Last data update: Jun 03, 2024. (Total: 46935 publications since 2009)
Records 1-30 (of 87 Records) |
Query Trace: Goldberg H [original query] |
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Environmental phenols and growth in infancy: The Infant Feeding and Early Development Study
Stevens DR , Goldberg M , Adgent M , Chin HB , Baird DD , Stallings VA , Sandler DP , Calafat AM , Ford EG , Zemel BS , Kelly A , Umbach DM , Rogan W , Ferguson KK . J Clin Endocrinol Metab 2024 CONTEXT: Higher mean and rapid increases in body mass index (BMI) during infancy are associated with subsequent obesity and may be influenced by exposure to endocrine-disrupting chemicals such as phenols. OBJECTIVE: In a prospective US-based cohort conducted 2010-2014, we investigated associations between environmental phenol exposures and BMI in 199 infants. METHODS: We measured seven urinary phenols at ages 6-8 and 12 weeks and assessed BMI z-score at up to 12 study visits between birth and 36 weeks. We examined individual and joint associations of averaged early infancy phenols with level of BMI z-score using mean differences (β [95% confidence intervals (CI)]) and with BMI z-score trajectories using relative risk ratios (RR [95% CI]). RESULTS: Benzophenone-3, methyl and propyl paraben, and all phenols jointly were positively associated with higher mean BMI z-score (0.07 [-0.05, 0.18], 0.10 [-0.08, 0.27], 0.08 [-0.09, 0.25], 0.17 [-0.08, 0.43], respectively). Relative to a Stable trajectory, benzophenone-3, 2,4-dichlorophenol, 2,5-dichlorophenol, and all phenols jointly were positively associated with risk of a Rapid Increase trajectory (1.46 [0.89, 2.39], 1.33 [0.88, 2.01], 1.66 [1.03, 2.68], 1.41 [0.71, 2.84], respectively). CONCLUSION: Early phenol exposure was associated with a higher mean and rapid increase in BMI z-score across infancy, signaling potential long-term cardiometabolic consequences of exposure. |
Environmental phenol exposures in 6- to 12-week-old infants: the Infant Feeding and Early Development (IFED) Study
Goldberg M , Adgent MA , Stevens DR , Chin HB , Ferguson KK , Calafat AM , Travlos G , Ford EG , Stallings VA , Rogan WJ , Umbach DM , Baird DD , Sandler DP . Environ Res 2024 119075 BACKGROUND: Exposure to phenols, endocrine-disrupting chemicals used in personal care and consumer products, is widespread. Data on infant exposures are limited despite heightened sensitivity to endocrine disruption during this developmental period. We aimed to describe distributions and predictors of urinary phenol concentrations among U.S. infants ages 6-12 weeks. METHODS: The Infant Feeding and Early Development (IFED) study is a prospective cohort study of healthy term infants enrolled during 2010-2013 in the Philadelphia region. We measured concentrations of seven phenols in 352 urine samples collected during the 6- or 8- and/or 12-week study visits from 199 infants. We used linear mixed models to estimate associations of maternal, sociodemographic, infant, and sample characteristics with natural-log transformed, creatinine-standardized phenol concentrations and present results as mean percent change from the reference level. RESULTS: Median concentrations (μg/L) were 311 for methylparaben, 10.3 for propylparaben, 3.6 for benzophenone-3, 2.1 for triclosan, 1.0 for 2,5-dichlorophenol, 0.7 for BPA, and 0.3 for 2,4-dichlorophenol. Geometric mean methylparaben concentrations were approximately 10 times higher than published estimates for U.S. children ages 3-5 and 6-11 years, while propylparaben concentrations were 3-4 times higher. Infants of Black mothers had higher concentrations of BPA (83%), methylparaben (121%), propylparaben (218%), and 2,5-dichorophenol (287%) and lower concentrations of benzophenone-3 (-77%) and triclosan (-53%) than infants of White mothers. Triclosan concentrations were higher in breastfed infants (176%) and lower in infants whose mothers had a high school education or less (-62%). Phenol concentrations were generally higher in summer samples. CONCLUSIONS: Widespread exposure to select environmental phenols among this cohort of healthy U.S. infants, including much higher paraben concentrations compared to those reported for U.S. children, supports the importance of expanding population-based biomonitoring programs to infants and toddlers. Future investigation of exposure sources is warranted to identify opportunities to minimize exposures during these sensitive periods of development. |
Prevalence, patterns, and predictors of SARS-CoV-2 RNA and culturable virus in tears of case-ascertained household cohort
So M , Goldberg SA , Lu S , Garcia-Knight M , Davidson MC , Tassetto M , Murray VW , Anglin K , Pineda-Ramirez J , Chen JY , Rugart PR , Richardson ET , Hagen MB , Midgley CM , Andino R , Seitzman GD , Gonzales J , Peluso MJ , Martin JN , Kelly JD . Am J Ophthalmol 2024 PURPOSE: To investigate the prevalence, patterns, and predictors of SARS-CoV-2 RNA and culturable virus in tears of case-ascertained household cohort. DESIGN: Prospective, longitudinal case-ascertained household cohort identified through convenience sampling. METHODS: This analysis was restricted to individuals who were non-hospitalized, symptomatic, and tested positive for SARS-CoV-2 by nasal RT-PCR. Tears and anterior nasal biospecimens were serially collected throughout the acute period. Tears specimens were collected by the study staff using Schirmer test strips, and nasal specimens were self-collected. For both, SARS-CoV-2 RNA was quantified using qRT-PCR and culturable virus was detected using presence of cytopathic effect (CPE) in tissue culture; positive CPE was confirmed by a qRT-PCR step. A series of cross-sectional unadjusted analyses were performed investigating the relationship between different sociodemographic determinants and biological factors associated with tears RNA positivity. RESULTS: Among the 83 SARS-CoV-2 infected participants, ten (12%) had at least one RNA positive tears specimen. Amongst these ten, five (50%) had concurrent presence of culturable virus, at a median of 7 days post symptom onset (IQR: 4-7 days) (absolute range: 4-8 days). CONCLUSIONS: In this longitudinal cohort, we found evidence of culturable virus in the tears of a small proportion of non-hospitalized SARS-CoV-2 infected individuals. Current public health infection precautions do not account for transmission via tears, so these findings may improve our understanding of potential sources of SARS-CoV-2 transmission and contribute to developing future guidelines. |
Viral determinants of acute COVID-19 symptoms in a nonhospitalized adult population in the pre-Omicron era
Goldberg SA , Lu S , Garcia-Knight M , Davidson MC , Tassetto M , Anglin K , Pineda-Ramirez J , Chen JY , Rugart PR , Mathur S , Forman CA , Donohue KC , Abedi GR , Saydah S , Briggs-Hagen M , Midgley CM , Andino R , Peluso MJ , Glidden DV , Martin JN , Kelly JD . Open Forum Infect Dis 2023 10 (8) ofad396 BACKGROUND: The influence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA level and presence of infectious virus on symptom occurrence is poorly understood, particularly among nonhospitalized individuals. METHODS: The study included 85 nonhospitalized, symptomatic adults, who were enrolled from September 2020 to November 2021. Data from a longitudinal cohort studied over 28 days was used to analyze the association of individual symptoms with SARS-CoV-2 viral RNA load, or the presence or level of infectious (culturable) virus. Presence of infectious virus and viral RNA load were assessed daily, depending on specimen availability, and amount of infectious virus was assessed on the day of maximum RNA load. Participants were surveyed for the start and end dates of 31 symptoms at enrollment and at days 9, 14, 21, and 28; daily symptom presence was determined analytically. We describe symptoms and investigate their possible association with viral determinants through a series of single or pooled (multiple days across acute period) cross-sectional analyses. RESULTS: There was an association between viral RNA load and the same-day presence of many individual symptoms. Additionally, individuals with infectious virus were more than three times as likely to have a concurrent fever than individuals without infectious virus, and more than two times as likely to have concurrent myalgia, chills, headache, or sore throat. CONCLUSIONS: We found evidence to support the association of viral RNA load and infectious virus on some, but not all symptoms. Fever was most strongly associated with the presence of infectious virus; this may support the potential for symptom-based isolation guidance for COVID-19. |
