Abstract Background Addressing Social Determinants of Health (SDOH) and health disparities is at the core of “Ending the HIV Epidemic.” To address SDOH, there is a funded HIV Care Coordination Program (CCP) at Henry Ford Health (HFH), with support to surmount SDOH in people with HIV (PWH). In this pilot study, we explore associations between SDOH and treatment failure (TF) in this program. Methods A retrospective study was conducted on PWH in our CCP at HFH from 2022 to 2023. Variables were extracted from data monitoring. CCP enrollment required referral by HIV providers. PWH were surveyed on SDOH related to ART challenges, and these SDOH were assessed throughout the course of one year. HIV genotypes were obtained upon enrollment, and HIV-1 viral load (VL) was collected every 3 months for one year. Significant differences between PWH with or without TF (defined as VL > 200 copies/mL at 1 year) were determined using Chi-Square test for categorical variables and Kruskal-Wallis for continuous variables. Multivariable logistic regression was used to find associations between independent variables and TF. Results A total of 144 PWH were included in this study and divided into with (n=26) and without (n=118) TF (Table 1). There were no statistically significant differences in age, gender, risk factors and mean years living with HIV between the two groups. TF PWH had significantly lower incidence of insurance issues and need for financial assistance. Using linear regression analysis while adjusting for age, race, gender, genotype and other SDOH factors, there was no significant association between insurance issues or financial assistance. Although drug resistant mutations (DRMs) were not linked to specific demographics or SDOH, TF PWH had a significantly higher number of DRMs at baseline (p< 0.0176, OR 3.45, 95% CI 1.24-9.60) and a trend towards increased low frequency (< 10%) DRMs. Conclusion TF occurred in 18% of PWH with adverse SDOH at enrollment into CCP. While we were unable to identify an association of specific SDOH with TF, the TF rate was elevated in these PWH. Overcoming SDOH is essential to achieve viral suppression. DRMs at CCP entry were significantly associated with TF, and were present in all those with TF. Our study is ongoing, and with larger numbers, we aim to assess the impact of SDOH in TF PWH in future studies. Disclosures Indira Brar, MD, Gilead: Advisor/Consultant|Gilead: Grant/Research Support|Gilead: Honoraria|Merck: Grant/Research Support|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Honoraria

Abstract Background We observed an increase in the frequency of false-positive (FP) human immunodeficiency virus (HIV) test results that correlated with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) prevalence. We measured FP rates of laboratory-based fourth-generation HIV antigen/antibody test among those with polymerase chain reaction (PCR)-confirmed infection with SARS-CoV-2 compared with FP rate of those who tested SARS-CoV-2 PCR-negative. Methods All patients PCR tested for SARS-CoV-2 within 2 weeks of an HIV fourth-generation assay were selected. Positive HIV fourth-generation assays were reviewed and divided into groups of FP, true positive (TP), and presumptive negative (PN). Variables included age, race, ethnicity, gender, pregnancy, and Coronavirus Disease 2019 (COVID-19) immunization status. Associations with positive SARS-CoV-2 tests were assessed using linear logistic regression. Multivariate logistic regression was used to assess sets of variables. Results There were 31 910 medical records that met criteria. The frequency of SARS-CoV-2 positive tests was calculated in groups of HIV TP, FP, and PN. In total, 31 575 patients had PN HIV test result, 248 patients had TP, and 87 patients had FP. Those with HIV FP tests had the highest percentage of COVID-19–positive test results at 19.5%, which was significantly higher than HIV PN (11.3%; P = .016) and HIV TP (7.7%; P = .002). After adjustment for all covariates, only FP HIV was significantly associated with COVID-19 (odds ratio, 4.22; P = .001). Conclusions This study reveals that patients with positive SARS-CoV-2 PCR tests are significantly more likely to have an FP fourth-generation HIV test than those with negative SARS-CoV-2 PCR tests.

