Browsing by Author "Cohen-Wolkowiez, Michael"

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    Access to COVID-19 testing by individuals with housing insecurity during the early days of the COVID-19 pandemic in the United States: a scoping review.
    (Frontiers in public health, 2023-01) Johannesson, Jon M; Glover, William A; Petti, Cathy A; Veldman, Timothy H; Tsalik, Ephraim L; Taylor, Donald H; Hendren, Stephanie; Neighbors, Coralei E; Tillekeratne, L Gayani; Kennedy, Scott W; Harper, Barrie; Kibbe, Warren A; Corbie, Giselle; Cohen-Wolkowiez, Michael; Woods, Christopher W; Lee, Mark J

    Introduction

    The COVID-19 pandemic focused attention on healthcare disparities and inequities faced by individuals within marginalized and structurally disadvantaged groups in the United States. These individuals bore the heaviest burden across this pandemic as they faced increased risk of infection and difficulty in accessing testing and medical care. Individuals experiencing housing insecurity are a particularly vulnerable population given the additional barriers they face. In this scoping review, we identify some of the barriers this high-risk group experienced during the early days of the pandemic and assess novel solutions to overcome these barriers.

    Methods

    A scoping review was performed following PRISMA-Sc guidelines looking for studies focusing on COVID-19 testing among individuals experiencing housing insecurity. Barriers as well as solutions to barriers were identified as applicable and summarized using qualitative methods, highlighting particular ways that proved effective in facilitating access to testing access and delivery.

    Results

    Ultimately, 42 studies were included in the scoping review, with 143 barriers grouped into four categories: lack of cultural understanding, systemic racism, and stigma; medical care cost, insurance, and logistics; immigration policies, language, and fear of deportation; and other. Out of these 42 studies, 30 of these studies also suggested solutions to address them.

    Conclusion

    A paucity of studies have analyzed COVID-19 testing barriers among those experiencing housing insecurity, and this is even more pronounced in terms of solutions to address those barriers. Expanding resources and supporting investigators within this space is necessary to ensure equitable healthcare delivery.
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    Association between simulated ketamine exposures and oxygen saturations in children.
    (International journal of pharmacokinetics, 2023-02) Commander, Sarah Jane; Gonzalez, Daniel; Kumar, Karan R; Spears, Tracy; Cohen-Wolkowiez, Michael; Zimmerman, Kanecia O; Lee, Jan Hau; Hornik, Christoph P

    Aim

    We performed a real-world data analysis to evaluate the relationship between simulated ketamine exposures and oxygen desaturation in children.

    Materials & methods

    A previously developed population pharmacokinetic model was used to simulate exposures and evaluate target attainment, as well as the association with oxygen desaturation in children ≤17 years treated with intravenous ketamine.

    Results

    In 2022 children, there was no significant association between simulated plasma ketamine concentrations and oxygen saturation; however, a higher cumulative area under the curve was associated with increased odds of progression to significant desaturation (<85%), though magnitude of effect was small.