Genome-wide patterns of gene expression in a wild primate indicate species-specific mechanisms associated with tolerance to natural simian immunodeficiency virus infection (preprint)
Simons ND , Eick GN , Ruiz-Lopez MJ , Hyeroba D , Omeja PA , Weny G , Chapman CA , Goldberg TL , Zheng H , Shankar A , Switzer WM , Frost SDW , Jones JH , Sterner KN , Ting N . bioRxiv 2018 395152 Over 40 species of nonhuman primates host simian immunodeficiency viruses (SIVs). In natural hosts, infection is generally assumed to be nonpathogenic due to a long coevolutionary history between host and virus, although pathogenicity is difficult to study in wild nonhuman primates. We used whole-blood RNA-seq and SIV prevalence from 29 wild Ugandan red colobus (Piliocolobus tephrosceles) to assess the effects of SIV infection on host gene expression in wild, naturally SIV-infected primates. We found no evidence for chronic immune activation in infected individuals, suggesting that SIV is not immunocompromising in this species, in contrast to HIV in humans. Notably, an immunosuppressive gene, CD101, was upregulated in infected individuals. This gene has not been previously described in the context of nonpathogenic SIV infection. This expands the known variation associated with SIV infection in natural hosts, and may suggest a novel mechanism for tolerance of SIV infection in the Ugandan red colobus. |
Infectious viral shedding of SARS-CoV-2 Delta following vaccination: a longitudinal cohort study (preprint)
Garcia-Knight M , Anglin K , Tassetto M , Lu S , Zhang A , Goldberg SA , Catching A , Davidson MC , Shak JR , Romero M , Pineda-Ramirez J , Sanchez RD , Rugart P , Donohue K , Massachi J , Sans HM , Djomaleu M , Mathur S , Servellita V , McIlwain D , Gaudiliere B , Chen J , Martinez EO , Tavs JM , Bronstone G , Weiss J , Watson JT , Briggs-Hagen M , Abedi GR , Rutherford GW , Deeks SG , Chiu C , Saydah S , Peluso MJ , Midgley CM , Martin JN , Andino R , Kelly JD . medRxiv 2022 19 (9) e1010802 The impact of vaccination on SARS-CoV-2 infectiousness is not well understood. We compared longitudinal viral shedding dynamics in unvaccinated and fully vaccinated adults. SARS-CoV-2-infected adults were enrolled within 5 days of symptom onset and nasal specimens were self-collected daily for two weeks and intermittently for an additional two weeks. SARS-CoV-2 RNA load and infectious virus were analyzed relative to symptom onset stratified by vaccination status. We tested 1080 nasal specimens from 52 unvaccinated adults enrolled in the pre-Delta period and 32 fully vaccinated adults with predominantly Delta infections. While we observed no differences by vaccination status in maximum RNA levels, maximum infectious titers and the median duration of viral RNA shedding, the rate of decay from the maximum RNA load was faster among vaccinated; maximum infectious titers and maximum RNA levels were highly correlated. Furthermore, amongst participants with infectious virus, median duration of infectious virus detection was reduced from 7.5 days (IQR: 6.0-9.0) in unvaccinated participants to 6 days (IQR: 5.0-8.0) in those vaccinated (P=0.02). Accordingly, the odds of shedding infectious virus from days 6 to 12 post-onset were lower among vaccinated participants than unvaccinated participants (OR 0.42 95% CI 0.19-0.89). These results indicate that vaccination had reduced the probability of shedding infectious virus after 5 days from symptom onset. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license. |
SARS-CoV-2 antibody prevalence in Sierra Leone, March 2021: a cross-sectional, nationally representative, age-stratified serosurvey (preprint)
Barrie MB , Lakoh S , Kelly JD , Kanu JS , Squire J , Koroma Z , Bah S , Sankoh O , Brima A , Ansumana R , Goldberg SA , Chitre S , Osuagwu C , Maeda J , Barekye B , Numbere TW , Abdulaziz M , Mounts A , Blanton C , Singh T , Samai M , Vandi MA , Richardson ET . medRxiv 2021 Background As of 26 March 2021, the Africa CDC had reported 4,159,055 cases of COVID-19 and 111,357 deaths among the 55 African Union Member States; however, no country has published a nationally representative serosurvey as of May 2021. Such data are vital for understanding the pandemic's progression on the continent, evaluating containment measures, and policy planning. Methods We conducted a cross-sectional, nationally representative, age-stratified serosurvey in Sierra Leone in March 2021 by randomly selecting 120 Enumeration Areas throughout the country and 10 randomly selected households in each of these. One to two persons per selected household were interviewed to collect information on socio-demographics, symptoms suggestive of COVID-19, exposure history to laboratory-confirmed COVID-19 cases, and history of COVID-19 illness. Capillary blood was collected by fingerstick, and blood samples were tested using the Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test Cassette. Total seroprevalence was was estimated after applying sampling weights. Findings The overall weighted seroprevalence was 2.6% (95% CI 1.9-3.4). This is 43 times higher than the reported number of cases. Rural seropositivity was 1.8% (95% CI 1.0-2.5), and urban seropositivity was 4.2% (95% CI 2.6-5.7). Interpretation Although overall seroprevalence was low compared to countries in Europe and the Americas (suggesting relatively successful containment in Sierra Leone), our findings indicate enormous underreporting of active cases. This has ramifications for the country's third wave (which started in June 2021), where the average number of daily reported cases was 87 by the end of the month: this could potentially be on the order of 3,700 actual infections, calling for stronger containment measures in a country with only 0.2% of people fully vaccinated. It may also reflect significant underreporting of incidence and mortality across the continent. |
Improving connections to early childhood systems of care via a universal home visiting program in Massachusetts
Kotake C , Fauth RC , Stetler K , Goldberg JL , Silva CF , Manning SE . Child Youth Serv Rev 2023 150 Welcome Family is a universal, short-term nurse home visiting program designed to promote optimal maternal and infant physical and mental well-being and provide an entry point into the early childhood system of care to all families with newborns up to 8 weeks old living in defined communities in Massachusetts. The present study examines whether: 1) Welcome Family meets its goal of successfully connecting families to two early childhood programs—evidence-based home visiting (EBHV) and early intervention (EI)—relative to families with similar background experiences who do not participate in Welcome Family, and 2) whether these impacts are conditional on families’ race and ethnicity and their primary language—two characteristics that are related to structural racism and health inequities. The study used coarsened exact matching (CEM) based on birth certificate data to match Welcome Family participants who enrolled during 2013–2017 to mothers and their infants living in the home visiting catchment areas who did not receive home visiting during the study period. Primary study outcomes included enrollment in any EBHV program supported by the Massachusetts Maternal, Infant, and Early Childhood Home Visiting (MA MIECHV) program up to age 1 year, measured using MA MIECHV home visiting program data, and EI service receipt for children aged up to age 3 years, measured using EI program data. Impacts were assessed by fitting weighted regression models adjusted for preterm birth, maternal depression, and substance use. Mothers’ race, ethnicity, and language were included in the model as moderators of Welcome Family impacts on enrollment in EBHV and EI. Welcome Family participants (n = 3,866) had more than double the odds of EBHV enrollments up to age 1 and had 1.39 greater odds of receiving EI individualized family service plans (IFSPs) up to age 3 relative to the comparison group (n = 46,561). Mothers’ primary language moderated Welcome Family impacts on EBHV enrollments. Universal, short-term programs such as Welcome Family may be an effective method of ensuring families who could benefit from more intensive early childhood services are identified, engaged, and enrolled. © 2023 Elsevier Ltd |
