Opportunity Information: Apply for MP CPI 18 001
The FY18 National Lupus Training, Outreach, and Clinical Trial Education Program is a discretionary federal grant opportunity from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Health (CFDA 93.137), focused on improving lupus-related education and strengthening equitable participation in clinical trials. The program is grounded in the reality that lupus is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues, causing inflammation and potential damage across multiple organs and body systems. The opportunity highlights systemic lupus erythematosus (SLE) as the most common form, noting that it can affect the skin, joints, kidneys, brain, lungs, blood vessels, and other organs. While treatment and disease management have improved, the cause remains unknown and there is still no cure, which makes research participation and effective clinical care education especially important.
A major emphasis of the grant is the disproportionate burden of SLE on racial and ethnic minority populations and the way that burden intersects with persistent underrepresentation in clinical trials. The notice points out that lupus is substantially more common among African Americans (reported as two to three times more common than in other groups), and that American Indians and Alaska Natives may have rates similar to or higher than African Americans, with Hispanics and Asians also significantly affected. It also stresses that women of childbearing age (roughly 15 to 44) are at the highest risk for disease onset and that women are affected far more often than men, cited as an estimated 12 to 1 ratio. Pediatric lupus is also specifically called out as a serious concern: reported prevalence for children ranges from 3.3 to 24.0 per 100,000 in the U.S., and about 10 to 20 percent of SLE diagnoses occur during childhood or adolescence, with pediatric-onset disease often being more severe and associated with faster accumulation of organ or tissue damage than adult-onset SLE.
The core problem the grant seeks to address is not only lupus education, but the structural and practical barriers that prevent minority communities from being recruited, enrolled, and retained across all phases of clinical trials. The opportunity explains that, despite decades of national effort, minority participation remains uneven and often drops off in later trial phases, which raises concerns about whether research findings generalize to the populations most affected by lupus and whether treatment advances will reduce or widen existing health disparities. The notice ties low participation to multiple recurring barriers documented in the literature: mistrust of the medical and research system (including mistrust connected to historical misconduct), limited access to affordable and continuous health care, transportation challenges that make participation difficult, gaps in patient understanding of what clinical trials are and why they matter, uncertainty about risks and benefits as presented in recruitment and consent materials, and the added challenge of reaching people with Limited English Proficiency when study materials and consent forms are not translated or culturally accessible.
The opportunity also underscores the role of health care providers and health systems in either enabling or constraining trial participation. It notes that providers are central messengers for lupus information and referrals, yet implicit bias and stereotypes can lead to fewer trial discussions or referrals for minority patients, sometimes based on assumptions about adherence to complex research protocols. Alongside patient-facing education, the grant framing suggests that improving provider practices, referral behaviors, and trust-building approaches is part of the pathway to better enrollment and retention. It references a multilevel, systems-based approach (attributed to Hamel et al.) in which institutions increase minority participation by building trusted community partnerships and strengthening relationships with local providers who primarily serve minority communities, with the broader goal of sustained community engagement rather than one-time recruitment efforts.
Administratively, the grant is listed as a discretionary award using the grant funding instrument, with an award ceiling of $375,000, an anticipated six awards, and a closing date of March 30, 2018 (created January 4, 2018). Eligibility is described broadly as "Others" with additional clarification expected in the full eligibility text. In practical terms, the program is aimed at supporting training and outreach efforts plus clinical trial education models that meaningfully increase awareness, trust, referrals, enrollment, and retention of diverse lupus patients in clinical research, thereby improving the quality and representativeness of lupus research and helping address persistent disparities in outcomes and access to advances in care.Apply for MP CPI 18 001
- The Department of Health and Human Services, Office of the Assistant Secretary for Health in the health sector is offering a public funding opportunity titled "FY18 The National Lupus Training, Outreach, and Clinical Trial Education Program (Lupus Program)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.137.
- This funding opportunity was created on Jan 04, 2018.
- Applicants must submit their applications by Mar 30, 2018 No Explanation. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $375,000.00 in funding.
- The number of recipients for this funding is limited to 6 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs): FY18 National Lupus Training, Outreach, and Clinical Trial Education Program (CFDA 93.137)
1. What is the FY18 National Lupus Training, Outreach, and Clinical Trial Education Program?
It is a discretionary federal grant opportunity from the U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Health, identified under CFDA 93.137. The program focuses on lupus-related training and outreach, with a strong emphasis on clinical trial education and improving equitable participation in lupus clinical research.
2. What is the main goal of this grant opportunity?
The central goal is to improve lupus education and to strengthen awareness, trust, referrals, enrollment, and retention of diverse lupus patients in clinical trials. The opportunity is designed to help ensure lupus research findings are more representative of the populations most affected and to reduce, rather than widen, existing health disparities.
3. Why does the program emphasize clinical trial education?
The notice highlights that the cause of lupus remains unknown and there is still no cure. Because research participation is essential to advancing treatment and care, the program prioritizes education models that help people understand what clinical trials are, why they matter, and how to navigate participation.
