Pragmatic Assessment of Influenza Vaccine Effectiveness in the Department of Defense (PAIVED): Updates from Year 4 of a Multi-site Trial

Background. The effectiveness of the influenza vaccine is varies with circulating strain concordance and timing of influenza spread in a community. The Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED) study is a multiyear, randomized clinical trial of three FDA-licensed vaccine types (egg-based, cellbased, and recombinant), designed to determine which influenza vaccine platform is most effective among adults in a military setting. Methods. Participants in the fourth year of PAIVED (2021-22 influenza season) were enrolled from September 2021 through January 2022 at 9 military facilities. Participants were asked each week about influenza-like illness (ILI) symptoms. If the participants reported ILI symptoms, research staff scheduled an acute and convalescent ILI visit. Additional details about the study are included in Figure 1. Results. In year 4, 4,688 participants were enrolled, among whom 63.8% were male, 56.5% were white, and the average age was 34 years (Tables 1 and 2). As of early April, 1,297 ILIs had been reported. Most participants reported a single ILI (987 (87%)), while 140 participants reported two ILIs and 10 reported three ILIs. The mean duration of the reported ILIs was 11 days, with a mean 5 days of limited activity. Three participants were hospitalized. Among the samples processed to date, influenza has been identified in four participants. Themost common pathogens in year 4 were SARS-CoV-2 and rhino/enterovirus (Figure 2). During all four years of PAIVED, we enrolled 15,449 participants, among whom 188 episodes of influenza have been identified so far (1.2%). Conclusion. The fourth year of PAIVED was characterized by early (preenrollment) spread of influenza in some areas, as well the nationwide spread of the SARS-CoV-2 Omicron variant in December. As the swabs are processed and participants? military health records are reviewed, we expect to identify more influenza cases;however, transmission patterns were far lower than historical averages due to pandemic precautions, making this surveillance data from identified strains more valuable. Comparative influenza vaccine effectiveness calculations will be performed to inform future vaccine purchasing decisions and we will compare serological response to the different vaccines. (Figure Presented).

Pathogen Co-infections and Trends in Influenza-like Illness in PAIVED

Background. The Pragmatic Assessment of Influenza Vaccine Effectiveness in the Department of Defense (DoD) (PAIVED) is a multicenter, multiservice study assessing influenza vaccine effectiveness in active-duty service members, retirees, and dependents. In its fourth season (2021/22), PAIVED offers a unique opportunity to examine influenza-like illness (ILI) trends prior to and during the COVID-19 pandemic in a prospectively followed, well-defined cohort. Methods. Over the past 4 influenza seasons, PAIVED has enrolled DoD beneficiaries who were randomized to receive egg-based, cell-based, or recombinant-derived influenza vaccine. Participants provided some basic demographic information and were then sent a weekly text or email that inquired about ILI symptoms, defined as 1) having cough or sore throat, plus 2) feeling feverish/having chills or having body aches/fatigue. Participants with ILI completed a daily symptom diary for one week and submitted a nasal swab for PCR-based pathogen detection. Results. Over the 4 seasons, 15,449 participants were followed for ILI (Table 1) with 3,407 participants reporting a total of 3,985 ILIs. For the 2021/22 season, ILI reports peaked in January (Figure 1). Overall, 4.7% of episodes had more than one pathogen identified (Table 2). Among the 122 coinfections identified to date, most were coinfections with rhinoviruses (91/122, 75%), including rhinovirus coinfections with seasonal coronaviruses (29, 24%), metapneumovirus (18, 15%), SARS-CoV-2 (17, 14%), and influenza (14, 11%). SARS-CoV-2 and influenza were found together in one sample. The lab data will continue to be processed for the current season (2021/22). Conclusion. ILI rates were lowest during the third year (2020/21), consistent with national influenza surveillance reports of influenza and outpatient ILI activity, suggesting that measures taken to reduce transmission of SARS-CoV-2 reduced the spread of other respiratory viruses. The emergence of the SARS-CoV-2 omicron variant in December 2021 was associated with higher ILI rates. Among those individuals for whom a sample was collected, coinfections were highest in 2018/19. Data collection and specimen analysis are ongoing for 2021/22. (Figure Presented).

