Opportunity Information: Apply for RFA AI 10 030
Apply for RFA AI 10 030
- The National Institutes of Health in the education health income security and social services sector is offering a public funding opportunity titled "International Epidemiologic Databases to Evaluate AIDS (IeDEA) (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394 Cancer Detection and Diagnosis Research 93.855 Allergy, Immunology and Transplantation Research 93.856 Microbiology and Infectious Diseases Research 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Aug 5, 2010 and posted on Aug 5, 2010.
- Applicants must submit their applications by Nov 10, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $10,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) State governments Public and State controlled institutions of higher education Independent school districts Private institutions of higher education Special district governments Small businesses City or township governments County governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The International Epidemiologic Databases to Evaluate AIDS (IeDEA) (U01) opportunity (Funding Opportunity Number RFA-AI-10-030) is a National Institutes of Health (NIH) cooperative agreement solicitation led by the National Institute of Allergy and Infectious Diseases (NIAID), with participation from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Cancer Institute (NCI). The central goal is to continue and expand the IeDEA Program, a long-running international effort that organizes large, multi-country observational HIV datasets so researchers can answer major real-world questions about HIV/AIDS outcomes, care, and health systems performance. Rather than focusing on a single clinical trial, this program emphasizes strengthening and using regional clinical and research databases to support population-level and patient-level epidemiology across diverse settings, including low- and middle-income contexts where routine clinical data can be especially valuable for understanding how HIV care works outside tightly controlled research environments.
A defining feature of IeDEA is its structure: the program is built around regional data centers, with up to seven regional awards expected under this announcement, plus a separate coordinating award to support network-wide integration. Each regional data center is meant to bring together clinical sites and existing data resources within a geographic area, then curate, manage, and analyze those data to address priority scientific questions. The cooperative agreement (U01) mechanism signals that NIH is not simply providing funds and stepping back; instead, the agency anticipates substantial scientific and programmatic involvement, including coordination across regions, shared standards, and collaborative planning to ensure that the combined network produces broadly useful, high-quality evidence.
Although HIV/AIDS is the primary focus, the FOA explicitly recognizes that HIV does not occur in isolation. NIAID highlights strong interest in co-occurring and intersecting conditions that shape outcomes in communities affected by HIV, including tuberculosis (TB), malaria, and the ways HIV influences cancer incidence, prevalence, and the spectrum of malignancies. More broadly, the program is framed to support research on other infectious diseases among adults and children in HIV-affected communities, described in the announcement as HTMCO (HIV/TB, malaria, cancer, and other infectious diseases). In practical terms, this means applicants are expected to design data resources and analytic plans that can evaluate not only HIV treatment and outcomes, but also co-infections, comorbidities, and long-term complications that have become increasingly important as people with HIV live longer on antiretroviral therapy.
The scientific work IeDEA aims to enable spans multiple applied research domains. The FOA emphasizes HIV/AIDS clinical epidemiology, comparative effectiveness research (understanding how different care strategies perform in typical practice settings), implementation science (studying how best to deliver and scale effective interventions), and cost-effectiveness analyses (linking outcomes to resource use and costs). By combining data from different health systems, countries, and patient populations, IeDEA is intended to produce evidence that is more generalizable than single-site studies and more sensitive to how context influences outcomes. The underlying idea is that harmonized, multi-setting observational data can help define and monitor epidemics more accurately and can answer time-sensitive policy and program questions that are difficult to study through randomized trials alone.
A major operational and methodological aim of the FOA is improving data quality through common methods and standards. IeDEA is expected to facilitate the development of approaches for data collection, data harmonization, and consistent variable definitions across participating sites and countries. This includes strengthening local observational databases so they are more complete, more comparable, and more usable for research while still reflecting routine clinical reality. The program also has an explicit capacity-building dimension: by improving local data systems and strengthening analytic and informatics expertise, the effort should increase scientific capacity in participating regions and create a foundation for future collaborations that extend beyond a single grant cycle.
The FOA also calls attention to advanced analytics, noting the intent to expand and support complex statistical methods appropriate for large observational datasets. This reflects common challenges in real-world clinical data, such as missingness, confounding, changes in treatment guidelines over time, differences in measurement practices across sites, and the need for scalable methods that can handle very large, heterogeneous cohorts. IeDEA is positioned not only to apply existing methods, but also to push the field forward in innovative ways by developing and validating analytic approaches suited to global observational HIV research. Importantly, the announcement notes that while HIV/AIDS is the central focus, the methods and harmonization products developed through IeDEA are expected to be useful for other infectious disease research areas as well.
