Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-27 (of 27 Records) |
Query Trace: Salerno C[original query] |
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Facilitators and barriers to adolescent participation in a TB clinical trial
Mangan JM , Hedges KNC , Salerno MM , Tatum K , Bouwkamp B , Frick MW , McKenna L , Muzanyi G , Engle M , Coetzee J , Yvetot J , Elskamp M , Lamunu D , Tizora MET , Namutamba D , Chaisson RE , Swindells S , Nahid P , Dorman SE , Kurbatova E . Int J Tuberc Lung Dis 2024 28 (5) 243-248 <sec id="st1"><title>BACKGROUND</title>The inclusion of adolescents in TB drug trials is essential for the development of safe, child-friendly regimens for the prevention and treatment of TB. TB Trials Consortium Study 31/AIDS Clinical Trials Group A5349 (S31/A5349) enrolled adolescents as young as 12 years old. We assessed investigator and coordinator described facilitators and barriers to adolescent recruitment, enrollment, and retention.</sec><sec id="st2"><title>METHODS</title>Interviews were conducted with six investigators from sites that enrolled adolescent participants and six investigators from non-enrolling sites. Additionally, two focus groups were conducted with study coordinators from enrolling sites and two focus groups with non-enrolling sites. Discussions were transcribed, analyzed, summarized, and summaries were reviewed by Community Research Advisors Group members and research group representatives for content validity.</sec><sec id="st3"><title>RESULTS</title>Investigators and coordinators attributed the successful enrollment of adolescents to the establishment and cultivation of external partnerships, flexibility to accommodate adolescents' schedules, staff engagement, recruitment from multiple locations, dedicated recruitment staff working onsite to access potential participants, creation of youth-friendly environments, and effective communications. Non-enrolling sites were mainly hindered by regulations. Suggestions for improvement in future trials focused on study planning and site preparations.</sec><sec id="st4"><title>CONCLUSION</title>Proactive partnerships and collaboration with institutions serving adolescents helped identify and reduce barriers to their inclusion in this trial.</sec>. |
Literature review of pathogen agnostic molecular testing of clinical specimens from difficult-to-diagnose patients: Implications for public health
Downie DL , Rao P , David-Ferdon C , Courtney S , Lee JS , Kugley S , MacDonald PDM , Barnes K , Fisher S , Andreadis JL , Chaitram J , Mauldin MR , Salerno RM , Schiffer J , Gundlapalli AV . Health Secur 2024 To better identify emerging or reemerging pathogens in patients with difficult-to-diagnose infections, it is important to improve access to advanced molecular testing methods. This is particularly relevant for cases where conventional microbiologic testing has been unable to detect the pathogen and the patient's specimens test negative. To assess the availability and utility of such testing for human clinical specimens, a literature review of published biomedical literature was conducted. From a corpus of more than 4,000 articles, a set of 34 reports was reviewed in detail for data on where the testing was being performed, types of clinical specimens tested, pathogen agnostic techniques and methods used, and results in terms of potential pathogens identified. This review assessed the frequency of advanced molecular testing, such as metagenomic next generation sequencing that has been applied to clinical specimens for supporting clinicians in caring for difficult-to-diagnose patients. Specimen types tested were from cerebrospinal fluid, respiratory secretions, and other body tissues and fluids. Publications included case reports and series, and there were several that involved clinical trials, surveillance studies, research programs, or outbreak situations. Testing identified both known human pathogens (sometimes in new sites) and previously unknown human pathogens. During this review, there were no apparent coordinated efforts identified to develop regional or national reports on emerging or reemerging pathogens. Therefore, development of a coordinated sentinel surveillance system that applies advanced molecular methods to clinical specimens which are negative by conventional microbiological diagnostic testing would provide a foundation for systematic characterization of emerging and underdiagnosed pathogens and contribute to national biodefense strategy goals. |
Surveillance for emerging and reemerging pathogens using pathogen agnostic metagenomic sequencing in the United States: A critical role for federal government agencies
Downie DL , Rao P , David-Ferdon C , Courtney S , Lee JS , Quiner C , MacDonald PDM , Barnes K , Fisher S , Andreadis JL , Chaitram J , Mauldin MR , Salerno RM , Schiffer J , Gundlapalli AV . Health Secur 2024 The surveillance and identification of emerging, reemerging, and unknown infectious disease pathogens is essential to national public health preparedness and relies on fluidity, coordination, and interconnectivity between public and private pathogen surveillance systems and networks. Developing a national sentinel surveillance network with existing resources and infrastructure could increase efficiency, accelerate the identification of emerging public health threats, and support coordinated intervention strategies that reduce morbidity and mortality. However, implementing and sustaining programs to detect emerging and reemerging pathogens in humans using advanced molecular methods, such as metagenomic sequencing, requires making large investments in testing equipment and developing networks of clinicians, laboratory scientists, and bioinformaticians. In this study, we sought to gain an understanding of how federal government agencies currently support such pathogen agnostic testing of human specimens in the United States. We conducted a landscape analysis of federal agency websites for publicly accessible information on the availability and type of pathogen agnostic testing and details on flow of clinical specimens and data. The website analysis was supplemented by an expert review of results with representatives from the federal agencies. Operating divisions within the US Department of Health and Human Services and the US Department of Veterans Affairs have developed and sustained extensive clinical and research networks to obtain patient specimens and perform metagenomic sequencing. Metagenomic facilities supported by US agencies were not equally geographically distributed across the United States. Although many entities have work dedicated to metagenomics and/or support emerging infectious disease surveillance specimen collection, there was minimal formal collaboration across agencies. |
Adverse events among persons with TB using in-person vs. electronic directly observed therapy
