BACKGROUND: Track PCC includes five geographic surveillance sites to conduct standardized population-based surveillance to estimate and track Post-COVID Conditions (PCC) by age, sex, race/ethnicity, geographic area, severity of initial infection, and risk factors among persons with evidence of SARS-CoV-2 infection (based on the Council of State and Territorial Epidemiologist [CSTE] case definitions for confirmed cases or laboratory-confirmed evidence of infection). METHODS: The study will estimate the incidence, prevalence, including temporal trends, and duration and severity of PCC symptoms, among children, adolescents, and adults. PCCs include a broad range of symptoms and conditions that continue or develop after acute SARS-CoV-2 infection or COVID-19 illness. Surveillance includes both passive and active components for diverse populations in Arizona, Indiana, and Utah as well as the Bronx Borough, NY, and part of Philadelphia County, PA. Passive surveillance will utilize electronic health records and health information exchanges within each site catchment area to longitudinally follow persons with COVID-19 to estimate PCC occurring at least 30 days after acute COVID-19 illness. Active surveillance will utilize self-report of PCCs from detailed surveys of persons ages 7 years and older with evidence of SARS-CoV-2 infection in the past 3 months. Respondents will complete follow-up surveys at 6-, 12- and 18-months post-infection. DISCUSSION: These data can help identify which groups are most affected by PCC, and what health differences among demographic groups exist, as well as indicate potential barriers to care. These additional levels of granularity can inform public health action and help direct needed clinical care for patients.

BACKGROUND: A better understanding of SARS-CoV-2 infection risk among Hispanic and Latino populations and in low-resource settings in the United States is needed to inform control efforts and strategies to improve health equity. Puerto Rico has a high poverty rate and other population characteristics associated with increased vulnerability to COVID-19, and there are limited data to date to determine community incidence. OBJECTIVE: This study describes the protocol and baseline seroprevalence of SARS-CoV-2 in a prospective community-based cohort study (COPA COVID-19 [COCOVID] study) to investigate SARS-CoV-2 infection incidence and morbidity in Ponce, Puerto Rico. METHODS: In June 2020, we implemented the COCOVID study within the Communities Organized to Prevent Arboviruses project platform among residents of 15 communities in Ponce, Puerto Rico, aged 1 year or older. Weekly, participants answered questionnaires on acute symptoms and preventive behaviors and provided anterior nasal swab samples for SARS-CoV-2 polymerase chain reaction testing; additional anterior nasal swabs were collected for expedited polymerase chain reaction testing from participants that reported 1 or more COVID-19-like symptoms. At enrollment and every 6 months during follow-up, participants answered more comprehensive questionnaires and provided venous blood samples for multiantigen SARS-CoV-2 immunoglobulin G antibody testing (an indicator of seroprevalence). Weekly follow-up activities concluded in April 2022 and 6-month follow-up visits concluded in August 2022. Primary study outcome measures include SARS-CoV-2 infection incidence and seroprevalence, relative risk of SARS-CoV-2 infection by participant characteristics, SARS-CoV-2 household attack rate, and COVID-19 illness characteristics and outcomes. In this study, we describe the characteristics of COCOVID participants overall and by SARS-CoV-2 seroprevalence status at baseline. RESULTS: We enrolled a total of 1030 participants from 388 households. Relative to the general populations of Ponce and Puerto Rico, our cohort overrepresented middle-income households, employed and middle-aged adults, and older children (P<.001). Almost all participants (1021/1025, 99.61%) identified as Latino/a, 17.07% (175/1025) had annual household incomes less than US $10,000, and 45.66% (463/1014) reported 1 or more chronic medical conditions. Baseline SARS-CoV-2 seroprevalence was low (16/1030, 1.55%) overall and increased significantly with later study enrollment time (P=.003). CONCLUSIONS: The COCOVID study will provide a valuable opportunity to better estimate the burden of SARS-CoV-2 and associated risk factors in a primarily Hispanic or Latino population, assess the limitations of surveillance, and inform mitigation measures in Puerto Rico and other similar populations. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/53837.

Serratia marcescens is an environmental gram-negative bacterium that causes invasive disease in rare cases. During 2020-2022, an outbreak of 21 invasive Serratia infections occurred in a prison in California, USA. Most (95%) patients had a history of recent injection drug use (IDU). We performed whole-genome sequencing and found isolates from 8 patients and 2 pieces of IDU equipment were closely related. We also identified social interactions among patients. We recovered S. marcescens from multiple environmental samples throughout the prison, including personal containers storing Cell Block 64 (CB64), a quaternary ammonium disinfectant solution. CB64 preparation and storage conditions were suboptimal for S. marcescens disinfection. The outbreak was likely caused by contaminated CB64 and propagated by shared IDU equipment and social connections. Ensuring appropriate preparation, storage, and availability of disinfectants and enacting interventions to counteract disease spread through IDU can reduce risks for invasive Serratia infections in California prisons.

In December 2021 the U.S. Government announced a new, whole-of-government $1.8 billion effort, the Initiative for Global Vaccine Access (Global VAX) in response to the global COVID-19 pandemic. Using the foundation of decades of U.S. government investments in global health and working in close partnership with local governments and key global and multilateral organizations, Global VAX enabled the rapid acceleration of the global COVID-19 vaccine rollout in selected countries, contributing to increased COVID-19 vaccine coverage in some of the world's most vulnerable communities. Through Global VAX, the U.S. Government has supported 125 countries to scale up COVID-19 vaccine delivery and administration while strengthening primary health care systems to respond to future health crises. The progress made by Global VAX has paved the way for a stronger global recovery and improved global health security.