Slaying little dragons: the impact of the Guinea Worm Eradication Program on dracunculiasis disability averted from 1990 to 2016
Cromwell EA , Roy S , Sankara DP , Weiss A , Stanaway J , Goldberg E , Pigott DM , Larson H , Vollset SE , Krohn K , Foreman K , Hotez P , Bhutta Z , Bekele BB , Edessa D , Kassembaum N , Mokdad A , Murray CJL , Hay SI . Gates Open Res 2018 2 30 Background: The objective of this study was to document the worldwide decline of dracunculiasis (Guinea worm disease, GWD) burden, expressed as disability-adjusted life years (DALYs), from 1990 to 2016, as estimated in the Global Burden of Disease study 2016 (GBD 2016). While the annual number of cases of GWD have been consistently reported by WHO since the 1990s, the burden of disability due to GWD has not previously been quantified in GBD. Methods: The incidence of GWD was modeled for each endemic country using annual national case reports. A literature search was conducted to characterize the presentation of GWD, translate the clinical symptoms into health sequelae, and then assign an average duration to the infection. Prevalence measures by sequelae were multiplied by disability weights to estimate DALYs. Results: The total DALYs attributed to GWD across all endemic countries (n=21) in 1990 was 50,725 (95% UI: 35,265-69,197) and decreased to 0.9 (95% UI: 0.5-1.4) in 2016. A cumulative total of 12,900 DALYs were attributable to GWD from 1990 to 2016. Conclusions: Using 1990 estimates of burden propagated forward, this analysis suggests that between 990,000 to 1.9 million DALYs have been averted as a result of the eradication program over the past 27 years. |
A standardized approach for collection of objective data to support outcome determination for late-phase TB trials
Kurbatova EV , Phillips PP , Dorman SE , Sizemore EE , Bryant KE , Purfield AE , Ricaldi J , Brown NE , Johnson JL , Wallis CL , Akol JP , Ocheretina O , Van Hung N , Mayanja-Kizza H , Lourens M , Dawson R , Nhung NV , Pierre S , Musodza Y , Shenje J , Badal-Faesen S , Vilbrun SC , Waja Z , Peddareddy L , Scott NA , Yuan Y , Vernon A , Goldberg SV , Swindells S , Chaisson RE , Nahid P . Am J Respir Crit Care Med 2023 207 (10) 1376-1382 INTRODUCTION: We developed a standardized method, "Possible poor treatment response" (PPTR), to help ascertain efficacy endpoints in Study S31/A5349 (NCT02410772), an open-label trial comparing two 4-month rifapentine-based regimens with a standard 6-month regimen for the treatment of pulmonary TB. We describe the use of the PPTR process and evaluate whether the goals of minimizing bias in efficacy endpoint assessment and attainment of relevant data to determine outcome for all participants were achieved. METHODS/DESIGN: A PPTR event was defined as the occurrence of one or more pre-specified triggers. Each PPTR required initiation of a standardized evaluation process that included obtaining multiple sputum samples for microbiology. RESULTS: Among 2,343 participants with culture-confirmed drug-susceptible TB, 454 individuals (19.4%) had a total of 534 individual PPTR events, of which 76.6% were microbiological (positive smear or culture at or after 17 weeks). At least one PPTR event was experienced by 92.4% (133 of 144) of participants with TB-related unfavorable outcome, and between 13.8 and 14.7% of participants with favorable and not assessable outcomes. 75% of participants with TB-related unfavorable outcomes had microbiological confirmation of failure to achieve disease-free cure. DISCUSSION: Standardized methodologies, such as our PPTR approach, could facilitate unbiased efficacy outcome determinations, improve discrimination between outcomes that are related and unrelated to regimen efficacy, and enhance the ability to conduct pooled analyses of contemporary trials. Clinical trial registration available at www. CLINICALTRIALS: gov, ID: NCT02410772. |
ICTV Virus Taxonomy Profile: Matonaviridae 2022.
Mankertz A , Chen MH , Goldberg TL , Hübschen JM , Pfaff F , Ulrich RG , Ictv Report Consortium . J Gen Virol 2022 103 (12) The family Matonaviridae comprises enveloped viruses with positive-sense RNA genomes of 9.6-10 kb. The genus Rubivirus includes rubella virus (species Rubivirus rubellae) infecting humans, ruhugu virus (species Rubivirus ruteetense) infecting bats and rustrela virus (species Rubivirus strelense) infecting rodents and zoo animals. Rubella virus is spread via droplets. Postnatal infection leads to benign disease with rash and fever. Infection of seronegative women with rubella virus during the first trimester of pregnancy will often result in severe foetal malformations, known as congenital rubella syndrome. Vaccines are globally available. This is a summary of the International Committee on Taxonomy of Viruses (ICTV) Report on the family Matonaviridae, which is available at ictv.global/report/matonaviridae. |
Association of culturable-virus detection and household transmission of SARS-CoV-2 - California and Tennessee, 2020-2022
Deyoe JE , Kelly JD , Grijalva CG , Bonenfant G , Lu S , Anglin K , Garcia-Knight M , Pineda-Ramirez J , Briggs Hagen M , Saydah S , Abedi GR , Goldberg SA , Tassetto M , Zhang A , Donohue KC , Davidson MC , Diaz Sanchez R , Djomaleu M , Mathur S , Shak JR , Deeks SG , Peluso MJ , Chiu CY , Zhu Y , Halasa NB , Chappell JD , Mellis A , Reed C , Andino R , Martin JN , Zhou B , Talbot HK , Midgley CM , Rolfes MA . J Infect Dis 2023 From two SARS-CoV-2 household transmission studies (enrolling April 2020 - January 2022) with rapid enrollment and specimen collection for 14 days, 61% (43/70) of primary cases had culturable-virus detected ≥6 days post-onset. Risk of secondary infection among household contacts tended to be greater when primary cases had culturable-virus detected after onset. Regardless of duration of culturable-virus, most secondary infections [70% (28/40)] had serial intervals <6 days, suggesting early transmission. These data examine viral culture as a proxy for infectiousness, reaffirm the need for rapid control measures after infection and highlight the potential for prolonged infectiousness (≥6 days) in many individuals. |
Attitudes and experiences surrounding female genital mutilation/cutting in the United States: A scoping review
Besera G , Goldberg H , Okoroh EM , Snead MC , Johnson-Agbakwu CE , Goodwin MM . J Immigr Minor Health 2022 To identify research and gaps in literature about FGM/C-related attitudes and experiences among individuals from FGM/C-practicing countries living in the United States,we conducted a scoping review guided by Arksey and O'Malley's framework. We searched Medline (OVID), Embase (OVID), PubMed, and SCOPUS and conducted a grey literature search for studies assessing attitudes or experiences related to FGM/C with data collected directly from individuals from FGM/C-practicing countries living in the United States. The search yielded 417 studies, and 40 met the inclusion criteria. Findings suggest that women and men from FGM/C-practicing countries living in the United States generally oppose FGM/C, and that women with FGM/C have significant physical and mental health needs and have found US healthcare providers to lack understanding of FGM/C. Future research can improve measurement of FGM/C by taking into account the sociocultural influences on FGM/C-related attitudes and experiences. |
Timeliness of early identification and referral of infants with social and environmental risks