4. Which form of lupus is specifically highlighted in the opportunity?
The opportunity specifically calls out systemic lupus erythematosus (SLE) as the most common form of lupus. It notes that SLE can affect multiple organs and body systems, including the skin, joints, kidneys, brain, lungs, blood vessels, and other organs.
5. Why does the notice focus on racial and ethnic minority populations?
Because SLE places a disproportionate burden on racial and ethnic minority populations, while those same communities remain persistently underrepresented in clinical trials. The notice raises concerns that uneven participation can limit whether findings generalize to the populations most affected and can influence whether advances in treatment reduce or widen disparities.
6. What does the opportunity say about lupus prevalence across racial and ethnic groups?
The notice states that lupus is substantially more common among African Americans, reported as two to three times more common than in other groups. It also notes that American Indians and Alaska Natives may have rates similar to or higher than African Americans, and that Hispanics and Asians are also significantly affected.
7. Who is at the highest risk for lupus onset, according to the notice?
The opportunity stresses that women of childbearing age (approximately ages 15 to 44) are at the highest risk for disease onset. It also notes that women are affected far more often than men, cited as an estimated 12 to 1 ratio.
8. Does the opportunity address pediatric lupus?
Yes. Pediatric lupus is specifically identified as a serious concern. The notice reports U.S. prevalence estimates for children ranging from 3.3 to 24.0 per 100,000, and notes that about 10 to 20 percent of SLE diagnoses occur during childhood or adolescence.
9. How does pediatric-onset lupus compare to adult-onset lupus in the notice?
The notice indicates that pediatric-onset disease is often more severe and is associated with faster accumulation of organ or tissue damage than adult-onset SLE.
10. What problem is the grant trying to solve besides general lupus education?
Beyond education, the grant targets structural and practical barriers that prevent minority communities from being recruited, enrolled, and retained across all phases of clinical trials. The notice emphasizes that minority participation often drops off in later phases of trials.
11. What barriers to minority participation in clinical trials are identified in the opportunity?
The notice links low participation to recurring barriers documented in the literature, including mistrust of the medical and research system (including mistrust connected to historical misconduct), limited access to affordable and continuous health care, transportation challenges, gaps in patient understanding of clinical trials, uncertainty about risks and benefits as presented in recruitment and consent materials, and difficulties reaching people with Limited English Proficiency when materials and consent forms are not translated or culturally accessible.
12. How does mistrust factor into clinical trial participation, according to the notice?
The opportunity notes that mistrust of the medical and research system is a documented barrier, including mistrust tied to historical misconduct. This mistrust can reduce willingness to consider enrollment and can affect retention over time.
13. What role do transportation and access to health care play in trial participation?
The notice identifies transportation challenges and limited access to affordable and continuous health care as practical barriers that can make it difficult for patients to join a study, attend visits, and remain in a trial through later phases.
14. How does Limited English Proficiency (LEP) affect enrollment and retention?
The opportunity points out that people with Limited English Proficiency can be harder to reach and support when study materials and consent forms are not translated or are not culturally accessible, which can reduce understanding and informed participation.
15. What does the notice say about the role of health care providers in clinical trial participation?
The notice emphasizes that providers are central messengers for lupus information and referrals. It also warns that implicit bias and stereotypes may lead to fewer trial discussions or referrals for minority patients, including assumptions about adherence to complex research protocols.
16. Why does the opportunity mention implicit bias in provider referral practices?
Because the notice frames provider behavior as a factor that can enable or constrain trial participation. If trial discussions or referrals happen less often for minority patients due to bias or stereotypes, enrollment and retention can be negatively impacted even when patients might otherwise be eligible and interested.
17. What approach does the opportunity suggest for improving minority participation in clinical trials?
The notice references a multilevel, systems-based approach (attributed to Hamel et al.), where institutions increase minority participation by building trusted community partnerships and strengthening relationships with local providers who primarily serve minority communities. The emphasis is on sustained community engagement rather than one-time recruitment.
18. What kinds of activities is this grant intended to support?
Based on the framing in the notice, the program is aimed at supporting training and outreach efforts plus clinical trial education models that meaningfully increase awareness, trust, referrals, enrollment, and retention of diverse lupus patients in clinical research.
19. What is the funding instrument and award type for this opportunity?
The opportunity is described as a discretionary award using the grant funding instrument.
20. What is the maximum award amount (award ceiling)?
The award ceiling is listed as $375,000.
21. How many awards are anticipated?
The notice indicates that approximately six awards are anticipated.
22. What are the key dates listed for the opportunity?
The opportunity was created on January 4, 2018, and the closing date is March 30, 2018.
23. Who is eligible to apply, based on the information provided?
Eligibility is described broadly as "Others," with additional clarification expected in the full eligibility text. The summary provided does not list specific eligible organization types beyond that label.
24. Which federal office is sponsoring this lupus-focused grant?
The sponsoring entity is the U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Health.
25. How does this program connect clinical trial participation to health equity?
The notice links equitable trial participation to whether research findings generalize to the populations most affected by lupus and whether treatment advances will reduce or widen disparities. By improving awareness, trust, referrals, enrollment, and retention among underrepresented groups, the program aims to strengthen the quality and representativeness of lupus research.
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