Last data update: May 13, 2024. (Total: 46773 publications since 2009)
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Correction to: Risk Factors for Death Among Hospitalized Patients Aged 21-64 Years Diagnosed with COVID-19-New York City, March 13-April 9, 2020.
Bushman D , Davidson A , Pathela P , Greene SK , Weiss D , Reddy V , Latash J . J Racial Ethn Health Disparities 2022 9 (4) 1600 |
Reduced Odds of SARS-CoV-2 Reinfection after Vaccination among New York City Adults, June-August 2021 (preprint)
Levin-Rector A , Firestein L , McGibbon E , Sell J , Lim S , Lee EH , Weiss D , Geevarughese A , Zucker JR , Greene SK . medRxiv 2021 11 Background Belief in immunity from prior infection and concern that vaccines might not protect against new variants are contributors to vaccine hesitancy. We assessed effectiveness of full and partial COVID-19 vaccination against reinfection when Delta was the predominant variant in New York City. Methods We conducted a case-control study in which case-patients with reinfection during June 15-August 31, 2021 and control subjects with no reinfection were matched (1:3) on age, sex, timing of initial positive test in 2020, and neighborhood poverty level. Conditional logistic regression was used to calculate matched odds ratios (mOR) and 95% confidence intervals (CI). Results Of 349,598 adult residents who tested positive for SARS-CoV-2 infection in 2020, did not test positive again >90 days after initial positive test through June 15, 2021, and did not die before June 15, 2021, 1,067 were reinfected during June 15-August 31, 2021. Of 1,048 with complete matching criteria data, 499 (47.6%) were known to be symptomatic for COVID-19-like-illness, and 75 (7.2%) were hospitalized. Unvaccinated individuals, compared with fully vaccinated individuals, had elevated odds of reinfection (mOR, 2.23; 95% CI, 1.90, 2.61), of symptomatic reinfection (mOR, 2.17; 95% CI, 1.72, 2.74), and of reinfection with hospitalization (mOR, 2.59; 95% CI, 1.43, 4.69). Partially versus fully vaccinated individuals had 1.58 (95% CI: 1.22, 2.06) times the odds of reinfection. All three vaccines authorized or approved for use in the U.S. were similarly effective. Conclusion Among adults with previous SARS-CoV-2 infection, vaccination reduced odds of reinfections when the Delta variant predominated. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
Pfizer-BioNTech COVID-19 vaccine effectiveness against SARS-CoV-2 infection among long-term care facility staff with and without prior infection in New York City, January-June 2021.
Peebles K , Arciuolo RJ , Romano AS , Sell J , Greene SK , Lim S , Mulready-Ward C , Ternier A , Badenhop B , Blaney K , Real JE , Spencer M , McPherson TD , Ahuja SD , Sullivan Meissner J , Zucker JR , Rosen JB . J Infect Dis 2023 227 (4) 533-542 BACKGROUND: Evidence is accumulating of coronavirus disease 2019 (COVID-19) vaccine effectiveness among persons with prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. METHODS: We evaluated the effect against incident SARS-CoV-2 infection of (1) prior infection without vaccination, (2) vaccination (2 doses of Pfizer-BioNTech COVID-19 vaccine) without prior infection, and (3) vaccination after prior infection, all compared with unvaccinated persons without prior infection. We included long-term care facility staff in New York City aged <65 years with weekly SARS-CoV-2 testing from 21 January to 5 June 2021. Test results were obtained from state-mandated laboratory reporting. Vaccination status was obtained from the Citywide Immunization Registry. Cox proportional hazards models adjusted for confounding with inverse probability of treatment weights. RESULTS: Compared with unvaccinated persons without prior infection, incident SARS-CoV-2 infection risk was lower in all groups: 54.6% (95% confidence interval, 38.0%-66.8%) lower among unvaccinated, previously infected persons; 80.0% (67.6%-87.7%) lower among fully vaccinated persons without prior infection; and 82.4% (70.8%-89.3%) lower among persons fully vaccinated after prior infection. CONCLUSIONS: Two doses of Pfizer-BioNTech COVID-19 vaccine reduced SARS-CoV-2 infection risk by ≥80% and, for those with prior infection, increased protection from prior infection alone. These findings support recommendations that all eligible persons, regardless of prior infection, be vaccinated against COVID-19. |
Comparative hospitalization risk for SARS-CoV-2 Omicron and Delta variant infections, by variant predominance periods and patient-level sequencing results, New York City, August 2021-January 2022.
Greene SK , Levin-Rector A , Kyaw NTT , Luoma E , Amin H , McGibbon E , Mathes RW , Ahuja SD . Influenza Other Respir Viruses 2022 17 (1) e13062 BACKGROUND: Comparing disease severity between SARS-CoV-2 variants among populations with varied vaccination and infection histories can help characterize emerging variants and support healthcare system preparedness. METHODS: We compared COVID-19 hospitalization risk among New York City residents with positive laboratory-based SARS-CoV-2 tests when 98% of sequencing results were Delta (August-November 2021) or Omicron (BA.1 and sublineages, January 2022). A secondary analysis defined variant exposure using patient-level sequencing results during July 2021-January 2022, comprising 1-18% of weekly confirmed cases. RESULTS: Hospitalization risk was lower among patients testing positive when Omicron (16,025/488,053, 3.3%) than when Delta predominated (8268/158,799, 5.2%). In multivariable analysis adjusting for demographic characteristics and prior diagnosis and vaccination status, patients testing positive when Omicron predominated, compared with Delta, had 0.72 (95% CI: 0.63, 0.82) times the hospitalization risk. In a secondary analysis of patients with sequencing results, hospitalization risk was similar among patients infected with Omicron (2042/29,866, 6.8%), compared with Delta (1780/25,272, 7.0%), and higher among the subset who received two mRNA vaccine doses (adjusted relative risk 1.64; 95% CI: 1.44, 1.87). CONCLUSIONS: Hospitalization risk was lower among patients testing positive when Omicron predominated, compared with Delta. This finding persisted after adjusting for prior diagnosis and vaccination status, suggesting intrinsic virologic properties, not population-based immunity, explained the lower severity. Secondary analyses demonstrated collider bias from the sequencing sampling frame changing over time in ways associated with disease severity. Representative data collection is necessary to avoid bias when comparing disease severity between previously dominant and newly emerging variants. |
Reduced Odds of SARS-CoV-2 Reinfection after Vaccination among New York City Adults, July-November 2021.
