Signals From Inflamed Perivascular Adipose Tissue Contribute to Small Vessel Dysfunction in Women Living With the Human Immunodeficiency Virus.

INTRODUCTION: People living with the human immunodeficiency virus (PWH) have microvascular disease. Since perivascular adipose tissue (PVAT) regulates microvascular function and adipose tissue is inflamed in PWH, we tested the hypothesis that PWH have inflamed PVAT that impairs the function of their small vessels. METHODS: Subcutaneous small arteries were dissected with or without (+ or -) PVAT from a gluteal skin biopsy from 11 women with treated HIV (WWH) aged < 50 years and 10 matched women without HIV and studied on isometric myographs. Nitric oxide (NO) and reactive oxygen species (ROS) were measured by fluorescence microscopy. Adipokines and markers of inflammation and ROS were assayed in PVAT. RESULTS: PVAT surrounding the small arteries in control women significantly (P < 0.05) enhanced acetylcholine (Ach)-induced endothelium dependent relaxation and NO and reduced contractions to thromboxane and endothelin-1. However, these effects of PVAT were reduced significantly (P < 0.05) in WWH whose PVAT released less adiponectin but more markers of ROS and inflammation. Moderation of contractions by PVAT were correlated positively with adipose adiponectin. CONCLUSION: PVAT from WWH has oxidative stress, inflammation and reduced release of adiponectin that may contribute to enhanced contractions and therefore could promote small artery dysfunction.

The influence of socioenvironmental risk factors on risk-taking behaviors among Bahamian adolescents: a structural equation modeling analysis.

Background: Adolescents' risk-taking behaviors can have profound impacts on their future health. Few studies have established a relationship between multiple social environmental factors and adolescent risk behaviors. We used structural equation modeling to examine the role of parental monitoring and environmental risks on adolescents' behavioral intentions and risk behaviors. Methods: Data were collected through the baseline survey of a national implementation project among 2205 Grade 6 students in 24 government schools in The Bahamas in 2019. Structural equation modeling examined relations among parental monitoring, environmental risk factors, behavioral intentions, and risk behaviors. Results: Students had engaged in various delinquent, substance use, and sexual risks. In the structural equation model, parental monitoring demonstrated direct negative (protective) effects on behavioral intentions and risk behaviors, whereas environmental risk factors had a direct positive effect on adolescent behavioral intentions and risk behaviors. The model had an R2 value of 0.57 for adolescent risk behaviors. Conclusion: Parental monitoring and environmental risk factors had strong influences on risk-taking behaviors of early adolescents. Future adolescent health behavior interventions should consider offering additional prevention resources to early adolescents who are exposed to multiple environmental risk factors.

Differential Viral Dynamics by Sex and Body Mass Index During Acute SARS-CoV-2 Infection: Results from a Longitudinal Cohort Study.

BACKGROUND: There is evidence of an association of severe COVID-19 outcomes with increased body mass index (BMI) and male sex. However, few studies have examined the interaction between sex and BMI on SARS-CoV-2 viral dynamics. METHODS: Participants conducted RT-PCR testing every 24-48 hours over a 15-day period. Sex and BMI were self-reported, and Ct values from E-gene were used to quantify viral load. Three distinct outcomes were examined using mixed effects generalized linear models, linear models, and logistic models, respectively: all Ct values (Model 1); nadir Ct value (model 2); and strongly detectable infection (at least one Ct value ≤28 during their infection) (Model 3). An interaction term between BMI and sex was included, and inverse logit transformations were applied to quantify the differences by BMI and sex using marginal predictions. RESULTS: In total, 7,988 participants enrolled in this study, and 439 participants (Model 1) and 309 (Model 2 and 3) were eligible for these analyses. Among males, increasing BMI was associated with lower Ct values in a dose-response fashion. For participants with BMIs greater than 29, males had significantly lower Ct values and nadir Ct values than females. In total, 67.8% of males and 55.3% of females recorded a strongly detectable infection; increasing proportions of men had Ct values <28 with BMIs of 35 and 40. CONCLUSIONS: We observed sex-based dimorphism in relation to BMI and COVID-19 viral load. Further investigation is needed to determine the cause, clinical impact, and transmission implications of this sex-differential effect of BMI on viral load.

Exploring effects of multi-level factors on transitions of risk-taking behaviors among middle-to-late adolescents.