From a funding and timeline perspective, NIH anticipated committing about USD 10.5 million in fiscal year 2011 to support up to seven regional data centers plus one coordinating award. Applicants were allowed to request project periods of up to five years. The announcement was posted on August 5, 2010, with an original and current closing date of November 10, 2010, and an archive date of December 11, 2010. The opportunity is categorized as discretionary funding and uses the cooperative agreement instrument. The CFDA numbers listed include 93.394 (Cancer Detection and Diagnosis Research), 93.855 (Allergy, Immunology and Transplantation Research), 93.856 (Microbiology and Infectious Diseases Research), and 93.865 (Child Health and Human Development Extramural Research). No cost sharing or matching requirement is indicated.
Eligibility for this FOA is broad and includes many types of U.S. and non-U.S. organizations, reflecting the international scope of IeDEA. Eligible applicants listed include federal, state, county, city or township governments; public and private institutions of higher education; nonprofits (including those with and without 501(c)(3) status, other than higher education institutions); for-profit organizations (including small businesses and other for-profits); independent school districts; special district governments; public housing authorities/Indian housing authorities; Native American tribal governments and organizations; and a range of mission-specific institutional categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. The inclusion of non-domestic (non-U.S.) entities underscores that foreign organizations could apply, consistent with the goal of building strong regional data centers in the locations most affected by HIV and related diseases.
Overall, this IeDEA (U01) funding opportunity is essentially a call to sustain and grow an international, regionally organized data infrastructure that turns routine clinical and research data into actionable evidence about HIV and key related conditions like TB, malaria, and cancer. It emphasizes harmonized data standards, strong analytic capability, and collaborative network governance so that regional findings can be compared and combined, ultimately improving the ability to track epidemics, evaluate care strategies in real-world settings, and support better health outcomes for adults and children in communities heavily affected by HIV/AIDS.
Frequently Asked Questions (FAQs)
1) What is the IeDEA (U01) funding opportunity?
The International Epidemiologic Databases to Evaluate AIDS (IeDEA) (U01) opportunity is an NIH cooperative agreement solicitation (Funding Opportunity Number RFA-AI-10-030) focused on continuing and expanding a long-running international program that organizes large, multi-country observational HIV datasets. The aim is to enable researchers to answer major real-world questions about HIV/AIDS outcomes, care, and health systems performance using routinely collected clinical and research data.
2) Which NIH institute is leading this solicitation, and who else is participating?
The solicitation is led by the National Institute of Allergy and Infectious Diseases (NIAID), with participation from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Cancer Institute (NCI).
3) What is the central goal of the IeDEA Program under this FOA?
The central goal is to sustain, strengthen, and expand the IeDEA Program as an international, regionally organized data infrastructure. The program is intended to curate, manage, harmonize, and analyze observational data so the network can produce high-quality, broadly useful evidence about HIV and related conditions across diverse real-world settings.
4) Is this opportunity focused on clinical trials?
No. The program emphasis is on observational epidemiology using large clinical and research databases rather than a single clinical trial. The focus is on population-level and patient-level analyses that reflect routine clinical reality, including in low- and middle-income contexts.
5) What does it mean that this is a cooperative agreement (U01)?
A cooperative agreement (U01) indicates that NIH anticipates substantial scientific and programmatic involvement. This includes coordination across regions, shared standards, collaborative planning, and network-wide integration so that the combined program produces high-quality evidence that can be compared and combined across regions.
6) How is the IeDEA program structured under this announcement?
The program is structured around regional data centers. Under this announcement, NIH expected to support up to seven regional awards, plus a separate coordinating award to support network-wide integration.
7) What is the role of a regional data center?
Each regional data center is expected to bring together clinical sites and existing data resources within a geographic area, then curate, manage, harmonize, and analyze those data to address priority scientific questions. Regional centers are also part of a coordinated network that uses shared methods and standards.
8) What is the purpose of the separate coordinating award?
The coordinating award is intended to support network-wide integration. Based on the FOA description, this includes facilitating coordination across regions, supporting shared standards, and helping ensure that the network functions as a cohesive program rather than as disconnected regional projects.
9) What disease areas are included besides HIV/AIDS?
While HIV/AIDS is the primary focus, the FOA explicitly highlights co-occurring and intersecting conditions that shape outcomes in HIV-affected communities. These include tuberculosis (TB), malaria, and cancers (including how HIV influences cancer incidence, prevalence, and the spectrum of malignancies). The FOA also frames the program to support other infectious diseases among adults and children in HIV-affected communities, described as HTMCO (HIV/TB, malaria, cancer, and other infectious diseases).
