Opportunity Information: Apply for RFA HL 20 025
The Heart, Lung, and Blood Co-morbiditieS Implementation Models in People Living with HIV (HLB SIMPLe) funding opportunity (RFA HL 20 025) is a National Institutes of Health cooperative agreement program designed to improve how proven, effective interventions for heart, lung, blood, and sleep (HLBS) comorbidities are actually delivered to people living with HIV (PLHIV) in low-resource settings. Rather than funding early discovery or testing whether an intervention works, this announcement focuses on the real-world problem that many interventions already known to be effective do not consistently reach patients or are not sustained over time within routine HIV care systems. The overall goal is to generate practical, scalable implementation approaches that strengthen prevention and treatment for HLBS conditions alongside HIV care and that can be sustained in everyday clinical, public health, and community-based environments.
A central feature of the FOA is its emphasis on late-stage implementation research, described here as research aimed at identifying strategies that drive durable uptake and long-term integration of evidence-based interventions. In practical terms, applicants are expected to study how to close the gap between evidence and routine practice by testing implementation strategies that improve adoption, fidelity, reach, quality, and sustainability of HLBS comorbidity services for PLHIV. The intent is to maximize population health impact, meaning projects should be designed with an eye toward outcomes that matter at scale, not just within a small pilot clinic. Although the research is conducted in World Bank-designated low- and middle-income countries (LMICs) and Small Island Developing States (SIDS), the program explicitly seeks results that can generalize to low-resource settings globally.
Projects funded through this FOA must be conducted in one or more of the specified world regions: East Asia and the Pacific, Europe and Central Asia, Latin America and the Caribbean, Middle East and North Africa, South Asia, and Sub-Saharan Africa. Beyond individual projects, NIH intends for the funded investigators to function as a collaborative alliance focused on T4 (late-stage) implementation research for HLBS comorbidities in PLHIV across LMICs. That alliance concept signals that awardees may be expected to coordinate on shared learning, cross-site comparisons, and complementary research questions that together build a stronger evidence base than any single study could provide.
The mechanism is a two-phase, milestone-driven UG3/UH3 cooperative agreement, which means NIH will have substantial programmatic involvement and the transition from the first phase to the second depends on meeting pre-specified milestones. The UG3 phase (about 1 to 2 years) supports study start-up and needs assessment activities, such as partnership building, refining workflows, assessing barriers and facilitators, tailoring implementation strategies to local contexts, finalizing protocols, and preparing sites and staff. If UG3 milestones are met, the project can transition into the UH3 phase (about 3 to 4 years), where the main implementation research is carried out, typically involving the active rollout and evaluation of strategies intended to improve delivery and sustainability of the proven interventions within real service systems. The maximum total project period is 5 years.
Eligibility is broad and includes many types of U.S. entities (state, county, and local governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses). Importantly, foreign institutions are eligible and explicitly encouraged, reflecting the fact that the research is intended to be led or co-led by teams with deep on-the-ground expertise in LMIC and SIDS contexts. The FOA is categorized under health and uses a cooperative agreement funding instrument, aligning with the milestone-based, partner-style relationship NIH often uses for complex, multi-site, implementation-focused programs.
From a funding and scale standpoint, the opportunity listed an award ceiling of $690,000 and anticipated making about 7 awards. The announcement was created on October 2, 2019, with an original closing date of December 10, 2019, and it is administered under the U.S. Department of Health and Human Services, National Institutes of Health. The FOA also notes that clinical trials are optional, which gives applicants flexibility to propose rigorous evaluation designs that may or may not meet NIHs formal definition of a clinical trial, depending on whether the study prospectively assigns participants to interventions or strategies and measures health-related outcomes.
Overall, the HLB SIMPLe FOA is aimed at moving beyond knowing what works to knowing how to make what works actually happen at scale for PLHIV who also face substantial risks from cardiovascular, pulmonary, hematologic, and sleep-related conditions. It prioritizes sustainable delivery models, context-appropriate implementation strategies, and collaborative learning across diverse LMIC and SIDS regions, with the expectation that the knowledge gained will be useful for strengthening integrated HIV and noncommunicable disease care in low-resource settings worldwide.Apply for RFA HL 20 025
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Heart, Lung, and Blood Co-morbiditieS Implementation Models in People Living with HIV (HLB SIMPLe) (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): 93.233, 93.837, 93.838, 93.839, 93.840, 93.989.
- This funding opportunity was created on Oct 02, 2019.
- Applicants must submit their applications by Dec 10, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $690,000.00 in funding.
- The number of recipients for this funding is limited to 7 candidate(s).
- 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, Public housing authorities/Indian housing authorities, 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 (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the HLB SIMPLe funding opportunity?
The Heart, Lung, and Blood Co-morbiditieS Implementation Models in People Living with HIV (HLB SIMPLe) funding opportunity (RFA HL 20 025) is a National Institutes of Health (NIH) cooperative agreement program focused on improving how proven interventions for heart, lung, blood, and sleep (HLBS) comorbidities are delivered to people living with HIV (PLHIV) in low-resource settings.
What problem is this program trying to solve?
This opportunity targets the real-world gap between evidence and routine practice. Many HLBS interventions are already known to be effective, but they are not consistently adopted, delivered with fidelity, reached by those who need them, maintained at quality, or sustained over time within everyday HIV care systems. The program funds research on how to make effective interventions actually happen reliably at scale.
Is this funding for discovering new interventions or testing whether an intervention works?