Adolescents experiment with risk behaviors, including delinquency, substance use, and sexual activity. Multi-level social factors, such as having high-risk peers, neighborhood risks, and parental monitoring, influence adolescents' behaviors. We modeled transition patterns in Bahamian adolescents' risk behaviors across three high school years and examined the effects of multi-level factors. We collected data from 2,564 Bahamian adolescents in Grade 10 and follow-ups through Grade 12. We used latent transition model to identify adolescents' risk statuses. Further analyses used multinomial logistic regression to explore the effects of multi-level factors on assignment to those latent statuses and transitions. We identified four distinct statuses: "low risk" (47.9% of the sample at baseline), "alcohol use" (36.8%), "alcohol use and sexual activity" (5.5%), and "high risk" (9.8%). Males were more likely to be in higher-risk statuses at baseline and to transition from a lower-risk status in Grade 10 to a higher-risk status in Grade 11. Social risk factors were significantly associated with higher-risk statuses at baseline. Neighborhood risk and peer risk involvement continued to affect transitions from lower to higher risk; parental monitoring did not have a significant effect in later years. Our findings have important implications for developing targeted and developmentally appropriate interventions to prevent and reduce risk behaviors among middle-to-late adolescents.

Association of neighborhood-level sociodemographic factors with Direct-to-Consumer (DTC) distribution of COVID-19 rapid antigen tests in 5 US communities.

BACKGROUND: Many interventions for widescale distribution of rapid antigen tests for COVID-19 have utilized online, direct-to-consumer (DTC) ordering systems; however, little is known about the sociodemographic characteristics of home-test users. We aimed to characterize the patterns of online orders for rapid antigen tests and determine geospatial and temporal associations with neighborhood characteristics and community incidence of COVID-19, respectively. METHODS: This observational study analyzed online, DTC orders for rapid antigen test kits from beneficiaries of the Say Yes! Covid Test program from March to November 2021 in five communities: Louisville, Kentucky; Indianapolis, Indiana; Fulton County, Georgia; O'ahu, Hawaii; and Ann Arbor/Ypsilanti, Michigan. Using spatial autoregressive models, we assessed the geospatial associations of test kit distribution with Census block-level education, income, age, population density, and racial distribution and Census tract-level Social Vulnerability Index. Lag association analyses were used to measure the association between online rapid antigen kit orders and community-level COVID-19 incidence. RESULTS: In total, 164,402 DTC test kits were ordered during the intervention. Distribution of tests at all sites were significantly geospatially clustered at the block-group level (Moran's I: p < 0.001); however, education, income, age, population density, race, and social vulnerability index were inconsistently associated with test orders across sites. In Michigan, Georgia, and Kentucky, there were strong associations between same-day COVID-19 incidence and test kit orders (Michigan: r = 0.89, Georgia: r = 0.85, Kentucky: r = 0.75). The incidence of COVID-19 during the current day and the previous 6-days increased current DTC orders by 9.0 (95% CI = 1.7, 16.3), 3.0 (95% CI = 1.3, 4.6), and 6.8 (95% CI = 3.4, 10.2) in Michigan, Georgia, and Kentucky, respectively. There was no same-day or 6-day lagged correlation between test kit orders and COVID-19 incidence in Indiana. CONCLUSIONS: Our findings suggest that online ordering is not associated with geospatial clustering based on sociodemographic characteristics. Observed temporal preferences for DTC ordering can guide public health messaging around DTC testing programs.

Performance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection : A Prospective Cohort Study.

BACKGROUND: The performance of rapid antigen tests (Ag-RDTs) for screening asymptomatic and symptomatic persons for SARS-CoV-2 is not well established. OBJECTIVE: To evaluate the performance of Ag-RDTs for detection of SARS-CoV-2 among symptomatic and asymptomatic participants. DESIGN: This prospective cohort study enrolled participants between October 2021 and January 2022. Participants completed Ag-RDTs and reverse transcriptase polymerase chain reaction (RT-PCR) testing for SARS-CoV-2 every 48 hours for 15 days. SETTING: Participants were enrolled digitally throughout the mainland United States. They self-collected anterior nasal swabs for Ag-RDTs and RT-PCR testing. Nasal swabs for RT-PCR were shipped to a central laboratory, whereas Ag-RDTs were done at home. PARTICIPANTS: Of 7361 participants in the study, 5353 who were asymptomatic and negative for SARS-CoV-2 on study day 1 were eligible. In total, 154 participants had at least 1 positive RT-PCR result. MEASUREMENTS: The sensitivity of Ag-RDTs was measured on the basis of testing once (same-day), twice (after 48 hours), and thrice (after a total of 96 hours). The analysis was repeated for different days past index PCR positivity (DPIPPs) to approximate real-world scenarios where testing initiation may not always coincide with DPIPP 0. Results were stratified by symptom status. RESULTS: Among 154 participants who tested positive for SARS-CoV-2, 97 were asymptomatic and 57 had symptoms at infection onset. Serial testing with Ag-RDTs twice 48 hours apart resulted in an aggregated sensitivity of 93.4% (95% CI, 90.4% to 95.9%) among symptomatic participants on DPIPPs 0 to 6. When singleton positive results were excluded, the aggregated sensitivity on DPIPPs 0 to 6 for 2-time serial testing among asymptomatic participants was lower at 62.7% (CI, 57.0% to 70.5%), but it improved to 79.0% (CI, 70.1% to 87.4%) with testing 3 times at 48-hour intervals. LIMITATION: Participants tested every 48 hours; therefore, these data cannot support conclusions about serial testing intervals shorter than 48 hours. CONCLUSION: The performance of Ag-RDTs was optimized when asymptomatic participants tested 3 times at 48-hour intervals and when symptomatic participants tested 2 times separated by 48 hours. PRIMARY FUNDING SOURCE: National Institutes of Health RADx Tech program.

