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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.
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.
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.
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.
OBJECTIVES/GOALS: Translating Research into Practice (TRIP), a hybrid implementation pragmatic clinical trial and CTSA collaboration, aims to implement a standardized breast cancer patient navigation protocol across five sites in Boston, MA. The goal of this study was to assess individual and institutional barriers and facilitators to implementing this protocol. METHODS/STUDY POPULATION: From November 2019 to August 2020, researchers conducted ethnographic observations of Patient Navigators (PN) at three of the five participating sites. Each PN at each site was observed for two, four-hour blocks by researchers trained in ethnographic research. Observers took notes using TRIPs 11 Step Protocol as a guide, which includes identifying patients at risk for delays in care, screening and referring patients to resources for health-related social needs, and tracking patients across the care continuum. Fieldnotes were uploaded into Dedoose and coded deductively by four researchers using a comparison and consensus approach. Researchers analyzed the data to identify barriers and facilitators to both implementing each protocol step and maximizing navigations ability to promote health equity. RESULTS/ANTICIPATED RESULTS: Across all sites, PNs faced barriers to adhering to the TRIP Protocol due to practical workflow constraints including their level of engagement across the cancer care continuum. Although there are other staff members who engage in navigation activities, navigation is often viewed solely as the responsibility of the PN. Operationalizing navigation as a person rather than a process creates confusion around the role, and PNs are often seen as a catchall position when other staff do not know how to help a patient. The time that PNs spend on tasks unrelated to core navigation activities described in the TRIP Protocol prevents PNs from navigating patients most at risk for delays in care. A lack of continuity across the care continuum can create role confusion for the PNs. DISCUSSION/SIGNIFICANCE: Patient Navigation can promote health equity; however, any task that pulls PNs away from navigating patients most at risk for delays in care diminishes this potential. PNs abilities to enact the TRIP protocol, which they saw as valuable, is circumscribed by the extent to which navigation is operationalized as a process within the institution.
Barriers to research participation by racial and ethnic minority group members are multi-factorial, stem from historical social injustices and occur at participant, research team, and research process levels. The informed consent procedure is a key component of the research process and represents an opportunity to address these barriers. This manuscript describes the development of the Strengthening Translational Research in Diverse Enrollment (STRIDE) intervention, which aims to improve research participation by individuals from underrepresented groups.
We used a community-engaged approach to develop an integrated, culturally, and literacy-sensitive, multi-component intervention that addresses barriers to research participation during the informed consent process. This approach involved having Community Investigators participate in intervention development activities and using community engagement studios and other methods to get feedback from community members on intervention components.
The STRIDE intervention has three components: a simulation-based training program directed toward clinical study research assistants that emphasizes cultural competency and communication skills for assisting in the informed consent process, an electronic consent (eConsent) framework designed to improve health-related research material comprehension and relevance, and a “storytelling” intervention in which prior research participants from diverse backgrounds share their experiences delivered via video vignettes during the consent process.
The community engaged development approach resulted in a multi-component intervention that addresses known barriers to research participation and can be integrated into the consent process of research studies. Results of an ongoing study will determine its effectiveness at increasing diversity among research participants.
The updated common rule, for human subjects research, requires that consents “begin with a ‘concise and focused’ presentation of the key information that will most likely help someone make a decision about whether to participate in a study” (Menikoff, Kaneshiro, Pritchard. The New England Journal of Medicine. 2017; 376(7): 613–615.). We utilized a community-engaged technology development approach to inform feature options within the REDCap software platform centered around collection and storage of electronic consent (eConsent) to address issues of transparency, clinical trial efficiency, and regulatory compliance for informed consent (Harris, et al. Journal of Biomedical Informatics 2009; 42(2): 377–381.). eConsent may also improve recruitment and retention in clinical research studies by addressing: (1) barriers for accessing rural populations by facilitating remote consent and (2) cultural and literacy barriers by including optional explanatory material (e.g., defining terms by hovering over them with the cursor) or the choice of displaying different videos/images based on participant’s race, ethnicity, or educational level (Phillippi, et al. Journal of Obstetric, Gynecologic, & Neonatal Nursing. 2018; 47(4): 529–534.).
We developed and pilot tested our eConsent framework to provide a personalized consent experience whereby users are guided through a consent document that utilizes avatars, contextual glossary information supplements, and videos, to facilitate communication of information.
The eConsent framework includes a portfolio of eight features, reviewed by community stakeholders, and tested at two academic medical centers.
Early adoption and utilization of this eConsent framework have demonstrated acceptability. Next steps will emphasize testing efficacy of features to improve participant engagement with the consent process.
To examine the association between food insecurity and emotional eating (EE) in US Latinxs and explore the mediating role of perceived stress.
Cross-sectional analysis. Food insecurity was measured with the six-item US Department of Agriculture Household Food Security Scale; EE with the Three-Factor Eating Questionnaire R18-V2; and perceived stress with Cohen’s Perceived Stress Scale-10. Covariates included age, sex, education, marital status, household size and country of birth. Mediation was tested using the Baron and Kenny method and the mediated proportion was calculated. Analyses included multivariable linear regression and multinomial logistic regression.
A largely Latinx city in Massachusetts, USA. Participants were recruited from a community health centre serving a large portion of this Latinx community.
Latinx individuals (n 580), aged 21–84 years.
Overall, 34·4 % were food insecure and 33·8 % experienced High EE. Food insecurity was associated (adjusted OR; 95 % CI) with higher odds of High EE (1·96; 1·28, 3·02) but not Low EE (1·27; 0·82, 1·99). Food insecurity was associated (β; 95 % CI) with higher perceived stress (5·69; 4·20, 7·19). Perceived stress was associated (adjusted OR; 95 % CI) with High EE (1·09; 1·06, 1·12) but not Low EE (1·00; CI 0·97, 1·02). When perceived stress was added in the main effects model, food insecurity was no longer associated (OR; 95 % CI) with High EE (1·31; 0·83, 2·07) and explained 69·9 % of the association between food insecurity and High EE.
The association between food insecurity and high EE among Latinxs may be largely mediated by perceived stress. Longitudinal studies are needed.
Mini-sabbaticals are formal short-term training and educational experiences away from an investigator’s home research unit. These may include rotations with other research units and externships at government research or regulatory agencies, industry and non-profit programs, and training and/or intensive educational programs. The National Institutes of Health have been encouraging training institutions to consider offering mini-sabbaticals, but given the newness of the concept, limited data are available to guide the implementation of mini-sabbatical programs. In this paper, we review the history of sabbaticals and mini-sabbaticals, report the results of surveys we performed to ascertain the use of mini-sabbaticals at Clinical and Translational Science Award hubs, and consider best practice recommendations for institutions seeking to establish formal mini-sabbatical programs.
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