BACKGROUND: Transfusion-related errors are largely preventable but may lead to blood product wastage and adverse reactions, resulting in patient harm. In the United States, the incidence of transfusion-related errors is poorly understood nationally. We used data from the National Healthcare Safety Network (NHSN) Hemovigilance Module to describe and quantify transfusion-related errors, as well as associated transfusion-related adverse reactions and blood product wastage. METHODS: During 2014-2022, data from the NHSN Hemovigilance Module were used to analyze errors, including near misses (errors with no transfusion), incidents (errors with transfusion), and associated serious adverse reactions (severe, life-threatening, or death). RESULTS: During 2014-2022, 80 acute care facilities (75 adult; 5 pediatric) reported 63,900 errors. Most errors occurred during patient blood sample collection (21,761, 34.1%) and blood sample handling (16,277, 25.5%). Less than one-fifth of reported errors (9822, 15.4%) had a completed incident form. Of those, 8780 (89.3%) were near misses and 1042 (10.7%) incidents. More than a third of near misses (3363, 38.3%) were associated with a discarded blood product, resulting in 4862 discarded components. Overall, 87 adverse reactions were associated with errors; six (7%) were serious. CONCLUSIONS: Over half of the transfusion-related errors reported to the Hemovigilance Module occurred during blood sample collection or sample handling. Some serious adverse reactions identified were associated with errors, suggesting that additional safety interventions may be beneficial. Increased participation in the Hemovigilance Module could enhance generalizability and further inform policy development regarding error prevention.

In 2021, the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and state and local health and regulatory partners investigated an outbreak of Salmonella enterica serovar Oranienburg infections linked to bulb onions from Mexico, resulting in 1040 illnesses and 260 hospitalizations across 39 states, the District of Columbia, and Puerto Rico. The Kansas Department of Agriculture recovered the outbreak strain of Salmonella Oranienburg from a sample of condiment collected from an ill person's home. The condiment was made with cilantro, lime, and onions, but, at the time of collection, there were no onions remaining in it. FDA conducted traceback investigations for white, yellow, and red bulb onions, cilantro, limes, tomatoes, and jalapeño peppers. Growers in the state of Chihuahua, Mexico, were identified as supplying the implicated onions that could account for exposure to onions for all illnesses included in the traceback investigation, but investigators could not determine a single source or route of contamination. FDA collected product and environmental samples across the domestic supply chain but did not recover the outbreak strain of Salmonella. Binational collaboration and information sharing supported Mexican authorities in collecting environmental samples from two packing plants and onion, water, and environmental samples from 15 farms and firms in Chihuahua, Mexico identified through FDA's traceback investigation, but did not recover the outbreak strain. Distributors of the implicated onions issued voluntary recalls of red, yellow, and white whole, fresh onions imported from the state of Chihuahua, Mexico. This outbreak showcased how investigators overcame significant traceback and epidemiologic challenges, the need for strengthening the ongoing collaboration between U.S. and Mexican authorities and highlighted the need for identifying practices across the supply chain that can help improve the safety of onions. © 2024

The Human Phenotype Ontology (HPO) is a widely used resource that comprehensively organizes and defines the phenotypic features of human disease, enabling computational inference and supporting genomic and phenotypic analyses through semantic similarity and machine learning algorithms. The HPO has widespread applications in clinical diagnostics and translational research, including genomic diagnostics, gene-disease discovery, and cohort analytics. In recent years, groups around the world have developed translations of the HPO from English to other languages, and the HPO browser has been internationalized, allowing users to view HPO term labels and in many cases synonyms and definitions in ten languages in addition to English. Since our last report, a total of 2239 new HPO terms and 49235 new HPO annotations were developed, many in collaboration with external groups in the fields of psychiatry, arthrogryposis, immunology and cardiology. The Medical Action Ontology (MAxO) is a new effort to model treatments and other measures taken for clinical management. Finally, the HPO consortium is contributing to efforts to integrate the HPO and the GA4GH Phenopacket Schema into electronic health records (EHRs) with the goal of more standardized and computable integration of rare disease data in EHRs.

INTRODUCTION: A study was conducted to examine treatment patterns and outcomes among women with a primary ovarian cancer diagnosis in the Midwest region of the United States, an area that has relatively fewer gynecologic oncologists (GOs) and diverse geography with respect to urban and rural areas. In this paper, we examine the methodology of working with central cancer registries (CCRs) to collect additional data items, including those related to GO involvement and detailed treatment. METHODS: Westat recruited 3 state CCRs from the Midwest to participate in the study. Cases were randomly selected from 2010-2012 ovarian, fallopian tube, or primary peritoneal cancer diagnoses in participating registry databases that met the selection criteria. CCRs abstracted additional information for selected cases, including study-specific data items regarding surgery and chemotherapy, GO involvement, and recurrence, where applicable. RESULTS: Abstracts with study-specific data items were collected among a total of 1,003 incidence ovarian cancer cases, with 432 additional abstracts for those cases identified as having recurrence. Variables with the highest frequency of unknowns were mostly for patients who had chemotherapy. While data were available for whether the patient received chemotherapy, the specifics about that chemotherapy were not always available, with dosing and unit being unknown in 27% of cases. There were several challenges with initiating and completing this study associated with recruitment, the data collection timeline, and the collection of study-specific data items. CONCLUSION: This paper outlines the methodologic approach and experience of collecting additional surgical and chemotherapy treatment variables and data on GO involvement in care from medical records. Experiences from this study provide critical lessons that can be applied to future data collection in this area. Ultimately, the accurate collection of these elements enables researchers to identify groups of women who are not receiving the benefit of optimal surgery or GO care and provides critical data on interventions for improved outcomes and survival in ovarian cancer patients.

