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Background: People with HIV (PWH) have a higher risk of COVID-19 morbidity and mortality. SARS-CoV-2 vaccination is highly effective in preventing severe COVID-19, although medical mistrust may contribute to vaccine hesitancy among PWH. Method(s): PWH from 8 sites in the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) completed the clinical assessment of patient-reported outcomes including a vaccine hesitancy instrument as part of routine care from 2/21-4/22. Participants were defined as vaccine hesitant if they had not yet received the SARS-CoV-2 vaccine and would probably or definitely not receive it. We assessed factors associated with SARS-CoV-2 vaccine hesitancy using logistic regression, and adjusted for demographics, unsuppressed viral load >200 copies/mL, calendar month and time on ART. Result(s): Overall, 3,278 PWH with a median age of 55 responded;19% were female sex at birth;93% were virally suppressed. At the time of survey, 27% reported they had not received the SARS-CoV-2 vaccine, of whom 27% (n=242;7% overall) reported vaccine hesitancy. Of these 242, 82% expressed concerns about vaccine efficacy;86% about side effects;38% reported distrust of healthcare, 53% reported concerns about vaccine contents (i.e. trackers, live virus);and 24% did not perceive risk from COVID-19. Factors associated with vaccine hesitancy included female sex (Adjusted Odds Ratio [AOR] 2.0;95% Confidence Interval (CI): 1.5-2.8;Table), Black vs. White race (AOR 1.8;95% CI: 1.3-2.5), age< 30 years (AOR 2.8;95% CI: 1.5-5.2), South/Midwest vs. Northeast region (AOR 1.7;95% CI: 1.2-2.4), years on ART (0.8;0.7-0.9) and unsuppressed viral load (AOR 2.2;95% CI: 1.4-3.5). Hesitancy decreased over time (AOR 0.9 per month;95% CI: 0.8-0.9). Vaccine side effects were the primary concern for women;vaccine contents for Black PWH and those who were unsuppressed;and lack of perceived COVID-19 risk for youth. Conclusion(s): Vaccine hesitancy was reported by approximately 7% of a U.S. multi-site cohort of PWH, and it was more prevalent among Black PWH, women, youth, those with unsuppressed viral loads, and residents of the South/ Midwest. The association between virologic non-suppression and vaccine hesitancy highlights the intertwined challenge of medical mistrust for both HIV and COVID-19. Although vaccine hesitancy decreased over time, renewed efforts will be needed to address concerns of PWH about the COVID-19 vaccine, given the ongoing need for revaccination with the evolution of the pandemic.
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Background: Disruptions in clinical services during the COVID-19 pandemic could compromise past progress towards meeting U.S. Ending the HIV Epidemic (EHE) goals. We examined changes in the proportion with virologic suppression (VS) before and since the onset of COVID-19 in a multi-site U.S. cohort of people with HIV (PWH) using an interrupted time series design. Method(s): We assessed VS (< 200 copies/mL) trajectories 1/1/2018-1/1/2022, comparing trends before and after March 21, 2020 at 8 HIV clinics within the U.S. Center for AIDS Research Network of Integrated Clinical Systems (CNICS'). Hierarchical mixed-effects logistic regression and interrupted time series analyses examined changes in the trend (i.e., slope) of VS over time, and maximum likelihood estimation was used to account for missing VS data among those lost to follow-up (LTFU) post-COVID-19. Analyses were adjusted for demographics, site, CDC transmission group, CD4 nadir, VS, time on ART. Result(s): Data from 17,999 participants were included, providing a total of 120,918 VS assessments. Median age was 53 (interquartile range 42-61);19% were female sex at birth;the mean time on ART was 9.5 years;18% were unsuppressed at any point;17.7% were LTFU. Among the overall population, prior gains in VS slowed during COVID-19 (adjusted odds ratio [AOR] 0.93 per quarter-year;95% CI: 0.88-0.98;p=0.004;Figure). Greater impacts occurred among women (AOR 0.90;95% CI 0.81-0.99;p=0.05), persons with a history of injection drug use (PWID) (AOR 0.77 95% CI: 0.66-0.90;p=0.001), and Black PWH (AOR 0.90;95% CI: 0.84-0.96;p=0.001) in whom prior positive VS trends plateaued or began to reverse (Figure). VS remained lower among those with unstable housing (AOR 0.44;95% CI: 0.40-0.50;p< 0.001) but stayed unchanged from the pre-pandemic period. Conclusion(s): Previous gains in VS slowed during the COVID-19 pandemic among PWH in a multi-site network of U.S. HIV clinics. Known disparities in VS according to housing status remain unchanged, but VS disparities worsened for PWH who were women, PWID, or Black. Changes in VS trends could be related to socioeconomic impacts of the pandemic, insurance lapses, reduction of in-person clinic services, fear of coming to clinics, or other factors. Renewed investment in HIV public health and clinical services will be vital to achieve the U.S. EHE goals following COVID-19, with additional targeted interventions to support key populations with persistent or worsening disparities needed.
