bluuebunny/crossref_metadata_2025 huggingface dataset:
1272. Feasibility and Successful Enrollment in Proof-of-Concept Trials to Assess Safety and Efficacy of a Broadly Neutralizing Monoclonal Antibody, VRC01, to Prevent HIV-1 Acquisitionin in Uninfected Individuals
Authors: Edupuganti Srilatha , Mgodi Nyaradzo M , Karuna Shelly , Andrew Philip , Kochar Nidhi , Marshall Kyle , Decamp Allan , Takuva Simbarashe , Anderson Maija , De La Grecca Robert , Gomez Lorenzo Margarita , Burns David , Goepfert Paul , McElrath Julie , Casapia Martin , Sanchez Jorge , Mukwekwerere Pamela G , Shava Emily , Lazarus Erica M , Hural John , Mascola John R , Cohen Myron , Corey Lawrence
Published: October 2019

Background

The Antibody-mediated Prevention (AMP) trials (HVTN 704/HPTN 085 and HVTN 703/HPTN 081) are the first efficacy trials to evaluate whether VRC01, a broadly neutralizing antibody (bnAb) that targets CD4 binding site of HIV envelope, prevents HIV acquisition in uninfected individuals. In these ongoing trials, 10 intravenous (IV) infusions of VRC01 are given every 8 weeks over a period of 2 years. We report on interim operational feasibility, enrollment and safety.

Methods

Participant recruitment was enhanced by extensive community engagement and education. Eligible participants were randomly assigned 1:1:1 to 10mg/kg, 30mg/kg of VRC01 or saline placebo. HVTN 704/HPTN 085 enrolled high-risk men (MSM) and transgender (TG) individuals who have sex with men at 26 sites in United States, Peru, Brazil, and Switzerland. HVTN 703/HPTN 081 enrolled high-risk heterosexual women at 20 sites in Botswana, Kenya, Malawi, Mozambique, South Africa, Tanzania, and Zimbabwe. HIV testing occurs monthly.

Results

In October 2018, the AMP trials completed enrollment of 4,625 participants. Enrollment met or exceeded targets throughout the trial period, peaked at 298 participants/month, and was slowed mid-trial to allow for sufficient drug supply at trial sites. In HVTN 704/HPTN 085, 2701 (target N = 2700) MSM/TG participants 18–50yrs were enrolled with median age of 28; 99% born male; 90% identified as male gender and 5% TG female. Race/ethnicity was 32% White, 15% Black and 57% Hispanic/Latino/a. 28% had a sexually transmitted infection (STI) including gonorrhea (GC), chlamydia (CT) or syphilis at enrollment. In HVTN 703/HPTN 081,1924 (target N = 1900) women 18–40yrs were enrolled with median age of 26;100% were born female (53% female gender, 47% gender not assessed); 99% were Black. 26% had a STI at enrollment including GC, CT, trichomonas or syphilis. Overall 36,945 infusions have been given so far with no serious procedural complications due to IV administration. Retention and adherence to the rigorous study schedule (monthly visits for 2 years) remain within an acceptable range.

Conclusion

The AMP trials have exceeded enrollment of target populations and are maintaining high rates of retention. With exceptional safety and operational feasibility, they are paving the way for future large-scale bnAb trials for HIV prevention and/or treatment.

Disclosures

All authors: No reported disclosures.
1287. PrEP-Engaged or PrEP Curious?: A Characterization and Comparison of Initial PrEP Appointment Attenders vs. Nonattenders
Authors: Kahal Deborah A , Goldstein Neal , Szabo Susan
Published: October 2019

Background

Human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP), with adequate adherence, is highly effective prevention of HIV-1 infection amongst high-risk individuals. While over 1 million individuals are PrEP-eligible in the U.S., those at highest risk for HIV, specifically young non-white men who have sex with men (MSM), represent some of the least penetrated groups to benefit from PrEP. No published data exists to characterize individuals with unattended initial PrEP appointments.

Methods

Our program, a Ryan White funded HIV clinic that also provides Hepatitis C and PrEP care, prospectively collected demographic data on all patients with an attended initial PrEP appointment between November 2015 and March 2019. We retrospectively abstracted the same data for individuals with unattended initial PrEP appointments (including cancelations and no shows) during the same period. Descriptive statistical analyses used rank-sum tests for skewed data (age) and Chi-squared tests for categorical data (all other variables).

Results

33% (34/103) of all individuals did not attend an initial appointment (table). Younger age and nonprivate insurance were the 2 sociodemographic variables that were significantly associated with unattended vs. attended initial appointments. Amongst those whose HIV risk factors were known, MSM were more likely to attend their appointment compared with non-MSM. 77% (26/34) of individuals with unattended initial appointments did not reschedule (figure). Notably, 12% (4/34) PrEP-eligible individuals previously presented to the clinic yet did not re-present for dedicated PrEP evaluation.

Conclusion

A significant proportion of individuals schedule but do not attend initial PrEP appointments. This cohort, particularly younger patients and those with nonprivate insurance, represents a distinct population - with a “near” yet incomplete engagement in care – for whom HIV prevention efforts and concerted outreach should be focused. Same day, rapid PrEP starts deserve serious consideration in order to capitalize on patient engagement when the opportunity presents. The paucity of data highlights the need for research of those who are PrEP-interested but not fully PrEP-engaged.