Design and implementation of a digital site-less clinical study of serial rapid antigen testing to identify asymptomatic SARS-CoV-2 infection.

Background: Rapid antigen detection tests (Ag-RDT) for SARS-CoV-2 with emergency use authorization generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially. We aim to describe a novel study design that was used to generate regulatory-quality data to evaluate the serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals. Methods: This prospective cohort study used a siteless, digital approach to assess longitudinal performance of Ag-RDT. Individuals over 2 years old from across the USA with no reported COVID-19 symptoms in the 14 days prior to study enrollment were eligible to enroll in this study. Participants throughout the mainland USA were enrolled through a digital platform between October 18, 2021 and February 15, 2022. Participants were asked to test using Ag-RDT and molecular comparators every 48 hours for 15 days. Enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are reported. Key Results: A total of 7361 participants enrolled in the study, and 492 participants tested positive for SARS-CoV-2, including 154 who were asymptomatic and tested negative to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 US states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide. Conclusions: The digital site-less approach employed in the "Test Us At Home" study enabled rapid, efficient, and rigorous evaluation of rapid diagnostics for COVID-19 and can be adapted across research disciplines to optimize study enrollment and accessibility.

Performance of Rapid Antigen Tests Based on Symptom Onset and Close Contact Exposure: A secondary analysis from the Test Us At Home prospective cohort study.

Background: The performance of rapid antigen tests for SARS-CoV-2 (Ag-RDT) in temporal relation to symptom onset or exposure is unknown, as is the impact of vaccination on this relationship. Objective: To evaluate the performance of Ag-RDT compared with RT-PCR based on day after symptom onset or exposure in order to decide on 'when to test'. Design Setting and Participants: The Test Us at Home study was a longitudinal cohort study that enrolled participants over 2 years old across the United States between October 18, 2021 and February 4, 2022. All participants were asked to conduct Ag-RDT and RT-PCR testing every 48 hours over a 15-day period. Participants with one or more symptoms during the study period were included in the Day Post Symptom Onset (DPSO) analyses, while those who reported a COVID-19 exposure were included in the Day Post Exposure (DPE) analysis. Exposure: Participants were asked to self-report any symptoms or known exposures to SARS-CoV-2 every 48-hours, immediately prior to conducting Ag-RDT and RT-PCR testing. The first day a participant reported one or more symptoms was termed DPSO 0, and the day of exposure was DPE 0. Vaccination status was self-reported. Main Outcome and Measures: Results of Ag-RDT were self-reported (positive, negative, or invalid) and RT-PCR results were analyzed by a central laboratory. Percent positivity of SARS-CoV-2 and sensitivity of Ag-RDT and RT-PCR by DPSO and DPE were stratified by vaccination status and calculated with 95% confidence intervals. Results: A total of 7,361 participants enrolled in the study. Among them, 2,086 (28.3%) and 546 (7.4%) participants were eligible for the DPSO and DPE analyses, respectively. Unvaccinated participants were nearly twice as likely to test positive for SARS-CoV-2 than vaccinated participants in event of symptoms (PCR+: 27.6% vs 10.1%) or exposure (PCR+: 43.8% vs. 22.2%). The highest proportion of vaccinated and unvaccinated individuals tested positive on DPSO 2 and DPE 5-8. Performance of RT-PCR and Ag-RDT did not differ by vaccination status. Ag-RDT detected 78.0% (95% Confidence Interval: 72.56-82.61) of PCR-confirmed infections by DPSO 4. For exposed participants, Ag-RDT detected 84.9% (95% CI: 75.0-91.4) of PCR-confirmed infections by day five post-exposure (DPE 5). Conclusions and Relevance: Performance of Ag-RDT and RT-PCR was highest on DPSO 0-2 and DPE 5 and did not differ by vaccination status. These data suggests that serial testing remains integral to enhancing the performance of Ag-RDT.

