Publications by authors named "Neela D Goswami"

32 Publications

Delayed Tuberculosis Diagnoses During the Coronavirus Disease 2019 (COVID-19) Pandemic in 2020-King County, Washington.

Clin Infect Dis 2021 07;73(Suppl 1):S74-S76

Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA.

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http://dx.doi.org/10.1093/cid/ciab387DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8135939PMC
July 2021

Evidence, Experience, Expertise, and the US Coronavirus Disease 2019 Public Health Response.

Clin Infect Dis 2021 07;73(Suppl 1):S1-S4

The U.S. Centers for Disease Control and Prevention (CDC), state, tribal, and local health departments assess available and promising interventions and individual and population health outcomes when crafting public health recommendations. This supplement provides a snapshot of some of the science, experience, and expertise supporting the COVID-19 response.
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http://dx.doi.org/10.1093/cid/ciab315DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8135329PMC
July 2021

Linezolid use for the treatment of multidrug-resistant tuberculosis, TB centers of excellence, United States, 2013-2018.

J Clin Tuberc Other Mycobact Dis 2021 Feb 16;22:100201. Epub 2020 Nov 16.

U.S. Centers for Disease Control and Prevention, Division of TB Elimination, Atlanta, GA, United States.

Background: In 2019, the World Health Organization released guidelines reflecting major changes in multidrug-resistant tuberculosis (MDR-TB) management-prioritizing fluoroquinolones, bedaquiline, and linezolid (LZD) while de-emphasizing previously favored injectable agents. In some cases, linezolid use is associated with gastrointestinal intolerance, mitochondrial toxicity, and significant drug interactions. CDC's Division of Tuberculosis Elimination supports a network of regional TB Centers of Excellence, which provide medical consultation to healthcare providers. Consultations are documented in a medical consultation database (MCD) enabling evaluation of management questions and recommendations. We describe the scope of clinical inquiries and responses specific to linezolid use for MDR-TB in the US.

Research Question: What are the major themes of provider and patient challenges regarding the use of linezolid for the treatment of MDR-TB in the US?

Methods: We queried MCD consults categorized as "MDR/XDR-TB" from 1/1/2013 to 12/31/2018. Only linezolid-specific consultations were included; incomplete and duplicate entries were excluded as were those citing linezolid historically or theoretically. Subgroup characteristics were assessed (e.g., Center, year, provider type). A descriptive coding scheme was developed through inductive thematic analysis.

Results: In 2013-2018 of the 1889 consults regarding MDR/XDR-TB, 934 MDR-TB consults referenced linezolid; 137 met inclusion criteria, representing between 4 and 10% of MDR-TB consults annually. Four main themes emerged: adverse effects (71.5%); concerns about linezolid use due to co-morbidities or concurrent medication use (15.3%); dosing adjustments (8.8%); and monitoring and maintenance logistics (4.4%).

Interpretations: Linezolid consults consistently exceeded 4% of all consults annually over the 6-year period, suggesting a need for access to expert opinion for providers using linezolid to manage MDR-TB. While only a snapshot of MDR-TB in the US, this evaluation summarizes major provider concerns regarding particular adverse effects, and highlights a need for evidence-based guidance regarding linezolid dosing and toxicity management.
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http://dx.doi.org/10.1016/j.jctube.2020.100201DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7732868PMC
February 2021

Novel 6-Month Treatment for Drug-Resistant Tuberculosis, United States.

Emerg Infect Dis 2021 01 23;27(1). Epub 2020 Nov 23.

The US Food and Drug Administration approved a 6-month regimen of pretomanid, bedaquiline, and linezolid for extensively drug-resistant or multidrug-intolerant tuberculosis after a trial in South Africa demonstrated 90% effectiveness 6 months posttreatment. We report on a patient who completed the regimen using a lower linezolid dose.
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http://dx.doi.org/10.3201/eid2701.203766DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7774582PMC
January 2021

A model for bringing TB expertise to HIV providers: Medical consultations to the CDC-funded Regional Tuberculosis Training and Medical Consultation Centers, 2013-2017.

PLoS One 2020 31;15(8):e0236933. Epub 2020 Aug 31.

Division of Tuberculosis Elimination, NCHHSTP, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.

Background: Persons living with human immunodeficiency virus (HIV) are at a greater risk of developing tuberculosis (TB) compared to people without HIV and of developing complications due to the complexity of TB/HIV coinfection management.

Methods: During 2013-2017, the Centers for Disease Control and Prevention (CDC) funded 5 TB Regional Training and Medical Consultation Centers (RTMCCs) (now known as TB Centers of Excellence or COEs) to provide medical consultation to providers for TB disease and latent TB infection (LTBI), with data entered into a Medical Consultation Database (MCD). Descriptive analyses of TB/HIV-related consultations were conducted using SAS® software, version [9.4] to determine the distribution of year of consultation, medical setting and provider type, frequency of consultations regarding a pediatric (<18 years) patient, and to categorize key concepts and themes arising within consultation queries and medical consultant responses.