    Conclusion

    By leveraging a population pharmacokinetic model and real-world data, we confirmed there is no relationship between simulated ketamine plasma concentration and oxygen desaturation.
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    Increasing access and uptake of SARS-CoV-2 at-home tests using a community-engaged approach.
    (Preventive medicine reports, 2022-10) D'Agostino, Emily M; Corbie, Giselle; Kibbe, Warren A; Hornik, Christoph P; Richmond, Al; Dunston, Angella; Damman, Allyn; Wruck, Lisa; Alvarado, Manuel; Cohen-Wolkowiez, Michael
    Inequalities around COVID-19 testing and vaccination persist in the U.S. health system. We investigated whether a community-engaged approach could be used to distribute free, at-home, rapid SARS-CoV-2 tests to underserved populations. Between November 18-December 31, 2021, 400,000 tests were successfully distributed via 67 community partners and a mobile unit to a majority Hispanic/Latino/Spanish population in Merced County, California. Testing before gathering (59 %) was the most common testing reason. Asians versus Whites were more likely to test for COVID-19 if they had close contact with someone who may have been positive (odds ratio [OR] = 3.4, 95 % confidence interval [CI] = 1.7-6.7). Minors versus adults were more likely to test if they had close contact with someone who was confirmed positive (OR = 1.7, 95 % CI = 1.0-3.0), whereas Asian (OR = 4.1, 95 % CI = 1.2-13.7) and Hispanic/Latino/Spanish (OR = 2.5, 95 % CI = 1.0-6.6) versus White individuals were more likely to test if they had a positive household member. Asians versus Whites were more likely to receive a positive test result. Minors were less likely than adults to have been vaccinated (OR = 0.2, 95 % CI = 0.1-0.3). Among unvaccinated individuals, those who completed the survey in English versus Spanish indicated they were more likely to get vaccinated in the future (OR = 8.2, 95 % CI = 1.5-44.4). Asians versus Whites were less likely to prefer accessing oral COVID medications from a pharmacy/drug store only compared with a doctor's office or community setting (OR = 0.3, 95 % CI = 0.2-0.6). Study findings reinforce the need for replicable and scalable community-engaged strategies for reducing COVID-19 disparities by increasing SARS-CoV-2 test and vaccine access and uptake.
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    RADx-UP Coordination and Data Collection: An Infrastructure for COVID-19 Testing Disparities Research.
    (American journal of public health, 2022-09) Corbie, Giselle; D'Agostino, Emily M; Knox, Susan; Richmond, Al; Woods, Christopher W; Dave, Gaurav; Perreira, Krista M; Marsolo, Keith; Wruck, Lisa M; Kibbe, Warren A; Cohen-Wolkowiez, Michael
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    RADx-UP Testing Core: Access to COVID-19 Diagnostics in Community-Engaged Research with Underserved Populations.
    (Journal of clinical microbiology, 2023-08) Narayanasamy, Shanti; Veldman, Timothy H; Lee, Mark J; Glover, William A; Tillekeratne, L Gayani; Neighbors, Coralei E; Harper, Barrie; Raghavan, Vidya; Kennedy, Scott W; Carper, Miranda; Denny, Thomas; Tsalik, Ephraim L; Reller, Megan E; Kibbe, Warren A; Corbie, Giselle; Cohen-Wolkowiez, Michael; Woods, Christopher W; Petti, Cathy A
    Research on the COVID-19 pandemic revealed a disproportionate burden of COVID-19 infection and death among underserved populations and exposed low rates of SARS-CoV-2 testing in these communities. A landmark National Institutes of Health (NIH) funding initiative, the Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program, was developed to address the research gap in understanding the adoption of COVID-19 testing in underserved populations. This program is the single largest investment in health disparities and community-engaged research in the history of the NIH. The RADx-UP Testing Core (TC) provides community-based investigators with essential scientific expertise and guidance on COVID-19 diagnostics. This commentary describes the first 2 years of the TC's experience, highlighting the challenges faced and insights gained to safely and effectively deploy large-scale diagnostics for community-initiated research in underserved populations during a pandemic. The success of RADx-UP shows that community-based research to increase access and uptake of testing among underserved populations can be accomplished during a pandemic with tools, resources, and multidisciplinary expertise provided by a centralized testing-specific coordinating center. We developed adaptive tools to support individual testing strategies and frameworks for these diverse studies and ensured continuous monitoring of testing strategies and use of study data. In a rapidly evolving setting of tremendous uncertainty, the TC provided essential and real-time technical expertise to support safe, effective, and adaptive testing. The lessons learned go beyond this pandemic and can serve as a framework for rapid deployment of testing in response to future crises, especially when populations are affected inequitably.
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    Safety and Pharmacokinetics of Exebacase in an Infant with Disseminated Staphylococcus aureus Infection.
    (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021-12-11) Moorthy, Ganga S; Greenberg, Rachel G; Hornik, Chi D; Cassino, Cara; Ghahramani, Parviz; Kumar, Karan R; Fowler, Vance G; Cohen-Wolkowiez, Michael
    Exebacase, an anti-staphylococcal lysin produced from a bacteriophage-encoded gene, is a promising adjunctive therapy for severe methicillin-resistant Staphylococcus aureus infections. We describe the first infant to receive exebacase, dosing, and pharmacokinetics (PK). Exebacase may be safe and efficacious in children; however, further clinical trials are needed to optimize dosing.
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    Solithromycin in Children and Adolescents With Community-acquired Bacterial Pneumonia.
    (The Pediatric infectious disease journal, 2022-07) Lang, Jason E; Hornik, Christoph P; Elliott, Carrie; Silverstein, Adam; Hornik, Chi; Al-Uzri, Amira; Bosheva, Miroslava; Bradley, John S; Borja-Tabora, Charissa Fay Corazon; Di John, David; Mendez Echevarria, Ana; Ericson, Jessica E; Friedel, David; Gonczi, Ferenc; Isidro, Marie Grace Dawn; James, Laura P; Kalocsai, Krisztina; Koutroulis, Ioannis; Laki, Istvan; Ong-Lim, Anna Lisa T; Nad, Marta; Simon, Gabor; Syed, Salma; Szabo, Eva; Benjamin, Daniel K; Cohen-Wolkowiez, Michael; SOLI-PEDS Program

    Background

    Solithromycin is a new macrolide-ketolide antibiotic with potential effectiveness in pediatric community-acquired bacterial pneumonia (CABP). Our objective was to evaluate its safety and effectiveness in children with CABP.