Predicting Adolescent Intervention Non-responsiveness for Precision HIV Prevention Using Machine Learning.

Interventions to teach protective behaviors may be differentially effective within an adolescent population. Identifying the characteristics of youth who are less likely to respond to an intervention can guide program modifications to improve its effectiveness. Using comprehensive longitudinal data on adolescent risk behaviors, perceptions, sensation-seeking, peer and family influence, and neighborhood risk factors from 2564 grade 10-12 students in The Bahamas, this study employs machine learning approaches (support vector machines, logistic regression, decision tree, and random forest) to identify important predictors of non-responsiveness for precision prevention. We used 80% of the data to train the models and the rest for model testing. Among different machine learning algorithms, the random forest model using longitudinal data and the Boruta feature selection approach predicted intervention non-responsiveness best, achieving sensitivity of 85.4%, specificity of 78.4% and AUROC of 0.93 on the training data, and sensitivity of 84.3%, specificity of 67.1%, and AUROC of 0.85 on the test data. Key predictors include self-efficacy, perceived response cost, parent monitoring, vulnerability, response efficacy, HIV/AIDS knowledge, communication about condom use, and severity of HIV/STI. Machine learning can yield powerful predictive models to identify adolescents who are unlikely to respond to an intervention. Such models can guide the development of alternative strategies that may be more effective with intervention non-responders.

Finding a Needle in a Haystack: Design and Implementation of a Digital Site-less Clinical Study of Serial Rapid Antigen Testing to Identify Asymptomatic SARS-CoV-2 Infection.

Background: Rapid antigen tests (Ag-RDT) for SARS-CoV-2 with Emergency Use Authorization generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially. Objective: To describe a novel study design to generate regulatory-quality data to evaluate serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals. Design: Prospective cohort study using a decentralized approach. Participants were asked to test using Ag-RDT and molecular comparators every 48 hours for 15 days. Setting: Participants throughout the mainland United States were enrolled through a digital platform between October 18, 2021 and February 15, 2022. Ag-RDTs were completed at home, and molecular comparators were shipped to a central laboratory. Participants: Individuals over 2 years old from across the U.S. with no reported COVID-19 symptoms in the 14 days prior to study enrollment were eligible to enroll in this study. Measurements: Enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are reported. Key Results: A total of 7,361 participants enrolled in the study, and 492 participants tested positive for SARS-CoV-2, including 154 who were asymptomatic and tested negative to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 U.S. states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide. Limitations: New, complex workflows required significant operational and data team support. Conclusions: The digital site-less approach employed in the 'Test Us At Home' study enabled rapid, efficient, and rigorous evaluation of rapid diagnostics for COVID-19, and can be adapted across research disciplines to optimize study enrollment and accessibility.

Performance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection.

Background: Performance of rapid antigen tests for SARS-CoV-2 (Ag-RDT) varies over the course of an infection, and their performance in screening for SARS-CoV-2 is not well established. We aimed to evaluate performance of Ag-RDT for detection of SARS-CoV-2 for symptomatic and asymptomatic participants. Methods: Participants >2 years old across the United States enrolled in the study between October 2021 and February 2022. Participants completed Ag-RDT and molecular testing (RT-PCR) for SARS-CoV-2 every 48 hours for 15 days. This analysis was limited to participants who were asymptomatic and tested negative on their first day of study participation. Onset of infection was defined as the day of first positive RT-PCR result. Sensitivity of Ag-RDT was measured based on testing once, twice (after 48-hours), and thrice (after 96 hours). Analysis was repeated for different Days Post Index PCR Positivity (DPIPP) and stratified based on symptom-status. Results: In total, 5,609 of 7,361 participants were eligible for this analysis. Among 154 participants who tested positive for SARS-CoV-2, 97 were asymptomatic and 57 had symptoms at infection onset. Serial testing with Ag-RDT twice 48-hours apart resulted in an aggregated sensitivity of 93.4% (95% CI: 89.1-96.1%) among symptomatic participants on DPIPP 0-6. Excluding singleton positives, aggregated sensitivity on DPIPP 0-6 for two-time serial-testing among asymptomatic participants was lower at 62.7% (54.7-70.0%) but improved to 79.0% (71.0-85.3%) with testing three times at 48-hour intervals. Discussion: Performance of Ag-RDT was optimized when asymptomatic participants tested three-times at 48-hour intervals and when symptomatic participants tested two-times separated by 48-hours.

