Opportunity Information: Apply for RFA CA 14 502
Apply for RFA CA 14 502
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Limited Competition AIDS Malignancy Clinical Trials Consortium (UM1)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393 Cancer Cause and Prevention Research 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research 93.396 Cancer Biology Research.
- This funding opportunity was created on Aug 8, 2014 and posted on Aug 8, 2014.
- Applicants must submit their applications by Jan 6, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $21,400,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $21,400,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following Only the current awardees of the AIDS Malignancy Consortium are eligible to apply to this FOA.
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Opportunity Summary:
This funding opportunity, RFA-CA-14-502, is a limited-competition NIH cooperative agreement (UM1) intended to continue support for the AIDS Malignancy Consortium (AMC). The AMC is a coordinated clinical trials network focused on cancers that occur in people living with HIV, including both AIDS-defining malignancies and other cancers that are increasingly important as HIV patients live longer with effective antiretroviral therapy. Because it is a limited competition, only the current AMC awardees are eligible to apply, and NIH expects to make a single award.
The core purpose of the award is to sustain and advance a clinical-trials-driven research program that improves prevention and treatment of HIV-associated cancers. The FOA emphasizes five main areas of work: first, the design, development, and evaluation of clinical interventions aimed at preventing and treating malignancies in HIV-infected patients; second, the development of better clinical management strategies and therapeutics specifically tailored to HIV-associated malignancies; third, investigation of the biology of these cancers within the context of clinical trials, meaning that trials are not only testing treatments but also collecting biologic and clinical data to understand mechanisms, predictors of response, and disease behavior; fourth, addressing issues of international importance in HIV-associated malignancies, reflecting that cancer burdens, co-infections, and access to diagnostics and therapies can differ substantially across regions; and fifth, ensuring that excess tumor tissue and other relevant biologic fluids generated through consortium studies are distributed to the AIDS and Cancer Specimen Resource so they can be used for ongoing and future research beyond the immediate trials.
A specific expectation in this funding period is continued development and execution of the ANCHOR study, which focuses on treating anal cancer high-grade squamous intraepithelial lesions (HSIL) to reduce progression to anal cancer. The FOA notes that the initiation of ANCHOR during the prior funding period relied on supplemental funds, and the consortium is now expected to carry that work forward as part of its broader mission. This highlights a practical priority of the program: running large, definitive, clinically meaningful trials in areas where cancer prevention in HIV populations can have clear public health impact.
Structurally, the consortium is designed as an integrated network with defined components that collectively support multicenter clinical research. It includes a coordinating center to manage network operations and trial execution, multiple clinical trial sites where patients are enrolled and treated, network laboratories to support standardized testing and translational assays, and a statistical center responsible for trial design support, data management, and analysis. The FOA also requires at least four disease-oriented scientific Working Groups, which organize the research agenda and trial concepts in key areas: a Kaposi sarcoma Working Group, a lymphoma Working Group, a Working Group focused on human papillomavirus (HPV)-associated cancers (consistent with ANCHOR and other HPV-related malignancy priorities), and a Working Group for non-AIDS-defining cancers, acknowledging the expanding spectrum of malignancies affecting people with HIV.
From an administrative and funding standpoint, this is a discretionary NIH opportunity under the cooperative agreement mechanism, which typically means NIH staff have substantial programmatic involvement compared to a standard research project grant. The total estimated funding and the award ceiling are both listed as $21.4 million, with no cost sharing or matching requirement. The opportunity was posted August 8, 2014, with an application closing date of January 6, 2015, and it is now archived. The CFDA listings associated with the FOA span cancer cause and prevention, detection and diagnosis, treatment, and biology, reflecting the consortiums end-to-end clinical and translational scope rather than a narrow focus on a single research category.
Overall, the opportunity is essentially a continuation award framework for an established, specialized clinical trials consortium: it supports infrastructure plus a coordinated portfolio of HIV-cancer intervention trials, embeds translational biology into clinical studies, maintains a commitment to internationally relevant research questions, and formalizes biospecimen sharing so that materials collected through trials can generate additional scientific value over time.
Frequently Asked Questions (FAQs): RFA-CA-14-502 (AIDS Malignancy Consortium continuation, UM1)
1) What is RFA-CA-14-502?
RFA-CA-14-502 is an NIH funding opportunity announcement for a limited-competition cooperative agreement (UM1) to continue support for the AIDS Malignancy Consortium (AMC), a coordinated clinical trials network focused on cancers occurring in people living with HIV.
2) What is the AIDS Malignancy Consortium (AMC)?
The AMC is a coordinated, multicenter clinical trials network that studies prevention and treatment strategies for HIV-associated cancers. Its scope includes AIDS-defining malignancies and other cancers that are becoming more prominent as people with HIV live longer due to effective antiretroviral therapy.
