Macapagal K, Benbow N, Li DH, Brown CH, Janulis P, Smith JD, Marsh E, Schackman BR, Linas BP, Madkins K, Swann G, Dean A, Bettin E, and Savinkina A
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- Male, Humans, Homosexuality, Male, Randomized Controlled Trials as Topic, Sexual and Gender Minorities, Acquired Immunodeficiency Syndrome
- Abstract
Background: Despite evidence that eHealth approaches can be effective in reducing HIV risk, their implementation requirements for public health scale up are not well established, and effective strategies to bring these programs into practice are still unknown. Keep It Up! (KIU!) is an online program proven to reduce HIV risk among young men who have sex with men (YMSM) and ideal candidate to develop and evaluate novel strategies for implementing eHealth HIV prevention programs. KIU! 3.0 is a Type III Hybrid Effectiveness-Implementation cluster randomized trial designed to 1) compare two strategies for implementing KIU!: community-based organizations (CBO) versus centralized direct-to-consumer (DTC) recruitment; 2) examine the effect of strategies and determinants on variability in implementation success; and 3) develop materials for sustainment of KIU! after the trial concludes. In this article, we describe the approaches used to achieve these aims., Methods: Using county-level population estimates of YMSM, 66 counties were selected and randomized 2:1 to the CBO and DTC approaches. The RE-AIM model was used to drive outcome measurements, which were collected from CBO staff, YMSM, and technology providers. Mixed-methods research mapped onto the domains of the Consolidated Framework for Implementation Research will examine determinants and their relationship with implementation outcomes., Discussion: In comparing our implementation recruitment models, we are examining two strategies which have shown effectiveness in delivering health technology interventions in the past, yet little is known about their comparative advantages and disadvantages in implementation. The results of the trial will further the understanding of eHealth prevention intervention implementation., Competing Interests: Declaration of Competing Interest The authors declare that they have no competing interests., (Copyright © 2023. Published by Elsevier Inc.)
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- 2023
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33. "Community members have more impact on their neighbors than celebrities": leveraging community partnerships to build COVID-19 vaccine confidence.
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Tjilos M, Tamlyn AL, Ragan EJ, Assoumou SA, Barnett KG, Martin P, Perkins RB, Linas BP, and Drainoni ML
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- Child, Humans, Haiti, Learning, Motivation, Vaccination, COVID-19 Vaccines, COVID-19 epidemiology, COVID-19 prevention & control
- Abstract
Background: Vaccines are a strong public health tool to protect against severe disease, hospitalization, and death from COVID-19. Still, inequities in COVID-19 vaccination rates and health outcomes continue to exist among Black and Latino populations. Boston Medical Center (BMC) has played a significant role in vaccinating medically underserved populations, and organized a series of community-engaged conversations to better understand community concerns regarding the COVID-19 vaccine. This paper describes the themes which resulted from these community-engaged conversations and proposes next steps for healthcare leaders., Methods: We accessed nine publicly available recordings of the community-engaged conversations which were held between March 2021 and September 2021 and ranged from 8 to 122 attendees. Six conversations prioritized specific groups: the Haitian-Creole community, the Cape Verdean community, the Latino community, the Black Christian Faith community, guardians who care for children living with disabilities, and individuals affected by systemic lupus erythematosus. Remaining conversations targeted the general public of the Greater Boston Area. We employed a Consolidated Framework for Implementation Research-driven codebook to code our data. Our analysis utilized a modified version of qualitative rapid analysis methods., Results: Five main themes emerged from these community-engaged conversations: (1) Structural factors are important barriers to COVID-19 vaccination; (2) Mistrust exists due to the negative impact of systemic oppression and perceived motivation of the government; (3) There is a desire to learn more about biological and clinical characteristics of the COVID-19 vaccine as well as the practical implications of being vaccinated; (4) Community leaders emphasize community engagement for delivering COVID-19 information and education and; (5) Community leaders believe that the COVID-19 vaccine is a solution to address the pandemic., Conclusion: This study illustrates a need for community-engaged COVID-19 vaccine messaging which reflects the nuances of the COVID-19 vaccine and pandemic without oversimplifying information. In highlighting common concerns of the Greater Boston Area which contribute to a lack of confidence in the COVID-19 vaccine, we underscore important considerations for public health and healthcare leadership in the development of initiatives which work to advance health equity., (© 2023. The Author(s).)
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- 2023
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34. A Microsimulation Study of the Cost-Effectiveness of Hepatitis C Virus Screening Frequencies in Hemodialysis Centers.
