Key Dates

Related Announcements

PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

NOT-DA-22-015 - Notice of NIDA's Participation in NOT- MD-21-008

Issued by

National Institute on Minority Health and Health Disparities (NIMHD)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute on Alcohol Abuse and Alcoholism ( NIAAA )

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Mental Health (NIMH)

National Institute of Nursing Research (NINR)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Office of Behavioral and Social Sciences Research (OBSSR)

Office of Research on Women's Health (ORWH)

Sexual and Gender Minority Research Office (SGMRO)

Purpose

This Notice of Special Interest (NOSI) highlights the need for research strategies and interventions to address vaccine hesitancy, uptake, and implementation among populations who experience health disparities in the US.* Research is needed to understand and address misinformation, distrust, and hesitancy regarding vaccines (e.g., SARS-CoV-2, pneumococcal, influenza, hepatitis B, human papilloma virus (HPV), and herpes zoster) among adults in the United States and territories, especially in populations at increased risk for morbidity and mortality due to long-standing systemic health and social inequities and chronic medical conditions. The purpose of this NOSI is to solicit community-engaged research to: 1) evaluate intervention strategies (e.g., expand reach, access) 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 at high risk and likely to experience vaccine hesitancy.

Background and Goals
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. Recent viral outbreaks of preventable diseases, such as SARS-CoV-2 (COVID-19) and increasing levels of vaccine hesitancy among populations with health disparities, highlight the need to develop and evaluate strategies to increase vaccine completion. NIH is committed to advancing scientific knowledge on methods to increase access to and uptake of vaccinations to prevent life-threatening illnesses.

There is evidence of disparities in the acceptance and uptake of vaccinations among adults from racial and ethnic minority populations, including vaccines for influenza and HPV. Recent 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 (e.g., not offering) playing a role. Research on HPV vaccination uptake shows a similar pattern of racial/ethnic minorities being less likely to initiate or complete the series. Vaccine hesitancy, which includes both a delay in acceptance, or declining immunizations despite the availability of adequate services, is 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, misinformation, considering immunization a low priority, perceived low risk of illness, limited knowledge about the disease or the benefits of vaccination, limited health literacy, 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 promote the uptake of vaccination among groups that experience health disparities. This NOSI is focused on adults 18 years and older with the exception of HPV-related topics, which may include minors 9 years and older. Effective measures and trusted sources are essential to address and reduce misinformation, build community trust, and to promote widespread vaccine dissemination, population level uptake, and adherence to vaccination protocols. 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, community, 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. Applications on urgent vaccination topics such as the uptake and/or series completion of the SARS-CoV-2 vaccine are encouraged.

Key questions to be addressed include but are not limited to:

• 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 the SARS-CoV-2 vaccine?
• How can social media, digital marketing, and other innovative technologies (such as smart phone applications) be integrated into vaccine promotion interventions to identify and address the sources of misinformation regarding vaccination?
• How can vaccine-related communications on coronavirus, HPV, influenza, and other vaccines 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 vaccination uptake and completion?
• What 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 vaccine interventions in 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, academic and community medical centers or health systems, safety-net health clinics such as federally qualified health care centers (FQHCs), social service systems, state and local 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 vaccination is an option; and c) conduct effective communication, co-creation, and dissemination activities to inform communities about the project and its findings. 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: Vaccine uptake and/or vaccine series 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 and distrust; community/social vaccine beliefs, misconceptions, misinformation, norms, and risk perceptions; adherence to vaccine protocols; 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; trust in government and health organizations providing vaccine recommendations; and anxiety and stigma.

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 to enhance diversity.

Research Topics:

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

• Examine interventions to reduce barriers to vaccine uptake and successful completion of the vaccine protocol.
• Determine baseline rates of hesitancy for the SARS-CoV-2 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) as administered by various staff (doctors, nurses, pharmacists, paraprofessionals, and trained community health workers).
• 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, cultural contexts, and interpersonal communication channels and how it relates to the uptake of vaccination.
• Evaluate vaccine messaging through various innovative technologies to identify core features and influencers (including social influencers and key messaging) 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, including health literacy and low-English and non-English proficiency.
• Conduct studies to test the acceptance and effectiveness of vaccine communications or behavioral interventions delivered by medical providers, scientists, clergy, community leaders, trained community health workers, or peers.
• Examine whether and the degree to which interest and acceptance of vaccine uptake 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 []. 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.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIAAA is interested in applications that address the uptake of vaccines and topics relevant to its mission and research priorities. Areas of interest include, but are not limited to:

• effects of heavy drinking or alcohol use disorder (AUD) on receptivity to immunization, and how such effects may differ in health disparity populations;
• whether alcohol use disorder or heavy drinking influence the degree to which vaccines are offered or promoted to patients, and how this may vary in health disparity populations;
• extent to which heavy drinking or AUD limits access to or availability of vaccines in minority or under served populations;
• what interventions and strategies are most effective to increase the reach, access, acceptance, and vaccine completion among heavy drinking and AUD individuals who are members of health disparity populations.

National Cancer Institute (NCI)

NCI is interested in research that focuses on vaccines that prevent cancer, including the HPV and hepatitis B (HBV). In addition, NCI is interested in research that addresses SARS-CoV-2 vaccine hesitancy, uptake and implementation among those directly affected by cancer, including cancer survivors (those living with cancer and those free of cancer) and their caregivers. Per the NOSI guidance, projects must include a focus on one or more NIH-designated populations who experience health disparities in the U.S.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIAMS is interested in applications that concern the uptake of vaccination, especially for SARS-CoV-2, among populations that experience health disparities and are patients with NIAMS core mission diseases (arthritis, musculoskeletal, and skin disorders).

