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.

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.

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.

Predictive algorithm to stratify newborns at-risk for child undernutrition in India: Secondary analysis of the National Family Health Survey-4.

Background: India is at the epicentre of global child undernutrition. Strategies to identify at-risk populations are needed in the context of limited resources. Methods: Data from children under the age of five surveyed in the 2015-2016 National Family Health Survey were used. Child undernutrition was assessed using anthropometric measurements. Predictor variables were identified from the extant literature and included if they could be measured at the time of delivery. Survey-weighted logistic regression was applied to model the outcome. Internal validation of the model was performed using 200 bootstrapped samples representing half of the total data sets. Results: In 2016, 54.4% (95% CI = 54.0%-54.8%) of Indian children were undernourished, according to a composite index of anthropometric failure. The predictive model for overall undernutrition included maternal (height, education, reproductive history, number of antenatal visits), child (sex, birthweight), and household characteristics (district of residence, caste, rural residence, toilet availability, presence of a separate kitchen). The model demonstrated reasonable discrimination ability (optimism-adjusted c = 0.67). The group of children classified in the lowest decile for risk of undernutrition had a prevalence of 25.9%, while the group classified in the highest decile had a prevalence of 77.4%. Conclusions: It is possible to stratify newborns at the time of delivery based on their risk for undernutrition in the first five years of life. The model developed by this study represents a first step in adopting a risk-score based approach for the most vulnerable population to receive services in a timely manner.

Association of trends in child undernutrition and implementation of the National Rural Health Mission in India: A nationally representative serial cross-sectional study on data from 1992 to 2015.

BACKGROUND: India launched the National Rural Health Mission (NRHM) in 2005 to strengthen its primary healthcare system in high-focus and northeast-focus states. One of the NRHM objectives was to reduce child undernutrition in India. METHODS AND FINDINGS: We used data from 1992, 1998, 2005, and 2015 National Family Health Survey (NFHS) of India to evaluate trends in child undernutrition prevalence before and after NRHM and across different categories of focus states. Stunting, Wasting, and Comprehensive Index of Anthropometric Failure (CIAF) were assessed using the World Health Organization (WHO) growth curves to assess chronic, acute, and overall undernutrition. The study included 187,452 children aged 3 years or under. Survey-weighted and confounder-adjusted average annualized reduction rates (AARRs) and predicted probability ratios were used to assess trends and socioeconomic disparities for child undernutrition, respectively. Nationwide, the prevalence of all types of undernutrition decreased from 1992 to 2015. However, the trends varied before and after NRHM implementation and differentially by focus states. After NRHM, acute undernutrition declined more rapidly among high-focus states (AARR 1.0%) but increased in normal-focus states (AARR -1.9% per year; p-value for the difference <0.001). In contrast, the prevalence of chronic undernutrition declined more rapidly (AARR 1.6%) in the normal-focus states in comparison to high-focus states (0.3%; p-value for the difference = 0.01). Income and caste-based disparities in acute undernutrition decreased but did not disappear after the implementation of the NRHM. However, similar disparities in prevalence of chronic undernutrition appear to be exacerbated after the implementation of the NRHM. Major limitations of this study include the observational and cross-sectional design, which preclude our ability to draw causal inferences. CONCLUSIONS: Our results suggests that NRHM implementation might be associated with improvement in wasting (acute) rather than stunting (chronic) forms of undernutrition. Strategies to combat undernutrition equitably, especially in high-focus states, are needed.

Comparison of Rapid Antigen Tests' Performance between Delta (B.1.61.7; AY.X) and Omicron (B.1.1.529; BA1) Variants of SARS-CoV-2: Secondary Analysis from a Serial Home Self-Testing Study.

