NOSI: Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing Among Underserved and/or Vulnerable Populations

Program Description

NIMHD supports this Notice of Special Interest (NOSI), which highlights the urgent need to understand and address morbidity and mortality disparities among underserved and vulnerable populations* across the United States due to Coronavirus Disease 2019 (COVID-19), caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). This NOSI will provide Emergency Competitive Revisions to active eligible grants and cooperative agreements to establish two-year community-engaged Testing Research Projects. These projects will examine SARS-CoV-2 infection patterns and efforts to increase access and effectiveness of diagnostic methods through the Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) initiative.

COVID-19 diagnostic testing is critical for slowing the spread of the virus and preventing future outbreaks. NIMHD will support supplements to individual NIH research awards that include community collaborations or partnerships to support COVID-19 testing to reach underserved and/or vulnerable populations. Applicants should work closely with communities to understand COVID-19 testing patterns, and implement strategies or interventions with the potential to rapidly (i.e., within six months of awards) increase reach, access, acceptance, uptake, and sustainment of FDA-authorized/approved diagnostics (especially viral tests).

This NOSI is one of four related Phase I RADx-UP funding opportunities. Funded projects will collaborate as part of a RADx-UP consortium led by a Coordination and Data Collection Center (CDCC) (RFA-OD-20-013). This consortium will serve as a resource for COVID-19 diagnostic testing and future public health pandemic outreach and mitigation activities. Investigators should also plan to collaborate with the RADx-UP Social, Ethical and Behavioral Implications (SEBI) program (NOT-OD-20-119), where possible, to support in-depth examination of social, ethical and behavioral implications related to COVID-19 testing and vaccination research.

Studies are encouraged to carefully consider the cultural, ethical, social, behavioral, historical, and economic implications associated with testing/diagnostic technologies and the collection, storage, and dissemination of health-related data for these underserved populations. Projects are expected to specify strategies to:

1. Address individual and structural social determinants of health (SDOH) that present barriers to participating in testing, follow-up, and retesting.
2. Create sustainable infrastructures that support rapid deployment of evidence-based approaches to testing, testing follow-up, and referral to treatment delivery.
3. Conduct effective outreach, communication, and dissemination activities to inform communities about the project and findings.

Key issues to be considered and addressed include, but are not limited to:

• Barriers to testing.
• Returning of test results.
• Understanding the implications of test results.
• Stigma and financial burden associated with a positive test result and follow-up care.
• Feasibility of effective self-isolation.
• Referrals for contact tracing for under-resourced communities, patients and their families.
• Privacy, confidentiality and data sharing.

NIMHD highly encourages studies that move away from an exclusively "top-down" approach by emphasizing collaborative partnerships with key stakeholders, including community partners and leaders, and leveraging existing partnerships to enhance COVD-19 testing. Community-based participatory research practices should be used throughout the research process.

Testing Research Projects of interest include, but are not limited to:

• Increasing reach, access, uptake, and impact for COVID-19 testing in underserved and/or vulnerable populations.
• Determining baseline rates of testing and evaluate innovative strategies to increase testing access, uptake, and sustainability.
• Conducting comparative effectiveness studies to test acceptance, uptake, and effectiveness of distinct COVID-19 test administration methods.
• Identifying, tracking, and increasing testing access in “testing deserts”.
• Examining factors at multiple levels (e.g., community-level factors, individual variables) that maximize the impact on population morbidity and mortality.
• Leveraging community relationships and cultural knowledge to drive testing implementation strategies, specifically with respect to community entry, trust building, and culturally appropriate ways to reduce testing barriers.
• Employing strategies for effective communication, education, or other engagement strategies to enhance patient-clinician communication.
• Examining implementation strategy effectiveness of different organizations (e.g., health care systems, schools, faith-based organizations).
• Creating strategies to widely disseminate up-to-date FDA-authorized/approved testing technologies (detection of viral nucleic acids, antigen and antibody tests, etc.).
• Employing evidence-based innovative technologies at the point-of-care, such as home-based self-testing kits, as they become available.
• Integrating new technology or techniques into the testing model over time, particularly those emerging from FDA authorization.

Projects are strongly encouraged to use the SDOH Collection of the PhenX Toolkit, and the NIH Public Emergency and Disaster Research Response (DR2). To the extent possible, data acquisition, collection, and curation strategies should be coordinated with the CDCC guidance for annotation and benchmarking of data, including obtaining appropriate consent for data sharing. Funded researchers will be strongly encouraged to share their survey items to make them public for other researchers to consider by submitting their surveys to NIHCOVID19Measures@nih.gov.

*Underserved populations are NIH-designated U.S. populations experiencing health disparities include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities.

For the purpose of this FOA, medically and/or socially vulnerable populations also include people who are: residents of nursing homes and assisted living facilities; community-dwelling older adults; individuals with intellectual, developmental, sensory, or physical disabilities, cognitive impairment or dementia, or communication disorders; homeless populations; individuals involved with the criminal or juvenile justice systems (incarcerated or under community supervision); individuals with medical comorbidities known to increase risk of severe COVID-19, including heart failure and related cardiovascular conditions, diabetes mellitus, chronic lung disease, obesity, HIV/AIDS; pregnant and post-partum women; children and adolescents; individuals living in congregate housing such as shelters or residential treatment facilities; individuals in overcrowded or public housing; individuals with substance use disorders or serious mental illness; migrant and immigrant populations; residents of tribal lands or reservations; communities exposed to high rates of air pollution or other toxic exposures; and rural and remote communities.

NIH Guide No.: NOT-OD-20-120

Page updated Jan. 12, 2024