bluuebunny/crossref_metadata_2025_split huggingface dataset:
Immunogenicity and Safety of a Candidate Subunit Adjuvanted Herpes Zoster Vaccine (HZ/su) in Adults Post Renal Transplant: a Phase III Randomized Clinical Trial
Authors: Vink Peter 
Published: October 2017

Abstract

Background
The incidence rate of herpes zoster (HZ) in individuals with solid organ transplants (SOTs) is estimated as 8–9 times higher than the rate in the overall US population (3.2/1000 person-years). No vaccine is currently available to prevent HZ in immunocompromised individuals. GSK’s HZ/su candidate vaccine, containing varicella-zoster virus glycoprotein E (gE) and AS01B Adjuvant System, has shown &gt;90% efficacy for HZ prevention in immunocompetent adults ≥50 years of age (YOA). We performed a study to determine immunogenicity and safety of HZ/su in adult renal transplant (RT) recipients (RTR) on chronic immunosuppressive therapy; RT was chosen as it can be representative of SOTs due to the nature of administered immunosuppressive therapies.

Methods
In this phase III, observer-blind, multicenter study (NCT02058589), RTRs ≥18 YOA were randomized 1:1 to receive 2 doses of HZ/su or placebo intramuscularly 1–2 months apart. gE-specific vaccine response rates (VRRs) and geometric means (GMs) were assessed for humoral and CD4+ cell-mediated immune (CMI) responses 1 month post dose 2 (M2). Solicited adverse events (AEs) were recorded for 7 days and unsolicited AEs and medically-attended AEs (MAEs) for 30 days after each dose. Solicited general and unsolicited AEs were also collected for 7 days prior to dose 1. Potential immune-mediated diseases (pIMDs) and serious AEs (SAEs) were recorded until 1 year post dose 2. Data from dose 1 through M2 is presented.

Results
At M2, 240 subjects (121 HZ/su; 119 placebo) were included in the humoral immunogenicity according-to-protocol (ATP) cohort. All immunogenicity success criteria were met at M2 (Table 1). VRRs for ATP humoral immune cohort and CMI sub-cohort (72 subjects: 36 HZ/su; 36 placebo) were higher in HZ/su groups. Humoral GM concentrations and CMI GM frequencies were significantly higher in HZ/su compared with placebo groups. The frequency of AEs was higher in HZ/su vs. placebo groups for solicited local AEs, but similar for solicited general AEs, unsolicited AEs, MAEs and SAEs. No pIMDs, vaccine-related SAEs or transplant rejections were reported (Table 2).

Conclusion
HZ/su was highly immunogenic in adults with RT at M2. No safety concerns were identified.

Funding
GlaxoSmithKline Biologicals SA

Disclosures
P. Vink, GSK group of companies: Employee, Salary and stock options and stock granted
Improved HIV markers and decreased emergencyroom usage and hospital admission with initiation of a pilot specialty pharmacy at a southeastern Ryan –White –funded clinic over a three year period
Authors: Ly Nguyen Minh , Condra Alton , Corbin-Johnson Della , Woodson Kay , Patel Manish , Colasanti Jonathan , Armstrong Wendy 
Published: October 2017

Abstract

Background
Specialty pharmacy (SP) provides timely medication delivery to patients and seeks to improve patient adherence through monthly pharmacist medication therapy management (MTM). Patients living with HIV/AIDS have both high cost medications and complex disease states and thus will benefit from SP. We report on the outcome of HIV therapy after 3 years of a pilot SP ina southern inner city RW funded clinic.

Methods
This is a single center retrospective chart review of patients at our clinic who were enrolled in the SP from 6/3/13–5/1/16 for at least 6 months. Baseline demographic characteristics and HIV markers (CD4, viral load) were collected. Outcomes of interest were: change in CD4 count, percent with viral suppression (VS), emergency room (ER) and hospital admission usage, as well as percent of scheduled providers’ appointment kept. Each individual had the same follow up time before and after SP initiation. Bivariate analysis compared outcomes preSP and during SP using Chi-square or Fisher exact tests for categorical and Wilcoxon rank-sum test for continuous variables.