Background: There is a need to understand the performance of rapid antigen tests (Ag-RDT) for detection of the Delta (B.1.61.7; AY.X) and Omicron (B.1.1.529; BA1) SARS-CoV-2 variants. Methods: Participants without any symptoms were enrolled from October 18, 2021 to January 24, 2022 and performed Ag-RDT and RT-PCR tests every 48 hours for 15 days. This study represents a non-pre-specified analysis in which we sought to determine if sensitivity of Ag-RDT differed in participants with Delta compared to Omicron variant. Participants who were positive on RT-PCR on the first day of the testing period were excluded. Delta and Omicron variants were defined based on sequencing and date of first RT-PCR positive result (RT-PCR+). Comparison of Ag-RDT performance between the variants was based on sensitivity, defined as proportion of participants with Ag-RDT+ results in relation to their first RT-PCR+ result, for different duration of testing with rapid Ag-RDT. Subsample analysis was performed based on the result of participants' second RT-PCR test within 48 hours of the first RT-PCR+ test. Results: From the 7,349 participants enrolled in the parent study, 5,506 met the eligibility criteria for this analysis. A total of 153 participants were RT-PCR+ (61 Delta, 92 Omicron); among this group, 36 (23.5%) tested Ag-RDT+ on the same day, and 84 (54.9%) tested Ag-RDT+ within 48 hours as first RT-PCR+. The differences in sensitivity between variants were not statistically significant (same-day: Delta 16.4% [95% CI: 8.2-28.1] vs Omicron 28.2% [95% CI: 19.4-38.6]; and 48-hours: Delta 45.9% [33.1-59.2] vs. Omicron 60.9% [50.1-70.9]). This trend continued among the 86 participants who had consecutive RT-PCR+ result (48-hour sensitivity: Delta 79.3% [60.3-92.1] vs. Omicron: 89.5% [78.5-96.0]). Conversely, the 38 participants who had an isolated RT-PCR+ remained consistently negative on Ag-RDT, regardless of the variant. Conclusions: The performance of Ag-RDT is not inferior among individuals infected with the SARS-CoV-2 Omicron variant as compared to the Delta variant. The improvement in sensitivity of Ag-RDT noted with serial testing is consistent between Delta and Omicron variant. Performance of Ag-RDT varies based on duration of RT-PCR+ results and more studies are needed to understand the clinical and public health significance of individuals who are RT-PCR+ for less than 48 hours.

Early childhood undernutrition, preadolescent physical growth, and cognitive achievement in India: A population-based cohort study.

BACKGROUND: There is a lack of nationally representative estimates for the consequences of early childhood undernutrition on preadolescent outcomes in India. Understanding this relationship is helpful to develop interventions that not only prevent child undernutrition but also mitigate its consequences. METHODS AND FINDINGS: In this cohort study, we analyzed prospectively gathered data from 2 waves of the India Human Development Survey (IHDS) to investigate the association of undernutrition during early childhood (0 to 5 years) in 2004 to 2005 with physical and cognitive outcomes during preadolescent (8 to 11 years) years in 2011 to 2012. These surveys interviewed 41,554 households across all 33 states and union territories in India in 2004 to 2005 and reinterviewed 83% of the households in 2011 to 2012. Primary exposure was assessed using the Composite Index of Anthropometric Failure (CIAF) based on 2004 to 2005 survey. Primary outcomes were short stature (height-for-age z-score [HAZ] <-2), thinness (body mass index [BMI] <18.5 kg/m2), reading, and arithmetic skills during preadolescence based on the 2011 to 2012 survey. Survey-weighted generalized linear models were used, and effect modification based on child sex and sociodemographic variables were evaluated using 3-way interaction terms. Of the 7,868 children included in this analysis, 4,334 (57.3%) were undernourished. Being undernourished was associated with increased odds of short stature (odds ratio [OR] 1.73, 95% confidence interval [CI] 1.45 to 2.06) and thinness (OR 1.52, 95% CI 1.33 to 1.73) during the preadolescent period, while it was associated with decreased odds of achieving a higher reading (cumulative odds ratio [cumOR]: 0.76, 0.66 to 0.87) and arithmetic (cumOR: 0.72, 0.63 to 0.82) outcomes. The disparity in outcomes based on CIAF increased with age, especially for female children. Increased level of female education within the household reduced the disadvantages of undernutrition among female children. Study limitations include observational and missing data, which limit our ability to draw strong causal inferences. CONCLUSIONS: In this study, we found that early child undernutrition was associated with several adverse preadolescent physical and cognitive outcomes, especially among female children. Improved female education mitigates this association. Female education promotion should assume a central role in Indian public health policy making.

Knowledge of Breastfeeding and Kangaroo Mother Care Practices Among General Practitioners in Rural Western India.

