A Per-Protocol Analysis Using Inverse-Probability-of-Censoring Weights in a Randomized Trial of Initial Protease Inhibitor Versus Nonnucleoside Reverse Transcriptase Inhibitor Regimens in Children.

Protocol adherence may influence measured treatment effectiveness in randomized controlled trials. Using data from a multicenter trial (Europe and the Americas, 2002-2009) of children with human immunodeficiency virus type 1 who had been randomized to receive initial protease inhibitor (PI) versus nonnucleoside reverse transcriptase inhibitor (NNRTI) antiretroviral therapy regimens, we generated time-to-event intention-to-treat (ITT) estimates of treatment effectiveness, applied inverse-probability-of-censoring weights to generate per-protocol efficacy estimates, and compared shifts from ITT to per-protocol estimates across and within treatment arms. In ITT analyses, 263 participants experienced 4-year treatment failure probabilities of 41.3% for PIs and 39.5% for NNRTIs (risk difference = 1.8% (95% confidence interval (CI): -10.1, 13.7); hazard ratio = 1.09 (95% CI: 0.74, 1.60)). In per-protocol analyses, failure probabilities were 35.6% for PIs and 29.2% for NNRTIs (risk difference = 6.4% (95% CI: -6.7, 19.4); hazard ratio = 1.30 (95% CI: 0.80, 2.12)). Within-arm shifts in failure probabilities from ITT to per-protocol analyses were 5.7% for PIs and 10.3% for NNRTIs. Protocol nonadherence was nondifferential across arms, suggesting that possibly better NNRTI efficacy may have been masked by differences in within-arm shifts deriving from differential regimen forgiveness, residual confounding, or chance. A per-protocol approach using inverse-probability-of-censoring weights facilitated evaluation of relationships among adherence, efficacy, and forgiveness applicable to pediatric oral antiretroviral regimens.

SARS-CoV-2 reinfections in a US university setting, Fall 2020 to Spring 2021.

BACKGROUND: SARS-CoV-2 reinfections are a public health concern because of the potential for transmission and clinical disease, and because of our limited understanding of whether and how well an infection confers protection against subsequent infections. Despite the public health importance, few studies have reported rigorous estimates of reinfection risk. METHODS: Leveraging Indiana University's comprehensive testing program to identify both asymptomatic and symptomatic SARS-CoV-2 cases, we estimated the incidence of SARS-CoV-2 reinfection among students, faculty, and staff across the 2020-2021 academic year. We contextualized the reinfection data with information on key covariates: age, sex, Greek organization membership, student vs faculty/staff affiliation, and testing type. RESULTS: Among 12,272 people with primary infections, we found a low level of SARS-CoV-2 reinfections (0.6%; 0.4 per 10,000 person-days). We observed higher risk for SARS-CoV-2 reinfections in Greek-affiliated students. CONCLUSIONS: We found evidence for low levels of SARS-CoV-2 reinfection in a large multi-campus university population during a time-period prior to widespread COVID-19 vaccination.

Use of research electronic data capture (REDCap) in a COVID-19 randomized controlled trial: a practical example.

BACKGROUND: Randomized controlled trials (RCT) are considered the ideal design for evaluating the efficacy of interventions. However, conducting a successful RCT has technological and logistical challenges. Defects in randomization processes (e.g., allocation sequence concealment) and flawed masking could bias an RCT's findings. Moreover, investigators need to address other logistics common to all study designs, such as study invitations, eligibility screening, consenting procedure, and data confidentiality protocols. Research Electronic Data Capture (REDCap) is a secure, browser-based web application widely used by researchers for survey data collection. REDCap offers unique features that can be used to conduct rigorous RCTs. METHODS: In September and November 2020, we conducted a parallel group RCT among Indiana University Bloomington (IUB) undergraduate students to understand if receiving the results of a SARS-CoV-2 antibody test changed the students' self-reported protective behavior against coronavirus disease 2019 (COVID-19). In the current report, we discuss how we used REDCap to conduct the different components of this RCT. We further share our REDCap project XML file and instructional videos that investigators can use when designing and conducting their RCTs. RESULTS: We reported on the different features that REDCap offers to complete various parts of a large RCT, including sending study invitations and recruitment, eligibility screening, consenting procedures, lab visit appointment and reminders, data collection and confidentiality, randomization, blinding of treatment arm assignment, returning test results, and follow-up surveys. CONCLUSIONS: REDCap offers powerful tools for longitudinal data collection and conduct of rigorous and successful RCTs. Investigators can make use of this electronic data capturing system to successfully complete their RCTs. TRIAL REGISTRATION: The RCT was prospectively (before completing data collection) registered at ClinicalTrials.gov; registration number: NCT04620798 , date of registration: November 9, 2020.