Disclosures

All authors: No reported disclosures.
1292. Integrating HIV and Hepatitis C Screening in a High-Risk Emergency Department Population
Authors: Chechi Tasleem , Tran Nam , Sage Allyson C , Waldman Sarah , May Larissa S
Published: October 2019

Background

With the acceleration of the hepatitis C (HCV) epidemic in the United States and the ongoing public health impact of undetected human immunodeficiency virus (HIV) co-infection, there is a critical need for enhanced secondary prevention efforts where patients accessing care are not routinely screened. The purpose of this program was to implement routine opt-out HIV and HCV screenings in a high-volume urban emergency department (ED) through the use of an EMR enhancement to increase a provider’s likelihood of testing eligible patients, and to provide linkage to care for patients identified to have positive tests.

Methods

From November 27, 2018 to March 31, 2019, EMR-based HIV and HCV screening was implemented in a quaternary care ED in Northern California. EMR best practice alerts were developed based on a combination of local and CDC guidelines and populated on registered patients receiving blood laboratories or receiving STI testing. Laboratory HIV/HCV screening utilized a unique two-specimen collection scheme to enable molecular testing without requiring patient return visits. Patients were excluded if they chose to opt out from testing or the provider deemed opt out was not possible. Upon notification of a positive test result through the EMR, a patient navigator was responsible for providing disease education and linking patients to care.

Results

The prevalence of HCV antibody positivity was 9.6% (637/6,627) and 0.97% (55/5,628) for HIV. Of the 255 HCV-RNA positives, 110 were known and 145 newly diagnosed. Of the 90 HIV patients, 31 were known and 8 newly diagnosed. Although current CDC hepatitis C screening guidelines recommend screening all adults born during 1945–1965, we conducted universal screening of adults 18 years or older. Of those screened antibody-positive for HCV 64% fell within the 1945–1965 birth cohort.

Conclusion

Introducing routine opt-out testing using an automated EMR-based screening program is an effective method to identify and screen eligible patients for HIV and HCV in episodic care safety net settings where universal screenings are not routinely implemented. The unexpectedly high rate of HIV seroprevalence suggests the ED environment continues to be an important setting to access populations not receiving routine care despite longstanding CDC recommendations for universal screening.

Disclosures

All authors: No reported disclosures.
1294. Long-Term Impact of an HIV Testing Program on High-Risk HIV Screening in the Emergency Department
Authors: Baron Jillian T , Schwartz Alexis , Davis Ebony , Uspal Julie E , Kelly Brendan
Published: October 2019

Background

Emergency Departments (EDs) are important sites for HIV testing. However, there is little guidance on how best to implement HIV testing in the ED. The purpose of this study was to evaluate HIV screening practices of high-risk individuals presenting to an ED in the absence (ED1) and in the presence (ED2) of an established HIV testing program within the same academic hospital.

Methods

We performed a retrospective chart review of all individuals 18 years or older presenting to either ED between January 1, 2016 and December 31, 2018. High-risk of HIV infection was determined by receipt of bacterial sexually transmitted infection (STI) testing for Neisseria gonorrhoeae or Chlamydia trachomatis. The primary outcome was receipt of any HIV test in the ED. Overall proportions of patients tested for HIV at the same time of STI testing were compared between sites by chi-square test. Predictors of HIV testing were analyzed by logistic regression.

Results

During the study period, 7,956 individuals received STI testing at ED1 and 10,815 received STI testing at ED2. The majority of individuals receiving STI testing at both sites were female, 81.2% at ED1 and 66.4% at ED2 (P <0.001). Only 4.0% of individuals received HIV testing at ED1 compared with 47.4% at ED2 (P <0.001). Individuals were significantly more likely to receive HIV testing at the time of STI testing in the ED with an HIV testing program (aOR 19.66, 95% CI 17.28–22.37). In the ED without an HIV testing program, individuals were more likely to receive HIV testing if they were male (aOR 3.57, 95% CI 2.78–4.55) and less likely if they were black (aOR 0.57, 95% CI 0.50–0.97). In the ED with an HIV testing program, individuals were more likely to receive HIV testing if they were male (aOR 2.17, 95% CI 1.92–2.44) and more likely if they were black (aOR 1.74, 95% CI 1.37–2.20).

Conclusion

Overall, the presence of an HIV testing program in the ED significantly increased the probability that individuals would receive an HIV test at the time of bacterial STI testing and mitigated disparities in care. The results of this study will help guide ongoing interventions to improve HIV screening among high-risk individuals in the emergency department.

Disclosures

All authors: No reported disclosures.
1299. Cluster of False-Positive “Fifth-Generation” HIV Test Results During Implementation of a Routine HIV Screening Program in an Emergency Department
Authors: Trotter Andrew B , Maheswaran Anjana , Kate Mannion Mary , Baghikar Sara , Lin Janet
Published: October 2019

Background

In November 2014, the University of Illinois Hospital (UI Health) introduced an electronic medical record (EMR)-driven HIV screening program in the emergency department (ED). In October 2016, our hospital laboratory introduced “Fifth-generation” HIV testing using the Bio-Rad BioPlex 2200 HIV Antigen/Antibody diagnostic assay. Fifth-generation HIV testing has the advantage of separately detecting and reporting HIV antibody and HIV-1 p24 antigen. Although the literature and manufacturer report high sensitivity and specificity of this test, we encountered higher than expected rates of false-positive tests during the introduction of this test.