BACKGROUND: Breastfeeding and Kangaroo Mother Care (KMC) are interventions to reduce neonatal mortality and undernutrition. We investigated the knowledge of allopathic and Ayurvedic, Yoga-naturopathy, Siddha, and Homeopathic (AYUSH) general practitioners in rural western India and identified attributes associated with awareness and knowledge on these topics. METHODS: This cross-sectional study of general practitioners in the Anand district of Gujarat, India, used an anonymous self-reported survey. Multivariable regression models were used to identify practitioner attributes associated with awareness and knowledge. RESULTS: Among the 158 respondents, a quarter (26.0%) were trained in allopathic medicine and 63.0% had practiced for 5 years or more. The average score of breastfeeding knowledge was 8.0 of 13. Most (79.1%) did not have any awareness of KMC. After adjusting for potential confounders, knowledge of breastfeeding practices among AYUSH practitioners was 4-fold greater than that of allopathic practitioners (incidence rate ratio: 3.9; 95% CI: 3.2-4.6). By contrast, AYUSH practitioners had 80% decreased odds of awareness about KMC compared with allopathic practitioners (odds ratio: 0.2; 95% CI: 0.1-0.3). DISCUSSION: This study demonstrates distinct knowledge gaps among allopathic and AYUSH general practitioners regarding breastfeeding and KMC. There is a need for tailored continuing medical education among general practitioners to enhance their clinical knowledge of newborn care practices to achieve improvements in neonatal health.

The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies.

The National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADxSM) Tech initiative to support the development and commercialization of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) point-of-care test devices. The primary objective of the Clinical Studies Core (CSC) was to perform SARS-CoV-2 device studies involving diverse populations and settings. Within a few months, the infrastructure for clinical studies was developed, including a master protocol, digital study platform, data management system, single IRB, and multi-site partnerships. Data from some studies are being used to support Emergency Use Authorization of novel SARS-CoV-2 test devices. The CSC reduced the typical time and cost of developing medical devices and highlighted the impactful role of academic and NIH partnership in addressing public health needs at a rapid pace during a global pandemic. The structure, deployment, and lessons learned from this experience are widely applicable to future in vitro diagnostic device clinical studies.

Adapting Helping Babies Breathe into a Virtual Curriculum: Methods, Results, and Lessons Learned.

Introduction. The Helping Babies Breathe (HBB) curriculum is an established, effective method to combat neonatal mortality. The COVID-19 pandemic has disrupted in-person HBB training sessions worldwide, portending deficits in the dissemination of this important intervention. Methods. A pilot study to compare in-person versus virtual HBB training among US-based pediatric and family medicine residents. Two HBB master trainers condensed the curriculum into an abbreviated course that was offered to 14 learners in-person (n = 6) and virtually via Zoom (n = 8). A standardized 10-item survey was administered before and after the session to measure reported self-efficacy of critical elements of HBB. Difference of difference analysis was performed to detect differences in post vs pre-training results among the 2 groups using STATA MP 15. Results. All learners showed improvement in preparedness, assessment, and skills subcomponents of self-efficacy with no notable differences based on the type of learning medium. At baseline, in-person learners had a 7-point higher self-efficacy score (69.7) in comparison to virtual learners (62.8; P = .26). After training, the confidence score improved significantly; by 14.3 units for in-person learners (P = .01) and 12.9 for virtual learners (P = .04). There was no statistically significant difference in improvement between the 2 groups (P = .67). Furthermore, all learners passed the post-training knowledge assessment. Discussion. Virtual learning of HBB may be an alternative option in the setting of resource and travel limitations. Future work needs to assess possible differences in attainment of assessment skills and retention of the HBB curriculum among virtual learners.

Screen time usage among preschoolers aged 2-6 in rural Western India: A cross-sectional study.

AIMS: We have evaluated screen time usage among preschool-aged (≤6 years) children in rural Western India. In addition, we have evaluated various lifestyle factors and their impact on the screen time of these children. MATERIALS AND METHODS: English-medium schools in the locality were chosen based on convenience. A self-report survey requesting family information and screen usage information was distributed to the parents. Daily screen time was categorized as a three-category variable. Ordered logistic regression with multivariable regression was performed to examine the association of risk factors with screen time. RESULTS: Average screen time among the 379 (208 males, 171 female) children amounted to 2.7 hours (SD: 1.7), with average daily television screen time of 1.6 hours (SD: 1.1). Most children (87.2%) started screen use by the age of 3. Only 65 (17.2%) participants met AAP recommendation. Households with three devices and smartphone usage by mothers increased the odds of screen time by 60% and two-folds, respectively. Compared to weekdays, children had increased screen time exposure (3.5 vs 2.7 hours, P < 0.001), outdoor activity time (2.3 vs 1.6, P < 0.001), and reading hours (1.2 vs 1.1, P = 0.03) on weekends. No association was observed between screen time and mother's occupation. CONCLUSIONS: More than 80% of children exceeded the advised screen time with television and smartphone being the major contributors. This issue has to be dealt with at both individual and societal levels. Increased awareness about the high prevalence of inappropriate use of screen time use within the Indian context is needed to inspire attention and interventions for this emerging public health problem in India.