Abstract Background Cabotegravir (CAB) + rilpivirine (RPV) is the first recommended complete long-acting (LA) regimen for maintenance of HIV-1 virologic suppression. The efficacy and safety of switching to CAB + RPV LA (CAR) has been shown in clinical trials. CAR injections offer less frequent dosing and address issues of adherence and disclosure related to daily oral cART. We describe the clinical characteristics and outcomes of switching a diverse group of people with HIV (PWH) to CAR in a real-world setting. Methods A retrospective cohort study was performed to assess virologic efficacy of intramuscular CAR given every 4 or 8 weeks among adult PWH receiving care at Henry Ford Health ID Clinic by an interdisciplinary team of physicians, nurses, social workers, and a pharmacist. Efficacy was defined as HIV-1 RNA < 20 copies/mL at 3 months. Demographics, clinical characteristics, and outcomes were extracted from the electronic medical record. Results We included the first 51 patients to receive CAR. Median age was 46 years (IQR 34 -59). Black individuals were 75%, cisgender males 84%, and transgender females 3.9% of participants. PWH were diagnosed a median of 12 years ago (IQR 11-17). At time of switch, 90% had HIV viral load (VL) < 20 copies/ml, and 9.8% of patients were viremic with < 75 copies/ml. Mean Cd4+ cell count was 871 cells/µL (IQR 632-1603). Prior to switch, 80% had received ≥ 2 cART regimens, 75% had INSTI exposure, and 45% had NNRTI exposure. Among 38 patients with HIV-1 genotypes available prior to switch, 4 had either baseline NNRTI or INSTI mutations (Table 2). For patients with VL data at 3 months, 37 of 38 (98%) had an undetectable VL. Virologic failure occurred in 1 PWH with BMI 35 who had a Y188L RT mutation in a 2009 genotype which did not include RPV (2011 approval), with subsequent emergence of pan-NNRTI and INSTI resistance. Conclusion A high degree of virologic suppression at 3 months was achieved among an older, diverse cohort of PWH cared for by an interdisciplinary team. Unrecognized baseline HIV resistance to NNRTI contributed to one virologic failure. It is important to assure that genotypic susceptibility interpretations are current and to carefully assess for eligibility before switching to CAR. Disclosures John Di Lodivico, PharmD, Midwest AIDS Training & Education Center: Honoraria|ViiV Healthcare: Advisor/Consultant|Wayne State University: Honoraria Indira Brar, MD, Gilead: Advisor/Consultant|Gilead: Grant/Research Support|Gilead: Honoraria|Janssen: Grant/Research Support|Janssen: Honoraria|ViiV: Advisor/Consultant|ViiV: Grant/Research Support|ViiV: Honoraria

Abstract Background COVID-19 has threatened health care for many individuals. Restriction of resources, redeployment of staff, and patient reluctance to make clinic appointments disrupts continuity of care of existing patients and limits access to care of new ones. To overcome this, our HIV clinic aggressively promoted a telehealth, MyChart (MC) application, and provided smart phone technology to those in need. Despite these efforts, we found that utilization of telehealth accounted for 4.7% of HIV clinic visits, compared to 25% in internal medicine clinics. In this report, we sought to obtain reasons why our patients were reluctant to use telehealth even in the midst of a pandemic. Methods All Ryan White (RW) people living with HIV (PLWH) at Henry Ford Hospital that were initiated in our telehealth pilot program were surveyed on the underutilization of MC. Utilization was determined by if PLWH responded to a MC notification sent by the telehealth navigator. Activity level was established on MC (Figure 1), and if PLWH did not respond, they were called as a follow up for survey answers. Results From 10/2020 – 01/2022, 206 PLWH were enrolled into our pilot program and given telehealth education. Of those successfully enrolled: 83.7% were black, 73% male, 57% were older than 45 years, 88% lived in Wayne County, and 27 needed and received pre-loaded smart phones. When contacted, 90 (44%) interacted on MC, 61 (29%) were unable to be reached and 55 (27%) successfully completed the survey (Figure 2). When asked why telehealth was not utilized, 27 (49%) stated they preferred in-person visits (Figure 3). Conclusion Telehealth programs can help overcome barriers to HIV care and maintain patient engagement when crises interrupt traditional care models. However, our study suggests that our PLWH preferred and felt safe engaging with in-person visits despite telehealth education and smartphone supplementation even in a pandemic. As the future of medicine moves towards telehealth management, we must not forget our vulnerable populations and find opportunities to safely engage with in-person visits. Disclosures Indira Brar, MD, Gilead: Grant/Research Support|Gilead: speakers bureau|Janssen: Grant/Research Support|Janssen: speakers bureau.

