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NOT-MD-22-006 - RESCINDED (Notice of Special Interest (NOSI): Research to Address Vaccine Hesitancy, Uptake, and Implementation among Populations that Experience Health Disparities)

Issued by

National Institute on Minority Health and Health Disparities (NIMHD)

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

National Institute of Dental and Craniofacial Research (NIDCR)

Sexual and Gender Minority Research Office (SGMRO)

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)

Purpose

This Notice of Special Interest (NOSI) highlights the need for research on strategies and interventions to increase vaccine uptake and implementation among populations experiencing health disparities in the United States (U.S.) and its territories. Research is needed to understand and address misinformation, uncertainty, distrust, and hesitancy regarding uptake of vaccines (e.g., SARS-CoV-2, pneumococcal, influenza, hepatitis B, human papilloma virus (HPV), varicella, tetanus, diphtheria, and pertussis [Tdap]) among individuals in the U.S. and its territories, especially in populations at increased risk for morbidity and mortality due to long-standing systemic health and social inequities, as well as chronic medical conditions. This NOSI is focused on individuals across the life span (i.e., all ages). The purpose of this NOSI is to solicit research that will: 1) understand and address barriers to increasing reach, access, and uptake of vaccinations among populations experiencing health disparities; 2) evaluate organizational, local, state, and federal policies and initiatives that mitigate or exacerbate disparities in vaccine access, uptake, and series completion, and 3) evaluate community-engaged interventions (e.g., expand reach, address psychosocial barriers, and social determinants of health [SDOH]) to facilitate vaccination uptake in clinical and community contexts.

Background and Goals

United States Food and Drug Administration (FDA)-authorized/approved vaccines and boosters, along with effective mitigation and prevention strategies, are critical for reducing rates of infection and slowing the spread of infectious diseases. Viral outbreaks of preventable diseases, such as COVID-19 and substantial levels of vaccine hesitancy among populations with health disparities, highlight the need to develop and evaluate strategies and policies to increase vaccine completion. NIH is committed to advancing scientific knowledge on methods and strategies to increase access to and uptake of vaccinations to prevent life-threatening illnesses.

There is evidence of disparities in the acceptance and uptake of vaccines (e.g., SARS-CoV-2 [COVID-19], influenza, pneumococcal, Tdap, and HPV) among racial and ethnic minority populations. These disparities also occur for routine as well as COVID-19 vaccinations among racial and ethnic minority infants and children as well as those from lower socioeconomic backgrounds, with parental perceptions of vaccine safety as a possible contributor. Research on HPV and COVID-19 vaccination uptake shows that racial and ethnic minority persons are less likely to initiate or complete the series. Research on influenza vaccination uptake shows a pattern of racial and ethnic minority persons being less likely to receive the vaccine, with socioeconomic and clinician or health care system factors as possible contributors. Vaccine hesitancy is comprised of one’s confidence in the safety and efficacy of the vaccines, complacency towards vaccine uptake/completion, and convenience in accessing the vaccine. For some vaccines, hesitancy is higher for populations experiencing health disparities and for minors under 18 years of age, parental consent is imperative. The reasons for hesitancy are varied, but may include concerns about perceived safety, public uncertainty, rapidly changing guidance, skepticism about the trustworthiness of the source(s) of vaccination recommendations, exposure to misinformation and disinformation, considering immunization a low priority, perceived low risk of illness, limited knowledge and health literacy about the disease, difficulty accessing services, clinician bias, out-of-pocket 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 populations experiencing health disparities. This NOSI is focused on vaccines across the life span. 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 behaviors across multiple levels (e.g., individual, community, societal etc.). Applications should make explicit their rationale for the specific populations of focus and describe the health disparities to be addressed.

