Key Dates

Related Announcements

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

Issued by

National Institute on Minority Health and Health Disparities (NIMHD)

Purpose

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.

Background

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:

• What interventions and strategies are most effective to increase the reach, access, acceptance, and vaccine completion among populations that experience health disparities?
• How can evidence-based interventions that have reduced vaccine hesitancy and increased both access and uptake of other vaccinations (e.g., influenza and HPV) be adapted and/or adopted to increase the uptake of COVID-19 vaccines?
• How can social media and other innovative technologies (such as smart phone applications) be integrated into vaccine promotion interventions to identify and address sources of misinformation regarding vaccination?
• How can vaccine-related communications be generated and promoted by clinicians and healthcare systems to be community and culturally appropriate?
• What are effective culturally specific and/or community competent approaches for reducing barriers and increasing the uptake of vaccinations?
• What structural factors, service delivery, or organizational level policies are effective in facilitating broad vaccination uptake and reducing barriers such as stigma, distrust, fear, discrimination, and exposure to misinformation?
• What are effective dissemination and implementation strategies related to vaccination in clinical and community settings?
• What rapid data collection methods (e.g., rapid ethnographic assessments) can be used to identify and prioritize a vaccine intervention within communities?

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:

Research topics of interest on COVID-19 vaccination include, but are not limited to, the following:

• Examine interventions to reduce barriers to vaccine uptake and successful completion.
• Determine baseline rates of hesitancy for the vaccine and use this information to evaluate innovative interventions to reduce concerns, increase trust and preparedness, and facilitate uptake of the vaccine in various settings and environments (e.g., primary care settings, medical centers, reproductive health clinics, dental clinics, community health clinics, pharmacies, Tribal health facilities, schools, workplaces, pharmacies, remote care settings, and non-healthcare contexts).
• Examine and address multilevel factors, including policies, community-level factors, health systems, interpersonal/family/professional and individual-level variables (e.g., cognitive and behavioral factors) that maximize vaccine access, uptake, and series completion.
• Examine and address the spread of vaccine misinformation across various social media-based platforms and interpersonal communication channels and how this relates to uptake of vaccination.
• Evaluate vaccine messaging through various innovative technologies to identify core features associated with vaccine adherence/uptake.
• Examine strategies for adoption and adaptation of effective communication, education, or other engagement strategies to enhance patient-clinician communication around vaccinations and related research.
• Conduct studies to test acceptance and effectiveness of vaccine communications delivered by clinicians, scientists, clergy, community leaders, trained community health workers or peers.
• Examine whether and the degree to which interest and acceptance of vaccine uptake may vary by real-life experience with the disease, including vaccine hesitancy among individuals who have recovered from COVID-19 or know others who have versus those who have lost family/friends/coworkers to COVID-19 or know others who have.
• Apply novel predictive analytics to identify geographical areas of health disparities and resources available to concentrate successful interventions to mitigate areas of high risk for future infections and healthcare burden.
• Identify somatic complaints and side effects and outcomes, particularly for those at higher medical risk, and medical and behavioral strategies used to decrease or prevent them and improve vaccine protocol adherence.
• Conduct interventions using proven implementation science approaches and frameworks (e.g., RE-AIM (Reach, effectiveness, adoption, implementation, maintenance) and examine facilitators and barriers to and fidelity of, intervention delivery of vaccines.

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:

• Data Harmonization for the Social Determinants of Health via the PhenX Toolkit: Investigators involved in human-subject studies are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data on SDOH across studies. In particular, studies with human participants should incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org).
• A trans-NIH working group is making existing COVID-19 survey items and investigator contact information publicly available through two NIH-supported platforms: the NIH Public Health Emergency and Disaster Research Response (DR2) [https://dr2.nlm.nih.gov/] and the PhenX Toolkit [https://www.phenxtoolkit.org/index.php]. Researchers addressing COVID-19 questions, whether population-based or for clinical research, are strongly encouraged to consider these COVID-19 specific survey item repositories and select existing survey items or protocol modules currently being fielded.

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:

• Projects supplementing grants that are not eligible for this NOSI (see Eligibility section below under Application and Submission Information ).

• Projects without a primary focus on COVID-19 vaccine uptake or completion outcomes among one or more NIH-designated health disparity populations.
• Projects not applying methods of community-engaged research.
• Projects examining COVID-19 vaccine uptake/completion outside of the U.S. or its territories.
• Projects focused on individuals under age 18.

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.

• 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)
• The funding instrument, or activity code, will be the same as the parent award.

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:

• be an RCMI U54 awarded under either RFA-MD-17-003, RFA-MD-17-006, RFA-MD-18-012, or RFA-MD-20-006,
• be an active NIH award (i.e., not be in an extension period) at the time of application, and
• have sufficient time left to complete the studies proposed within the requested project period.

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:

• Budget: Individual requests can be no more than $500,000 in direct costs over the entire project period and must reflect the actual needs of the proposed project.
• The Research Strategy section of the application is limited to 6 pages.
• Project Period: The project period is limited to 3 years with a 2-year minimum, the parent award must be active when the application is submitted (within the originally reviewed and approved project period of the existing parent RCMI U54), and the requested project end date may not be more than 6.5 years after the budget period start date of the existing competitive segment (e.g., if the competitive segment started 9/20/2017, the latest end date would be 3/19/24).
• Application Due Dates: March 5, 2021 and May 3, 2021 by 5:00 PM local time of the applicant organization. This NOSI expires on May 4, 2021. An application submitted in response to this NOSI that is received on May 4, 2021 or later will be withdrawn.
• Multiple submissions per a RCMI U54 award are not allowed.
• Specific to applications that target PA-20-272 (Administrative Supplements): The process for Streamlined Submissions using the eRA Commons cannot be used for PA-20-272.
• IMPORTANT: For funding consideration, applicants must designate "NOT-MD-21-012 (without quotation marks) in the Agency Routing Identifier field (Box 4b) of the SF424 (R&R) form. Applications without this information in Box 4b will not be considered for this initiative.
• All applications must be submitted electronically using a single-project application form package:
  • Administrative supplement applications to PA-20-272 must use the application form package with the Competition ID of FORMS-F-ADMINSUPP-RESEARCH".
  • Competitive revision applications to PA-18-935 must use the application form package with the Competition ID of NOT-MD-21-012-FORMS-F."

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.

Inquiries

Scientific/Research Contact

Deborah E. Linares, Ph.D., M.A.

National Institute on Minority Health and Health Disparities (http://www.nimhd.nih.gov)

Telephone: 301-402-2516

Email: deborah.linares@nih.gov

Financial/Grants Management Contact

Priscilla Grant, JD

National Institute on Minority Health and Health Disparities (NIMHD)

Email: pg38h@nih.gov