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Background: Given effectiveness of SARS-CoV-2 vaccines and outpatient antiviral and monoclonal antibody therapy for reducing progression to severe COVID-19, we sought to estimate the impact of these interventions on risk of hospitalization following SARS-CoV-2 infection in a large US healthcare system. Method(s): All patients >=18 of age in the UNC Health system, with first positive SARS-CoV-2 RT-PCR test or U07.1 ICD-10-CM (diagnosis date) during 07/01/2021- 05/31/2022, were included. The outcome was first hospitalization with U07.1 ICD-10-CM primary diagnosis <=14 days after SARS-CoV-2 diagnosis date. SARS-CoV-2 vaccinations were included if received >=14 days prior to diagnosis. Outpatient therapies were included if administered after diagnosis date and before hospital admission. Age, gender, race, ethnicity, and comorbidities associated with COVID-19 (using ICD-10-CM, if documented >=14 days prior to diagnosis date) were also evaluated. Risk ratios for hospitalization were estimated using generalized linear models, and predictors identified using extreme gradient boosting using feature influence with Shapley additive explanations algorithm. Result(s): The study population included 54,886 patients, 41% men and 27% >=60 years of age. One-third of SARS-CoV-2 diagnoses occurred July-December 2021 and 67% December-May 2022 (predominantly Delta and Omicron variants, respectively). Overall 7.0% of patients were hospitalized for COVID-19, with median hospitalization stay of 5 days (IQR: 3-9). 32% and 12% of patients received >=1 SARS-CoV-2 vaccine dose and outpatient therapy, respectively. Unadjusted and age-adjusted hospitalization risk decreased with vaccination and outpatient therapy (TABLE). Comparing patients who received 3 vaccine doses versus none we observed a 66% relative reduction in risk, with stronger association for more recent vaccination. For patients who received nirmatrelvir/ ritonavir versus no therapy we observed a 99% relative reduction in risk. In predictive models, older age was the most influential predictor of being hospitalized with COVID-19, while vaccination and outpatient therapy were the most influential factors predicting non-hospitalization. Conclusion(s): The impact of recent SARS-CoV-2 vaccination and outpatient antiviral and monoclonal antibody therapy on reducing COVID-19 hospitalization risk was striking in this large healthcare system covering Delta and Omicron variant timeframes. SARS-CoV-2 vaccinations and outpatient therapeutics are critical for preventing severe COVID-19. Unadjusted and age-adjusted risk ratios for hospitalization among patients with SARS-CoV-2.