Fauth RC , Kotake C , Manning SE , Goldberg JL , Easterbrooks MA , Buxton B , Downs K . Prev Sci 2022 24 (1) 1-11 The Early Intervention Parenting Partnerships (EIPP) program is a home visiting program that provides home visits, group services, assessments and screenings, and referrals delivered by a multidisciplinary team to expectant parents and families with infants who experience socioeconomic barriers, emotional and behavioral health challenges, or other stressors. The present study examines whether EIPP successfully meets its aims of screening families for social and environmental factors that may increase the risk of children's developmental delays and connect them to the larger statewide early intervention (EI) system relative to families with similar background characteristics who do not receive EIPP. Coarsened exact matching was used to match EIPP participants who enrolled between 2013 and 2017 to a comparison group of families identified from birth certificates. Primary study outcomes including EI referrals, evaluations, and service receipt for children from 3 months to 3 years were measured using EI program data. Secondary outcomes included EI referral source, EI eligibility criteria (e.g., presence of biological, social, or environmental factors that may increase later risk for developmental delay), and information on service use. Impacts were assessed by fitting weighted regression models adjusted for preterm birth and maternal depression and substance use. EIPP participants were more likely than the comparison group to be referred to, evaluated for, and receive EI services. EIPP facilitated the identification of EI-eligible children who are at risk for developmental delays due to social or environmental factors, such as violence and substance use in the home, child protective services involvement, high levels of parenting stress, and parent chronic illness or disability. EIPP serves as an entry point into the EI system, helping families attain the comprehensive supports they may need to optimize their well-being and enhance children's development. |
Exploring and mitigating plague for One Health purposes
Eads DA , Biggins DE , Wimsatt J , Eisen RJ , Hinnebusch BJ , Matchett MR , Goldberg AR , Livieri TM , Hacker GM , Novak MG , Buttke DE , Grassel SM , Hughes JP , Atiku LA . Curr Trop Med Rep 2022 9 (4) 169-184 Purpose of Review: In 2020, the Appropriations Committee for the U.S. House of Representatives directed the CDC to develop a national One Health framework to combat zoonotic diseases, including sylvatic plague, which is caused by the flea-borne bacterium Yersinia pestis. This review builds upon that multisectoral objective. We aim to increase awareness of Y. pestis and to highlight examples of plague mitigation for One Health purposes (i.e., to achieve optimal health outcomes for people, animals, plants, and their shared environment). We draw primarily upon examples from the USA, but also discuss research from Madagascar and Uganda where relevant, as Y. pestis has emerged as a zoonotic threat in those foci. Recent Findings: Historically, the bulk of plague research has been directed at the disease in humans. This is not surprising, given that Y. pestis is a scourge of human history. Nevertheless, the ecology of Y. pestis is inextricably linked to other mammals and fleas under natural conditions. Accumulating evidence demonstrates Y. pestis is an unrelenting threat to multiple ecosystems, where the bacterium is capable of significantly reducing native species abundance and diversity while altering competitive and trophic relationships, food web connections, and nutrient cycles. In doing so, Y. pestis transforms ecosystems, causing “shifting baselines syndrome” in humans, where there is a gradual shift in the accepted norms for the condition of the natural environment. Eradication of Y. pestis in nature is difficult to impossible, but effective mitigation is achievable; we discuss flea vector control and One Health implications in this context. Summary: There is an acute need to rapidly expand research on Y. pestis, across multiple host and flea species and varied ecosystems of the Western US and abroad, for human and environmental health purposes. The fate of many wildlife species hangs in the balance, and the implications for humans are profound in some regions. Collaborative multisectoral research is needed to define the scope of the problem in each epidemiological context and to identify, refine, and implement appropriate and effective mitigation practices. © 2022, This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply. |
Infectious viral shedding of SARS-CoV-2 Delta following vaccination: A longitudinal cohort study.
Garcia-Knight M , Anglin K , Tassetto M , Lu S , Zhang A , Goldberg SA , Catching A , Davidson MC , Shak JR , Romero M , Pineda-Ramirez J , Diaz-Sanchez R , Rugart P , Donohue K , Massachi J , Sans HM , Djomaleu M , Mathur S , Servellita V , McIlwain D , Gaudiliere B , Chen J , Martinez EO , Tavs JM , Bronstone G , Weiss J , Watson JT , Briggs-Hagen M , Abedi GR , Rutherford GW , Deeks SG , Chiu C , Saydah S , Peluso MJ , Midgley CM , Martin JN , Andino R , Kelly JD . PLoS Pathog 2022 18 (9) e1010802 The impact of vaccination on SARS-CoV-2 infectiousness is not well understood. We compared longitudinal viral shedding dynamics in unvaccinated and fully vaccinated adults. SARS-CoV-2-infected adults were enrolled within 5 days of symptom onset and nasal specimens were self-collected daily for two weeks and intermittently for an additional two weeks. SARS-CoV-2 RNA load and infectious virus were analyzed relative to symptom onset stratified by vaccination status. We tested 1080 nasal specimens from 52 unvaccinated adults enrolled in the pre-Delta period and 32 fully vaccinated adults with predominantly Delta infections. While we observed no differences by vaccination status in maximum RNA levels, maximum infectious titers and the median duration of viral RNA shedding, the rate of decay from the maximum RNA load was faster among vaccinated; maximum infectious titers and maximum RNA levels were highly correlated. Furthermore, amongst participants with infectious virus, median duration of infectious virus detection was reduced from 7.5 days (IQR: 6.0-9.0) in unvaccinated participants to 6 days (IQR: 5.0-8.0) in those vaccinated (P = 0.02). Accordingly, the odds of shedding infectious virus from days 6 to 12 post-onset were lower among vaccinated participants than unvaccinated participants (OR 0.42 95% CI 0.19-0.89). These results indicate that vaccination had reduced the probability of shedding infectious virus after 5 days from symptom onset. |
Magnitude and determinants of SARS-CoV-2 household transmission: a longitudinal cohort study.
Daniel Kelly J , Lu S , Anglin K , Garcia-Knight M , Pineda-Ramirez J , Goldberg SA , Tassetto M , Zhang A , Donohue K , Davidson MC , Romero M , Sanchez RD , Djomaleu M , Mathur S , Chen JY , Forman CA , Servellita V , Montejano RD , Shak JR , Rutherford GW , Deeks SG , Abedi GR , Rolfes MA , Saydah S , Briggs-Hagen M , Peluso MJ , Chiu C , Midgley CM , Andino R , Martin JN . Clin Infect Dis 2022 75 S193-S204 BACKGROUND: Households have emerged as important venues for SARS-CoV-2 transmission. Little is known, however, regarding the magnitude and determinants of household transmission in increasingly vaccinated populations. METHODS: From September 2020 to January 2022, symptomatic non-hospitalized individuals with SARS-CoV-2 infection by RNA detection were identified within 5 days of symptom onset; all individuals resided with at least one other SARS-CoV-2-uninfected household member. These infected persons (cases) and their household members (contacts) were subsequently followed with questionnaire-based measurement and serial nasal specimen collection. The primary outcome was SARS-CoV-2 infection among contacts. RESULTS: We evaluated 42 cases and their 74 household contacts. Among the contacts, 32 (43%) became infected, of whom 5/32 (16%) were asymptomatic; 81% of transmissions occurred by 5 days after the case's symptom onset. From 21 unvaccinated cases, 14-day cumulative incidence of SARS-CoV-2 infection among contacts was 18/40 (45%; 95% CI: 29, 62), most of whom were unvaccinated. From 21 vaccinated cases, 14-day cumulative incidence of SARS-CoV-2 infection was 14/34 (41%; 95% CI: 25, 59) among all contacts and 12/29 (41%; 95% CI: 24, 61) among vaccinated contacts. At least one co-morbid condition among cases and 10 or more days of RNA detection in cases were associated with increased risk of infection among contacts. CONCLUSIONS: Among households including individuals with symptomatic SARS-CoV-2 infection, both vaccinated-to-vaccinated and unvaccinated-to-unvaccinated transmission of SARS-CoV-2 to household contacts was common. Because vaccination alone did not notably reduce risk of infection, household contacts will need to employ additional interventions to avoid infection. |
Zootherapy as a potential pathway for zoonotic spillover: a mixed-methods study of the use of animal products in medicinal and cultural practices in Nigeria.