Background COVID-19, a novel respiratory illness caused by SARS-CoV-2, has become a global pandemic. As of December 2020, 4.8% of the 941 people living with HIV in our Ryan White clinic have tested polymerase chain reaction positive for SARS-CoV-2. The aim of our study was to estimate the seroprevalence of COVID-19 in our Ryan White people living with HIV, irrespective of known past infection. Methods We conducted a cross-sectional study that recruited people living with HIV in the Ryan White program at Henry Ford Hospital in Detroit, Michigan, from September 2020 through May 2021. All Ryan White patients were offered participation during clinic visits. After informed consent, patients completed a survey, and had blood sampled for SARS-CoV-2 antibody testing. Results Of the 529 individuals who completed the written survey, 504 participants were tested for SARS-CoV-2 antibody and 52 people living with HIV were COVID-19 immunoglobulin (Ig) G positive resulting in a seroprevalence of 10.3%. Among 36 persons with PCR-confirmed COVID-19, 52.8% were IgG negative. Inclusion of PCR positive but IgG-negative people living with HIV yields a COVID-19 infection prevalence of 14.1%. Conclusions These findings suggest that passive public health-based antibody surveillance in people living with HIV significantly underestimates past infection.

Abstract Background The COVID-19 Pandemic led to many restrictions in health care services, and as a consequence, an expansion of telehealth capabilities. In order to meet the needs of PLWH along the Care Continuum, we developed a process to promote the use of our MyChart app. This HIPAA-compliant app allows patients to view their medical records, communicate with their providers, make appointments, and have video visits on their smart devices. This report describes our preliminary findings. Methods PLWH enrolled in the Ryan White Program, in the Infectious Diseases Clinic at Henry Ford Hospital who had not used telehealth services were asked to sign up for our MyChart (electronic medical record software) initiative. A telehealth Navigator interviewed and taught PLWH how to download and use MyChart, and supplied pre-loaded phones, as needed, to make virtual visits accessible. We collected demographic and clinical information and reasons for not using telehealth services. Results From October 2020 to May 2021, 209 PLWH were enrolled into our pilot program (Table 1). Of these: 48% were 45-64 years old (yo), while 21% were >/+ 60 yo and 3% < 25 yo; 75% were male, 85% Black; 48% MSM, and 84% virally suppressed (HIV RNA < 200 copies/mm3). When asked why they were not using telehealth services, 29% reported a lack of technology or capability to install MyChart on their phones, 27% needed further education, and 18% and had not prioritized installation of the application. Conclusion The crises created by the COVID-19 pandemic revealed a new role for telehealth services. Although available to all PLWH in our RW program, many had never used telehealth services. Over half lacked compatible devices or needed help to download or use the app. Compared to younger PLWH, older individuals were more likely to need assistance. Further work is needed to understand and promote digital parity. Disclosures All Authors: No reported disclosures