A population-based study of concurrent prescriptions of opioid analgesic and selective serotonin reuptake inhibitor medications during pregnancy and risk for adverse birth outcomes.

BACKGROUND: Pregnant women with painful conditions often have mental health problems, including depression and anxiety. Co-morbid conditions may cause pregnant women to use multiple medications, although safety of such practice is poorly understood. OBJECTIVES: We investigated the influence of combined prescriptions of opioid analgesics and selective serotonin reuptake inhibitors (SSRIs) during pregnancy on two adverse birth outcomes. METHODS: We analysed Swedish population-based births (n = 688 914) between 2007 and 2013. Using national registers, we obtained data on filled medication prescriptions, birth outcomes, and a wide range of parental characteristics. We estimated preterm birth and small-for-gestational-age risk following independent or combined prescriptions of the two medications compared with no filled prescriptions for either medication. We adjusted for confounders using inverse probability of treatment weights. RESULTS: After adjusting for confounders, preterm birth risk was higher among women with opioid analgesic prescriptions only (5.9%; risk ratio [RR] 1.27, 95% confidence interval [CI] 1.22, 1.33), SSRIs only (6.2%; RR 1.34, 95% CI 1.27, 1.42), and both medications (7.8%; RR 1.70, 95% CI 1.47, 1.96) compared with unexposed women (4.6%). The interaction between the medications on preterm birth was small (risk difference [RD] 0.4%, 95% CI -0.8%, 1.6%); relative excess risk due to interaction [RERI] 0.09, 95% CI -0.17, 0.34; RR 1.00, 95% CI 0.85, 1.17). For small for gestational age, risk was approximately 2% across all groups, and there was no interaction between the medications (RD 0.3%, 95% CI -0.4%, 1.1%); RERI 0.15, 95% CI -0.16, 0.47; RR 1.15, 95% CI 0.87, 1.52). CONCLUSIONS: Compared with unexposed pregnancies, those with either medication alone had a small increased risk for preterm birth but no increased risk for small for gestational age. The magnitude of associations with combined exposure to both medications were not greater than the sum of the associations with each medication considered individually.

Health insurance and AIDS Drug Assistance Program (ADAP) increases retention in care among women living with HIV in the United States.

Our objective was to examine the association between healthcare payer type and missed HIV care visits among 1,366 US women living with HIV (WLWH) enrolled in the prospective Women's Interagency HIV Study (WIHS). We collected secondary patient-level data (October 1, 2017-September 30, 2018) from WLWH at nine WIHS sites. We used bivariate and multivariable binary logistic regression to examine the relationship between healthcare payer type (cross-classification of patients' ADAP and health insurance enrollment) and missed visits-based retention in care, defined as no-show appointments for which patients did not reschedule. Our sample included all WLWH who self-reported having received HIV care at least once during the two consecutive biannual WIHS visits a year prior to October 1, 2017-September 30, 2018. In the bivariate model, compared to uninsured WLWH without ADAP, WLWH with private insurance + ADAP were more likely to be retained in care, as were WLWH with Medicaid only and private insurance only. In the adjusted model, WLWH with private insurance only were more likely to be retained in care compared to uninsured WLWH without ADAP. Private health insurance and ADAP are associated with increased odds of retention in care among WLWH.