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Epstein RL, Pramanick T, Baptiste D, Buzzee B, Reese PP, Linas BP, and Sawinski D
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- Humans, Hepacivirus, Cost-Benefit Analysis, Mass Screening, Renal Dialysis, Antiviral Agents therapeutic use, Hepatitis C diagnosis, Hepatitis C epidemiology, Hepatitis C, Chronic diagnosis, Hepatitis C, Chronic epidemiology, Hepatitis C, Chronic drug therapy
- Abstract
Background: National guidelines recommend twice-yearly hepatitis C virus (HCV) screening for patients receiving in-center hemodialysis. However, studies examining the cost-effectiveness of HCV screening methods or frequencies are lacking., Methods: We populated an HCV screening, treatment, and disease microsimulation model with a cohort representative of the US in-center hemodialysis population. Clinical outcomes, costs, and cost-effectiveness of the Kidney Disease Improving Global Outcomes (KDIGO) 2018 guidelines-endorsed HCV screening frequency (every 6 months) were compared with less frequent periodic screening (yearly, every 2 years), screening only at hemodialysis initiation, and no screening. We estimated expected quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs) between each screening strategy and the next less expensive alternative strategy, from a health care sector perspective, in 2019 US dollars. For each strategy, we modeled an HCV outbreak occurring in 1% of centers. In sensitivity analyses, we varied mortality, linkage to HCV cure, screening method (ribonucleic acid versus antibody testing), test sensitivity, HCV infection rates, and outbreak frequencies., Results: Screening only at hemodialysis initiation yielded HCV cure rates of 79%, with an ICER of $82,739 per QALY saved compared with no testing. Compared with screening at hemodialysis entry only, screening every 2 years increased cure rates to 88% and decreased liver-related deaths by 52%, with an ICER of $140,193. Screening every 6 months had an ICER of $934,757; in sensitivity analyses using a willingness-to-pay threshold of $150,000 per QALY gained, screening every 6 months was never cost-effective., Conclusions: The KDIGO-recommended HCV screening interval (every 6 months) does not seem to be a cost-effective use of health care resources, suggesting that re-evaluation of less-frequent screening strategies should be considered., (Copyright © 2022 by the American Society of Nephrology.)
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- 2023
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35. The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial: rationale and design of an emergency department-based randomized clinical trial of linkage-to-care strategies for hepatitis C.
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Rowan SE, Haukoos J, Kamis KF, Hopkins E, Gravitz S, Lyle C, Al-Tayyib AA, Gardner EM, Galbraith JW, Hsieh YH, Lyons MS, Rothman RE, White DAE, Morgan JR, Linas BP, Sabel AL, and Wyles DL
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- Adult, Humans, Prospective Studies, Hepacivirus, Emergency Service, Hospital, Treatment Outcome, Mass Screening methods, Hepatitis C diagnosis, Hepatitis C drug therapy
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Background: Hepatitis C (HCV) poses a major public health problem in the USA. While early identification is a critical priority, subsequent linkage to a treatment specialist is a crucial step that bridges diagnosed patients to treatment, cure, and prevention of ongoing transmission. Emergency departments (EDs) serve as an important clinical setting for HCV screening, although optimal methods of linkage-to-care for HCV-diagnosed individuals remain unknown. In this article, we describe the rationale and design of The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial., Methods: The DETECT Hep C Linkage-to-Care Trial will be a single-center prospective comparative effectiveness randomized two-arm parallel-group superiority trial to test the effectiveness of linkage navigation and clinician referral among ED patients identified with untreated HCV with a primary hypothesis that linkage navigation plus clinician referral is superior to clinician referral alone when using treatment initiation as the primary outcome. Participants will be enrolled in the ED at Denver Health Medical Center (Denver, CO), an urban, safety-net hospital with approximately 75,000 annual adult ED visits. This trial was designed to enroll a maximum of 280 HCV RNA-positive participants with one planned interim analysis based on methods by O'Brien and Fleming. This trial will further inform the evaluation of cost effectiveness, disparities, and social determinants of health in linkage-to-care, treatment, and disease progression., Discussion: When complete, the DETECT Hep C Linkage-to-Care Trial will significantly inform how best to perform linkage-to-care among ED patients identified with HCV., Trial Registration: ClinicalTrials.gov ID: NCT04026867 Original date: July 1, 2019 URL: https://clinicaltrials.gov/ct2/show/NCT04026867., (© 2023. The Author(s).)
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- 2023
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36. Laboratory test trends within 72 hours of hospital admission associated with death among COVID-19 patients.
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Zambrano S, Davis M, Leeds DR, Noronha K, McLaughlin A, Burns RH, Mulvey E, Linas BP, and Assoumou SA
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- Humans, SARS-CoV-2, Retrospective Studies, Hospitalization, Hospitals, COVID-19 epidemiology
- Abstract
Early identification of patients at risk for severe coronavirus disease 2019 (COVID-19) is crucial for appropriate triage and determination of need for closer monitoring. Few studies have examined laboratory trends in COVID-19 infection and sought to quantify the degree to which laboratory values affect mortality. We conducted a retrospective cohort (n = 407) study of hospitalized patients with COVID-19 early in the course of the pandemic, from March 16th to April 8th, 2020 and compared baseline to repeat laboratory testing 72 hours into admission. The primary outcome was death. We found that rises of 25 mg/L C-reactive protein, 50 units/L lactate dehydrogenase, and 100 ng/mL ferritin were associated with 23%, 28%, and 1% increased odds of death, respectively. In contrast, changes in fibrinogen, D-dimer, white blood cell count, and creatinine in the first few days of hospital admission were not associated with mortality. These quantitative findings may assist clinicians in determining the risk of potential clinical decline in patients with COVID-19 and influence early management., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)
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- 2022
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37. Evaluating equity in community-based naloxone access among racial/ethnic groups in Massachusetts.