Friant S , Bonwitt J , Ayambem WA , Ifebueme NM , Alobi AO , Otukpa OM , Bennett AJ , Shea C , Rothman JM , Goldberg TL , Jacka JK . One Health Outlook 2022 4 (1) 5 BACKGROUND: Understanding how and why people interact with animals is important for the prevention and control of zoonoses. To date, studies have primarily focused on the most visible forms of human-animal contact (e.g., hunting and consumption), thereby blinding One Health researchers and practitioners to the broader range of human-animal interactions that can serve as cryptic sources of zoonotic diseases. Zootherapy, the use of animal products for traditional medicine and cultural practices, is widespread and can generate opportunities for human exposure to zoonoses. Existing research examining zootherapies omits details necessary to adequately assess potential zoonotic risks. METHODS: We used a mixed-methods approach, combining quantitative and qualitative data from questionnaires, key informant interviews, and field notes to examine the use of zootherapy in nine villages engaged in wildlife hunting, consumption, and trade in Cross River State, Nigeria. We analyzed medicinal and cultural practices involving animals from a zoonotic disease perspective, by including details of animal use that may generate pathways for zoonotic transmission. We also examined the sociodemographic, cultural, and environmental contexts of zootherapeutic practices that can further shape the nature and frequency of human-animal interactions. RESULTS: Within our study population, people reported using 44 different animal species for zootherapeutic practices, including taxonomic groups considered to be "high risk" for zoonoses and threatened with extinction. Variation in use of animal parts, preparation norms, and administration practices generated a highly diverse set of zootherapeutic practices (n = 292) and potential zoonotic exposure risks. Use of zootherapy was patterned by demographic and environmental contexts, with zootherapy more commonly practiced by hunting households (OR = 2.47, p < 0.01), and prescriptions that were gender and age specific (e.g., maternal and pediatric care) or highly seasonal (e.g., associated with annual festivals and seasonal illnesses). Specific practices were informed by species availability and theories of healing (i.e., "like cures like" and sympathetic healing and magic) that further shaped the nature of human-animal interactions via zootherapy. CONCLUSIONS: Epidemiological investigations of zoonoses and public health interventions that aim to reduce zoonotic exposures should explicitly consider zootherapy as a potential pathway for disease transmission and consider the sociocultural and environmental contexts of their use in health messaging and interventions. |
SARS-CoV-2 antibody prevalence in Sierra Leone, March 2021: a cross-sectional, nationally representative, age-stratified serosurvey.
Barrie MB , Lakoh S , Kelly JD , Kanu JS , Squire JS , Koroma Z , Bah S , Sankoh O , Brima A , Ansumana R , Goldberg SA , Chitre S , Osuagwu C , Frankfurter R , Maeda J , Barekye B , Numbere TW , Abdulaziz M , Mounts A , Blanton C , Singh T , Samai M , Vandi M , Richardson ET . BMJ Glob Health 2021 6 (11) INTRODUCTION: As of 26 March 2021, the Africa Centres for Disease Control and Prevention had reported 4 159 055 cases of COVID-19 and 111 357 deaths among the 55 African Union member states; however, no country has published a nationally representative serosurvey as of October 2021. Such data are vital for understanding the pandemic's progression on the continent, evaluating containment measures, and policy planning. METHODS: We conducted a cross-sectional, nationally representative, age-stratified serosurvey in Sierra Leone in March 2021 by randomly selecting 120 Enumeration Areas throughout the country and 10 randomly selected households in each of these. One to two persons per selected household were interviewed to collect information on sociodemographics, symptoms suggestive of COVID-19, exposure history to laboratory-confirmed COVID-19 cases, and history of COVID-19 illness. Capillary blood was collected by fingerstick, and blood samples were tested using the Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test Cassette. Total seroprevalence was estimated after applying sampling weights. RESULTS: The overall weighted seroprevalence was 2.6% (95% CI 1.9% to 3.4%). This was 43 times higher than the reported number of cases. Rural seropositivity was 1.8% (95% CI 1.0% to 2.5%), and urban seropositivity was 4.2% (95% CI 2.6% to 5.7%). DISCUSSION: Overall seroprevalence was low compared with countries in Europe and the Americas (suggesting relatively successful containment in Sierra Leone). This has ramifications for the country's third wave (which started in June 2021), during which the average number of daily reported cases was 87 by the end of the month:this could potentially be on the order of 3700 actual infections per day, calling for stronger containment measures in a country with only 0.2% of people fully vaccinated. It may also reflect significant under-reporting of incidence and mortality across the continent. |
Influenza vaccine effectiveness within prospective cohorts of healthcare personnel in Israel and Peru 2016-2019
Thompson MG , Soto G , Perez A , Newes-Adeyim G , Yoo YM , Hirsch A , Katz M , Tinoco Y , Shemer Avni Y , Ticona E , Malosh R , Martin E , Matos E , Reynolds S , Wesley M , Ferdinands J , Cheung A , Levine M , Bravo E , Arriola CS , Ester Castillo M , Carlos Castro J , Dawood F , Goldberg D , Manuel Neyra Quijandría J , Azziz-Baumgartner E , Monto A , Balicer R . Vaccine 2021 39 (47) 6956-6967 BACKGROUND: There are limited data on influenza vaccine effectiveness (IVE) in preventing laboratory-confirmed influenza illness among healthcare personnel (HCP). METHODS: HCP with direct patient contact working full-time in hospitals were followed during three influenza seasons in Israel (2016-2017 to 2018-2019) and Peru (2016 to 2018). Trivalent influenza vaccines were available at all sites, except during 2018-2019 when Israel used quadrivalent vaccines; vaccination was documented by electronic medical records, vaccine registries, and/or self-report (for vaccinations outside the hospital). Twice-weekly active surveillance identified acute respiratory symptoms or febrile illness (ARFI); self-collected respiratory specimens were tested by real-time reverse transcription polymerase chain reaction (PCR) assay. IVE was 100 × 1-hazard ratio (adjusted for sex, age, occupation, and hospital). RESULTS: Among 5,489 HCP who contributed 10,041 person-seasons, influenza vaccination coverage was 47% in Israel and 32% in Peru. Of 3,056 ARFIs in Israel and 3,538 in Peru, A or B influenza virus infections were identified in 205 (7%) in Israel and 87 (2.5%) in Peru. IVE against all viruses across seasons was 1% (95% confidence interval [CI] = -30%, 25%) in Israel and 12% (95% CI = -61%, 52%) in Peru. CONCLUSION: Estimates of IVE were null using person-time models during six study seasons in Israel and Peru. |
2021 Taxonomic update of phylum Negarnaviricota (Riboviria: Orthornavirae), including the large orders Bunyavirales and Mononegavirales.