10) What kinds of research questions is IeDEA intended to support?
The program is designed to support major applied research domains using multi-setting observational data, including:
- HIV/AIDS clinical epidemiology
- Comparative effectiveness research (how different care strategies perform in typical practice settings)
- Implementation science (how to deliver and scale effective interventions)
- Cost-effectiveness analyses (linking outcomes to resource use and costs)
11) Why does the FOA emphasize multi-country, multi-setting observational data?
The FOA positions harmonized observational data as a way to produce evidence that is more generalizable than single-site studies and more sensitive to how context influences outcomes. By combining information across different health systems, countries, and populations, the network can address time-sensitive policy and program questions that may be difficult to study with randomized trials alone.
12) What are the expectations around data harmonization and standards?
A major operational and methodological aim is improving data quality through common methods and standards. The program is expected to facilitate approaches for data collection, data harmonization, and consistent variable definitions across participating sites and countries, strengthening local observational databases so they are more complete, comparable, and usable for research.
13) Does the FOA include capacity building?
Yes. The FOA describes an explicit capacity-building dimension, including improving local data systems and strengthening analytic and informatics expertise. The intent is to increase scientific capacity in participating regions and lay groundwork for future collaborations beyond a single grant cycle.
14) What methodological challenges does the FOA anticipate, and how does it address them?
The FOA notes an intent to expand and support complex statistical methods appropriate for large observational datasets. It acknowledges common real-world data challenges such as missing data, confounding, changing treatment guidelines over time, differences in measurement practices across sites, and the need for scalable approaches for very large, heterogeneous cohorts.
15) Is the program expected to develop new analytic approaches or only apply existing ones?
The FOA indicates IeDEA is positioned both to apply existing methods and to push the field forward by developing and validating analytic approaches suited to global observational HIV research.
16) Are the methods and harmonization products expected to be useful beyond HIV?
Yes. The FOA states that while HIV/AIDS is the central focus, the methods and harmonization products developed through IeDEA are expected to be useful for other infectious disease research areas as well.
17) How much funding was NIH expecting to commit, and how many awards were anticipated?
NIH anticipated committing about USD 10.5 million in fiscal year 2011 to support up to seven regional data centers plus one coordinating award.
18) What is the maximum project period allowed under this opportunity?
Applicants were allowed to request project periods of up to five years.
19) What are the key dates for this FOA?
The announcement was posted on August 5, 2010. The original and current closing date was November 10, 2010. The archive date was December 11, 2010.
20) What type of funding is this categorized as?
The opportunity is categorized as discretionary funding and uses the cooperative agreement instrument (U01).
21) Is cost sharing or matching required?
No cost sharing or matching requirement is indicated in the information provided.
22) Who is eligible to apply?
Eligibility is broad and includes many types of U.S. and non-U.S. organizations, reflecting the international scope. Eligible applicants include government entities (federal, state, county, city/township), public and private institutions of higher education, nonprofits (with and without 501(c)(3) status, other than higher education institutions), for-profit organizations (including small businesses), independent school districts, special district governments, public housing authorities/Indian housing authorities, Native American tribal governments and organizations, and mission-specific institutional categories such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.
23) Can non-U.S. (foreign) organizations apply?
Yes. The eligibility description includes non-domestic (non-U.S.) entities, consistent with the goal of building strong regional data centers in locations heavily affected by HIV and related diseases.
24) What does HTMCO mean in the context of this FOA?
In this FOA, HTMCO refers to HIV/TB, malaria, cancer, and other infectious diseases. It reflects the program interest in conditions that intersect with HIV and affect outcomes in HIV-affected communities.
25) Which CFDA numbers are associated with this opportunity?
The CFDA numbers listed include 93.394 (Cancer Detection and Diagnosis Research), 93.855 (Allergy, Immunology and Transplantation Research), 93.856 (Microbiology and Infectious Diseases Research), and 93.865 (Child Health and Human Development Extramural Research).
26) What is the practical value of strengthening routine clinical data in this program?
The FOA emphasizes that routine clinical data can be especially valuable for understanding how HIV care works outside tightly controlled research environments. Strengthening and harmonizing these data supports more accurate epidemic monitoring, more generalizable evidence, and evaluation of care strategies in typical practice settings across diverse health systems.
27) What is meant by "network-wide integration" in IeDEA?
Based on the FOA description, network-wide integration refers to aligning regions through shared standards, coordinated planning, and collaborative governance so that findings can be compared across regions and data can be combined to answer larger questions than any single region could address alone.
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