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Nolen S, Zang X, Chatterjee A, Behrends CN, Green TC, Linas BP, Morgan JR, Murphy SM, Walley AY, Schackman BR, and Marshall BDL
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- United States epidemiology, Humans, Naloxone therapeutic use, Analgesics, Opioid therapeutic use, Racial Groups, United States Department of Veterans Affairs, Massachusetts, Drug Overdose, Opiate Overdose
- Abstract
Background: Racial/ethnic minorities have experienced disproportionate opioid-related overdose death rates in recent years. In this context, we examined inequities in community-based naloxone access across racial/ethnic groups in Massachusetts., Methods: We used data from: the Massachusetts Department of Public Health on community-based overdose education and naloxone distribution (OEND) programs; the Massachusetts Office of the Chief Medical Examiner on opioid-related overdose deaths, and; the United States Census American Community Survey for regional demographic/socioeconomic details to estimate community populations by race/ethnicity and racial segregation between African American/Black and white residents. Race/ethnicity groups included in the analysis were African American/Black (non-Hispanic), Hispanic, white (non-Hispanic), and "other" (non-Hispanic). We evaluated racial/ethnic differences in naloxone distribution across regions in Massachusetts and neighborhoods in Boston descriptively and spatially, plotting the race/ethnicity-specific number of kits per opioid-related overdose death per jurisdiction. Lastly, we constructed generalized estimating equations models with a negative binomial distribution to compare the race/ethnicity-specific naloxone distribution rate by OEND programs., Results: From 2016-2019, the median annual rate of naloxone kits received from OEND programs in Massachusetts per racial/ethnicity group ranged between 160 and 447 per 100,000. In a multivariable analysis, we found that the naloxone distribution rates for racial/ethnic minorities were lower than the rate for white residents. We also found naloxone was more likely to be distributed in racially segregated communities than non-segregated communities., Conclusion: We identified racial/ethnic inequities in naloxone receipt by individuals in Massachusetts. Additional resources focused on designing and implementing OEND programs for racial/ethnic minorities are warranted to ensure equitable access to naloxone., Competing Interests: Conflict of Interest No conflict declared., (Copyright © 2022 Elsevier B.V. All rights reserved.)
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- 2022
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38. Estimating Absenteeism Related to Nonalcohol Substance Use in a US National Cohort of Full-Time Employees.
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Morgan JR, Murphy SM, Assoumou SA, and Linas BP
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- Humans, Cost of Illness, Employment, Cohort Studies, Absenteeism, Substance-Related Disorders epidemiology
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Objective: We aimed to estimate absenteeism due to substance use disorder among full-time employees., Methods: We used the 2018 National Survey on Drug Use and Health to identify a sample of individuals employed full time. We used a survey-weighted multivariable negative binomial model to evaluate the association between absenteeism and type of substance use disorder controlling for available demographic information., Results: In the adjusted model, we estimated that opioid use without a disorder had the highest absenteeism for use, and polysubstance use disorder had the highest absenteeism among use disorders. In a hypothetical firm of 10,000 employees, we estimate $232,000 of lost wage value annually., Conclusions: Substance use is associated with absenteeism and presents a compelling argument for employers to promote programs that support treatment for employees and reduce downstream costs associated with absenteeism and turnover., Competing Interests: Conflicts of interest: Dr Murphy consulted for Fresh Tonic Marketing on a project unrelated to this work., (Copyright © 2022 American College of Occupational and Environmental Medicine.)
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- 2022
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39. Comparing Projected Fatal Overdose Outcomes and Costs of Strategies to Expand Community-Based Distribution of Naloxone in Rhode Island.
