Determinants of receipt of prostate cancer screening among men living with HIV enrolled in an urban HIV Clinic in the United States over the period of 2000-2020.

BACKGROUND: Prostate cancer is projected to account for the greatest proportion of cancer-related burden among men with HIV. However, incidence is reportedly lower than in men without HIV, potentially due to differences in screening. Factors influencing receipt of screening in men with HIV are unknown. We described receipt of prostate-specific antigen (PSA) testing and assessed factors for association with receipt of PSA test. METHODS: Demographics, measures of HIV and related care, and non-HIV care were assessed for association with receipt of first PSA test in men ≥40 years old each calendar year in 2000-2020 using univariable and multivariable Poisson regression. Models were additionally stratified by calendar period to identify changes in determinants of PSA test as prostate cancer screening guidelines changed. RESULTS: Men (n = 2,063) 72% Non-Hispanic Black, median age of 47 (IQR: 41, 53), contributed median of 4.7 years (IQR: 2.3, 10.0) of follow-up. Receipt of antiretroviral therapy (aIRR = 1.33; 95% CI: 1.14, 1.55), engagement in HIV care (aIRR = 2.09; 95% CI: 1.66, 2.62), history of testosterone-replacement therapy (aIRR = 1.34; 95% CI: 1.19, 1.50), urologist evaluation (aIRR = 1.66; 95% CI: 1.35, 2.05), and receipt of PSA test in preceding two years (no elevated PSA aIRR = 2.37; 95% CI: 2.16, 2.61; elevated PSA aIRR = 4.35; 95% CI: 3.24, 5.84) were associated with PSA testing in men aged 50 or older. Associations varied across calendar time. CONCLUSION: Findings suggest men with greater interaction with healthcare are more likely to receive PSA test. Measures of control of HIV did not appear to influence the decision to screen.

Cohort profile: the Johns Hopkins COVID Long Study (JHCLS), a United States Nationwide Prospective Cohort Study.

Purpose: COVID-19 disease continues to affect millions of individuals worldwide, both in the short and long term. The post-acute complications of SARS-CoV-2 infection, referred to as long COVID, result in diverse symptoms affecting multiple organ systems. Little is known regarding how the symptoms associated with long COVID progress and resolve over time. The Johns Hopkins COVID Long Study aims to prospectively examine the short- and long-term consequences of COVID-19 disease in individuals both with and without a history of SARS-CoV-2 infection using self-reported data collected in an online survey. Participants: Sixteen thousand, seven hundred sixty-four adults with a history of SARS-CoV-2 infection and 799 adults without a history of SARS-CoV-2 infection who completed an online baseline survey. Findings to date: This cohort profile describes the baseline characteristics of the Johns Hopkins COVID Long Study. Among 16,764 participants with a history of SARS-CoV-2 infection and defined long COVID status, 75% reported a good or excellent health status prior to infection, 99% reported experiencing at least one COVID-19 symptom during the acute phase of infection, 9.9% reported a hospitalization, and 63% were defined as having long COVID using the WHO definition. Future plans: Analysis of longitudinal data will be used to investigate the progression and resolution of long COVID symptoms over time.

Characterizing multimorbidity in ALIVE: Comparing single and ensemble clustering methods.

Multimorbidity, defined as having 2 or more chronic conditions, is a growing public health concern, but research in this area is complicated by the fact that multimorbidity is a highly heterogenous outcome. Individuals in a sample may have a differing number and varied combinations of conditions. Clustering methods, such as unsupervised machine learning algorithms, may allow us to tease out the unique multimorbidity phenotypes. However, many clustering methods exist and choosing which to use is challenging because we do not know the true underlying clusters. Here, we demonstrate the use of 3 individual algorithms (partition around medoids, hierarchical clustering, and probabilistic clustering) and a clustering ensemble approach (which pools different clustering approaches) to identify multimorbidity clusters in the AIDS Linked to the Intravenous Experience cohort study. We show how the clusters can be compared based on cluster quality, interpretability, and predictive ability. In practice, it is critical to compare the clustering results from multiple algorithms and to choose the approach that performs best in the domain(s) that aligns with plans to use the clusters in future analyses.

Who is missed in a community-based survey: Assessment and implications of biases due to incomplete sampling frame in a community-based serosurvey, Choma and Ndola Districts, Zambia, 2022.