Salerno MM , Burzynski J , Mangan JM , Hill A , deCastro BR , Goswami ND , Lam CK , Macaraig M , Schluger NW , Vernon AA . Int J Tuberc Lung Dis 2023 27 (11) 833-840 BACKGROUND: We evaluated patient safety within a randomized crossover trial comparing electronic directly observed therapy (eDOT) to in-person DOT (ipDOT) in persons undergoing TB treatment in New York City, NY, USA.METHODS: Participant symptoms, symptom severity, and clinical management were documented. We assessed adverse event reports (AERs) by DOT method during the two-period crossover. Using Cox proportional-hazards mixed-effects models, we estimated the adjusted hazard ratio (aHR) of participants reporting an adverse event (AE) vs. not reporting an AE.RESULTS: Of 211 participants, 57 (27.0%) reported AEs during the two-period crossover; of these, 54.4% (31/57) were reported while using eDOT vs. 45.6% (26/57) while using ipDOT. Controlling for study group and period, the aHR for eDOT vs. ipDOT was 0.98 (95% CI 0.49-1.93). Although statistically not significant, the wide confidence intervals suggest that a significant association cannot be entirely ruled out. Gastrointestinal symptoms were most frequently reported (42.1%, 24/57). AER types and severity did not differ significantly by DOT method. Days from symptom onset to medical attention was similar across DOT methods (median: 1.0 day, IQR 0.0-2.0). No participants switched DOT methods due to AERs or monitoring concerns.CONCLUSION: Further evaluation to ascertain whether AERs differ when patients use eDOT vs. ipDOT is warranted. |
Severe acute respiratory syndrome coronavirus 2 seroprevalence and longitudinal antibody response following natural infection in pregnancy: A prospective cohort study
Drake AL , Escudero JN , Aurelio MC , Wetzler EA , Ellington SR , Zapata LB , Galang RR , Snead MC , Yamamoto K , Salerno CC , Richardson BA , Greninger AL , Kachikis AB , Englund JA , LaCourse SM . Womens Health (Lond) 2023 19 17455057231190955 BACKGROUND: Antenatal care provides unique opportunities to assess severe acute respiratory syndrome coronavirus 2 seroprevalence and antibody response duration after natural infection detected during pregnancy; transplacental antibody transfer may inform peripartum and neonatal protection. We estimated seroprevalence and durability of antibodies from natural infection (anti-nucleocapsid immunoglobulin G) among pregnant people, and evaluated transplacental transfer efficiency. OBJECTIVE AND DESIGN: We conducted a cross-sectional study to measure severe acute respiratory syndrome coronavirus 2 seroprevalence, and a prospective cohort study to longitudinally measure anti-nucleocapsid immunoglobulin G responses and transplacental transfer of maternally derived anti-nucleocapsid antibodies. METHODS: We screened pregnant people for the seroprevalence study between 9 December 2020 and 19 June 2021 for anti-nucleocapsid immunoglobulin G in Seattle, Washington. We enrolled anti-nucleocapsid immunoglobulin G positive people from the seroprevalence study or identified through medical records with positive reverse transcription polymerase chain reaction or antigen positive results in a prospective cohort between 9 December 2020 and 9 August 2022. RESULTS: In the cross-sectional study (N = 1284), 5% (N = 65) tested severe acute respiratory syndrome coronavirus 2 anti-nucleocapsid immunoglobulin G positive, including 39 (60%) without prior positive reverse transcription polymerase chain reaction results and 42 (65%) without symptoms. In the prospective cohort study (N = 107 total; N = 65 from the seroprevalence study), 86 (N = 80%) had anti-nucleocapsid immunoglobulin G positive results during pregnancy. Among 63 participants with delivery samples and prior anti-nucleocapsid positive results, 29 (46%) were anti-nucleocapsid immunoglobulin G negative by delivery. Of 34 remaining anti-nucleocapsid immunoglobulin G positive at delivery with paired cord blood, 19 (56%) had efficient transplacental anti-nucleocapsid immunoglobulin G antibody transfer. Median time from first anti-nucleocapsid immunoglobulin G positive to below positive antibody threshold was 19 weeks and did not differ by prior positive reverse transcription polymerase chain reaction status. CONCLUSIONS: Maternally derived severe acute respiratory syndrome coronavirus 2 antibodies to natural infection may wane before delivery. Vaccines are recommended for pregnant persons to reduce severe illness and confer protection to infants. |
Projected resurgence of COVID-19 in the United States in July-December 2021 resulting from the increased transmissibility of the Delta variant and faltering vaccination (preprint)
Truelove S , Smith CP , Qin M , Mullany LC , Borchering RK , Lessler J , Shea K , Howerton E , Contamin L , Levander J , Salerno J , Hochheiser H , Kinsey M , Tallaksen K , Wilson S , Shin L , Rainwater-Lovett K , Lemaitre JC , Dent J , Kaminsky J , Lee EC , Perez-Saez J , Hill A , Karlen D , Chinazzi M , Davis JT , Mu K , Xiong X , Piontti APY , Vespignani A , Srivastava A , Porebski P , Venkatramanan S , Adiga A , Lewis B , Klahn B , Outten J , Schlitt J , Corbett P , Telionis PA , Wang L , Peddireddy AS , Hurt B , Chen J , Vullikanti A , Marathe M , Hoops S , Bhattacharya P , Machi D , Chen S , Paul R , Janies D , Thill JC , Galanti M , Yamana T , Pei S , Shaman J , Reich NG , Healy JM , Slayton RB , Biggerstaff M , Johansson MA , Runge MC , Viboud C . medRxiv 2021 WHAT IS ALREADY KNOWN ABOUT THIS TOPIC? The highly transmissible SARS-CoV-2 Delta variant has begun to cause increases in cases, hospitalizations, and deaths in parts of the United States. With slowed vaccination uptake, this novel variant is expected to increase the risk of pandemic resurgence in the US in July-December 2021. WHAT IS ADDED BY THIS REPORT? Data from nine mechanistic models project substantial resurgences of COVID-19 across the US resulting from the more transmissible Delta variant. These resurgences, which have now been observed in most states, were projected to occur across most of the US, coinciding with school and business reopening. Reaching higher vaccine coverage in July-December 2021 reduces the size and duration of the projected resurgence substantially. The expected impact of the outbreak is largely concentrated in a subset of states with lower vaccination coverage. WHAT ARE THE IMPLICATIONS FOR PUBLIC HEALTH PRACTICE? Renewed efforts to increase vaccination uptake are critical to limiting transmission and disease, particularly in states with lower current vaccination coverage. Reaching higher vaccination goals in the coming months can potentially avert 1.5 million cases and 21,000 deaths and improve the ability to safely resume social contacts, and educational and business activities. Continued or renewed non-pharmaceutical interventions, including masking, can also help limit transmission, particularly as schools and businesses reopen. |
COVID-19 reopening strategies at the county level in the face of uncertainty: Multiple Models for Outbreak Decision Support (preprint)
Shea K , Borchering RK , Probert WJM , Howerton E , Bogich TL , Li S , van Panhuis WG , Viboud C , Aguás R , Belov A , Bhargava SH , Cavany S , Chang JC , Chen C , Chen J , Chen S , Chen Y , Childs LM , Chow CC , Crooker I , Valle SYD , España G , Fairchild G , Gerkin RC , Germann TC , Gu Q , Guan X , Guo L , Hart GR , Hladish TJ , Hupert N , Janies D , Kerr CC , Klein DJ , Klein E , Lin G , Manore C , Meyers LA , Mittler J , Mu K , Núñez RC , Oidtman R , Pasco R , Piontti APY , Paul R , Pearson CAB , Perdomo DR , Perkins TA , Pierce K , Pillai AN , Rael RC , Rosenfeld K , Ross CW , Spencer JA , Stoltzfus AB , Toh KB , Vattikuti S , Vespignani A , Wang L , White L , Xu P , Yang Y , Yogurtcu ON , Zhang W , Zhao Y , Zou D , Ferrari M , Pannell D , Tildesley M , Seifarth J , Johnson E , Biggerstaff M , Johansson M , Slayton RB , Levander J , Stazer J , Salerno J , Runge MC . medRxiv 2020 Policymakers make decisions about COVID-19 management in the face of considerable uncertainty. We convened multiple modeling teams to evaluate reopening strategies for a mid-sized county in the United States, in a novel process designed to fully express scientific uncertainty while reducing linguistic uncertainty and cognitive biases. For the scenarios considered, the consensus from 17 distinct models was that a second outbreak will occur within 6 months of reopening, unless schools and non-essential workplaces remain closed. Up to half the population could be infected with full workplace reopening; non-essential business closures reduced median cumulative infections by 82%. Intermediate reopening interventions identified no win-win situations; there was a trade-off between public health outcomes and duration of workplace closures. Aggregate results captured twice the uncertainty of individual models, providing a more complete expression of risk for decision-making purposes. |
