Clinical Management of Hospitalized Coronavirus Disease 2019 Patients in the United States.

BACKGROUND: The objective of this study was to characterize hospitalized coronavirus disease 2019 (COVID-19) patients and describe their real-world treatment patterns and outcomes over time. METHODS: Adult patients hospitalized on May 1, 2020-December 31, 2020 with a discharge diagnosis of COVID-19 were identified from the Premier Healthcare Database. Patient and hospital characteristics, treatments, baseline severity based on oxygen support, length of stay (LOS), intensive care unit (ICU) utilization, and mortality were examined. RESULTS: The study included 295657 patients (847 hospitals), with median age of 66 (interquartile range, 54-77) years. Among each set of demographic comparators, the majority were male, white, and over 65. Approximately 85% had no supplemental oxygen charges (NSOc) or low-flow oxygen (LFO) at baseline, whereas 75% received no more than NSOc or LFO as maximal oxygen support at any time during hospitalization. Remdesivir (RDV) and corticosteroid treatment utilization increased over time. By December, 50% were receiving RDV and 80% were receiving corticosteroids. A higher proportion initiated COVID-19 treatments within 2 days of hospitalization in December versus May (RDV, 87% vs 40%; corticosteroids, 93% vs 62%; convalescent plasma, 68% vs 26%). There was a shift toward initiating RDV in patients on NSOc or LFO (68.0% [May] vs 83.1% [December]). Median LOS decreased over time. Overall mortality was 13.5% and it was highest for severe patients (invasive mechanical ventilation/extracorporeal membrane oxygenation [IMV/ECMO], 53.7%; high-flow oxygen/noninvasive ventilation [HFO/NIV], 32.2%; LFO, 11.7%; NSOc, 7.3%). The ICU use decreased, whereas mortality decreased for NSOc and LFO. CONCLUSIONS: Clinical management of COVID-19 is rapidly evolving. This large observational study found that use of evidence-based treatments increased from May to December 2020, whereas improvement in outcomes occurred over this time-period.

Remdesivir Treatment in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19): A Comparative Analysis of In-hospital All-cause Mortality in a Large Multicenter Observational Cohort.

BACKGROUND: Remdesivir (RDV) improved clinical outcomes among hospitalized patients with coronavirus disease 2019 (COVID-19) in randomized trials, but data from clinical practice are limited. METHODS: We examined survival outcomes for US patients hospitalized with COVID-19 between August and November 2020 and treated with RDV within 2 days of hospitalization vs those not receiving RDV during their hospitalization using the Premier Healthcare Database. Preferential within-hospital propensity score matching with replacement was used. Additionally, patients were also matched on baseline oxygenation level (no supplemental oxygen charges [NSO], low-flow oxygen [LFO], high-flow oxygen/noninvasive ventilation [HFO/NIV], and invasive mechanical ventilation/extracorporeal membrane oxygenation [IMV/ECMO]) and 2-month admission window and excluded if discharged within 3 days of admission (to exclude anticipated discharges/transfers within 72 hours, consistent with the Adaptive COVID-19 Treatment Trial [ACTT-1] study). Cox proportional hazards models were used to assess time to 14-/28-day mortality overall and for patients on NSO, LFO, HFO/NIV, and IMV/ECMO. RESULTS: A total of 28855 RDV patients were matched to 16687 unique non-RDV patients. Overall, 10.6% and 15.4% RDV patients died within 14 and 28 days, respectively, compared with 15.4% and 19.1% non-RDV patients. Overall, RDV was associated with a reduction in mortality at 14 days (hazard ratio [95% confidence interval]: 0.76 [0.70-0.83]) and 28 days (0.89 [0.82-0.96]). This mortality benefit was also seen for NSO, LFO, and IMV/ECMO at 14 days (NSO: 0.69 [0.57-0.83], LFO: 0.68 [0.80-0.77], IMV/ECMO: 0.70 [0.58-0.84]) and 28 days (NSO: 0.80 [0.68-0.94], LFO: 0.77 [0.68-0.86], IMV/ECMO: 0.81 [0.69-0.94]). Additionally, HFO/NIV RDV group had a lower risk of mortality at 14 days (0.81 [0.70-0.93]) but no statistical significance at 28 days. CONCLUSIONS: RDV initiated upon hospital admission was associated with improved survival among patients with COVID-19. Our findings complement ACTT-1 and support RDV as a foundational treatment for hospitalized COVID-19 patients.