Community-based serological studies are increasingly relied upon to measure disease burden, identify population immunity gaps, and guide control and elimination strategies; however, there is little understanding of the potential for and impact of sampling biases on outcomes of interest. As part of efforts to quantify measles immunity gaps in Zambia, a community-based serological survey using stratified multi-stage cluster sampling approach was conducted in Ndola and Choma districts in May-June 2022, enrolling 1245 individuals. We carried out a follow-up study among individuals missed from the sampling frame of the serosurvey in July-August 2022, enrolling 672 individuals. We assessed the potential for and impact of biases in the community-based serosurvey by i) estimating differences in characteristics of households and individuals included and excluded (77% vs 23% of households) from the sampling frame of the serosurvey and ii) evaluating the magnitude these differences make on healthcare-seeking behavior, vaccination coverage, and measles seroprevalence. We found that missed households were 20% smaller and 25% less likely to have children. Missed individuals resided in less wealthy households, had different distributions of sex and occupation, and were more likely to seek care at health facilities. Despite these differences, simulating a survey in which missed households were included in the sampling frame resulted in less than a 5% estimated bias in these outcomes. Although community-based studies are upheld as the gold standard study design in assessing immunity gaps and underlying community health characteristics, these findings underscore the fact that sampling biases can impact the results of even well-conducted community-based surveys. Results from these studies should be interpreted in the context of the study methodology and challenges faced during implementation, which include shortcomings in establishing accurate and up-to-date sampling frames. Failure to account for these shortcomings may result in biased estimates and detrimental effects on decision-making.

Association of Alcohol Use with COVID-19 Infection and Hospitalization Among People Living with HIV in the United States, 2020.

Alcohol use was associated with elevated COVID-19 risk in the general population. People with HIV (PWH) have high prevalences of alcohol use. To evaluate the effect of alcohol use on COVID-19 risks among PWH, we estimated the risk of COVID-19 diagnosis and COVID-19-related hospitalization among PWH in routine care at 8 HIV primary care centers that contributed data to the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort according to their alcohol use just prior to the COVID-19 pandemic. The CNICS data repository includes demographic characteristics, clinical diagnoses, and laboratory test results from electronic medical records and other sources. Alcohol use, substance use, and mental health symptoms were self-reported on tablet-based standardized surveys. Alcohol use was categorized according to standard, sex-specific Alcohol Use Disorder Identification Test-Consumption instrument cut-offs. We followed 5,496 PWH (79% male, 48% Black race, median age = 53 years) from March 1, 2020 to December 31, 2020. Relative to PWH with no baseline alcohol use, the adjusted hazard ratio (aHR) of COVID-19 diagnosis was 1.09 (95% confidence interval [CI]: 0.78, 1.51) for lower-risk drinking and 1.19 (95%CI: 0.81, 1.73) for unhealthy drinking. The aHR of COVID-19-related hospitalization was 0.82 (95%CI: 0.33, 1.99) for lower-risk drinking and 1.25 (95%CI: 0.50, 3.09) for unhealthy drinking. Results were not modified by recent cocaine or non-prescribed opioid use, depressive symptoms, or diagnoses of alcohol use disorder. The study suggested a slightly increased, but not statistically significant risk of COVID-19 diagnosis and hospitalization associated with unhealthy alcohol use.

Evaluating the Sick Quitting Hypothesis for Frailty Status and Reducing Alcohol Use Among People With HIV in a Longitudinal Clinical Cohort Study.

ABSTRACT: "Sick quitting," a phenomenon describing reductions in alcohol consumption following poor health, may explain observations that alcohol appears protective for frailty risk. We examined associations between frailty and reductions in drinking frequency among people with HIV (PWH). At six Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) sites between January 2012 and August 2021, we assessed whether frailty, measured through validated modified frailty phenotype, precedes reductions in drinking frequency. We associated time-updated frailty with quitting and reducing frequency of any drinking and heavy episodic drinking (HED), adjusted for demographic and clinical characteristics in Cox models. Among 5,654 PWH reporting drinking, 60% reported >monthly drinking and 18% reported ≥monthly HED. Over an average of 5.4 years, frail PWH had greater probabilities of quitting (HR: 1.56, 95% confidence interval [95% CI] [1.13-2.15]) and reducing (HR: 1.35, 95% CI [1.13-1.62]) drinking frequency, as well as reducing HED frequency (HR: 1.58, 95% CI [1.20-2.09]) versus robust PWH. Sick quitting likely confounds the association between alcohol use and frailty risk, requiring investigation for control.