SARS-CoV-2 seroprevalence and longitudinal antibody response following natural infection in pregnancy: a prospective cohort study (preprint)
Drake AL , Escudero JN , Aurelio MC , Ellington SR , Zapata LB , Galang RR , Snead MC , Yamamoto K , Salerno C , Richardson BA , Greninger AL , Kachikis AB , Englund JA , LaCourse SM . medRxiv 2022 30 Importance: Antenatal care provides unique opportunities to assess SARS-CoV-2 seroprevalence and antibody response duration after natural infection detected during pregnancy; transplacental antibody transfer may inform peripartum and neonatal protection. Objective(s): Estimate seroprevalence and durability of antibodies from natural infection (anti-nucleocapsid (anti-N) IgG) among pregnant people, and evaluate transplacental transfer efficiency. Design(s): Seroprevalence study: cross-sectional SARS-CoV-2 antibody screening among pregnant people December 9, 2020-June 19, 2021. Cohort study: Pregnant people screened anti-N IgG+ by Abbott Architect chemiluminescent immunoassay in seroprevalence study or identified through medical records with RT-PCR+ or antigen positive results enrolled in a prospective cohort December 9, 2020-June 30, 2022 to longitudinally measure anti-N IgG responses. We collected cord blood and assessed transplacental transfer of maternally-derived anti-N antibodies. Setting(s): Three hospitals and 14 affiliated clinics providing antenatal and delivery care, Seattle, Washington metropolitan area. Participant(s): Seroprevalence study: pregnant people were screened for SAR-CoV-2 anti-N IgG during routine care. Cohort study: Pregnant people with evidence of prior SARS-CoV-2 infection (screened anti-N IgG+ from seroprevalence study or identified with a RT-PCR+ or antigen positive result from medical records) were enrolled in a cohort study to longitudinally measure anti-N IgG responses. Exposure(s) (for observational studies): COVID-19 diagnosis, symptoms, and disease severity. Main Outcome(s) and Measure(s): Presence and durability of SARS-CoV-2 anti-N IgG, transplacental transfer of maternally-derived anti-N IgG. Result(s): Of 1289 pregnant people screened in the seroprevalence study, 5% (65) tested SARS-CoV-2 anti-N IgG+, including 39 (60%) without prior RT-PCR+ or antigen positive results and 53 (82%) without symptoms. Among 89 participants enrolled in the cohort study, 73 (82%) had anti-N IgG+ results during pregnancy. Among 49 participants with delivery samples 33 (67%) were anti-N IgG negative by delivery. Of 24 remaining anti-N IgG+ at delivery with paired cord blood samples, 12 (50%) had efficient transplacental anti-N IgG antibody transfer. Median time from first anti-N IgG to below positive antibody threshold was 17 weeks and did not differ by prior RT-PCR+ or antigen positive status. Conclusions and Relevance: Maternally-derived SARS-CoV-2 antibodies to natural infection may wane before delivery. Vaccines are recommended for pregnant persons to reduce severe illness and confer protection to infants. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
Challenges associated with electronic and in-person directly observed therapy during a randomized trial
Mangan JM , Burzynski J , deCastro BR , Salerno MM , Lam CK , Macaraig M , Reaves M , Kiskadden-Bechtel S , Bowers S , Sathi C , Dias MP , Goswami ND , Vernon A . Int J Tuberc Lung Dis 2023 27 (4) 298-307 BACKGROUND: Electronic directly observed therapy (eDOT) has been proposed as an alternative to traditional in-person DOT (ipDOT) for monitoring TB treatment adherence. Information about the comparative performance and implementation of eDOT is limited.METHODS: The frequency of challenges during DOT, challenge type, and effect on medication observation were documented by DOT method during a crossover, noninferiority randomized controlled trial. A logistic mixed-effects model that adjusted for the study design was used to estimate the percentage of successfully observed doses when challenges occurred.RESULTS: A total of 20,097 medication doses were scheduled for observation with either eDOT (15,405/20,097; 76.7%) or ipDOT (4,692/20,097; 23.3%) for 213 study participants. In total, one or more challenges occurred during 17.3% (2,672/15,405) of eDOT sessions and 15.6% (730/4,692) of ipDOT sessions. Among 4,374 documented challenges, 27.3% (n = 1,192) were characterized as technical, 65.9% (n = 2,881) were patient-related, and 6.9% (n = 301) were program-related. Estimated from the logistic model (n = 6,782 doses, 173 participants), the adjusted percentage of doses successfully observed during problematic sessions was 21.7% (95% CI 11.2-37.8) for eDOT and 4.2% (95% CI 1.1-14.7) for ipDOT.CONCLUSION: Compared to ipDOT, challenges were encountered in a slightly higher percentage of eDOT sessions but were more often resolved to enable successful dose observation during problematic sessions. |
COVID-19 Self-Test Data: Challenges and Opportunities - United States, October 31, 2021-June 11, 2022.
Ritchey MD , Rosenblum HG , DelGuercio K , Humbard M , Santos S , Hall J , Chaitram J , Salerno RM . MMWR Morb Mortal Wkly Rep 2022 71 (32) 1005-1010 Self-tests* to detect current infection with SARS-CoV-2, the virus that causes COVID-19, are valuable tools that guide individual decision-making and risk reduction() (1-3). Increased self-test use (4) has likely contributed to underascertainment of COVID-19 cases (5-7), because unlike the requirements to report results of laboratory-based and health care provider-administered point-of-care COVID-19 tests,() public health authorities do not require reporting of self-test results. However, self-test instructions include a recommendation that users report results to their health care provider so that they can receive additional testing and treatment if clinically indicated.() In addition, multiple manufacturers of COVID-19 self-tests have developed websites or companion mobile applications for users to voluntarily report self-test result data. Federal agencies use the data reported to manufacturers, in combination with manufacturing supply chain information, to better understand self-test availability and use. This report summarizes data voluntarily reported by users of 10.7 million self-tests from four manufacturers during October 31, 2021-June 11, 2022, and compares these self-test data with data received by CDC for 361.9 million laboratory-based and point-of-care tests performed during the same period. Overall trends in reporting volume and percentage of positive results, as well as completeness of reporting demographic variables, were similar across test types. However, the limited amount and quality of data reported from self-tests currently reduces their capacity to augment existing surveillance. Self-tests provide important risk-reduction information to users, and continued development of infrastructure and methods to collect and analyze data from self-tests could improve their use for surveillance during public health emergencies. |
Projected resurgence of COVID-19 in the United States in July-December 2021 resulting from the increased transmissibility of the Delta variant and faltering vaccination.
