U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Health (OASH), Office of Minority Health (OMH)
03/30/18 6:00 PM ET
Grants to USA and territories nonprofits, for-profits, government agencies, and IHEs to reduce health disparities related to lupus. Applicants are advised that registrations required to apply may take up to one month to completed. Funding may be requested for the recruitment and enrollment of minority populations into clinical trials, and for the development for clinical tribal education models for minority populations.
The Lupus Program seeks to reduce lupus-related health disparities among racial and ethnic minority populations disproportionately affected by this disease and also increase minority participation in clinical trials by: (1) developing public-private and community partnerships to promote recruitment and enrollment of minority populations affected by lupus into clinical trials (Priority A); and (2) creating a research plan and develop/test effective clinical trial education models in lupus for minority populations (Priority B).
Priority A is designed to improve the enrollment of minority populations in clinical trials through partnerships that work to create culturally and linguistically appropriate tools, resources and materials for minority populations affected by lupus, their caregivers and health care providers, and assess the impact of current minority clinical trial education and participation programs. Priority B requires that applicants design and implement a research plan that aims to create effective clinical trial education models in lupus for minority populations using an experimental or quasi-experimental framework. Applicants will be required to develop an action plan to disseminate the education models designed to increase minority populations’ participation.
OMH expects the Lupus Program will accomplish the following goals:
Priority A: Increase the number of public-private and community partnerships with culturally and linguistically appropriate education and participation programs directed toward improving minority recruitment and enrollment in clinical trials related to lupus; Priority B: Increase the number of innovative and effective provider education models that improve attitudes and practices of health care providers and paraprofessionals that will refer minority populations to clinical trials.
The assistance or benefits of the Lupus Program may not be denied to any person based on race, sex, color, or national origin.
HHS/OASH encourages applicants to review all program requirements, eligibility information, application format and submission information, evaluation criteria and other information in this funding announcement to ensure that its application complies with all requirements and instructions.
Lupus is a chronic autoimmune disease that causes inflammation in different tissues of the body which leads to numerous clinical symptoms, and poses disease management and treatment challenges for patients and health care providers. Normal functioning immune systems produce antibodies which are designed to protect against infection or foreign agents. In autoimmune disorders, such as lupus, the immune system cannot differentiate between foreign microorganisms and healthy tissue, which triggers the creation of autoantibodies that attack the body’s healthy tissue, causing widespread inflammation as well as tissue and organ damage. The most common form of lupus is system lupus erythematosus (SLE) which affects different parts of the body including internal organs, joints, skin, brain, lungs, kidneys, and blood vessels. Prevalence rates for children in the United States affected with SLE have been reported to range from 3.3 to 24.0 per 100,000.3 An estimated 10 to 20% of SLE diagnoses present during childhood and adolescence, pediatric-onset cases are often associated with more severe symptoms that subsequently lead to rapid tissue or organ damage accrual than adult-onset SLE.4 Although science has made significant advances in the treatment and management of this disease, the cause of lupus is unknown and there is still no cure.
Lupus, in particular SLE, disproportionately affects minority populations, including African Americans, Hispanics, Asians, and American Indians/Alaska Natives. Lupus is two to three times more common in African Americans Other studies have demonstrated American Indian and Alaska Natives have similar or higher rates of SLE to African Americans. The onset of lupus may occur at any age including in young children or the elderly; however, women of child bearing age (between 15 to 44 years old) are at the highest risk of onset. Women are more likely to be affected by lupus than men at an estimated ratio of 12 to 1. The racial and ethnic health disparity in lupus is closely related to the disparity seen in minority participation in clinical trials associated with autoimmune disorders.