Lower endoscopy, early-onset, and average-onset colon cancer among Medicaid beneficiaries with and without HIV.

BACKGROUND: Studies suggest a lower colorectal cancer (CRC) risk and lower or similar CRC screening among people with HIV (PWH) compared with the general population. We evaluated the incidence of lower endoscopy and average-onset (diagnosed at ≥50) and early-onset (diagnosed at <50) colon cancer by HIV status among Medicaid beneficiares with comparable sociodemographic factors and access to care. METHODS: We obtained Medicaid Analytic eXtract (MAX) data from 2001 to 2015 for 14 states. We included 41 727 243 and 42 062 552 unique individuals with at least 7 months of continuous eligibility for the endoscopy and colon cancer analysis, respectively. HIV and colon cancer diagnoses and endoscopy procedures were identified from inpatient and other nondrug claims. We used Cox proportional hazards regression models to assess endoscopy and colon cancer incidence, controlling for age, sex, race/ethnicity, calendar year and state of enrollment, and comorbidities conditions. RESULTS: Endoscopy and colon cancer incidence increased with age in both groups. Compared with beneficiaries without HIV, PWH had an increased hazard of endoscopy; this association was strongest among those 18-39 years [hazard ratio: 1.85, 95% confidence interval (95% CI) 1.77-1.92] and attenuated with age. PWH 18-39 years also had increased hazard of early-onset colon cancer (hazard ratio: 1.66, 95% CI:1.05-2.62); this association was attenuated after comorbidity adjustment. Hazard ratios were null among all beneficiaries less than 50 years of age. PWH had a lower hazard of average-onset colon cancer compared with those without HIV (hazard ratio: 0.79, 95% CI: 0.66-0.94). CONCLUSION: PWH had a higher hazard of endoscopy, particularly at younger ages. PWH had a lower hazard of average-onset colon cancer. Early-onset colon cancer was higher among the youngest PWH but not associated with HIV overall.

Comparing Cancer Incidence in an Observational Cohort of Medicaid Beneficiaries With and Without HIV, 2001-2015.

BACKGROUND: Life expectancy among people with HIV (PWH) is increasing, making chronic conditions-including cancer-increasingly relevant. Among PWH, cancer burden has shifted from AIDS-defining cancers (ADCs) toward non-AIDS-defining cancers (NADCs). SETTING: We described incidence of cancer in a claims-based cohort of Medicaid beneficiaries. We included 43,426,043 Medicaid beneficiaries (180,058 with HIV) from 14 US states, aged 18-64, with >6 months of enrollment (with no dual enrollment in another insurance) and no evidence of a prveious cancer. METHODS: We estimated cumulative incidence of site-specific cancers, NADCs, and ADCs, by baseline HIV status, using age as the time scale and accounting for death as a competing risk. We compared cumulative incidence across HIV status to estimate risk differences. We examined cancer incidence overall and by sex, race/ethnicity, and calendar period. RESULTS: PWH had a higher incidence of ADCs, infection-related NADCs, and death. For NADCs such as breast, prostate, and colon cancer, incidence was similar or higher among PWH below age 50, but higher among those without HIV by age 65. Incidence of lung and head and neck cancer was always higher for female beneficiaries with HIV, whereas the curves crossed for male beneficiaries. We saw only small differences in incidence trends by race/ethnicity. CONCLUSION: Our findings suggest an increased risk of certain NADCs at younger ages among PWH, even when compared against other Medicaid beneficiaries, and highlight the importance of monitoring PWH for ADCs and NADCs. Future work should explore possible mechanisms explaining the differences in incidence for specific cancer types.

An injury-responsive mmp14b enhancer is required for heart regeneration.

Mammals have limited capacity for heart regeneration, whereas zebrafish have extraordinary regeneration abilities. During zebrafish heart regeneration, endothelial cells promote cardiomyocyte cell cycle reentry and myocardial repair, but the mechanisms responsible for promoting an injury microenvironment conducive to regeneration remain incompletely defined. Here, we identify the matrix metalloproteinase Mmp14b as an essential regulator of heart regeneration. We identify a TEAD-dependent mmp14b endothelial enhancer induced by heart injury in zebrafish and mice, and we show that the enhancer is required for regeneration, supporting a role for Hippo signaling upstream of mmp14b. Last, we show that MMP-14 function in mice is important for the accumulation of Agrin, an essential regulator of neonatal mouse heart regeneration. These findings reveal mechanisms for extracellular matrix remodeling that promote heart regeneration.