Truelove S , Smith CP , Qin M , Mullany LC , Borchering RK , Lessler J , Shea K , Howerton E , Contamin L , Levander J , Salerno J , Hochheiser H , Kinsey M , Tallaksen K , Wilson S , Shin L , Rainwater-Lovett K , Lemairtre JC , Dent Hulse J , Kaminsky J , Lee EC , Perez-Saez J , Hill A , Karlen D , Chinazzi M , Davis JT , Mu K , Xiong X , Pastore YPiontti A , Vespignani A , Srivastava A , Porebski P , Venkatramanan S , Adiga A , Lewis B , Klahn B , Outten J , Orr M , Harrison G , Hurt B , Chen J , Vullikanti A , Marathe M , Hoops S , Bhattacharya P , Machi D , Chen S , Paul R , Janies D , Thill JC , Galanti M , Yamana TK , Pei S , Shaman JL , Healy JM , Slayton RB , Biggerstaff M , Johansson MA , Runge MC , Viboud C . Elife 2022 11 In Spring 2021, the highly transmissible SARS-CoV-2 Delta variant began to cause increases in cases, hospitalizations, and deaths in parts of the United States. At the time, with slowed vaccination uptake, this novel variant was expected to increase the risk of pandemic resurgence in the US in summer and fall 2021. As part of the COVID-10 Scenario Modeling Hub, an ensemble of nine mechanistic models produced six-month scenario projections for July-December 2021 for the United States. These projections estimated substantial resurgences of COVID-19 across the US resulting from the more transmissible Delta variant, projected to occur across most of the US, coinciding with school and business reopening. The scenarios revealed that reaching higher vaccine coverage in July-December 2021 reduced the size and duration of the projected resurgence substantially, with the expected impacts was largely concentrated in a subset of states with lower vaccination coverage. Despite accurate projection of COVID-19 surges occurring and timing, the magnitude was substantially underestimated 2021 by the models compared with the of the reported cases, hospitalizations, and deaths occurring during July-December, highlighting the continued challenges to predict the evolving COVID-19 pandemic. Vaccination uptake remains critical to limiting transmission and disease, particularly in states with lower vaccination coverage. Higher vaccination goals at the onset of the surge of the new variant were estimated to avert over 1.5 million cases and 21,000 deaths, though may have had even greater impacts, considering the underestimated resurgence magnitude from the model. |
In-person vs electronic directly observed therapy for tuberculosis treatment adherence: A randomized noninferiority trial
Burzynski J , Mangan JM , Lam CK , Macaraig M , Salerno MM , deCastro BR , Goswami ND , Lin CY , Schluger NW , Vernon A . JAMA Netw Open 2022 5 (1) e2144210 IMPORTANCE: Electronic directly observed therapy (DOT) is used increasingly as an alternative to in-person DOT for monitoring tuberculosis treatment. Evidence supporting its efficacy is limited. OBJECTIVE: To determine whether electronic DOT can attain a level of treatment observation as favorable as in-person DOT. DESIGN, SETTING, AND PARTICIPANTS: This was a 2-period crossover, noninferiority trial with initial randomization to electronic or in-person DOT at the time outpatient tuberculosis treatment began. The trial enrolled 216 participants with physician-suspected or bacteriologically confirmed tuberculosis from July 2017 to October 2019 in 4 clinics operated by the New York City Health Department. Data analysis was conducted between March 2020 and April 2021. INTERVENTIONS: Participants were asked to complete 20 medication doses using 1 DOT method, then switched methods for another 20 doses. With in-person therapy, participants chose clinic or community-based DOT; with electronic DOT, participants chose live video-conferencing or recorded videos. MAIN OUTCOMES AND MEASURES: Difference between the percentage of medication doses participants were observed to completely ingest with in-person DOT and with electronic DOT. Noninferiority was demonstrated if the upper 95% confidence limit of the difference was 10% or less. We estimated the percentage of completed doses using a logistic mixed effects model, run in 4 modes: modified intention-to-treat, per-protocol, per-protocol with 85% or more of doses conforming to the randomization assignment, and empirical. Confidence intervals were estimated by bootstrapping (with 1000 replicates). RESULTS: There were 173 participants in each crossover period (median age, 40 years [range, 16-86 years]; 140 [66%] men; 80 [37%] Asian and Pacific Islander, 43 [20%] Black, and 71 [33%] Hispanic individuals) evaluated with the model in the modified intention-to-treat analytic mode. The percentage of completed doses with in-person DOT was 87.2% (95% CI, 84.6%-89.9%) vs 89.8% (95% CI, 87.5%-92.1%) with electronic DOT. The percentage difference was -2.6% (95% CI, -4.8% to -0.3%), consistent with a conclusion of noninferiority. The 3 other analytic modes yielded equivalent conclusions, with percentage differences ranging from -4.9% to -1.9%. CONCLUSIONS AND RELEVANCE: In this trial, the percentage of completed doses under electronic DOT was noninferior to that under in-person DOT. This trial provides evidence supporting the efficacy of this digital adherence technology, and for the inclusion of electronic DOT in the standard of care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03266003. |
State of public health emergency response leadership training: A multitiered organizational perspective
Salerno A , Li Y , Davis XM , Stennies G , Barnett DJ , Fisher MK , Biesiadecki L , Dekker D , Pham N , Pearson JL , Podgornik MN , Hunter DW , Vagi S , Hsu EB . Am J Disaster Med 2021 16 (3) 167-177 OBJECTIVE: To capture organizational level information on the current state of public health emergency response leadership training. DESIGN: A web-based questionnaire. PARTICIPANTS: This multitiered assessment of health departments included two distinct respondent groups: (1) Public Health Emergency Preparedness (PHEP) Cooperative Agreement recipients (n = 34) and (2) local health departments (LHDs) (n = 169) representative of different agency sizes and populations served. RESULTS: Overall, PHEP and LHD respondents expressed a clear preference for participatory learning with practical drills/exercises and participatory workshops as the preferred training delivery modes. Compared with technical and role-specific training, leadership training was less available. For both PHEP and LHD respondents, staff availability for training is most notably limited due to lack of time. For PHEP respondents, a common factor limiting agency ability to offer training is lack of mentors/instructors, whereas for LHD respondents, it is limited funding. CONCLUSIONS: Efforts should focus on increasing accessibility and the continued development of rigorous and effective training based on practical experience in all aspects of multitiered public health emergency response leadership. |
Performance characteristics of the Abbott BinaxNOW SARS-CoV-2 antigen test in comparison to real-time RT-PCR and viral culture in community testing sites during November 2020.