Background: COVID-19 first reported in the US on 1/2020 is a global pandemic. In PLWH, COVID-19 outcomes have been reported to be similar or worse compared to the general population;however, the seroprevalence in this group has not been identified. As of 6/2020, 2.7% of the 960 PLWH in our Ryan-White (RW) clinic have tested PCR+ for COVID-19. Yet, these likely represent only a fraction of COVID-19 infections, as an unknown proportion of cases are mild or asymptomatic and not diagnosed. Our goal was to estimate the seroprevalence in our RW patients (pts), irrespective of known past COVID-19 infection. The RW program funds HIV care for a diverse group impacted by a number of social determinants of health, including low socioeconomic status. Methods: We conducted a seroprevalence study, which recruited pts in the RW program at Henry Ford Hospital. All RW pts were offered participation during clinic visits. After informed consent, pts completed a survey and had blood sampled for COVID-19 antibody using the Beckman Coulter Access SARS-CoV-2 IgG assay. Pts' electronic medical records were reviewed for demographic clinical features, including previous COVID-19 testing. The study was IRB approved. Results: 187 PLWH were enrolled from 9/2020-11/2020 (Table 1). Median age: 46 (IQR: 34-57);153 males;152 black;24 reported a previous COVID-19 exposure;66 had a BMI of >/= 30. Mean CD4 count was 629.5 (IQR: 390-859), and 129 pts were HIV suppressed. 17 had PCR-confirmed COVID-19, and 16 reported symptoms consistent with COVID-19 but with unconfirmed diagnoses. Of 187 PLWH, 25 (13%) were COVID-19 IgG+ of whom 8 were previously PCR+. 9/17 PLWH who were PCR+ for COVID-19 were COVID-19 IgG negative at a mean of 7 months from the initial PCR test. Conclusion: The COVID-19 seroprevalence of 13% reported in this study of PLWH in our clinic was about 5-fold greater than the number of reported cases by PCR+ in the same population. This estimate of past infection is also an underestimate given the absence of antibody at the time of the serological testing in 53% of PLWH with documented PCR+ infection and the likelihood of infection in some of those never tested. Conversely, the impact of health disparities on the RW pts likely increases the chance of acquisition of COVID-19 compared to other populations. In order to better understand the penentration of COVID-19 into the PLWH community, a greater understanding of the dynamics of the antibody response to COVID-19 is needed.

BACKGROUND:Justice-involved youth have higher rates of sexually transmitted infections (STIs), and a higher prevalence of the associated sexual risk behaviors. Sexual risk behaviors are also associated with alcohol and drug use. Research suggests that a history of trauma is an important predictor of alcohol and drug use in youth offenders, and therefore is a likely contributor to sexual risk behavior in this population. The objective of this analysis is to determine the association of trauma, specifically, domestic violence and forced sex, to six sexual risk behaviors and a history of chlamydia among detained youth. METHODS:The analysis uses data from a convenience sample of detainees assenting to HIV testing conducted December 2016 - August 2017 using the state-certified Voluntary Counseling Testing and Referral (VCTR) process. RESULTS:Of the 379 youth that received VCTR at the facility, 308 (81.3%) were used in this analysis. Report of domestic violence was significantly associated with sex under the influence of alcohol and was also significantly associated with sex under the influence of marijuana. Forced sex was associated with a sexual partner of unknown HIV status. CONCLUSIONS:Traumatic experiences were related to sexual risk behaviors in this analysis, and substance use was strongly implicated in the association. Trauma is known to be a catalyst to sexual risk behaviors, substance use, and delinquency in adolescence. Results support the findings of other investigators and re-iterate the need for trauma-informed interventions that can improve the life trajectories of detained youth.

Abstract Rationale: Transmitted resistance to integrase strand inhibitors (INSTI) has been uncommon, but is slowly becoming more prevalent among those living with HIV. In an era with 2-drug regimens for antiretroviral therapy, transmitted resistance for INSTI is alarming. Patient concerns: A 28-year-old African American female was recently diagnosed with HIV during a 30-week prenatal visit. Diagnosis: HIV 4th generation test was positive as well as confirmation. Genotype was performed using next generation sequencing. Interventions: Patient was initially rapidly started on a dolutegravir based regimen and changed to a protease inhibitor regimen once her genotype reported an S230R mutation. Outcomes: Patient became virally suppressed on antiretroviral therapy and delivered an HIV negative baby. Lessons: INSTI resistance testing should be done for treatment-naïve and INSTI-naïve persons, particularly when considering 2 drug INSTI based regimens.

