Opportunity Information: Apply for RFA AI 19 005
The funding opportunity titled "HIV Prevention Clinical Trials Network Leadership and Operations Center (UM1 Clinical Trial Required)" (RFA AI 19 005) is a National Institutes of Health (NIH) cooperative agreement solicitation for an organization to serve as the Leadership and Operations Center (LOC) for the HIV Prevention Clinical Trials Network. Through the UM1 mechanism, NIH is looking for an applicant that can provide both high-level scientific direction and day-to-day operational management for a large, multi-site HIV prevention clinical trials network. The emphasis on "Clinical Trial Required" signals that the awardee is expected to be directly involved in the planning, coordination, and execution of clinical trials work, consistent with NIH expectations for networks that actively conduct and oversee clinical research rather than only providing support services.
As the network’s LOC, the successful applicant would function as the central hub responsible for overall administrative leadership and scientific leadership across the HIV Prevention Clinical Trials Network. In practical terms, this typically means coordinating network governance and decision-making structures, aligning scientific priorities with feasible trial concepts, and ensuring that multi-site studies are implemented consistently and efficiently. The LOC role generally includes developing and maintaining operational systems for trial start-up and conduct (such as protocol development workflows, site coordination, training and communications, and performance monitoring), and supporting network-wide collaboration so that trials can be launched and managed on reliable timelines. Because it is a cooperative agreement, the award is expected to involve substantial NIH programmatic involvement, meaning the NIH will be an active partner in shaping priorities and oversight rather than acting solely as a passive funder.
Eligibility is broad and includes many types of domestic U.S. organizations and governmental entities. Eligible applicants listed include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations (other than federally recognized tribal governments); public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education when applying under those nonprofit categories); for-profit organizations (other than small businesses); small businesses; and other entities that meet NIH requirements. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions. This reflects NIH’s intent to allow a wide range of institutions with the capacity to lead complex clinical research networks to compete.
Foreign eligibility is specifically limited. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply as part of the applicant organization. At the same time, the FOA allows "foreign components" as defined in the NIH Grants Policy Statement, which generally means a U.S.-based applicant can include certain international elements of the research when they are scientifically justified and structured in compliance with NIH policy, even though a foreign organization cannot serve as the prime applicant.
This opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument, reflecting the collaborative nature of NIH-run clinical trial networks. The activity area spans education, health, income security, and social services, and it is associated with CFDA numbers 93.242, 93.279, 93.855, and 93.865. The original closing date was August 1, 2019, and the FOA was created on January 24, 2019. The public summary does not specify an award ceiling or the expected number of awards in the provided source text, but the core objective is clear: NIH sought a single, capable Leadership and Operations Center to guide and run the administrative and scientific backbone of the HIV Prevention Clinical Trials Network under an active, trial-conducting UM1 cooperative agreement structure.Apply for RFA AI 19 005
- The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "HIV Prevention Clinical Trials Network Leadership and Operations Center (UM1 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.279, 93.855, 93.865.
- This funding opportunity was created on 2019-01-24.
- Applicants must submit their applications by 2019-08-01. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, 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 having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQ)
What is the official title of this funding opportunity?
The funding opportunity is titled "HIV Prevention Clinical Trials Network Leadership and Operations Center (UM1 Clinical Trial Required)." The FOA identifier provided is RFA AI 19 005.
Who is offering this grant opportunity?
This is a National Institutes of Health (NIH) funding opportunity.
What type of funding instrument is being used?
The opportunity uses a cooperative agreement. This means NIH is expected to have substantial programmatic involvement and will be an active partner in priorities and oversight rather than only serving as a passive funder.
What does UM1 mean in this context?
The opportunity uses the UM1 mechanism. Based on the provided description, NIH is seeking an applicant that can provide both high-level scientific direction and day-to-day operational management for a large, multi-site HIV prevention clinical trials network.
What does "Clinical Trial Required" mean?
"Clinical Trial Required" signals that the awardee is expected to be directly involved in the planning, coordination, and execution of clinical trials work. It is intended for networks that actively conduct and oversee clinical research, not organizations that only provide support services.
What is the main purpose of this FOA?
NIH sought an organization to serve as the Leadership and Operations Center (LOC) for the HIV Prevention Clinical Trials Network, functioning as the central hub for administrative leadership and scientific leadership across the network.
What is the Leadership and Operations Center (LOC)?
The LOC is the central hub responsible for overall administrative leadership and scientific leadership across the HIV Prevention Clinical Trials Network, including coordinating governance, aligning scientific priorities with feasible trial concepts, and ensuring multi-site studies are implemented consistently and efficiently.
What kinds of responsibilities would the LOC typically have?
Based on the provided summary, the LOC would typically be responsible for coordinating network governance and decision-making structures; aligning scientific priorities with feasible trial concepts; ensuring consistent multi-site implementation; developing and maintaining operational systems for trial start-up and conduct (for example, protocol development workflows, site coordination, training and communications, and performance monitoring); and supporting network-wide collaboration so trials can be launched and managed on reliable timelines.
How involved is NIH expected to be during the award?
Because this is a cooperative agreement, NIH is expected to be actively involved in shaping priorities and oversight, reflecting substantial NIH programmatic involvement.
Is this opportunity intended for a single central organization or multiple awardees?
The provided summary indicates NIH sought a single, capable Leadership and Operations Center to guide and run the administrative and scientific backbone of the network. The public summary does not specify the expected number of awards beyond that characterization.
What program or network is this award supporting?