BACKGROUND: The Department of Health and Human Services' National Blood Collection and Utilization Survey (NBCUS) has been conducted biennially since 1997. Data are used to estimate national blood collection and use. Supplemental data from the 2021 NBCUS not presented elsewhere are presented here. METHODS: Data on survey participation, donor characteristics, blood component cost, transfusion-associated adverse reactions, and implementation of blood safety measures, including pathogen-reduction of platelets, during 2021, were analyzed. Comparisons are made to 2019 survey data where available (2013-2019 for survey participation). RESULTS: During 2021, there were 11,507,000 successful blood donations in the United States, a 4.8% increase from 2019. Persons aged 45-64 years accounted for 42% of all successful blood donations. Donations by persons aged 65 years and older increased by 40.7%, while donations among minorities and donors aged <25 years decreased. From 2019 to 2021, the median price hospitals paid per unit of leukoreduced red blood cells, leukoreduced and pathogen-reduced apheresis platelets, and fresh frozen plasma increased. The largest increase in price per unit of blood component in 2021 was for leukoreduced apheresis platelets, which increased by ~$51. Between 2019 and 2021, the proportion of transfusing facilities reporting use of pathogen-reduced platelets increased, from 13% to 60%. Transfusion-related adverse reactions declined slightly between 2019 and 2021, although the rate of transfusion-transmitted bacterial infections remained unchanged. CONCLUSION: During 2021, blood donations increased nationally, although donations from those aged <25 years and minorities declined. The prices hospitals paid for most blood products increased, as did the use of pathogen-reduced platelets.

Background: Leptospirosis, caused by Leptospira bacteria, is a common zoonosis worldwide more prevalent in the tropics. Reservoir species and risk factors have been identified but surveys for environmental sources of leptospirosis are rare. Furthermore, understanding of environmental Leptospira containing pathogenic genes and possibly capable of causing disease is incomplete and could result in some pathogenic strains evading detection, thereby convoluting diagnosis, prevention, and epidemiology. Methodology/Principal Findings: We collected environmental samples from 22 sites in Puerto Rico during three sampling periods over 14-months (Dec 2018-Feb 2020); 10 water and 10 soil samples were collected at each site. Samples were screened for pathogenic Leptospira DNA using the lipL32 PCR assay and positive samples were sequenced to assess genetic diversity. One urban site in San Juan was sampled three times over 14 months to assess persistence in soil; live leptospires were obtained during the last sampling period. Isolates were whole genome sequenced and LipL32 expression was assessed in vitro. We detected pathogenic Leptospira DNA at 15/22 sites; both soil and water were positive at 5/15 sites. We recovered lipL32 sequences from 83/86 positive samples (15/15 positive sites) and secY sequences from 32/86 (10/15 sites); multiple genotypes were identified at 12 sites. These sequences revealed significant diversity across samples, including four novel lipL32 phylogenetic clades. Most samples from the serially sampled site were lipL32 positive at each time point. We sequenced the genomes of six saprophytic and two pathogenic Leptospira isolates; the latter represent a novel pathogenic Leptospira species likely belonging to a new serogroup. Conclusions/Significance: Diverse and novel pathogenic Leptospira are widespread in the environment in Puerto Rico. The disease potential of the novel lineages is unknown but several persisted for >1 year in soil, which could contaminate water. This work increases understanding of environmental Leptospira and should improve leptospirosis surveillance and diagnostics. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.

Respiratory syncytial virus (RSV) is the predominant cause of acute lower respiratory infection (ALRI) in young children worldwide, yet no licensed RSV vaccine exists to help prevent the millions of illnesses and hospitalizations and tens of thousands of young lives taken each year. Monoclonal antibody (mAb) prophylaxis exists for prevention of RSV in a small subset of very high-risk infants and young children, but the only currently licensed product is impractical, requiring multiple doses and expensive for the low-income settings where the RSV disease burden is greatest. A robust candidate pipeline exists to one day prevent RSV disease in infant and pediatric populations, and it focuses on two promising passive immunization approaches appropriate for low-income contexts: maternal RSV vaccines and long-acting infant mAbs. Licensure of one or more candidates is feasible over the next one to three years and, depending on final product characteristics, current economic models suggest both approaches are likely to be cost-effective. Strong coordination between maternal and child health programs and the Expanded Program on Immunization will be needed for effective, efficient, and equitable delivery of either intervention. This 'Vaccine Value Profile' (VVP) for RSV is intended to provide a high-level, holistic assessment of the information and data that are currently available to inform the potential public health, economic and societal value of pipeline vaccines and vaccine-like products. This VVP was developed by a working group of subject matter experts from academia, non-profit organizations, public private partnerships and multi-lateral organizations, and in collaboration with stakeholders from the WHO headquarters. All contributors have extensive expertise on various elements of the RSV VVP and collectively aimed to identify current research and knowledge gaps. The VVP was developed using only existing and publicly available information.

Under a contract with the US Centers for Disease Control and Prevention (CDC), Westat is conducting data quality evaluations (DQEs) to assess completeness and validation of selected cancer sites. In year 2, we evaluated cases diagnosed in 2018 from melanoma of the skin, bladder, pancreas, kidney and renal pelvis, and ovary. Seventeen central cancer registries (CCRs) funded by the National Program of Cancer Registries (NPCR) participated. Two components were evaluated: validation and completeness.