Impact of COVID-19 Pandemic on Influenza-like Illness (ILI) Experience among Healthcare Workers in Military Treatment Facilities

Background. Healthcare workers (HCWs) are at heightened risk of exposure to respiratory pathogens, and occupy an important epidemiologic position in the COVID-19 pandemic. PAIVED, a multicenter, multiservice study assessing influenza vaccine effectiveness in the Department of Defense over four consecutive influenza seasons (2018-22), provides an opportunity to describe influenza like illness (ILI) experience and assess the impact of SARS-CoV-2 in HCWs compared to non-HCWs. Methods. PAIVED participants were randomized to receive either egg-based, cell-based, or recombinant-derived influenza vaccine and then surveyed weekly for ILI. At enrollment, participants provided key demographic data including whether they were HCWs with direct patient contact. ILI was defined a priori as 1) having cough or sore throat plus 2) feeling feverish/having chills or having body aches/fatigue. Participants with ILI completed a symptom diary for seven days and submitted a nasal swab for pathogen detection. Study recruitment was conducted from September-January over four consecutive years. Results. Of 13188 eligible participants enrolled, 4819 (36%) were HCWs. Overall, HCWs were more likely to be female (43% vs 31%), active duty military (86% vs 69%), and to identify as white (61% vs 56%). HCWs more commonly reported ILI than non-HCWs (25% vs 21%, p< 0.01). Of those experiencing ILI, SARS-CoV-2 was identified in a higher proportion of HCWs than non-HCWs (17% vs 12%, p< 0.01). Influenza was isolated in similar proportion of HCWs and non-HCWs (5% vs 4%). Each group reported similar ILI duration and severity (p< 0.01). Conclusion. In a prior analysis of the 2019-20 PAIVED season, HCWs were more likely than non-HCWs to report ILI, have shorter illness duration, and isolate influenza A (H1N1). The propensity for HCWs to report ILI persisted over the four years. While SARS-CoV-2 emerged as a major pathogen in both groups, HCWs were more likely to have it identified as a cause of ILI, suggesting increased risk of symptomatic SARS-CoV-2 in our HCW population. Influenza incidence was lower than that of SARS-COV-2, and did not differ between HCWs and non-HCWs. Mean duration of illness did not differ between groups over four years;this equalization may relate to the higher incidence of SARS-CoV-2 in HCWs.

Factors associated with response to a phone-administered alcohol and substance use survey during the COVID-19 pandemic among women in the MACS/WIHS Combined Cohort Study: Who are we missing?