Results: Of 14,586 consultations captured by the MCD in 2013-2017, 544 (4%) were categorized as TB/HIV-related, with 100 (18%) received in 2013, 129 (24%) in 2014, 104 (19%) in 2015, 117 (22%) in 2016, and 94 (17%) in 2017. Most TB/HIV consultations came from nurses (54%) or physicians (43%) and from local (65%) or state health departments (10%). Only 17 (3%) of HIV-related consultations involved pediatric cases. Off the 544 TB/HIV consultations, 347 (64%) concerned the appropriate treatment regimen for TB/HIV or LTBI/HIV for a patient on or not on antiretroviral therapy (ART).

Conclusions: The data support a clear and ongoing gap in areas of specialized HIV knowledge by TB experts that could be supplemented with proactive educational outreach. The specific categories of TB/HIV inquiries captured by this analysis are strategically informing future targeted training and educational activities planned by the CDC TB Centers of Excellence, as well as guiding HIV educational efforts at regional and national TB meetings.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0236933PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458296PMC
October 2020

Impact of Targeted Local Interventions on Tuberculosis Awareness and Screening Among Persons Experiencing Homelessness During a Large Tuberculosis Outbreak in Atlanta, Georgia, 2015-2016.

Public Health Rep 2020 Jul/Aug;135(1_suppl):90S-99S

25798 Emory University Rollins School of Public Health, Atlanta, GA, USA.

Objectives: Tuberculosis (TB) outbreaks disproportionately affect persons experiencing homelessness (PEH) in the United States. During 2014-2016, a resurgent TB outbreak occurred among PEH in Atlanta, Georgia. To control the outbreak, citywide policies and educational interventions were implemented in January 2015. Policy changes standardized and enforced TB screening requirements for PEH in homeless shelters. Educational campaigns informed PEH of the outbreak and encouraged TB screening. We evaluated factors associated with, and the effect policy changes and educational interventions had on, TB screening and awareness among PEH in Atlanta.

Methods: Questions related to TB screening and awareness of the outbreak were added to an annual US Department of Housing and Urban Development survey of PEH in Atlanta in 2015 (n = 296 respondents) and 2016 (n = 1325 respondents). We analyzed the 2016 survey data to determine characteristics associated with outcomes.

Results: From 2015 to 2016, reported TB screening increased from 81% to 86%, and awareness of the TB outbreak increased from 68% to 75%. In 2016, sheltered PEH were significantly more likely than unsheltered PEH to report being evaluated for TB in the previous 6 months (prevalence odds ratio [pOR] = 3.18; 95% confidence interval [CI], 2.28-4.47) and to report being aware of the TB outbreak (pOR = 4.00; 95% CI, 2.89-5.55).

Conclusions: Implementation of required TB screening and educational interventions may reduce the incidence and severity of TB outbreaks among PEH in other communities. Furthermore, the annual survey of PEH offers an opportunity to collect data to better inform practices and policies.
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http://dx.doi.org/10.1177/0033354920932644DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7407052PMC
September 2020

Tuberculosis in the United States: Medical Consultation Services Provided by 5 Tuberculosis Regional Training and Medical Consultation Centers, 2013-2017.

Open Forum Infect Dis 2019 Jun 4;6(6):ofz167. Epub 2019 Apr 4.

Southeastern National Tuberculosis Center, University of Florida,Gainesville, Florida.

With only 9105 new US tuberculosis (TB) cases reported in 2017, expert consultation is essential for TB care. Data were captured 2013-2017 from consultations by 5 CDC-funded centers, now the TB Centers of Excellence (COEs). 14 586 consultations were provided to TB providers, most related to TB disease and treatment regimens.
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http://dx.doi.org/10.1093/ofid/ofz167DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6499898PMC
June 2019

Tuberculosis Screening, Testing, and Treatment of U.S. Health Care Personnel: Recommendations from the National Tuberculosis Controllers Association and CDC, 2019.

MMWR Morb Mortal Wkly Rep 2019 May 17;68(19):439-443. Epub 2019 May 17.

The 2005 CDC guidelines for preventing Mycobacterium tuberculosis transmission in health care settings include recommendations for baseline tuberculosis (TB) screening of all U.S. health care personnel and annual testing for health care personnel working in medium-risk settings or settings with potential for ongoing transmission (1). Using evidence from a systematic review conducted by a National Tuberculosis Controllers Association (NTCA)-CDC work group, and following methods adapted from the Guide to Community Preventive Services (2,3), the 2005 CDC recommendations for testing U.S. health care personnel have been updated and now include 1) TB screening with an individual risk assessment and symptom evaluation at baseline (preplacement); 2) TB testing with an interferon-gamma release assay (IGRA) or a tuberculin skin test (TST) for persons without documented prior TB disease or latent TB infection (LTBI); 3) no routine serial TB testing at any interval after baseline in the absence of a known exposure or ongoing transmission; 4) encouragement of treatment for all health care personnel with untreated LTBI, unless treatment is contraindicated; 5) annual symptom screening for health care personnel with untreated LTBI; and 6) annual TB education of all health care personnel.
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http://dx.doi.org/10.15585/mmwr.mm6819a3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6522077PMC
May 2019

Response to Isoniazid-Resistant Tuberculosis in Homeless Shelters, Georgia, USA, 2015-2017.