Age-and-sex stratified prevalence of atrial fibrillation in rural Western India: Results of SMART-India, a population-based screening study.

BACKGROUND: Early detection of Atrial Fibrillation (AF) is a public health priority across the globe because AF-related strokes are preventable. Despite an ongoing stroke epidemic in India, a public health strategy for AF screening and treatment is missing because the epidemiology of AF in India remains poorly defined. METHODS: This population-based study used mobile technology to derive age and sex-stratified AF prevalence by screening 7 participants in each of six age and sex strata (age 40-55, 56-65, 65+, and male and female) from 50 villages (2100 participants). A health worker from each village used a handheld digital electrocardiogram (iECG) device (Kardia) to screen for AF on 3 separate days, and administered a questionnaire. All abnormal (AF or unclassified) iECGs were reviewed by the Indian cardiologist and AF determination confirmed by a US-based cardiac electrophysiologist. RESULTS: Of the 2100 individuals enrolled, iECGs were collected from 2074 participants (98.8%) and 1947 (92.7%) participants responded to the questionnaire. AF was identified in 33 participants (1.6%), two-thirds on the first iECG. AF prevalence was higher among males (2.3% vs 1.0%, p = 0.03) and in older people (0.6%, 0.9%, 2.1%, 5.6%; p < 0.01). CONCLUSIONS: The prevalence of AF observed in our population-based sample is comparable to rates found in studies from North America and Western Europe and increases similarly with age. AF screening using village health workers in rural India is feasible and presents an opportunity for a strategy to address the stroke epidemic in India through primary prevention.

Caste matters: perceived discrimination among women in rural India.

The aim of this study is to examine the relationship of caste and class with perceived discrimination among pregnant women from rural western India. A cross-sectional survey was administered to 170 pregnant women in rural Gujarat, India, who were enrolled in a longitudinal cohort study. The Everyday Discrimination Scale and the Experiences of Discrimination questionnaires were used to assess perceived discrimination and response to discrimination. Based on self-report caste, women were classified into three categories with increasing historical disadvantage: General, Other Backward Castes (OBC), and Scheduled Caste or Tribes (SC/ST). Socioeconomic class was determined using the standardized Kuppuswamy scale. Regression models for count and binomial data were used to examine association of caste and class with experience of discrimination and response to discrimination. Sixty-eight percent of women experienced discrimination. After adjusting for confounders, there was a consistent trend and association of discrimination with caste but not class. In comparison to General Caste, lower caste (OBC, SC/ST) women were more likely to (1) experience discrimination (OBC OR: 2.2, SC/ST: 4.1; p trend: 0.01); (2) have a greater perceived discrimination score (OBC IRR: 1.3, SC/ST: 1.5; p trend: 0.07); (3) accept discrimination (OBC OR: 6.4, SC/ST: 7.6; p trend: < 0.01); and (4) keep to herself about discrimination (OBC OR: 2.7, SC/ST: 3.6; p trend: 0.04). The differential experience of discrimination by lower caste pregnant women in comparison to upper caste pregnant women and their response to such experiences highlight the importance of studying discrimination to understand the root causes of existing caste-based disparities.

Study protocol for Smartphone Monitoring for Atrial fibrillation in Real-Time in India (SMART-India): a community-based screening and referral programme.