Background. Early in the COVID-19 pandemic, many clinical studies pivoted to remote research visits, which have a higher non-response rate compared to in-person assessments. Survey non-response can bias estimates of alcohol and substance use prevalence. Our objective was to identify factors associated with responding to an alcohol and substance use phone survey administered during the COVID-19 pandemic to women enrolled in the MACS/WIHS Combined Cohort Study, a multicenter U.S. prospective cohort of adults living with and without HIV. Methods. We assessed associations of pre-pandemic (April-Sept. 2019) sociodemographic factors, HIV status, housing status, depressive symptoms, alcohol use, and substance use measures with response to a pandemic (Aug.-Sept. 2020) phone survey using multivariable logistic regression. Response probability weights generated from the regression model were applied to the sample and prevalence estimates of risky drinking (> 7 drinks/week or > 3 drinks/day) and substance use (opioids, stimulants, sedatives) in the COVID-19 pandemic were compared to the unweighted sample. Results. Of 1,834 women with pre-pandemic data, 62% were of Black race, 46% had an annual income < $12K, 71% were living with HIV and the mean age was 52.4 (SD 9.3) years. The phone survey response rate was 77.5%. In the adjusted model, the odds of responding were lower at research sites in the Western (aOR 0.35 95% CI 0.21-0.57) and Southern US (aOR 0.29 95% CI 0.19-0.44, ref=Midwest), in women of Hispanic ethnicity (aOR 0.47 95% CI 0.33-0.66, ref=Black race), and in those who reported substance use (aOR 0.62 95% CI 0.40-0.95). By contrast, the odds were higher for women of white race (aOR 1.63 95% CI 1.02-2.70) and those with stable housing (aOR 1.71 95% CI 1.22-2.39). Un weighted versus weighted prevalence estimates were 11.1% vs. 11.6% for risky drinking and 6.1% vs. 6.9% for substance use. Conclusion. Among a sample of socioeconomically disadvantaged women, women of Hispanic ethnicity, and those who were unstably housed and reported substance use at baseline had lower odds of responding to an alcohol and substance use phone survey conducted early in the COVID-19 pandemic. As remote survey methods become more common, investigators should ensure that data remain representative of the target population.

Emergence of the SARS-CoV-2 Omicron Variant in the Pragmatic Assessment of Influenza Vaccine Effectiveness in the Department of Defense (PAIVED) Study

Background. Novel SARS-CoV-2 (SCV2) variants may differ in epidemiology and clinical impact. PAIVED, a randomized trial comparing the efficacy of 3 different platforms of inactivated influenza vaccines in adult military health system beneficiaries, actively surveils participants for influenza-like illness (ILI), including COVID-19, and conducts targeted investigations among those who develop ILI. The current season (2021/22) offered an opportunity to assess symptomatology associated with emerging SCV2 variants in this prospective cohort. Methods. Following receipt of influenza vaccine, PAIVED participants receive a weekly email or text message querying for ILI symptoms. Those who reported ILI completed a validated symptom diary (FLU-PRO Plus) daily for 7 days and collected a nasal swab. Nasal specimens underwent multiplex PCR testing, followed by SCV2 genome sequencing as applicable. PAIVED study participants from the 2021-22 influenza season who reported an ILI, had confirmed infection with SCV2 for which sequence data is available, and completed at least one FLU-PRO Plus survey were included in this analysis. Results. To date, 293 participants (7% of active cohort;22.5% reporting ILI) tested positive for SCV2;sequencing has identified 23 Delta and 200 Omicron variants (199 BA.1, 1 BA.2). Among the 212 participants with sequenced SCV2 and symptom data, 55% were male, 57% were white, and 85% were active-duty military (Table 1). Overall, peak symptom severity was classified as mild to moderate in 79.3% of cases, fever duration averaged 2.5+/-2.2 days, and there were activity limitations for a mean of 5.2+/-3.8 days. No differences in maximum symptom scores (total or by domain) were detected for participants infected with Omicron compared to Delta. Figure 1 depicts variation in mean symptom scores by day of ILI, grouped by variant Conclusion. Omicron emerged as the predominant SCV2 variant causing ILI in our cohort this season, typically manifesting with mild symptoms. Further exploration of potential differences in ILI experience between SCV2 variants and other ILI causes, plus the impact and timing of vaccination, will add insight into the relative contribution of such factors on symptomatology.

Adjusting the TMIST study design to accommodate slower than expected accrual: ECOG-ACRIN EA1151