Background: COVID-19 disease has spread globally and was declared a pandemic on March 11, 2020, by the World Health Organization. On March 10, the State of Michigan confirmed its first 2 cases of COVID-19, and the number of confirmed cases has reached 47,182 as of May 11, 2020, with 4555 deaths. Setting: Currently, little is known if patients living with HIV (PLWH) are at a higher risk of severe COVID-19 or if their antiretrovirals are protective. This study presents epidemiologic and clinical features of COVID-19 infected PLWH in Detroit, Michigan. Methods: This is a case series that included 14 PLWH with laboratory-confirmed COVID-19 infection who were evaluated at Henry Ford Hospital in Detroit, Michigan, between March 20, 2020, and April 30, 2020. Results: Fourteen PLWH were diagnosed with COVID-19. Twelve patients were men and 2 were women; 13 patients were virally suppressed. Eight patients were hospitalized, and 6 patients were told to self-quarantine at home after their diagnoses. Three patients who were admitted expired during their hospital stay. No patient required bilevel positive airway pressure or nebulizer use in the emergency department, and none developed acute respiratory distress syndrome, pulmonary embolism, deep venous thrombosis, or a cytokine storm while on therapy for COVID-19. Conclusion: Although the clinical spectrum of COVID-19 among PLWH cannot be fully ascertained by this report, it adds to the data that suggest that HIV-positive patients with SARS-CoV-2 infection are not at a greater risk of severe disease or death as compared to HIV-negative patients.

We report a case of a 78-year-old female with a medical history of metastatic breast cancer receiving chemotherapy who presented to the emergency department (ED) in the summertime complaining of dizziness and a cough. She had recently been seen by her primary care provider for shortness of breath, at which time a left-sided infiltrate was noted on chest X ray. A 5-day course of oral azithromycin had been prescribed for community-acquired pneumonia (CAP). She failed to improve and did not complete the treatment, because she presented to the ED prior to the end of therapy. She reported decreased appetite, fatigue, and shortness of breath. On physical examination, she was afebrile and tachycardic, and diminished breath sounds were auscultated in the left base. The complete blood count was notable for the absence of leukocytosis. Blood cultures were sent, and a chest X ray revealed hazy opacities in the left upper lobe (Fig. 1). No other testing, including respiratory or molecular tests, was conducted at that time, and the patient left the ED against medical advice.

People living with human immunodeficiency virus (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD) and are prone to statin-related adverse events from drug–drug interactions with certain antiretroviral regimens. This study sought to evaluate the efficacy and safety of evolocumab in dyslipidemic PLHIV. BEIJERINCK (EvolocumaB Effect on LDL-C Lowering in SubJEcts with Human Immunodeficiency VirRus and INcreased Cardiovascular RisK) is a randomized, double-blind, multinational trial comparing monthly subcutaneous evolocumab 420 mg with placebo in PLHIV with hypercholesterolemia/mixed dyslipidemia taking maximally-tolerated statin therapy. The primary endpoint was the percent change (baseline to week 24) in low-density lipoprotein cholesterol (LDL-C); secondary endpoints included achievement of LDL-C <70 mg/dl and percent change in other plasma lipid and lipoprotein levels. Treatment-emergent adverse events were also examined. A total of 464 patients were analyzed (mean age of 56.4 years, 82.5% male, mean duration with HIV of 17.4 years). ASCVD was documented in 35.6% of patients, and statin intolerance/contraindications to statin use were present in 20.7% of patients. Evolocumab reduced LDL-C by 56.9% (95% confidence interval: 61.6% to 52.3%) from baseline to week 24 versus placebo. An LDL-C level of <70 mg/dl was achieved in 73.3% of patients in the evolocumab group versus 7.9% in the placebo group. Evolocumab also significantly reduced other atherogenic lipid levels, including non–high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) (all p < 0.0001). Evolocumab was well tolerated, and treatment-emergent adverse events patient incidence was similar among evolocumab and placebo groups. Evolocumab was safe and significantly reduced lipid levels in dyslipidemic PLHIV on maximally-tolerated statin therapy. Evolocumab is an effective therapy for lowering atherogenic lipoproteins in PLHIV with high cardiovascular risk. (Safety, Tolerability & Efficacy on LDL-C of Evolocumab in Subjects With HIV & Hyperlipidemia/Mixed Dyslipidemia; NCT02833844)