Emerg Infect Dis 2019 03;25(3):593-595

In 2008, an outbreak of isoniazid-resistant tuberculosis was identified among residents of homeless shelters in Atlanta, Georgia, USA. When initial control efforts involving standard targeted testing failed, a comprehensive approach that involved all providers of services for the homeless successfully interrupted the outbreak.
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http://dx.doi.org/10.3201/eid2503.181678DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6390744PMC
March 2019

Associations Between Neighborhood Characteristics, Social Cohesion, and Perceived Sex Partner Risk and Non-Monogamy Among HIV-Seropositive and HIV-Seronegative Women in the Southern U.S.

Arch Sex Behav 2018 07 25;47(5):1451-1463. Epub 2018 Apr 25.

Department of Behavioral Sciences and Health Education, Rollins School of Public Health at Emory University, Atlanta, GA, USA.

Neighborhood social and physical factors shape sexual network characteristics in HIV-seronegative adults in the U.S. This multilevel analysis evaluated whether these relationships also exist in a predominantly HIV-seropositive cohort of women. This cross-sectional multilevel analysis included data from 734 women enrolled in the Women's Interagency HIV Study's sites in the U.S. South. Census tract-level contextual data captured socioeconomic disadvantage (e.g., tract poverty), number of alcohol outlets, and number of non-profits in the census tracts where women lived; participant-level data, including perceived neighborhood cohesion, were gathered via survey. We used hierarchical generalized linear models to evaluate relationships between tract characteristics and two outcomes: perceived main sex partner risk level (e.g., partner substance use) and perceived main sex partner non-monogamy. We tested whether these relationships varied by women's HIV status. Greater tract-level socioeconomic disadvantage was associated with greater sex partner risk (OR 1.29, 95% CI 1.06-1.58) among HIV-seropositive women and less partner non-monogamy among HIV-seronegative women (OR 0.69, 95% CI 0.51-0.92). Perceived neighborhood trust and cohesion was associated with lower partner risk (OR 0.83, 95% CI 0.69-1.00) for HIV-seropositive and HIV-seronegative women. The tract-level number of alcohol outlets and non-profits were not associated with partner risk characteristics. Neighborhood characteristics are associated with perceived sex partner risk and non-monogamy among women in the South; these relationships vary by HIV status. Future studies should examine causal relationships and explore the pathways through which neighborhoods influence partner selection and risk characteristics.
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http://dx.doi.org/10.1007/s10508-018-1205-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5955810PMC
July 2018

Plasma Cell Variant Multicentric Castleman Disease and Kaposi's Sarcoma in a Treatment-Naive HIV-Infected Patient.

AIDS Res Hum Retroviruses 2018 02 18;34(2):127-128. Epub 2018 Jan 18.

1 Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine , Atlanta, Georgia .

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http://dx.doi.org/10.1089/aid.2017.0117DOI Listing
February 2018

Use of Activity Space in a Tuberculosis Outbreak: Bringing Homeless Persons Into Spatial Analyses.

Open Forum Infect Dis 2017 9;4(1):ofw280. Epub 2017 Jan 9.

Department of Epidemiology, Rollins School of Public Health and.

Background: Tuberculosis (TB) causes significant morbidity and mortality in US cities, particularly in poor, transient populations. During a TB outbreak in Fulton County, Atlanta, GA, we aimed to determine whether local maps created from multiple locations of personal activity per case would differ significantly from traditional maps created from single residential address.

Methods: Data were abstracted for patients with TB disease diagnosed in 2008-2014 and receiving care at the Fulton County Health Department. Clinical and activity location data were abstracted from charts. Kernel density methods, activity space analysis, and overlay with homeless shelter locations were used to characterize case spatial distribution when using single versus multiple addresses.

Results: Data were collected for 198 TB cases, with over 30% homeless US-born cases included. Greater spatial dispersion of cases was found when utilizing multiple versus single addresses per case. Activity spaces of homeless and isoniazid (INH)-resistant cases were more spatially congruent with one another than non-homeless and INH-susceptible cases ( < .0001 and < .0001, respectively).

Conclusions: Innovative spatial methods allowed us to more comprehensively capture the geography of TB-infected homeless persons, who made up a large portion of the Fulton County outbreak. We demonstrate how activity space analysis, prominent in exposure science and chronic disease, supports that routine capture of multiple location TB data may facilitate spatially different public health interventions than traditional surveillance maps.
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http://dx.doi.org/10.1093/ofid/ofw280DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5414060PMC
January 2017

Associations between neighborhood characteristics and sexual risk behaviors among HIV-infected and HIV-uninfected women in the southern United States.

Ann Epidemiol 2017 04 10;27(4):252-259.e1. Epub 2017 Apr 10.

Department of Behavioral Sciences and Health Education, Rollins School of Public Health at Emory University, Atlanta, GA.

Purpose: Neighborhood characteristics shape sexual risk in HIV-uninfected adults in the United States (US). We assess relationships between census tract characteristics and sexual risk behaviors in a predominantly HIV-infected cohort of women living in the Southern US.

Methods: This cross-sectional multilevel analysis included data from 737 HIV-infected and HIV-uninfected women enrolled in the Women's Interagency HIV Study. Administrative data captured characteristics of census tracts where women lived; participant-level data were gathered via survey. We used principal components analysis to condense tract-level variables into components: social disorder (e.g., violent crime rate), and social disadvantage (e.g., alcohol outlet density). We used hierarchical generalized linear models to assess relationships between tract-level characteristics and condomless vaginal intercourse, anal intercourse, and condomless anal intercourse.