Results
During the 3-year period, there were 212 individuals referred to SP, of which 170 participated in the program. There were 92(54%) men, 136(80%) black. The median age was 48.3 years (IQR: 28.5–56.3). The average duration of follow up pre and during SP was 22.1(IQR: 16.5–27) months. In terms of insurance, 69(40%) had Medicare, 22(13%) had Medicaid, 22(13%) had private insurance, 54(32%) received AIDS drug Assistance Program (ADAP), and 3(2%) had Ryan White. Patients resided an average distance from the clinic of 17.4(IQR: 8.8–25) miles. The respective outcomes before and during SP were: CD4: 350(IQR: 181–551) vs. 413(IQR: 263–611 cells/mL (P &lt; 0.0001), VS in 78 ± 30% vs. 91 ± 20% (P &lt; 0.0001). The proportion of patients with emergency room usage or hospital admissions was 68(40%) vs. 49(29%) (P = 0.036). There was no difference in the rate of kept providers’ appointment (66.6 %(IQR: 53.8–78.6%) vs. 63.8 %(50-77%) (P = 0.19). There was no reported death during the follow –up period.

Conclusion
This pilot SP program at the RW clinic showed statistically significant improvement of CD4 count and VS, as well as 40 % decrease in odds of using ER or hospital admission. Further studies are needed to determine whether SP is beneficial to people living with HIV/AIDS in other settings.

Disclosures
M. Patel, ViiV: Scientific Advisor, Consulting fee
Linkage to HIV Outpatient Care Following an Inpatient Stay
Authors: Nurutdinova Diana , Ramachandran Shruti , Kadam Sukanya , Mojica Vince , Mullen Michael , Baney Matt 
Published: October 2017

Abstract

Background
Immediate linkage to outpatient HIV follow-up care after hospitalization is a crucial opportunity to review treatment plan and coordinate necessary and additional services. The purpose of this review is to evaluate potential gaps in transition from inpatient to outpatient care services in persons with HIV. Data from multiple electronic medical records and billing systems were used to assess the rate of follow-up care at HIV outpatient facilities within the Mount Sinai Health System (MSHS), among patients hospitalized in four of the largest hospitals within MSHS.

Methods
ICD-10 codes were utilized to capture all hospitalized patients in 2016 with a primary or secondary diagnosis of HIV and their discharge date, across various electronic systems used by MSHS hospitals. Additional visit data was pulled from the EMR used by the five HIV outpatient facilities in order to determine the linkage to care rate. Linkage to HIV care was defined as the proportion of patients who attended an appointment at one of five HIV outpatient clinics within MSHS, within 90 days of discharge.

Results
A total of 3,992 inpatient discharges were associated with the diagnosis of HIV at the Mount Sinai Health System in 2016. Among these, 2,760 (69%) were male and 1,970 (49%) were African Americans while 56% were in the range of 50–69 years. The average length of stay was 6.6 days (SE±0.6). Out of these discharges, 1020 (25%) were scheduled to be seen at the system’s HIV outpatient care facilities within the 90 day interval. Subsequently, 275 patients (27%) have kept their appointments.

Conclusion
The data suggests that a smaller proportion of the inpatient discharges is linked to care within the system in addition to low appointment compliance rate. Further efforts to optimize early linkage to care and retention may help to affect patient outcomes. Interventions focusing on chronic disease management may assist to further improve these rates. At the systems level, enhanced and increased discharge planning and coordination is required between inpatient units and outpatient clinics in addition to greater outreach by outpatient clinics immediately upon discharge.

Disclosures
All authors: No reported disclosures.
Social Determinants of Health and Disparities in Linkage to Care Among Newly Diagnosed HIV Cases – South Carolina, 2009–2011
Authors: Gill Harmeet , Babatunde Oluwole , Weissman Sharon 
Published: October 2017

Abstract

Background
Key to improved HIV outcomes is early diagnosis, linkage to care (LTC), retention in care (RIC) and viral load (VL) suppression. As treatment for HIV has become more effective, the gap in racial disparities has widened for LTC, RIC and VL. Social determinants of health (SDH) are conditions such as poverty level, income, education, employment that are responsible for most health inequities. SDH are drivers of disparities in HIV prevalence. The objective of this study is to evaluate the impact of SDH on racial disparities on time to LTC for newly diagnosed HIV infected individuals in South Carolina (SC).

Methods
Data was obtained from the SC enhanced HIV/AIDS Reporting System. Analysis includes individuals diagnosed with HIV in SC from 2009–2011. LTC was calculated as the time from HIV diagnosis to first CD4 or VL test. Early LTC was defined as within 30 days. Late LTC was &gt;30 to 365 days. Individuals not LTC by 365 days were considered to have never been linked to care (NLTC). Census tract data was used to determine SHD (poverty, education, income, and unemployment) based on residence at the time of HIV diagnosis. Descriptive analysis was performed on data from newly infected individuals. Factors potentially associated with late LTC and NLTC including patient demographics, behavioral risk, residence at diagnosis and SDH were investigated.