Methods

We retrospectively reviewed the results of our ED HIV screening program from October 2016 to March 2019 to describe the outcomes of HIV testing, determine the rates of false-positive HIV tests and determine if false-positive rates were temporally clustered. We also investigated various potential causes of higher than expected false positives including pre-analytical and analytical error. We defined a false-positive test as a repeatedly reactive initial HIV antigen and/or HIV-1 antibody result with a subsequent negative or indeterminate HIV-1/2 antibody differentiation immunoassay and negative HIV-1 nucleic amplification test.

Results

During the review period, out of a total of 17,385 HIV tests which were performed, 85 tests were confirmed positive and 27 were false positives. This represents an HIV prevalence of 0.5%. Eighteen of the 27 false positives occurred during an 8 month period between October 2016 and April 2017 (see Figure 1). During our investigation of potential causes of the false-positive tests, we discovered that a reagent lot for the test was changed in June 2017 which resulted in a significant decrease in the false-positive rate (0.33% to 0.07%).

Conclusion

We provide data which suggests that a reagent lot may have been the cause of higher than expected false-positive tests for HIV testing. Monitoring of testing outcomes during implementation of a routine HIV testing program can help identify potential root causes of false-positive tests.

Disclosures

All authors: No reported disclosures.
1311. Ryan White HIV Care Continuum Model Doubled the Rate of Community HIV Viral Suppression for Newly Diagnosed Patients: A 10-Year Review
Authors: Rizk Christina , Zhao Alice , Miceli Janet , Shea Portia , Villanueva Merceditas , Barakat Lydia A
Published: October 2019

Background

It is estimated that 1,295 per 100,000 are people living with HIV (PLWH) in New Haven, which is the second highest rate of HIV prevalence in Connecticut. Since 2009, New Haven has established the Ryan White (RW) HIV Care Continuum. The main goals of HIV care are early linkage to care, ART initiation, and HIV viral suppression. This study is designed to understand the trends and outcomes in newly diagnosed PLWH in New Haven County.

Methods

This study is a retrospective medical record review of all newly diagnosed RW eligible PLWH from January 1, 2009 to December 31, 2018. The data were collected in REDCap database and included demographics, HIV risk factor, presence of mental health and/or substance abuse disorder, date of diagnosis, date of initial visit, and ART initiation. Health outcomes such as AIDS at diagnosis and rate of viral suppression were evaluated. The data were then analyzed to show the trends over 10 years.

Results

From January 1, 2009 to December 31, 2018 there were 420 newly diagnosed RW PLWH. Sixty-seven percent of those were male, 56% were non-white, 47% self-identified as Men who have Sex with Men (MSM), and 41% were heterosexual. Twenty-nine percent had AIDS-defining condition at the time of the diagnosis. Thirty-four percent of the 420 patients had a mental health and/or substance use disorder; 53% of those were MSM and 51% were non-white. Over the 10-year period, it was noted that the duration between date of HIV diagnosis and linkage to care as well as ART initiation decreased. This decline was associated with a substantial increase in viral suppression. The average time between the dates of HIV diagnosis and initial visit decreased from 269 days in 2009 to 13 days in 2018. Moreover, the average time between the dates of diagnosis and ART initiation dropped from 308 days in 2009 to 15 days in 2018. The 1-year HIV viral suppression rate subsequently doubled from 44% in 2009 to 87% in 2018 (P < 0.01).

Conclusion

The Ryan White HIV Care Continuum Model with emphasis on early linkage to care and ART initiation can have a significant impact on HIV viral suppression at a community level for newly diagnosed patients. Another important observation in this study was the alarming high rate of AIDS at diagnosis, which highlights the need for universal HIV testing, and early diagnosis.

Disclosures

All authors: No reported disclosures.
1313. Complementary Effects of Medical Follow-up and Virologic Suppression for Reincarcerated Inmates Living with HIV
Authors: Badowski Melissa E , Stafford R Kane , Drummond Brian W , Chiampas Thomas D , Michienzi Sarah M , Patel Mahesh C , Young Jeremy
Published: October 2019

Background

Although prison presents an opportunity to achieve virologic suppression (VS) among people living with HIV, continued success is not guaranteed upon release.

Methods

A retrospective cohort study was performed in reincarcerated Illinois prisoners from January 1, 2016 to July 31, 2018. Patients were included if they were age ≥18 years, carried a diagnosis of HIV/AIDS, on antiretroviral therapy (ART) at the time of release, and had CD4 and HIV-1 RNA labs drawn within 6 months of release and reincarceration. Potential subjects were excluded if reincarcerated within 30 days due to a technical violation and not receiving ART at the time of prison release. Primary and secondary endpoints were percent of patients achieving VS upon reincarceration and percent of patients following at an HIV clinic while released. Statistical analysis included descriptive statistics, chi-square, and paired t-tests.

Results

Among 505 patients released during the study period, 95 patients were reincarcerated and 80 were included (Figure 1). Demographic information can be found in Table 1. Fifty-one patients (64%) reported follow-up at an HIV clinic while released, whereas 29 (36%) did not. Patients who had VS at the time of prison release were more likely to make their follow-up appointment (90%) compared with those who did not (69%) (P < 0.001). In addition, patients making their follow-up appointment were also more likely to have VS at the time of reincarceration (86% vs. 10%, P < 0.001). Recidivist patients adherent to ART were less likely to experience decreases in mean CD4 count (P = 0.03) (Table 2). Subjects reporting a history of substance use were more likely not to re-engage in post-release HIV care (P = 0.001), but no difference was noted in patients with a documented psychiatric history (P = 0.2).

Conclusion

Patients failing to meet VS at the time of prison release should be targeted for more intensive re-entry medical and case management support to ensure adherence to follow-up and maintenance of immunologic function.