INTRODUCTION: Atrial fibrillation (AF), the world's most common arrhythmia, often goes undetected and untreated in low-resource communities, including India, where AF epidemiology is undefined. AF is an important risk factor for stroke, which plagues an estimated 1.6 million Indians annually. As such, early detection of AF and management of high-risk patients is critically important to decrease stroke burden in individuals with AF. This study aims to describe the epidemiology of AF in Anand District, Gujarat, India, characterise the clinical profile of individuals who are diagnosed with AF and determine the performance of two mobile technologies for community-based AF screening. METHODS: This observational study builds on findings from a previous feasibility study and leverages two novel technologies as well as an existing community health programme to perform door-to-door AF screening for 2000 people from 60 villages of Anand District, Gujarat, India using local health workers. A single-lead ECG and a pulse-based application is used to screen each individual for AF three times over a period of 5 days. Participants with suspected arrhythmias are followed up by study cardiologist who makes final diagnoses. Participants diagnosed with AF are initiated on treatment based on current anticoagulation guidelines and clinical reasoning. ANALYTICAL PLAN: Age-stratified and sex-stratified prevalence of AF in the Anand District will be calculated for sample and estimated for Anand distribution using survey design weights. Sociodemographic and clinical factors associated with AF will be evaluated using multivariable regression methods. Performance of each mobile technology in detecting AF will be evaluated using a 12-lead ECG interpretation as the gold standard. ETHICS AND DISSEMINATION: This protocol was approved separately by the Institutional Review Board of University of Massachusetts Medical School and the Human Research Ethics Committee at Charutar Arogya Mandal. The findings of this study will be disseminated through peer-reviewed journals and scientific conferences.

RAHI-SATHI Indo-U.S. Collaboration: The Evolution of a Trainee-Led Twinning Model in Global Health Into a Multidisciplinary Collaborative Program.

BACKGROUND: In recent years there has been a surge in the number of global health programs operated by academic institutions. However, most of the existing programs describe partnerships that are primarily faculty-driven and supported by extramural funding. PROGRAM DESCRIPTION: Research and Advocacy for Health in India (RAHI, or "pathfinder" in Hindi) and Support and Action Towards Health-Equity in India (SATHI, or "partnership" in Hindi) are 2 interconnected, collaborative efforts between the University of Massachusetts Medical School (UMMS) and Charutar Arogya Mandal (CAM), a medical college and a tertiary care center in rural western India. The RAHI-SATHI program is the culmination of a series of student/trainee-led research and capacity strengthening initiatives that received institutional support in the form of faculty mentorship and seed funding. RAHI-SATHI's trainee-led twinning approach overcomes traditional barriers faced by global health programs. Trainees help mitigate geographical barriers by acting as a bridge between members from different institutions, garner cultural insight through their ability to immerse themselves in a community, and overcome expertise limitations through pre-planned structured mentorship from faculty of both institutions. Trainees play a central role in cultivating trust among the team members and, in the process, they acquire personal leadership skills that may benefit them in their future careers. CONCLUSION: This paradigm of trainee-led twinning partnership promotes sustainability in an uncertain funding climate and provides a roadmap for conducting foundational work that is essential for the development of a broad, university-wide global health program.

High Burden of Unrecognized Atrial Fibrillation in Rural India: An Innovative Community-Based Cross-Sectional Screening Program.

BACKGROUND: Atrial fibrillation, the world's most common arrhythmia, is a leading risk factor for stroke, a disease striking nearly 1.6 million Indians annually. Early detection and management of atrial fibrillation is a promising opportunity to prevent stroke but widespread screening programs in limited resource settings using conventional methods is difficult and costly. OBJECTIVE: The objective of this study is to screen people for atrial fibrillation in rural western India using a US Food and Drug Administration-approved single-lead electrocardiography device, Alivecor. METHODS: Residents from 6 villages in Anand District, Gujarat, India, comprised the base population. After obtaining informed consent, a team of trained research coordinators and community health workers enrolled a total of 354 participants aged 50 years and older and screened them at their residences using Alivecor for 2 minutes on 5 consecutive days over a period of 6 weeks beginning June, 2015. RESULTS: Almost two-thirds of study participants were 55 years or older, nearly half were female, one-third did not receive any formal education, and more than one-half were from households earning less than US $2 per day. Twelve participants screened positive for atrial fibrillation yielding a sample prevalence of 5.1% (95% CI 2.7-8.7). Only one participant had persistent atrial fibrillation throughout all of the screenings, and 9 screened positive only once. CONCLUSIONS: Our study suggests a prevalence of atrial fibrillation in this Indian region (5.1%) that is markedly higher than has been previously reported in India and similar to the prevalence estimates reported in studies of persons from North America and Europe. Historically low reported burden of atrial fibrillation among individuals from low and middle-income countries may be due to a lack of routine screening. Mobile technologies may help overcome resource limitations for atrial fibrillation screening in underserved and low-resource settings.