Food insecurity, gestational weight gain and gestational diabetes in the National Children's Study, 2009-2014.

BACKGROUND: Household food insecurity (HFI) and gestational diabetes mellitus (GDM) are both common during pregnancy, yet it is unknown if these two factors are related. We aimed to determine the independent and joint associations between HFI, gestational weight gain (GWG) and GDM among pregnant women in the USA. METHODS: We used data from 592 women in the National Children's Study, Initial Vanguard Study from 2009 to 2014. HFI was assessed using the Household Food Security Survey Module at the first study visit; GDM was assessed through questionnaires and medical chart review. Logistic regression models were used to investigate the exposures of HFI, GWG and their joint effect on GDM. RESULTS: Among participants, 20.1% were marginally food secure or food insecure and 7.4% were diagnosed with GDM. The elevated unadjusted association between HFI and GDM was attenuated after adjustment (aOR: 1.12; 95%CI: 0.47, 2.66). There was an elevated risk of GDM associated with inadequate GWG, (aOR: 2.42; 95%CI: 0.97, 6.00), but results were imprecise. There were no statistically significant associations in the joint exposure analysis. CONCLUSION: The relationship between HFI and GDM is mostly explained by other covariates, but there is some evidence that inadequate GWG is a possible risk factor for GDM.

Neighborhood Poverty and Control of HIV, Hypertension, and Diabetes in the Women's Interagency HIV Study.

Neighborhoods with high poverty rates have limited resources to support residents' health. Using census data, we calculated the proportion of each Women's Interagency HIV Study participant's census tract (neighborhood) living below the poverty line. We assessed associations between neighborhood poverty and (1) unsuppressed viral load [VL] in HIV-seropositive women, (2) uncontrolled blood pressure among HIV-seropositive and HIV-seronegative hypertensive women, and (3) uncontrolled diabetes among HIV-seropositive and HIV-seronegative diabetic women using modified Poisson regression models. Neighborhood poverty was associated with unsuppressed VL in HIV-seropositive women (> 40% versus ≤ 20% poverty adjusted prevalence ratio (PR), 1.42; 95% confidence interval (CI) 1.04-1.92). In HIV-seronegative diabetic women, moderate neighborhood poverty was associated with uncontrolled diabetes (20-40% versus ≤ 20% poverty adjusted PR, 1.75; 95% CI 1.02-2.98). Neighborhood poverty was associated with neither uncontrolled diabetes among HIV-seropositive diabetic women, nor uncontrolled hypertension in hypertensive women, regardless of HIV status. Women living in areas with concentrated poverty may need additional resources to control health conditions effectively.

Prior incarceration associated with missed HIV care visits among young people living with HIV in the US.

Maintenance in HIV care is important to achieve optimal personal health and HIV viral load suppression for young people living with HIV (PLWH). We assessed the relationship between incarceration and missed visits in a longitudinal data cohort of PLWH (n = 910), ages 12-24, from 14 adolescent trial network sites across the US. The time from study entry to missed visits was modeled using Cox proportional hazards models. The cohort was mostly male (78%) and African American (75%) with a median age of 22. Prior incarceration had been experienced by 39% of the cohort, with a median number of times incarcerated of 2 (IQR: 1-3). The crude and adjusted hazard ratios for missed HIV care visits comparing those with incarceration histories to those without were 1.27 (95% CI: 1.06, 1.54) and 1.53 (95% CI: 1.26, 1.86). Among those returning to care, HIV viral loads were more likely to be unsuppressed among those with incarceration history compared to those without (RR: 1.28, 95% CI: 0.95, 1.74). This association was attenuated to the null after adjustment for suppression of viral load prior to the missed visit. Young PLWH with incarceration histories are at higher risk of missing HIV care visits.