Levin-Rector A , Firestein L , McGibbon E , Sell J , Lim S , Lee EH , Weiss D , Geevarughese A , Zucker JR , Greene SK . Clin Infect Dis 2022 76 (3) e469-e476 BACKGROUND: Belief that vaccination is not needed for individuals with prior infection contributes to COVID-19 vaccine hesitancy. Among individuals infected with SARS-CoV-2 before vaccines became available, we assessed whether vaccinated individuals had reduced odds of reinfection. METHODS: We conducted a case-control study among adult New York City residents who tested positive for SARS-CoV-2 infection in 2020, did not test positive again >90 days after initial positive test through July 1, 2021, and did not die before July 1, 2021. Case-patients with reinfection during July-November 2021 and control subjects with no reinfection were matched (1:3) on age, sex, timing of initial positive test in 2020, and neighborhood poverty level. Matched odds ratios (mOR) and 95% confidence intervals (CI) were calculated using conditional logistic regression. RESULTS: Of 349,827 eligible adults, 2,583 were reinfected during July-November 2021. Of 2,401 with complete matching criteria data, 1,102 (45.9%) were known to be symptomatic for COVID-19-like-illness, and 96 (4.0%) were hospitalized. Unvaccinated individuals, compared with individuals fully vaccinated within the prior 90 days, had elevated odds of reinfection (mOR, 3.21; 95% CI, 2.70, 3.82), of symptomatic reinfection (mOR, 2.97; 95% CI, 2.31, 3.83), and of reinfection with hospitalization (mOR, 2.09; 95% CI, 0.91, 4.79). All three vaccines authorized or approved for use in the U.S. were similarly effective. CONCLUSION: Vaccination reduced odds of reinfections when the Delta variant predominated. Further studies should assess risk of severe outcomes among reinfected persons as new variants emerge, infection- and vaccine-induced immunity wanes, and booster doses are administered. |
Risk Factors for Death Among Hospitalized Patients Aged 21-64 Years Diagnosed with COVID-19-New York City, March 13-April 9, 2020.
Bushman D , Davidson A , Pathela P , Greene SK , Weiss D , Reddy V , New York City Fatal Case-Control Study Team , Latash J . J Racial Ethn Health Disparities 2021 9 (4) 1-16 BACKGROUND: COVID-19 mortality studies have primarily focused on persons aged ≥ 65 years; less is known about decedents aged <65 years. METHODS: We conducted a case-control study among NYC residents aged 21-64 years hospitalized with COVID-19 diagnosed March 13-April 9, 2020, to determine risk factors for death. Case-patients (n=343) were hospitalized decedents with COVID-19 and control-patients (n=686) were discharged from hospitalization with COVID-19 and matched 2:1 to case-patients on age and residential neighborhood. Conditional logistic regression models were adjusted for patient sex, insurance status, and marital status. Matched adjusted odds ratios (aORs) were calculated for selected underlying conditions, combinations of conditions, and race/ethnic group. RESULTS: Median age of both case-patients and control-patients was 56 years (range: 23-64 years). Having ≥ 1 selected underlying condition increased odds of death 4.45-fold (95% CI: 2.33-8.49). Patients with diabetes; morbid obesity; heart, kidney, or lung disease; cancer; neurologic/neurodevelopmental conditions; mental health conditions; or HIV had significantly increased odds of death. Compared with having neither condition, having both diabetes and obesity or diabetes and heart disease was associated with approximately threefold odds of death. Five select underlying conditions were more prevalent among non-Hispanic Black control-patients than among control-patients of other races/ethnicities. CONCLUSIONS AND RELEVANCE: Selected underlying conditions were risk factors for death, and most prevalent among racial/ethnic minorities. Social services; health care resources, including vaccination; and tailored public health messaging are important for COVID-19 prevention. Strengthening these strategies for racial/ethnic minority groups could minimize COVID-19 racial/ethnic disparities. |
Population-based Estimates of COVID-19-like Illness, COVID-19 Illness, and Rates of Case Ascertainment, Hospitalizations, and Deaths - Non-Institutionalized New York City Residents, March-April 2020.
Alroy KA , Crossa A , Dominianni C , Sell J , Bartley K , Sanderson M , Fernandez S , Levanon Seligson A , Lim SW , Wang SM , Dumas SE , Perlman SE , Konty K , Olson DR , Gould LH , Greene SK . Clin Infect Dis 2021 73 (9) 1707-1710 Using a population-based, representative telephone survey, ~930,000 New York City residents had COVID-19 illness beginning March 20-April 30, 2020, a period with limited testing. For every 1000 persons estimated with COVID-19 illness, 141.8 were tested and reported as cases, 36.8 were hospitalized, and 12.8 died, varying by demographic characteristics. |
Detection and Genetic Characterization of Community-Based SARS-CoV-2 Infections - New York City, March 2020.