Results: Greater social disorder was associated with less anal intercourse (OR = 0.63, 95% CI = 0.43-0.94) and condomless anal intercourse (OR = 0.49, 95% CI = 0.30-0.80), regardless of HIV status. There were no statistically significant additive or multiplicative interactions between tract characteristics and HIV status.

Conclusions: Neighborhood characteristics are associated with sexual risk behaviors among women living in the Southern US, these relationships do not vary by HIV status. Future studies should establish temporality and explore the causal pathways through which neighborhoods influence sexual risk.
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http://dx.doi.org/10.1016/j.annepidem.2017.03.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5502822PMC
April 2017

A Minority of Patients Newly Diagnosed with AIDS Are Started on Antiretroviral Therapy at the Time of Diagnosis in a Large Public Hospital in the Southeastern United States.

J Int Assoc Provid AIDS Care 2017 Mar/Apr;16(2):174-179. Epub 2017 Feb 15.

1 Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.

Prompt antiretroviral therapy (ART) initiation after AIDS diagnosis, in the absence of certain opportunistic infections such as tuberculosis and cryptococcal meningitis, delays disease progression and death, but system barriers to inpatient ART initiation at large hospitals in the era of modern ART have been less studied. We reviewed hospitalizations for persons newly diagnosed with AIDS at Grady Memorial Hospital in Atlanta, Georgia in 2011 and 2012. Individual- and system-level variables were collected. Logistic regression models were used to estimate the odds ratios (ORs) for ART initiation prior to discharge. With Georgia Department of Health surveillance data, we estimated time to first clinic visit, ART initiation, and viral suppression. In the study population (n = 81), ART was initiated prior to discharge in 10 (12%) patients. Shorter hospital stay was significantly associated with lack of ART initiation at the time of HIV diagnosis (8 versus 24 days, OR: 1.14, 95% confidence interval: 1.04-1.25). Reducing barriers to ART initiation for newly diagnosed HIV-positive patients with short hospital stays may improve time to viral suppression.
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http://dx.doi.org/10.1177/2325957417692679DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6192024PMC
December 2017

The Perilous Road from HIV Diagnosis in the Hospital to Viral Suppression in the Outpatient Clinic.

AIDS Res Hum Retroviruses 2016 08 15;32(8):729-36. Epub 2016 Apr 15.

1 Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine , Atlanta, Georgia .

The HIV care continuum has received considerable attention in recent years, however, few care continua focus on the population of patients who are diagnosed during an inpatient hospital admission. We aimed to describe the HIV care continuum for patients newly diagnosed during hospitalization through 24-month follow-up. A retrospective chart review of HIV patients diagnosed at Grady Memorial Hospital from 2011 to 2012 was performed and records were matched to Georgia Department of Public Health HIV/AIDS surveillance data. Descriptive statistics and statistical tests of independence were utilized. Ninety-four new diagnoses were confirmed during the 2-year study period. Median age was 43 years (interquartile range [IQR] 30-51), 77% were male, 72% were non-Hispanic Black, 31% were men who have sex with men (MSM), and 77% were uninsured. Median CD4 count at diagnosis was 134 cells/μL (IQR 30-307). Eighty-four percent received their diagnosis before hospital discharge, 68% linked to care by 90 days, 73% were retained for 12 months, 48% were virologically suppressed by 12 months, 58% were retained for 24 continuous months, and 38% achieved continuous viral suppression (VS) during the initial 24 months after diagnosis. Late diagnosis is a persistent problem in hospitalized patients. Despite relative success with linkage to care and 12-month retention in care, a minority of patients maintained retention and VS for 24 continuous months.
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http://dx.doi.org/10.1089/AID.2015.0346DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4971416PMC
August 2016

Patient Report and Review of Rapidly Growing Mycobacterial Infection after Cardiac Device Implantation.

Emerg Infect Dis 2016 Mar;22(3):389-95

Mycobacterial infections resulting from cardiac implantable electronic devices are rare, but as more devices are implanted, these organisms are increasingly emerging as causes of early-onset infections. We report a patient with an implantable cardioverter-defibrillator pocket and associated bloodstream infection caused by an organism of the Mycobacterium fortuitum group, and we review the literature regarding mycobacterial infections resulting from cardiac device implantations. Thirty-two such infections have been previously described; most (70%) were caused by rapidly growing species, of which M. fortuitum group species were predominant.When managing such infections, clinicians should consider the potential need for extended incubation of routine cultures or dedicated mycobacterial cultures for accurate diagnosis; combination antimicrobial drug therapy, even for isolates that appear to be macrolide susceptible, because of the potential for inducible resistance to this drug class; and the arrhythmogenicity of the antimicrobial drugs traditionally recommended for infections caused by these organisms.
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http://dx.doi.org/10.3201/eid2203.150584DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4766885PMC
March 2016

Understanding Local Spatial Variation Along the Care Continuum: The Potential Impact of Transportation Vulnerability on HIV Linkage to Care and Viral Suppression in High-Poverty Areas, Atlanta, Georgia.

J Acquir Immune Defic Syndr 2016 May;72(1):65-72

*Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA; †Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA; ‡Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA; §Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA; ‖Georgia Department of Public Health, Atlanta, GA; and ¶Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA.