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Background. Substantial changes in access and delivery of primary HIV care occurred during the COVID-19 pandemic. To assess how care access changed during the COVID-19 pandemic, we estimated ED use among PWH in care 2017-2021 in the southeastern US. Methods. For each calendar year, among PWH in care in the UNC CFAR HIV Clinical Cohort (defined as having a clinic visit in the current or prior year), we estimated the percent of patients with >= 1 ED visit in a given year, overall and by age, gender, race/ethnicity, HIV viral load (VL), and CD4 count. We estimated risk ratios (RRs) comparing patient characteristics and years 2020-2021 vs. 2017-2019, using Poisson regression with generalized estimating equations to account for repeated measures. Results. Among 2129 PWH in care 2017-2021 (N=1700-1800 in each year), 57% identified as Black, 31% White, 8% Hispanic, 26% women, with median age of 47 years (IQR 35-55). During the study period, there were 3645 ED visits over 8813 person-years, a rate of 41.4 ED visits-per 100 person-years(95% CI 36.8-46.5) per 100 person-years. The 845 PWHwith at least one ED visit during the study period contributed amedian of 2 visits each (IQR1-5). The unadjusted probability of having>=1 EDvisit in a given year was higher among women vs. men (RR=1.14, 95% CI 0.99-1.32), Black vs. White PWH (1.31, 1.13-1.52), with VL >= 40 copies/mL (1.40, 1.20-1.64), and with CD4 < 200 (1.66, 1.32-2.09) or 200-349 (1.50, 1.25-1.79) vs. >= 500 cells/muL;age was not associated with ED use. Comparedwith 2017-2019, the annual probability of having>=1 EDvisit was lower in 2020-2021, with RRs of 0.83 (95% CI 0.76-0.90) in unadjusted analyses and 0.80 (95%CI 0.71-0.90) after adjusting for demographics, VL, and CD4. There was also a significant unadjusted decrease for 2020-2021 vs. 2017-2019 among women, men, PWH who were Black, White, < 40 or 50-59 years old, and with CD4 >500 (Fig. B-F, all P< 0.05). Conclusion. Among PWH in HIV care, ED use was higher among women, Black PWH, and PWH with poorly controlled HIV. ED use decreased 2020-2021 in most groups, indicating that PWH during the COVID-19 pandemic may be delaying seeking care for acute conditions, or accessing care in other ways. Work is ongoing to characterize reasons for ED visits across calendar years and examine the impact of reduced ED utilization among PWH.
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Aims: To describe longitudinal associations between health-related quality of life (HR-QoL) scores and demographic, clinical, and health behavioral characteristics in a multisite U.S. cohort of adults in HIV care. Method(s): People with HIV (PWH) completed an electronic assessment of patient-reported outcomes (PROs) as part of routine clinical care between 2016 and 2021 including measures for HR-QoL (EQ-5D-3L), substance use (ASSIST, AUDIT/AUDIT-C), smoking, and HIV stigma, among others. We used generalized linear latent and mixed models with nonparametric random effects for the intercept term to accommodate repeated measures on individuals to examine longitudinal factors associated with HR-QoL overall and stratified by birth-sex. Result(s): PWH (n = 10,559, median age at first assessment = 49, 17.8% cis-gender women, 1.4% transgender women;68.3% non-White) completed 33,866 assessments. Lower HR-QoL scores were associated with increasing age (p <= 0.0001);identifying as female (cis or transgender) compared to cisgender male (p <= 0.0001, p = 0.005, respectively);living in the Southeast or Western US relative to Northeast (both p <= 0.0001);identifying as a sexual orientation other than gay (heterosexual p = 0.03, bisexual p = 0.009, other p <= 0.0001);higher internalized HIV stigma (p <= 0.0001);current or former smoking (both p <= 0.0001);past methamphetamine use (p = 0.015) and current cocaine/crack, methamphetamine, opioid and cannabis use (p <= 0.0001 for each except cannabis, which was p = 0.007). Higher HR-QoL scores were associated with race/ethnicities other than White (Black: p = 0.002, Hispanic: p = 0.002, other: p <= 0.0001);the COVID-19 pandemic period (March 2020-December 2021) (p <= 0.0001);and increased AUDIT/AUDIT-C score (p = 0.001). In sex stratified models men (n = 8666) had higher HR-QoL scores among non-white compared to white (Black p = 0.0006, Hispanic p = 0.007, Other p <= 0.0001);and during the COVID period (p <= 0.0001). Men had lower HR-QoL scores among heterosexual and bisexual men relative to gay (p = 0.004, p = 0.005), if they were a former smoker (p <= 0.0001), and among past or current methamphetamine users relative to nonusers (p = 0.002, p <= 0.0001). Women (n = 1893) had higher HR-QoL scores if in care longer (p = 0.005), and lower HR-QoL if in the South (p <= 0.0001), if previously used cocaine/crack (p <= 0.0001), or if currently uses marijuana (p = 0.001). Conclusion(s): Our findings describe HR-QoL and its associations among a large diverse cohort of PWH, identifying potentially modifiable factors to improve HR-QoL, such as substance use, smoking, and impact of HIV-related stigma.