Greene SK , Keating P , Wahnich A , Weiss D , Pathela P , Harrison C , Rakeman J , Langley G , Tong S , Tao Y , Uehara A , Queen K , Paden CR , Szymczak W , Orner EP , Nori P , Lai PA , Jacobson JL , Singh HK , Calfee DP , Westblade LF , Vasovic LV , Rand JH , Liu D , Singh V , Burns J , Prasad N , Sell J , CDC COVID-19 Surge Laboratory Group , Abernathy Emily , Anderson Raydel , Bankamp Bettina , Bell Melissa , Galloway Renee , Graziano James , Kim Gimin , Kondas Ashley , Lee Christopher , Radford Kay , Rogers Shannon , Smith Peyton , Tiller Rebekah , Weiner Zachary , Wharton Adam , Whitaker Brett . MMWR Morb Mortal Wkly Rep 2020 69 (28) 918-922 To limit introduction of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), the United States restricted travel from China on February 2, 2020, and from Europe on March 13. To determine whether local transmission of SARS-CoV-2 could be detected, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) conducted deidentified sentinel surveillance at six NYC hospital emergency departments (EDs) during March 1-20. On March 8, while testing availability for SARS-CoV-2 was still limited, DOHMH announced sustained community transmission of SARS-CoV-2 (1). At this time, twenty-six NYC residents had confirmed COVID-19, and ED visits for influenza-like illness* increased, despite decreased influenza virus circulation.(†) The following week, on March 15, when only seven of the 56 (13%) patients with known exposure histories had exposure outside of NYC, the level of community SARS-CoV-2 transmission status was elevated from sustained community transmission to widespread community transmission (2). Through sentinel surveillance during March 1-20, DOHMH collected 544 specimens from patients with influenza-like symptoms (ILS)(§) who had negative test results for influenza and, in some instances, other respiratory pathogens.(¶) All 544 specimens were tested for SARS-CoV-2 at CDC; 36 (6.6%) tested positive. Using genetic sequencing, CDC determined that the sequences of most SARS-CoV-2-positive specimens resembled those circulating in Europe, suggesting probable introductions of SARS-CoV-2 from Europe, from other U.S. locations, and local introductions from within New York. These findings demonstrate that partnering with health care facilities and developing the systems needed for rapid implementation of sentinel surveillance, coupled with capacity for genetic sequencing before an outbreak, can help inform timely containment and mitigation strategies. |
Applying infectious disease forecasting to public health: a path forward using influenza forecasting examples
Lutz CS , Huynh MP , Schroeder M , Anyatonwu S , Dahlgren FS , Danyluk G , Fernandez D , Greene SK , Kipshidze N , Liu L , Mgbere O , McHugh LA , Myers JF , Siniscalchi A , Sullivan AD , West N , Johansson MA , Biggerstaff M . BMC Public Health 2019 19 (1) 1659 BACKGROUND: Infectious disease forecasting aims to predict characteristics of both seasonal epidemics and future pandemics. Accurate and timely infectious disease forecasts could aid public health responses by informing key preparation and mitigation efforts. MAIN BODY: For forecasts to be fully integrated into public health decision-making, federal, state, and local officials must understand how forecasts were made, how to interpret forecasts, and how well the forecasts have performed in the past. Since the 2013-14 influenza season, the Influenza Division at the Centers for Disease Control and Prevention (CDC) has hosted collaborative challenges to forecast the timing, intensity, and short-term trajectory of influenza-like illness in the United States. Additional efforts to advance forecasting science have included influenza initiatives focused on state-level and hospitalization forecasts, as well as other infectious diseases. Using CDC influenza forecasting challenges as an example, this paper provides an overview of infectious disease forecasting; applications of forecasting to public health; and current work to develop best practices for forecast methodology, applications, and communication. CONCLUSIONS: These efforts, along with other infectious disease forecasting initiatives, can foster the continued advancement of forecasting science. |
Sampling considerations for a potential Zika virus urosurvey in New York City
Thompson CN , Lee CT , Immerwahr S , Resnick S , Culp G , Greene SK . Epidemiol Infect 2018 146 (13) 1628-1634 In 2016, imported Zika virus (ZIKV) infections and the presence of a potentially competent mosquito vector (Aedes albopictus) implied that ZIKV transmission in New York City (NYC) was possible. The NYC Department of Health and Mental Hygiene developed contingency plans for a urosurvey to rule out ongoing local transmission as quickly as possible if a locally acquired case of confirmed ZIKV infection was suspected. We identified tools to (1) rapidly estimate the population living in any given 150-m radius (i.e. within the typical flight distance of an Aedes mosquito) and (2) calculate the sample size needed to test and rule out the further local transmission. As we expected near-zero ZIKV prevalence, methods relying on the normal approximation to the binomial distribution were inappropriate. Instead, we assumed a hypergeometric distribution, 10 missed cases at maximum, a urine assay sensitivity of 92.6% and 100% specificity. Three suspected example risk areas were evaluated with estimated population sizes of 479-4,453, corresponding to a minimum of 133-1244 urine samples. This planning exercise improved our capacity for ruling out local transmission of an emerging infection in a dense, urban environment where all residents in a suspected risk area cannot be feasibly sampled. |
Disparities in Zika virus testing and incidence among women of reproductive age - New York City, 2016
Lee CT , Greene SK , Baumgartner J , Fine A . J Public Health Manag Pract 2017 24 (6) 533-541 CONTEXT: The New York City Department of Health and Mental Hygiene (NYC DOHMH) performs surveillance for reportable diseases, including Zika virus (ZIKV) infection and disease, to inform public health responses. Incidence rates of other mosquito-borne diseases related to international travel are associated with census tract poverty level in NYC, suggesting that high poverty areas might be at higher risk for ZIKV infections. OBJECTIVES: We assessed ZIKV testing rates and incidence of travel-associated infection among reproductive age women in NYC to identify areas with high incidence and low testing rates and assess the effectiveness of public health interventions. DESIGN: We analyzed geocoded ZIKV surveillance data collected by NYC DOHMH. Women aged 15 to 44 years tested during January-July 2016 (n = 4733) were assigned to census tracts, which we grouped by poverty level and quartile of the number of persons born in countries or territories with mosquito-borne ZIKV transmission as a proxy for risk of travel to these areas. We calculated crude ZIKV testing rates, incidence rates, and incidence rate ratios (IRRs). SETTING: New York City. RESULTS: Eight percent of patients (n = 376) tested had evidence of ZIKV infection. Cumulative incidence was higher both in areas with higher versus lower poverty levels (IRR = 2.4; 95% confidence interval [CI], 2.0-3.0) and in areas with the largest versus smallest populations of persons born in countries or territories with mosquito-borne ZIKV transmission (IRR = 11.3; 95% CI, 6.2-20.7). Initially, ZIKV testing rates were lowest in higher poverty areas with the largest populations of persons born in countries or territories with mosquito-borne ZIKV transmission (15/100 000), but following targeted interventions, testing rates were highest in these areas (80/100 000). CONCLUSIONS: Geocoded data enabled us to identify communities with low testing but high ZIKV incidence rates, intervene to promote testing and reduce barriers to testing, and measure changes in testing rates. |
Outbreak of non-tuberculous mycobacteria skin or soft tissue infections associated with handling fish - New York City, 2013-2014
Yacisin K , Hsieh JL , Weiss D , Ackelsberg J , Lee E , Jones L , Leung YL , Li L , Yung J , Slavinski S , Hanson H , Ridpath A , Kornblum J , Lin Y , Robbe-Austerman S , Rakeman J , Siemetzki-Kapoor U , Stuber T , Greene SK . Epidemiol Infect 2017 145 (11) 1-11 Mycobacterium marinum, a bacterium found in freshwater and saltwater, can infect persons with direct exposure to fish or aquariums. During December 2013, the New York City Department of Health and Mental Hygiene learned of four suspected or confirmed M. marinum skin or soft tissue infections (SSTIs) among persons who purchased whole fish from Chinese markets. Ninety-eight case-patients with non-tuberculous mycobacteria (NTM) SSTIs were identified with onset June 2013-March 2014. Of these, 77 (79%) were female. The median age was 62 years (range 30-91). Whole genome sequencing of clinical isolates revealed two main clusters and marked genetic diversity. Environmental samples from distributors yielded NTM though not M. marinum. We compared 56 case-patients with 185 control subjects who shopped in Chinese markets, frequency-matched by age group and sex. Risk factors for infection included skin injury to the finger or hand (odds ratio [OR]: 15.5; 95% confidence interval [CI]: 6.9-37.3), hand injury while preparing fish or seafood (OR 8.3; 95% CI 3.8-19.1), and purchasing tilapia (OR 3.6; 95% CI 1.1-13.9) or whiting (OR 2.7; 95% CI 1.1-6.6). A definitive environmental outbreak source was not identified. |
Increasing antibiotic resistance in Shigella spp. from infected New York City Residents, New York, USA
Murray K , Reddy V , Kornblum JS , Waechter H , Chicaiza LF , Rubinstein I , Balter S , Greene SK , Braunstein SL , Rakeman JL , Dentinger CM . Emerg Infect Dis 2017 23 (2) 332-335 Approximately 20% of Shigella isolates tested in New York City, New York, USA, during 2013-2015 displayed decreased azithromycin susceptibility. Case-patients were older and more frequently male and HIV infected than those with azithromycin-susceptible Shigella infection; 90% identified as men who have sex with men. Clinical interpretation guidelines for azithromycin resistance and outcome studies are needed. |
A Large Community Outbreak of Legionnaires' Disease Associated With a Cooling Tower in New York City, 2015.