BACKGROUND: The United States Preventive Services Task Force (USPSTF) recommends breast, cervical, and colorectal cancer screening among eligible adults, but information on screening use in the US territories is limited. METHODS: To estimate the proportion of adults up-to-date with breast, cervical, and colorectal cancer screening based on USPSTF recommendations, we analyzed Behavioral Risk Factor Surveillance System data from 2016, 2018, and 2020 for the 50 US states and DC (US) and US territories of Guam and Puerto Rico and from 2016 for the US Virgin Islands. Age-standardized weighted proportions for up-to-date cancer screening were examined overall and by select characteristics for each jurisdiction. RESULTS: Overall, 67.2% (95% CI: 60.6-73.3) of women aged 50-74 years in the US Virgin Islands, 74.8% (70.9-78.3) in Guam, 83.4% (81.7-84.9) in Puerto Rico, and 78.3% (77.9-78.6) in the US were up-to-date with breast cancer screening. For cervical cancer screening, 71.1% (67.6-74.3) of women aged 21-65 years in Guam, 81.3% (74.6-86.5) in the US Virgin Islands, 83.0% (81.7-84.3) in Puerto Rico, and 84.5% (84.3-84.8) in the US were up-to-date. For colorectal cancer screening, 45.2% (40.0-50.5) of adults aged 50-75 years in the US Virgin Islands, 47.3% (43.6-51.0) in Guam, 61.2% (59.5-62.8) in Puerto Rico, and 69.0% (68.7-69.3) in the US were up-to-date. Adults without health care coverage reported low test use for all three cancers in all jurisdictions. In most jurisdictions, test use was lower among adults with less than a high school degree and an annual household income of < $25,000. CONCLUSION: Cancer screening test use varied between the US territories, highlighting the importance of understanding and addressing territory-specific barriers. Test use was lower among groups without health care coverage and with lower income and education levels, suggesting the need for targeted evidence-based interventions.

INTRODUCTION: Reports have suggested the COVID-19 pandemic resulted in blood donation shortages and adverse impacts on the blood supply. Using data from the National Blood Collection and Utilization Survey (NBCUS), we quantified the pandemic's impact on red blood cell (RBC) and apheresis platelet collections and transfusions in the United States during year 2020. METHODS: The 2021 NBCUS survey instrument was modified to include certain blood collection and utilization variables for 2020. The survey was distributed to all US blood collection centers, all US hospitals performing ≥1000 surgeries annually, and a 40% random sample of hospitals performing 100-999 surgeries annually. Weighting and imputation were used to generate national estimates for whole blood and apheresis platelet donation; RBC and platelet transfusion; and convalescent plasma distribution. RESULTS: Whole blood collections were stable from 2019 (9,790,000 units; 95% CI: 9,320,000-10,261,000) to 2020 (9,738,000 units; 95% CI: 9,365,000-10,110,000). RBC transfusions decreased by 6.0%, from 10,852,000 units (95% CI: 10,444,000-11,259,000) in 2019 to 10,202,000 units (95% CI: 9,811,000-10,593,000) in 2020. Declines were steepest during March-April 2020, with transfusions subsequently rebounding. Apheresis platelet collections increased from 2,359,000 units (95% CI: 2,240,000-2,477,000) in 2019 to 2,408,000 units (95% CI: 2,288,000-2,528,000) in 2020. Apheresis platelet transfusions increased from 1,996,000 units (95% CI: 1,846,000-2,147,000) in 2019 to 2,057,000 units (95% CI: 1,902,000-2,211,000) in 2020. CONCLUSION: The COVID-19 pandemic resulted in reduced blood donations and transfusions in some months during 2020 but only a minimal annualized decline compared with 2019.

This study characterizes community perceptions on a large-scale project seeking to reduce the population of Aedes aegypti mosquitoes and prevent arboviral disease transmission in Ponce, Puerto Rico; and to leverage on these perceptions to make modifications to ensure effective project implementation. In 2017-2018 the team conducted informal interviews, focus groups, and in-depth interviews with leaders and residents of the communities, focusing on challenges and potential solutions to the project implementation. Possible challenges to the project implementation included the lack of geographic consistency between clusters defined by researchers and the participants' description of the communities' geographic boundaries. Few children living in the communities could affect the ability of the project to adequately measure arboviral disease incidence. Also, population attrition due to out-migration, and lack of community leaders and communication channels after Hurricane Maria could affect participation in project activities. Lack of trust on strangers was an important challenge due to criminal activity involving violence and drug use in some community areas. Solutions to the identified challenges included identifying emerging leaders and implementing community meetings to promote project activities. The information that community members provided helped us to understand the natural disasters' impact on population attrition in these communities with a disproportionate impact in younger groups, resulting in an aging population. We identified lack of community organization and leadership and increasing number of abandoned houses that could turn into Aedes aegypti breeding sites. The formative work helped to better define the geographic areas that the study would cover, evaluate the acceptability of innovative vector control methods, and identify communication methods used by residents. With this information, challenges and potential solutions in recruiting participants were anticipated, and the community engagement and communications plans were developed. We recommend selecting clusters before research, because opinions towards mosquito control technologies could vary in added clusters.