Disclosures

All authors: No reported disclosures.
1314. HOME CARE: Reaching Our Lost to Follow-up Patients and Overcoming Barriers to Care Utilizing Nontraditional Care Models
Authors: Goldman Erin , Union Sheronda , McClendon Tammie , Veltman Jennifer
Published: October 2019

Background

Of the 11098 people living with HIV in southeast Michigan, over 30% are out of care, with transportation being the most commonly identified barriers. To address this barrier and re-engage patients into care, we introduced an HIV homecare program. The objective of this study was to describe the implementation of the homecare program and document the outcomes of patients enrolled.

Methods

In 2016, WSUPG ID clinic saw 1990 patients and had additional 95 clients who were virally unsuppressed and lost to care for 12 months. We called all 95 of these clients and offered homecare. We also advertised our program internally, to the Detroit Public Health Departments’ Data to Care Program (Link up Detroit), and to community-based organizations. Referred patients were seen by a NP/MA team supervised by an infectious disease attending. HIV medical care delivered in home utilized same standards of care as for outpatient setting, including lab draws and counseling. Patients also had the ability to text/call provider directly on the program cell phone. This project was funding through a Part A Ryan White MAI grant.

Results

Of the 95 clients out-of-care, 38 (40%) were unreachable, 41 (43%) were reachable and 16 (17%) did not qualify (relocation, incarcerated, deceased, in-care at the time of call). 5 (5%) enrolled in homecare and additional 29 patients were referred to our program. A total of 34 patients enrolled from September 20, 2017 to September 20, 2018. Among the 34 clients, mental health barriers were the most frequently reported (depression in 20, schizophrenia or bipolar in 7, anxiety in 23, and history of trauma in 11). Of the 34 clients, 24 have achieved virologic suppression at least once during their enrollment. Among the 26 clients with 6+ months of follow-up, 17 have achieved virologic suppression.

Conclusion

Homecare offers a new, innovative healthcare delivery system which is effective at achieving viral suppression in a challenging patient population and is a successful strategy to re-engage patients in care.

Disclosures

All authors: No reported disclosures.
1315. Food Insecurity and Viral Suppression in Human Immunodeficiency Virus Patients on Antiretroviral Treatment at an Urban Primary Care Practice
Authors: Doan Huynh Chi , Gutierrez Diana , Dakin Nicolette M , Valdivia Liza
Published: October 2019

Background

The U.S. Department of Agriculture (USDA) defines food insecurity as a lack of consistent access to enough food for an active and healthy life. A review of the literature indicates that there are only few studies on food insecurity and people living with human immunodeficiency virus (HIV) in the United States, despite it being one of the most basic physiological need. Here, we aimed to examine the association between food insecurity and viral load suppression in people with HIV on antiretroviral therapy (ART) at an HIV primary care practice.

Methods

This was a cross-sectional study conducted at an urban university hospital HIV primary care practice in Brooklyn, New York. It included patients seen during a six month period, from July 1 until December 31, 2018, that were found to have an unsuppressed viral load while reporting being on ART. We defined unsuppressed viral load as viral load >200 copies/milliliters. Food security was measured with the Household Food Insecurity Access Scale (HFIAS), a questionnaire by USAID’s Food and Nutrition Technical Assistance Program, which has demonstrated cross-cultured validity. It categorized patients into four groups: food secure and mildly, moderately or severely food insecure. Patient were contacted in clinic during their appointment or by telephone survey.

Results

A total of 145 patients were found to have an unsuppressed viral load while on ART, with 54 patients (37%) reporting food insecurity. Based on HFIAS’s classification, 44 patients (30%) reported mild or moderate food insecurity, and 10 patients (7%) reported severe food insecurity. The study population demographics was 86% African American or blacks, 12% Hispanics and 2% of other race. Seventy-three patients (50%) also reported receiving benefits from New York’s Supplemental Nutrition Assistance Program.

Conclusion

Food insecurity can be associated with unsuppressed viral load and was found in over one-third of our study population, with half relying on food assistance programs. It represents a complex problem fundamentally connected to issues such as poverty and unstable housing, which can negatively impact patient engagement and retention in care. Our findings highlight the importance of integrating food and social services into HIV programs, especially in lower-income populations.

Disclosures

All authors: No reported disclosures.
1329. Experiences and Emotional Challenges of Antiretroviral Treatment (ART)—Findings from the Positive Perspectives Study
Authors: De Los Rios Patricia , Young Benjamin , Marcotullio Simone , Punekar Yogesh , Koteff Justin , Ustianowski Andrew , Murungi Andrew
Published: October 2019

Background

While advances in treatment have dramatically improved the lives of people living with HIV (PLHIV), a number of important unmet needs remain. We conducted an international survey of PLHIV to explore their treatment experience and emotional challenges of ART.

Methods

Qualitative in-depth interviews were performed with PLHIV to identify key hypotheses. A steering group (led by community members) developed the survey tool which was fielded online from November 2016 to July 2017 in 8 high-income countries in North America (NA), Europe, and Australia. A mixed sampling/recruitment approach was used to ensure a broad cross-section of PLHIV. Respondents were screened for eligibility prior to receiving access to the online survey.