Background: The ECOG-ACRIN Tomosynthesis Mammographic Imaging Screening Trial (TMIST), which opened in 2017, is a randomized trial designed to assess whether Tomosynthesis Mammography (TM) should replace Digital Mammography (DM) for breast cancer screening. It is hypothesized that women assigned to TM for 3-5 screening rounds will have fewer advanced breast cancers than the women assigned to DM. Advanced cancers are those that have distant metastases or positive nodes, are invasive tumors greater than or equal to 2.0 cm in size, or are invasive tumors greater than 1.0 cm in size that are triple negative or HER 2+. The initially planned enrollment of 164,946 women was due to be completed by the end of 2020, with follow-up concluded by 2025. There were substantial challenges in meeting this timeline, including the organizational and funding structure of the NCI National Clinical Trials Network which is dependent upon sites using their existing staffing resources (not always readily available at the time of study activation). This led to longer than anticipated start of enrollment for most interested sites and lower than anticipated annual enrollment per participating site based ultimately on the staffing support that could be allocated to manage TMIST. In addition, research staffing shortages and periodic research operations closures due to COVID-19 have also impacted enrolling TMIST sites, though unevenly, since the start of the pandemic. Enrollment plateaued at approximately 2,100 subjects per month by the end of 2020. With that accrual rate expected, the trial design was modified to reduce the sample size so that the study could be completed by 2027. Methods: With the approval of the NCI CIRB, we changed how the primary endpoint measure for TMIST is assessed from the number of advanced cancers that occur by 4.5 years after randomization to the time from randomization to occurrence of advanced cancers. All advanced cancers occurring within 7 years of randomization are now included and all participants followed for at least three years. In addition, the power of the study of the study was modified from 0.9 to 0.85, while the originally assumed effect size at 4.5 years was retained These changes allowed a reduction of sample size to 128,905, with subject recruitment projected to end in 2024. As of February 14, 2022, there are 125 sites open, 114 in the U.S. and 11 in other countries, with an additional 31 sites planning to open. As of February 14, 2022, a total of 63,845 women have been enrolled in the trial worldwide at 115 sites, with 20% of US participants self-identifying as belonging to minority racial and ethnic groups and 70% consenting to optional blood and/or buccal cell collection.

Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED): Updates from Year 2 of Multi-Site Trial

Despite nearly universal influenza vaccination for active duty military personnel, breakthrough influenza infections occur. We are reporting on the second year of the Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED), comparing three FDA-licensed influenza vaccine types (egg-based, cell -based, and recombinant) to assess differences in immunogenicity and effectiveness.

Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED): Updates from Year 3 of Multi-Site Trial

Background. The SARS-CoV-2 pandemic has spotlighted respiratory infections and the value of effective vaccines. The SARS-CoV-2 vaccine has been remarkably effective;however, influenza vaccine effectiveness has been reported to be lower among active duty military populations than in the general public (18% vs 36%). The Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED) study compares 3 FDA-licensed influenza vaccine types (egg-based, cell-based, and recombinant) to assess differences in immunogenicity and effectiveness in adults. Methods. Participants in the 3rd year of PAIVED (2020/21 influenza season) were enrolled from October 2020 through January 2021. Participants received weekly surveys about influenza-like-illnesses (ILI) experienced in the past week;if they reported an ILI, they were queried about symptom duration and severity, and asked to self-collect a nasal swab and dried blood sample. Four weeks later, more information about symptom duration and illness burden was obtained via telephone interview, and the participant collected a second blood sample. Results. PAIVED year 3 enrolled 3,269 participants (Table 1). 278 participants reported 1 ILI , while 60 reported 2 ILIs, and 18 reported 3 ILIs. No pathogen was identified for most processed ILI samples (78%);the most common viruses were SARS-CoV-2 (25, 12%), rhinovirus (24, 12%), and seasonal coronaviruses (4, 2%). No influenza has been identified thus far. Among those participants who had convalescent ILI visits (275), the median duration of the reported ILIs was 9 days (IQR 5, 15), with a median of 4 days (IQR 2, 7) of limited activity, and 2 days (IQR 0, 3) with fever. Three individuals were hospitalized. Conclusion. There have been relatively low rates of ILI identified in this study during this season, with only 11% of the participants reporting an ILI so far, consistent with low rates of non-COVID-19 ILI reported elsewhere during the current pandemic. We anticipate some influenza cases may be identified as more samples are processed. Planned analyses include calculating comparative influenza vaccine effectiveness to inform future vaccine purchasing decisions, as well as comparing serological response to the different vaccines.