BACKGROUND: National Blood Collection and Utilization Surveys (NBCUS) have reported decreases in U.S. blood collections and transfusions since 2008. The declines began to stabilize in 2015-2017, with a subsequent increase in transfusions in 2019. Data from the 2021 NBCUS were analyzed to understand the current dynamics of blood collection and use in the United States. METHODS: In March 2022, all community-based (53) and hospital-based (83) blood collection centers, a randomly selected 40% of transfusing hospitals performing 100-999 annual inpatient surgeries, and all transfusing hospitals performing ≥1000 annual inpatient surgeries were sent a 2021 NBCUS survey to ascertain blood collection and transfusion data. Responses were compiled, and national estimates were calculated for the number of units of blood and blood components collected, distributed, transfused, and outdated in 2021. Weighting and imputation were applied to account for non-responses and missing data, respectively. RESULTS: Survey response rates were 92.5% (49/53) for community-based blood centers, 74.7% (62/83) for hospital-based blood centers, and 76.3% (2102/2754) for transfusing hospitals. Overall, 11,784,000 (95% confidence interval [CI], 11,392,000-12,177,000) whole blood and apheresis red blood cell (RBC) units were collected in 2021, a 1.7% increase from 2019; 10,764,000 (95% CI, 10,357,000-11,171,000) whole blood-derived and apheresis RBC units were transfused, a 0.8% decrease. Total platelet units distributed increased by 0.8%; platelet units transfused decreased by 3.0%; plasma units distributed increased by 16.2%; and plasma units transfused increased by 1.4%. DISCUSSION: The 2021 NBCUS findings demonstrate a stabilization in U.S. blood collections and transfusions, suggesting a plateau has been reached for both.

Burkholderia thailandensis, an opportunistic pathogen found in the environment, is a bacterium closely related to B. pseudomallei, the cause of melioidosis. Human B. thailandensis infections are uncommon. We isolated B. thailandensis from water in Texas and Puerto Rico and soil in Mississippi in the United States, demonstrating a potential public health risk.

The US Centers for Disease Control and Prevention (CDC) supports international partners in introducing vaccines, including those against SARS-CoV-2 virus. CDC contributes to the development of global technical tools, guidance, and policy for COVID-19 vaccination and has established its COVID-19 International Vaccine Implementation and Evaluation (CIVIE) program. CIVIE supports ministries of health and their partner organizations in developing or strengthening their national capacities for the planning, implementation, and evaluation of COVID-19 vaccination programs. CIVIE's 7 priority areas for country-specific technical assistance are vaccine policy development, program planning, vaccine confidence and demand, data management and use, workforce development, vaccine safety, and evaluation. We discuss CDC's work on global COVID-19 vaccine implementation, including priorities, challenges, opportunities, and applicable lessons learned from prior experiences with Ebola, influenza, and meningococcal serogroup A conjugate vaccine introductions.

INTRODUCTION: Diarrhoea remains a leading cause of child morbidity and mortality. Systematically collected and analysed data on the aetiology of hospitalised diarrhoea in low-income and middle-income countries are needed to prioritise interventions. METHODS: We established the Global Pediatric Diarrhea Surveillance network, in which children under 5 years hospitalised with diarrhoea were enrolled at 33 sentinel surveillance hospitals in 28 low-income and middle-income countries. Randomly selected stool specimens were tested by quantitative PCR for 16 causes of diarrhoea. We estimated pathogen-specific attributable burdens of diarrhoeal hospitalisations and deaths. We incorporated country-level incidence to estimate the number of pathogen-specific deaths on a global scale. RESULTS: During 2017-2018, 29 502 diarrhoea hospitalisations were enrolled, of which 5465 were randomly selected and tested. Rotavirus was the leading cause of diarrhoea requiring hospitalisation (attributable fraction (AF) 33.3%; 95% CI 27.7 to 40.3), followed by Shigella (9.7%; 95% CI 7.7 to 11.6), norovirus (6.5%; 95% CI 5.4 to 7.6) and adenovirus 40/41 (5.5%; 95% CI 4.4 to 6.7). Rotavirus was the leading cause of hospitalised diarrhoea in all regions except the Americas, where the leading aetiologies were Shigella (19.2%; 95% CI 11.4 to 28.1) and norovirus (22.2%; 95% CI 17.5 to 27.9) in Central and South America, respectively. The proportion of hospitalisations attributable to rotavirus was approximately 50% lower in sites that had introduced rotavirus vaccine (AF 20.8%; 95% CI 18.0 to 24.1) compared with sites that had not (42.1%; 95% CI 33.2 to 53.4). Globally, we estimated 208 009 annual rotavirus-attributable deaths (95% CI 169 561 to 259 216), 62 853 Shigella-attributable deaths (95% CI 48 656 to 78 805), 36 922 adenovirus 40/41-attributable deaths (95% CI 28 469 to 46 672) and 35 914 norovirus-attributable deaths (95% CI 27 258 to 46 516). CONCLUSIONS: Despite the substantial impact of rotavirus vaccine introduction, rotavirus remained the leading cause of paediatric diarrhoea hospitalisations. Improving the efficacy and coverage of rotavirus vaccination and prioritising interventions against Shigella, norovirus and adenovirus could further reduce diarrhoea morbidity and mortality.

