Administrative Supplements for P30 Cancer Centers Support Grants (CCSG) to Stimulate Research in Non-AIDS Defining Cancers (NADCs) in Aging Populations
Key Dates
Release Date: January 9, 2020
Request Receipt Due: March 31, 2020
Earliest Anticipated Start Date for Awards: July 1, 2020
Purpose
The National Cancer Institute (NCI) announces an opportunity for supplemental funding to stimulate research in non-AIDS defining cancers (NADCs) among aging HIV+ individuals via support of pilot projects at NCI-designated Cancer Centers (CC). Findings from this supplement are aimed to expand our knowledge of the impact of aging on the pathogenesis of NADCs.
All NCI-Designated Cancer Centers are eligible for funding. A letter of intent is not required; a full proposal of no more than 6 pages must be submitted by the request receipt date to the NCI Office of Cancer Centers. Funding is contingent upon NCI approval of the proposal, which will include both a scientific and budgetary evaluation. Only one supplement will be allowed per institution. These administrative supplements are designed to address focused areas of challenge such as pattern, natural history, and optimization of treatment of NADCs occurring in aging HIV+ individuals.
Background
The number of older individuals living with HIV/AIDS has risen dramatically over the last decade. In 2016, nearly half of HIV+ people in the United States (US) were aged 50 and older. Though new HIV diagnoses are declining among people aged 50 and older, around 1 in 6 HIV diagnoses in 2017 were in this group. Older people are more likely than younger people to have late-stage HIV infection at the time of diagnosis, which means they start treatment late and possibly suffer more immune-system damage. The introduction and widespread use of combination antiretroviral therapy (cART) in the mid-1990s has dramatically improved the health outcomes of HIV+ individuals, leading to decreases in AIDS-defining cancers such as Kaposi’s sarcoma and non-Hodgkin’s lymphoma. However, the longer life expectancy now observed in these individuals has led to the increased incidence of diseases with a longer latency period, such as NADCs. NADCs now account for 50% of all cancers among HIV+ individuals. The incidence and mortality from NADC in HIV+ individuals > 50 years of age have not been extensively studied; however, some studies have shown an increased incidence in liver, bladder, lung, and Hodgkin’s lymphoma.
It has become apparent that individuals living with prolonged HIV infection exhibit many of the clinical characteristics commonly observed in aging, such as multiple co-morbidities, polypharmacy, physical and cognitive impairment, functional decline, alterations in body composition, and increased vulnerability to stressors. Moreover, the clinical picture of HIV in older adults may be complicated by many other risk factors, including infections with oncogenic viruses (e.g., human papillomavirus [HPV], Kaposi-sarcoma associated herpesvirus [KSHV/HHV-8], Epstein-Barr virus [EBV], hepatitis B virus [HBV], and hepatitis C virus [HCV]), obesity, and substance abuse including nicotine, alcohol, marijuana, and prescription drugs. Also, people living with HIV(PLWH) on cART often have a degree of immunologic impairment and chronic immune activation, even when their CD4 count is normal. Aging itself is associated with immunologic impairment, and it is unclear how these factors interact in aging PLWH. As such, improved management of older individuals with HIV will require a much deeper understanding of the interface between aging, HIV, associated co-morbid conditions, and concurrent treatment.
Scope
Specific areas of study may include, but are not limited to, the following examples:
• Biology of Aging and Cancer
• Effects of comorbidities (consequences of the aging process and/or the progression of HIV/AIDS)
• Effects of polypharmacy including antiretroviral therapy on treatment of NADCs
• Treatment efficacy and tolerance
• Cancer control for early detection, diagnosis, prevention, treatment, prognosis and survivorship
Eligible Institutions
Cancer Centers whose P30 CCSG will be in a cost-extension at the time the award is made in FY20 are not eligible for this supplement.
Number of Applications
Only one application per institution is allowed. Each application must include a cover letter from the NCI-Cancer Center Director with concurrence from the Authorized
Organization Official (AOR).
Letter of Intent
A letter of intent is not required for this supplement.
Terms and Conditions of Funding and Allowable Costs
The budget should justify all the direct and indirect costs. Supplements are for 2 years only, although a one-year no-cost extension will be allowed. We anticipate that up to 8 to 9 awards of no more than $250,000 total cost each will be made in the 2020 fiscal year. Any proposal that cannot be completed within the 2-year time frame will be viewed as non-responsive. Allowable costs include funding for the Project Leader of the study (maximum of 20% effort), who must be a member of the NCI-designated cancer center; funding for required expertise to complete this project; and costs for supplies. The purchase of large pieces of equipment through this supplement will not be permitted.
Supplement Award Application Procedures
1. Cover Letter
A cover letter should accompany each application and include the following:
a. Request for an administrative supplement to support the project
b. Title of the supplement
c. P30 grant number
d. Contact information for the Cancer Center Director and the Project Leader
e. Signatures of the Cancer Center Director and the Authorized Organization Representative (AOR)
2. Application
a. Standard PHS 398 (pages: 1-5)
i. Item 2: check yes and provide the title indicated in the cover letter, 1.b.
ii. Item 7A-8B, denote the direct and total costs for the project.
iii. The AOR must sign the face page.
iv. Include a detailed budget description.
v. Provide NIH biographical sketches for the P30 Principal Investigator and the Project Leader.
3. Summary of the Project Proposed
The applicant should attach a summary of the project including a description of aims; specific approach to be used to complete this project; investigators; and environment where the work will be performed. A full budget with justification should be included. A statement of how the proposed project would meet the NIH HIV/AIDS Research Priorities as listed in the NOT-OD-15-137. It should explain which high priority topic or topics will be addressed. General projects focusing, for example, on EBV, HPV, KSHV or other oncogenic viruses or HIV alone are not eligible for support under this supplement award.
4. Justification of Staff
Provide NIH biographical sketches of all key personnel.
Note that in order to qualify for a supplement, the name of the Project Leader must be proposed at the time of submission.
Application Submission
Applications may be submitted as a signed, scanned PDFs to Ms. Nga Nguyen at nga.nguyen2@nih.gov by 5:00 p.m. (local time) on the receipt date.
Evaluation Criteria
Supplements will be administratively evaluated by NCI staff with appropriate expertise. There will not be a secondary review process.
Awards
Awards will be based on responsiveness to the goals of this announcement and the availability of funds.
Reporting Requirements
As part of the annual progress report of the parent NCI Cancer Center Support Grants include information on what has been accomplished via the administrative supplement during the funding period. A copy of the annual progress report for the administrative supplement should also be sent to Dr. Hasnaa Shafik by email at shafikh@mail.nih.gov.
Questions
Please contact Dr. Hasnaa Shafik (telephone: 240-276-5600; Email: shafikh@mail.nih.gov) for questions related to the supplement.