Results

1111 PLHIV were surveyed (74% male, 41% 35–49 years; 39% from NA). The majority (98%) were currently taking ARTs with 53% taking a single tablet regimen. Of those on treatment, 87% were satisfied with their current ART. Overall, results for NA respondents were similar to the global results. Many participants reported emotional challenges associated with their daily HIV treatment experience: 66% agreed taking ART every day was a reminder of their HIV status; 25% agreed being tied to a daily medication limited their day-to-day life; and 29% agreed they felt stressed and under pressure to take their HIV medication at the right time every day. Those not “open” about their HIV status were more likely to feel stressed by their medication and felt that it limited them. 37% of participants frequently or quite often hid their HIV medication to avoid revealing their HIV status, particularly amongst those who reported experiencing stigma or high emotional impact of HIV. 89% felt that advances in treatment will improve their quality of life. Reducing long-term adverse effects of ART and lowering dosing frequency were considered the most important areas for improvement; this was similar across demographics such as country, age, and gender.

Conclusion

In this international survey of PLHIV, despite overall satisfaction with current ART, significant emotional burden and daily impact of treatment persists. PLHIV consider the reduction of long-term adverse effects and dosing frequency important areas for improving ART.

Disclosures

All authors: No reported disclosures.
1336. Impact of Procalcitonin-Guided Antibiotic Management in Chronic Obstructive Pulmonary Disease Exacerbation and Community-Acquired Pneumonia
Authors: Triner Molly , Patel Sunita , Craft Rachael , Rajkumar Aarthi , Patel Tejas
Published: October 2019

Background

Chronic obstructive pulmonary disease (COPD) exacerbation and community-acquired pneumonia (CAP) are major drivers of antibiotic overuse, primarily due to challenges in pathogen identification. Procalcitonin is a serum biomarker that assists in distinguishing bacterial infection from other causes. The purpose of this study was to determine whether the use of a procalcitonin (PCT) guided algorithm in patients diagnosed with COPD exacerbation and/or CAP can reduce antibiotic exposure without negatively impacting clinical outcomes.

Methods

This was a quasi-experimental study conducted at Mercy Medical Center in Canton, Ohio. The patient data for the retrospective cohort (control group) was collected from the months of September 2017 through January 2018. The prospective phase (PCT group) took place during the months of September 2018 through January 2019. Physicians utilized a procalcitonin guided algorithm to determine appropriate initiation and duration of antibiotic use in patients admitted with a primary diagnosis of COPD exacerbation and/or CAP. The primary outcome was the duration of antibiotic therapy, measured in days. Secondary outcomes included all-cause hospital readmission within 30 days of discharge, respiratory-related hospital readmission within 30 days of discharge, 30-day mortality, hospital length of stay, and adverse events to antibiotics.

Results

A total of 76 patients were included in the study, 43 in the control group and 33 in the PCT group. Baseline characteristics were similar between groups. The use of a PCT algorithm significantly decreased duration of antibiotics by 2.7 days in comparison to the control group (2.6 [n = 33] vs. 5.3 [n = 43] days; P < 0.001; 95% CI). Secondary safety outcomes between the PCT and control group were similar, including all-cause hospital readmission within 30 days of discharge (30.3% vs. 25.6%; P = 0.648), respiratory-related hospital readmission within 30 days of discharge (80.0% [n = 10] vs. 81.8% [n = 11]; P = 0.731), and 30-day mortality (no incidence in either group).

Conclusion

The use of a PCT algorithm significantly reduced duration of antibiotics by 2.7 days without negatively impacting clinical outcomes in patients being treated for COPD exacerbation and/or CAP.

Disclosures

All authors: No reported disclosures.
1339. Impact of Implementing Procalcitonin Testing with Comprehensive Education on Procalcitonin Ordering Habits and Antibiotic Usage
Authors: Johnsrud Joyce , Dare Ryan K
Published: October 2019

Background

Procalcitonin (PCT) has emerged as a biomarker distinguishing bacterial from non-bacterial infections with FDA approval for acute respiratory infections and sepsis. Studies show that PCT use can reduce patient harm while decreasing antibiotic usage. Our objective was to evaluate PCT use at our hospital and assess the impact of a comprehensive education intervention.

Methods

In-house PCT testing was implemented at our institution April 2018 along with a rigorous education campaign. Interventions consisted of face-to-face didactics with 5 provider groups, distribution of evidence-based interpretation algorithms, development of EMR prompts to guide appropriate ordering, and creation of syndrome-specific interpretation displayed with PCT results. Retrospective analysis comparing pre-intervention (December 2017) to post-intervention (October 2018) was performed evaluating ordering habits and impact of PCT result on antibiotic management. Statistical analysis was performed using STATA 14.2.

Results

218 PCT orders from 170 patients and 263 PCT orders from 170 patients were included in the pre- and post-intervention periods, respectively. All provider groups who received face-to-face education changed PCT ordering habits. Orders placed in ED and ICU locations increased (P < 0.01 and P = 0.01, respectively) while orders from floor locations decreased (P < 0.01). Serial PCT orders increased (20% vs. 33%; P < 0.01). PCT orders for FDA-approved indications improved (71% vs. 90%; P < 0.01) and following intervention, services who received in-person didactics were more likely to order PCT for FDA-approved indications than untrained groups (93% vs. 80%; P < 0.01). Clinicians were less likely to adjust therapy when PCT was low than when elevated in both periods (55% vs. 72%; P = 0.01; 61% vs. 77%; P = 0.01, respectively). Providers appropriately altered or continued therapy at similar rates during both periods (64% vs. 70%; P = 0.2).

Conclusion

Providing comprehensive PCT education significantly impacted PCT ordering habits. Testing improved to comply with FDA-approved indications, specifically in providers who received face-to-face education. Appropriate alteration of therapy based on PCT results were similar between groups suggesting repeat education is needed to avoid confirmation bias.

