U01MD018294

You and Me Healthy: Testing Protocol

In the United States, over 79 million people have been infected with SARS-CoV-2 and more than 900,000 have died. Unfortunately, cases and deaths have disproportionately affected underserved populations. It is crucial to address disparities in timely testing and drug access in order to maximize the impact of novel treatments early in the disease and transform the course of the pandemic.

Community-driven interventions have provided access to testing in underserved populations earlier in the pandemic. However, these interventions need to be tailored to promote test and treat protocols and ensure rapid access to treatment in response to current threats. This proposal aims to evaluate a systematic and scalable community-engaged test and treat protocol that provides rapid access to self-testing, "next steps" guidance, and local resources to facilitate treatment in underserved populations.

To achieve this, we will evaluate a community engagement toolkit called the You & Me Healthy Toolkit. This toolkit has been developed based on our expertise and experience and will be used to implement community-based test distribution and test and treat responses to the next phase of the COVID-19 pandemic in underserved populations. Our central hypothesis is that the You & Me Healthy Toolkit will enable rapid design and implementation of a community-driven, scientifically robust, and impactful COVID-19 test and treatment intervention.

We will leverage successful partnerships and infrastructure established through two large national RADx-UP funded SARS-CoV-2 testing and education interventions (Say Yes! COVID Test, You & Me COVID-Free). Additionally, we have an actively enrolling registry of participants interested in community-engaged research (You & Me Healthy Registry), partnerships with community engagement experts (Community Campus Partnerships for Health), and a history of collaboration with 150+ local community partners in Merced County, CA, and Pitt County, NC, with a high proportion of minority (Hispanic/Latino/Latinx and Black), high-poverty, and low health insurance coverage populations.

We will apply this toolkit to develop a rapid-deployment test and treat protocol implemented through our partners in two communities. This protocol will be launched in direct response to SARS-CoV-2 infection surges or at community-identified high-risk events over a 15-month period. To test our hypothesis, we will focus on the following specific aims:

1) Evaluate the You & Me Healthy Toolkit's ability to rapidly create effective academic-community research partnerships for promoting COVID-19 test access.
2) Document the results of at-home tests using a community-engaged scalable reporting approach.
3) Evaluate the ability of a test and treat protocol and local resourcing to facilitate timely access to testing, guidance, resource linkage, and therapeutics.

This work will demonstrate the value of a generalizable toolkit to promote rapid and effective academic-community partnerships. It will enable timely testing and access to effective therapeutics in underserved populations in response to COVID-19 surges or transmission threats.

Duke University

NOT APPLICABLE

93.360 - Biomedical Advanced Research and Development Authority (BARDA), Biodefense Medical Countermeasure Development

National Institute for Minority Health and Health Disparities (NIMHD) [HHS - NIH]

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Durham, North Carolina 277157969 United States

Single Zip Code

Emergency Award: RADx-UP Community-Engaged Research on Rapid SARS-CoV-2 Testing among Underserved and Vulnerable Populations (U01 Clinical Trial Optional) (RFA-OD-22-006)

COVID-19 $2,213,145 (100%) percent of this Cooperative Agreement was funded by COVID-19 emergency acts including the American Rescue Plan Act of 2021.
Amendment Since initial award the End Date has been extended from 10/31/24 to 10/31/25 and the total obligations have increased 98% from $1,116,426 to $2,213,145.