Results
From 2009–2011, 2151 individuals were newly diagnosed with HIV. Of these 1636 (76.1%) were LTC early, 285 (13.2%) were LTC late and 230 (10.7%) were NLTC. NLTC was associated with male gender, lower initial CD4 count, and earlier stage of HIV at time of diagnoses (P &lt;0.01). In multivariable analysis early HIV stage at HIV diagnosis (aOR: 1.82; 95% CI 1.3, 2.5) and living in census tracts with lower income (aOR 0.65; 95% CI 0.44, 0.97) are associated with late LTC. Male gender (aOR 2.66; 95% CI 1.49, 4.76) unknown HIV risk group (aOR 2.03; 95% CI 1.11, 2.74) and early HIV stage at diagnosis (aOR 4.59; 95% CI 2.33, 9.04) are associated with NLTC.

Conclusion
In SC, almost ¼ of newly diagnosed HIV infected individuals from 2009–2011 were LTC late or NLTC. SDH were not associated with late LTC or NLTC. Living in a low income census tract was associated with a lower risk for late LTC, possible because of access to Ryan White Services. Male gender and earlier HIV stage were factors with greatest association with late LTC and NLTC.

Disclosures
All authors: No reported disclosures.
Impact of Patient Navigators in Linkage to Care for HIV-Positive Patients in an Urban Emergency Department in Newark, NJ
Authors: Maldonado Samuel , Sugalski Gregory , Closeil Garry , Swaminathan Shobha 
Published: October 2017

Abstract

Background
Despite CDC recommendations, areas with high HIV prevalence have not implemented routine HIV testing, stating among other concerns, inability to effectively link them to care. We implemented a routine HIV testing program in the Emergency Department (ED) at University Hospital in Newark, NJ that had 46,164 visits from July 2015 to November 2016 and looked at the impact of patient navigators (PN) on linkage to care (LTC) rates.

Methods
This was a retrospective study of all patients newly diagnosed (ND) with HIV or previously positive (PP) but lost to follow-up (LTFU) in select areas of the ED from July 2015 to November 2016. We collected information on demographics, HIV risk factor, and looked at the impact of PN on LTC by comparing months the PN was able to make personal contact compared with months when the PN was unavailable for substantial periods of time.

Results
A total of 9,511 individuals were screened, and 151 (1.6%) had a positive HIV test; 8 died and 2 were incarcerated. Of the remaining 141, 102 (72%) were LTC. The mean age was 49, 57% Male, 77% Black, 14% Hispanic, and 6% White. The reported HIV risk factors were 67% Heterosexual, 9% MSM, 6% IV drug use (IDU) and 18% Other. Of the patients with a positive HIV test, 60 (43%) were ND and 81 (57%) were PP. Only 52% ND patients were LTC, while 88% PP patients were LTC. Black and Hispanic patients tended to be PP (60% of both groups), while White patients tended to be ND (75% of white patients were ND). The risk factors for ND were 44% Heterosexual, 39% MSM, and 25% IDU. Average LTC while the PN was unavailable decreased from 78% to 56%. There were no demographic differences in the LTC group compared with the LTFU group. IDU had the highest rate of being LTFU at 37% followed by MSM and Heterosexual at approximately 23% each. The primary reason for LTFU was incorrect contact information in the medical record such as wrong address or phone number. PN would make 3 phone calls, send 2 letters and 1 outreach attempt. If all of those failed, the PN notified the state health department.

Conclusion
PN have a positive impact on LTC even in busy ED settings. Given limitations of staffing a busy ED 24/7, we need to develop strategies to link patients even if the PN is not present. To address this limitation, we plan on looking at the impact of involving medical residents to help with linkage to care after business hours.

Disclosures
S. Swaminathan, Gilead Sciences: Grant Investigator and Scientific Advisor, Consulting fee and Research grant
Predictors of Viral Load Suppression in HIV-infected Patient in Rural Eastern North Carolina.
Authors: Fadul Nada , Taylor Peyton , Kearney Gregory 
Published: October 2017

Abstract

Background
Virologic suppression (VLS) has been shown to improve clinical outcomes and prevent disease transmission in Human Immunodeficiency Virus (HIV) infected patients. However, only 30% of those living with HIV in the United States (US) are currently VLS. HIV incidence and prevalence are increasing rapidly in the rural Southeastern region of the US and models to predict VLS in this population are needed.