Almendares O , Prince-Guerra JL , Nolen LD , Gunn JKL , Dale AP , Buono SA , Deutsch-Feldman M , Suppiah S , Hao L , Zeng Y , Stevens VA , Knipe K , Pompey J , Atherstone C , Bui DP , Powell T , Tamin A , Harcourt JL , Petway M , Bohannon C , Folster JM , MacNeil A , Salerno R , Kuhnert-Tallman W , Tate JE , Thornburg N , Kirking HL , Villanueva JM , Rose DA , Neatherlin JC , Anderson M , Rota PA , Honein MA , Bower WA . J Clin Microbiol 2021 60 (1) Jcm0174221 Point-of-care antigen tests are an important tool for SARS-CoV-2 detection. Antigen tests are less sensitive than real-time reverse-transcriptase PCR (rRT-PCR). Data on the performance of the BinaxNOW antigen test compared to rRT-PCR and viral culture by symptom and known exposure status, timing during disease or exposure period and demographic variables are limited. During November 3(rd)-17(th), 2020, we collected paired upper respiratory swab specimens to test for SARS-CoV-2 by rRT-PCR and Abbott BinaxNOW (BinaxNOW) antigen test at two community testing sites in Pima County, Arizona. We administered a questionnaire to capture symptoms, known exposure status and previous SARS-CoV-2 test results. Specimens positive by either test were analyzed by viral culture. Previously we showed overall BinaxNOW sensitivity was 52.5%. Here we showed BinaxNOW sensitivity increased to 65.7% among currently symptomatic individuals reporting a known exposure. BinaxNOW sensitivity was lower among participants with a known exposure and previously symptomatic (32.4%) or never symptomatic (47.1%) within 14 days of testing. Sensitivity was 71.1% in participants within a week of symptom onset. In participants with a known exposure, sensitivity was highest 8-10 days post-exposure (75%). The positive predictive value for recovery of virus in cell culture was 56.7% for BinaxNOW-positive and 35.4% for rRT-PCR-positive specimens. Result reporting time was 2.5 hours for BinaxNOW and 26 hours for rRT-PCR. Point-of-care antigen tests have a shorter turn-around time compared to laboratory-based nucleic acid amplification tests, which allows for more rapid identification of infected individuals. Antigen test sensitivity limitations are important to consider when developing a testing program. |
Advancing diagnostic stewardship for healthcare associated infections, antibiotic resistance, and sepsis
Curren EJ , Lutgring JD , Kabbani S , Diekema DJ , Gitterman S , Lautenbach E , Morgan DJ , Rock C , Salerno RM , McDonald LC . Clin Infect Dis 2021 74 (4) 723-728 Diagnostic stewardship means ordering the right tests, for the right patient at the right time to inform optimal clinical care. Diagnostic stewardship is an integral part of antibiotic stewardship efforts to optimize antibiotic use and improve patient outcomes, including reductions in antibiotic resistance, and treatment of sepsis. CDC's Division of Healthcare Quality Promotion (DHQP) hosted a meeting on improving patient safety through diagnostic stewardship with a focus on the use of the laboratory. The meeting identified emerging issues in the field of diagnostic stewardship, raised awareness of these issues among stakeholders, and discussed strategies and interventions to address the issues-all with an emphasis on improved outcomes and patient safety. This white paper summarizes the key takeaways of the meeting including needs for diagnostic stewardship implementation, promising future avenues for diagnostic stewardship implementation, and areas of needed research. |
Sedentary behavior in United States adults: Fall 2019
Matthews CE , Carlson SA , Saint-Maurice PF , Patel S , Salerno E , Loftfield E , Troiano RP , Fulton JE , Sampson JN , Tribby C , Keadle S , Berrigan D . Med Sci Sports Exerc 2021 53 (12) 2512-2519 PURPOSE: Higher levels of sedentary behavior are associated with early mortality, but the distribution of sedentary time by classes of behavior and demographic groups is poorly described in United States (US) adults. To quantify the amount and sources of sedentary time in US adults we conducted a nationwide survey using a novel validated self-administerd previous-day recall method and compare these values with a commonly used sitting time question. METHODS: Participants from the AmeriSpeak panel aged 20 to 75 years (N = 2,640) completed up to two Activities Completed over Time in 24 Hours (ACT24) previous day recalls. Recalls were conducted on randomly selected days in October and November 2019. Survey sample design were applied to reflect the US population. RESULTS: Mean age was 45.3 years, 51% were female, 67% non-Hispanic white, and 37% had a body mass index of ≥30 kg/m2. US adults reported a mean 9.5 hrs/d of sedentary time (95% confidence interval [CI] 9.4, 9.7 hrs/d), which was 34% more than reported using a common surveillance measure (p < 0.01). Most daily sedentary time was accumulated in the leisure and work life domains, with leisure accounting for 47% (4.3 hrs/d [95%CI 4.2, 4.5 hrs/d]) of the total sedentary time. Eighty-two percent of leisure time was spent sedentary, mainly watching television/videos or engaged in internet/computer use. CONCLUSIONS: US adults appear to spend more time in sedentary behavior than previously thought and the majority of this time is accumulated at work and in leisure-time. Reducing sedentary screen-time during leisure in favor of physically active could be an important intervention target in the effort to increase physical activity in US adults. |
Clinical Laboratory Biosafety Gaps: Lessons Learned from Past Outbreaks Reveal a Path to a Safer Future
Cornish NE , Anderson NL , Arambula DG , Arduino MJ , Bryan A , Burton NC , Chen B , Dickson BA , Giri JG , Griffith NK , Pentella MA , Salerno RM , Sandhu P , Snyder JW , Tormey CA , Wagar EA , Weirich EG , Campbell S . Clin Microbiol Rev 2021 34 (3) e0012618 Patient care and public health require timely, reliable laboratory testing. However, clinical laboratory professionals rarely know whether patient specimens contain infectious agents, making ensuring biosafety while performing testing procedures challenging. The importance of biosafety in clinical laboratories was highlighted during the 2014 Ebola outbreak, where concerns about biosafety resulted in delayed diagnoses and contributed to patient deaths. This review is a collaboration between subject matter experts from large and small laboratories and the federal government to evaluate the capability of clinical laboratories to manage biosafety risks and safely test patient specimens. We discuss the complexity of clinical laboratories, including anatomic pathology, and describe how applying current biosafety guidance may be difficult as these guidelines, largely based on practices in research laboratories, do not always correspond to the unique clinical laboratory environments and their specialized equipment and processes. We retrospectively describe the biosafety gaps and opportunities for improvement in the areas of risk assessment and management; automated and manual laboratory disciplines; specimen collection, processing, and storage; test utilization; equipment and instrumentation safety; disinfection practices; personal protective equipment; waste management; laboratory personnel training and competency assessment; accreditation processes; and ethical guidance. Also addressed are the unique biosafety challenges successfully handled by a Texas community hospital clinical laboratory that performed testing for patients with Ebola without a formal biocontainment unit. The gaps in knowledge and practices identified in previous and ongoing outbreaks demonstrate the need for collaborative, comprehensive solutions to improve clinical laboratory biosafety and to better combat future emerging infectious disease outbreaks. |
Modeling of Future COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination Rates and Nonpharmaceutical Intervention Scenarios - United States, April-September 2021.