For this NOSI, NIMHD is interested in projects including a focus on one or more populations whom NIH designates as experiencing health disparities in the U.S., which include racial and ethnic minority groups (Blacks or African American, Hispanic or Latino, American Indian and Alaska Native, Asian American, Native Hawaiian and Pacific Islander populations), people with less privileged socioeconomic status, sexual and gender minority [SGM] persons, and underserved rural populations. Please see: https://www.nimhd.nih.gov/about/overview/ for more information. Research is encouraged among distinct subpopulations based on the country of origin (e.g., Koreans, Vietnamese, Cambodian, etc., rather than Asian Americans). Multidisciplinary projects that examine or address factors at multiple levels and across multiple domains are strongly encouraged (see the NIMHD Research Framework: https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html for more information). Projects to increase vaccine uptake among groups with multiple marginalized identities among SGM and rural populations are encouraged (e.g., racial and ethnic minority groups living in rural areas, SGM persons from racial and ethnic minority groups).

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

• What multilevel interventions and strategies are most effective to increase the reach, access, acceptance, and vaccine completion among racial and ethnic minorities and individuals with lower educational attainment?
• What multilevel interventions can effectively target individual beliefs, risk perceptions, and behavior to increase vaccine acceptance among SGM persons from racial and ethnic minority groups?
• How can we adapt evidence-based interventions that have reduced vaccine hesitancy and increased both access and uptake of other vaccinations (e.g., influenza and HPV) for all recommended vaccines among children from racial and ethnic minority and low socioeconomic status backgrounds?
• 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 and disinformation regarding vaccination?
• How can vaccine-related communications on SARS-CoV-2, HPV, influenza, and other vaccines be generated and promoted by clinicians and healthcare systems to be community and/or culturally appropriate?
• What are effective culturally specific and/or community competent approaches for reducing barriers and increasing 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 local, state, or federal policies are effective in mitigating disparities in vaccine access, uptake, and series completion?
• How does scientific uncertainty, including rapidly changing vaccine guidance impact vaccine uptake among racial and ethnic minority and socioeconomically disadvantaged populations?
• What unintended negative consequences do vaccine related policies create, such as exacerbating disparities in access or vaccine series completion?
• What are effective dissemination and implementation strategies related to vaccination in clinical and community settings among racial and ethnic minority groups and sexual and gender minorities in rural and urban areas?
• What rapid data collection methods (e.g., rapid ethnographic assessments) can be used to identify and prioritize vaccine interventions in communities?

Primary Data Collection Studies

Responsive grant applications must involve a formal collaboration with one or more of the following:

• Tribal governments and agencies;
• Academic and community medical centers or health systems, safety-net health clinics (e.g., free clinics, federally qualified health care centers [FQHC]), social service systems (e.g., women infants and children [WIC] centers), public health agencies;
• Community-based or faith-based organizations or groups, schools including Head Start locations, workplaces, childcare settings; or
• NIH-funded SARS-CoV-2 initiatives focused on populations who experience health disparities: Community Engagement Alliance (CEAL) Against COVID-19 Disparities initiative or the Rapid Acceleration of Diagnostics Underserved Populations (RADx^SM-UP) initiative where appropriate (i.e., population focus and/or intervention designs are similar, or study sites are geographically co-located or near the applicant’s proposed study site).

Studies are encouraged to collaborate and partner with key community stakeholders and leverage community resources and local service delivery settings to enhance vaccine access, delivery, and uptake. Applicants should have: 1) a history of successful recruitment and retention of participants within the populations of focus, 2) create sustainable collaborations and implementation in communities disproportionately affected by illnesses for which vaccination is an option; and 3) conduct effective communication, co-creation, and dissemination activities to inform communities about the project and its findings. Projects must have clearly defined 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. Approaches to engaging 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.

Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions: Investigators who wish to evaluate the effect of an intervention on vaccine uptake/series completion are strongly encouraged to use appropriate intervention study designs, such as a parallel group- or cluster-randomized trial, a stepped-wedge group- or cluster randomized trial, a rigorous quasi-experimental design such as a group- or cluster-level regression discontinuity design or an interrupted time-series design, or a rigorous alternative. Intervention designs that lack comparison conditions or sites (e.g., an intervention implemented in a single clinic or neighborhood) are strongly discouraged. Whenever participants are assigned to study arms in groups or clusters (e.g., families, clinics, schools, worksites, communities, counties, states) and observations taken on individual participants are analyzed for intervention effects, special methods are required for analysis and sample size. Methods consistent with plans for assignment of participants and delivery of interventions should be documented in the application. Additional information is available at: https://researchmethodsresources.nih.gov/ . Applications should also delineate outcomes (such as receipt of a target vaccine) and how the intervention or strategies can be sustained and scaled-up to improve population health.

Secondary Data Analysis Studies

Projects of interest may include studies evaluating the effects of vaccine mandates or other policies, e.g., analyses drawing on natural experiments to understand how organizational, local, state, and federal policies and initiatives mitigate or exacerbate disparities in vaccine access, uptake, and series completion.

Study Outcomes

Primary outcomes: Vaccine uptake and/or vaccine series completion across the lifespan 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; uncertainty; parental perceptions related to vaccines; parental consent; trust in science supporting vaccine research; and distrust in government and health organizations providing vaccine recommendations.

Applications are also strongly encouraged to support early-stage investigators from diverse backgrounds, including from groups underrepresented in the biomedical research workforce.

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 recommended immunizations.
• Determine shifting baseline rates of hesitancy for specific vaccines (e.g., SARS-CoV-2) or multiple vaccines 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 community health workers).
• Implement and test the effect of behavioral change models to increase vaccine uptake and series completion.
• Evaluate interventions to understand and address parental vaccine hesitancy and examine the impact on vaccine uptake and series completion among children and adolescents
• Test strategies to target vaccine misinformation, disinformation, and/or public uncertainty regarding vaccines and improve vaccine uptake
• Develop and test family-based strategies to increase parental consent and vaccine access and uptake
• Evaluate novel behavioral interventions leveraging digital technology to promote adherence with vaccine uptake/series completion and prevention strategies (i.e., hand washing, social distancing).
• Evaluate the impact of organizational, local, state, and federal policies (e.g., vaccine mandates in work, childcare, travel, or school settings, COVID mitigation strategies, work policies) in exacerbating or mitigating disparities in vaccine access, uptake, and series completion.
• 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 and disinformation 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 and 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, including health literacy and limited-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 continued to have symptoms of long COVID.
• Apply novel predictive analytics to identify geographical areas of low(er) vaccine uptake, accessibility, and/or resources available to concentrate on successful interventions to reduce risks for future infections and healthcare burden.
• Conduct interventions using proven implementation science approaches and frameworks, e.g., Reach, effectiveness, adoption, implementation, maintenance (RE-AIM), and examine facilitators and barriers and fidelity of intervention delivery of vaccines.
• Examine systems or organizational level strategies to effectively communicate and disseminate appropriate vaccine information rapidly and improve vaccine uptake during the context of uncertainty.

National Cancer Institute

NCI is interested in research strategies, policy evaluations, and interventions that focus on vaccines that prevent cancer, including the human papillomavirus (HPV) and hepatitis B (HBV) vaccines. In addition, NCI is interested in research that addresses vaccine hesitancy, uptake, and implementation for childhood and adult vaccinations among those directly affected by cancer, including cancer survivors (whether they are currently living with cancer or free of cancer) across the lifespan and their caregivers. These vaccines may include influenza, SARS-CoV-2, pneumococcal, Tdap, varicella, hepatitis A and B, meningococcal, and HPV vaccines, among others, as recommended by the CDC and/or the patient’s healthcare provider.

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 NOSI, 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-21-014 for information about NIDCR’s clinical trials program.

