February 4, 2021
PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
PA-18-935 - Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)
NOT-OD-20-118 - Guide Notice of Information Highlighting Harmonization and Data Sharing Expectations for Supplement and Revision Projects Addressing Social, Behavioral, Economic and Health Impacts of the COVID-19 Public Health Emergency
National Institute on Minority Health and Health Disparities (NIMHD)
This Notice of Special Interest (NOSI) highlights the urgent need for research strategies and interventions to address SARS-CoV-2 vaccine hesitancy, uptake, and implementation among populations who experience health disparities in the United States (U.S.). Research is urgently needed to understand and address misinformation, distrust, and hesitancy regarding the SARS-CoV-2 (COVID-19) vaccine among adults in the U.S. and its territories, especially among populations who are at increased risk for morbidity and mortality due to long-standing systemic health and social inequities and chronic medical conditions. ThisNOSI solicits community-engaged research to: 1) evaluate innovative interventions to facilitate vaccination uptake in clinical and community contexts; and 2) address the barriers to increasing reach, access, and uptake of vaccinations among health disparity populations. Applications for this NOSI are limited to NIH Research Centers in Minority Institution's (RCMI) currently active U54 awards, which are not in an extension at the time of application submission.
United States Food and Drug Administration (FDA)-authorized/approved vaccines, along with effective prevention strategies, are critical for reducing rates of infection and slowing the spread of viruses. Given the urgency of addressing the COVID-19 pandemic and the rollout of newly FDA-authorized/approved SARS-CoV-2 vaccines efforts, NIH is committed to advancing scientific knowledge on methods to increase access to and uptake of vaccinations to prevent life-threatening illnesses. Evidence indicates that populations disproportionately affected by COVID-19 infections, hospitalization, and mortality report vaccine-related concerns, fear, and lower willingness to accept the vaccine once available (i.e., vaccine hesitancy), highlighting the urgent need to develop and evaluate interventions to increase vaccine uptake and completion.
There is evidence of disparities in the acceptance and uptake of other vaccinations among adults from racial and ethnic minority populations, including vaccines for influenza, pneumococcal, herpes zoster, and human papilloma virus (HPV). For instance, research on influenza vaccination uptake shows a pattern of racial and ethnic minorities being less likely to receive the vaccine, with socioeconomic and clinician/health care system factors as possible contributors. Research on HPV vaccination uptake shows a similar pattern of racial/ethnic minorities being less likely to initiate or complete the series. Vaccine hesitancy is comprised of one’s confidence in vaccines, complacency towards vaccine uptake/completion, and convenience in accessing the vaccine. Rates of vaccine hesitancy are higher for populations experiencing health disparities. The reasons for hesitancy are varied, but may include concerns about perceived safety, skepticism about the trustworthiness of the source(s) of vaccination recommendations, considering immunization a low priority, perceived low risk of illness, limited knowledge and health literacy about the disease, difficulty accessing services, clinician bias, cost, or personal, and cultural or religious beliefs discouraging vaccination.
The overall goal of this NOSI is to apply scientific methods to understand factors that influence access to and uptake of COVID-19 vaccination in groups among groups that experience health disparities. This NOSI is focused on adults 18 years and older. Effective measures and trusted sources are essential to reduce misinformation, build community trust, and to promote widespread vaccine dissemination, population level uptake, and adherence to the vaccine protocol. Applications are encouraged to consider upstream factors (e.g., interpersonal, community, health system, policy), as well as relevant cultural and historical factors associated with individual beliefs, risk perceptions, and behavior across multiple levels (e.g., individual, interpersonal, etc.). The intervention research development for reducing barriers to access, acceptance, and uptake of vaccines in groups that experience health disparities should undertake or leverage community-engaged methods.
Key questions to be addressed include, but are not limited to the following COVID-19 vaccination topics:
This funding opportunity encourages studies that move away from an exclusively "top-down" public health vaccination approach by emphasizing collaborative partnerships with key stakeholders such as community partners, leaders, and knowledge holders, leveraging community resources and local service delivery settings to enhance vaccine access, delivery, uptake, and ultimate community benefit. Approaches to engage community stakeholders through the research process, such as team science, community-engaged research, participatory action research, empowerment evaluation approaches, community asset mapping, citizen science, and community health workers are strongly encouraged.