Borchering RK , Viboud C , Howerton E , Smith CP , Truelove S , Runge MC , Reich NG , Contamin L , Levander J , Salerno J , van Panhuis W , Kinsey M , Tallaksen K , Obrecht RF , Asher L , Costello C , Kelbaugh M , Wilson S , Shin L , Gallagher ME , Mullany LC , Rainwater-Lovett K , Lemaitre JC , Dent J , Grantz KH , Kaminsky J , Lauer SA , Lee EC , Meredith HR , Perez-Saez J , Keegan LT , Karlen D , Chinazzi M , Davis JT , Mu K , Xiong X , Pastore YPiontti A , Vespignani A , Srivastava A , Porebski P , Venkatramanan S , Adiga A , Lewis B , Klahn B , Outten J , Schlitt J , Corbett P , Telionis PA , Wang L , Peddireddy AS , Hurt B , Chen J , Vullikanti A , Marathe M , Healy JM , Slayton RB , Biggerstaff M , Johansson MA , Shea K , Lessler J . MMWR Morb Mortal Wkly Rep 2021 70 (19) 719-724 After a period of rapidly declining U.S. COVID-19 incidence during January-March 2021, increases occurred in several jurisdictions (1,2) despite the rapid rollout of a large-scale vaccination program. This increase coincided with the spread of more transmissible variants of SARS-CoV-2, the virus that causes COVID-19, including B.1.1.7 (1,3) and relaxation of COVID-19 prevention strategies such as those for businesses, large-scale gatherings, and educational activities. To provide long-term projections of potential trends in COVID-19 cases, hospitalizations, and deaths, COVID-19 Scenario Modeling Hub teams used a multiple-model approach comprising six models to assess the potential course of COVID-19 in the United States across four scenarios with different vaccination coverage rates and effectiveness estimates and strength and implementation of nonpharmaceutical interventions (NPIs) (public health policies, such as physical distancing and masking) over a 6-month period (April-September 2021) using data available through March 27, 2021 (4). Among the four scenarios, an accelerated decline in NPI adherence (which encapsulates NPI mandates and population behavior) was shown to undermine vaccination-related gains over the subsequent 2-3 months and, in combination with increased transmissibility of new variants, could lead to surges in cases, hospitalizations, and deaths. A sharp decline in cases was projected by July 2021, with a faster decline in the high-vaccination scenarios. High vaccination rates and compliance with public health prevention measures are essential to control the COVID-19 pandemic and to prevent surges in hospitalizations and deaths in the coming months. |
Evaluation of Abbott BinaxNOW Rapid Antigen Test for SARS-CoV-2 Infection at Two Community-Based Testing Sites - Pima County, Arizona, November 3-17, 2020.
Prince-Guerra JL , Almendares O , Nolen LD , Gunn JKL , Dale AP , Buono SA , Deutsch-Feldman M , Suppiah S , Hao L , Zeng Y , Stevens VA , Knipe K , Pompey J , Atherstone C , Bui DP , Powell T , Tamin A , Harcourt JL , Shewmaker PL , Medrzycki M , Wong P , Jain S , Tejada-Strop A , Rogers S , Emery B , Wang H , Petway M , Bohannon C , Folster JM , MacNeil A , Salerno R , Kuhnert-Tallman W , Tate JE , Thornburg NJ , Kirking HL , Sheiban K , Kudrna J , Cullen T , Komatsu KK , Villanueva JM , Rose DA , Neatherlin JC , Anderson M , Rota PA , Honein MA , Bower WA . MMWR Morb Mortal Wkly Rep 2021 70 (3) 100-105 Rapid antigen tests, such as the Abbott BinaxNOW COVID-19 Ag Card (BinaxNOW), offer results more rapidly (approximately 15-30 minutes) and at a lower cost than do highly sensitive nucleic acid amplification tests (NAATs) (1). Rapid antigen tests have received Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for use in symptomatic persons (2), but data are lacking on test performance in asymptomatic persons to inform expanded screening testing to rapidly identify and isolate infected persons (3). To evaluate the performance of the BinaxNOW rapid antigen test, it was used along with real-time reverse transcription-polymerase chain reaction (RT-PCR) testing to analyze 3,419 paired specimens collected from persons aged ≥10 years at two community testing sites in Pima County, Arizona, during November 3-17, 2020. Viral culture was performed on 274 of 303 residual real-time RT-PCR specimens with positive results by either test (29 were not available for culture). Compared with real-time RT-PCR testing, the BinaxNOW antigen test had a sensitivity of 64.2% for specimens from symptomatic persons and 35.8% for specimens from asymptomatic persons, with near 100% specificity in specimens from both groups. Virus was cultured from 96 of 274 (35.0%) specimens, including 85 (57.8%) of 147 with concordant antigen and real-time RT-PCR positive results, 11 (8.9%) of 124 with false-negative antigen test results, and none of three with false-positive antigen test results. Among specimens positive for viral culture, sensitivity was 92.6% for symptomatic and 78.6% for asymptomatic individuals. When the pretest probability for receiving positive test results for SARS-CoV-2 is elevated (e.g., in symptomatic persons or in persons with a known COVID-19 exposure), a negative antigen test result should be confirmed by NAAT (1). Despite a lower sensitivity to detect infection, rapid antigen tests can be an important tool for screening because of their quick turnaround time, lower costs and resource needs, high specificity, and high positive predictive value (PPV) in settings of high pretest probability. The faster turnaround time of the antigen test can help limit transmission by more rapidly identifying infectious persons for isolation, particularly when used as a component of serial testing strategies. |
SARS-CoV-2 Serologic Assay Needs for the Next Phase of the US COVID-19 Pandemic Response.