Kuhn JH , Adkins S , Agwanda BR , Al Kubrusli R , Alkhovsky Aльxoвcкий Cepгeй Bлaдимиpoвич SV , Amarasinghe GK , Avšič-Županc T , Ayllón MA , Bahl J , Balkema-Buschmann A , Ballinger MJ , Basler CF , Bavari S , Beer M , Bejerman N , Bennett AJ , Bente DA , Bergeron É , Bird BH , Blair CD , Blasdell KR , Blystad DR , Bojko J , Borth WB , Bradfute S , Breyta R , Briese T , Brown PA , Brown JK , Buchholz UJ , Buchmeier MJ , Bukreyev A , Burt F , Büttner C , Calisher CH , Cao 曹孟籍 M , Casas I , Chandran K , Charrel RN , Cheng Q , Chiaki 千秋祐也 Y , Chiapello M , Choi IR , Ciuffo M , Clegg JCS , Crozier I , Dal Bó E , de la Torre JC , de Lamballerie X , de Swart RL , Debat H , Dheilly NM , Di Cicco E , Di Paola N , Di Serio F , Dietzgen RG , Digiaro M , Dolnik O , Drebot MA , Drexler JF , Dundon WG , Duprex WP , Dürrwald R , Dye JM , Easton AJ , Ebihara 海老原秀喜 H , Elbeaino T , Ergünay K , Ferguson HW , Fooks AR , Forgia M , Formenty PBH , Fránová J , Freitas-Astúa J , Fu 付晶晶 J , Fürl S , Gago-Zachert S , Gāo 高福 GF , García ML , García-Sastre A , Garrison AR , Gaskin T , Gonzalez JJ , Griffiths A , Goldberg TL , Groschup MH , Günther S , Hall RA , Hammond J , Han 韩彤 T , Hepojoki J , Hewson R , Hong 洪健 J , Hong 洪霓 N , Hongo 本郷誠治 S , Horie 堀江真行 M , Hu JS , Hu T , Hughes HR , Hüttner F , Hyndman TH , Ilyas M , Jalkanen R , Jiāng 姜道宏 D , Jonson GB , Junglen S , Kadono 上遠野冨士夫 F , Kaukinen KH , Kawate M , Klempa B , Klingström J , Kobinger G , Koloniuk I , Kondō 近藤秀樹 H , Koonin EV , Krupovic M , Kubota 久保田健嗣 K , Kurath G , Laenen L , Lambert AJ , Langevin SL , Lee B , Lefkowitz EJ , Leroy EM , Li 李邵蓉 S , Li 李龙辉 L , Lǐ 李建荣 J , Liu 刘华珍 H , Lukashevich IS , Maes P , de Souza WM , Marklewitz M , Marshall SH , Marzano SL , Massart S , McCauley JW , Melzer M , Mielke-Ehret N , Miller KM , Ming TJ , Mirazimi A , Mordecai GJ , Mühlbach HP , Mühlberger E , Naidu R , Natsuaki 夏秋知英 T , Navarro JA , Netesov Heтёcoв Cepгeй Bиктopoвич SV , Neumann G , Nowotny N , Nunes MRT , Olmedo-Velarde A , Palacios G , Pallás V , Pályi B , Papa Άννα Παπά A , Paraskevopoulou Σοφία Παρασκευοπούλου S , Park AC , Parrish CR , Patterson DA , Pauvolid-Corrêa A , Pawęska JT , Payne S , Peracchio C , Pérez DR , Postler TS , Qi 亓立莹 L , Radoshitzky SR , Resende RO , Reyes CA , Rima BK , Luna GR , Romanowski V , Rota P , Rubbenstroth D , Rubino L , Runstadler JA , Sabanadzovic S , Sall AA , Salvato MS , Sang R , Sasaya 笹谷孝英 T , Schulze AD , Schwemmle M , Shi 施莽 M , Shí 石晓宏 X , Shí 石正丽 Z , Shimomoto 下元祥史 Y , Shirako Y , Siddell SG , Simmonds P , Sironi M , Smagghe G , Smither S , Song 송진원 JW , Spann K , Spengler JR , Stenglein MD , Stone DM , Sugano J , Suttle CA , Tabata A , Takada 高田礼人 A , Takeuchi 竹内繁治 S , Tchouassi DP , Teffer A , Tesh RB , Thornburg NJ , Tomitaka 冨高保弘 Y , Tomonaga 朝長啓造 K , Tordo N , Torto B , Towner JS , Tsuda 津田新哉 S , Tu 涂长春 C , Turina M , Tzanetakis IE , Uchida J , Usugi 宇杉富雄 T , Vaira AM , Vallino M , van den Hoogen B , Varsani A , Vasilakis Νίκος Βασιλάκης N , Verbeek M , von Bargen S , Wada 和田治郎 J , Wahl V , Walker PJ , Wang 王林发 LF , Wang 王国平 G , Wang 王雁翔 Y , Wang 王亚琴 Y , Waqas M , Wèi 魏太云 T , Wen 温少华 S , Whitfield AE , Williams JV , Wolf YI , Wu 吴建祥 J , Xu 徐雷 L , Yanagisawa 栁澤広宣 H , Yang 杨彩霞 C , Yang 杨作坤 Z , Zerbini FM , Zhai 翟立峰 L , Zhang 张永振 YZ , Zhang 张松 S , Zhang 张靖国 J , Zhang 张哲 Z , Zhou 周雪平 X . Arch Virol 2021 166 (12) 3513-3566 In March 2021, following the annual International Committee on Taxonomy of Viruses (ICTV) ratification vote on newly proposed taxa, the phylum Negarnaviricota was amended and emended. The phylum was expanded by four families (Aliusviridae, Crepuscuviridae, Myriaviridae, and Natareviridae), three subfamilies (Alpharhabdovirinae, Betarhabdovirinae, and Gammarhabdovirinae), 42 genera, and 200 species. Thirty-nine species were renamed and/or moved and seven species were abolished. This article presents the updated taxonomy of Negarnaviricota as now accepted by the ICTV. |
Urinary and salivary endocrine measurements to complement Tanner staging in studies of pubertal development
Goldberg M , Ciesielski Jones AJ , McGrath JA , Barker-Cummings C , Cousins DS , Kipling LM , Meadows JW , Kesner JS , Marcus M , Monteilh C , Sandler DP . PLoS One 2021 16 (5) e0251598 BACKGROUND: Many studies investigating pubertal development use Tanner staging to assess maturation. Endocrine markers in urine and saliva may provide an objective, sensitive, and non-invasive method for assessing development. OBJECTIVE: Our objective was to examine whether changes in endocrine levels can indicate the onset of pubertal development prior to changes in self-rated Tanner stage. METHODS: Thirty-five girls and 42 boys aged 7 to 15 years were enrolled in the Growth and Puberty (GAP) study, a longitudinal pilot study conducted from 2007-2009 involving children of women enrolled in the Agricultural Health Study (AHS) in Iowa. We collected saliva and urine samples and assessed pubertal development by self-rated Tanner staging (pubic hair, breast development (girls), genital development (boys)) at three visits over six months. We measured dehydroepiandrosterone (DHEA) in saliva and creatinine-adjusted luteinizing hormone (LH), testosterone, follicle stimulating hormone (FSH), estrone 3-glucuronide (E13G) and pregnanediol 3-glucuronide (Pd3G) concentrations in first morning urine. We evaluated the relationships over time between Tanner stage and each biomarker using repeated measures analysis. RESULTS: Among girls still reporting Tanner breast stage 1 at the final visit, FSH levels increased over the 6-month follow-up period and were no longer lower than higher stage girls at the end of follow-up. We observed a similar pattern for testosterone in boys. By visit 3, boys still reporting Tanner genital stage 1 or pubic hair stage 1 had attained DHEA levels that were comparable to those among boys reporting Tanner stages 2 or 3. CONCLUSIONS: Increasing concentrations of FSH in girls and DHEA and testosterone in boys over a 6-month period revealed the start of the pubertal process prior to changes in self-rated Tanner stage. Repeated, non-invasive endocrine measures may complement the more subjective assessment of physical markers in studies determining pubertal onset. |
Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis
Dorman SE , Nahid P , Kurbatova EV , Phillips PPJ , Bryant K , Dooley KE , Engle M , Goldberg SV , Phan HTT , Hakim J , Johnson JL , Lourens M , Martinson NA , Muzanyi G , Narunsky K , Nerette S , Nguyen NV , Pham TH , Pierre S , Purfield AE , Samaneka W , Savic RM , Sanne I , Scott NA , Shenje J , Sizemore E , Vernon A , Waja Z , Weiner M , Swindells S , Chaisson RE . N Engl J Med 2021 384 (18) 1705-1718 BACKGROUND: Rifapentine-based regimens have potent antimycobacterial activity that may allow for a shorter course in patients with drug-susceptible pulmonary tuberculosis. METHODS: In an open-label, phase 3, randomized, controlled trial involving persons with newly diagnosed pulmonary tuberculosis from 13 countries, we compared two 4-month rifapentine-based regimens with a standard 6-month regimen consisting of rifampin, isoniazid, pyrazinamide, and ethambutol (control) using a noninferiority margin of 6.6 percentage points. In one 4-month regimen, rifampin was replaced with rifapentine; in the other, rifampin was replaced with rifapentine and ethambutol with moxifloxacin. The primary efficacy outcome was survival free of tuberculosis at 12 months. RESULTS: Among 2516 participants who had undergone randomization, 2343 had a culture positive for Mycobacterium tuberculosis that was not resistant to isoniazid, rifampin, or fluoroquinolones (microbiologically eligible population; 768 in the control group, 791 in the rifapentine-moxifloxacin group, and 784 in the rifapentine group), of whom 194 were coinfected with human