Opportunity Information: Apply for RFA AI 21 018
Limited Interaction Targeted Epidemiology (LITE-2): To Advance HIV Prevention (UG3/UH3 Clinical Trial Optional) is a National Institutes of Health (NIH) cooperative agreement funding opportunity (RFA-AI-21-018) designed to modernize and scale HIV prevention research by using innovative, technology-driven approaches to run large epidemiologic cohort studies in the United States. The central idea is to support projects that can recruit and follow large numbers of people who are at elevated risk for HIV acquisition, with a strong emphasis on groups experiencing disproportionate HIV burden. The FOA specifically highlights men who have sex with men (MSM), people who inject drugs (PWID), and transgender women and men, and it calls for particular attention to minority communities and age groups with the highest risk of HIV transmission.
The main scientific goal is to build and maintain large cohorts using low-burden, electronic, or otherwise limited-interaction methods that make participation easier and more scalable than traditional in-person research models. Applicants are expected to use innovative digital tools and electronic strategies to recruit participants, verify eligibility as appropriate, and retain them over time, enabling investigators to compare outcomes between participants who become HIV-positive during follow-up and those who remain HIV-negative. In practice, this supports studying incident HIV infection and related behavioral, social, or structural factors at scale, while also improving the feasibility of long-term follow-up in populations that can be hard to reach with conventional clinic-based research.
In addition to observational epidemiology, the FOA allows an optional clinical trial component. This optional element is aimed at developing and testing digitally delivered interventions that promote HIV risk reduction and ultimately reduce HIV incidence. That could include technology-enabled prevention supports such as app-based messaging, remote counseling, adherence support for prevention tools, or other digital strategies that can be delivered with minimal in-person contact, consistent with the limited-interaction theme of the program.
Mechanistically, the award uses the UG3/UH3 phased cooperative agreement structure, which is commonly used by NIH when projects need a defined start-up phase followed by a larger implementation phase. Under this structure, the UG3 phase typically supports early milestones like finalizing protocols, demonstrating recruitment and retention workflows, establishing data systems, and proving feasibility. If predefined milestones are met, the project can transition to the UH3 phase, which generally supports full-scale cohort execution and, if proposed, the intervention testing portion. Because this is a cooperative agreement, NIH staff are expected to have substantial involvement compared to a standard research project grant, meaning awardees can anticipate ongoing collaboration, oversight, and milestone-based management.
Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status) other than institutions of higher education; for-profit organizations other than small businesses; small businesses; public housing authorities/Indian housing authorities; and federally recognized Native American tribal governments, as well as tribal organizations other than federally recognized tribal governments. The FOA also explicitly encourages or includes a wide range of institution types and community-connected entities, such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), 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, and U.S. territories or possessions.
At the same time, the opportunity is limited to U.S.-based applicants and activities. Non-domestic (non-U.S.) entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed. This restriction aligns with the FOA’s focus on U.S. populations and U.S. HIV prevention priorities.
Administratively, the opportunity is categorized as discretionary funding and uses a cooperative agreement funding instrument. It sits within an activity area spanning education and health, income security, and social services, and it is associated with CFDA numbers 93.242, 93.279, 93.855, and 93.865. The FOA was created on April 7, 2021, and the original closing date listed is August 4, 2021. The award ceiling and expected number of awards are not specified in the provided source details.
Overall, LITE-2 is essentially a call for large, modern, tech-forward HIV cohort studies that can efficiently reach high-risk populations, sustain participation over time with minimal friction, generate strong epidemiologic comparisons around HIV incidence, and, where proposed, test digital prevention interventions that can be delivered at scale to reduce new HIV infections.Apply for RFA AI 21 018
- The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Limited Interaction Targeted Epidemiology (LITE-2): To Advance HIV Prevention (UG3/UH3 Clinical Trial Optional)" 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 2021-04-07.
- Applicants must submit their applications by 2021-08-04. (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 (FAQs)
What is the LITE-2 funding opportunity?
Limited Interaction Targeted Epidemiology (LITE-2): To Advance HIV Prevention (UG3/UH3 Clinical Trial Optional) is a National Institutes of Health (NIH) cooperative agreement funding opportunity (RFA-AI-21-018). It is designed to modernize and scale HIV prevention research by supporting large epidemiologic cohort studies in the United States that use innovative, technology-driven, limited-interaction approaches.
Which NIH funding mechanism does LITE-2 use?
This opportunity uses a UG3/UH3 phased cooperative agreement structure. UG3 generally supports start-up and feasibility work with defined milestones, and UH3 supports full implementation if those milestones are met.