Comparing neighborhood and state contexts for women living with and without HIV: understanding the Southern HIV epidemic.

In the South, people living with HIV experience worse health outcomes than in other geographic regions, likely due to regional political, structural, and socioeconomic factors. We describe the neighborhoods of women (n = 1,800) living with and without HIV in the Women's Interagency HIV Study (WIHS), a cohort with Southern sites in Chapel Hill, NC; Atlanta, GA; Birmingham, AL; Jackson, MS; and Miami, FL; and non-Southern sites in Brooklyn, NY; Bronx, NY; Washington, DC; San Francisco, CA; and Chicago, IL. In 2014, participants' addresses were geocoded and matched to several administrative data sources. There were a number of differences between the neighborhood contexts of Southern and non-Southern WIHS participants. Southern states had the lowest income eligibility thresholds for family Medicaid, and consequently higher proportions of uninsured individuals. Modeled proportions of income devoted to transportation were much higher in Southern neighborhoods (Location Affordability Index of 28-39% compared to 16-23% in non-Southern sites), and fewer participants lived in counties where hospitals reported providing HIV care (55% of GA, 63% of NC, and 76% of AL participants lived in a county with a hospital that provided HIV care, compared to >90% at all other sites). Finally, the states with the highest adult incarceration rates were all in the South (per 100,000 residents: AL 820, MS 788, GA 686, FL 644). Many Southern states opted not to expand Medicaid, invest little in transportation infrastructure, and have staggering rates of incarceration. Resolution of racial and geographic disparities in HIV health outcomes will require addressing these structural barriers.

Associations Between Neighborhood Characteristics, Social Cohesion, and Perceived Sex Partner Risk and Non-Monogamy Among HIV-Seropositive and HIV-Seronegative Women in the Southern U.S.

Neighborhood social and physical factors shape sexual network characteristics in HIV-seronegative adults in the U.S. This multilevel analysis evaluated whether these relationships also exist in a predominantly HIV-seropositive cohort of women. This cross-sectional multilevel analysis included data from 734 women enrolled in the Women's Interagency HIV Study's sites in the U.S. South. Census tract-level contextual data captured socioeconomic disadvantage (e.g., tract poverty), number of alcohol outlets, and number of non-profits in the census tracts where women lived; participant-level data, including perceived neighborhood cohesion, were gathered via survey. We used hierarchical generalized linear models to evaluate relationships between tract characteristics and two outcomes: perceived main sex partner risk level (e.g., partner substance use) and perceived main sex partner non-monogamy. We tested whether these relationships varied by women's HIV status. Greater tract-level socioeconomic disadvantage was associated with greater sex partner risk (OR 1.29, 95% CI 1.06-1.58) among HIV-seropositive women and less partner non-monogamy among HIV-seronegative women (OR 0.69, 95% CI 0.51-0.92). Perceived neighborhood trust and cohesion was associated with lower partner risk (OR 0.83, 95% CI 0.69-1.00) for HIV-seropositive and HIV-seronegative women. The tract-level number of alcohol outlets and non-profits were not associated with partner risk characteristics. Neighborhood characteristics are associated with perceived sex partner risk and non-monogamy among women in the South; these relationships vary by HIV status. Future studies should examine causal relationships and explore the pathways through which neighborhoods influence partner selection and risk characteristics.

Relationships between neighbourhood characteristics and current STI status among HIV-infected and HIV-uninfected women living in the Southern USA: a cross-sectional multilevel analysis.