Background: Engagement in care is central to reducing mortality for HIV-infected persons and achieving the White House National AIDS Strategy of 80% viral suppression in the US by 2020. Where an HIV-infected person lives impacts his or her ability to achieve viral suppression. Reliable transportation access for healthcare may be a key determinant of this place-suppression relationship.

Methods: ZIP code tabulation areas (ZCTAs) were the units of analysis. We used geospatial and ecologic analyses to examine spatial distributions of neighborhood-level variables (eg, transportation accessibility) and associations with: (1) community linkage to care, and (2) community viral suppression. Among Atlanta ZCTAs with data for newly diagnosed HIV cases (2006-2010), we used Moran I to evaluate spatial clustering and linear regression models to evaluate associations between neighborhood variables and outcomes.

Results: In 100 ZCTAs with 8413 newly diagnosed HIV-positive residents, a median of 60 HIV cases were diagnosed per ZCTA during the 5-year period. We found significant clustering of ZCTAs with low linkage to care and viral suppression (Moran I = 0.218, P < 0.05). In high-poverty ZCTAs, a 10% point increase in ZCTA-level household vehicle ownership was associated with a 4% point increase in linkage to care (P = 0.02, R = 0.16). In low-poverty ZCTAs, a 10% point increase in ZCTA-level household vehicle ownership was associated with a 30% point increase in ZCTA-level viral suppression (P = 0.01, R = 0.08).

Conclusions: Correlations between transportation variables and community-level care linkage and viral suppression vary by area poverty level and provide opportunities for interventions beyond individual-level factors.
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http://dx.doi.org/10.1097/QAI.0000000000000914DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4837075PMC
May 2016

Community-based HCV screening: knowledge and attitudes in a high risk urban population.

BMC Infect Dis 2014 Feb 10;14:74. Epub 2014 Feb 10.

Division of Infectious Diseases and International Health, Duke University Medical Center, Box 102358, Durham, NC 27710, USA.

Background: In an attempt to curtail the rising morbidity and mortality from undiagnosed HCV (hepatitis C virus) in the United States, screening guidelines have been expanded to high-risk individuals and persons born 1945-1965. Community-based screening may be one strategy in which to reach such persons; however, the acceptance of HCV testing, when many high-risk individuals may not have access to HCV specific medications, remains unknown.

Methods: We set out to assess attitudes about HCV screening and knowledge about HCV disease at several community-based testing sites that serve high-risk populations. This assessment was paired with a brief HCV educational intervention, followed by post-education evaluation.

Results: Participants (n = 140) were surveyed at five sites; two homeless shelters, two drug rehabilitation centers, and a women's "drop-in" center. Personal acceptance of HCV testing was almost unanimous, and 90% of participants reported that they would still want to be tested even if they were unable to receive HCV treatment. Baseline hepatitis C knowledge was poor; however, the brief educational intervention significantly improved knowledge and increased acceptability of testing when medical access issues were explicitly stated.

Conclusions: Despite inconsistencies in access to care and treatment, high-risk communities want to know their HCV status. Though baseline HCV knowledge was poor in this population, a brief on-site educational intervention improved both knowledge and acceptability of HCV testing and care. These data support the establishment of programs that utilize community-based screening, and also provide initial evidence for acceptance of the implementation of the recently expanded screening guidelines among marginalized communities.
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http://dx.doi.org/10.1186/1471-2334-14-74DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3945609PMC
February 2014

A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design.

Trials 2014 Jan 22;15:31. Epub 2014 Jan 22.

Department of Epidemiology, Rollins School of Public Health, Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.

Background: The proportion of clinical research sponsored by industry will likely continue to expand as federal funds for academic research decreases, particularly in the fields of HIV/AIDS and hepatitis C (HCV). While HIV and HCV continue to burden the US population, insufficient data exists as to how industry sponsorship affects clinical trials involving these infectious diseases. Debate exists about whether pharmaceutical companies undertake more market-driven research practices to promote therapeutics, or instead conduct more rigorous trials than their non-industry counterparts because of increased resources and scrutiny. The ClinicalTrials.gov registry, which allows investigators to fulfill a federal mandate for public trial registration, provides an opportunity for critical evaluation of study designs for industry-sponsored trials, independent of publication status. As part of a large public policy effort, the Clinical Trials Transformation Initiative (CTTI) recently transformed the ClinicalTrials.gov registry into a searchable dataset to facilitate research on clinical trials themselves.

Methods: We conducted a cross-sectional analysis of 477 HIV and HCV drug treatment trials, registered with ClinicalTrials.gov from 1 October 2007 to 27 September 2010, to study the relationship of study sponsorship with randomized study design. The likelihood of using randomization given industry (versus non-industry) sponsorship was reported with prevalence ratios (PR). PRs were estimated using crude and stratified tabular analysis and Poisson regression adjusting for presence of a data monitoring committee, enrollment size, study phase, number of study sites, inclusion of foreign study sites, exclusion of persons older than age 65, and disease condition.

Results: The crude PR was 1.17 (95% CI 0.94, 1.45). Adjusted Poisson models produced a PR of 1.13 (95% CI 0.82, 1.56). There was a trend toward mild effect measure modification by study phase, but this was not statistically significant. In stratified tabular analysis the adjusted PR was 1.14 (95% CI 0.78, 1.68) among phase 2/3 trials and 1.06 (95% CI 0.50, 2.22) among phase 4 trials.