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Background. Little is known about how race and ethnicity, imperfect (albeit accessible) proxies for structural racism, impact COVID-19 incidence among people with HIV (PWH). We report the cumulative incidence and incidence rate ratios (IRR) for COVID-19 in a long-term multi-site cohort of PWH across the US Figure 1. Cumulative incidence of COVID-19 in the CNICS cohort Methods. We examined COVID-19 cumulative incidence and IRR among PWH in care between 3/1/2020 and 12/31/2020 at seven sites in the CFAR Network of Integrated Clinical Systems (CNICS) cohort. We define COVID-19 incident case as having a laboratory-confirmed (RT-PCR/Ag) SARS-CoV-2 positive result or diagnosis verified by chart review. Reinfections were excluded. Results are presented as monthly and quarterly cumulative incidence and IRR with 95% CI stratified by CD4 count, self-reported race/ethnicity, and site. Follow-up was censored on the earliest of diagnosis of COVID-19 disease, loss to follow up, or 12/31/2020 Results. Among 15,780 PWH in care in the CNICS cohort during the study period, 62% were non-white, with a median (IQR) age of 52 (IQR 40-59), 95% were on antiretroviral therapy, 17% had a CD4 count less than 350, and 6% less than 200. Overall, 651 PWH tested positive for COVID-19 for a cumulative incidence of 4.13%. COVID-19 cumulative incidence increased from 0.77% at the end of the first quarter to 4.12% by the end of December 2020. At the peak of the pandemic in December 2020, the cumulative incidence in Black PWH was 1.68 fold higher than in white PWH (p=.033) and 2.35 fold higher in Hispanics than in whites (P< .0001), figure 1. Similarly, the IRR for COVID-19 was 1.71 (95% CI 1.42-2.07) for Black and 2.40 (95% CI 1.91-3.01) for Hispanic PWH relative to white. Although there was variation across sites, reflecting geographic differences in pandemic waves and access to COVID-19 testing, overall individual trends remained the same. COVID-19 cumulative incidence was similar across CD4 cell count strata Conclusion. Our results suggest effects of structural racial disparities on COVID-19 incidence in this diverse population of PWH across the US, with higher and disproportionate rates of COVID-19 in Black and Hispanic PWH. Incidence estimates are conservative because testing was not uniform, and no systematic testing was conducted.