Methods
We conducted a retrospective chart review of patients 18 years or older, who were newly diagnosed with HIV and receiving care at our Ryan White funded clinic between September 2014 and September 2016. We collected demographic information, comorbid conditions, clinic appointment data, and laboratory values. VLS suppression was defined as an HIV viral load &lt;200 copies/mL at 3 months. Pearson Chi square analysis was done using SPSS to evaluate the association between these variables and VLS.

Results
A total of 183 patients were included in the study, 42 (23%) females, 39 (21%) white, 41 (22%) less than 25 years of age, 65 (36%) uninsured and 102 (56%) men who have sex with men. The majority 139 (76%) of patients lived below the 150% federal poverty limit. During 3 months follow up 113/183 (61%) were VLS. There were no statistically significant associations between age, gender, ethnicity, presence of mental health and substance abuse disorders, housing stability, education or poverty level level and VLS. 60/104 (56%) of those who were insured achieved VLS compared with 48/65 (73%) of those who were uninsured (P = 0.033)

Conclusion
VLS was achieved in 61% of the HIV infected patients in eastern North Carolina. Patients without insurance had a statistically significantly higher rate of VLS as compared with those with insurance. It is noteworthy that patients who were uninsured received ambulatory medical and support services as well as medication assistance through Ryan White funding. Future prospective studies are needed to further evaluate the association between insurance status and VLS in federally funded clinics.

Disclosures
All authors: No reported disclosures.
Travel time to Clinic but not Neighborhood Crime Rate is associated with Retention in Care among HIV-positive Patients
Authors: Ridgway Jessica P , Almirol Ellen , Schmitt Jessica , Schuble Todd , Schneider John 
Published: October 2017

Abstract

Background
Retention in HIV care can be impacted by structural factors such as crime, poverty, and clinic accessibility. We aimed to determine whether crime rate, travel time, or travel distance to clinic were associated with retention in care or viral suppression (VS) among people living with HIV (PLWH) at the largest provider of HIV care on the South Side of Chicago.

Methods
Using publicly available data in the Chicago Open Data Portal, we geocoded patient home addresses and clinic location. We measured distance from patient home to clinic, and travel time from patient home to clinic using car and Chicago Transit Authority (CTA) public transportation. We further measured crime rate within a two block radius of the public transportation route to clinic. Retention was defined as &gt;2 visits, 90 days apart within 12 months, and patients were classified into 3 groups: continuously retained (CR), intermittently retained (IR), or lost to follow-up (LTFU), i.e., no visit in the last 12-months. Kruskal–Wallis rank-sum with Dunns pairwise test was used to determine whether travel time, travel distance, and crime rate were associated with retention or viral suppression.

Results
780 patients were included in the study. Of these 273 (35%) were CR, 392 (50%) were IR, and 115 (15%) were LTFU. Figure 1 shows maps with geocoded data. Median distance from clinic was 3.6 [2.1–5.6] miles among those CR, 3.9 [2.5–6.0] miles among the IR, and 3.9 [2.6–6.2] miles among those LTFU. Median travel time by CTA was 37.2 [31.8–53.0] mins for CR, 42.9 [33–53] mins for IR, and 42.9 [33–59.1] mins for LTFU; by car was 15.9 [9.6–33] mins for CR, 17.1 [11.8–24.6] mins for IR, and 17.5 [12.2–24.1] mins for LTFU. Crime rate was similar across all retention groups. Though no associations were statistically significant at P &lt; 0.05, there was a trend toward shorter distance (P = 0.07) and shorter car travel time (P = 0.06) among CR vs. IR. There was also a trend toward lower neighborhood crime rates among those VS vs. those not VS (P = 0.07).

Conclusion
Retention in care was not impacted by residing in high crime neighborhoods in Chicago. PLWHA who lived farther from HIV clinic and had longer travel time showed a trend toward being more likely to be IR in care vs. CR, but there was no such association for VS. Travel time may impact patient likelihood to attend HIV care appointments, but not necessarily adherence to ART.