Background: Despite treatment with licensed antiviral agents, high rates of influenza-related morbidity and mortality occur worldwide.Methods: Adults hospitalized with laboratory-confirmed influenza were randomized (1:1) to a single double-blind infusion of high-titer anti-influenza intravenous immunoglobulin (hIVIG) or saline placebo. The primary endpoint was an ordered categorical outcome, ranging in severity from death to post-discharge resumption of normal activities, assessed at Day 7. The odds ratio (OR) (hIVIG versus placebo) of a favorable outcome was estimated with a proportional odds model.Findings: Of 308 randomized patients, 73% and 27% had influenza A and B, respectively; antiviral use was 95%. As expected, hIVIG produced a robust rise in influenza A hemagglutination inhibition (HAI) titers, and smaller rises in influenza B titers. Viral load declined after 3 days by 1.99 (hIVIG) versus 2.32 log10 copies/mL (placebo) (p=0.49). The OR for favorable outcome was 1.25 (95% confidence interval [CI] 0.79-1.97, p=0.33). ORs for influenza A and B were 0.94 (95% CI: 0.55-1.59) and 3.19 (95% CI: 1.21-8.42), respectively (p=0.02 for difference). This difference between influenza A and B was mirrored for secondary clinical outcomes, changes in viral load, and in sensitivity analyses, overall and by strain. To investigate this outcome further, anti-HA antibody affinities were measured in the hIVIG lots administered, and much stronger antibody affinities for B strains were observed than for A in hIVIG used.Interpretation: Overall, hIVIG was not superior to placebo for adults hospitalized with influenza. In contrast to our pre-study subgroup hypothesis based upon conventional HAI titers in hIVIG, benefit was evident for those with influenza B but not A. Consistent with findings of a contemporaneous anti-influenza plasma trial (IRC005), adjunctive immunotherapy appears ineffective for severe influenza A. The beneficial effect of hIVIG for influenza B is supported by antibody affinity analyses, but confirmation of clinical benefit is warranted.Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02287467.Funding: NIAID, NIH.Declaration of Interest: There are no competing interests to declare in regard to this manuscript submission.Ethical Approval: The trial was approved by the institutional review board or ethics committee for each clinical site. All patients provided written informed consent.

BACKGROUNDSyphilis transmission can be prevented by prompt diagnosis and treatment of primary and secondary infection. We evaluated the performance of a point-of-care rapid syphilis treponemal (RST) test in an emergency department (ED) setting.METHODSBetween June 2015 and April 2016, men aged 18 to 34 years seeking services in a Detroit ED, and with no history of syphilis, were screened for syphilis with the RST test, rapid plasma reagin (RPR) test, and Treponema pallidum particle agglutination assay (TP-PA). A positive reference standard was both a reactive RPR and a reactive TP-PA. We compared test results in self-reported men who have sex with men (MSM) to non-MSM.RESULTSAmong 965 participants, 10.9% of RST tests were reactive in MSM and only 1.5% in non-MSM (P < 0.001). Sensitivity of the RST test was 76.9% and specificity was 99.0% (positive predictive value, 50.0%) compared with the positive reference standard. Three discordant specimens found negative with the RST test but positive with the reference standard had an RPR titer of 1:1, compared with 10 specimens with concordant positive results that had a median RPR titer of 1:16. The RST sensitivity was 50.0% (positive predictive value, 68.4%) compared to the TP-PA test alone. Among men seeking care in an ED, the RST detected 76.9% of participants with a reactive RPR and TP-PA.CONCLUSIONSThe RST test detected all of the participants with an RPR titer ≥1:2 but less than 20% of participants with a positive TP-PA and negative RPR. The RST test was useful to detect a high proportion of participants with an active syphilis in an urban ED.