OBJECTIVES: Neighbourhood characteristics (eg, high poverty rates) are associated with STIs among HIV-uninfected women in the USA. However, no multilevel analyses investigating the associations between neighbourhood exposures and STIs have explored these relationships among women living with HIV infection. The objectives of this study were to: (1) examine relationships between neighbourhood characteristics and current STI status and (2) investigate whether the magnitudes and directions of these relationships varied by HIV status in a predominantly HIV-infected cohort of women living in the Southern USA. METHODS: This cross-sectional multilevel analysis tests relationships between census tract characteristics and current STI status using data from 737 women enrolled at the Women's Interagency HIV Study's southern sites (530 HIV-infected and 207 HIV-uninfected women). Administrative data (eg, US Census) described the census tract-level social disorder (eg, violent crime rate) and social disadvantage (eg, alcohol outlet density) where women lived. Participant-level data were gathered via survey. Testing positive for a current STI was defined as a laboratory-confirmed diagnosis of chlamydia, gonorrhoea, trichomoniasis or syphilis. Hierarchical generalised linear models were used to determine relationships between tract-level characteristics and current STI status, and to test whether these relationships varied by HIV status. RESULTS: Eleven per cent of participants tested positive for at least one current STI. Greater tract-level social disorder (OR=1.34, 95% CI 0.99 to 1.87) and social disadvantage (OR=1.34, 95% CI 0.96 to 1.86) were associated with having a current STI. There was no evidence of additive or multiplicative interaction between tract-level characteristics and HIV status. CONCLUSIONS: Findings suggest that neighbourhood characteristics may be associated with current STIs among women living in the South, and that relationships do not vary by HIV status. Future research should establish the temporality of these relationships and explore pathways through which neighbourhoods create vulnerability to STIs. TRIAL REGISTRATION NUMBER: NCT00000797; results.

Characteristics of African American Women and Their Partners With Perceived Concurrent Partnerships in 4 Rural Counties in the Southeastern U.S.

BACKGROUND: To the individual with concurrent partners, it is thought that having concurrent partnerships confers no greater risk of acquiring HIV than having multiple consecutive partnerships. However, an individual whose partner has concurrent partnerships (partner's concurrency) is at increased risk for incident HIV infection. We sought to better understand relationships characterized by partner's concurrency among African American women. METHODS: A total of 1013 African American women participated in a cross-sectional survey from 4 rural Southeastern counties. RESULTS: Older age at first sex was associated with lower prevalence of partner's concurrency (prevalence ratio, 0.70; 95% confidence interval, 0.57-0.87), but the participant's age was not associated with partner's concurrency. After adjusting for covariates, ever having experienced intimate partner violence (IPV) and forced sex were most strongly associated with partner's concurrency (prevalence ratios, 1.61 [95% confidence intervals, 1.23-2.11] and 1.65 [1.20-2.26], respectively). Women in mutually monogamous partnerships were the most likely to receive economic support from their partners; women whose partners had concurrent partnerships did not report more economic benefit than did those whose partners were monogamous. CONCLUSIONS: Associations between history of IPV and forced sex with partner's concurrency suggest that women with these experiences may particularly benefit from interventions to reduce partner's concurrency in addition to support for reducing IPV and other sexual risks. To inform these interventions, further research to understand partnerships characterized by partner's concurrency is warranted.

Association between unprotected ultraviolet radiation exposure and recurrence of ocular herpes simplex virus.

Studies have suggested that exposure to ultraviolet (UV) light may increase risk of herpes simplex virus (HSV) recurrence. Between 1993 and 1997, the Herpetic Eye Disease Study (HEDS) randomized 703 participants with ocular HSV to receipt of acyclovir or placebo for prevention of ocular HSV recurrence. Of these, 308 HEDS participants (48% female and 85% white; median age, 49 years) were included in a nested study of exposures thought to cause recurrence and were followed for up to 15 months. We matched weekly UV index values from the National Oceanic and Atmospheric Administration to each participant's study center and used marginal structural Cox models to account for time-varying psychological stress and contact lens use and selection bias from dropout. There were 44 recurrences of ocular HSV, yielding an incidence of 4.3 events per 1,000 person-weeks. Weighted hazard ratios comparing persons with ≥8 hours of time outdoors to those with less exposure were 0.84 (95% confidence interval (CI): 0.27, 2.63) and 3.10 (95% CI: 1.14, 8.48) for weeks with a UV index of <4 and ≥4, respectively (ratio of hazard ratios = 3.68, 95% CI: 0.43, 31.4). Though results were imprecise, when the UV index was higher (i.e., ≥4), spending 8 or more hours per week outdoors was associated with increased risk of ocular HSV recurrence.