No. This announcement is not aimed at early discovery or first proving effectiveness. It emphasizes late-stage implementation research, meaning the interventions are already evidence-based, and the research focuses on implementation strategies and delivery models that improve uptake, integration, and sustainability in real-world HIV care settings.
What health areas are included under HLBS comorbidities?
The FOA focuses on comorbidities related to heart, lung, blood, and sleep (HLBS) conditions among people living with HIV, alongside routine HIV care.
What is the overall goal of the FOA?
The overall goal is to generate practical, scalable implementation approaches that strengthen prevention and treatment for HLBS conditions alongside HIV care, in ways that can be sustained in everyday clinical, public health, and community-based environments.
What type of research does the FOA prioritize?
The FOA prioritizes T4 (late-stage) implementation research focused on strategies that drive durable uptake and long-term integration of evidence-based interventions. Projects are expected to test implementation strategies that improve adoption, fidelity, reach, quality, and sustainability of HLBS comorbidity services for PLHIV.
What does "late-stage implementation research" mean in this FOA?
In this context, late-stage implementation research means studying how to close the gap between evidence and routine practice by identifying and testing strategies that help evidence-based interventions become part of standard care and remain in place over time, especially in low-resource HIV care systems.
What outcomes are projects expected to focus on?
Projects should be designed with population health impact in mind. The FOA highlights outcomes that matter at scale, such as improving adoption, fidelity, reach, quality, and sustainability of HLBS services within routine HIV care systems, rather than producing results limited to a small pilot clinic.
Where must the research be conducted?
Projects must be conducted in World Bank-designated low- and middle-income countries (LMICs) and Small Island Developing States (SIDS), and must take place in one or more specified world regions: East Asia and the Pacific; Europe and Central Asia; Latin America and the Caribbean; Middle East and North Africa; South Asia; and Sub-Saharan Africa.
Are results expected to be useful beyond the specific study sites?
Yes. While the studies are conducted in LMICs and SIDS, the FOA explicitly seeks results that can generalize to low-resource settings globally.
What does it mean that this is a cooperative agreement?
The program uses a cooperative agreement funding instrument (UG3/UH3), which indicates substantial NIH programmatic involvement. This structure is designed for complex projects where NIH and awardees work in a more partner-like arrangement, including milestone-driven progress and coordination expectations.
What is the UG3/UH3 phased structure?
This FOA uses a two-phase, milestone-driven UG3/UH3 mechanism. The UG3 phase supports start-up and preparatory activities. If pre-specified UG3 milestones are met, the project can transition to the UH3 phase for the main implementation research and evaluation.
How long is the UG3 phase and what is it for?
The UG3 phase is approximately 1 to 2 years and supports activities such as partnership building, needs assessment, refining workflows, assessing barriers and facilitators, tailoring implementation strategies to local contexts, finalizing protocols, and preparing sites and staff.
How long is the UH3 phase and what happens during it?
The UH3 phase is approximately 3 to 4 years. It is when the primary implementation research is carried out, typically involving active rollout and evaluation of strategies intended to improve delivery and sustainability of proven HLBS interventions within real service systems.
What is the maximum project period?
The maximum total project period is 5 years across both phases combined.
What are milestones and why do they matter?
Milestones are pre-specified goals that guide progress, especially during the UG3 start-up period. Meeting UG3 milestones is required for transition into the UH3 phase, where the main implementation research occurs.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. entities (state, county, and local governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses). Foreign institutions are also eligible and explicitly encouraged.
Are foreign institutions really allowed to apply as applicants?
Yes. The FOA states that foreign institutions are eligible and explicitly encouraged, reflecting the intent for projects to be led or co-led by teams with strong on-the-ground expertise in LMIC and SIDS settings.
Is the program focused on collaboration across awardees?
Yes. NIH intends funded investigators to function as a collaborative alliance focused on T4 implementation research for HLBS comorbidities in PLHIV across LMICs. This suggests coordination on shared learning, cross-site comparisons, and complementary research questions.
How many awards are anticipated?
The opportunity anticipated making about 7 awards.
What is the listed award ceiling?
The opportunity listed an award ceiling of $690,000.
Which agency administers this funding opportunity?
This opportunity is administered under the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH).
When was the opportunity created and when did it close?
The announcement was created on October 2, 2019, and had an original closing date of December 10, 2019.
Are clinical trials required?
No. The FOA notes that clinical trials are optional, allowing applicants to propose rigorous evaluation designs that may or may not meet the NIH definition of a clinical trial, depending on the design.
How does the FOA describe when a study might be considered a clinical trial?
The FOA references the NIH definition in practical terms: whether the study prospectively assigns participants to interventions or strategies and measures health-related outcomes. Depending on those design features, a project may or may not be considered a clinical trial.
What kinds of settings should implementation strategies be designed for?
The FOA emphasizes everyday service environments, including routine HIV care systems and integrated delivery in clinical, public health, and community-based settings, with a strong focus on low-resource contexts.
What is meant by "sustainable delivery models" in this FOA?
Based on the FOA description, sustainability refers to long-term integration of evidence-based HLBS services into routine HIV care in a way that persists over time, maintaining quality and reach within real-world systems rather than being limited to short-term projects.
What is the main takeaway of the HLB SIMPLe FOA?
The FOA is about moving beyond knowing what works to knowing how to make what works happen reliably at scale for people living with HIV who also face major risks from cardiovascular, pulmonary, hematologic, and sleep-related conditions, particularly in LMIC and SIDS low-resource settings.
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