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Zang X, Bessey SE, Krieger MS, Hallowell BD, Koziol JA, Nolen S, Behrends CN, Murphy SM, Walley AY, Linas BP, Schackman BR, and Marshall BDL
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- Humans, Naloxone therapeutic use, Rhode Island epidemiology, Health Status Disparities, Delivery of Health Care, Opiate Overdose, Drug Overdose epidemiology, Illicit Drugs
- Abstract
Importance: In 2021, the state of Rhode Island distributed 10 000 additional naloxone kits compared with the prior year through partnerships with community-based organizations., Objective: To compare various strategies to increase naloxone distribution through community-based programs in Rhode Island to identify one most effective and efficient strategy in preventing opioid overdose deaths (OODs)., Design, Setting, and Participants: In this decision analytical model study conducted from January 2016 to December 2022, a spatial microsimulation model with an integrated decision tree was developed and calibrated to compare the outcomes of alternative strategies for distributing 10 000 additional naloxone kits annually among all individuals at risk for opioid overdose in Rhode Island., Interventions: Distribution of 10 000 additional naloxone kits annually, focusing on people who inject drugs, people who use illicit opioids and stimulants, individuals at various levels of risk for opioid overdose, or people who misuse prescription opioids vs no additional kits (status quo). Two expanded distribution implementation approaches were considered: one consistent with the current spatial distribution patterns for each distribution program type (supply-based approach) and one consistent with the current spatial distribution of individuals in each of the risk groups, assuming that programs could direct the additional kits to new geographic areas if required (demand-based approach)., Main Outcomes and Measures: Witnessed OODs, cost per OOD averted (efficiency), geospatial health inequality measured by the Theil index, and between-group variance for OOD rates., Results: A total of 63 131 simulated individuals were estimated to be at risk for opioid overdose in Rhode Island based on current population data. With the supply-based approach, prioritizing additional naloxone kits to people who use illicit drugs averted more witnessed OODs by an estimated mean of 18.9% (95% simulation interval [SI], 13.1%-30.7%) annually. Expanded naloxone distribution using the demand-based approach and focusing on people who inject drugs had the best outcomes across all scenarios, averting an estimated mean of 25.3% (95% SI, 13.1%-37.6%) of witnessed OODs annually, at the lowest mean incremental cost of $27 312 per OOD averted. Other strategies were associated with fewer OODs averted at higher costs but showed similar patterns of improved outcomes and lower unit costs if kits could be reallocated to areas with greater need. The demand-based approach reduced geospatial inequality in OOD rates in all scenarios compared with the supply-based approach and status quo., Conclusions and Relevance: In this decision analytical model study, variations in the effectiveness, efficiency, and health inequality of the different naloxone distribution expansion strategies and approaches were identified. Future efforts should be prioritized for people at highest risk for overdose (those who inject drugs or use illicit drugs) and redirected toward areas with the greatest need. These findings may inform future naloxone distribution priority settings.
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- 2022
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40. Barriers to accessing treatment for substance use after inpatient managed withdrawal (Detox): A qualitative study.
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David AR, Sian CR, Gebel CM, Linas BP, Samet JH, Sprague Martinez LS, Muroff J, Bernstein JA, and Assoumou SA
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- Adult, Female, Heroin, Humans, Male, Opiate Substitution Treatment methods, Qualitative Research, Residential Treatment, United States, Inpatients, Opioid-Related Disorders drug therapy
- Abstract
Introduction: Access to and uptake of evidence-based treatment for substance use disorder, specifically opioid use disorder (OUD), are limited despite the high death toll from drug overdose in the United States in recent years. Patient perceived barriers to evidence-based treatment after completion of short-term inpatient medically managed withdrawal programs (detox) have not been well studied. The purpose of the current study is to elicit patients' perspectives on challenges to transition to treatment, including medications for OUD (MOUD), after detox and potential solutions., Methods: We conducted semi-structured interviews (N = 24) at a detox center (2018-2019) to explore patients' perspectives on obstacles to treatment. The study managed the data in NVivo and we used content analysis to identify themes., Results: Patients' characteristics included the following: 54 % male; mean age 37 years; self-identified as White 67 %, Black 13 %, Latinx 8 %, Native Hawaiian/Pacific Islander 4 %, and other 8 %; heroin use in the past 3 months 67 %; and ever injecting drugs 71 %. Patients identified the following barriers: 1) lack of continuity of care; 2) limited number of detox and residential treatment program beds; 3) unstable housing; and 4) lack of options when choosing a treatment pathway. Solutions proposed by participants included: 1) increase low-barrier access to community MOUD; 2) add case managers at the detox center to establish continuity of care after discharge; 3) increase assistance with housing; and 4) encourage patient participation in treatment decisions., Conclusions: Patients identified lack of continuity of care, especially care coordination, as a major barrier to substance use treatment. Increasing treatment utilization, including MOUD, necessitates a multimodal approach to continuity of care, low-barrier access to MOUD, and support to address unstable housing. Patients want care that incorporates options and respect for. individualized preferences and needs., Competing Interests: Declaration of competing interest The authors have no conflicts of interest to declare. Linda Sprague Martinez is an external evaluator for the Boston Public Health Commission and Action for Boston Area Development and a research consultant for BMC and The City School., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2022
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41. Commentary on Grove et al.: a progress report on the US overdose response.
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Linas BP
- Subjects
- Humans, Research Report, Drug Overdose, Opioid-Related Disorders drug therapy
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- 2022
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42. Modeling the cost-effectiveness and impact on fatal overdose and initiation of buprenorphine-naloxone treatment at syringe service programs.