The Effects of Race and Comorbidity Burden on Inflammatory Biomarkers among Persons Hospitalized with COVID-19

Background. African Americans (AA) and Latinos, compared with Whites, experience disproportionately higher rates of morbidity and mortality in COVID-19. Exuberant inflammatory responses may explain, in part, the differences in disease severity in COVID-19 observed among different demographic groups. Methods. In a retrospective cohort study, we analyzed data from patients aged ≥18 years hospitalized for COVID-19 (confirmed by positive SARS-CoV-2 PCR) from 3/1/2020 - 12/31/2020 at Emory Healthcare hospitals. Patient demographics, clinical characteristics, and peak levels of high-sensitivity C-reactive protein (hs-CRP) during hospitalization were ed from electronic medical record. Comorbidity burden was defined as the number of six total comorbidities assessed per patient. Multivariable logistic regression (adjusted for age, sex, body mass index [BMI], smoking status) assessed the effects of race and comorbidity burden on peak hs-CRP level. Results. 3,860 patients, median age 60 [18-108] years, 51% female, 57% AA, 28% White, 6% Latino and 9% other races were enrolled. Median comorbidity burden per patient was 2 (Q1-Q3, 1-3), with prevalent comorbidities distributed as follows: 68% had hypertension, 43% renal disease, 42% diabetes, 16% cardiovascular disease, 12% lung disease, and 5% cancer. Unadjusted peak hs-CRP (mg/L) levels were highest among Latino patients (144.9) followed by other races (137), AA (130.3), and Whites (122.2). In adjusted models (including race), the mean difference in peak hs-CRP (mg/L) compared with patients who had no comorbidities was 18.7 (p=0.108), 56.7 (p< 0.001), and 78.2 mg/L (p< 0.001) for 1, 2, and ≥3 comorbidities, respectively. In adjusted models (including comorbidity burden), the mean level of peak hs-CRP, compared with Whites, was 34.2 (p< 0.001), 38.4 (p=0.003), and 36.0 mg/L (p=0.06) higher in AA, Latinos, and other races, respectively. Conclusion. Among patients hospitalized with COVID-19, non-White race and comorbidity burden were associated with significantly higher levels of inflammation. These findings suggest that exuberant inflammatory responses may be driving, in part, the differences in COVID-19 disease severity observed across different demographic groups.

Before and After: The Impact of the COVID-19 Pandemic on Influenza-Like Illness Trends in PAIVED

Background. The Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED) is a multicenter study assessing influenza vaccine effectiveness in active duty service members, retirees, and dependents. PAIVED recently completed its third year and offers a unique opportunity to examine influenza-like illness (ILI) trends prior to and during the COVID-19 pandemic in a prospective, well-defined cohort. Methods. During the 2018-19, 2019-20, and 2020-21 influenza seasons, PAIVED enrolled DoD beneficiaries presenting for annual influenza vaccination. After collecting baseline demographic data, participants were randomized to receive egg-based, cell-based, or recombinant-derived influenza vaccine. Weekly throughout the influenza season of enrollment, participants were surveyed electronically for ILI, defined as (1) having cough or sore throat, plus (2) feeling feverish/having chills or having body aches/fatigue. Participants with ILI completed a daily symptom diary for seven days and submitted a nasal swab for pathogen detection. Results. Over the three seasons, there were 10,656 PAIVED participants: 1514 (14.2%) in 2018-19, 5876 (55.1%) in 2019-20, and 3266 (30.6%) in 2020-21. The majority were male (68-73% per year) with a mean age of 34±14.8 years at enrollment. 2266 participants reported a total of 2673 unique ILIs. The highest percentage of participants with ILI was in 2019-20 (28.2%), versus 19.6% in 2018-19 and 9.6% in 2020-21. Figure 1 depicts the percent of individuals reporting ILI by week of the season for each of the PAIVED seasons. Notably, after March 21, 2020, the weekly incidence of participants reporting ILI never exceeded 1%. Figure 1. Percent of PAIVED participants reporting ILI by week of season. Conclusion. The low incidence of reported ILI in PAIVED participants during the COVID-19 pandemic is consistent with national influenza surveillance reports of influenza and outpatient ILI activity, suggesting that mitigation measures taken to reduce transmission of SARS-CoV-2 reduced the spread of other respiratory viruses.