Patterns and predictors of COVID-19 vaccination among young adults at 44 US sites: Secondary analysis of a randomized, controlled, open-label trial, March - December 2021.

BACKGROUND: The introduction of vaccines during the COVID-19 pandemic provided an opportunity to slow transmission of SARS-CoV-2, but initial uptake of COVID-19 vaccination was slow. We analyzed data from a randomized clinical trial of the mRNA-1273 vaccine (NCT04811664) to describe the patterns of uptake of COVID-19 vaccines among young adults. METHODS: The CoVPN 3006 trial randomized adults ages 18-29 from 44 sites in the United States to receive 1) immediate mRNA-1273 vaccination from the study site, or 2) standard of care, including the option to seek vaccination at any time in the future. Randomization occurred between March and November 2021, and an observational arm of adults who declined vaccination was enrolled beginning June 2021. Among participants in the standard of care (SoC) or Vaccine Declined arms, we estimated demographic, behavioral, and health history correlates of vaccination, and the four-month cumulative incidence of COVID-19 vaccination using inverse probability weighted Kaplan-Meier estimators. RESULTS: Among 728 SoC and 470 Vaccine Declined participants, 79% and 16% received COVID-19 vaccination, respectively. SoC and Vaccine Declined participants were more likely to seek and receive vaccination if they reported COVID-19 preventive behaviors, including wearing masks, physically distancing, and avoiding large gatherings. We identified strong predictors of vaccination in the Vaccine Declined arm, including attending class in person (adjusted risk ratio [aRR]: 0.47, 95% confidence interval [CI] 0.21, 1.03), having a COVID-19 relevant medical condition (aRR: 1.95, 95% CI: 0.89, 4.26), and avoiding large gatherings (aRR: 2.24, 95% CI: 1.18, 4.25), though low vaccination rates in this arm led to imprecise estimates. CONCLUSIONS: Individuals who initially decline vaccination can be convinced to vaccinate, particularly if they are already practicing other forms of COVID-19 prevention. Continued outreach and education from the scientific community can combat low vaccine confidence.

Development and validation of a model for measuring alcohol consumption from transdermal alcohol content data among college students.

BACKGROUND AND AIMS: Transdermal alcohol content (TAC) data collected by wearable alcohol monitors could potentially contribute to alcohol research, but raw data from the devices are challenging to interpret. We aimed to develop and validate a model using TAC data to detect alcohol drinking. DESIGN: We used a model development and validation study design. SETTING: Indiana, USA PARTICIPANTS: In March to April 2021, we enrolled 84 college students who reported drinking at least once a week (median age = 20 years, 73% white, 70% female). We observed participants' alcohol drinking behavior for 1 week. MEASUREMENTS: Participants wore BACtrack Skyn monitors (TAC data), provided self-reported drinking start times in real time (smartphone app) and completed daily surveys about their prior day of drinking. We developed a model using signal filtering, peak detection algorithm, regression and hyperparameter optimization. The input was TAC and outputs were alcohol drinking frequency, start time and magnitude. We validated the model using daily surveys (internal validation) and data collected from college students in 2019 (external validation). FINDINGS: Participants (N = 84) self-reported 213 drinking events. Monitors collected 10 915 hours of TAC. In internal validation, the model had a sensitivity of 70.9% (95% CI = 64.1%-77.0%) and a specificity of 73.9% (68.9%-78.5%) in detecting drinking events. The median absolute time difference between self-reported and model-detected drinking start times was 59 min. Mean absolute error (MAE) for the reported and detected number of drinks was 2.8 drinks. In an exploratory external validation among five participants, number of drinking events, sensitivity, specificity, median time difference and MAE were 15%, 67%, 100%, 45 minutes and 0.9 drinks, respectively. Our model's output was correlated with breath alcohol concentration data (Spearman's correlation [95% CI] = 0.88 [0.77, 0.94]). CONCLUSION: This study, the largest of its kind to date, developed and validated a model for detecting alcohol drinking using transdermal alcohol content data collected with a new generation of alcohol monitors. The model and its source code are available as Supporting Information (https://osf.io/xngbk).