Comparison of Rapid Antigen Tests' Performance Between Delta and Omicron Variants of SARS-CoV-2 : A Secondary Analysis From a Serial Home Self-testing Study.

BACKGROUND: It is important to document the performance of rapid antigen tests (Ag-RDTs) in detecting SARS-CoV-2 variants. OBJECTIVE: To compare the performance of Ag-RDTs in detecting the Delta (B.1.617.2) and Omicron (B.1.1.529) variants of SARS-CoV-2. DESIGN: Secondary analysis of a prospective cohort study that enrolled participants between 18 October 2021 and 24 January 2022. Participants did Ag-RDTs and collected samples for reverse transcriptase polymerase chain reaction (RT-PCR) testing every 48 hours for 15 days. SETTING: The parent study enrolled participants throughout the mainland United States through a digital platform. All participants self-collected anterior nasal swabs for rapid antigen testing and RT-PCR testing. All Ag-RDTs were completed at home, whereas nasal swabs for RT-PCR were shipped to a central laboratory. PARTICIPANTS: Of 7349 participants enrolled in the parent study, 5779 asymptomatic persons who tested negative for SARS-CoV-2 on day 1 of the study were eligible for this substudy. MEASUREMENTS: Sensitivity of Ag-RDTs on the same day as the first positive (index) RT-PCR result and 48 hours after the first positive RT-PCR result. RESULTS: A total of 207 participants were positive on RT-PCR (58 Delta, 149 Omicron). Differences in sensitivity between variants were not statistically significant (same day: Delta, 15.5% [95% CI, 6.2% to 24.8%] vs. Omicron, 22.1% [CI, 15.5% to 28.8%]; at 48 hours: Delta, 44.8% [CI, 32.0% to 57.6%] vs. Omicron, 49.7% [CI, 41.6% to 57.6%]). Among 109 participants who had RT-PCR-positive results for 48 hours, rapid antigen sensitivity did not differ significantly between Delta- and Omicron-infected participants (48-hour sensitivity: Delta, 81.5% [CI, 66.8% to 96.1%] vs. Omicron, 78.0% [CI, 69.1% to 87.0%]). Only 7.2% of the 69 participants with RT-PCR-positive results for shorter than 48 hours tested positive by Ag-RDT within 1 week; those with Delta infections remained consistently negative on Ag-RDTs. LIMITATION: A testing frequency of 48 hours does not allow a finer temporal resolution of the analysis of test performance, and the results of Ag-RDTs are based on self-report. CONCLUSION: The performance of Ag-RDTs in persons infected with the SARS-CoV-2 Omicron variant is not inferior to that in persons with Delta infections. Serial testing improved the sensitivity of Ag-RDTs for both variants. The performance of rapid antigen testing varies on the basis of duration of RT-PCR positivity. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute of the National Institutes of Health.

Use of a Digital Assistant to Report COVID-19 Rapid Antigen Self-test Results to Health Departments in 6 US Communities.

Importance: Widespread distribution of rapid antigen tests is integral to the US strategy to address COVID-19; however, it is estimated that few rapid antigen test results are reported to local departments of health. Objective: To characterize how often individuals in 6 communities throughout the United States used a digital assistant to log rapid antigen test results and report them to their local departments of health. Design, Setting, and Participants: This prospective cohort study is based on anonymously collected data from the beneficiaries of the Say Yes! Covid Test program, which distributed more than 3 000 000 rapid antigen tests at no cost to residents of 6 communities (Louisville, Kentucky; Indianapolis, Indiana; Fulton County, Georgia; O'ahu, Hawaii; Ann Arbor and Ypsilanti, Michigan; and Chattanooga, Tennessee) between April and October 2021. A descriptive evaluation of beneficiary use of a digital assistant for logging and reporting their rapid antigen test results was performed. Interventions: Widespread community distribution of rapid antigen tests. Main Outcomes and Measures: Number and proportion of tests logged and reported to the local department of health through the digital assistant. Results: A total of 313 000 test kits were distributed, including 178 785 test kits that were ordered using the digital assistant. Among all distributed kits, 14 398 households (4.6%) used the digital assistant, but beneficiaries reported three-quarters of their rapid antigen test results to their state public health departments (30 965 tests reported of 41 465 total test results [75.0%]). The reporting behavior varied by community and was significantly higher among communities that were incentivized for reporting test results vs those that were not incentivized or partially incentivized (90.5% [95% CI, 89.9%-91.2%] vs 70.5%; [95% CI, 70.0%-71.0%]). In all communities, positive tests were less frequently reported than negative tests (60.4% [95% CI, 58.1%-62.8%] vs 75.5% [95% CI, 75.1%-76.0%]). Conclusions and Relevance: These results suggest that application-based reporting with incentives may be associated with increased reporting of rapid tests for COVID-19. However, increasing the adoption of the digital assistant may be a critical first step.