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Adams JW, Savinkina A, Fox A, Behrends CN, Madushani RWMA, Wang J, Chatterjee A, Walley AY, Barocas JA, and Linas BP
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- Analgesics, Opioid therapeutic use, Buprenorphine, Naloxone Drug Combination therapeutic use, Cost-Benefit Analysis, Humans, Narcotic Antagonists, Opiate Substitution Treatment methods, Syringes, Buprenorphine therapeutic use, Drug Overdose drug therapy, Opiate Overdose, Opioid-Related Disorders epidemiology
- Abstract
Aim: To estimate the number of treatment initiations, averted fatal opioid overdoses and the cost-effectiveness associated with offering buprenorphine-naloxone (buprenorphine) treatment on-site within existing syringe service programs (SSPs) in Massachusetts, USA., Design, Setting and Participants: This was a cohort-based mathematical model and cost-effectiveness analysis. We derived model inputs from state and national surveillance data, clinical trials and observational cohort studies. We compared an intervention scenario where 30% of SSP clients initiated buprenorphine treatment on-site at least once annually to a status quo scenario where no buprenorphine was available on-site among community treatment providers in Massachusetts, 2020-30. In individuals with opioid use disorder (OUD) we assumed that 80% of SSP clients had recently injected drugs and that treatment within SSPs would have similar or improved retention compared with standard-of-care buprenorphine programs, but higher rates of active opioid use while in treatment., Measurements: Number of treatment initiations (i.e. individuals began treatment on a medication for opioid use disorder or entered medically managed withdrawal), averted fatal opioid overdoses, quality-adjusted life-years (QALYs) and life-time discounted costs from a health sector and a limited societal perspective., Findings: The status quo scenario resulted in 23 051 fatal overdoses and 1 511 613 treatment initiations over a 10-year simulation period. An intervention scenario with on-site SSP buprenorphine treatment averted 4797 (-20.8%) fatal opioid overdoses and resulted in 129 359 (+8.6%) additional treatment initiations compared with the status quo. The intervention scenario was the dominating scenario: providing OUD treatment through Massachusetts SSPs cost less (-$3612 per person) with patients accumulating more QALYs (0.2 per person) compared with the status quo scenario., Conclusions: Offering buprenorphine treatment on-site within syringe service programs has the potential to decrease fatal overdoses substantially, improve treatment engagement and save on costs., (© 2022 Society for the Study of Addiction.)
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- 2022
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43. Metamodeling for Policy Simulations with Multivariate Outcomes.
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Zhong H, Brandeau ML, Yazdi GE, Wang J, Nolen S, Hagan L, Thompson WW, Assoumou SA, Linas BP, and Salomon JA
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- Humans, Linear Models, Normal Distribution, Policy, Algorithms, Neural Networks, Computer
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Purpose: Metamodels are simplified approximations of more complex models that can be used as surrogates for the original models. Challenges in using metamodels for policy analysis arise when there are multiple correlated outputs of interest. We develop a framework for metamodeling with policy simulations to accommodate multivariate outcomes., Methods: We combine 2 algorithm adaptation methods-multitarget stacking and regression chain with maximum correlation-with different base learners including linear regression (LR), elastic net (EE) with second-order terms, Gaussian process regression (GPR), random forests (RFs), and neural networks. We optimize integrated models using variable selection and hyperparameter tuning. We compare the accuracy, efficiency, and interpretability of different approaches. As an example application, we develop metamodels to emulate a microsimulation model of testing and treatment strategies for hepatitis C in correctional settings., Results: Output variables from the simulation model were correlated (average ρ = 0.58). Without multioutput algorithm adaptation methods, in-sample fit (measured by R
2 ) ranged from 0.881 for LR to 0.987 for GPR. The multioutput algorithm adaptation method increased R2 by an average 0.002 across base learners. Variable selection and hyperparameter tuning increased R2 by 0.009. Simpler models such as LR, EE, and RF required minimal training and prediction time. LR and EE had advantages in model interpretability, and we considered methods for improving the interpretability of other models., Conclusions: In our example application, the choice of base learner had the largest impact on R2 ; multioutput algorithm adaptation and variable selection and hyperparameter tuning had a modest impact. Although advantages and disadvantages of specific learning algorithms may vary across different modeling applications, our framework for metamodeling in policy analyses with multivariate outcomes has broad applicability to decision analysis in health and medicine.- Published
- 2022
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44. Nutritional Supplementation Would Be Cost-Effective for Reducing Tuberculosis Incidence and Mortality in India: The Ration Optimization to Impede Tuberculosis (ROTI-TB) Model.