Physical Health and Mental Fatigue Disability Associated with Long COVID: Baseline Results from a US Nationwide Cohort.

BACKGROUND: Persistent symptoms after severe acute respiratory disease coronavirus 2 (SARS-COV-2; long COVID) occur in 10%-55% of individuals, but the impact on daily functioning and disability remains unquantified. METHODS: To characterize disability associated with long COVID, we analyzed baseline data from an online, US-based cohort study. Adult participants included those reporting a history of COVID-19 (n = 8874) or never having COVID-19 (n = 633) without prior disability. The main outcomes were self-reported physical mobility, instrumental activities of daily living (IADL), and mental fatigue disability, assessed by measuring 5 disability components: difficulty walking a quarter mile or climbing 10 stairs (mobility), difficulty doing light or heavy housework (IADL), and Wood Mental Fatigue Inventory score (mental fatigue). RESULTS: Of 7926 participants with long COVID, 65% were classified with at least one disability, as compared with 6% and 14% for resolved COVID and no COVID, respectively. Additionally, 22% were classified as disabled in all 3 categories. Age, prior comorbidity, increased body mass index, female sex, COVID-19 hospitalization, non-white/multi-race were associated with higher disability burden. Dizziness and heavy limbs at infection were associated with disability regardless of hospitalization. Dyspnea and tremors were associated with disability in non-hospitalized individuals. Vaccination was protective against disability. CONCLUSIONS: We observed a high burden of new disability associated with long COVID, which has serious implications for individual and societal health. Longitudinal evaluation of COVID-19 patients is necessary to identify patterns of recovery and treatment options.

Transfusion reactions associated with COVID-19 convalescent plasma in outpatient clinical trials.

BACKGROUND: COVID-19 convalescent plasma (CCP) is an important therapeutic option for outpatients at high risk of hospitalization from SARS-CoV-2 infection. We assessed the safety of outpatient CCP transfusions administered during clinical trials. STUDY DESIGN AND METHODS: We analyzed data pertaining to transfusion-related reactions from two randomized controlled trials in the U.S. that evaluated the efficacy of CCP versus control plasma in various ambulatory settings. Multivariable logistic regression was used to assess whether CCP was associated with transfusion reactions, after adjusting for potential confounders. RESULTS: The combined study reported 79/1351 (5.9%) adverse events during the transfusion visit, with the majority 62/1351 (4.6%) characterized by mild, allergic-type findings of urticaria, and/or pruritus consistent with minor allergic transfusion reactions; the other reported events were attributed to the patients' underlying disease, COVID-19, or vasovagal in nature. We found no difference in the likelihood of allergic transfusion reactions between those receiving CCP versus control plasma (adjusted odds ratio [AOR], 0.75; 95% CI, 0.43-1.31). Risk of urticaria and/or pruritus increased with a pre-existing diagnosis of asthma (AOR, 2.33; 95% CI, 1.16-4.67). We did not observe any CCP-attributed antibody disease enhancement in participants with COVID-19 or increased risk of infection. There were no life-threatening severe transfusion reactions and no patients required hospitalization related to transfusion-associated complications. DISCUSSION: Outpatient plasma administration was safely performed for nearly 1400 participants. CCP is a safe therapeutic option for outpatients at risk of hospitalization from COVID-19.

Alcohol use and the longitudinal HIV care continuum for people with HIV who enrolled in care between 2011 and 2019.

