At-home testing to mitigate community transmission of SARS-CoV-2: protocol for a public health intervention with a nested prospective cohort study.

BACKGROUND: The COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to evolve as a global health crisis. Although highly effective vaccines have been developed, non-pharmaceutical interventions remain critical to controlling disease transmission. One such intervention-rapid, at-home antigen self-testing-can ease the burden associated with facility-based testing programs and improve testing access in high-risk communities. However, its impact on SARS-CoV-2 community transmission has yet to be definitively evaluated, and the socio-behavioral aspects of testing in underserved populations remain unknown. METHODS: As part of the Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program funded by the National Institutes of Health, we are implementing a public health intervention titled "Say Yes! COVID Test" (SYCT) involving at-home self-testing using a SARS-CoV-2 rapid antigen assay in North Carolina (Greenville, Pitt County) and Tennessee (Chattanooga City, Hamilton County). The intervention is supported by a multifaceted communication and community engagement strategy to ensure widespread awareness and uptake, particularly in marginalized communities. Participants receive test kits either through online orders or via local community distribution partners. To assess the impact of this intervention on SARS-CoV-2 transmission, we will conduct a non-randomized, ecological study using community-level outcomes. Specifically, we will evaluate trends in SARS-CoV-2 cases and hospitalizations, SARS-CoV-2 viral load in wastewater, and population mobility in each community before, during, and after the SYCT intervention. Individuals who choose to participate in SYCT will also have the option to enroll in an embedded prospective cohort substudy gathering participant-level data to evaluate behavioral determinants of at-home self-testing and socio-behavioral mechanisms of SARS-CoV-2 community transmission. DISCUSSION: This is the first large-scale, public health intervention implementing rapid, at-home SARS-CoV-2 self-testing in the United States. The program consists of a novel combination of an at-home testing program, a broad communications and community engagement strategy, an ecological study to assess impact, and a research substudy of the behavioral aspects of testing. The findings from the SYCT project will provide insights into innovative methods to mitigate viral transmission, advance the science of public health communications and community engagement, and evaluate emerging, novel assessments of community transmission of disease.

Estimating the impact of addressing food needs on diabetes outcomes.

Objective: To estimate the association between food needs and diabetes outcomes. Research design and methods: Longitudinal cohort study, using a target trial emulation approach. 96,792 adults with type 2 diabetes mellitus who underwent food need assessment in a network of community-based health centers were followed up to 36 months after initial assessment. We used targeted minimum loss estimation to estimate the association between not experiencing food needs, compared with experiencing food needs, and hemoglobin a1c (HbA1c), systolic and diastolic blood pressure (SBP and DBP), and LDL cholesterol. The study period was June 24th, 2016 to April 30th, 2023. Results: We estimated that not experiencing food needs, compared with experiencing food needs, would be associated with 0.12 percentage points lower (95% Confidence Interval [CI] -0.16% to -0.09%, p = < 0.0001) mean HbA1c at 12 months. We further estimated that not experiencing food needs would be associated with a 12-month SBP that was 0.67 mm Hg lower (95%CI -0.97 to -0.38 mm Hg, p < .0001), DBP 0.21 mm Hg lower (95%CI -0.38 to -0.04 mm Hg, p = .01). There was no association with lower LDL cholesterol. Results were similar at other timepoints, with associations for HbA1c, SBP, and DBP of similar magnitude, and no difference in LDL cholesterol. Conclusions: We estimated that not experiencing food needs may be associated with modestly better diabetes outcomes. These findings support testing interventions that address food needs as part of their mechanism of action.