The economic impact of school closures during the 2015 flood in Richland County, South Carolina

Research on the societal costs of disaster-related US school closures has focused, and due to COVID-19 will likely continue to focus, on pandemics, with very limited research on closures from natural hazards. This is surprising given that school closures occur frequently to protect children, teachers, and staff pre-event as well as post-disaster to convert facilities into emergency shelters, etc. This study investigates the secondary effects from post-flooding, temporary school closures after the catastrophic 2015 flash flood in Richland County, South Carolina. Lost productivity from school closures was quantified using the Human Capital Method. Out of the 208 completed surveys, 75% of households had children that missed school. Post-stratifying survey results on race produced an average of $437 in lost productivity due to school closures and an overall $2175 in lost productivity due to flood-related impacts in general. Expressed in FEMA benefit-cost analysis terms, our study shows that schools have a standard value of $215 per household and per day for the unweighted sample ($180 for the race-weighted sample). Furthermore, households' disutility for a late start is almost as great as their disutility for a school closure. These exploratory findings suggest that unplanned school closures should be minimized, and community characteristics carefully considered to avoid unintended socioeconomic consequences.

A REVIEW OF FRAILTY AND PATIENT DISCHARGE OUTCOMES IN A NEWLY FORMED PHYSIOTHERAPY TEAM IN A LEVEL 4 TEACHING HOSPITAL

Background The clinical frailty score (CFS) is a 9 point validated outcome measure used to measure function, mobility, cognition and co-morbidities in patients aged 65 or older. The physiotherapy department was restructured due to COVID-19 pandemic. This resulted in the formation of a mixed specialty team which consisted of Frailty Intervention Team (FIT), Medical Respiratory, Acute Medicine Service, Orthopaedics, General Rehabilitation and Care of the Older Person (COTOP). This service review aimed to identify frailty using the CFS across services and to compare CFS versus age, length of stay, falls history and discharge outcomes. Methods The CFS data was collected over two weeks. Inclusion criteria included patients who scored ≥4 on the CFS. Exclusion criteria included patients aged under 65. Variables such as age, history of falls, LOS and discharge destinations were compared across all services using Microsoft Excel. Results 166 patients were included, the average CFS was 5.24 and the average age was 77.2 years. COTOP had the oldest (Av. age 85.4), frailest (Av. CFS 6.1) and longest avLOS (25.3 days) across all services. Frailty was prevalent across all services, with 81% of patients on the medical respiratory service classed as frail. Patients who scored a CFS of ≥4 had higher falls risk and greater LOS. Of the medical respiratory cohort only 12% were discharged to rehabilitation with 77% discharged home. Orthopaedics had the highest percentage of patients discharged to rehabilitation (44%), followed by the general rehabilitation (34%). Only 14% of the COTOP patients were transferred to rehabilitation. Conclusion A high incidence of frailty and falls history was identified across all services. Patients who scored lower on the CFS resulted in reduced LOS and were more likely to be discharged directly home. Proactive screening and detection of frailty allows for targeted interventions that may improve outcomes and inform early discharge planning.