PURPOSE: We described the impact of alcohol use on longitudinal engagement in HIV care including loss to follow-up, durability of viral suppression, and death. METHODS: We followed a cohort of 1781 people with HIV from enrolled in care at one of seven US clinics, 2011-2019 through 102 months. We used a multistate, time-varying Markov process and restricted mean time to summarize engagement in HIV care over follow-up according to baseline self-reported alcohol use (none, moderate, or unhealthy). RESULTS: Our sample (86% male, 54% White) had median age of 35 years. Over 102 months, people with no, moderate, and unhealthy alcohol use averaged 62.3, 61.1, and 59.5 months virally suppressed, respectively. People who reported unhealthy or moderate alcohol use spent 5.1 (95% confidence intervals (CI): 0.8, 9.3) and 7.6 (95%CI: 3.1, 11.7) more months lost to care than nondrinkers. Compared to no use, unhealthy alcohol use was associated with 3.4 (95%CI: -5.6, -1.6) fewer months in care, not virally suppressed. There were no statistically significant differences after adjustment for demographic and clinical characteristics. CONCLUSIONS: Moderate or unhealthy drinking at enrollment in HIV care was associated with poor retention in care. Alcohol use was not associated with time spent virally suppressed.

The temporal relationship of alcohol use and subsequent self-reported health status among people with HIV.

Background: Alcohol use among people with HIV is associated with worse HIV treatment outcomes. Its impact on self-reported health status is unclear. Setting: Longitudinal cohort of people with HIV engaged in care across 7 clinics participating in the Centers for AIDS Research Network of Integrated Care Systems between January 2011 and June 2014. Methods: A total of 5046 participants were studied. A quantile regression model estimated the association of alcohol use levels with subsequent self-reported health status score, accounting for multiple covariates including depressive symptoms. Women, men who have sex with women, and men who have sex with men were analyzed separately. Results: Prevalence of heavy alcohol use was 21%, 31%, and 37% among women, men who have sex with women, and men who have sex with men, respectively. Women with heavy alcohol use had a subsequently decreased median self-reported health status score compared to women with no or moderate alcohol use (odds ratio [OR]: 0.76; 95% confidence interval [CI]: 0.58-0.99); this association was not explained by the presence of depressive symptoms. There was no observed association of alcohol use level on subsequent self-reported health status among men who have sex with women. Men who have sex with men reporting no alcohol use had a subsequently decreased median self-reported health status compared to moderate alcohol use (OR: 0.88; 95% CI: 0.80-0.97). Conclusion: Heavy alcohol use is associated with worsened self-reported health status at subsequent visits among women with HIV and not men with HIV.

Respondent-driven sampling is more efficient than facility-based strategies at identifying undiagnosed people who inject drugs living with HIV in India.

INTRODUCTION: Injection drug use drives HIV epidemics in many low-resource settings, yet many people who inject drugs (PWID) living with HIV are not diagnosed. We assessed the ability of respondent-driven sampling (RDS) - which uses peer network connections - to identify undiagnosed PWID living with HIV compared to a facility-based strategy in India. METHODS: In six Indian cities from 2014 to 2017, integrated care centers (ICCs) provided HIV testing. From 2016 to 2017, RDS samples of PWID in these same cities were conducted. Using biometric matching, characteristics associated with identification by RDS only and both RDS and ICC, compared to ICC only were explored. Undiagnosed individuals tested positive and did not report a prior diagnosis. The number needed to recruit (NNR) (average number recruited to find one undiagnosed PWID living with HIV) and the identification rate (average number undiagnosed PWID identified per week) assessed the efficiency of RDS vs. ICCs. RESULTS: There were 10,759 ICC clients and 6012 RDS participants; 40% of RDS participants were also ICC clients resulting in 14,397 unduplicated PWID. PWID identified by RDS vs. ICC only were more likely to be male (adjusted odds ratios [aOR] RDS only: 6.8, both: 2.7) and living with HIV but undiagnosed (aOR RDS only: 2.5, both: 1.5). Overall, the RDS NNR was 11 and the ICC NNR was 26. The RDS identification rate (18.6/week) was faster than the ICC identification rate (2.7/week) overall and in all cities. CONCLUSIONS: RDS required screening fewer PWID and more rapidly identified undiagnosed PWID living with HIV as compared to ICCs.

Defining representativeness of study samples in medical and population health research.

Medical and population health science researchers frequently make ambiguous statements about whether they believe their study sample or results are representative of some (implicit or explicit) target population. This article provides a comprehensive definition of representativeness, with the goal of capturing the different ways in which a study can be representative of a target population. It is proposed that a study is representative if the estimate obtained in the study sample is generalisable to the target population (owing to representative sampling, estimation of stratum specific effects, or quantitative methods to generalise or transport estimates) or the interpretation of the results is generalisable to the target population (based on fundamental scientific premises and substantive background knowledge). This definition is explored in the context of four covid-19 studies, ranging from laboratory science to descriptive epidemiology. All statements regarding representativeness should make clear the way in which the study results generalise, the target population the results are being generalised to, and the assumptions that must hold for that generalisation to be scientifically or statistically justifiable.