BACKGROUND: To determine whether Positive Health Check, a highly tailored video doctor intervention, can improve viral suppression and retention in care. SETTING: Four clinics that deliver HIV primary care. METHODS: A hybrid type 1 effectiveness-implementation randomized trial design was used to test study hypotheses. Participants (N = 799) who were not virally suppressed, were new to care, or had fallen out of care were randomly assigned to receive Positive Health Check or the standard of care alone. The primary endpoint was viral load suppression, and the secondary endpoint was retention in care, both assessed at 12 months, using an intention-to-treat approach. A priori subgroup analyses based on sex assigned at birth and race were examined as well. RESULTS: There were no statistically significant differences between Positive Health Check (N = 397) and standard of care (N = 402) for either endpoint. However, statistically significant group differences were identified from a priori subgroup analyses. Male participants receiving Positive Health Check were more likely to achieve suppression at 12 months than male participants receiving standard of care adjusted risk ratio [aRR] [95% confidence interval (CI)] = 1.14 (1.00 to 1.29), P = 0.046}. For retention in care, there was a statistically significant lower risk for a 6-month visit gap in the Positive Health Check arm for the youngest participants, 18-29 years old [aRR (95% CI) = 0.55 (0.33 to 0.92), P = 0.024] and the oldest participants, 60-81 years old [aRR (95% CI) = 0.49 (0.30 to 0.81), P = 0.006]. CONCLUSIONS: Positive Health Check may help male participants with HIV achieve viral suppression, and younger and older patients consistently attend HIV care. REGISTRY NAME: Positive Health Check Evaluation Trial. Trial ID: 1U18PS004967-01. URL: https://clinicaltrials.gov/ct2/show/NCT03292913.

Chikungunya virus (CHIKV) caused a large outbreak in Puerto Rico in 2014, followed by a Zika virus (ZIKV) outbreak in 2016. Communities Organized for the Prevention of Arboviruses (COPA) is a cohort study in southern Puerto Rico, initiated in 2018 to measure arboviral disease risk and provide a platform to evaluate interventions. To identify risk factors for infection, we assessed prevalence of previous CHIKV infection and recent ZIKV and DENV infection in a cross-sectional study among COPA participants. Participants aged 1-50 years (y) were recruited from randomly selected households in study clusters. Each participant completed an interview and provided a blood specimen, which was tested by anti-CHIKV IgG ELISA assay and anti-ZIKV and anti-DENV IgM MAC-ELISA assays. We assessed individual, household, and community factors associated with a positive result for CHIKV or ZIKV after adjusting for confounders. During 2018-2019, 4,090 participants were enrolled; 61% were female and median age was 28y (interquartile range [IQR]: 16-41). Among 4,035 participants tested for CHIKV, 1,268 (31.4%) had evidence of previous infection. CHIKV infection prevalence was lower among children 1-10 years old compared to people 11 and older (adjusted odds ratio [aOR] 2.30; 95% CI 1.71-3.08). Lower CHIKV infection prevalence was associated with home screens (aOR 0.51; 95% CI 0.42-0.61) and air conditioning (aOR 0.64; 95% CI 0.54-0.77). CHIKV infection prevalence also varied by study cluster of residence and insurance type. Few participants (16; 0.4%) had evidence of recent DENV infection by IgM. Among 4,035 participants tested for ZIKV, 651 (16%) had evidence of recent infection. Infection prevalence increased with older age, from 7% among 1-10y olds up to 19% among 41-50y olds (aOR 3.23; 95% CI 2.16-4.84). Males had an increased risk of Zika infection prevalence compared with females (aOR 1.31; 95% CI 1.09-1.57). ZIKV infection prevalence also decreased with the presence of home screens (aOR 0.66; 95% CI 0.54-0.82) and air conditioning (aOR 0.69; 95% CI 0.57-0.84). Similar infection patterns were observed for recent ZIKV infection prevalence and previous CHIKV infection prevalence by age, and the presence of screens and air conditioners in the home decreased infection risk from both viruses by as much as 50%.

Due to their documented epidemiological relevance as hosts for influenza A viruses (IAV), humans, poultry and pigs in backyard production systems (BPS) within wetlands could be key to the emergence of novel IAV variants able to transmit between humans or animals. To better understand the circulation of IAV at the human-animal interface of BPS within wetlands, we studied IAV in backyard duck flocks and pig herds in the Pacific Coast of Guatemala. From April 2013 to October 2014, we estimated the monthly IAV per cent seropositive and viral positive flocks and herds in two resource-limited communities. We detected antibodies in sera against the IAV nucleoprotein through ELISA. We also detected IAV viral RNA in respiratory (ducks and pigs) and cloacal (ducks) swabs through rRT-PCR directed at the matrix gene. We attempted viral isolation in eggs or MDCK cells followed by sequencing from swabs positive for IAV. During our study period, IAV seropositivity in duck flocks was 38%, and viral positivity was 23% (n = 86 BPS sampled). IAV seropositivity in pig herds was 42%, and viral positivity was 20% (n = 90 BPS sampled). Both flocks and herds had detectable antibodies against IAV mostly year-round, and IAV was detected in several months. We isolated an H3N2 virus from one pig sampled at the end of 2013. Standard nucleotide BLAST searches indicate that the isolated virus was similar to seasonal viruses circulating in humans, suggesting human-to-pig transmission. Our data show concurrent circulation of IAV in multiple species of poultry and pigs that were commingled in rudimentary conditions in proximity to humans, but no significant risk factors could be identified.