Disclosures

All authors: No reported disclosures.
1345. Randomized Control Trial to Evaluate the Clinical and Cytokine Response Profile to Oral Thalidomide in Leprosy Patients with Erythema Nodosum Leprosum
Authors: Chopra Ajay , Mitra Debdeep
Published: October 2019

Background

Leprosy is a chronic granulomatous disease caused by Mycobacterium leprae. Erythema Nodosum Leprosum is an acute inflammatory Type III hypersensitivity response during the chronic course of the disease process. This immune response manifests clinically as painful red nodules and systemic symptoms similar to sepsis with neutrophilic leukocytosis. Capsule Thalidomide is the drug of choice for treating this condition.

Methods

A randomized control study to study the immunological markers involved in the pathogenesis of erythema nododsum leprosum and its successful suppression by Thalidomide should provide newer insight into the pathogenesis of this disease process, provide better diagnostic and therapeutic options and better markers to predict prognosis. Based on the previous studies our aim was to find a correlation with tumor necrosis factor-a, interferon-gamma, and Cd-64 expression on activated circulating neutrophils during Type II lepra reaction and the successful response to capsule Thalidomide. Venous blood samples were collected from all the samples and after 7 days post thalidomide therapy, only in the treated population. All the patients with type II lepra reaction responded to Capsule Thalidomide clinically and all the skin lesions resolved in 7–14 days. Blood samples and skin biopsy was subjected to histopathology, immunofluorescence assay, immunohistochemical staining, quantitative RT–PCR (reverse transcriptase-polymerase chain reaction) and flow cytometry.

Results

Study found out that Interferon Γand Tumor necrosis factor-Α are sensitive markers in diagnosing erythema nodosum leprosum and Cd-64 expression on activated circulating neutrophils is both a specific and sensitive marker. Cd-64 expression also had a positive correlation with Thalidomide treatment and clinical response.

Conclusion

Cd-64 expression on circulating neutrophils is a potential early biophysical marker for diagnosing erythema nodosum leprosum and can be used as a tool to assess thalidomide response. InterferonΓ and Tumor necrosis factorΑ are sensitive markers to screen for lepra reactions and this study showed no significant correlation with Thalidomide therapy.

Disclosures

All authors: No reported disclosures.
1356. A Randomized Controlled Trial of Prednisolone vs. TNF-α inhibitor Infliximab in the Management of Type 1 Lepra Reaction in Leprosy Patients
Authors: Chopra Ajay , Mitra Debdeep
Published: October 2019

Background

Leprosy is a chronic granulomatous infectious disease caused by Mycobacterium leprae. Type 1 lepra reactions (T1R) are an acute inflammatory response during the chronic course of the disease. If it is not treated promptly with immune suppression, it can lead to a permanent disability affecting hands, feet and eyes. tumor necrosis factor-alpha (TNF-a) which is produced mainly by inflammatory T cells is up-regulated in patients of Type I Lepra reaction. Conventionally oral corticosteroids steroids have been the mainstay in the management of Type 1 Lepra reactions. This novel biologic drug is a targeted therapy which blocks the offending interleukin molecule without any serious adverse effects. We report the results of this randomized control study wherein an immuno-modulator biologic molecule has been safely used to treat an inflammatory reaction in a chronic infectious disease. Outcomes were measured using recurrence rate, a clinical severity score, quality of life and adverse events.

Methods

62 patients with new Type 1 Lepra reactions were randomized to receive Infliximab (a chimeric monoclonal antibody biologic drug that works against tumor necrosis factor-alpha (TNF-α) or Prednisolone for 20 weeks. TNF-α levels were correlated before and after the intervention.

Results

Recovery rates in skin signs were similar in both groups (91% vs. 86%). Improvements in nerve function both, new and old, sensory (68% vs. 49%) and motor (72% vs. 77%) loss were higher (but not significantly so) in the patients on Infliximab. Recurrences rates of lepra reaction (24%) were high in both groups, and recurrences occurred significantly earlier (8 weeks) in patients on Infliximab, who needed 10% more additional prednisolone. Serious major and minor adverse events rates were much lesser with Infliximab as compared with Prednisolone alone. Both groups had a significant improvement in their quality of life after the study, measured by the short-form survey SF-36.

Conclusion

This is the first double-blind randomized control trial assessing Infliximab, in the management of lepra reaction. It could be a safe alternative second-line drug for patients with leprosy reactions who are not improving with prednisolone or are experiencing adverse events related to prednisolone.

Disclosures

All authors: No reported disclosures.
1361. Knowledge, Attitude, and Practices on Drug-Resistant Tuberculosis Infection Control Among Healthcare Workers in Nepal: A Cross-Sectional Study
Authors: Kumar. Shrestha Sailesh , Bhattarai Ratna , Raj Joshi Lok , Kumar Shrestha Suvesh , Basnet Rajendra , Thapa Anil , Narsingh Kc Kedar
Published: October 2019

Background

Healthcare centers are important sites for tuberculosis transmission, particularly in low-income settings where the burden of tuberculosis is high and infection control practices are often inadequate. This study aims to assess the knowledge, attitude, and practices of drug-resistant tuberculosis infection control among the healthcare workers under the National Tuberculosis Control Program in Nepal.