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Background: COVID-19 outcomes among people with HIV (PWH) remain inconclusive. We characterized all cases of COVID-19 identified in a long-term multi-site cohort of PWH, as well as factors associated with increasing severity of COVID-19 during the early months of the COVID-19 pandemic. Methods: We examined all PWH with SARS-CoV-2 infection and COVID-19 disease identified from laboratory testing data (RT-PCR, antigen test results) and ICD-10 codes March-July 2020 from seven sites in the CFAR Network of Integrated Clinical Systems (CNICS) cohort. Cases were verified by medical record review. We evaluated predictors of increased disease severity, indicated by hospitalization. Relative risks were estimated using Poisson regression, adjusted for clinical and demographic characteristics using disease risk scores. Results: Among 13,862 PWH in care (20% female, median age 52 (IQR 40-59), 58% Black or Hispanic race/ethnicity), 198 COVID-19 cases were detected during the study period. A higher proportion of PWH with COVID-19 were female (27%), Black or Hispanic (76%), and had BMI ≥30 (45%). No significant differences in CD4+ count (current or lowest) were seen between PWH with and without COVID-19. We found evidence suggesting more unstable housing among COVID-19 cases compared to non-cases (14% vs. 9%). Among PWH with COVID-19, 38 (19%) were hospitalized, 10 (5%) required intensive care, 8 (4%) received invasive mechanical ventilation, and 4 (2%) died. Hospitalization among PWH with COVID-19 was associated with: CD4+ count ≤350 (aRR 1.77;95% CI 1.05, 2.98);age ≥60 (aRR 2.0;95%CI 1.13, 3.54);pre-existing kidney disease with eGFR <60 (aRR 1.76;95% CI 0.99, 3.13);and BMI ≥30 (aRR 1.96;95% CI 1.02, 3.78) (Table). Conclusion: The population frequency of COVID-19 detected in PWH was 1.4%, likely an underestimate of the true frequency of SARS-CoV-2 infection and COVID-19 disease due to evolving testing availability and access over time. A higher proportion of PWH with COVID-19 were Black or Hispanic, in excess of the overrepresentation of people of color with HIV compared to the general population. PWH with decreased eGFR, low CD4+ count, and obesity had greater risk of more severe COVID-19 disease. Our results highlight disparities in risk of COVID-19 acquisition among PWH in the US and indicate additional vigilance in screening and monitoring of COVID-19 among PWH with these characteristics. The expected accrual of additional COVID-19 cases will allow more precise evaluation of the impact of comorbidities. (Figure Presented).
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Background: It is not known if people with HIV (PWH) in the United States (US) have different access to SARS-CoV-2 RT-PCR (COVID-19) testing, or positivity proportions (among those tested), than people without HIV (PWOH). We describe COVID-19 testing and positivity proportions in 6 large geographically and demographically diverse cohorts of PWH and PWOH. Methods: The Corona-Infectious-Virus Epidemiology Team (CIVET) is comprised of five COVID-19 clinical cohorts within a health system (Kaiser Permanente Northern California, Oakland, CA;Kaiser Permanente Mid-Atlantic States, Rockville, MD;University of North Carolina Health, Chapel Hill, NC;Vanderbilt University Medical Center, Nashville, TN;Veterans Aging Cohort Study) and one established classical HIV cohort (MACS/WIHS Combined Cohort Study). Each participating cohort is restricted to individuals who were alive and “in-cohort” in 2020 (definitions of which were operationalized to fit the structure of each cohort). We calculated the percentage of patients in-cohort who were COVID-19 tested, and the proportion COVID-19 positive monthly, by HIV status, from March 1 to August 31, 2020. We report findings from the classical cohort separately because results are based on self-reported information. Results: In the 5 clinical cohorts, PWH ranged from N=2,515 to 31,040, and N=77,019 to 3,710,360 PWOH. Over the 6 month study period, the percentage of PWH who were tested for COVID-19 (13.5%-21.2%) was slightly higher than PWOH (10.8%-14.3%) in each of the cohorts (p-values in each cohort <0.001). However, among those tested, the percentage of patients with positive COVID-19 tests was similar regardless of HIV status (Figure). In the classical cohort that contributed self-reported testing and positive information (PWH N=2,222;PWOH N=1,417), the proportion tested was similar by HIV status (PWH 38.1% vs. PWOH 37.4%), but PWH had a greater positivity proportion (9.0%) compared with PWOH (5.3%, p-value=0.012). Conclusion: Although PWH had higher testing rates compared with PWOH, we did not find evidence of increased positivity among those tested in 5 clinical cohorts with large diverse populations across the US. We will continue to monitor testing, positivity, and COVID-19 related health outcomes in PWH and PWOH using our multiple data sources and leveraging the expertise of established longitudinal cohort studies in the CIVETS collaboration.