Target Trial Emulation: A Design Tool for Cancer Clinical Trials.

PURPOSE: To apply target trial emulation to explore the potential impact of eligibility criteria on the primary outcome of a randomized controlled trial. METHODS: Simulations of a real-world explanatory trial of transarterial radioembolization for advanced unresectable hepatocellular carcinoma with portal vein invasion were performed to examine the effects of cohort specification on survival outcomes and patient sample size. Simulations comprised 24 different permutations of the trial varied on three disease nonspecific eligibility parameters. Treatment and control arms for these emulated trials were drawn from the National Cancer Database and matched by treatment propensity. Target trial emulation served as the causal framework for this analysis, allowing the architecture of a true controlled experiment to address forms of bias routinely encountered in comparative effectiveness studies involving real-world observational data. RESULTS: Twenty-four propensity score-matched cohorts comprising a wider clinical spectrum of patients than specified by the original target trial were successfully generated using the National Cancer Database. The arms for each of the emulated trials demonstrated exchangeability across all eligibility criteria and other clinical covariates. Significant treatment benefits were associated with only a narrow range of eligibility criteria, indicating that the original target trial was well specified. CONCLUSION: The impact of patient selection on treatment outcomes can be studied using target trial emulation. This analytical framework can furthermore serve to leverage existing real-world data to inform the task of cohort specification for a randomized controlled trial, facilitating a more data-driven approach for this important step in clinical trial design.

Wearable alcohol monitors for alcohol use data collection among college students: Feasibility and acceptability.

OBJECTIVE: We assessed the feasibility and acceptability of using BACtrack Skyn wearable alcohol monitors for alcohol research in a college student population. METHODS: We enrolled n = 5 (Sample 1) and n = 84 (Sample 2) Indiana University undergraduate students to wear BACtrack Skyn devices continuously over a 5-day to 7-day study period. We assessed feasibility in both samples by calculating compliance with study procedures, and by analyzing amount and distributions of device output [e.g., transdermal alcohol content (TAC), temperature, motion]. In Sample 1, we assessed feasibility and acceptability with the Feasibility of Intervention Measure (FIM) scale and the Acceptability of Intervention Measure (AIM) scale. RESULTS: All participants were able to successfully use the alcohol monitors, producing a total of 11,504 h of TAC data. TAC data were produced on 567 days of the 602 total possible days of data collection. The distribution of the TAC data showed between-person variation, as would be expected with between-person differences in drinking patterns. Temperature and motion data were also produced as expected. Sample 1 participants (n = 5) reported high feasibility and acceptability of the wearable alcohol monitors in survey responses with a mean FIM score of 4.3 (of 5.0 possible score) and mean AIM score of 4.3 (of 5.0 possible score). CONCLUSIONS: The high feasibility and acceptability we observed underscore the promise of using BACtrack Skyn wearable alcohol monitors to improve our understanding of alcohol consumption among college students, a population at particularly high risk for alcohol-related harms.

Relationship between high-risk alcohol consumption and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seroconversion: a prospective sero-epidemiological cohort study among American college students.