Comparison of HIV Screening Strategies in the Emergency Department: A Randomized Clinical Trial.

Importance: The National HIV Strategic Plan for the US recommends HIV screening in emergency departments (EDs). The most effective approach to ED-based HIV screening remains unknown. Objective: To compare strategies for HIV screening when integrated into usual ED practice. Design, Setting, and Participants: This randomized clinical trial included patients visiting EDs at 4 US urban hospitals between April 2014 and January 2016. Patients included were ages 16 years or older, not critically ill or mentally altered, not known to have an HIV positive status, and with an anticipated length of stay 30 minutes or longer. Data were analyzed through March 2021. Interventions: Consecutive patients underwent concealed randomization to either nontargeted screening, enhanced targeted screening using a quantitative HIV risk prediction tool, or traditional targeted screening as adapted from the Centers for Disease Control and Prevention. Screening was integrated into clinical practice using opt-out consent and fourth-generation antigen-antibody assays. Main Outcomes and Measures: New HIV diagnoses using intention-to-treat analysis, absolute differences, and risk ratios (RRs). Results: A total of 76 561 patient visits were randomized; median (interquartile range) age was 40 (28-54) years, 34 807 patients (51.2%) were women, and 26 776 (39.4%) were Black, 22 131 (32.6%) non-Hispanic White, and 14 542 (21.4%) Hispanic. A total of 25 469 were randomized to nontargeted screening; 25 453, enhanced targeted screening; and 25 639, traditional targeted screening. Of the nontargeted group, 6744 participants (26.5%) completed testing and 10 (0.15%) were newly diagnosed; of the enhanced targeted group, 13 883 participants (54.5%) met risk criteria, 4488 (32.3%) completed testing, and 7 (0.16%) were newly diagnosed; and of the traditional targeted group, 7099 participants (27.7%) met risk criteria, 3173 (44.7%) completed testing, and 7 (0.22%) were newly diagnosed. When compared with nontargeted screening, targeted strategies were not associated with a higher rate of new diagnoses (enhanced targeted and traditional targeted combined: difference, -0.01%; 95% CI, -0.04% to 0.02%; RR, 0.7; 95% CI, 0.30 to 1.56; P = .38; and enhanced targeted only: difference, -0.01%; 95% CI, -0.04% to 0.02%; RR, 0.70; 95% CI, 0.27 to 1.84; P = .47). Conclusions and Relevance: Targeted HIV screening was not superior to nontargeted HIV screening in the ED. Nontargeted screening resulted in significantly more tests performed, although all strategies identified relatively low numbers of new HIV diagnoses. Trial Registration: ClinicalTrials.gov Identifier: NCT01781949.

Applying National Estimates of Adults With Indications for Pre-Exposure Prophylaxis to Populations of Men Who Have Sex With Men and People Who Inject Drugs in Colorado: Modeling Study.