Feasibility of At-Home Serial Testing Using Over-the-Counter SARS-CoV-2 Tests With a Digital Smartphone App for Assistance: Longitudinal Cohort Study.

BACKGROUND: The ongoing SARS-CoV-2 pandemic necessitates the development of accurate, rapid, and affordable diagnostics to help curb disease transmission, morbidity, and mortality. Rapid antigen tests are important tools for scaling up testing for SARS-CoV-2; however, little is known about individuals' use of rapid antigen tests at home and how to facilitate the user experience. OBJECTIVE: This study aimed to describe the feasibility and acceptability of serial self-testing with rapid antigen tests for SARS-CoV-2, including need for assistance and the reliability of self-interpretation. METHODS: A total of 206 adults in the United States with smartphones were enrolled in this single-arm feasibility study in February and March 2021. All participants were asked to self-test for COVID-19 at home using rapid antigen tests daily for 14 days and use a smartphone app for testing assistance and to report their results. The main outcomes were adherence to the testing schedule, the acceptability of testing and smartphone app experiences, and the reliability of participants versus study team's interpretation of test results. Descriptive statistics were used to report the acceptability, adherence, overall rating, and experience of using the at-home test and MyDataHelps app. The usability, acceptability, adherence, and quality of at-home testing were analyzed across different sociodemographic, age, and educational attainment groups. RESULTS: Of the 206 enrolled participants, 189 (91.7%) and 159 (77.2%) completed testing and follow-up surveys, respectively. In total, 51.3% (97/189) of study participants were women, the average age was 40.7 years, 34.4% (65/189) were non-White, and 82% (155/189) had a bachelor's degree or higher. Most (n=133/206, 64.6%) participants showed high testing adherence, meaning they completed over 75% of the assigned tests. Participants' interpretations of test results demonstrated high agreement (2106/2130, 98.9%) with the study verified results, with a κ score of 0.29 (P<.001). Participants reported high satisfaction with self-testing and the smartphone app, with 98.7% (157/159) reporting that they would recommend the self-test and smartphone app to others. These results were consistent across age, race/ethnicity, and gender. CONCLUSIONS: Participants' high adherence to the recommended testing schedule, significant reliability between participants and study staff's test interpretation, and the acceptability of the smartphone app and self-test indicate that self-tests for SARS-CoV-2 with a smartphone app for assistance and reporting is a highly feasible testing modality among a diverse population of adults in the United States.

Comparing standard versus enhanced implementation of an evidence-based HIV prevention program among Bahamian sixth grade students: findings from nationwide implementation trials.

BACKGROUND: Effective implementation strategies are needed to address the challenges encountered by teachers in implementation of evidence-based HV prevention programs in schools. The current study: 1) compares implementation fidelity of Focus on Youth in the Caribbean (FOYC) plus Caribbean Informed Parents and Children Together (CImPACT) intervention using enhanced implementation strategies (including biweekly monitoring/feedback and site-based mentoring) to those using more traditional approach (teacher training only); and 2) evaluates the impact of school coordinators' and mentors' performance on teachers' implementation fidelity and student outcomes. METHODS: Data from an enhanced implementation trial in 2019-2020, involving 24 government primary schools, 79 teachers, and 2252 students, were compared to data from a standard implementation trial in 2011-2012, involving 35 government primary schools, 110 teachers and 2811 students using mixed-effects modeling and structural equation modeling. FINDINGS: Teachers in the 2019-2020 trial taught more core activities (28.3 vs. 16.3, t = 10.80, P < 0.001) and sessions (7.2 vs. 4.4, t = 9.14, P < 0.001) than those participating in the 2011-2012 trial. Teachers taught > 80% of the intervention curriculum in 2019-2020 compared to 50% curriculum delivery in 2011-2012. Teachers who had a "very good" or "excellent" school coordinator in their schools taught more core activities than those who had a "satisfactory" school coordinator (30.4 vs. 29.6 vs. 22.3, F = 18.54, P < 0.001). Teachers who worked in a school which had a "very good" mentor, taught more core activities than those teachers who did not have a mentor or had only a "satisfactory" mentor (30.4 vs. 27.6; t = 2.96; p = 0.004). Teachers' confidence in implementing core activities, comfort level with the curriculum, attitudes towards sex education in schools, and perceived principal support were significantly related to increased self-efficacy, which in turn was related to teachers' implementation fidelity. The degree of implementation was significantly associated with improved student outcomes. IMPLICATIONS/CONCLUSION: An evidence-based HIV prevention intervention can achieve a high degree of implementation when delivered with enhanced implementation strategies and implementation monitoring. Future program implementers should consider the purposeful selection and training of school coordinators and mentors to support low-implementing teachers as a potentially important strategy when attempting to achieve high-quality implementation of school-based interventions.