Weiss D , Boyd C , Rakeman JL , Greene SK , Fitzhenry R , McProud T , Musser K , Huang L , Kornblum J , Nazarian EJ , Fine AD , Braunstein SL , Kass D , Landman K , Lapierre P , Hughes S , Tran A , Taylor J , Baker D , Jones L , Kornstein L , Liu B , Perez R , Lucero DE , Peterson E , Benowitz I , Lee KF , Ngai S , Stripling M , Varma JK . Public Health Rep 2017 132 (2) 33354916689620 OBJECTIVES: Infections caused by Legionella are the leading cause of waterborne disease outbreaks in the United States. We investigated a large outbreak of Legionnaires' disease in New York City in summer 2015 to characterize patients, risk factors for mortality, and environmental exposures. METHODS: We defined cases as patients with pneumonia and laboratory evidence of Legionella infection from July 2 through August 3, 2015, and with a history of residing in or visiting 1 of several South Bronx neighborhoods of New York City. We describe the epidemiologic, environmental, and laboratory investigation that identified the source of the outbreak. RESULTS: We identified 138 patients with outbreak-related Legionnaires' disease, 16 of whom died. The median age of patients was 55. A total of 107 patients had a chronic health condition, including 43 with diabetes, 40 with alcoholism, and 24 with HIV infection. We tested 55 cooling towers for Legionella, and 2 had a strain indistinguishable by pulsed-field gel electrophoresis from 26 patient isolates. Whole-genome sequencing and epidemiologic evidence implicated 1 cooling tower as the source of the outbreak. CONCLUSIONS: A large outbreak of Legionnaires' disease caused by a cooling tower occurred in a medically vulnerable community. The outbreak prompted enactment of a new city law on the operation and maintenance of cooling towers. Ongoing surveillance and evaluation of cooling tower process controls will determine if the new law reduces the incidence of Legionnaires' disease in New York City. |
Reportable Bacterial Infections among New York City-Born Infants, 2001-2009
Isaac BM , Masonbrink A , Kennedy J , Greene SK , Hennessy RR , Rosen JB , Trieu L , Ngai S , Morse SS , Weiss D . J Pediatr 2016 174 218-225.e4 OBJECTIVE: To determine rates of reportable bacterial infections among infants in New York City and identify populations at risk and preventable causes of morbidity. STUDY DESIGN: This retrospective cohort study matched live births in New York City from 2001-2009 to reported cases of bacterial infections among infants less than 1 year of age. Characteristics recorded on birth certificates were compared between infants with bacterial enteric infection, bacterial nonenteric infection, and no reportable bacterial infection. Multinomial logistic regression and multivariable logistic regression were used to identify risk factors for infection. RESULTS: Bacterial infection was reported in 4.6 cases per 1000 live births. Of 4524 infants with a reportable infection, the majority (2880, 63%) had an enteric infection. Asian/Pacific Islanders in Brooklyn were the borough-level race/ethnic group with the highest enteric infection rate (8.5 per 1000 live births). Citywide, infants with enteric infections were disproportionately male, from higher poverty neighborhoods, born to foreign-born mothers, and enrolled in Special Supplemental Food Program for Women, Infants, and Children or Medicaid. In contrast, infants with nonenteric infections were more likely to have low birthweight and mothers characterized by US birth and black race or white Hispanic race/ethnicity. CONCLUSIONS: Distinct patterns of risk factors for enteric and nonenteric bacterial infections among infants were identified. The results suggest that infants born to Asian/Pacific Islander mothers residing in Brooklyn should be a focus of enteric disease prevention. More research is necessary to better understand what behaviors increase the risk of enteric disease in this population. |
Absence of venous thromboembolism risk following quadrivalent human papillomavirus vaccination, Vaccine Safety Datalink, 2008-2011
Naleway AL , Crane B , Smith N , Daley MF , Donahue J , Gee J , Greene SK , Harrington T , Jackson LA , Klein NP , Tseng HF , Vellozzi C , Weintraub ES . Vaccine 2015 34 (1) 167-71 BACKGROUND: To investigate concerns about a potential association between quadrivalent human papillomavirus vaccination (HPV4) and venous thromboembolism (VTE), we conducted a self-controlled case series study in adolescents and young adults 9-26 years of age in the Vaccine Safety Datalink. METHODS: We identified potential VTE cases diagnosed in 2008 through 2011 who had also received at least one HPV4 dose during that period. We confirmed each presumptive diagnosis by medical record review. We calculated incidence rate ratios (IRRs) and 95% confidence intervals (CI) to estimate the risk in the 1-60 day period following HPV4 exposure and in subsets of that period. IRRs were stratified by age, gender, hormonal contraceptive use, and recent surgery or trauma. RESULTS: We identified 313 potential cases of VTE among HPV4 vaccinees, and 291 (93%) had sufficient medical records for review. Of these, we confirmed 156 (54%) cases. VTE was uncommon among males (n=3) and 9-12 year olds (n=4). Nearly all confirmed cases (97%) had at least one known risk factor for VTE, including hormonal contraceptive use, obesity, and hypercoagulability. Sixteen (10%) confirmed cases occurred in the 1-60 days following HPV4 exposure. The risk of VTE varied from 1.47 (95% CI: 0.47-4.64) in the 1-7 days following HPV4 exposure to 0.92 (95% CI: 0.54-1.57) in the 1-60 days following vaccination. It was not possible to calculate a stratified IRR for males due to small sample size; the other risk factors evaluated did not significantly affect the risk of VTE after HPV4 exposure. CONCLUSION: The risk of developing VTE among 9- to 26-year-olds was not elevated following HPV4 exposure. Sample size limited our ability to rigorously evaluate potential effect modifiers, such as gender, through stratified analysis. |
Risk factors for serogroup C meningococcal disease during outbreak among men who have sex with men, New York City, New York, USA
Ridpath A , Greene SK , Robinson BF , Weiss D . Emerg Infect Dis 2015 21 (8) 1458-61 Risk factors for illness during a serogroup C meningococcal disease outbreak among men who have sex with men in New York City, New York, USA, in 2012-2013 included methamphetamine and cocaine use and sexually transmitted infections. Outbreak investigations should consider routinely capturing information regarding drug use and sex-related risk factors. |