3) What is the main purpose of this award?
The core purpose is to sustain and advance a clinical-trials-driven research program aimed at improving prevention and treatment of HIV-associated malignancies, while also embedding biologic and clinical discovery within the conduct of those trials.
4) Is this opportunity open competition?
No. This is a limited-competition opportunity. Only the current AMC awardees are eligible to apply.
5) How many awards does NIH expect to make?
NIH expects to make a single award under this funding opportunity.
6) What funding mechanism is used?
The opportunity uses the NIH cooperative agreement mechanism (UM1), which generally includes substantial programmatic involvement by NIH staff compared with a standard research project grant.
7) What is the total estimated funding and award ceiling?
The total estimated funding is listed as $21.4 million, and the award ceiling is also listed as $21.4 million.
8) Is cost sharing or matching required?
No. The announcement specifies no cost sharing or matching requirement.
9) What are the key scientific and programmatic areas emphasized in the FOA?
The FOA emphasizes five main areas:
- Design, development, and evaluation of clinical interventions to prevent and treat malignancies in HIV-infected patients.
- Development of improved clinical management strategies and therapeutics tailored to HIV-associated malignancies.
- Investigation of cancer biology within the context of clinical trials by collecting biologic and clinical data to understand mechanisms, predictors of response, and disease behavior.
- Addressing issues of international importance in HIV-associated malignancies, recognizing regional differences in cancer burden, co-infections, and access to diagnostics and therapies.
- Distribution of excess tumor tissue and relevant biologic fluids generated through consortium studies to the AIDS and Cancer Specimen Resource for broader ongoing and future research use.
10) What types of cancers are within scope for the AMC work supported by this FOA?
The scope includes cancers occurring in people living with HIV, spanning both AIDS-defining malignancies and non-AIDS-defining cancers that have become increasingly important as survival improves with antiretroviral therapy.
11) What is the ANCHOR study and how does it relate to this funding opportunity?
A specific expectation for this funding period is continued development and execution of the ANCHOR study. ANCHOR focuses on treating anal cancer high-grade squamous intraepithelial lesions (HSIL) to reduce progression to anal cancer. The FOA notes ANCHOR was initiated in the prior period using supplemental funds, and the consortium is expected to carry it forward as part of its broader mission.
12) Why does the FOA highlight ANCHOR as a priority?
The FOA uses ANCHOR to underscore a practical priority of the program: conducting large, definitive, clinically meaningful trials in areas where prevention in HIV populations can yield clear public health impact.
13) How is the consortium structured to support multicenter clinical trials?
The AMC is described as an integrated network with defined components supporting multicenter clinical research, including:
- A coordinating center to manage network operations and trial execution.
- Multiple clinical trial sites where patients are enrolled and treated.
- Network laboratories to support standardized testing and translational assays.
- A statistical center responsible for trial design support, data management, and analysis.
14) Are Working Groups required under this FOA?
Yes. The FOA requires at least four disease-oriented scientific Working Groups to organize the research agenda and trial concepts.
15) What Working Groups are specified?
The FOA specifies the following Working Groups:
- Kaposi sarcoma Working Group
- Lymphoma Working Group
- HPV-associated cancers Working Group (aligned with ANCHOR and other HPV-related priorities)
- Non-AIDS-defining cancers Working Group
16) What does it mean that the FOA embeds translational biology into clinical trials?
It means the trials are expected to do more than test interventions. They also collect biologic and clinical data to improve understanding of mechanisms, predictors of response, and disease behavior in HIV-associated cancers.
17) What does the FOA require regarding biospecimen sharing?
The FOA requires that excess tumor tissue and other relevant biologic fluids generated through consortium studies be distributed to the AIDS and Cancer Specimen Resource, enabling additional research beyond the immediate clinical trials.
18) Does the FOA address international research needs?
Yes. One of the emphasized areas is addressing issues of international importance in HIV-associated malignancies, reflecting that cancer burden, co-infections, and access to diagnostics and therapies can vary substantially across regions.
19) When was this opportunity posted and when did it close?
The opportunity was posted on August 8, 2014, and the application closing date was January 6, 2015.
20) Is this funding opportunity still active?
No. The opportunity is described as archived.
21) What general research categories (CFDA areas) are associated with this FOA?
The CFDA listings associated with the FOA span cancer cause and prevention, detection and diagnosis, treatment, and biology, reflecting an end-to-end clinical and translational scope.
22) In practical terms, what does this FOA support?
Based on the description provided, it supports both (1) consortium infrastructure (coordinating center, trial sites, laboratories, statistical center, and Working Groups) and (2) a coordinated portfolio of HIV-cancer intervention trials that include biologic discovery, international relevance, and formalized biospecimen sharing.
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