Uptake of HPV Vaccine among young adults with disabilities, 2011 to 2018.

INTRODUCTION: Little is known about human papillomavirus (HPV) vaccine uptake among young adults with disabilities (YAWD), despite this population having a higher risk of HPV infection and related cancers compared to the general population. OBJECTIVE: To compare the prevalence of HPV vaccination among young adults with disabilities to young adults without disabilities. We hypothesized that YAWD would have a lower prevalence of HPV vaccination than the general population. METHODS: This cross-sectional study used data for the years 2011 to 2018 of the National Health Interview Survey. Our analysis included 14,577 people (weighted n = 34,420,024) aged 18 to 26 years. Univariate and multivariable logistic models were used to estimate the role of disability on HPV vaccination uptake among young adults and to identify potential factors associated with HPV vaccination among YAWD. RESULTS: The proportion of female and male YAWD with HPV vaccination was similar to those without disabilities, regardless of sex (Female Adjusted Odds Ratio (OR): 1.16; 95% Confidence Interval (CI): 0.91 to 1.48; Male Adjusted OR: 1.05; 95% CI: 0.69 to 1.60). Among female and male YAWD, the proportion with HPV vaccination was 56.1% and 28.5%, respectively. Other factors significantly associated with HPV vaccination among YAWD included age, country of birth, healthcare utilization, and insurance status. CONCLUSIONS: HPV vaccination among YAWD did not differ significantly from those without disabilities; however, the prevalence of HPV vaccination among young adult males and females remains significantly below national goals. Connecting young adults, specifically male YAWD, to the healthcare system is of utmost importance to improve HPV vaccination uptake.

COVID-19 Variant Surveillance and Social Determinants in Central Massachusetts: Development Study.

BACKGROUND: Public health scientists have used spatial tools such as web-based Geographical Information System (GIS) applications to monitor and forecast the progression of the COVID-19 pandemic and track the impact of their interventions. The ability to track SARS-CoV-2 variants and incorporate the social determinants of health with street-level granularity can facilitate the identification of local outbreaks, highlight variant-specific geospatial epidemiology, and inform effective interventions. We developed a novel dashboard, the University of Massachusetts' Graphical user interface for Geographic Information (MAGGI) variant tracking system that combines GIS, health-associated sociodemographic data, and viral genomic data to visualize the spatiotemporal incidence of SARS-CoV-2 variants with street-level resolution while safeguarding protected health information. The specificity and richness of the dashboard enhance the local understanding of variant introductions and transmissions so that appropriate public health strategies can be devised and evaluated. OBJECTIVE: We developed a web-based dashboard that simultaneously visualizes the geographic distribution of SARS-CoV-2 variants in Central Massachusetts, the social determinants of health, and vaccination data to support public health efforts to locally mitigate the impact of the COVID-19 pandemic. METHODS: MAGGI uses a server-client model-based system, enabling users to access data and visualizations via an encrypted web browser, thus securing patient health information. We integrated data from electronic medical records, SARS-CoV-2 genomic analysis, and public health resources. We developed the following functionalities into MAGGI: spatial and temporal selection capability by zip codes of interest, the detection of variant clusters, and a tool to display variant distribution by the social determinants of health. MAGGI was built on the Environmental Systems Research Institute ecosystem and is readily adaptable to monitor other infectious diseases and their variants in real-time. RESULTS: We created a geo-referenced database and added sociodemographic and viral genomic data to the ArcGIS dashboard that interactively displays Central Massachusetts' spatiotemporal variants distribution. Genomic epidemiologists and public health officials use MAGGI to show the occurrence of SARS-CoV-2 genomic variants at high geographic resolution and refine the display by selecting a combination of data features such as variant subtype, subject zip codes, or date of COVID-19-positive sample collection. Furthermore, they use it to scale time and space to visualize association patterns between socioeconomics, social vulnerability based on the Centers for Disease Control and Prevention's social vulnerability index, and vaccination rates. We launched the system at the University of Massachusetts Chan Medical School to support internal research projects starting in March 2021. CONCLUSIONS: We developed a COVID-19 variant surveillance dashboard to advance our geospatial technologies to study SARS-CoV-2 variants transmission dynamics. This real-time, GIS-based tool exemplifies how spatial informatics can support public health officials, genomics epidemiologists, infectious disease specialists, and other researchers to track and study the spread patterns of SARS-CoV-2 variants in our communities.