Office of Disease Prevention (ODP)

The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 NIH Institutes and Centers, the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP is interested in providing co-funding support for research that has strong implications for disease and injury prevention and health equity and that include innovative and appropriate research design, measurement, and analysis methods. Furthermore, the ODP has a specific interest in projects that develop and/or test preventive interventions. For this NOSI, ODP is interested in research that addresses vaccine hesitancy, uptake, and implementation strategies of vaccines among populations that experience health disparities and that address topics relevant to the mission and research priorities outlined in the ODP strategic plan. For additional information about ODP’s research priorities and interests, please refer to the ODP Strategic Plan for Fiscal Years 2019 2023.

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. Research studying trends in vaccination coverage over time reveals substantial differences in uptake based upon gender, income, race and ethnicity, and geographic location. To optimally improve population health, safe and effective vaccines must be both acceptable and accessible to all. To further acceptability, both research and outreach communications seeking to enhance vaccine confidence and promote vaccination coverage should be designed with consideration of sex and gender. Clinical research has shown sex differences in some vaccine responses, including vaccine efficacy and adverse events. ORWH is interested in providing support for interdisciplinary, behavioral, clinical, and/or translational studies incorporating intersectional analyses of sex and gender differences in vaccine hesitancy and immunization uptake among populations experiencing health disparities, including groups of women who are understudied, underrepresented, and underreported in research. Proposals seeking to shed light on an array of dimensions where inequities exist (i.e., household/caregiving responsibility inequities; disparities related to healthcare, housing inequities, and sexual and reproductive health) and their impact on adoption of preventive interventions are of particular interest. Projects must align with at least one of the strategic goals and objectives outlined in the 2019-2023 Trans-NIH Strategic Plan for Women’s Health Research.

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 SDOH 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. Studies should incorporate measures from the Core and Specialty collections that are available in the SDOH Collection of the PhenX Toolkit (www.phenxtoolkit.org).
• Existing COVID-19 survey items and investigator contact information are 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: [email protected].

Applications not responsive to the NOSI:

• Projects without a primary focus on vaccine uptake or completion outcomes among one or more NIH-designated population experiencing health disparities.
• Projects examining vaccine uptake/completion outside of the U.S. or its territories.

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 notice of funding opportunities (NOFOs) or any reissues of these announcements through the expiration date of this notice.

Applicants must select the IC and associated NOFO to use for submission of an application in response to the NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that NOFO. Non-responsive applications will be withdrawn from consideration for this initiative. In addition, applicants using NIH Parent announcements (listed below) will be assigned to those ICs on this NOSI that have indicated those NOFOs are acceptable and based on usual application-IC assignment practices.

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-23-008 (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 Scientific Research Contacts listed on this NOSI well in advance of the anticipated submission date to better determine appropriateness and interest of the IC.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Integrative Biological and Behavioral Sciences

Deborah E. Linares, Ph.D., M.A.
NIMHD
Telephone: 301-402-2516
Email: [email protected]

Clinical and Health Services Research

Rada K Dagher, Ph.D., M.P.H.
NIMHD
Telephone: 301-451-2187
Email: [email protected]

Community Health and Population Sciences

Nancy L. Jones, Ph.D., M.A.
NIMHD
Telephone: 301-594-8945
Email: [email protected]v

Robin Vanderpool, Dr.P.H.
NCI
Telephone: 240-276-6558
Email: [email protected]

Margaret Grisius, DDS
National Institute Of Dental & Craniofacial Research (NIDCR)
E-mail: [email protected]

Elizabeth Neilson, Ph.D., M.P.H., M.S.N.
Office of Disease Prevention
Telephone: 301-827-5578
Email: [email protected]

Damiya Eve Whitaker
Office of Research On Women's Health (ORWH)
Phone: 240-276-6170
E-mail: [email protected]

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: [email protected]

Marie Mancini, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-5014
E-mail: [email protected]

Financial/Grants Management Contact(s)

Priscilla Grant, J.D.NIMHD
Telephone: 301-594-8412
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: (240) 276-6277
E-mail: [email protected]

Gabriel Hidalgo, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-827-4630
E-mail: [email protected]

Erik Edgerton
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-7760
E-mail: [email protected]