BACKGROUND: Oral pre-exposure prophylaxis (PrEP) is a highly effective option for HIV prevention. To realize the full benefit of PrEP at the population level, uptake must reach those at the greatest risk of HIV acquisition. Guidance published by Centers for Disease Control and Prevention (CDC) suggests that the number of individuals with indications for PrEP is 1.1-1.2 million nationally based on survey data of key populations and local transmission patterns. We applied these estimates at state and county levels to determine the number of individuals who might benefit from PrEP locally and compared our estimates to CDC-published estimates for Colorado. OBJECTIVE: This analysis aimed to produce estimates of key populations with indications for PrEP in Colorado as a whole and by county type. These estimates will be used for public health strategic planning for HIV prevention goals at the state and county jurisdictional levels. METHODS: Colorado population estimates were obtained from the state demography office, which utilizes US decennial census data and input from county and local agencies to forecast the population. We limited our analysis to adults aged 18-59 years to be consistent with CDC methodology for PrEP estimates. We performed a literature review to define the best population-level percentages to determine numbers of HIV-negative men who have sex with men (MSM) and people who inject drugs (PWID) in Colorado. These percentages were applied to the state and to each county by its rural-urban designation. Finally, CDC-derived percentages of MSM and PWID with indications for PrEP were applied to these estimates to determine numbers of MSM and PWID who may benefit from PrEP use. RESULTS: In 2017, 3,252,648 adults aged 18-59 years were living in Colorado. By applying published estimates of percentages of men who had sex with other men in the past 12 months, we determined that 41,353-49,624 adult males could be considered sexually active MSM. We estimated that 9758-13,011 adults aged 18-59 years were likely to have injected drugs in the past 12 months. By accounting for numbers of people living with HIV in those categories and applying the CDC PrEP percentages of MSM and PWID with indications for PrEP nationally, we estimated that 8792-12,528 MSM and PWID in Colorado had indications for PrEP; this number is smaller than that estimated by CDC, although within the lower CI limit. CONCLUSIONS: By employing a simple framework consisting of census data, literature review, population estimates, and national estimates for PrEP indicators, we derived estimates for potential PrEP use in our state. Statewide estimates of key populations by state and county type will enable health officials to set informed goals and track progress toward optimizing PrEP uptake. This formula may be applicable to other states with similar epidemics and resources. .

A New Resource for STD Clinical Providers: The Sexually Transmitted Diseases Clinical Consultation Network.

An online consultation tool, the Sexually Transmitted Diseases Clinical Consultation Network is a new resource for sexually transmitted disease clinicians and clinic managers. An initial evaluation shows that most requests (29%) were from medical doctors, followed by nurse practitioners (22%). Syphilis queries comprised 39% of consults followed by gonorrhea (12%) and chlamydia (11%).

Assessing the Changing Landscape of Sexual Health Clinical Service After the Implementation of the Affordable Care Act.

INTRODUCTION: Federal health reform has the potential to impact many public health services, especially sexual health clinics. To assess the impact of such reform within the Denver Sexual Health Clinic (DSHC), we conducted a survey of patients to better understand our client population and their care-seeking behavior. METHODS: Survey data were collected from patients attending the DSHC at 3 different points in time to ascertain insurance status, reasons for not having insurance, reasons for choosing care at the DSHC, and health care use over the past 12 months. RESULTS: A total of 1603 surveys were completed. Forty-two percent of participants were enrolled in health insurance at the time of visit. The percentage of patients with Medicaid increased more than 200% across the survey cycles. Cost was the main reason cited for not having insurance. Participants identified confidentiality and convenience among the top reasons for seeking care at the DSHC regardless of sex or insurance. Although there was no difference in health care use for sexual health services, individuals with health insurance were more likely to have used nonsexual health services in the past 12 months than those without insurance. CONCLUSIONS: Patients continue to visit the DSHC despite having health insurance. Sexual health clinics must work to understand what drives people to seek care so that they can better prepare for the future.

Brief report: Validation of a quantitative HIV risk prediction tool using a national HIV testing cohort.

Routine screening is recommended for HIV detection. HIV risk estimation remains important. Our goal was to validate the Denver HIV Risk Score using a national cohort from the Centers for Disease Control and Prevention. Patients of 13 years and older were included, 4,830,941 HIV tests were performed, and 0.6% newly diagnosed infections were identified. Of all visits, 9% were very low risk (HIV prevalence = 0.20%), 27% low risk (HIV prevalence = 0.17%), 41% moderate risk (HIV prevalence = 0.39%), 17% high risk (HIV prevalence = 1.19%), and 6% very high risk (HIV prevalence = 3.57%). The Denver HIV Risk Score accurately categorized patients into different HIV risk groups.

Evaluation of the National HIV Behavioral Surveillance System among men who have sex with men in Denver, Colorado.

Denver Public Health implements the National HIV Behavioral Surveillance System (NHBS), a cyclical survey of populations at increased risk for HIV. We evaluated the implementation of NHBS among Denver men who have sex with men (MSM), considering the system's simplicity, data quality, representativeness, and sensitivity to trends. We found that the time required for implementation and the complexity of data management and analysis are barriers to disseminating local findings. Data quality has improved in each cycle of the study but must be protected by continually checking for errors and training field staff to be attentive to detail. Compared with the US census and other convenience samples of Denver MSM, the overall demographic representativeness of NHBS has improved over time. However, there is concern that the underlying population included in the study may be changing. NHBS survey data show evidence of two suspected trends in the local MSM population at risk for HIV: increasing sexual risk-taking and the transition away from bars as a dominant partner-finding location. It is unclear whether the increasing reports of sexual risk-taking reflect a real trend or simply a change in the population sampled, since most NHBS participants are recruited at gay bars and other venues. To ensure that the sample continues to represent the underlying population at risk and accurately identify trends, it is necessary to closely monitor MSM sample characteristics during implementation and incorporate weighted data provided by the Centers for Disease Control and Prevention into analyses.

Improving HIV/STD prevention in the care of persons living with HIV through a national training program.

Persons living with HIV (PLWH) are living longer, remaining sexually active, and may continue risky sexual behaviors. As such, it is crucial for providers to ask all HIV-positive patients about behaviors related to HIV transmission and STD acquisition. The "Ask, Screen, Intervene" (ASI) curriculum was developed to increase provider knowledge, skills, and motivation to incorporate risk assessment and prevention services into the care of PLWH. The ASI curriculum was delivered to 2558 HIV-care providers at 137 sites between September 30, 2007 and December 31, 2010. Immediately post-training, participants self-reported significant gains in perceived confidence to demonstrate ASI knowledge and skills (p < 0.001) and 89% agreed they would update practices as a result of the training. Three to six months post-training, 320 participants who served PLWH or supervised HIV-care providers self-reported more frequently performing ASI skills (p < 0.001), and 71% self-reported greater perceived confidence than before training to perform those skills (p < 0.001). Limitations include self-reported measures and a 30% response rate to the 3-6 month follow-up survey. Our findings suggest that a well-coordinated training program can reach a national audience of HIV-care providers, significantly increase self-reported capacity to incorporate HIV/STD prevention into the care of PLWH, and increase implementation of national recommendations.

Opportunity Knocks: HIV Prevention in Primary Care.

Expansions in health care coverage, a comprehensive framework for HIV prevention and care, electronic medical records, and novel HIV prevention modalities create a current opportunity to change the trajectory of the HIV epidemic in the United States. HIV is increasingly disproportionately found in populations historically at higher risk, including gay men and other men who have sex with men, transgender women, injection drug users, and persons of color. This underscores the need for providers to identify persons at higher risk for HIV and assure the provision of screening and prevention services. In turn, universal screening for HIV-testing every adolescent and adult at least once in their lifetime-will increasingly be necessary to find the infrequent cases of HIV in lower risk populations. In both these domains, primary care providers will play a unique role in complementing traditional providers of HIV prevention and care services by increasing the proportion of their patients who have been screened for HIV, opening dialogues around sexual health, including asking about sexual orientation and gender identity, and prescribing antivirals as pre- and postexposure prophylaxis for their non-HIV-infected patients. Primary care providers must understand and embrace their importance along the HIV prevention and care continuum.

Knowledge of pre-exposure prophylaxis (PrEP) for HIV prevention among men who have sex with men in Denver, Colorado.

As part of the National HIV Behavioral Surveillance System among men who have sex with men (MSM) in Denver, Colorado, we assessed knowledge of pre-exposure prophylaxis (PrEP); willingness to use PrEP; and potential changes in risk behaviors among HIV-negative participants reporting sexual activity with a male partner in the preceding 12 months. We examined knowledge of PrEP before (2008) and after (2011) results of the iPrEx trial were available. Of the 425 participants in the 2008 sample, 91 (21 %) were aware of PrEP compared to 131 (28 %) of the 461 participants in the 2011 sample (adjusted prevalence ratio: 1.43, 95 % confidence interval: 1.18, 1.72). Despite the increase in 2011, few MSM in Denver were aware of PrEP. Educating high-risk MSM about the potential utility of PrEP as an adjunct to other effective prevention methods is needed when considering the addition of PrEP to the HIV prevention arsenal.