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Sinha P, Lakshminarayanan SL, Cintron C, Narasimhan PB, Locks LM, Kulatilaka N, Maloomian K, Prakash Babu S, Carwile ME, Liu AF, Horsburgh CR, Acuna-Villaorduna C, Linas BP, and Hochberg NS
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- Adult, Cost-Benefit Analysis, Dietary Supplements, Humans, Incidence, India epidemiology, Quality of Life, HIV Infections epidemiology, HIV Infections prevention & control, Malnutrition epidemiology, Malnutrition prevention & control, Tuberculosis epidemiology, Tuberculosis prevention & control
- Abstract
Background: Undernutrition is the leading cause of tuberculosis (TB) in India and is associated with increased TB mortality. Undernutrition also decreases quality of life and economic productivity., Methods: We assessed the cost-effectiveness of providing augmented rations to undernourished Indians through the government's Targeted Public Distribution System (TPDS). We used Markov state transition models to simulate disease progression and mortality among undernourished individuals in 3 groups: general population, household contacts (HHCs) of people living with TB, and persons living with human immunodeficiency virus (HIV). The models calculate costs and outcomes (TB cases, TB deaths, and disability-adjusted life years [DALYs]) associated with a 2600 kcal/day diet for adults with body mass index (BMI) of 16-18.4 kg/m2 until they attain a BMI of 20 kg/m2 compared to a status quo scenario wherein TPDS rations are unchanged. We employed deterministic and probabilistic sensitivity analyses to test result robustness., Results: Over 5 years, augmented rations could avert 81% of TB cases and 88% of TB deaths among currently undernourished Indians. Correspondingly, this intervention could forestall 78% and 48% of TB cases and prevent 88% and 70% of deaths among undernourished HHCs and persons with HIV, respectively. Augmented rations resulted in 10-fold higher resolution of undernutrition and were highly cost-effective with (incremental cost-effectiveness ratio [ICER] of $470/DALY averted). ICER was lower for HHCs ($360/DALY averted) and the HIV population ($250/DALY averted)., Conclusions: A robust nutritional intervention would be highly cost-effective in reducing TB incidence and mortality while reducing chronic undernutrition in India., Competing Interests: Potential conflicts of interest. L. M. L. reports Thrasher Research Fund Early Career award to study anemia in India. C. R. H. reports being a consultant for Otsuka Pharmaceuticals (no fees received to date); being on the DSMB for the BEAT-TUBERCULOSIS Study, the SUDOCU Study, and the Stool4TB study (all unpaid); and is the Vice-President of the International Union Against Tuberculosis and Lung Disease. N.S.H. reports being on American Society of Tropical Medicine and Hygiene, Respiratory Diseases and Tuberculosis Working Group, Scientific Program Committee. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
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- 2022
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45. The Hepatitis C Care Cascade During the Direct-Acting Antiviral Era in a United States Commercially Insured Population.
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Ferrante ND, Newcomb CW, Forde KA, Leonard CE, Torgersen J, Linas BP, Rowan SE, Wyles DL, Kostman J, Trooskin SB, and Lo Re V 3rd
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Background: Periodic surveillance of the hepatitis C virus (HCV) care cascade is important for tracking progress toward HCV elimination goals, identifying gaps in care, and prioritizing resource allocation. In the pre-direct-acting antiviral (DAA) era, it was estimated that 50% of HCV-infected individuals were diagnosed and that 16% had been prescribed interferon-based therapy. Since then, few studies utilizing nationally representative data from the DAA era have been conducted in the United States., Methods: We performed a cross-sectional study to describe the HCV care cascade in the United States using the Optum de-identified Clinformatics® Data Mart Database to identify a nationally representative sample of commercially insured beneficiaries between January 1, 2014 and December 31, 2019. We estimated the number of HCV-viremic individuals in Optum based on national HCV prevalence estimates and determined the proportion who had: (1) recorded diagnosis of HCV infection, (2) recorded HCV diagnosis and underwent HCV RNA testing, (3) DAA treatment dispensed, and (4) assessment for cure., Results: Among 120,311 individuals estimated to have HCV viremia in Optum during the study period, 109,233 (90.8%; 95% CI, 90.6%-91.0%) had a recorded diagnosis of HCV infection, 75,549 (62.8%; 95% CI, 62.5%-63.1%) had a recorded diagnosis of HCV infection and underwent HCV RNA testing, 41,102 (34.2%; 95% CI, 33.9%-34.4%) were dispensed DAA treatment, and 25,760 (21.4%; 95% CI, 21.2%-21.6%) were assessed for cure., Conclusions: Gaps remain between the delivery of HCV-related care and national treatment goals among commercially insured adults. Efforts are needed to increase HCV treatment among people diagnosed with chronic HCV infection to achieve national elimination goals., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
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- 2022
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46. The role of increasing pharmacy and community distributed naloxone in the opioid overdose epidemic in Massachusetts, Rhode Island, and New York City.