Methods

In this descriptive cross-sectional survey, we studied the healthcare workers from all the functioning drug-resistant tuberculosis treatment centers across Nepal between March 1, 2018 and March 15, 2018. Nepal Health Research Council provided ethical clearance. Trained enumerators obtained informed consent and conducted face-to-face interviews with a pretested questionnaire to collect data on the basic characteristics of healthcare workers, their self-reported knowledge, attitude, and practice on tuberculosis infection control. We assigned a score of one to the correct response and zero to the incorrect or no response and calculated a composite score in each of the knowledge, attitude, and practice domains. We ascertained the healthcare workers as having good knowledge, appropriate attitude, and optimal practices when the composite score was at least 50%. We summarized the numerical variables with median and interquartile range (IQR) and the categorical variables with proportions.

Results

A total of 95 out of 102 healthcare workers from 11 drug-resistant tuberculosis treatment centers participated in the study. There were 46 male and 49 female respondents. The median age was 33 years (IQR 26–42). The majority of them (53, 56%) were mid-level paramedics. The median work experience in drug-resistant tuberculosis was 2 years (IQR 1–5). We found 91 (96%) respondents had a good knowledge of tuberculosis infection control with the median knowledge score of 14 (IQR 12–14), 49 (52%) respondents had an appropriate attitude with the median attitude score of 5 (IQR 4–6) and 35 (37%) respondents had optimal practices with the median practice score of 5 (IQR 4–7).

Conclusion

Healthcare workers at the drug-resistant tuberculosis treatment centers in Nepal had good knowledge of tuberculosis infection control but it did not translate into an appropriate attitude or optimal practices.

Disclosures

All authors: No reported disclosures.
1366. Prognostic Factors for Unfavorable Outcomes of Patients with Spinal Tuberculosis in a Country with an Intermediate Tuberculosis Burden: a Multi-Center Cohort Study
Authors: Ho Kim Jung , young Ahn Jin , Jin Jeong Su , su Ku Nam , yong Choi Jun , Keun Kim Young , Yeom Joon-Sup , Goo Song Young
Published: October 2019

Background

Spinal tuberculosis (TB) remains an important concern. Although spinal TB often has sequelae such as myelopathy after treatment, the predictive factors affecting such unfavorable outcomes are not yet known. Therefore, we investigated the clinical manifestations and predictors of unfavorable treatment outcomes in patients with spinal TB.

Methods

We performed a multi-center retrospective cohort study of patients with spinal TB. The clinical features, comorbidities, laboratory data, imaging findings and treatment outcomes of the patients were analyzed. The unfavorable outcome was defined according to previous studies. The prognostic factors for unfavorable outcomes as the primary outcome were determined using multivariate logistic regression analysis and a linear mixed model were used to compare time course of inflammatory markers during treatment.

Results

A total of 185 patients (85 males and 100 females) were included. The mean age of the patients was 57.2 years. Of them, 115 underwent surgery during treatment, with a median treatment duration of 12 months. Fifty-nine patients had unfavorable outcomes. In multivariate regression analysis, the factors associated with unfavorable outcome were old age (odds ratio [OR], 2.51; P = 0.034), acid-fast bacilli (AFB) smear positivity in specimens obtained through biopsy (OR, 3.05; P = 0.039), and elevated erythrocyte sedimentation rate (ESR) at the end of treatment (OR, 3.85; P = 0.002). Patients with unfavorable outcomes had a significant trend toward higher ESR during treatment compared with patients with favorable outcome (P = 0.009). Duration of anti-TB and surgical treatment did not affect prognosis.

Conclusion

Elevated ESR at the end of treatment could be used as a marker to identify spinal TB patients with a poor prognosis. Patients whose ESR are not normalized during treatment, as well as those with old age and AFB smear positivity, should be aware of unfavorable outcomes.

Disclosures

All authors: No reported disclosures.
1386. Reduction in Expected Survival Associated with Nontuberculous Mycobacterial Pulmonary Infection
Authors: Mourad Ahmad , Baker Arthur W , Stout Jason E
Published: October 2019

Background

Nontuberculous mycobacteria (NTM) are emerging agents of pulmonary disease, estimated to affect >80,000 people in the United States. While the spectrum of pulmonary NTM severity is broad, some published series report 5-year mortality of up to 40%.

Methods

We conducted a retrospective cohort study to examine mortality of patients with positive respiratory cultures for NTM in the Duke Health System from January 1, 1996 to June 30, 2015, compared with the expected mortality in the US population among a cohort with the same demographic composition. We included patients with ≥2 positive NTM respiratory cultures, or 1 positive culture plus an associated ICD diagnosis. Patients with disseminated NTM, HIV, cystic fibrosis, and solid-organ or hematopoietic cell transplants were excluded, as were isolates of Mycobacterium gordonae. Five specific comorbidities (cancer, chronic obstructive pulmonary disease, stroke, chronic renal failure, myocardial infarction) were assessed with ICD codes. Survival was measured from the date of first positive NTM culture and censored as of 6/30/2015.

Results

We identified 653 patients who met the case definition. 451 (69%) were female; 548 (84%) were Caucasian, and the median age was 69 years (IQR 59–76). 544 (83.3%) patients had only Mycobacterium avium complex (MAC) isolates in cultures; 39 (6%) had only M. abscessus; 33 (5%) had both MAC and M. abscessus; 37 (5.7%) had other NTM isolates. Most patients (n = 410, 62.8%) had none of the evaluated comorbidities prior to NTM diagnosis. Median follow-up time was 1252 days (IQR 449–2688). Median survival in our cohort among persons with and without comorbidities was 1973 days (95% CI 1487–2995) and 3952 days (95% CI 3496–5186), respectively. Median expected survival in the demographically-matched population cohort was significantly longer at 5479 days (P<.0001). Mortality at 5 years was 47.9% (39.7–55.0) and 27.2% (95% CI 22.1–32.0) among NTM patients with and without comorbidities, respectively, vs. expected mortality of 5.7% in the general population.