The Environmental Influences on Child Health Outcomes (ECHO)-Wide Cohort.

The Environmental Influences on Child Health Outcomes (ECHO)-Wide Cohort Study (EWC), a collaborative research design comprising 69 cohorts in 31 consortia, was funded by the National Institutes of Health (NIH) in 2016 to improve children's health in the United States. The EWC harmonizes extant data and collects new data using a standardized protocol, the ECHO-Wide Cohort Data Collection Protocol (EWCP). EWCP visits occur at least once per life stage, but the frequency and timing of the visits vary across cohorts. As of March 4, 2022, the EWC cohorts contributed data from 60,553 children and consented 29,622 children for new EWCP data and biospecimen collection. The median (interquartile range) age of EWCP-enrolled children was 7.5 years (3.7-11.1). Surveys, interviews, standardized examinations, laboratory analyses, and medical record abstraction are used to obtain information in 5 main outcome areas: pre-, peri-, and postnatal outcomes; neurodevelopment; obesity; airways; and positive health. Exposures include factors at the level of place (e.g., air pollution, neighborhood socioeconomic status), family (e.g., parental mental health), and individuals (e.g., diet, genomics).

Comparison of allocation strategies of convalescent plasma to reduce excess infections and mortality from SARS-CoV-2 in a US-like population.

BACKGROUND: While the use of convalescent plasma (CP) in the ongoing COVID-19 pandemic has been inconsistent, CP has the potential to reduce excess morbidity and mortality in future pandemics. Given constraints on CP supply, decisions surrounding the allocation of CP must be made. STUDY DESIGN AND METHODS: Using a discrete-time stochastic compartmental model, we simulated implementation of four potential allocation strategies: administering CP to individuals in early hospitalization with COVID-19; administering CP to individuals in outpatient settings; administering CP to hospitalized individuals and administering any remaining CP to outpatient individuals and administering CP in both settings while prioritizing outpatient individuals. We examined the final size of SARS-CoV-2 infections, peak and cumulative hospitalizations, and cumulative deaths under each of the allocation scenarios over a 180-day period. We compared the cost per weighted health benefit under each strategy. RESULTS: Prioritizing administration to patients in early hospitalization, with remaining plasma administered in outpatient settings, resulted in the highest reduction in mortality, averting on average 15% more COVID-19 deaths than administering to hospitalized individuals alone (95% CI [11%-18%]). Prioritizing administration to outpatients, with remaining plasma administered to hospitalized individuals, had the highest percentage of hospitalizations averted (22% [21%-23%] higher than administering to hospitalized individuals alone). DISCUSSION: Convalescent plasma allocation strategy should be determined by the relative priority of averting deaths, infections, or hospitalizations. Under conditions considered, mixed allocation strategies (allocating CP to both outpatient and hospitalized individuals) resulted in a larger percentage of infections and deaths averted than administering CP in a single setting.

Transfusing Convalescent Plasma as Post-Exposure Prophylaxis Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Double-Blinded, Phase 2 Randomized, Controlled Trial.

BACKGROUND: The efficacy of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) convalescent plasma (CCP) for preventing infection in exposed, uninfected individuals is unknown. CCP might prevent infection when administered before symptoms or laboratory evidence of infection. METHODS: This double-blinded, phase 2 randomized, controlled trial (RCT) compared the efficacy and safety of prophylactic high titer (≥1:320 by Euroimmun ELISA) CCP with standard plasma. Asymptomatic participants aged ≥18 years with close contact exposure to a person with confirmed coronavirus disease 2019 (COVID-19) in the previous 120 hours and negative SARS-CoV-2 test within 24 hours before transfusion were eligible. The primary outcome was new SARS-CoV-2 infection. RESULTS: In total, 180 participants were enrolled; 87 were assigned to CCP and 93 to control plasma, and 170 transfused at 19 sites across the United States from June 2020 to March 2021. Two were excluded for screening SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) positivity. Of the remaining 168 participants, 12/81 (14.8%) CCP and 13/87 (14.9%) control recipients developed SARS-CoV-2 infection; 6 (7.4%) CCP and 7 (8%) control recipients developed COVID-19 (infection with symptoms). There were no COVID-19-related hospitalizations in CCP and 2 in control recipients. Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25.3 vs 25.2 days; P = .49) and COVID-19 (26.3 vs 25.9 days; P = .35) was similar for both groups. CONCLUSIONS: Administration of high-titer CCP as post-exposure prophylaxis, although appearing safe, did not prevent SARS-CoV-2 infection. CLINICAL TRIALS REGISTRATION: NCT04323800.