Engaging the radiology community in the National Clinical Trials Network: The ECOG-ACRIN TMIST experience

Background: ECOG-ACRIN launched the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) through the National Cancer Institute's National Clinical Trials Network (NCTN) - a network of academic medical centers, community hospitals, and private clinical practices that are committed to participating in NCI-funded clinical trials. The NCI NCTN was developed to support rapid trial start-up of NCI-funded cancer control/prevention, cancer treatment, and nontherapeutic clinical trials that occur within the institution through centralized institutional administration and shared clinical resource allocation (personnel, lab services). TMIST is a randomized clinical trial assessing two breast cancer screening imaging modalities, tomosynthesis and digital mammography, in the population of women presenting for screening mammography and therefore requires active involvement of radiology. Methods: TMIST seeks to enroll 164,946 women, ages 45 to 74 years who present for screening mammography. Because the population under evaluation are women already scheduled for screening mammography, the mammography clinic is critical to successful recruitment as well as adherence to imaging randomization assignments over a 5-year period and therefore must be actively engaged in this trial with a breast imaging radiologist championing the trial within this service. To get active engagement of breast imaging radiologists, we needed to first make them aware of TMIST. Breast imaging radiologists that were already actively involved in the NCTN received notification of the trial through the NCTN email lists. So our goal was to come up with a strategy to reach out to breast imaging radiologists that were not active members in the NCTN. This was achieved through in-person informational sessions to introduce the trial at national and international breast imaging meetings, introduction of the trial and the workings of the NCTN network to the radiology community through articles placed in American College of Radiology (ACR) newsletters, ads promoting TMIST on ACR social media platforms, and direct email by the TMIST study chair to key radiology stakeholders. As of February 15, 2021, there are 115 sites open: 106 in the U.S. and 9 internationally with an additional 54 sites planning to open. A total of 39,366 women are enrolled in the trial with twothirds also consenting to optional blood and/or buccal cell collection. Minority populations' participation in the trial is over 20%. A significant drop in enrollment occurred in Spring 2020 coinciding with the suspension of mammography services globally due to COVID-19 beginning mid- March 2020. Enrollment and follow-up screening visits for TMIST restarted in May 2020 and gradually ramped back up to pre-COVID totals in September 2020. Our highest monthly accrual so far occurred in November 2020 with 2,148 subjects enrolled.

A review of telephone consultations for head and neck cancer follow up: a patient satisfaction survey.

OBJECTIVE: To review patient satisfaction with the change in practice towards telephone consultations during and after the coronavirus disease 2019 pandemic for head and neck cancer follow up. METHOD: A retrospective analysis was conducted of head and neck cancer telephone appointments during a six-month period in a tertiary referral centre. RESULTS: Patients found the telephone consultations beneficial (98 per cent), with 30 per cent stating they were relieved to not have to attend hospital. Patients who travelled further, those with lower stage disease and patients with a greater interval from initial treatment were most satisfied with the telephone consultations. Sixty-eight per cent of patients stated they would be happy to have telephone consultations as part of their regular follow up after the pandemic. CONCLUSION: Patients found the telephone consultations beneficial and 30 per cent considered them preferable to face-to-face appointments. This study demonstrates that telephone consultations can be used as an adjunct to face-to-face appointments in an effort to reduce hospital attendances whilst maintaining close follow up.