immunodeficiency virus and 1703 had cavitation on chest radiography. A total of 2234 participants could be assessed for the primary outcome (assessable population; 726 in the control group, 756 in the rifapentine-moxifloxacin group, and 752 in the rifapentine group). Rifapentine with moxifloxacin was noninferior to the control in the microbiologically eligible population (15.5% vs. 14.6% had an unfavorable outcome; difference, 1.0 percentage point; 95% confidence interval [CI], -2.6 to 4.5) and in the assessable population (11.6% vs. 9.6%; difference, 2.0 percentage points; 95% CI, -1.1 to 5.1). Noninferiority was shown in the secondary and sensitivity analyses. Rifapentine without moxifloxacin was not shown to be noninferior to the control in either population (17.7% vs. 14.6% with an unfavorable outcome in the microbiologically eligible population; difference, 3.0 percentage points [95% CI, -0.6 to 6.6]; and 14.2% vs. 9.6% in the assessable population; difference, 4.4 percentage points [95% CI, 1.2 to 7.7]). Adverse events of grade 3 or higher occurred during the on-treatment period in 19.3% of participants in the control group, 18.8% in the rifapentine-moxifloxacin group, and 14.3% in the rifapentine group. CONCLUSIONS: The efficacy of a 4-month rifapentine-based regimen containing moxifloxacin was noninferior to the standard 6-month regimen in the treatment of tuberculosis. (Funded by the Centers for Disease Control and Prevention and others; Study 31/A5349 ClinicalTrials.gov number, NCT02410772.). |
Zika Prevention Behaviors Among Women of Reproductive Age in Puerto Rico, 2016
Ellington SR , Simeone RM , Serrano-Rodriguez RA , Bertolli J , Swartzendruber A , Goldberg HI , Mercado AS , Jamieson DJ , Honein MA , Cordero JF , Shapiro-Mendoza CK . Am J Prev Med 2021 61 (3) e149-e155 INTRODUCTION: Zika virus is primarily transmitted through mosquito bites. Because Zika virus infection during pregnancy can cause serious birth defects, reproductive-aged women need protection from Zika virus infection. This report describes Zika virus prevention behaviors among women aged 18-49 years and assesses whether pregnancy status and healthcare provider counseling increases Zika virus prevention behaviors. METHODS: A population-based cell phone survey of women aged 18-49 years living in Puerto Rico was conducted in July-November 2016. Data were analyzed in 2018-2019. Prevalence estimates and 95% CIs were calculated for Zika virus prevention behaviors. Adjusted prevalence ratios were estimated to examine the association of pregnancy status with healthcare provider counseling on Zika virus prevention behaviors, controlling for age, education, and health insurance status. RESULTS: Most women reported using screens on open doors/windows (87.7%) and eliminating standing water in/around their homes (92.3%). Other Zika virus prevention behaviors were less common (<33%). In adjusted analysis, pregnant women were more likely than women not at risk for unintended pregnancy to report using mosquito repellent every/most days (adjusted prevalence ratio=1.44, 95% CI=1.13, 1.85). Healthcare provider counseling was associated with receiving professional spraying/larvicide treatment (adjusted prevalence ratio=1.42, 95% CI=1.17, 1.74), sleeping under a bed net (adjusted prevalence ratio=2.37, 95% CI=1.33, 4.24), using mosquito repellent (adjusted prevalence ratio=1.57, 95% CI=1.40, 1.77), and wearing long sleeves/pants (adjusted prevalence ratio=1.32, 95% CI=1.12, 1.55). CONCLUSIONS: Receipt of healthcare provider counseling was more consistently associated with Zika virus prevention behaviors than pregnancy status. Healthcare provider counseling is an important strategy for increasing the uptake of Zika virus prevention behaviors among women aged 18-49 years. |
Optimizing drug inventory management with a web-based information system: The TBTC study 31/ACTG A5349 experience
Scott NA , Lee KK , Sadowski C , Kurbatova E , Goldberg SV , Nsubuga P , Kitshoff R , Whitelaw C , Thuy HN , Batra K , Allen-Blige C , Davis H , Kim J , Phan M , Fedrick P , Chiu KW , Heilig CM , Sizemore E . Contemp Clin Trials 2021 105 106377 INTRODUCTION: Efficient management of study drug inventory shipments is critical to keep research sites enrolling into multisite clinical treatment trials. A standard manual drug-management process used by the Tuberculosis Trials Consortium (TBTC), did not accommodate import permit approval timelines, shipment transit-times and time-zone differences. We compared a new web-based solution with the manual process, during an international 34-site clinical trial conducted by the TBTC and the AIDS Clinical Trials Group (ACTG); TBTC Study 31/ACTG A5349. MATERIAL AND METHODS: We developed and implemented a technological solution by integrating logistical and regulatory requirements for drug importation with statistical simulations that estimated stock-out times in an online Drug Management Module (DMM). We measured the average shipment-related drug stock-outs and time to drug availability, to assess the efficiency of the DMM compared to the manual approach. RESULTS: An Interrupted Time-Series (ITS) analysis showed a 15% [p-value = 0.03; 95% C.I. (-28.8%, -2.0%)] reduction in average shipment-related study drug stock-out after DMM implementation. The DMM streamlined the restocking process at study sites, reducing median transit-time for sites associated with a depot by 2 days [95% C.I. (-3.0, -1.0)]. Under the DMM, study drugs were available for treatment assignment on the day received, compared to one day after receipt under the manual process. DISCUSSION: The DMM provided TBTC's Data and Coordinating Center and site staff with more efficient procedures to manage and consistently maintain study drug inventory at enrolling sites. This DMM framework can improve efficiency in future multicenter clinical trials. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (Identifier: NCT02410772) on April 8, 2015. |
HIV outbreaks among people who inject drugs in Europe, North America, and Israel
Des Jarlais DC , Sypsa V , Feelemyer J , Abagiu AO , Arendt V , Broz D , Chemtob D , Seguin-Devaux C , Duwve JM , Fitzgerald M , Goldberg DJ , Hatzakis A , Jipa RE , Katchman E , Keenan E , Khan I , Konrad S , McAuley A , Skinner S , Wiessing L . Lancet HIV 2020 7 (6) e434-e442 During 2011-16, HIV outbreaks occurred among people who inject drugs (PWID) in Canada (southeastern Saskatchewan), Greece (Athens), Ireland (Dublin), Israel (Tel Aviv), Luxembourg, Romania (Bucharest), Scotland (Glasgow), and USA (Scott County, Indiana). Factors common to many of these outbreaks included community economic problems, homelessness, and changes in drug injection patterns. The outbreaks differed in size (from under 100 to over 1000 newly reported HIV cases among PWID) and in the extent to which combined prevention had been implemented before, during, and after the outbreaks. Countries need to ensure high coverage of HIV prevention services and coverage higher than the current UNAIDS recommendation might be needed in areas in which short acting drugs are injected. In addition, monitoring of PWID with special attention for changing drug use patterns, risk behaviours, and susceptible subgroups (eg, PWID experiencing homelessness) needs to be in place to prevent or rapidly detect and contain new HIV outbreaks. |
Trends in state policy support for sexual minorities and HIV-related outcomes among men who have sex with men in the United States, 2008-2014