Conclusion

NTM pulmonary infection in our cohort was associated with significantly lower survival than expected in the general population. The impact of NTM infection itself vs. other comorbidities on survival requires further study.

Disclosures

All authors: No reported disclosures.
1424. Association Between Erythrocyte Sedimentation Rate (ESR) Change and Treatment Failure in Patients with Osteomyelitis
Authors: Pearson Christopher D , Holzum Dorothy , Moenster Ryan P , Linneman Travis W
Published: October 2019

Background

Erythrocyte sedimentation rate (ESR) is monitored during therapy for osteomyelitis (OM) but the degree of reduction associated with treatment success remains unclear.

Methods

This retrospective cohort study evaluated patients treated for at least 2 weeks with intravenous (IV) antibiotics for OM through the VA St. Louis HCS from 1 January 2010 to 1 January 2018 with at least 2 ESR values during their therapy. Patients were excluded if they had comorbidities that could cause elevations in ESR. The primary outcome was the rate of treatment failure in patients achieving ≥50% decrease in ESR from baseline compared with those without a 50% decrease. Treatment failure was defined as a need for unplanned surgical intervention or re-initiation of antibiotic therapy for OM of the same anatomical site within 6-months after initial therapy was discontinued. The presence of diabetes, peripheral vascular disease (PVD), age >70, baseline creatinine clearance (CrCl) < 50 mL/minute, surgical intervention as part of initial therapy, and ESR reduction ≥50% from baseline were included in a univariate analysis with variables with a P < 0.2 included in a multivariate logistic regression model.

Results

A total of 143 patients were included; 74 patients with a ≥50% decrease in ESR and 69 patients with a decrease <50%. Mean initial ESRs were not different between groups (79.5±31 vs. 79.9 ± 32 mm/hour, P = 0.95), but end-of-treatment values were significantly higher in the <50% reduction group vs. ≥50% (20.6 ± 14 vs. 72.4 ± 42 mm/hour, P < 0.05, respectively). There were no baseline differences between groups in regards to age, rates of diabetes, PVD, CrCl < 50 mL/minute, initial surgical therapy management, or definitive vs. empiric therapy. Thirty percent (22/74) of patients with a ≥50% reduction in ESR failed treatment vs. 55% (38/69) in patients with a <50% reduction (P < 0.01). Only ESR reduction of ≥50% met criteria for inclusion in the multivariate regression model and was associated with a 65.5% relative risk reduction in treatment failure (OR 0.345; 95% CI 0.173–0.687; P = 0.002).

Conclusion

Achieving an ESR reduction of ≥50% from baseline during treatment for OM was independently associated with a significant reduction in risk of treatment failure.

Disclosures

All authors: No reported disclosures.
1432. Estimating the Incubation Period of Salmonella Urinary Tract Infection (UTI) Using Foodborne Outbreak Data
Authors: Jacobs Slifka Kara M , Blackstock Anna , Nguyen Von , Schwensohn Colin , Gieraltowski Laura , Mahon Barbara
Published: October 2019

Background

Urinary tract infections (UTI) are common bacterial infections that may occur as a part of foodborne outbreaks. Salmonella, a less common cause of UTI, has been identified during foodborne outbreaks, but the epidemiology and pathogenesis are poorly understood.

Methods

PulseNet, the United States national molecular subtyping network for foodborne disease surveillance, was used to identify Salmonella isolates associated with outbreaks from 2004 to 2013 containing at least one urine and one stool isolate in which the duration was ≤1 year and a food vehicle was suspected or confirmed. We standardized isolation dates across outbreaks by calculating the mean date for stool isolation within an outbreak and subtracting this from the date of each stool/urine isolate in that outbreak. A linear-mixed model with random effect for stool/urine was used to estimate the difference in incubation periods between stool/urine isolates. We also surveyed patients from a 2012 Salmonella Cubana outbreak with many urinary isolates and associated with sprouts, to ask about diarrhea, UTI symptoms, diagnosis, and treatment. Descriptive statistics were calculated.

Results

Urine isolates had later isolation dates than stool isolates for 102 of the 110 outbreaks identified. The average difference between stool and urine isolates was 10.6 days (95% CI: 6.0, 15.2). Seven women from the Salmonella Cubana outbreak were reached. All women were diagnosed with either a UTI (6/7 = 86%) and/or kidney infection (2/7 = 29%) and were treated with antibiotics (7/7 = 100%). All six women completing the survey reported multiple signs and/or symptoms including frequency, urgency, dysuria, and hematuria with only two women reporting diarrhea prior to UTI.

Conclusion

Salmonella UTI seen during foodborne outbreaks are symptomatic foodborne infections not associated with diarrhea and appear to have a longer incubation period than Salmonella gastrointestinal (GI) illness. A 13- to 16-day incubation period for Salmonella UTI may be more appropriate, calculated by adding a 3- to 4-day GI illness incubation period plus delay in obtaining a stool isolate. Foodborne UTI investigation may need to change as the current method of obtaining a food history for the 6–72 hours prior to illness does not accurately reflect the incubation period for Salmonella UTI.

Disclosures

All authors: No reported disclosures.