Comorbidity burden is associated with hospitalization for COVID-19 among PWH

Background: The contributions of non-AIDS comorbidities and HIV-related factors to coronavirus disease 2019 (COVID-19) outcomes among persons with HIV (PWH) remain unclear. We aimed to identify risk factors for COVID-19 hospitalization among PWH. Methods: We evaluated all adult (≥18 years) PWH with a positive SARS-CoV-2 PCR evaluated in a public safety-net hospital system, a Ryan White-funded HIV clinic and a Veterans Affairs medical center in Atlanta, GA between March 1, 2020 and November 15, 2020. Demographic and clinical characteristics and COVID-19 disease outcomes were ascertained by medical record abstraction. We performed multivariable logistic regression to determine associations with COVID-19 hospitalization. Results: 180 patients (mean age 49 years, 78% male, 78% Black, 14% Latinx) were included. 97% were on antiretroviral therapy (ART), 91% had HIV-1 RNA <200 copies/ml, and mean CD4 count was 527 cells/mm3. 60 patients (33%) were hospitalized, 28 (47%) required supplemental oxygen. Overall mortality rate among PWH was 1.63%;mortality among hospitalized PWH was 5%. 130 patients (72%) had at least 1 non-AIDS comorbidity;22% had >4 comorbidities (hypertension, dyslipidemia, obesity and diabetes were most prevalent). In univariable models, age, hypertension, dyslipidemia, diabetes, heart disease, and chronic kidney disease were associated with hospitalization. HIV characteristics including CD4 count, viral load, and ART use were not associated with hospitalization. After adjusting for those baseline characteristicsassociated with hospitalization, only age [aOR(95%CI) 1.073 (1.036-1.110), p<0.0001] and diabetes mellitus [aOR(95%CI) 2.653 (1.027-6.853), p=0.0439] were associated with hospitalization. In a multivariable model adjusting only for age, comorbidity count was associated with a 25% increased risk for hospitalization [aOR(95% CI) 1.245 (1.013-1.531), p=0.0375];and having ≥4 comorbidities was associated with a 2.8-fold increased risk of hospitalization compared with 0-1 comorbidities [aOR(95% CI) 2.848 (1.174-6.910), p=0.0240] (Figure). In age-adjusted analyses restricted to CD4 <200 cells/mm3 or HIV-1 RNA >200 copies/mL, HIV-related factors were not associated with hospitalization. Conclusion: In a cohort of PWH with well-controlled HIV and COVID-19, age and non-AIDS comorbidities, but not HIV-related factors, were associated with hospitalization for COVID-19. Further research into causes of severe COVID-19 among PWH is warranted. (Figure Presented).

Pragmatic assessment of influenza vaccine effectiveness in the dod (PAIVED): Updates from year 2 of multi-site trial

Background. Despite nearly universal influenza vaccination for active duty military personnel, breakthrough influenza infections occur. We are reporting on the second year of the Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED), comparing three FDA-licensed influenza vaccine types (eggbased, cell-based, and recombinant) to assess differences in immunogenicity and effectiveness. Methods. Participants in the second year of PAIVED were enrolled from Oct 2019 through Jan 2020 at 9 military facilities. Participants received weekly inquiries about influenza-like-illnesses (ILI) experienced in the past week, and if the participant reported having a cough or sore throat and a) muscle/body aches or fatigue and/or b) being feverish or having chills, they were scheduled for a clinic visit. During this visit, a blood sample and a nasal swab were collected, as well as information about symptom duration and severity. A second (convalescent) visit was conducted approximately 4 weeks later, which involved collecting additional information about the duration of symptoms and illness burden, as well as a second blood draw. Due to the COVID-19 pandemic, acute and convalescent visits were disrupted at most sites in March and April due to COVID-19 precautions. Results. PAIVED year 2 enrolled 5,892 participants who completed demographic forms (Table 1). Among those who reported any ILIs, most reported one ILI (1,345), while 264 reported two ILIs, and 42 reported three ILIs. Nasal swabs were processed from 273 ILIs at four sites (Fig 1), and 14 cases of influenza were identified thus far. The median duration of ILIs was ten days, with a median of three days of limited activity, and two days with fever. Nine individuals were hospitalized. Table 1. Demographic characteristics of individuals enrolled in PAIVED 2019/20 Figure 1. Lab results as of 5/15 (N=273 samples) Conclusion: Over 25% of participants reported an ILI, and 5% of the nasal swabs that have been tested thus far have been positive for influenza. While most samples have not yet been analyzed, we have identified some breakthrough cases of influenza among vaccinated participants. Planned analyses include comparative vaccine effectiveness in order to inform future vaccine purchasing decisions.