Applicants are expected to be able to leverage existing partnerships, such as with Tribal governments and agencies where applicable, academic and community medical centers or health systems, safety-net health clinics such as federally qualified health care centers (FQHCs), social service systems, public health departments, community and faith-based organizations, and schools, workplaces, or child care settings, to complete the study aims. Applicants should have a history of successful recruitment and retention of participants within the populations of focus. Projects are expected to incorporate research strategies to: a) address individual and structural social determinants of health (SDOH) (See: PhenX SDOH toolkit: https://www.phenxtoolkit.org/collections/view/6) that present barriers to vaccine access and uptake; b) create sustainable collaborations and implementation in communities disproportionately affected by illnesses for which SARS-CoV-2 vaccination is an option; and c) conduct effective communication and dissemination activities to inform communities about the project and its findings. Consistent with community-engaged research, applicants are expected to have established partnerships with community organizations with whom they will work, and projects must have clearly defined the roles for all partners. As appropriate, study budgets should include funds for community collaborations and partnerships to be fully engaged in research design and implementation.
Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions: Investigators who wish to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods may be warranted for analysis and sample size estimation. Group randomization may not be feasible in some circumstances for community-based interventions among populations who experience health disparities. Applicants should use methods that are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.
Applications should also delineate outcomes (such as receipt of target vaccine) and how the intervention or strategies can be sustained and scaled-up to improve population health.
Primary outcomes: SARS-CoV-2 vaccine uptake and/or vaccine completion per recommendations by the CDC's Advisory Committee on Immunization Practices (https://www.cdc.gov/vaccines/acip/index.html), as applicable.
Secondary outcomes (include, but are not limited to): Vaccine hesitancy – including vaccine confidence, vaccine convenience, vaccine complacency; community/social vaccine beliefs, norms, and risk perceptions; vaccine distribution and implementation across various sectors/settings; implementation of policies to increase individual access and uptake; access to immunization services; service delivery improvements; trust in science supporting vaccine research; and distrust in government and health organizations providing vaccine recommendations.
Projects must include a focus on one or more NIH-designated populations who experience health disparities in the United States, which include racial and ethnic minority groups (Blacks or African Americans, Hispanics or Latinos, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders), less privileged socioeconomic status, sexual and gender minorities, and underserved rural populations. Projects that examine or address factors at multiple levels are strongly encouraged (see the NIMHD Research Framework for examples of determinants of health at different levels: https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html). Research is encouraged among distinct sub-populations based on the country of origin (e.g., Koreans, Vietnamese, Cambodian, etc., rather than Asian Americans).
Projects are also strongly encouraged to support early stage investigators including those from backgrounds underrepresented in the biomedical workforce.
Research topics of interest on COVID-19 vaccination include, but are not limited to, the following:
Maximizing comparisons across datasets or studies and data integration are essential for collaboration. Projects funded through this NOSI are strongly encouraged to use the following resources:
Additionally, researchers with funding through this NOSI 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.
Applications not responsive to the NOSI:
Applications nonresponsive to these terms will be withdrawn for this NOSI initiative.
Application and Submission Information
Applications in response to this NOSI must be submitted using one of the following target opportunities or subsequent reissued equivalent.
Administrative supplement work that is proposed through PA-20-272 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) must be within the general scope of the research that is already supported.
Applications that involve a change in scope (e.g., the addition of human subjects or children to a grant that has not been previously so coded and approved, must apply to PA-18-935 Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional).
For the purpose of this NIMHD NOSI, eligible activity codes for applications to PA-20-272 and PA-18-935 are limited to the following: U54.
To be eligible for either an Administrative Supplement or Urgent Competitive Revision under this NOSI, the parent Research Centers in Minority Institutions (RCMI) U54 award on which the supplement or revision application is based must:
All instructions in the SF424 (R&R) Application Guide and in the target funding opportunity announcement (PA-20-272 or PA-18-935) must be followed, with the following additions:
Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with Program staff listed on this NOSI and the Program Official of the parent award well in advance of the anticipated submission date to better determine appropriateness and interest of the NIMHD.
*This phrase is intended to refer to individuals who belong to a “health disparity population” as defined in section 464z-3(d)(1) of the Public Health Service Act, 42 U.S.C. 285t(d)(1): “A population is a health disparity population if, as determined by the Director of the Institute after consultation with the Director of the Agency for Healthcare Research and Quality, there is a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population.” https://www.govinfo.gov/content/pkg/USCODE-2018-title42/pdf/USCODE-2018-title42-chap6A-subchapIII-partC-subpart20-sec285t.pdf. As of October 2020, NIH-designated U.S. health disparity populations 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. Please see https://www.nimhd.nih.gov/about/overview/.
Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.
Deborah E. Linares, Ph.D., M.A.
National Institute on Minority Health and Health Disparities (http://www.nimhd.nih.gov)
Financial/Grants Management Contact
Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)