Initial linkage and subsequent retention in HIV care for a newly diagnosed HIV-infected cohort in Denver, Colorado.

This is a retrospective cohort study of 352 newly diagnosed HIV-infected individuals in Denver, from 2005 to 2007. Utilizing data from 3 health care systems, 2 clinical trials units, and statewide Colorado HIV laboratory reporting databases, we tracked initial linkage to HIV care, retention in care, loss to follow-up, and transitions between HIV care providers. After more than 2.6 years of follow-up, 256 (73%) individuals linked to HIV care within 180 days. Of the 301 individuals who eventually linked to care, 168 (56%) had at least one 180-day gap in care, while 49 (16%) had a 360-day gap. Transitions in care were common, with 131 (37%) individuals accessing care from 2 different providers and 15% having evidence of living outside of Colorado. In this newly diagnosed HIV-infected cohort, linkage to care was slow and long-term retention in care was poor. Transitions between HIV care providers were common and may impair engagement in care over time. Out-of-state migration was frequent and may cause an underestimation of engagement in care.

Comparison of enhanced targeted rapid HIV screening using the Denver HIV risk score to nontargeted rapid HIV screening in the emergency department.

STUDY OBJECTIVE: A clinical prediction tool, the Denver HIV Risk Score, was recently developed to help identify patients with increased probability of undiagnosed HIV infection. Our goal was to compare targeted rapid HIV screening using the Denver HIV Risk Score to nontargeted rapid HIV screening in an urban emergency department (ED) and urgent care. METHODS: We used a prospective, before-after design at an urban medical center with an approximate annual census of 110,000 visits. Patients aged 13 years or older were eligible for screening. Targeted HIV screening of patients identified as high-risk by nurses using the Denver HIV Risk Score during medical screening was compared to nontargeted HIV screening offered by medical screening nurses during 2 separate 4-month time periods. The primary outcome was newly diagnosed HIV-infected patients. RESULTS: 28,506 patients presented during the targeted phase, 1,718 were identified as high-risk, and 551 completed HIV testing. Of these, 7 (1.3%, 95% confidence interval [CI] 0.5% to 2.6%) were newly diagnosed with HIV infection. 29,510 patients presented during the nontargeted phase and 3,591 completed HIV testing. Of these, 7 (0.2%, 95% CI 0.1% to 0.4%) were newly diagnosed with HIV infection. Targeted HIV screening was significantly associated with identification of newly diagnosed HIV infection when compared to nontargeted screening, adjusting for patient demographics and payer status (relative risk [RR] 10.4, 95% CI 3.4 to 32.0). CONCLUSION: Targeted HIV screening using the Denver HIV Risk Score was strongly associated with new HIV diagnoses when compared to nontargeted screening. Although both HIV screening methods identified the same absolute number of newly diagnosed patients, significantly fewer tests were required during the targeted phase to achieve the same effect.

Programmatic cost evaluation of nontargeted opt-out rapid HIV screening in the emergency department.