For the past twenty-five years, national efforts have been made by researchers and healthcare providers to increase minority participation in clinical trials. Recent evidence suggests that some progress has been made in enrolling minorities in different phases of clinical trial research, but there is still room for improvement. There is strong evidence that previous misconduct in human medical research is associated with the low participation of minorities in current clinical trials. To increase participation in clinical trials, researchers have studied the barriers to participation in medical research but few have developed intervention strategies or models to address the lack of minorities in all phases of clinical trials. Several studies exploring barriers to recruitment and enrollment have concluded the following themes contribute to the lack of participation in minority communities – patient mistrust of the medical and research community, lack of access to health care, the lack of participant understanding about clinical trials and the perceived direct or indirect benefits of medical research, and perceptions and biases of health providers about minority participation in clinical trials.
Evidence from earlier studies indicated that patients from minority backgrounds, especially African Americans, have issues with trusting the medical community due to a history of exploitation of their community in medical research. A more recent study suggests that lack of access to transportation is a significant barrier for minority patients.13 Often the lack of access to affordable health care in minority populations contributes to the frequent use of emergency rooms or urgent care for medical treatment, this absence of continuity in care may contribute to the decreased likelihood of a patient being referred to a clinical trial.
Patients with medical conditions may be unaware that they are eligible to enroll in clinical trials due to the lack of knowledge or awareness about trial participation. Many minority patients may also hold the belief that neither they nor their community will directly benefit from participating in a trial, and thus may decline enrollment. Others may find the presumed risks of participating in a trial not clearly outlined in recruitment or informed consent materials. Information about clinical trials should also be made available for those with Limited English Proficiency (LEP), who are often not recruited due to the expense and difficulty with translating trial information and consent forms into multiple languages. Improving the knowledge and understanding about clinical trials and the importance of diverse participant populations in medical research may increase the participation rates of minority populations in clinical trials.
Health care providers play a key role in communicating information about lupus to patients, and this also includes relaying information about enrolling into clinical trials. Research shows implicit bias against minority populations can prohibit physicians from presenting enrollment into clinical trials as an option. An example of this bias is a health provider not referring a patient to a trial due to the perception that minority participants are less likely to adhere to complicated instructions given in research studies. These biases are often influenced by racial stereotypes in society and can limit the referral for trial enrollment for populations that differ from the referring physician.
A multilevel model solution derived from general systems theory posited by Hamel et al., suggests medical institutions can increase minority participation in clinical trials by enhancing community engagement through trusted partnerships with members (organizations) of the community for which it serves. Additionally, their model supports developing relationships with local health providers that work directly with minority populations. Anecdotal reports suggest that minority populations, in particular African Americans and Hispanics, are more likely to participate in phase I of a clinical trial although these same populations have much lower rates of participation in the subsequent clinical trial phases.
The underrepresentation of minority populations in all phases of clinical trials generates concern about the reduced generalizability of results derived from research findings in medical research, and further widens the gap of health disparities in disease management and treatment of lupus. In order to address the barriers related to the recruitment, enrollment, and retention of minority participants into all phases of clinical trials, researchers must focus on developing effective clinical trial education models that focus on the inclusion of a diverse population of participants in clinical trials.
The purpose of the National Lupus Training, Outreach, and Clinical Trial Education Program (Lupus Program) is to eliminate health disparities among racial and ethnic minority populations and disadvantaged populations disproportionately affected by lupus, and improve the participation of minority populations in clinical trials. The Lupus Program aims to promote collaborative efforts between organizations and agencies that serve the lupus community, in order to expand the development of culturally and linguistically appropriate tools, resources and materials for persons living with lupus, their caregivers and health care providers.
Each application must propose to conduct activities in one of two priority areas:
Priority A: Public-Private-Community Partnerships
Priority A focuses on developing public-private and community partnerships and evaluating minority clinical trial education and participation programs.
Priority A applications must propose projects with activities designed to:
-Foster public-private and community partnerships to address minority populations’ participation in clinical trials;
-Evaluate the effectiveness of current clinical trial education and participation programs; and
-Engage the lupus community to expand the development of culturally and linguistically appropriate tools, resources, and materials geared towards adults and children affected by lupus, as well as, their caregivers and health care providers.
Each Priority A project must target a minimum of two or a maximum of three Medically Underserved Areas and Populations (MUA/Ps), as defined in Appendix A to this Announcement.
Priority B: Effective and Innovative Clinical Trial Education Models
Priority B focuses on designing a research plan and developing effective clinical trial education models in lupus for minority populations and education models for health care providers and health paraprofessionals.
Priority B applications must propose projects that will:
-Create a research plan for effective clinical trial education models focused on increasing the enrollment of minority populations into clinical trials at all phases;
-Examine the attitudes, beliefs, and practices (behavioral intentions) of primary care physicians (PCPs), other health care providers and paraprofessionals associated with the referral of minority populations to clinical trials;
-Develop and test innovative model education programs for PCPs, other health care providers and paraprofessionals serving minority populations;
-Implement PCP, other health care provider, and paraprofessional educational interventions using the selected model during the project period, and adapt the intervention(s) for clinical trial education to address lupus using a culturally and linguistically appropriate framework for minority populations;
-Design recruitment and participation initiatives for PCPs with the goal of increasing clinical trial participation and education among minority populations;
-Develop and submit an action plan for disseminating a successful education intervention; and
-Prepare a manuscript for publication that reports the results of the educational intervention evaluation during the project period.
Each Priority B project must target a minimum of two or a maximum of three Medically Underserved Areas and Populations (MUA/Ps).
Project Requirements for Both Priority A and Priority B:
All applicants are required to use the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care (National CLAS Standards) as a framework to develop Priority A and Priority B proposals.
OMH expects successful applicants to utilize standard practices necessary for effective collaborative partnerships. This includes developing a structure for involvement, regularly engaging community and partnering organizations in the design and review of strategies, tools, resources, and approaches needed to carry out the Lupus Program, and leveraging the strengths of each partner organization without duplication of effort.
In addition, OMH expects that successful applicants will have significant demonstrated expertise in:
-Lupus epidemiology, diagnosis, treatment, and disparity related issues in both adults and children;
-Implementing and executing the most effective strategies for achieving desired outcomes resulting from provider and paraprofessional education;
-Designing and testing provider, paraprofessional and caregiver education model(s);
-Gaining access to representative samples of health care providers and paraprofessionals;
-Implementing a provider, paraprofessional and caregiver education program;
-Evaluating provider, paraprofessional and caregiver education programs across the full spectrum of health professions and para professions serving in primary care settings; and
-Training providers and paraprofessionals in delivering culturally and linguistically appropriate care.
For both priorities, the applicant must demonstrate that the proposed project involves a collaborative partnership with at least two partners (including the applicant), one of whom must be a:
-Federally Qualified Health Center (FQHC), community health center, or local hospital;
-State or local professional organization that represents PCPs or other health care providers, or paraprofessionals; or
-Native American tribe or tribal organization or other tribal cultural organization.
Each applicant for funding under the Lupus Program must serve as the lead agency for the project, responsible for its implementation and management; and serve as the fiscal agent for the federal grant if awarded. The applicant organization must represent a collaborative partnership that includes a variety of networks. Collaborating network partners may include, but are not limited to, community health center, local healthcare center and hospital, community center and other healthcare provider, chronic disease management program, etc.
Applicants must also have the necessary partnerships already in place to conduct the proposed intervention(s). Moreover, successful applicants will have a history of forming, managing, and engaging community and partnering organizations in the conduct of health related initiatives.
Each application must address only Priority A or Priority B, and must state whether it seeks funding for Priority A or Priority B. If multiple applications for the same project are submitted under a priority area, only the last application submitted prior to the deadline will be considered.
These demonstration grants are not intended to fund ongoing program operations or replace existing or expiring funding, but rather to test modifications or new innovative programs that are grounded in and build upon successful evidence-based programs.
The assistance or benefits of the Lupus Program may not be denied to any person based on race, sex, color, or national origin.
OMH expects that, for the project’s targeted geographic areas, the lupus intervention will result in:
-Increased number of public-private and community partnerships that promote lupus- related clinical trial education and participation programs;
-Increased use of culturally and linguistically appropriate tools, resources and materials to disseminate clinical trial information to patients and their families;
-Increased number of individuals with knowledge about lupus and its symptoms and information about participating in clinical trials; and
-Evaluation of the effectiveness of existing clinical trial education and participation programs.
-Identification of successful and effective evidence-based provider education intervention models to improve knowledge, attitudes, and practices of PCPs, other health care providers and paraprofessionals regarding minority participation in clinical trials;
-Use of experimental design to evaluate culturally and linguistically appropriate lupus clinical trial education, recruitment, and participation intervention models that focus on minority populations; and
-An action plan for disseminating the education models to increase minority populations’ participation in lupus clinical trials.
Performance Measures: Process and Outcome Measures
OMH requires that all funded projects document program progress through the use of process and outcome performance measures throughout the project’s period of performance. The process and outcome measures should be depicted in the proposed project’s logic model, and clearly align with the proposed project’s objectives, strategies and practices or activities, and long-term goals.
All projects must include process and outcome measures of implementation of the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care (National CLAS Standards). To measure the impact of implementation of the National CLAS Standards, OMH recommends use of the Consumers Assessment of Health Providers and Systems (CAHPS) Cultural Competency Item Set and/or the Experience of Care and Health Outcomes Survey.
OMH recommends the following process and outcome measures:
Priority A programs should:
(1) Foster public-private and community partnerships to address minority populations’ participation in clinical trials; evaluate the effectiveness of current clinical trial education and participation programs; and
(2) Engage the lupus community to expand the development of culturally and linguistically appropriate tools, resources, and materials geared towards adults and children affected by lupus, as well as, their caregivers and health care providers.
GrantWatch ID#: 183029
Expected Number of Awards: Up to 6 total for both Priority A and Priority B
Grant ranges are $325,000 - $375,000 for Priority A per budget period; and $425,000 - $500,000 for Priority B per budget period.
The period of performance is not to exceed 2 years. The budget period length is 12 months. The anticipated start date is July 1, 2018.
-Special district governments
-Public and State controlled institutions of higher education
-Native American tribal governments (Federally recognized)
-Public Housing authorities/Indian housing authorities
-Native American tribal organizations (other than federally recognized tribal governments)
-Nonprofits with 501(c)(3) IRS status (other than institution of higher education)
-Nonprofits without 501(c)(3) IRS status (other than institution of higher education)
-Private Institutions of higher education
-For-profit organizations (other than small business)
-Small, minority, and women-owned businesses
A technical assistance webinar for potential applicants will be held on February 7, 2018, from 3:00 PM – 4:00pm Eastern Time. In addition, a technical assistance webinar for potential applicants on “Evaluation –Review the Basics” will be held on February 8, 2018, from 3:00 PM – 4:00 PM Eastern Time.
Your application is due March 30, 2018 by 6:00 PM Eastern Time. To receive consideration, you must submit your application electronically via Grants.gov no later than this due date and time.
To ensure adequate time to successfully submit your application, HHS/OASH recommends that you register as early as possible in Grants.gov since the registration process can take up to one month. Applicants must have a DUNS number and SAM registration.
Additional Program Information:
View this opportunity on Grants.gov:
Before starting your grant application, please review the funding source's website listed below for updates/changes/addendums/conferences/LOIs.
Register for the February 7 webinar:
Register for the February 8 webinar:
Office of Grants Management:
Administrative and Budgetary Requirements:
Office of Grants Management
1101 Wootton Parkway, Suite 550
Office of Minority Health
Division of Program Operations
1101 Wootton Parkway, Suite 600
Rockville, MD 20852
Electronic Submission Requirements:
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