Background Since the 1918 influenza pandemic, non-randomised studies and small clinical trials have suggested that convalescent plasma or anti-influenza hyperimmune intravenous immunoglobulin (hIVIG) might have clinical benefit for patients with influenza infection, but definitive data do not exist. We aimed to evaluate the safety and efficacy of hIVIG in a randomised controlled trial. Methods This randomised, double-blind, placebo-controlled trial was planned for 45 hospitals in Argentina, Australia, Denmark, Greece, Mexico, Spain, Thailand, UK, and the USA over five influenza seasons from 2013-14 to 2017-18. Adults (>= 18 years of age) were admitted for hospital treatment with laboratory-confirmed influenza A or B infection and were randomly assigned (1:1) to receive standard care plus either a single 500-mL infusion of high-titre hIVIG (0.25 g/kg bodyweight, 24.75 g maximum; hIVIG group) or saline placebo (placebo group). Eligible patients had a National Early Warning score of 2 points or greater at the time of screening and their symptoms began no more than 7 days before randomisation. Pregnant and breastfeeding women were excluded, as well as any patients for whom the treatment would present a health risk. Separate randomisation schedules were generated for each participating clinical site using permuted block randomisation. Treatment assignments were obtained using a web-based application by the site pharmacist who then masked the solution for infusion. Patients and investigators were masked to study treatment. The primary endpoint was a six-category ordinal outcome of clinical status at day 7, ranging in severity from death to resumption of normal activities after discharge. The choice of day 7 was based on haemagglutination inhibition titres from a pilot study. It was analysed with a proportional odds model, using all six categories to estimate a common odds ratio (OR). An OR greater than 1 indicated that, for a given category, patients in the hIVIG group were more likely to be in a better category than those in the placebo group. Prespecified primary analyses for safety and efficacy were based on patients who received an infusion and for whom eligibility could be confirmed. This trial is registered with ClinicalTrials.gov, NCT02287467. Findings 313 patients were enrolled in 34 sites between Dec 11, 2014, and May 28, 2018. We also used data from 16 patients enrolled at seven of the 34 sites during the pilot study between )an 15, 2014, and April 10, 2014. 168 patients were randomly assigned to the hIVIG group and 161 to the placebo group. 21 patients were excluded (12 from the hIVIG group and 9 from the placebo group) because they did not receive an infusion or their eligibility could not be confirmed. Thus, 308 were included in the primary analysis. IsIVIG treatment produced a robust rise in haemagglutination inhibition titres against influenza A and smaller rises in influenza B titres. Based on the proportional odds model, the OR on day 7 was 1.25 (95% CI 0.79-1.97; p=0.33). In subgroup analyses for the primary outcome, the OR in patients with influenza A was 0.94 (0.55-1.59) and was 3.19 (1.21-8.42) for those with influenza B (interaction p=0.023). Through 28 days of follow-up, 47 (30%) of 156 patients in the hIVIG group and in 45 (30%) of 152 patients in the placebo group had the composite safety outcome of death, a serious adverse event, or a grade 3 or 4 adverse event (hazard ratio [HR] 1.06, 95% CI 0.70-1.60; p=0.79). Six (4%) patients in the hIVIG group and five (3%) in the placebo group died, but these deaths were not necessarily related to treatment. Interpretation When administered alongside standard care (most commonly oseltamivir), hIVIG was not superior to placebo for adults hospitalised with influenza infection. By contrast with our prespecified subgroup hypothesis that hIVIG would result in more favourable responses in patients with influenza A than B, we found the opposite effect. The clinical benefit of hIVIG for patients with influenza B is supported by antibody affinity analyses, but confirmation is warranted. Copyright (C) 2019 The Author(s). Published by Elsevier Ltd.