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Morgan JR, Freibott CE, Jalali A, Jeng PJ, Walley AY, Chatterjee A, Green TC, Nolan ML, Linas BP, Marshall BDL, and Murphy SM
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Background: Naloxone distributed to people at risk for opioid overdose has been associated with reduced overdose death rates; however, associations of retail pharmacy-distributed naloxone with overdose mortality have not been evaluated., Methods: Our analytic cohort uses retail pharmacy claims data; three health departments' community distribution data; federal opioid overdose data; and American Community Survey data. Data were analyzed by 3-digit ZIP Code and calendar quarter-year (2016Q1-2018Q4), and weighted by population. We regressed opioid-related overdose mortality on retail-pharmacy and community naloxone distribution, and community-level demographics using a linear model, hypothesizing that areas with high overdose rates would have higher current levels of naloxone distribution but that increasing naloxone distribution from one quarter to the next would be associated with lower overdose., Results: From Q1-2016 to Q4-2018, the unadjusted naloxone distribution rate increased from 97 to 257 kits per 100,000 persons, while the unadjusted opioid overdose mortality rate fell from 8.1 to 7.2 per 100,000 persons. The concurrent level of naloxone distribution (both pharmacy and community) was positively and significantly associated with fatal opioid overdose rates. We did not detect associations between change in naloxone distribution rates and overdose mortality., Conclusion: Naloxone distribution volumes were correlated with fatal opioid overdose, suggesting medication was getting to communities where it was needed most. Amid high rates of overdose driven by fentanyl in the drug supply, our findings suggest additional prevention, treatment, and harm reduction interventions are required-and dramatically higher naloxone volumes needed-to reverse the opioid overdose crisis in the US., Competing Interests: Declaration of Competing Interests The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. ✰All authors report no conflict of interest.
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- 2022
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47. Population-level impact of initiating pharmacotherapy and linking to care people with opioid use disorder at inpatient medically managed withdrawal programs: an effectiveness and cost-effectiveness analysis.
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Savinkina A, Madushani RWMA, Eftekhari Yazdi G, Wang J, Barocas JA, Morgan JR, Assoumou SA, Walley AY, Linas BP, and Murphy SM
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- Analgesics, Opioid therapeutic use, Cost-Benefit Analysis, Humans, Inpatients, Opiate Substitution Treatment, United States, Buprenorphine therapeutic use, Drug Overdose drug therapy, Drug Overdose prevention & control, Opioid-Related Disorders drug therapy
- Abstract
Background and Aims: Medications for opioid use disorder (MOUD) are shown to reduce opioid use and the risk of overdose. People with opioid use disorder (OUD) who exit inpatient medically managed withdrawal programs (detox) without initiating MOUD and linking to outpatient care have high rates of overdose. While detox encounters provide a theoretical opportunity for MOUD initiation, this is not ubiquitous in the United States. We used simulation modeling to estimate the population-level health effects and cost-effectiveness of a policy encouraging MOUD initiation during inpatient detox encounters., Design, Setting and Participants: We employed a dynamic population state-transition model to evaluate the effectiveness and cost-effectiveness of using detox programs as venues for initiating MOUD in Massachusetts, United States. We compared standard of care, where no detox patients initiate MOUD or link to outpatient MOUD providers, to strategies of offering MOUD to detox patients and linking those patients to outpatient MOUD., Measures: Budgetary impact to the Massachusetts health-care sector, incremental cost-effectiveness ratios (ICER) and total counts and percentage differences of fatal overdoses prevented., Findings: Initiating MOUD in detox with perfect linkage to outpatient MOUD would reduce fatal overdoses by 4.5% [95% confidence interval (CI) = 2.3-5.9], at an ICER of $56 000 per quality-adjusted life-year (QALY) gained, compared with the standard of care. With moderate linkage, fatal overdoses would be reduced by 2.3% (95% CI= 1.2-3.1) with an ICER of $78 500 per QALY gained, compared with standard of care. Budgetary increase to Massachusetts health-care spending ranged from 0.5-1%., Conclusion: A simulation model indicates that initiation of medications for opioid use disorder and linkage policies among detox patients in Massachusetts, USA could prevent fatal opioid overdoses in the opioid use disorder population and would be cost-effective from a health-care sector perspective., (© 2022 Society for the Study of Addiction.)
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- 2022
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48. Medicaid Hepatitis C Virus Treatment Policies: Impact on Testing and Treatment in the Commercially Insured.
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Epstein RL, Wang J, White LF, Kapadia SN, Morgan JR, Bao Y, and Linas BP
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- Fibrosis, Hepacivirus, Humans, Policy, United States epidemiology, Hepatitis C diagnosis, Hepatitis C drug therapy, Hepatitis C epidemiology, Medicaid
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Introduction: A total of 23 state Medicaid programs continue to restrict hepatitis C virus (HCV) medication access by liver disease or substance-use criteria, creating obstacles to HCV elimination and significant care disparities. Because public insurers often set precedents for private insurer coverage and clinician practice patterns, this study sought to analyze whether spillover occurs from state Medicaid HCV treatment restrictions to HCV screening and treatment rates in commercially insured individuals., Methods: Investigators analyzed 2014‒2017 commercial claims data across 48 U.S. states (721,961,965 person-months) and used an interrupted times series design to compare hepatitis C virus screening and treatment rates before and after state Medicaid HCV treatment policy changes, adjusting for state-level random effects, Medicaid expansion status, and state drug overdose incidence rates, in states that relaxed Medicaid policy over the study period. Analysis occurred during 2019‒2021., Results: Hepatitis C virus screening rates among commercially insured individuals increased after the corresponding state Medicaid program relaxed HCV treatment policy. Among states that changed Medicaid policy, those that reduced fibrosis or both fibrosis and abstinence restrictions experienced increased HCV screening rates by the study end compared with states that changed only abstinence restrictions (rate ratio=1.29; 95% CI=1.15, 1.44; and rate ratio=1.32; 95% CI=1.17, 1.50, respectively). Similar patterns did not occur in HCV treatment rates, which declined after 2015 across groups., Conclusions: These data show that HCV screening rates increased among commercially insured individuals after the removal of Medicaid HCV treatment restrictions in the same state. This suggests that Medicaid treatment policies can spill over to affect health outcomes among commercially insured populations., (Copyright © 2022 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)
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- 2022
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49. Projected Long-Term Impact of the Coronavirus Disease 2019 (COVID-19) Pandemic on Hepatitis C Outcomes in the United States: A Modeling Study.