Association between Guillain-Barre syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis
Salmon DA , Proschan M , Forshee R , Gargiullo P , Bleser W , Burwen DR , Cunningham F , Garman P , Greene SK , Lee GM , Vellozzi C , Yih WK , Gellin B , Lurie N . Lancet 2013 381 (9876) 1461-8 BACKGROUND: The influenza A (H1N1) 2009 monovalent vaccination programme was the largest mass vaccination initiative in recent US history. Commensurate with the size and scope of the vaccination programme, a project to monitor vaccine adverse events was undertaken, the most comprehensive safety surveillance agenda in the USA to date. The adverse event monitoring project identified an increased risk of Guillain-Barre syndrome after vaccination; however, some individual variability in results was noted. Guillain-Barre syndrome is a rare but serious health disorder in which a person's own immune system damages their nerve cells, causing muscle weakness, sometimes paralysis, and infrequently death. We did a meta-analysis of data from the adverse event monitoring project to ascertain whether influenza A (H1N1) 2009 monovalent inactivated vaccines used in the USA increased the risk of Guillain-Barre syndrome. METHODS: Data were obtained from six adverse event monitoring systems. About 23 million vaccinated people were included in the analysis. The primary analysis entailed calculation of incidence rate ratios and attributable risks of excess cases of Guillain-Barre syndrome per million vaccinations. We used a self-controlled risk-interval design. FINDINGS: Influenza A (H1N1) 2009 monovalent inactivated vaccines were associated with a small increased risk of Guillain-Barre syndrome (incidence rate ratio 2.35, 95% CI 1.42-4.01, p=0.0003). This finding translated to about 1.6 excess cases of Guillain-Barre syndrome per million people vaccinated. INTERPRETATION: The modest risk of Guillain-Barre syndrome attributed to vaccination is consistent with previous estimates of the disorder after seasonal influenza vaccination. A risk of this small magnitude would be difficult to capture during routine seasonal influenza vaccine programmes, which have extensive, but comparatively less, safety monitoring. In view of the morbidity and mortality caused by 2009 H1N1 influenza and the effectiveness of the vaccine, clinicians, policy makers, and those eligible for vaccination should be assured that the benefits of inactivated pandemic vaccines greatly outweigh the risks. FUNDING: US Federal Government. |
Risk of adverse events following oseltamivir treatment in influenza outpatients, Vaccine Safety Datalink Project, 2007-2010
Greene SK , Li L , Shay DK , Fry AM , Lee GM , Jacobsen SJ , Baxter R , Irving SA , Jackson ML , Naleway AL , Nordin JD , Narwaney KJ , Lieu TA . Pharmacoepidemiol Drug Saf 2013 22 (4) 335-44 PURPOSE: An association between the influenza antiviral medication oseltamivir and neuropsychiatric events has been suggested by post-marketing case reports in Japan. This possible association was not supported by cohort studies in the U.S. conducted prior to the 2009 influenza A (H1N1) pandemic, when usage rates were comparatively low. We assessed oseltamivir safety before and during the pandemic using biologically plausible risk intervals, particularly focusing on psychiatric events. METHODS: Outpatients with influenza episodes from January 2007 through June 2010 were identified using diagnosis codes and positive tests at eight health care systems (sites) in the Vaccine Safety Datalink Project. Oseltamivir-treated and untreated patients were matched according to calendar week, age, sex, site, and propensity for treatment. Within this matched cohort, conditional logistic regression models were used to estimate the risk of four neuropsychiatric and five other adverse events (AEs) during pre-specified risk intervals. RESULTS: Among 27,684 matched pairs, no associations were identified between oseltamivir treatment and any pre-defined AE. The absolute risks of incident psychiatric events in the 1-7 day risk interval were 0.126% for oseltamivir-treated and 0.105% for untreated patients (odds ratio = 1.21, 95% confidence interval [CI]: 0.74, 1.97; risk difference = 0.022%, 95% CI: -0.035%, 0.078%); the most common diagnosis was unspecified anxiety state. Results were similar for 1-14 and 1-2 day risk intervals and for pediatric/adolescent subgroups. CONCLUSIONS: Consistent with prior U.S. cohort studies, no evidence was identified for an increased risk of neuropsychiatric or other AEs following oseltamivir treatment. Safety should be prospectively monitored to inform antiviral medication usage recommendations. (Copyright (c) 2012 John Wiley & Sons, Ltd.) |
Secular trends in diagnostic code density in electronic healthcare data from health care systems in the Vaccine Safety Datalink Project
Hechter RC , Qian L , Sy LS , Greene SK , Weintraub ES , Naleway AL , Rowhani-Rahbar A , Donahue JG , Daley MF , Vazquez-Benitez G , Lugg MM , Jacobsen SJ . Vaccine 2013 31 (7) 1080-5 Large observational vaccine safety studies often use automated diagnoses extracted from medical care databases to identify pre-specified potential adverse events following immunization (AEFI). We assessed the secular trends and variability in the number of diagnoses per encounter regardless of immunization status referred as diagnostic code density, by healthcare setting, age, and pre-specified condition in eight large health care systems of the Vaccine Safety Datalink project during 2001-2009. An increasing trend in diagnostic code density was observed in all healthcare settings and age groups, with variations across the sites. Sudden increases in diagnostic code density were observed at certain sites when changes in coding policies or data inclusion criteria took place. When vaccine safety studies use an historical comparator, the increased diagnostic code density over time may generate low expected rates (based on historical data) and high observed rates (based on current data), suggesting a false positive association between a vaccine and AEFI. The ongoing monitoring of the diagnostic code density can provide guidance on study design and choice of appropriate comparison groups. It can also be used to ensure data quality and allow timely correction of errors in an active safety surveillance system. |
Risk of confirmed Guillain-Barre syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety Datalink Project, 2009-2010
Greene SK , Rett M , Weintraub ES , Li L , Yin R , Amato AA , Ho DT , Sheikh SI , Fireman BH , Daley MF , Belongia EA , Jacobsen SJ , Baxter R , Lieu TA , Kulldorff M , Vellozzi C , Lee GM . Am J Epidemiol 2012 175 (11) 1100-9 An increased risk of Guillain-Barre syndrome (GBS) following administration of the 1976 swine influenza vaccine led to a heightened focus on GBS when monovalent vaccines against a novel influenza A (H1N1) virus of swine origin were introduced in 2009. GBS cases following receipt of monovalent inactivated (MIV) and seasonal trivalent inactivated (TIV) influenza vaccines in the Vaccine Safety Datalink Project in 2009-2010 were identified in electronic data and confirmed by medical record review. Within 1-42 days following vaccination, 9 cases were confirmed in MIV recipients (1.48 million doses), and 8 cases were confirmed in TIV-only recipients who did not also receive MIV during 2009-2010 (1.72 million doses). Five cases following MIV and 1 case following TIV-only had an antecedent respiratory infection, a known GBS risk factor; furthermore, unlike TIV, MIV administration was concurrent with heightened influenza activity. In a self-controlled risk interval analysis comparing GBS onset within 1-42 days following MIV with GBS onset 43-127 days following MIV, the risk difference was 5.0 cases per million doses (95% confidence interval: 0.5, 9.5). No statistically significant increased GBS risk was found within 1-42 days following TIV-only vaccination versus 43-84 days following vaccination (risk difference = 1.1 cases per million doses, 95% confidence interval: -3.1, 5.4). Further evaluation to assess GBS risk following both vaccination and respiratory infection is warranted. |
Patterns in influenza antiviral medication use before and during the 2009 H1N1 pandemic, Vaccine Safety Datalink Project, 2000-2010
Greene SK , Shay DK , Yin R , McCarthy NL , Baxter R , Jackson ML , Jacobsen SJ , Nordin JD , Irving SA , Naleway AL , Glanz JM , Lieu TA . Influenza Other Respir Viruses 2012 6 (6) e143-51 BACKGROUND: U.S. recommendations for using influenza antiviral medications changed in response to viral resistance (to reduce adamantane use) and during the 2009 H1N1 pandemic (to focus on protecting high-risk patients). Little information is available on clinician adherence to these recommendations. We characterized population-based outpatient antiviral medication usage, including diagnosis and testing practices, before and during the pandemic. METHODS: Eight medical care organizations in the Vaccine Safety Datalink Project provided data on influenza antiviral medication dispensings from January 2000 through June 2010. Dispensing rates were explored in relation to changes in recommendations and influenza diagnosis and laboratory testing frequencies. Factors associated with oseltamivir dispensings in pandemic versus pre-pandemic periods were identified using multivariable logistic regression. RESULTS: Antiviral use changed coincident with recommendations to avoid adamantanes in 2006, to use alternatives to oseltamivir in 2008, and to use oseltamivir during the pandemic. Of 38,019 oseltamivir dispensings during the pandemic, 31% were to patients not assigned an influenza diagnosis, and 97% were to patients not tested for influenza. Oseltamivir was more likely to be dispensed in pandemic versus pre-pandemic periods to patients <25 years old and to those with underlying conditions, including chronic pulmonary disease or pregnancy (P < 0.0001 for each factor in multivariable analysis). CONCLUSIONS: Antiviral medication usage patterns suggest that clinicians followed recommendations to change antiviral prescribing based on resistance and to focus on high-risk patients during the pandemic. Medications were commonly dispensed to patients without influenza diagnoses and tests, suggesting that antiviral dispensings may offer useful supplemental data for monitoring influenza incidence. |
Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010-2011
Tse A , Tseng HF , Greene SK , Vellozzi C , Lee GM . Vaccine 2012 30 (11) 2024-2031 In fall 2010 in the southern hemisphere, an increased risk of febrile seizures was noted in young children in Australia in the 24h after receipt of trivalent inactivated influenza vaccine (TIV) manufactured by CSL Biotherapies. Although the CSL TIV vaccine was not recommended for use in young children in the US, during the 2010-2011 influenza season near real-time surveillance was conducted for febrile seizures in the 0-1 days following first dose TIV in a cohort of 206,174 vaccinated children ages 6 through 59 months in the Vaccine Safety Datalink Project. On a weekly basis, surveillance was conducted with the primary approach of a self-controlled risk interval design and the secondary approach of a current vs. historical vaccinee design. Sequential statistical methods were employed to account for repeated analyses of accumulating data. Signals for seizures based on computerized data were identified in mid November 2010 using a current vs. historical design and in late December 2010 using a self-controlled risk interval design. Further signal evaluation was conducted with chart-confirmed febrile seizure cases using only data from the primary approach (i.e. self-controlled risk interval design). The magnitude of the incidence rate ratio and risk difference comparing risk of seizures in the 0-1 days vs. 14-20 days following TIV differed by receipt of concomitant 13-valent pneumococcal conjugate vaccine (PCV13). Among children 6-59 months of age, the incidence rate ratio (IRR) for TIV adjusted for concomitant PCV13 was 2.4 (95% CI 1.2, 4.7) while the IRR for PCV13 adjusted for concomitant TIV was 2.5 (95% CI 1.3, 4.7). The IRR for concomitant TIV and PCV13 was 5.9 (95% CI 3.1, 11.3). Risk difference estimates varied by age due to the varying baseline risk for seizures in young children, with the highest estimates occurring at 16 months (12.5 per 100,000 doses for TIV without concomitant PCV13, 13.7 per 100,000 doses for PCV13 without concomitant TIV, and 44.9 per 100,000 doses for concomitant TIV and PCV13) and the lowest estimates occurring at 59 months (1.1 per 100,000 doses for TIV without concomitant PCV13, 1.2 per 100,000 doses for PCV13 without concomitant TIV, and 4.0 per 100,000 doses for concomitant TIV and PCV13). Incidence rate ratio and risk difference estimates were lower for children receiving TIV without concomitant PCV13 or PCV13 without concomitant TIV. Because of the importance of preventing influenza and pneumococcal infections and associated complications, our findings should be placed in a benefit-risk framework to ensure that population health benefits are maximized. |
Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data