Physical and mental health disability associated with long-COVID: Baseline results from a US nationwide cohort.

Importance: Persistent symptoms after SARS-COV-2 infection, or long-COVID, may occur in anywhere from 10-55% of those who have had COVID-19, but the extent of impact on daily functioning and disability remains unquantified. Objective: To characterize physical and mental disability associated with long-COVID. Design: Cross-sectional analysis of baseline data from a cohort study. Setting: Online US nationwide survey. Participants: Adults 18 years of age and older who live in the US who either report a history of COVID-19 illness (n=8,874) or report never having had COVID-19 (n=633). Main Outcome and Measures: Self-reported mobility disability (difficulty walking a quarter of a mile and/or up 10 stairs, instrumental activities of daily living [IADL] disability (difficulty doing light or heavy housework), and mental fatigue as measured by the Wood Mental Fatigue Inventory (WMFI). Results: Of 7,926 participants with long-COVID, the median age was 45 years, 84% were female, 89% self-reported white race, and 7.4% self-reported Hispanic/Latino ethnicity. Sixty-five percent of long-COVID participants were classified as having at least one disability, compared to 6% of those with resolved-COVID (n=948) and 14% of those with no-COVID (n=633). Of long-COVID participants, about 1% and 5% were classified as critically physically disabled or mentally fatigued, respectively. Age, prior comorbidity, increased BMI, female gender, hospitalization for COVID-19, non-white race, and multi-race were all associated with significantly higher disability burden. Dizziness at the time of infection (33% non-hospitalized, 39% hospitalized) was associated with all five disability components in both hospitalized and non-hospitalized groups. Heavy limbs, dyspnea, and tremors were associated with four of the five components of disability in the non-hospitalized group, and heavy limbs was associated with four of the five components in the hospitalized group. Vaccination was protective against development of disability. Conclusion and Relevance: We observed a high burden of physical and mental disability associated with long-COVID which has serious implications for individual and societal health that may be partially mitigated by vaccination. Longitudinal characterization and evaluation of COVID-19 patients is necessary to identify patterns of recovery and treatment options.

Alcohol consumption upon direct-acting antiviral therapy for hepatitis C among persons with human immunodeficiency virus in the United States.

BACKGROUND: Direct-acting antivirals (DAA) are highly effective against hepatitis C virus (HCV) infection among persons with human immunodeficiency virus (PWH). However, alcohol use post-DAA treatment poses a continued threat to the liver. Whether the focus on liver health alone during HCV treatment can impact alcohol consumption is unclear. Therefore, we examined the change in alcohol use among HCV-coinfected PWH who received DAA therapy by non-addiction medical providers. METHODS: In our longitudinal clinical cohort study, we identified HCV-coinfected PWH who received interferon-free DAA therapy between January 2014 and June 2019 in the Centers for AIDS Research Network of Integrated Clinical Systems. The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) was the alcohol screening instrument. We used mixed-effects logistic regression models to estimate the longitudinal change in alcohol use upon DAA therapy. RESULTS: Among 738 HCV-coinfected PWH, 339 (46 %) reported any alcohol use at the end of HCV treatment, including 113 (15 %) with high-risk use (i.e., AUDIT-C ≥3 for women, ≥4 for men). Concurrently, 280 (38 %) PWH noted active drug use, and 357 (48 %) were currently smoking. We observed no changes in the odds of any alcohol or high-risk alcohol use over time with DAA therapy. Findings were similar in the PWH subgroup with a history of alcohol use before DAA treatment. CONCLUSIONS: For PWH with HCV, alcohol use did not change following interferon-free DAA treatment by non-addiction medical providers. Thus, clinicians should consider integrating targeted alcohol use interventions into HCV care to motivate reduced alcohol consumption and safeguard future liver health.