This scoping review was conducted to collate and summarize the published research literature addressing sexual and gender minority care in the emergency department (ED).Using PRISMA-ScR criteria, an electronic search was conducted of CINAHL, Embase, Ovid Medline, and Web of Science for all studies that were published after 1995 involving sexual and gender minorities, throughout all life stages, presenting to an ED. We excluded non-US and Canadian studies and editorials. Titles and abstracts were screened, and full-text review was performed independently with 4 reviewers. Abstraction focused on study design, demographics, and outcomes, and the resulting data were analyzed using an ad hoc iterative thematic analysis.We found 972 unique articles and excluded 743 after title and abstract screening. The remaining 229 articles underwent full-text review, and 160 articles were included. Themes identified were HIV in sexual and gender minorities (n=61), population health (n=46), provider training (n=29), ED avoidance or barriers (n=23), ED use (n=21), and sexual orientation/gender identity information collection (n=9).The current literature encompassing ED sexual and gender minority care cluster into 6 themes. There are considerable gaps to be addressed in optimizing culturally competent and equitable care in the ED for this population. Future research to address these gaps should include substantial patient stakeholder engagement in all aspects of the research process to ensure patient-focused outcomes congruent with sexual and gender minority values and preferences.

Long-lived reservoirs of persistent HIV are a major barrier to a cure. CD4+ hematopoietic stem and progenitor cells (HSPCs) have the capacity for lifelong survival, self-renewal, and the generation of daughter cells. Recent evidence shows that they are also susceptible to HIV infection in vitro and in vivo. Whether HSPCs harbor infectious virus or contribute to plasma virus (PV) is unknown. Here, we provide strong evidence that clusters of identical proviruses from HSPCs and their likely progeny often match residual PV. A higher proportion of these sequences match residual PV than proviral genomes from bone marrow and peripheral blood mononuclear cells that are observed only once. Furthermore, an analysis of near-full-length genomes isolated from HSPCs provides evidence that HSPCs harbor functional HIV proviral genomes that often match residual PV. These results support the conclusion that HIV-infected HSPCs form a distinct and functionally significant reservoir of persistent HIV in infected people.

Abstract Background OPAT is widely implemented in the United States. However, there are concerns surrounding discharge of IDU with a peripherally inserted central catheter (PICC). The objective of this study was to evaluate the characteristics and treatment outcomes of IDUs discharged on OPAT. Methods This is a retrospective observational study conducted on patients discharged from an Infectious Diseases unit at a quaternary academic healthcare center in Detroit. Charts of all IDUs discharged on OPAT between 2011 and 2017 were reviewed. Current or former IDU were discharged on OPAT if they met the following criteria: self-reported history of IDU, stable living conditions, controlled psychiatric illness (if present), and willingness to sign a discharge agreement to refrain from using the PICC as a route for illicit drugs. Patients were categorized based on clinic follow-up vs. no clinic follow-up. Outcomes evaluated were: cured (completed treatment and symptom free for 1 month after completion), improved (symptoms were improved but there was no confirmation of treatment completion); and relapsed (readmitted within 30 days for the same infection or sequela). Outcomes of patients with no clinic follow-up were based on chart review of subsequent emergency department visits or admissions. Results Patient characteristics are shown in Table 1. Of the 61 patients evaluated, 33 (54.1%) attended clinic follow-up and 28 (45.9%) did not. Outcomes based on clinic follow-up are shown in Table 2. Of the 18 patients who were cured, 16 attended clinic follow-up vs. two who did not. Conclusion This study demonstrates that some IDUs can be discharged safely on OPAT. Patients with clinic follow-up had improved outcomes compared with those who did not. Further studies are needed to look at other predictors of outcome in this patient population. Table 1: Patient Characteristics PatientsN = 61 (%) Age (mean ± SD) ±12.4 Male 33 (54.1) Length of stay (days)mean ± SD ± 10.9 IVDU status Active 49 (80.3) Former 10 (16.4) Unknown 2 (3.3) Psychiatric illness 12 (19.7) Disposition Home 37 (60.6) Nursing facility 24 (39.3) Table 2. Outcome Based on Clinic Follow-up Clinic Follow-upN = 33 (%) No Clinic Follow-upN = 12 (%) P value Cured 16 (48.5) 2 (16.7) 0.086 Improved 14 (42.4) 6 (50) 0.74 Relapsed 3 (9) 4 (33.3) 0.069 Sixteen patients were excluded from the analysis because their outcome was unknown. Disclosures All authors: No reported disclosures.