Nelson JC , Cook AJ , Yu O , Dominguez C , Zhao S , Greene SK , Fireman BH , Jacobsen SJ , Weintraub ES , Jackson LA . Pharmacoepidemiol Drug Saf 2012 21 Suppl 1 62-71 PURPOSE: Many challenges arise when conducting a sequentially monitored medical product safety surveillance evaluation using observational electronic data captured during routine care. We review existing sequential approaches for potential use in this setting, including a continuous sequential testing method that has been utilized within the Vaccine Safety Datalink (VSD) and group sequential methods, which are used widely in randomized clinical trials. METHODS: Using both simulated data and preliminary data from an ongoing VSD evaluation, we discuss key sequential design considerations, including sample size and duration of surveillance, shape of the signaling threshold, and frequency of interim testing. RESULTS AND CONCLUSIONS: All designs control the overall Type 1 error rate across all tests performed, but each yields different tradeoffs between the probability and timing of true and false positive signals. Designs tailored to monitor efficacy outcomes in clinical trials have been well studied, but less consideration has been given to optimizing design choices for observational safety settings, where the hypotheses, population, prevalence and severity of the outcomes, implications of signaling, and costs of false positive and negative findings are very different. Analytic challenges include confounding, missing and partially accrued data, high misclassification rates for outcomes presumptively defined using diagnostic codes, and unpredictable changes in dynamically accessed data over time (e.g., differential product uptake). Many of these factors influence the variability of the adverse events under evaluation and, in turn, the probability of committing a Type 1 error. Thus, to ensure proper Type 1 error control, planned sequential thresholds should be adjusted over time to account for these issues. (Copyright (c) 2012 John Wiley & Sons, Ltd.) |
H1N1 and seasonal influenza vaccine safety in the Vaccine Safety Datalink Project
Lee GM , Greene SK , Weintraub ES , Baggs J , Kulldorff M , Fireman BH , Baxter R , Jacobsen SJ , Irving S , Daley MF , Yin R , Naleway A , Nordin JD , Li L , McCarthy N , Vellozzi C , Destefano F , Lieu TA . Am J Prev Med 2011 41 (2) 121-8 BACKGROUND: The emergence of pandemic H1N1 influenza virus in early 2009 prompted the rapid licensure and use of H1N1 monovalent inactivated (MIV) and live, attenuated (LAMV) vaccines separate from seasonal trivalent inactivated (TIV) and live, attenuated (LAIV) influenza vaccines. A robust influenza immunization program in the U.S. requires ongoing monitoring of potential adverse events associated with vaccination. PURPOSE: To prospectively conduct safety monitoring of H1N1 and seasonal influenza vaccines during the 2009-2010 season. METHODS: The Vaccine Safety Datalink (VSD) Project monitors approximately 9.2 million members in eight U.S. medical care organizations. Electronic data on vaccines and pre-specified adverse events were updated and analyzed weekly for signal detection from November 2009 to April 2010 using either a self-controlled design or a current versus historical comparison. Statistical signals were further evaluated using alternative approaches to identify temporal clusters and to control for time-varying confounders. RESULTS: As of May 1, 2010, a total of 1,345,663 MIV, 267,715 LAMV, 2,741,150 TIV, and 157,838 LAIV doses were administered in VSD. No significant associations were noted during sequential analyses for Guillain-Barre syndrome, most other neurologic outcomes, and allergic and cardiac events. For MIV, a statistical signal was observed for Bell's palsy for adults aged ≥25 years on March 31, 2010, using the self-controlled approach. Subsequent analyses revealed no significant temporal cluster. Case-centered logistic regression adjusting for seasonality demonstrated an OR for Bell's palsy of 1.26 (95% CI=0.97, 1.63). CONCLUSIONS: No major safety problems following H1N1 or seasonal influenza vaccines were detected in the 2009-2010 season in weekly sequential analyses. Seasonality likely contributed to the Bell's palsy signal following MIV. Prospective safety monitoring followed by rigorous signal refinement is critical to inform decision-making by regulatory and public health agencies. |
Near real-time vaccine safety surveillance with partially accrued data
Greene SK , Kulldorff M , Yin R , Yih WK , Lieu TA , Weintraub ES , Lee GM . Pharmacoepidemiol Drug Saf 2011 20 (6) 583-90 PURPOSE: The Vaccine Safety Datalink (VSD) Project conducts near real-time vaccine safety surveillance using sequential analytic methods. Timely surveillance is critical in identifying potential safety problems and preventing additional exposure before most vaccines are administered. For vaccines that are administered during a short period, such as influenza vaccines, timeliness can be improved by undertaking analyses while risk windows following vaccination are ongoing and by accommodating predictable and unpredictable data accrual delays. We describe practical solutions to these challenges, which were adopted by the VSD Project during pandemic and seasonal influenza vaccine safety surveillance in 2009/2010. METHODS: Adjustments were made to two sequential analytic approaches. The Poisson-based approach compared the number of pre-defined adverse events observed following vaccination with the number expected using historical data. The expected number was adjusted for the proportion of the risk window elapsed and the proportion of inpatient data estimated to have accrued. The binomial-based approach used a self-controlled design, comparing the observed numbers of events in risk versus comparison windows. Events were included in analysis only if they occurred during a week that had already passed for both windows. RESULTS: Analyzing data before risk windows fully elapsed improved the timeliness of safety surveillance. Adjustments for data accrual lags were tailored to each data source and avoided biasing analyses away from detecting a potential safety problem, particularly early during surveillance. CONCLUSIONS: The timeliness of vaccine and drug safety surveillance can be improved by properly accounting for partially elapsed windows and data accrual delays. Copyright (c) 2011 John Wiley & Sons, Ltd. |
Accuracy of influenza vaccination status in a computer-based immunization tracking system of a managed care organization