Is this a grant or a cooperative agreement?
It is a cooperative agreement (not a standard research project grant). NIH staff are expected to have substantial involvement, including collaboration, oversight, and milestone-based management.
What is the main purpose of LITE-2?
The main scientific goal is to build and maintain large cohorts of people at elevated risk for HIV acquisition using low-burden, electronic, or otherwise limited-interaction methods. The intent is to enable scalable recruitment and long-term follow-up compared to traditional in-person research models.
What kinds of studies are encouraged under LITE-2?
LITE-2 emphasizes large epidemiologic cohort studies that can recruit and follow large numbers of participants in the U.S., using innovative digital tools and electronic strategies to support recruitment, eligibility verification as appropriate, and retention over time.
What does "limited interaction" mean in this FOA?
Based on the description provided, "limited interaction" refers to low-burden participation models that rely on electronic or digital approaches and minimize in-person contact, making studies easier to participate in and more scalable.
Who is the target participant population?
The cohorts are expected to focus on people at elevated risk for HIV acquisition, with strong emphasis on populations experiencing disproportionate HIV burden. The FOA specifically highlights men who have sex with men (MSM), people who inject drugs (PWID), and transgender women and men.
Does the FOA call for attention to specific communities?
Yes. It calls for particular attention to minority communities and age groups with the highest risk of HIV transmission, consistent with its emphasis on disproportionate HIV burden.
What outcomes or comparisons are these cohorts intended to support?
The cohort design is intended to enable investigators to compare outcomes between participants who become HIV-positive during follow-up and those who remain HIV-negative, supporting the study of incident HIV infection and related behavioral, social, or structural factors.
Does LITE-2 allow clinical trials?
Yes. A clinical trial component is optional. The optional element is aimed at developing and testing digitally delivered interventions intended to promote HIV risk reduction and reduce HIV incidence.
What kinds of interventions are envisioned for the optional clinical trial component?
Examples described include technology-enabled prevention supports such as app-based messaging, remote counseling, adherence support for prevention tools, or other digital strategies that can be delivered with minimal in-person contact.
What typically happens in the UG3 phase?
The UG3 phase typically supports early milestones such as finalizing protocols, demonstrating recruitment and retention workflows, establishing data systems, and proving feasibility.
What typically happens in the UH3 phase?
If predefined UG3 milestones are met, projects can transition to the UH3 phase, which generally supports full-scale cohort execution and, if proposed, intervention testing.
Is transition from UG3 to UH3 automatic?
No. Transition is milestone-based. The description indicates that moving to UH3 depends on meeting predefined milestones established for the UG3 phase.
Who can apply for this opportunity?
Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include various state and local governments; public and private institutions of higher education; nonprofits (with or without 501(c)(3) status) other than institutions of higher education; for-profit organizations other than small businesses; small businesses; public housing authorities/Indian housing authorities; federally recognized Native American tribal governments; and tribal organizations other than federally recognized tribal governments.
Are specific institution types explicitly encouraged or included?
Yes. The FOA explicitly encourages or includes institution types and community-connected entities such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), 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, and U.S. territories or possessions.
Are non-U.S. (foreign) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply.
Can a U.S. organization include non-domestic components or foreign components?
No. Non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.
Are projects required to take place in the United States?
Yes. The opportunity is limited to U.S.-based applicants and activities, aligning with its focus on U.S. populations and U.S. HIV prevention priorities.
What is the FOA number and identifier?
The funding opportunity announcement is identified as RFA-AI-21-018.
When was this FOA created and what is the listed closing date?
The FOA was created on April 7, 2021, and the original closing date listed is August 4, 2021.
Is the award ceiling or the expected number of awards provided?
No. The award ceiling and the expected number of awards are not specified in the provided details.
How is this opportunity categorized administratively?
It is categorized as discretionary funding and uses a cooperative agreement funding instrument.
What activity areas does this opportunity relate to?
It is described as sitting within an activity area spanning education and health, income security, and social services.
Which CFDA numbers are associated with this FOA?
The associated CFDA numbers listed are 93.242, 93.279, 93.855, and 93.865.
What is the overall concept behind LITE-2 in plain terms?
LITE-2 calls for large, modern, tech-forward HIV cohort studies that can efficiently reach high-risk populations, keep participation low-burden over time, produce strong epidemiologic comparisons around HIV incidence, and optionally test scalable digital prevention interventions designed to reduce new HIV infections.
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