Design and Preliminary Findings of Adherence to the Self-Testing for Our Protection From COVID-19 (STOP COVID-19) Risk-Based Testing Protocol: Prospective Digital Study.

BACKGROUND: Serial testing for SARS-CoV-2 is recommended to reduce spread of the virus; however, little is known about adherence to recommended testing schedules and reporting practices to health departments. OBJECTIVE: The Self-Testing for Our Protection from COVID-19 (STOP COVID-19) study aims to examine adherence to a risk-based COVID-19 testing strategy using rapid antigen tests and reporting of test results to health departments. METHODS: STOP COVID-19 is a 12-week digital study, facilitated using a smartphone app for testing assistance and reporting. We are recruiting 20,000 participants throughout the United States. Participants are stratified into high- and low-risk groups based on history of COVID-19 infection and vaccination status. High-risk participants are instructed to perform twice-weekly testing for COVID-19 using rapid antigen tests, while low-risk participants test only in the case of symptoms or exposure to COVID-19. All participants complete COVID-19 surveillance surveys, and rapid antigen results are recorded within the smartphone app. Primary outcomes include participant adherence to a risk-based serial testing protocol and percentage of rapid tests reported to health departments. RESULTS: As of February 2022, 3496 participants have enrolled, including 1083 high-risk participants. Out of 13,730 tests completed, participants have reported 13,480 (98.18%, 95% CI 97.9%-98.4%) results to state public health departments with full personal identifying information or anonymously. Among 622 high-risk participants who finished the study period, 35.9% showed high adherence to the study testing protocol. Participants with high adherence reported a higher percentage of test results to the state health department with full identifying information than those in the moderate- or low-adherence groups (high: 71.7%, 95% CI 70.3%-73.1%; moderate: 68.3%, 95% CI 66.0%-70.5%; low: 63.1%, 59.5%-66.6%). CONCLUSIONS: Preliminary results from the STOP COVID-19 study provide important insights into rapid antigen test reporting and usage, and can thus inform the use of rapid testing interventions for COVID-19 surveillance.

If you build it, will they use it? Use of a Digital Assistant for Self-Reporting of COVID-19 Rapid Antigen Test Results during Large Nationwide Community Testing Initiative.

Importance: Wide-spread distribution of rapid-antigen tests is integral to the United States' strategy to address COVID-19; however, it is estimated that few rapid-antigen test results are reported to local departments of health. Objective: To characterize how often individuals in six communities throughout the United States used a digital assistant to log rapid-antigen test results and report them to their local Department of Health. Design: This prospective cohort study is based on anonymously collected data from the beneficiaries of The Say Yes! Covid Test program, which distributed 3,000,000 rapid antigen tests at no cost to residents of six communities between April and October 2021. We provide a descriptive evaluation of beneficiaries' use of digital assistant for logging and reporting their rapid antigen test results. Main Outcome and Measures: Number and proportion of tests logged and reported to the Department of Health through the digital assistant. Results: A total of 178,785 test kits were ordered by the digital assistant, and 14,398 households used the digital assistant to log 41,465 test results. Overall, a small proportion of beneficiaries used the digital assistant (8%), but over 75% of those who used it reported their rapid antigen test results to their state public health department. The reporting behavior varied between communities and was significantly different for communities that were incentivized for reporting test results (p < 0.001). In all communities, positive tests were less reported than negative tests (60.4% vs 75.5%; p<0.001). Conclusions and Relevance: These results indicate that app-based reporting with incentives may be an effective way to increase reporting of rapid tests for COVID-19; however, increasing the adoption of the digital assistant is a critical first step.