Gundlapalli AV , Salerno RM , Brooks JT , Averhoff F , Petersen LR , McDonald LC , Iademarco MF . Open Forum Infect Dis 2021 8 (1) ofaa555 BACKGROUND: There is a need for validated and standardized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative immunoglobulin G (IgG) and neutralization assays that can be used to understand the immunology and pathogenesis of SARS-CoV-2 infection and support the coronavirus disease 2019 (COVID-19) pandemic response. METHODS: Literature searches were conducted to identify English language publications from peer-reviewed journals and preprints from January 2020 through November 6, 2020. Relevant publications were reviewed for mention of IgG or neutralization assays for SARS-CoV-2, or both, and the methods of reporting assay results. RESULTS: Quantitative SARS-CoV-2 IgG results have been reported from a limited number of studies; most studies used in-house laboratory-developed tests in limited settings, and only two semiquantitative tests have received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA). As of November 6, 2020, there is only one SARS-CoV-2 neutralization assay with FDA EUA. Relatively few studies have attempted correlation of quantitative IgG titers with neutralization results to estimate surrogates of protection. The number of individuals tested is small compared with the magnitude of the pandemic, and persons tested are not representative of disproportionately affected populations. Methods of reporting quantitative results are not standardized to enable comparisons and meta-analyses. CONCLUSIONS: Lack of standardized SARS-CoV-2 quantitative IgG and neutralization assays precludes comparison of results from published studies. Interassay and interlaboratory validation and standardization of assays will support efforts to better understand antibody kinetics and longevity of humoral immune responses postillness, surrogates of immune protection, and vaccine immunogenicity and efficacy. Public-private partnerships could facilitate realization of these advances in the United States and worldwide. |
Building a public-private partnership to enhance laboratory preparedness and response in the United States
Salerno R , Chaitram J , Andreadis J . Disaster Med Public Health Prep 2020 15 (5) 1-9 The public health community has recognized that it cannot handle responses to all possible public health emergencies on its own. The public health sector has deep scientific expertise and excels at initial identification, complex characterization, and test development. The private sector has many resources and capabilities that can complement and augment the public health response. This is especially true in the clinical laboratory sector. Many commercial laboratories are designed for high-volume, high-throughput diagnostic testing in a way that public health laboratories are not. Significant steps have been taken since 2017 to improve the communication and coordination between public health and the private clinical laboratory community, especially during a response to a public health emergency. This paper describes the strong foundation that has been built for an improved clinical and public health laboratory response to the next public health emergency. |
Advancing the public health laboratory system through partnerships
St George K , Ned-Sykes R , Salerno R , Pentella MA . Public Health Rep 2019 134 3s-5s In many areas of health care, we have witnessed a trend toward increased collaborations and partnerships between investigators, teams, programs, institutions, and agencies. As challenges in health care are frequently complex, multifaceted approaches may result in more effective problem-solving than those undertaken by individual groups or facilities. We have seen these approaches in diverse areas, from cross-functional clinical care teams, to large research initiatives that harness the expertise of multiple investigators, to joint ventures and other collaborations among health care organizations. In public health, partnerships are essential for solving the increasingly complex, multifaceted challenges that are encountered. For public health laboratories (PHLs) in particular, collaborations may include a variety of alliances, including PHL networks; partnerships between PHLs and other laboratories (eg, clinical, commercial, environmental, agricultural, veterinary); and partnerships between PHLs and industry, academia, and other public agencies. The numerous benefits of these collaborations include improved service capabilities and efficiencies, as well as enhanced emergency response and disease prevention strategies. |
Institutionalizing One Health: From assessment to action
Machalaba CC , Salerno RH , Barton Behravesh C , Benigno S , Berthe FCJ , Chungong S , Duale S , Echalar R , Karesh WB , Ormel HJ , Pelican K , Rahman M , Rasmuson M , Scribner S , Stratton J , Suryantoro L , Wannous C . Health Secur 2018 16 S37-s43 A One Health approach is critical to strengthening health security at country, regional, and global levels. However, operationally its uptake remains limited. Recent momentum in assessing capacity to effectively prevent, detect, and respond to disease threats has resulted in identification of gaps that require dedicated action. This article highlights relevant tools, standards, and guidance to assist countries and institutions in meeting the collective vision articulated at the 2018 Prince Mahidol Award Conference on "Making the World Safe from the Threats of Emerging Infectious Diseases." Taking stock of assessment findings, resources, priorities, and implementation initiatives across human and animal health, environment and disaster risk reduction sectors can help expand participation in global health security, target risk drivers, and form synergies for collective action and shared gains for both emerging and endemic disease challenges. In addition to health security gains, a multisectoral, One Health approach can drive benefits for wider health sector and global development goals. |
Initial public health laboratory response after Hurricane Maria - Puerto Rico, 2017
Concepcion-Acevedo J , Patel A , Luna-Pinto C , Pena RG , Cuevas Ruiz RI , Arbolay HR , Toro M , Deseda C , De Jesus VR , Ribot E , Gonzalez JQ , Rao G , De Leon Salazar A , Ansbro M , White BB , Hardy MC , Georgi JC , Stinnett R , Mercante AM , Lowe D , Martin H , Starks A , Metchock B , Johnston S , Dalton T , Joglar O , Stafford C , Youngblood M , Klein K , Lindstrom S , Berman L , Galloway R , Schafer IJ , Walke H , Stoddard R , Connelly R , McCaffery E , Rowlinson MC , Soroka S , Tranquillo DT , Gaynor A , Mangal C , Wroblewski K , Muehlenbachs A , Salerno RM , Lozier M , Sunshine B , Shapiro C , Rose D , Funk R , Pillai SK , O'Neill E . MMWR Morb Mortal Wkly Rep 2018 67 (11) 333-336 Hurricane Maria made landfall in Puerto Rico on September 20, 2017, causing major damage to infrastructure and severely limiting access to potable water, electric power, transportation, and communications. Public services that were affected included operations of the Puerto Rico Department of Health (PRDOH), which provides critical laboratory testing and surveillance for diseases and other health hazards. PRDOH requested assistance from CDC for the restoration of laboratory infrastructure, surveillance capacity, and diagnostic testing for selected priority diseases, including influenza, rabies, leptospirosis, salmonellosis, and tuberculosis. PRDOH, CDC, and the Association of Public Health Laboratories (APHL) collaborated to conduct rapid needs assessments and, with assistance from the CDC Foundation, implement a temporary transport system for shipping samples from Puerto Rico to the continental United States for surveillance and diagnostic and confirmatory testing. This report describes the initial laboratory emergency response and engagement efforts among federal, state, and nongovernmental partners to reestablish public health laboratory services severely affected by Hurricane Maria. The implementation of a sample transport system allowed Puerto Rico to reinitiate priority infectious disease surveillance and laboratory testing for patient and public health interventions, while awaiting the rebuilding and reinstatement of PRDOH laboratory services. |