Hatzenbuehler ML , McKetta S , Goldberg N , Sheldon A , Friedman SR , Cooper HL , Beane S , Williams LD , Tempalski B , Smith JC , Ibragimov U , Mermin J , Stall R . J Acquir Immune Defic Syndr 2020 85 (1) 39-45 BACKGROUND: To examine trends in state-level policy support for sexual minorities and HIV outcomes among MSM. METHODS: This longitudinal analysis linked state-level policy support for sexual minorities (N=94 Metropolitan Statistical Areas [MSAs] in 38 states) to 7 years of data (2008-2014) from CDC on HIV outcomes among MSM. Using latent growth mixture modeling, we combined 11 state-level policies (e.g., non-discrimination laws including sexual orientation as a protected class) from 1999-2014, deriving 3 latent groups: consistently low policy support; consistently high policy support; and increasing trajectory of policy support. Outcomes were HIV diagnoses per 10,000 MSM; late diagnoses (number of deaths within 12 months of HIV diagnosis and AIDS diagnoses within three months of HIV diagnosis) per 10,000 MSM; AIDS diagnoses per 10,000 MSM with HIV; and AIDS-related mortality per 10,000 MSM with AIDS. RESULTS: Compared to MSAs in states with low levels and increasing policy support for sexual minorities, MSAs in states with the highest level of policy support had lower risks of HIV diagnoses (Risk Difference [RD]=-37.9, 95% Confidence Interval [CI]: -54.7, -21.0), late diagnoses (RD=-12.5, 95% CI: -20.4, -4.7), and AIDS-related mortality (RD=-33.7, 95% CI: -61.2, -6.2), controlling for time and 7 MSA-level covariates. In low policy support states, 27% of HIV diagnoses, 21% of late diagnoses, and 10% of AIDS deaths among MSM were attributable to policy climate. CONCLUSION: State-level policy climate related to sexual minorities was associated with HIV health outcomes among MSM and could be a potential public health tool for HIV prevention and care. |
Assessment of contraceptive use in Puerto Rico during the 2016 Zika virus outbreak
Ellington SR , Serrano Rodriguez R , Goldberg H , Bertolli J , Simeone R , Soto Mercado A , Pazol K , Jamieson DJ , Honein MA , Swartzendruber A , Miles T , Cordero J , Shapiro-Mendoza C . Contraception 2020 101 (6) 405-411 OBJECTIVES: The objectives of this analysis were to 1) estimate prevalence of contraceptive use among women at risk for unintended pregnancy and 2) identify correlates of contraceptive use among women with ongoing or potential need for contraceptive services in Puerto Rico during the 2016 Zika virus (ZIKV) outbreak. Study Design We conducted a cell-phone survey July-November, 2016. Women aged 18-49 years living in Puerto Rico were eligible. We completed 3,059 interviews; the overall response rate was 69.2%. After weighting, the data provide population-based estimates. For this analysis, we included women at risk for unintended pregnancy, and assessed ongoing or potential need for contraceptive services in this group, excluding women using permanent contraceptive methods. RESULTS: Most women reported using contraception (82.8%), and use increased with age. Female sterilization and male condoms were most frequently reported (40.8% and 17.1%, respectively). Among women with ongoing or potential need for contraceptive services, 24.7% talked to a healthcare provider about ZIKV, and 31.2% reported a change in childbearing intentions due to ZIKV. Most women were at least a little worried about getting infected with ZIKV (74.3%) or having a baby with a birth defect (80.9%). Being very worried about getting infected with ZIKV and already having Zika were significantly associated with use of any contraception (adjusted prevalence ratio: 1.19, 95% CI: 1.03-1.38 and 1.32, 95% CI: 1.01-1.72, respectively). CONCLUSIONS: These findings underscore the need for regular contraceptive prevalence studies to inform programs about contraceptive needs, especially during public health emergencies. IMPLICATIONS: When the 2016 Zika virus outbreak began in Puerto Rico there were no recent population-based data available on contraceptive prevalence. To fill this information gap, we conducted a population-based survey. Our findings provided baseline contraceptive prevalence estimates to support response planning and allocation of health resources. |
Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1.
van Doremalen N , Bushmaker T , Morris DH , Holbrook MG , Gamble A , Williamson BN , Tamin A , Harcourt JL , Thornburg NJ , Gerber SI , Lloyd-Smith JO , de Wit E , Munster VJ . N Engl J Med 2020 382 (16) 1564-1567 To the Editor: A novel human coronavirus that is now named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (formerly called HCoV-19) emerged in Wuhan, China, in late 2019 and is now causing a pandemic.1 We analyzed the aerosol and surface stability of SARS-CoV-2 and compared it with SARS-CoV-1, the most closely related human coronavirus.2 | | We evaluated the stability of SARS-CoV-2 and SARS-CoV-1 in aerosols and on various surfaces and estimated their decay rates using a Bayesian regression model (see the Methods section in the Supplementary Appendix, available with the full text of this letter at NEJM.org). SARS-CoV-2 nCoV-WA1-2020 (MN985325.1) and SARS-CoV-1 Tor2 (AY274119.3) were the strains used. Aerosols (<5 μm) containing SARS-CoV-2 (105.25 50% tissue-culture infectious dose [TCID50] per milliliter) or SARS-CoV-1 (106.75-7.00 TCID50 per milliliter) were generated with the use of a three-jet Collison nebulizer and fed into a Goldberg drum to create an aerosolized environment. The inoculum resulted in cycle-threshold values between 20 and 22, similar to those observed in samples obtained from the upper and lower respiratory tract in humans. |
High-dose rifapentine with or without moxifloxacin for shortening treatment of pulmonary tuberculosis: Study protocol for TBTC study 31/ACTG A5349 phase 3 clinical trial
Dorman SE , Nahid P , Kurbatova EV , Goldberg SV , Bozeman L , Burman WJ , Chang KC , Chen M , Cotton M , Dooley KE , Engle M , Feng PJ , Fletcher CV , Ha P , Heilig CM , Johnson JL , Lessem E , Metchock B , Miro JM , Nhung NV , Pettit AC , Phillips PPJ , Podany AT , Purfield AE , Robergeau K , Samaneka W , Scott NA , Sizemore E , Vernon A , Weiner M , Swindells S , Chaisson RE . Contemp Clin Trials 2020 90 105938 INTRODUCTION: Phase 2 clinical trials of tuberculosis treatment have shown that once-daily regimens in which rifampin is replaced by high dose rifapentine have potent antimicrobial activity that may be sufficient to shorten overall treatment duration. Herein we describe the design of an ongoing phase 3 clinical trial testing the hypothesis that once-daily regimens containing high dose rifapentine in combination with other anti-tuberculosis drugs administered for four months can achieve cure rates not worse than the conventional six-month treatment regimen. METHODS/DESIGN: S31/A5349 is a multicenter randomized controlled phase 3 non-inferiority trial that compares two four-month regimens with the standard six-month regimen for treating drug-susceptible pulmonary tuberculosis in HIV-negative and HIV-positive patients. Both of the four-month regimens contain high-dose rifapentine instead of rifampin, with ethambutol replaced by moxifloxacin in one regimen. All drugs are administered seven days per week, and under direct observation at least five days per week. The primary outcome is tuberculosis disease-free survival at twelve months after study treatment assignment. A total of 2500 participants will be randomized; this gives 90% power to show non-inferiority with a 6.6% margin of non-inferiority. DISCUSSION: This phase 3 trial formally tests the hypothesis that augmentation of rifamycin exposures can shorten tuberculosis treatment to four months. Trial design and standardized implementation optimize the likelihood of obtaining valid results. Results of this trial may have important implications for clinical management of tuberculosis at both individual and programmatic levels. TRIAL REGISTRATION: NCT02410772. Registered 8 April 2015,https://www.clinicaltrials.gov/ct2/show/NCT02410772?term=02410772&rank=1. |
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