AIMS: To estimate the associations between high-risk alcohol consumption and (1) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seroconversion, (2) self-reported new SARS-CoV-2 infection and (3) symptomatic COVID-19. DESIGN: Prospective cohort study. SETTING: Indiana University Bloomington (IUB), IN, USA. PARTICIPANTS: A total of 1027 IUB undergraduate students (64% female), aged 18 years or older, residing in Monroe County, Indiana, seronegative for SARS-CoV-2 at study baseline. MEASUREMENTS: Primary exposure was high-risk alcohol consumption measured with an Alcohol Use Disorders Identification Test (AUDIT) questionnaire score of 8 or more. Primary outcome was SARS-CoV-2 seroconversion since baseline, assessed with two SARS-CoV-2 antibody tests, at baseline (September 2020) and end-line (November 2020). Secondary outcomes were (a) self-reported new SARS-CoV-2 infection at the study end-line and (b) self-reported symptomatic COVID-19 at baseline. FINDINGS: Prevalence of high-risk alcohol consumption was 32 %. In models adjusted for demographics, students with high-risk alcohol consumption status had 2.44 [95% confidence interval (CI) = 1.35, 4.25] times the risk of SARS-CoV-2 seroconversion and 1.84 (95% CI = 1.04, 3.28) times the risk of self-reporting a positive SARS-CoV-2 infection, compared with students with no such risk. We did not identify any association between high-risk alcohol consumption and symptomatic COVID-19 (prevalence ratio = 1.17, 95% CI = 0.93, 1.47). Findings from sensitivity analyses corroborated these results and suggested potential for a dose-response relationship. CONCLUSIONS: Among American college students, high-risk alcohol consumption appears to be associated with higher risk for severe acute respiratory syndrome coronavirus 2 seroconversion/infection.

The relationship between acquaintance with a SARS-CoV-2 death, positive SARS-CoV-2 test results, and sleep duration among college students in fall 2020.

Background: The aim of this study was to test whether two SARS-CoV-2 experiences, knowing someone who had died of SARS-CoV-2 infection and having received a positive SARS-CoV-2 test result, were associated with shorter sleep duration among undergraduate students. Methods: An online cross-sectional study was conducted at a large public Midwestern university in September 2020 (fall semester). Self-reported average sleep duration and the exposures of interest, knowing someone who died from a SARS-CoV-2 infection and their own SARS-CoV-2 test result, were collected from 1,058 undergraduate study participants. Results: Respondents who knew someone who had died of a SARS-CoV-2 infection were more likely to report having a short sleep duration, compared to respondents who did not know someone who had died of a SARS-CoV-2 infection (aOR = 1.80, 95% CI: 1.14, 2.79). However, those with a positive SARS-CoV-2 test result were less likely to report a short sleep duration, compared to respondents without a positive test history (aOR = 0.47, 95% CI: 0.21, 0.91). Conclusions: These findings suggest that college students' knowing someone who had died of SARS-CoV-2 infection and having received a positive SARS-CoV-2 test result are associated with sleep duration. However, different experiences may impact sleep differently, so further research is warranted to better understand how unusual events impact the sleep of college students.

The association between social factors and COVID-19 protective behaviors and depression and stress among midwestern US college students.

PURPOSE: The aim of this cross-sectional study was to examine the relationship between social factors and COVID-19 protective behaviors and two outcomes: depressive and perceived stress symptoms. METHODS: In September 2020, 1,064 randomly selected undergraduate students from a large midwestern university completed an online survey and provided information on demographics, social activities, COVID-19 protective behaviors (i.e., avoiding social events and staying home from work and school), and mental health symptoms. Mental health symptoms were measured using the Center for Epidemiological Studies Depression-10 questionnaire for depression and the Perceived Stress Scale-10 for stress symptoms. RESULTS: The results showed respondents who were males and also the respondents who were "hanging out" with more people while drinking alcohol reported significantly lower depressive symptoms and lower stress symptoms. On the contrary, staying home from work or school "very often" was associated with higher stress symptoms, compared with "never/rarely" staying home from work/school. Similarly, having a job with in-person interaction was also associated with increased stress. CONCLUSIONS: These findings suggest that lack of social engagement was associated with depression and stress symptoms among college students during the COVID-19 pandemic. Planning social activities that align with recommended safety precautions, as well as meet students' social needs, should be an important priority for higher education institutions.