Disclosures
J. P. Ridgway, Gilead FOCUS: Grant Investigator, Grant recipient
Improving Appointment Adherence among Young Adults with HIV in Peru with an mHealth Intervention: a Feasibility Study
Authors: Prochazka Mateo , Batey D Scott , Zinski Anne , Dionne-Odom Jodie , Otero Larissa , Rodriguez J Martin , González Elsa 
Published: October 2017

Abstract

Background
Mobile Health (mHealth) interventions, including short message services (SMS) reminders and motivational messages, are associated with improved HIV appointment adherence, though feasibility is context-dependent. We assessed the feasibility of an mHealth intervention to improve appointment adherence among young adults with HIV in Lima, Peru.

Methods
Between November 2016 and April 2017, we implemented a one-way mHealth pilot intervention in an outpatient hospital without electronic medical records. We enrolled young adults (age 18–29) entering HIV care in a 3-component intervention: (i) reminder SMS prior to scheduled appointments (provider, laboratory, pharmacy); (ii) motivational SMS after each visit; and (iii) phone call following a missed visit. Feasibility evaluation included enrollment acceptance, visit tracking (information captured in the study database within 3 days of attendance), and proportion of intervention delivery (threshold &gt;90%). We performed a qualitative assessment to identify implementation challenges reviewing staff field notes and meeting minutes.

Results
We enrolled 80/94 (85.1%) eligible participants. The median age was 25 years and 83% were male. The median time of follow-up after enrollment was 115 [interquartile range (IQR): 84–141] days, and participants had a median of 10 (IQR: 8–14) visits during the study period. Among 850 total participant visits, study personnel tracked 751 (88.4%); most (80.8%) untracked visits were pharmacy pickups. Of all tracked visits, most (78.7%) were scheduled appointments and 160 (21.3%) were unscheduled walk-ins. Intervention delivery reached 556/591 (94.1%) for reminder SMS; 733/751 (97.6%) for motivational messages, and 169/170 (99.4%) phone calls for missed visits, 127 (75.1%) of which were answered. Qualitative assessment revealed 2 major themes: real-time appointment tracking in a paper-based system consumed most staff time and resources, and meticulous in-person coordination between the implementation and hospital staff was essential for tracking.

Conclusion
An mHealth intervention to improve appointment adherence among young adults with HIV in Peru appears feasible with dedicated staff and a reliable appointment tracking system. Digitalized appointment systems may be needed to address challenges for scale-up.

Disclosures
All authors: No reported disclosures.
Patient-level Factors Associated with HIV Suppression at Admission Across a Large Integrated Healthcare System
Authors: FigueroaSierra Marileys , Schmidt Monica , Spencer Melanie D , Leonard Michael 
Published: October 2017

Abstract

Background
Linkage to care is a critical step for achieving HIV viral suppression and improving outcomes in newly diagnosed individuals. An unexpectedly high number of patients who have undiagnosed HIV or ineffective viral suppression are identified upon admission to acute care. This study aims to understand factors that may be associated with lack of viral suppression for patients who are newly diagnosed at admission.

Methods
Patients with HIV, admitted to one of our eight acute care facilities were identified (n = 1,632) from medical records. Of these, 94 were newly diagnosed and 1,538 had a prior diagnosis of HIV. Factors that may impact the viral suppression status (&lt;200 copies/mL) prior to admission were examined. Median income and percentage of individuals living below poverty were inferred from the American Community Survey (U.S. Census) data based on a patient’s zipcode. All other factors were extracted from the medical record at the time of admission. Chi square tests and t-tests were used to compare patients who were virally suppressed to those who were not.

Results
The average age was 48 years old and 60% were male and 82% black race. Patients who presented and were not virally suppressed were more likely to be between the ages of 40–60 and of black race. Distributions of age groups and race were significantly different between those virally suppressed and those who were not suppressed at admission (P &lt; 0.05 for both). Blacks and whites between 40 and 60 years were more likely than other race and age groups to present at admission without viral suppression. Patients from geographic areas associated with high poverty and lower median income were less likely to be virally suppressed at admission (23.2% vs. 25.2%; P &lt; 0.05 for poverty and $41,183 vs. $43,757; P &lt; 0.05) for income.

Conclusion
These results indicate that age, race and geographically inferred income and poverty are significantly different between patients who are virally suppressed at admission and those who have a detectable viral load. Further investigation is needed to better understand how these patient-level factors, including socioeconomics, impact linkage to care as well as how best to allocate resources to better engage and retain patients in HIV care to improve their long-term outcomes.

Disclosures
All authors: No reported disclosures.