BACKGROUND: Leptospirosis, caused by Leptospira bacteria, is a common zoonosis worldwide, especially in the tropics. Reservoir species and risk factors have been identified but surveys for environmental sources are rare. Furthermore, understanding of environmental Leptospira containing virulence associated genes and possibly capable of causing disease is incomplete, which may convolute leptospirosis diagnosis, prevention, and epidemiology. METHODOLOGY/PRINCIPAL FINDINGS: We collected environmental samples from 22 sites in Puerto Rico during three sampling periods over 14-months (Dec 2018-Feb 2020); 10 water and 10 soil samples were collected at each site. Samples were screened for DNA from potentially pathogenic Leptospira using the lipL32 PCR assay and positive samples were sequenced to assess genetic diversity. One urban site in San Juan was sampled three times over 14 months to assess persistence in soil; live leptospires were obtained during the last sampling period. Isolates were whole genome sequenced and LipL32 expression was assessed in vitro. We detected pathogenic Leptospira DNA at 15/22 sites; both soil and water were positive at 5/15 sites. We recovered lipL32 sequences from 83/86 positive samples (15/15 positive sites) and secY sequences from 32/86 (10/15 sites); multiple genotypes were identified at 12 sites. These sequences revealed significant diversity across samples, including four novel lipL32 phylogenetic clades within the pathogenic P1 group. Most samples from the serially sampled site were lipL32 positive at each time point. We sequenced the genomes of six saprophytic and two pathogenic Leptospira isolates; the latter represent a novel pathogenic Leptospira species likely belonging to a new serogroup. CONCLUSIONS/SIGNIFICANCE: Diverse and novel pathogenic Leptospira are widespread in the environment in Puerto Rico. The disease potential of these lineages is unknown but several were consistently detected for >1 year in soil, which could contaminate water. This work increases understanding of environmental Leptospira diversity and should improve leptospirosis surveillance and diagnostics.

BACKGROUND: Positive Health Check (PHC) is an evidenced-based video doctor intervention developed for improving the medication adherence, retention in care, and viral load suppression of people with HIV receiving clinical care. SETTING: Four HIV primary care clinics within the United States. METHODS: As part of a type 1 hybrid trial, a mixed-methods approach was used to longitudinally assess the following 3 key implementation constructs over a 23-month period: innovation-values fit (ie, the extent to which staff perceive innovation use will foster the fulfillment of their values), organizational readiness for change (ie, the extent to which organizational members are psychologically and behaviorally prepared to implement organizational change), and implementation climate (ie, the extent to which implementation is expected, supported, and rewarded). Quantitative mixed-effects regression analyses were conducted to assess changes over time in these constructs. Qualitative analyses were integrated to help provide validation and understanding. RESULTS: Innovation-values fit and organizational readiness for change were found to be high and relatively stable. However, significant curvilinear change over time was found for implementation climate. Based on the qualitative data, implementation climate declined toward the end of implementation due to decreased engagement from clinic champions and differences in priorities between research and clinic staff. CONCLUSIONS: The PHC intervention was found to fit within HIV primary care service settings, but there were some logistical challenges that needed to be addressed. Additionally, even within the context of an effectiveness trial, significant and nonlinear change in implementation climate should be expected over time.

BACKGROUND: Epidemiologic research among migrant populations is limited by logistical, methodological, and ethical challenges, but it is necessary for informing public health and humanitarian programming. OBJECTIVE: We describe a methodology to estimate HIV prevalence among Venezuelan migrants in Colombia. METHODS: Respondent-driven sampling, a nonprobability sampling method, was selected for attributes of reaching highly networked populations without sampling frames and analytic methods that permit estimation of population parameters. Respondent-driven sampling was modified to permit electronic referral of peers via SMS text messaging and WhatsApp. Participants complete sociobehavioral surveys and rapid HIV and syphilis screening tests with confirmatory testing. HIV treatment is not available for migrants who have entered Colombia through irregular pathways; thus, medicolegal services integrated into posttest counseling provide staff lawyers and legal assistance to participants diagnosed with HIV or syphilis for sustained access to treatment through the national health system. Case finding is integrated into respondent-driven sampling to allow partner referral. This study is implemented by a local community-based organization providing HIV support services and related legal services for Venezuelans in Colombia. RESULTS: Data collection was launched in 4 cities in July and August 2021. As of November 2021, 3105 of the target 6100 participants were enrolled, with enrollment expected to end by February/March 2022. CONCLUSIONS: Tailored methods that combine community-led efforts with innovations in sampling and linkage to care can aid in advancing health research for migrant and displaced populations. Worldwide trends in displacement and migration underscore the value of improved methods for translation to humanitarian and public health programming. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36026.

In trials of oral HIV pre-exposure prophylaxis (PrEP), multiple approaches have been used to measure adherence, including self-report, pill counts, electronic dose monitoring devices, and biological measures such as drug levels in plasma, peripheral blood mononuclear cells, hair, and/or dried blood spots. No one of these measures is ideal and each has strengths and weaknesses. However, accurate estimates of adherence to oral PrEP are important as drug efficacy is closely tied to adherence, and secondary analyses of trial data within identified adherent/non-adherent subgroups may yield important insights into real-world drug effectiveness. We develop a statistical approach to combining multiple measures of adherence and show in simulated data that the proposed method provides a more accurate measure of true adherence than self-report. We then apply the method to estimate adherence in the ADAPT study (HPTN 067) in South African women.