Comparison of measured multi-decadal rainfall variability with farmers’ perceptions of and responses to seasonal changes in western Uganda
Diem JE , Hartter J , Salerno J , McIntyre E , Stuart Grandy A . Reg Environ Change 2016 17 (4) 1127–1140 Smallholder farmers in Sub-Saharan Africa (SSA) are not only dealing with decreased production from land degradation, but are also impacted heavily by climate variability. Farmers perceive decreased rainfall or shortened rainy seasons throughout SSA; however, the link between perceptions and climate variability is complex, especially in areas with increasing land degradation. Moreover, little is known about climate variability and farmers’ perceptions in central equatorial Africa. The purpose of this study is to quantify interannual rainfall variability from 1983 to 2014 in western Uganda and to relate the rainfall variability and associated changes in soil moisture to perceptions and coping strategies of local farmers. Surveys of 308 farming households and 14 group interviews were conducted near Kibale National Park, and daily satellite-based rainfall data for the region were extracted from the African Rainfall Climatology version 2 database. Results indicate a decrease in the long rains by approximately 3 weeks throughout much of the region; thus, soil-water deficits have intensified. Farmers perceived later onsets of both the short rains and long rains, while also reporting decreasing soil fertility and crop yields. Therefore, farmers’ perceptions of rainfall variability in the Kibale region may reflect more the decrease in soil fertility than the shortened rainy seasons and decreased soil moisture. Expanding croplands has been the farmers’ most prevalent coping strategy to decreased yields; however, nearly all the unfarmed land in western Uganda is now in protected areas. Consequently, western Uganda is facing a crisis at the nexus of population growth, land use change, and climate change. |
Emergency response in a global health crisis: epidemiology, ethics, and Ebola application
Salerno J , Hlaing WM , Weiser T , Striley C , Schwartz L , Angulo FJ , Neslund VS . Ann Epidemiol 2016 26 (4) 234-7 PURPOSE: The link between ethics and epidemiology can go unnoticed in contemporary gatherings of professional epidemiologists or trainees at conferences and workshops, as well as in teaching. Our goal is to provide readers with information about the activities of the College and to provide a broad perspective on a recent major issue in epidemiology. METHODS: The Ethics Committee of the American College of Epidemiology (ACE) presented a plenary session at the 2015 Annual Meeting in Atlanta, GA, on the complexities of ethics and epidemiology in the context of the 2014-2015 Ebola virus disease outbreak and response in West Africa. This article presents a summary and further discussion of that plenary session. RESULTS: Three main topic areas were presented: clinical trials and ethics in public health emergencies, public health practice, and collaborative work. A number of key ethical concepts were highlighted and discussed in relation to Ebola and the ACE Ethics Guidelines. CONCLUSIONS: The Ebola virus disease outbreak is an example of a public health humanitarian crisis from which we hope to better understand the role of professional epidemiologists in public health practice and research and recognize ethical challenges epidemiologists faced. |
Genome of Rhodnius prolixus, an insect vector of Chagas disease, reveals unique adaptations to hematophagy and parasite infection.
Mesquita RD , Vionette-Amaral RJ , Lowenberger C , Rivera-Pomar R , Monteiro FA , Minx P , Spieth J , Carvalho AB , Panzera F , Lawson D , Torres AQ , Ribeiro JM , Sorgine MH , Waterhouse RM , Montague MJ , Abad-Franch F , Alves-Bezerra M , Amaral LR , Araujo HM , Araujo RN , Aravind L , Atella GC , Azambuja P , Berni M , Bittencourt-Cunha PR , Braz GR , Calderon-Fernandez G , Carareto CM , Christensen MB , Costa IR , Costa SG , Dansa M , Daumas-Filho CR , De-Paula IF , Dias FA , Dimopoulos G , Emrich SJ , Esponda-Behrens N , Fampa P , Fernandez-Medina RD , da Fonseca RN , Fontenele M , Fronick C , Fulton LA , Gandara AC , Garcia ES , Genta FA , Giraldo-Calderon GI , Gomes B , Gondim KC , Granzotto A , Guarneri AA , Guigo R , Harry M , Hughes DS , Jablonka W , Jacquin-Joly E , Juarez MP , Koerich LB , Latorre-Estivalis JM , Lavore A , Lawrence GG , Lazoski C , Lazzari CR , Lopes RR , Lorenzo MG , Lugon MD , Majerowicz D , Marcet PL , Mariotti M , Masuda H , Megy K , Melo AC , Missirlis F , Mota T , Noriega FG , Nouzova M , Nunes RD , Oliveira RL , Oliveira-Silveira G , Ons S , Pagola L , Paiva-Silva GO , Pascual A , Pavan MG , Pedrini N , Peixoto AA , Pereira MH , Pike A , Polycarpo C , Prosdocimi F , Ribeiro-Rodrigues R , Robertson HM , Salerno AP , Salmon D , Santesmasses D , Schama R , Seabra-Junior ES , Silva-Cardoso L , Silva-Neto MA , Souza-Gomes M , Sterkel M , Taracena ML , Tojo M , Tu ZJ , Tubio JM , Ursic-Bedoya R , Venancio TM , Walter-Nuno AB , Wilson D , Warren WC , Wilson RK , Huebner E , Dotson EM , Oliveira PL . Proc Natl Acad Sci U S A 2015 112 (48) 14936-14941 Rhodnius prolixus not only has served as a model organism for the study of insect physiology, but also is a major vector of Chagas disease, an illness that affects approximately seven million people worldwide. We sequenced the genome of R. prolixus, generated assembled sequences covering 95% of the genome ( approximately 702 Mb), including 15,456 putative protein-coding genes, and completed comprehensive genomic analyses of this obligate blood-feeding insect. Although immune-deficiency (IMD)-mediated immune responses were observed, R. prolixus putatively lacks key components of the IMD pathway, suggesting a reorganization of the canonical immune signaling network. Although both Toll and IMD effectors controlled intestinal microbiota, neither affected Trypanosoma cruzi, the causal agent of Chagas disease, implying the existence of evasion or tolerance mechanisms. R. prolixus has experienced an extensive loss of selenoprotein genes, with its repertoire reduced to only two proteins, one of which is a selenocysteine-based glutathione peroxidase, the first found in insects. The genome contained actively transcribed, horizontally transferred genes from Wolbachia sp., which showed evidence of codon use evolution toward the insect use pattern. Comparative protein analyses revealed many lineage-specific expansions and putative gene absences in R. prolixus, including tandem expansions of genes related to chemoreception, feeding, and digestion that possibly contributed to the evolution of a blood-feeding lifestyle. The genome assembly and these associated analyses provide critical information on the physiology and evolution of this important vector species and should be instrumental for the development of innovative disease control methods. |
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