    Methods

    This phase 2/3, randomized, open-label, active-control, multicenter study randomly assigned solithromycin (capsules, suspension or intravenous) or an appropriate comparator antibiotic in a 3:1 ratio (planned n = 400) to children 2 months to 17 years of age with CABP. Primary safety endpoints included treatment-emergent adverse events (AEs) and AE-related drug discontinuations. Secondary effectiveness endpoints included clinical improvement following treatment without additional antimicrobial therapy.

    Results

    Unrelated to safety, the sponsor stopped the trial prior to completion. Before discontinuation, 97 participants were randomly assigned to solithromycin (n = 73) or comparator (n = 24). There were 24 participants (34%, 95% CI, 23%-47%) with a treatment-emergent AE in the solithromycin group and 7 (29%, 95% CI, 13%-51%) in the comparator group. Infusion site pain and elevated liver enzymes were the most common related AEs with solithromycin. Study drug was discontinued due to AEs in 3 subjects (4.3%) in the solithromycin group and 1 (4.2%) in the comparator group. Forty participants (65%, 95% CI, 51%-76%) in the solithromycin group achieved clinical improvement on the last day of treatment versus 17 (81%, 95% CI, 58%-95%) in the comparator group. The proportion achieving clinical cure was 60% (95% CI, 47%-72%) and 68% (95% CI, 43%-87%) for the solithromycin and comparator groups, respectively.

    Conclusions

    Intravenous and oral solithromycin were generally well-tolerated and associated with clinical improvement in the majority of participants treated for CABP.
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    Use of a Digital Assistant to Report COVID-19 Rapid Antigen Self-test Results to Health Departments in 6 US Communities.
    (JAMA network open, 2022-08) Herbert, Carly; Shi, Qiming; Kheterpal, Vik; Nowak, Chris; Suvarna, Thejas; Durnan, Basyl; Schrader, Summer; Behar, Stephanie; Naeem, Syed; Tarrant, Seanan; Kalibala, Ben; Singh, Aditi; Gerber, Ben; Barton, Bruce; Lin, Honghuang; Cohen-Wolkowiez, Michael; Corbie-Smith, Giselle; Kibbe, Warren; Marquez, Juan; Baek, Jonggyu; Hafer, Nathaniel; Gibson, Laura; O'Connor, Laurel; Broach, John; Heetderks, William; McManus, David; Soni, Apurv

    Importance

    Widespread distribution of rapid antigen tests is integral to the US strategy to address COVID-19; however, it is estimated that few rapid antigen test results are reported to local departments of health.

    Objective

    To characterize how often individuals in 6 communities throughout the United States used a digital assistant to log rapid antigen test results and report them to their local departments of health.

    Design, setting, and participants

    This prospective cohort study is based on anonymously collected data from the beneficiaries of the Say Yes! Covid Test program, which distributed more than 3 000 000 rapid antigen tests at no cost to residents of 6 communities (Louisville, Kentucky; Indianapolis, Indiana; Fulton County, Georgia; O'ahu, Hawaii; Ann Arbor and Ypsilanti, Michigan; and Chattanooga, Tennessee) between April and October 2021. A descriptive evaluation of beneficiary use of a digital assistant for logging and reporting their rapid antigen test results was performed.

    Interventions

    Widespread community distribution of rapid antigen tests.

    Main outcomes and measures

    Number and proportion of tests logged and reported to the local department of health through the digital assistant.

    Results

    A total of 313 000 test kits were distributed, including 178 785 test kits that were ordered using the digital assistant. Among all distributed kits, 14 398 households (4.6%) used the digital assistant, but beneficiaries reported three-quarters of their rapid antigen test results to their state public health departments (30 965 tests reported of 41 465 total test results [75.0%]). The reporting behavior varied by community and was significantly higher among communities that were incentivized for reporting test results vs those that were not incentivized or partially incentivized (90.5% [95% CI, 89.9%-91.2%] vs 70.5%; [95% CI, 70.0%-71.0%]). In all communities, positive tests were less frequently reported than negative tests (60.4% [95% CI, 58.1%-62.8%] vs 75.5% [95% CI, 75.1%-76.0%]).

    Conclusions and relevance

    These results suggest that application-based reporting with incentives may be associated with increased reporting of rapid tests for COVID-19. However, increasing the adoption of the digital assistant may be a critical first step.