Arboviral diseases transmitted by Aedes species mosquitoes pose an increasing public health challenge in tropical regions. Wolbachia-mediated population suppression (Wolbachia suppression) is a vector control method used to reduce Aedes mosquito populations by introducing male mosquitoes infected with Wolbachia, a naturally occurring endosymbiotic bacterium. When Wolbachia-infected male mosquitoes mate with female wild mosquitoes, the resulting eggs will not hatch. Public support is vital to the successful implementation and sustainability of vector control interventions. Communities Organized to Prevent Arboviruses (COPA) is a cohort study to determine the incidence of arboviral disease in Ponce, Puerto Rico and evaluate vector control methods. Focus groups were conducted with residents of COPA communities to gather their opinion on vector control methods; during 2018-2019, adult COPA participants were interviewed regarding their views on Wolbachia suppression; and a follow-up questionnaire was conducted among a subset of participants and non-participants residing in COPA communities. We analyzed factors associated with support for this method. Among 1,528 participants in the baseline survey, median age was 37 years and 63% were female. A total of 1,032 (68%) respondents supported Wolbachia suppression. Respondents with an income of $40,000 or more were 1.34 times as likely [95% CI: 1.03, 1.37] to support Wolbachia suppression than those who earned less than $40,000 annually. Respondents who reported repellant use were 1.19 times as likely to support Wolbachia suppression [95% CI: 1.03, 1.37]. A follow-up survey in 2020 showed that most COPA participants (86%) and non-participants living in COPA communities (84%) supported Wolbachia suppression during and after an educational campaign. The most frequent questions regarding this method were related to its impact on human and animal health, and the environment. Continuous community engagement and education efforts before and during the implementation of novel vector control interventions are necessary to increase and maintain community support.

The Abbott BinaxNOW rapid antigen test is cheaper and faster than real-time reverse transcription PCR (rRT-PCR) for detecting severe acute respiratory syndrome coronavirus 2. We compared BinaxNOW with rRT-PCR in 769 paired specimens from 342 persons during a coronavirus disease outbreak among horse racetrack workers in California, USA. We found positive percent agreement was 43.3% (95% CI 34.6%-52.4%), negative percent agreement 100% (95% CI 99.4%-100%), positive predictive value 100% (95% CI 93.5%-100%), and negative predictive value 89.9% (95% CI 87.5%-92.0%). Among 127 rRT-PCR-positive specimens, the 55 with paired BinaxNOW-positive results had a lower mean cycle threshold than the 72 with paired BinaxNOW-negative results (17.8 vs. 28.5; p<0.001). Of 100 specimens with cycle threshold <30, a total of 51 resulted in positive virus isolation; 45 (88.2%) of those were BinaxNOW-positive. Our comparison supports immediate isolation for BinaxNOW-positive persons and confirmatory testing for negative persons.

BACKGROUND/AIM: Adiposity trajectories reflect dynamic process of growth and may predict later life health better than individual measures. Prenatal phthalate exposures may program later childhood adiposity, but findings from studies examining these associations are conflicting. We investigated associations between phthalate biomarker concentrations during pregnancy with child adiposity trajectories. METHODS: We followed 514 mother-child pairs from the Mexico City PROGRESS cohort from pregnancy through twelve years. We measured concentrations of nine phthalate biomarkers in 2nd and 3rd trimester maternal urine samples to create a pregnancy average using the geometric mean. We measured child BMI z-score, fat mass index (FMI), and waist-to-height ratio (WHtR) at three study visits between four and 12 years of age. We identified adiposity trajectories using multivariate latent class growth modeling, considering BMI z-score, FMI, and WHtR as joint indicators of latent adiposity. We estimated associations of phthalates biomarkers with class membership using multinomial logistic regression. We used quantile g-computation to estimate the potential effect of the total phthalate mixture and assessed effect modification by sex. RESULTS: We identified three trajectories of child adiposity, a "low-stable", a "low-high", and a "high-high" group. A doubling of the sum of di (2-ethylhexyl) phthalate metabolites (ΣDEHP), was associated with 1.53 (1.08, 2.19) greater odds of being in the "high-high" trajectory in comparison to the "low-stable" group, whereas a doubling in di-isononyl phthalate metabolites (ΣDiNP) was associated with 1.43 (1.02, 2.02) greater odds of being in the "low-high" trajectory and mono (carboxy-isononyl) phthalate (MCNP) was associated with 0.66 (0.45, 97) lower odds of being in the "low-high" trajectory. No sex-specific associations or mixture associations were observed. CONCLUSIONS: Prenatal concentrations of urinary DEHP metabolites, DiNP metabolites, and MCNP, a di-isodecyl phthalate metabolite, were associated with trajectories of child adiposity. The total phthalate mixture was not associated with early life child adiposity.

INTRODUCTION: An estimated 116 million American adults (47.3%) have hypertension. Most adults with hypertension do not have it controlled-3 in 4 (92.1 million) U.S. adults with hypertension have a blood pressure ≥130/80 mmHg. The Pharmacists' Patient Care Process is a standardized patient-centered approach to the provision of pharmacist care that is done in collaboration with other healthcare providers. Through the Michigan Medicine Hypertension Pharmacists' Program, pharmacists use the Pharmacists' Patient Care Process to provide hypertension management services in collaboration with physicians in primary care and community pharmacy settings. In 2019, the impact of Michigan Medicine Hypertension Pharmacists' Program patient participation on blood pressure control was evaluated. METHODS: Propensity scoring was used to match patients in the intervention group with patients in the comparison group and regression analyses were then conducted to compare the 2 groups on key patient outcomes. Negative binomial regression was used to examine the number of days with blood pressure under control. The findings presented in this brief are part of a larger multimethod evaluation. RESULTS: More patients in the intervention group than in the comparison group achieved blood pressure control at 3 months (66.3% vs 42.4%) and 6 months (69.1% vs 56.5%). The intervention group experienced more days with blood pressure under control within a 3-month (18.6 vs 9.5 days) and 6-month period (57.0 vs 37.4 days) than the comparison group did. CONCLUSIONS: Findings support the effectiveness of the Michigan Medicine Hypertension Pharmacists' Program approach to implementing the Pharmacists' Patient Care Process to improve blood pressure control.