This award supports the HIV Prevention Clinical Trials Network.
What is the application eligibility in general terms?
Eligibility is broad and includes many types of domestic U.S. organizations and governmental entities, as listed in the provided text.
Which U.S. government entities are eligible to apply?
Eligible applicants include state governments; county governments; city or township governments; and special district governments.
Are educational institutions eligible to apply?
Yes. Eligible applicants include independent school districts; public and state-controlled institutions of higher education; and private institutions of higher education. The FOA also highlights eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are tribal governments and tribal organizations eligible?
Yes. Eligible applicants include federally recognized Native American tribal governments and other Native American tribal organizations (other than federally recognized tribal governments). The FOA also highlights Indian/Native American tribal governments that are not federally recognized as an additional eligible category.
Are nonprofits eligible to apply?
Yes. Eligible applicants include nonprofit organizations with or without 501(c)(3) status, as long as they are not institutions of higher education when applying under those nonprofit categories.
Are for-profit organizations eligible to apply?
Yes. Eligible applicants include for-profit organizations (other than small businesses) as well as small businesses.
Are public housing authorities eligible to apply?
Yes. Eligible applicants include public housing authorities and Indian housing authorities.
Are faith-based or community-based organizations eligible to apply?
Yes. The FOA highlights faith-based or community-based organizations as an additional eligible applicant category.
Are federal agencies eligible to apply?
Yes. The FOA highlights eligible federal agencies as an additional eligible applicant category.
Are U.S. territories or possessions eligible?
Yes. The FOA highlights U.S. territories or possessions as an additional eligible applicant category.
Can a foreign (non-U.S.) organization apply as the prime applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization.
Can a non-domestic component of a U.S. organization apply as part of the applicant organization?
No. Non-domestic components of U.S. organizations are not eligible to apply as part of the applicant organization.
Does the FOA allow any international involvement at all?
Yes. While foreign organizations cannot serve as the prime applicant, the FOA allows "foreign components" as defined in the NIH Grants Policy Statement, when scientifically justified and structured in compliance with NIH policy.
What kind of funding category is this opportunity?
The opportunity is categorized as discretionary funding.
What activity areas does this FOA span?
The activity area spans education, health, income security, and social services, as stated in the provided summary.
What CFDA numbers are associated with this opportunity?
The opportunity is associated with CFDA numbers 93.242, 93.279, 93.855, and 93.865.
When was the FOA created?
The FOA was created on January 24, 2019.
What was the closing date for applications?
The original closing date was August 1, 2019.
Is there an award ceiling listed in the provided summary?
No. The public summary provided does not specify an award ceiling.
Does the provided summary state the expected number of awards?
No. The public summary provided does not specify the expected number of awards.
What is the core objective NIH was trying to achieve through this award?
The core objective described is to select a capable Leadership and Operations Center to guide and run the administrative and scientific backbone of the HIV Prevention Clinical Trials Network under an active, trial-conducting UM1 cooperative agreement structure.
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| HIV/AIDS Clinical Trials Networks Statistical and Data Management Centers (SDMC) (UM1 Clinical Trial Required) Apply for RFA AI 19 002 Funding Number: RFA AI 19 002 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| U.S.-South Africa Program for Collaborative Biomedical Research - Phase 2 (HIV/AIDS) (R01 Clinical Trial Optional) Apply for RFA AI 19 022 Funding Number: RFA AI 19 022 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $350,000 |
| U.S.-South Africa Program for Collaborative Biomedical Research - Phase 2 (HIV/AIDS) (U01 Clinical Trial Optional) Apply for RFA AI 19 023 Funding Number: RFA AI 19 023 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $250,000 |
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| Brain Initiative: Research to Develop and Validate Advanced Human Cell-Based Assays To Model Brain Structure and Function (R01 Clinical Trial Not Allowed) Apply for RFA MH 20 140 Funding Number: RFA MH 20 140 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $500,000 |
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| BRAIN Initiative: Proof of Concept Development of Early Stage Next Generation Human Brain Imaging (R01 Clinical Trial Not Allowed) Apply for RFA EB 19 001 Funding Number: RFA EB 19 001 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $300,000 |
| BRAIN Initiative: Development of Next Generation Human Brain Imaging Tools and Technologies (U01 Clinical Trial not allowed) Apply for RFA EB 19 002 Funding Number: RFA EB 19 002 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
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| Clinical Sites for the ECHO IDeA States Pediatric Clinical Trials Network - 2 (UG1 Clinical Trial Required) Apply for RFA OD 19 026 Funding Number: RFA OD 19 026 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $275,000 |
| Small Research Grants for Analyses of Gabriella Miller Kids First Pediatric Research Data (R03 Clinical Trial Not Allowed) Apply for PAR 19 375 Funding Number: PAR 19 375 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $200,000 |
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| Research on biopsychosocial factors of social connectedness and isolation on health, wellbeing, illness, and recovery (R01 Basic Experimental Studies with Humans Required) Apply for PAR 19 384 Funding Number: PAR 19 384 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
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| HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed) Apply for RFA NS 20 011 Funding Number: RFA NS 20 011 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Pediatric HIV/AIDS Cohort Study (PHACS) 2020 (P01 Clinical Trial Not Allowed) Apply for RFA HD 20 002 Funding Number: RFA HD 20 002 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $12,000,000 |
| BRAIN Initiative Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00 Independent Clinical Trial Not Allowed) Apply for RFA NS 19 043 Funding Number: RFA NS 19 043 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
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