BACKGROUND: The Centers for Disease Control and Prevention recommends nontargeted opt-out HIV screening in healthcare settings. Cost effectiveness is critical when considering potential screening methods. Our goal was to compare programmatic costs of nontargeted opt-out rapid HIV screening with physician-directed diagnostic rapid HIV testing in an urban emergency department (ED) as part of the Denver ED HIV Opt-Out Trial. METHODS: This was a prospective cohort study nested in a larger quasi-experiment. Over 16 months, nontargeted rapid HIV screening (intervention) and diagnostic rapid HIV testing (control) were alternated in 4-month time blocks. During the intervention phase, patients were offered HIV testing using an opt-out approach during registration; during the control phase, physicians used a diagnostic approach to offer HIV testing to patients. Each method was fully integrated into ED operations. Direct program costs were determined using the perspective of the ED. Time-motion methodology was used to estimate personnel activity costs. Costs per patient newly-diagnosed with HIV infection by intervention phase, and incremental cost effectiveness ratios were calculated. RESULTS: During the intervention phase, 28,043 eligible patients were included, 6,933 (25%) completed testing, and 15 (0.2%, 95% CI: 0.1%-0.4%) were newly-diagnosed with HIV infection. During the control phase, 29,925 eligible patients were included, 243 (0.8%) completed testing, and 4 (1.7%, 95% CI: 0.4%-4.2%) were newly-diagnosed with HIV infection. Total annualized costs for nontargeted screening were $148,997, whereas total annualized costs for diagnostic HIV testing were $31,355. The average costs per HIV diagnosis were $9,932 and $7,839, respectively. Nontargeted HIV screening identified 11 more HIV infections at an incremental cost of $10,693 per additional infection. CONCLUSIONS: Compared to diagnostic testing, nontargeted HIV screening was more costly but identified more HIV infections. More effective and less costly testing strategies may be required to improve the identification of patients with undiagnosed HIV infection in the ED.

Implementation and effectiveness of an expedited partner therapy program in an urban clinic.

BACKGROUND: Partner notification of exposure to gonorrhea or chlamydia is traditionally conducted by the index case or a disease intervention specialist. However, a significant proportion of partners remain untreated and thus are at risk for continued transmission. Expedited partner therapy (EPT) obviates the requirement for a health care visit by the partner: the index case delivers medications to the partner. Although shown to be efficacious in randomized control trials, effectiveness studies of delivering EPT in real-world situations are needed. We describe the implementation, patient characteristics, and clinical impact of an EPT program at the Denver Metro Health Clinic (DMHC). METHODS: We identified 2578 patient visits eligible for EPT (heterosexual men or women diagnosed as having chlamydia or gonorrhea) from November, 2006, to April, 2011. We examined EPT acceptance rates over clinical process improvements. To measure clinical impact, we assessed the association between initial acceptance of EPT and infection status among 351 patients who returned for retesting. RESULTS: Requiring complete documentation of EPT in the clinic electronic medical record increased EPT acceptance from 20% to 48%. Expedited partner therapy acceptance was associated with a reduced risk of chlamydial reinfection (odds ratio, 0.7; 95% confidence interval, 0.3-1.6) and a reduced risk of gonorrheal reinfection (odds ratio, 0.5; 95% confidence interval, 0.2-1.4); however, these changes were not statistically significant. CONCLUSIONS: Expedited partner therapy at the DMHC was substantially enhanced by process changes in the clinic and may be associated with a decreased risk of reinfection.

Derivation and validation of the Denver Human Immunodeficiency Virus (HIV) risk score for targeted HIV screening.

Targeted screening remains an important approach to human immunodeficiency virus (HIV) testing. The authors aimed to derive and validate an instrument to accurately identify patients at risk for HIV infection, using patient data from a metropolitan sexually transmitted disease clinic in Denver, Colorado (1996-2008). With multivariable logistic regression, they developed a risk score from 48 candidate variables using newly identified HIV infection as the outcome. Validation was performed using an independent population from an urban emergency department in Cincinnati, Ohio. The derivation sample included 92,635 patients; 504 (0.54%) were diagnosed with HIV infection. The validation sample included 22,983 patients; 168 (0.73%) were diagnosed with HIV infection. The final score included age, gender, race/ethnicity, sex with a male, vaginal intercourse, receptive anal intercourse, injection drug use, and past HIV testing, and values ranged from -14 to +81. For persons with scores of <20, 20-29, 30-39, 40-49, and ≥50, HIV prevalences were 0.31% (95% confidence interval (CI): 0.20, 0.45) (n = 27/8,782), 0.41% (95% CI: 0.29, 0.57) (n = 36/8,677), 0.99% (95% CI: 0.63, 1.47) (n = 24/2,431), 1.59% (95% CI: 1.02, 2.36) (n = 24/1,505), and 3.59% (95% CI: 2.73, 4.63) (n = 57/1,588), respectively. The risk score accurately categorizes patients into groups with increasing probabilities of HIV infection.