National Institute of Mental Health (NIMH)

NIMH is interested in applications that address the uptake of vaccines and topics relevant to its mission and research priorities as provided in its strategic plan. For information, please see: https://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml.

National Heart, Lung, and Blood Institute (NHLBI)

NHLBI will participate only in PA-20-185, NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). Researchers interested in proposing clinical trials for vaccine hesitancy related to heart, lung, blood, and diseases should consult with NHLBI staff and consider the FOA NHLBI PAR-19-328 Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required). Research priorities for NHLBI include increasing the knowledge base on vaccine hesitancy and implementation research on adoption, uptake, adherence of vaccine protocols, vaccine hesitancy, community engagement, and reducing health disparities, particularly for populations at higher risk for infectious diseases due to chronic cardiovascular and pulmonary diseases.

National Institute of Dental and Craniofacial Research (NIDCR)

NIDCR supports research on vaccination programs to prevent oral diseases and conditions (e.g., HPV vaccination) as well as opportunities for dental care providers to contribute to broader public health efforts (e.g., influenza or COVID-19 vaccination), as allowable by state practice acts. For this FOA, NIDCR is interested in research to develop improved methods of promoting vaccine uptake among groups that experience health disparities.

Areas of interest include, but are not limited to:

• Research to understand the feasibility and acceptability of vaccine programs in dental settings among health disparity populations.
• Research to characterize barriers to and facilitators of vaccine uptake for health disparity populations.
• Research on the use of innovative healthcare delivery models or interventions to improve vaccine uptake within health disparity populations (e.g., Screening, Brief Intervention, and Referral to Treatment or SBIRT models; use of electronic health records to facilitate coordinated care).

Investigators proposing research that meets the NIH definition of clinical trials are strongly advised to use NIDCR’s UG3/UH3 mechanism and are encouraged to contact program staff. Please see NOT-DE-18-014 for information about NIDCR’s clinical trials program.

Office of Research on Women’s Health (ORWH)

ORWH is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH and is supported in the larger scientific community. Clinical research studies have shown sex differences in some vaccine responses, including vaccine efficacy and adverse events. Integrating the purposeful accounting of sex as a biological variable (SABV) and gender as a social variable in biomedical research on COVID-19 will enable appropriate risk assessment, enhance understanding of differences in responsiveness, and ensure that a safe and effective, vaccine is developed that will be accessible and acceptable to all to prevent the spread of disease. ORWH is interested in providing support for interdisciplinary, behavioral, clinical, and/or translational studies incorporating intersectional analyses of sex and gender differences in vaccine uptake among populations experiencing health disparities, including groups of women who are understudied, underrepresented, and underreported in research. For additional guidance, please refer to the 2019-2023 Trans-NIH Strategic Plan for the Health of Women on the ORWH website (https://www.nih.gov/women/strategicplan).

Applications not responsive to the NOSI:

• Projects without a primary focus on vaccine uptake or completion outcomes among one or more NIH-designated health disparity populations.
• Projects not applying methods of community-engaged research.
• Projects examining vaccine uptake/completion outside of the U.S. or its territories.
• Projects focused on individuals under age 18, with the exception of projects focused on the HPV vaccine, which may include minors 9 years and older.

Applications nonresponsive to these terms will be withdrawn for this NOSI initiative.

Application and Submission Information

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PA-20-183- Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-185- NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-MD-21-008 (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.

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 well in advance of the anticipated submission date to better determine appropriateness and interest of the IC.

*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(s)

Integrative Biological and Behavioral Sciences

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

Clinical and Health Services Research

Rada K Dagher, Ph.D., M.P.H.

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

Telephone: 301-451-2187

Email: rada.dagher@nih.gov

Community Health and Population Sciences

Nancy L. Jones, Ph.D., M.A.
National Institute on Minority Health and Health Disparities (http://www.nimhd.nih.gov)
Telephone: 301-594-8945
Email: nancy.jones@nih.gov

Robin Vanderpool, Dr.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6558
Email: robin.vanderpool@nih.gov

Cheryl Anne Boyce
National Heart, Lung, And Blood Institute (NHLBI)
Phone: 301-435-1070
E-mail: cboyce@mail.nih.gov

Barbara L. Mulach, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 240-627-3322
E-mail: bmulach@niaid.nih.gov

Judy Arroyo, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-0717
Email: jarroyo@mail.nih.gov

Stephanie M. George
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-4974
E-mail: stephanie.george@nih.gov

Collene Lawhorn, Ph.D.

National Institute of Mental Health (NIMH)

Phone: 301-451-4262

Email: collene.lawhorn@nih.gov

Margaret Grisius, DDS
National Institute of Dental and Craniofacial Research (NIDCR)
Phone: 301-451-5096
E-mail: margaret.grisius@nih.gov

Dionne Godette-Greer, PhD
National Institute Of Nursing Research (NINR)
E-mail: dionne.godette@nih.gov

Financial/Grants Management Contact(s)

Priscilla Grant, J.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: grantp@mail.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Phone: (240) 276-6277
E-mail: wolfreyc@mail.nih.gov

John Hrivnak
National Heart, Lung, And Blood Institute (NHLBI)
Phone: 301-827-7717
E-mail: john.hrivnak@nih.gov

Vandhana Khurana, MBA
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 240-669-2966
Email:vandhana.khurana@nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov