FY18 The National Lupus Training, Outreach, and Clinical Trial Education Program (Lupus Program)

The summary for the FY18 The National Lupus Training, Outreach, and Clinical Trial Education Program (Lupus Program) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Office of the Assistant Secretary for Health, which is the U.S. government agency offering this grant.
FY18 The National Lupus Training, Outreach, and Clinical Trial Education Program (Lupus Program): 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 bodys 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. 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. 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. 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 15. 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.
Federal Grant Title: FY18 The National Lupus Training, Outreach, and Clinical Trial Education Program (Lupus Program)
Federal Agency Name: Office of the Assistant Secretary for Health (HHS-OPHS)
Grant Categories: Health
Type of Opportunity: Discretionary
Funding Opportunity Number: MP-CPI-18-001
Type of Funding: Grant
CFDA Numbers: 93.137
CFDA Descriptions: Information not provided
Current Application Deadline: March 30th, 2018
Original Application Deadline: March 30th, 2018
Posted Date: January 8th, 2018
Creation Date: January 8th, 2018
Archive Date: April 29th, 2018
Total Program Funding:
Maximum Federal Grant Award: $375,000
Minimum Federal Grant Award: $325,000
Expected Number of Awards: 6
Cost Sharing or Matching: No
Last Updated: January 8th, 2018
Applicants Eligible for this Grant
Others (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on Eligibility
State governments County governments 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
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FY18 The National Lupus Training, Outreach, and Clinical Trial Education Program (Lupus Program)
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