Conclusions: No significant relationship was found between industry sponsorship and use of randomization in trial design in this cross-sectional study. Prospective studies evaluating other aspects of trial design may shed further light on the relationship between industry sponsorship and appropriate trial methodology.
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http://dx.doi.org/10.1186/1745-6215-15-31DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3901894PMC
January 2014

Integrated screening for tuberculosis and HIV in tuberculosis contact investigations: lessons learned in North Carolina.

Public Health Rep 2014 Jan-Feb;129 Suppl 1:21-5

North Carolina Department of Health and Human Services, Communicable Diseases Branch, HIV/STD Program ; University of North Carolina at Chapel Hill, Division of Infectious Diseases, Chapel Hill, NC.

Combating the syndemics of tuberculosis (TB) and HIV in the United States will require increasing efficiency as the incidence of TB declines. Fortunately, new tools such as the interferon gamma release assays can be combined with existing strategies such as opt-out HIV testing to facilitate simultaneous, integrated testing for both infections. We describe the lessons learned from our experience with integrated testing for TB and HIV in the setting of TB contact investigations in North Carolina. Integrated testing represents a unique opportunity to leverage TB and HIV program resources to enhance case detection and improve linkages to care. However, joint training in field investigations and diagnostics is critical prior to conducting contact investigations. Furthermore, integrated testing must be tightly coupled to treatment and prevention programs to reduce disease transmission and morbidity from untreated disease in communities.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3862984PMC
http://dx.doi.org/10.1177/00333549141291S104DOI Listing
March 2014

The state of infectious diseases clinical trials: a systematic review of ClinicalTrials.gov.

PLoS One 2013 16;8(10):e77086. Epub 2013 Oct 16.

Division of Infectious Diseases and International Health, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, United States of America.

Background: There is a paucity of clinical trials informing specific questions faced by infectious diseases (ID) specialists. The ClinicalTrials.gov registry offers an opportunity to evaluate the ID clinical trials portfolio.

Methods: We examined 40,970 interventional trials registered with ClinicalTrials.gov from 2007-2010, focusing on study conditions and interventions to identify ID-related trials. Relevance to ID was manually confirmed for each programmatically identified trial, yielding 3570 ID trials and 37,400 non-ID trials for analysis.

Results: The number of ID trials was similar to the number of trials identified as belonging to cardiovascular medicine (n = 3437) or mental health (n = 3695) specialties. Slightly over half of ID trials were treatment-oriented trials (53%, vs. 77% for non-ID trials) followed by prevention (38%, vs. 8% in non-ID trials). ID trials tended to be larger than those of other specialties, with a median enrollment of 125 subjects (interquartile range [IQR], 45-400) vs. 60 (IQR, 30-160) for non-ID trials. Most ID studies are randomized (73%) but nonblinded (56%). Industry was the funding source in 51% of ID trials vs. 10% that were primarily NIH-funded. HIV-AIDS trials constitute the largest subset of ID trials (n = 815 [23%]), followed by influenza vaccine (n = 375 [11%]), and hepatitis C (n = 339 [9%]) trials. Relative to U.S. and global mortality rates, HIV-AIDS and hepatitis C virus trials are over-represented, whereas lower respiratory tract infection trials are under-represented in this large sample of ID clinical trials.

Conclusions: This work is the first to characterize ID clinical trials registered in ClinicalTrials.gov, providing a framework to discuss prioritization, methodology, and policy.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0077086PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3797691PMC
August 2014

The footprint of old syphilis: using a reverse screening algorithm for syphilis testing in a U.S. Geographic Information Systems-Based Community Outreach Program.

Sex Transm Dis 2013 Nov;40(11):839-41

From the *Department of Medicine, Duke University Medical Center, Durham, NC; and †Department of Medicine, University of North Carolina, Chapel Hill, NC.

The impact of syphilis reverse sequence screening has not been evaluated in community outreach. Using reverse sequence screening in neighborhoods identified with geographic information systems, we found that among 239 participants, 45 (19%) were seropositive. Of these, 3 (7%) had untreated syphilis, 33 (73%) had previously treated syphilis infection, and 9 (20%) had negative nontreponemal test results.
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http://dx.doi.org/10.1097/OLQ.0000000000000025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4280062PMC
November 2013

Geographic information system-based screening for TB, HIV, and syphilis (GIS-THIS): a cross-sectional study.

PLoS One 2012 2;7(10):e46029. Epub 2012 Oct 2.

Department of Medicine, Duke University Medical Center, Durham, North Carolina, United States of America.

Objective: To determine the feasibility and case detection rate of a geographic information systems (GIS)-based integrated community screening strategy for tuberculosis, syphilis, and human immunodeficiency virus (HIV).

Design: Prospective cross-sectional study of all participants presenting to geographic hot spot screenings in Wake County, North Carolina.

Methods: The residences of tuberculosis, HIV, and syphilis cases incident between 1/1/05-12/31/07 were mapped. Areas with high densities of all 3 diseases were designated "hot spots." Combined screening for tuberculosis, HIV, and syphilis were conducted at the hot spots; participants with positive tests were referred to the health department.