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Barocas JA, Savinkina A, Lodi S, Epstein RL, Bouton TC, Sperring H, Hsu HE, Jacobson KR, Schechter-Perkins EM, Linas BP, and White LF
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- Antiviral Agents therapeutic use, Hepacivirus, Humans, Liver Cirrhosis drug therapy, Pandemics, United States epidemiology, COVID-19 epidemiology, Hepatitis C epidemiology
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Background: The coronavirus disease 2019 (COVID-19) pandemic disrupted access to and uptake of hepatitis C virus (HCV) care services in the United States. It is unknown how substantially the pandemic will impact long-term HCV-related outcomes., Methods: We used a microsimulation to estimate the 10-year impact of COVID-19 disruptions in healthcare delivery on HCV outcomes including identified infections, linkage to care, treatment initiation and completion, cirrhosis, and liver-related death. We modeled hypothetical scenarios consisting of an 18-month pandemic-related disruption in HCV care starting in March 2020 followed by varying returns to pre-pandemic rates of screening, linkage, and treatment through March 2030 and compared them to a counterfactual scenario in which there was no COVID-19 pandemic or disruptions in care. We also performed alternate scenario analyses in which the pandemic disruption lasted for 12 and 24 months., Results: Compared to the "no pandemic" scenario, in the scenario in which there is no return to pre-pandemic levels of HCV care delivery, we estimate 1060 fewer identified cases, 21 additional cases of cirrhosis, and 16 additional liver-related deaths per 100 000 people. Only 3% of identified cases initiate treatment and <1% achieve sustained virologic response (SVR). Compared to "no pandemic," the best-case scenario in which an 18-month care disruption is followed by a return to pre-pandemic levels, we estimated a smaller proportion of infections identified and achieving SVR., Conclusions: A recommitment to the HCV epidemic in the United States that involves additional resources coupled with aggressive efforts to screen, link, and treat people with HCV is needed to overcome the COVID-19-related disruptions., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
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- 2022
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50. Addressing Inequities in SARS-CoV-2 Vaccine Uptake: The Boston Medical Center Health System Experience.
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Assoumou SA, Peterson A, Ginman E, James T, Pierre CM, Hamilton S, Chapman S, Goldie J, Koenig R, Mendez-Escobar E, Leaver H, Graham R, Crichlow R, Weaver T, Cotterell S, Valdez G, De Las Nueces D, Scott NA, Linas BP, and Cherry PM
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- COVID-19 Vaccines, Community Health Centers, Humans, SARS-CoV-2, Vaccination, COVID-19 epidemiology, COVID-19 prevention & control, Vaccines
- Abstract
Academic medical centers could play an important role in increasing access to and uptake of SARS-CoV-2 vaccines, especially in Black and Latino communities that have been disproportionately affected by the pandemic. This article describes the vaccination program developed by the Boston Medical Center (BMC) health system (New England's largest safety-net health system), its affiliated community health centers (CHCs), and community partners. The program was based on a conceptual framework for community interventions and aimed to increase equitable access to vaccination in the hardest-hit communities through community-based sites in churches and community centers, mobile vaccination events, and vaccination on the BMC campus. Key strategies included a communication campaign featuring trusted messengers, a focus on health equity, established partnerships with community leaders and CHCs, and strong collaboration with local health departments and the Commonwealth of Massachusetts to ensure equitable allocation of the vaccine supply. Process factors involved the use of robust analytics relying on the Centers for Disease Control and Prevention's Social Vulnerability Index (SVI). The vaccination program administered 109 938 first doses, with 94 703 (86%) given at community sites and 2466 (2%) given at mobile sites. Mobile vaccination events were key in reaching younger people living in locations with the highest SVIs. Challenges included the need for a robust operational infrastructure and mistrust of the health system given the long history of economic disinvestment in the surrounding community. The BMC model could serve as a blueprint for other medical centers interested in implementing programs aimed at increasing vaccine uptake during a pandemic and in developing an infrastructure to address other health-related disparities.
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- 2022
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