Sy LS , Liu IL , Solano Z , Cheetham TC , Lugg MM , Greene SK , Weintraub ES , Jacobsen SJ . Vaccine 2010 28 (32) 5254-9 Influenza vaccine safety and effectiveness studies conducted using electronic medical records rely on accurate assessment of influenza vaccination status. However, influenza immunization in non-traditional settings (e.g., the workplace) may not be captured in patient immunization tracking systems. We compared influenza vaccination status from electronic records with self-reported vaccination status for five hundred and two 50-79 years olds enrolled in a large managed care organization. Influenza vaccination status in the medical record had a high positive predictive value and specificity (both >99%). The negative predictive value was 80% and sensitivity was 78%. These data suggest that an electronic record of influenza vaccination reliably indicates immunization, while the absence of such a record is only moderately accurate, partly due to vaccines received in non-traditional settings. |
Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project
Greene SK , Kulldorff M , Lewis EM , Li R , Yin R , Weintraub ES , Fireman BH , Lieu TA , Nordin JD , Glanz JM , Baxter R , Jacobsen SJ , Broder KR , Lee GM . Am J Epidemiol 2010 171 (2) 177-88 The emergence of pandemic H1N1 influenza in 2009 has prompted public health responses, including production and licensure of new influenza A (H1N1) 2009 monovalent vaccines. Safety monitoring is a critical component of vaccination programs. As proof-of-concept, the authors mimicked near real-time prospective surveillance for prespecified neurologic and allergic adverse events among enrollees in 8 medical care organizations (the Vaccine Safety Datalink Project) who received seasonal trivalent inactivated influenza vaccine during the 2005/06-2007/08 influenza seasons. In self-controlled case series analysis, the risk of adverse events in a prespecified exposure period following vaccination was compared with the risk in 1 control period for the same individual either before or after vaccination. In difference-in-difference analysis, the relative risk in exposed versus control periods each season was compared with the relative risk in previous seasons since 2000/01. The authors used Poisson-based analysis to compare the risk of Guillain-Barre syndrome following vaccination in each season with that in previous seasons. Maximized sequential probability ratio tests were used to adjust for repeated analyses on weekly data. With administration of 1,195,552 doses to children under age 18 years and 4,773,956 doses to adults, no elevated risk of adverse events was identified. Near real-time surveillance for selected adverse events can be implemented prospectively to rapidly assess seasonal and pandemic influenza vaccine safety. |
Accuracy of data on influenza vaccination status at four Vaccine Safety Datalink sites
Greene SK , Shi P , Dutta-Linn MM , Shoup JA , Hinrichsen VL , Ray P , Nordin JD , Kuckler L , Weintraub ES , Yih WK . Am J Prev Med 2009 37 (6) 552-5 BACKGROUND: Studies of influenza vaccination using electronic medical records rely on accurate classification of vaccination status. Vaccinations not entered into electronic records would be unavailable for study. PURPOSE: This study evaluated the sensitivity and negative predictive value (NPV) of electronic records for influenza vaccination and factors associated with failure to capture vaccinations. METHODS: In four diverse medical care organizations in the Vaccine Safety Datalink, those aged 50-79 years with no influenza vaccination record during the 2007-2008 season were surveyed by telephone, and electronic records were analyzed in 2008. The sensitivity and NPV of electronic records were estimated, using survey responses as the gold standard. Logistic regression models determined associations between 1-NPV and demographic factors, risk of influenza complications, and healthcare utilization levels. RESULTS: Data were obtained for 933 survey participants and 1,085,916 medical care organization members. Sites varied significantly in the sensitivity (51%, 68%, 79%, 89%) and NPV (46%, 62%, 66%, 87%) of electronic records. In multivariate analysis, the rate of failure to capture vaccinations was significantly higher for those aged 65-79 years than for those aged 50-64 years at three sites. Of vaccinations not captured by electronic records, 58% were reportedly administered in nontraditional settings, usually workplaces; the rest were given within the sites. CONCLUSIONS: Influenza vaccination studies relying on electronic records may misclassify substantial proportions of vaccinated individuals as unvaccinated, producing biased estimates of vaccine effectiveness. Sites with limited sensitivity to capture vaccinations administered within their organization should seek possible remedies. More complete capture of vaccinations administered to older patients and in nontraditional settings would further reduce misclassification. |
Effect of a point-of-use water treatment and safe water storage intervention on diarrhea in infants of HIV-infected mothers
Harris JR , Greene SK , Thomas TK , Ndivo R , Okanda J , Masaba R , Nyangau I , Thigpen MC , Hoekstra RM , Quick RE . J Infect Dis 2009 200 (8) 1186-93 To reduce mother-to-child transmission of human immunodeficiency virus (HIV) in resource-poor settings, the World Health Organization recommends exclusive breast-feeding for 6 months, followed by rapid weaning if replacement feeding is affordable, feasible, available, safe, and sustainable. In the Kisumu Breastfeeding Study (trial registration: Clinicaltrials.gov identifier NCT00146380 ), infants of HIV-infected mothers who received antiretroviral therapy experienced high rates of diarrhea at weaning. To address this problem, mothers in the Kisumu Breastfeeding Study were given safe water storage vessels, hygiene education, and bleach for household water treatment. We compared the incidence of diarrhea in infants enrolled before (cohort A) and after (cohort B) implementation of the intervention. Cohort B infants experienced less diarrhea than cohort A infants, before and after weaning ([Formula: see text] and [Formula: see text], respectively); however, during the weaning period, there were no differences in the frequency of diarrhea between cohorts ([Formula: see text]). Testing of stored water in cohort B homes indicated high adherence (monthly range, 80%-95%) to recommended chlorination practices. Among infants who were weaned early, provision of safe water may be insufficient to prevent weaning-associated diarrhea. |
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