Results And Conclusions: Participants (N = 247) reported high-risk characteristics: 67% previously incarcerated, 40% had lived in a homeless shelter, and 29% had a history of crack cocaine use. However, 34% reported never having been tested for HIV, and 41% did not recall prior tuberculin skin testing. Screening identified 3% (8/240) of participants with HIV infection, 1% (3/239) with untreated syphilis, and 15% (36/234) with latent tuberculosis infection. Of the eight persons with HIV, one was newly diagnosed and co-infected with latent tuberculosis; he was treated for latent TB and linked to an HIV provider. Two other HIV-positive persons had fallen out of care, and as a result of the study were linked back into HIV clinics. Of 27 persons with latent tuberculosis offered therapy, nine initiated and three completed treatment. GIS-based screening can effectively penetrate populations with high disease burden and poor healthcare access. Linkage to care remains challenging and will require creative interventions to impact morbidity.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0046029PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3462803PMC
April 2013

Predictors of latent tuberculosis treatment initiation and completion at a U.S. public health clinic: a prospective cohort study.

BMC Public Health 2012 Jun 21;12:468. Epub 2012 Jun 21.

Duke University Medical Center, Durham, NC, USA.

Background: Treatment of latent tuberculosis infection (LTBI) is a key component in U.S. tuberculosis control, assisted by recent improvements in LTBI diagnostics and therapeutic regimens. Effectiveness of LTBI therapy, however, is limited by patients' willingness to both initiate and complete treatment. We aimed to evaluate the demographic, medical, behavioral, attitude-based, and geographic factors associated with LTBI treatment initiation and completion of persons presenting with LTBI to a public health tuberculosis clinic.

Methods: Data for this prospective cohort study were collected from structured patient interviews, self-administered questionnaires, clinic intake forms, and U.S. census data. All adults (>17 years) who met CDC guidelines for LTBI treatment between January 11, 2008 and May 6, 2009 at Wake County Health and Human Services Tuberculosis Clinic in Raleigh, North Carolina were included in the study. In addition to traditional social and behavioral factors, a three-level medical risk variable (low, moderate, high), based on risk factors for both progression to and transmission of active tuberculosis, was included for analysis. Clinic distance and neighborhood poverty level, based on percent residents living below poverty level in a person's zip code, were also analyzed. Variables with a significance level <0.10 by univariate analysis were included in log binomial models with backward elimination. Models were used to estimate risk ratios for two primary outcomes: (1) LTBI therapy initiation (picking up one month's medication) and (2) therapy completion (picking up nine months INH therapy or four months rifampin monthly).

Results: 496 persons completed medical interviews and questionnaires addressing social factors and attitudes toward LTBI treatment. 26% persons initiated LTBI therapy and 53% of those initiating completed therapy. Treatment initiation predictors included: a non-employment reason for screening (RR 1.6, 95% CI 1.0-2.5), close contact to an infectious TB case (RR 2.5, 95% CI 1.8-3.6), regular primary care(RR 1.4, 95% CI 1.0-2.0), and history of incarceration (RR 1.7, 95% CI 1.0-2.8). Persons in the "high" risk category for progression/transmission of TB disease had higher likelihood of treatment initiation (p < 0.01), but not completion, than those with lower risk.

Conclusions: Investment in social support and access to regular primary care may lead to increased LTBI therapy adherence in high-risk populations.
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http://dx.doi.org/10.1186/1471-2458-12-468DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3438075PMC
June 2012

Ertapenem for treatment of osteomyelitis: a case series.

BMC Res Notes 2011 Nov 2;4:478. Epub 2011 Nov 2.

Department of Medicine, Duke University Medical Center, Durham, NC, USA.

Background: Ertapenem is a once-daily broad spectrum carbapenem that is increasingly used to treat polymicrobial osteomyelitis due to diabetic foot and traumatic wound infections. However, limited data exists on ertapenem use for osteomyelitis. This study aimed to characterize outcomes and adverse effects with empiric use of ertapenem for osteomyelitis.

Findings: A total of 112 patients presenting to Duke, Durham Regional or Durham VA Medical Centers with a suspected diagnosis of osteomyelitis and ertapenem use from 11/2001 to 8/2009 were screened, and 12 subjects met inclusion criteria for the study. Mean age was 60 ± 16 years, 68% were female, 75% were Caucasian, and the most common comorbidities included diabetes (58%), peripheral vascular disease (42%), and history of tobacco use (75%). Over half of the patients presented to a primary care clinic or emergency room greater than six months after the onset of clinical symptoms. Bone culture was obtained for diagnostic guidance in only two cases; and surgical intervention was pursued in three cases. Patients received a mean duration of 34.6 ± 7.8 days of therapy, and in three cases, subsequent suppressive oral antibiotics were given. Six (50%) patients met criteria for clinical success, defined as resolution of clinical signs and symptoms of infection such that discontinuation of antibiotics was deemed appropriate at end of ertapenem therapy, without recurrence at one year follow-up. No adverse drug effects were noted.

Conclusions: In this case series of mostly community-acquired, lower extremity osteomyelitis, bone biopsy was infrequent, and an average six-week course of empiric ertapenem was well-tolerated with curative rates of 50% at one year.
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http://dx.doi.org/10.1186/1756-0500-4-478DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3219740PMC
November 2011

Feasibility and willingness-to-pay for integrated community-based tuberculosis testing.

BMC Infect Dis 2011 Nov 2;11:305. Epub 2011 Nov 2.

Department of Medicine, Duke University Medical Center, Durham, NC 27710, USA.

Background: Community-based screening for TB, combined with HIV and syphilis testing, faces a number of barriers. One significant barrier is the value that target communities place on such screening.

Methods: Integrated testing for TB, HIV, and syphilis was performed in neighborhoods identified using geographic information systems-based disease mapping. TB testing included skin testing and interferon gamma release assays. Subjects completed a survey describing disease risk factors, healthcare access, healthcare utilization, and willingness to pay for integrated testing.

Results: Behavioral and social risk factors among the 113 subjects were prevalent (71% prior incarceration, 27% prior or current crack cocaine use, 35% homelessness), and only 38% had a regular healthcare provider. The initial 24 subjects reported that they would be willing to pay a median $20 (IQR: 0-100) for HIV testing and $10 (IQR: 0-100) for TB testing when the question was asked in an open-ended fashion, but when the question was changed to a multiple-choice format, the next 89 subjects reported that they would pay a median $5 for testing, and 23% reported that they would either not pay anything to get tested or would need to be paid $5 to get tested for TB, HIV, or syphilis. Among persons who received tuberculin skin testing, only 14/78 (18%) participants returned to have their skin tests read. Only 14/109 (13%) persons who underwent HIV testing returned to receive their HIV results.

Conclusion: The relatively high-risk persons screened in this community outreach study placed low value on testing. Reported willingness to pay for such testing, while low, likely overestimated the true willingness to pay. Successful TB, HIV, and syphilis integrated testing programs in high risk populations will likely require one-visit diagnostic testing and incentives.
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http://dx.doi.org/10.1186/1471-2334-11-305DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3217890PMC
November 2011

Evolution of drug-resistant viral populations during interruption of antiretroviral therapy.

J Virol 2011 Jul 13;85(13):6403-15. Epub 2011 Apr 13.

Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC 27710, USA.

Analysis of a large number of HIV-1 genomes at multiple time points after antiretroviral treatment (ART) interruption allows determination of the evolution of drug-resistant viruses and viral fitness in vivo in the absence of drug selection pressure. Using a parallel allele-specific sequencing (PASS) assay, potential primary drug-resistant mutations in five individual patients were studied by analyzing over 18,000 viral genomes. A three-phase evolution of drug-resistant viruses was observed after termination of ART. In the first phase, viruses carrying various combinations of multiple-drug-resistant (MDR) mutations predominated with each mutation persisting in relatively stable proportions while the overall number of resistant viruses gradually increased. In the second phase, viruses with linked MDR mutations rapidly became undetectable and single-drug-resistant (SDR) viruses emerged as minority populations while wild-type viruses quickly predominated. In the third phase, low-frequency SDR viruses remained detectable as long as 59 weeks after treatment interruption. Mathematical modeling showed that the loss in relative fitness increased with the number of mutations in each viral genome and that viruses with MDR mutations had lower fitness than viruses with SDR mutations. No single viral genome had seven or more drug resistance mutations, suggesting that such severely mutated viruses were too unfit to be detected or that the resistance gain offered by the seventh mutation did not outweigh its contribution to the overall fitness loss of the virus. These data provide a more comprehensive understanding of evolution and fitness of drug-resistant viruses in vivo and may lead to improved treatment strategies for ART-experienced patients.
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http://dx.doi.org/10.1128/JVI.02389-10DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3126484PMC
July 2011

Discriminating between latent and active tuberculosis with multiple biomarker responses.

Tuberculosis (Edinb) 2011 May 10;91(3):250-6. Epub 2011 Mar 10.

Center for AIDS Research, Department of Molecular Genetics and Microbiology, Duke University Medical Center, Durham, NC 27710, USA.

We sought to identify biomarker responses to tuberculosis specific antigens which could 1) improve the diagnosis of tuberculosis infection and 2) allow the differentiation of active and latent infections. Seventy subjects with active tuberculosis (N = 12), latent tuberculosis (N = 32), or no evidence of tuberculosis infection (N = 26) were evaluated. We used the Luminex Multiplexed Bead Array platform to simultaneously evaluate 25 biomarkers in the supernatant of whole blood samples following overnight stimulation using the Quantiferon(®) Gold In-Tube kit. We defined the response to stimulation as the difference (within an individual patient) between the response to the pooled tuberculosis antigens and the negative control. IP-10 response was significantly higher in tuberculosis-infected (active or latent) subjects compared to the uninfected group (p < 0.0001). Among the 25 parameters, expression levels of IL-15 and MCP-1 were found to be significantly higher in the active tuberculosis group compared to the latent tuberculosis group (p = 0.0006 and 0.0030, respectively). When combined, IL-15 and MCP-1 accurately identified 83% of active and 88% of latent infections. The combination of IL-15 and MCP-1 responses was accurate in distinguishing persons with active tuberculosis from persons with latent tuberculosis in this study.
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http://dx.doi.org/10.1016/j.tube.2011.02.006DOI Listing
May 2011
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