Opportunity Information: Apply for RFA HL 20 026

The Heart, Lung, and Blood Co-morbiditieS Implementation Models in People Living with HIV (HLB-SIMPLe) Research Coordinating Center opportunity (RFA HL 20 026) is a National Institutes of Health cooperative agreement (U24; clinical trial not allowed) designed to create a single, centralized Research Coordinating Center (RCC) that supports a linked set of UG3/UH3 phased cooperative agreement projects. Those UG3/UH3 projects focus on late-stage implementation research in people living with HIV (PLHIV), specifically targeting how to deliver and sustain proven, effective prevention and treatment interventions for heart, lung, blood, and sleep (HLBS) comorbidities in real-world settings. The central idea is not to invent new clinical interventions, but to figure out practical, durable ways to get existing evidence-based HLBS interventions routinely used in clinical care, public health programs, and community-based services, and to keep them working at scale.

A key feature of this FOA is its emphasis on low- and middle-income countries (LMICs), as designated by the World Bank, and Small Island Developing States (SIDS). The RCC is meant to knit together a global alliance of funded implementation research teams operating across multiple world regions, including East Asia and the Pacific, Europe and Central Asia, Latin America and the Caribbean, the Middle East and North Africa, South Asia, and Sub-Saharan Africa. In practice, this means the coordinating center is responsible for enabling cross-site alignment and shared learning across very different health systems, resource levels, and HIV care delivery contexts, while keeping the network focused on the common goal of improving HLBS-related outcomes for PLHIV through better implementation.

The FOA defines "late-stage implementation research" as research that identifies strategies to achieve sustainable uptake of proven-effective interventions in routine settings and maximize population health impact. That definition signals that the network is expected to work on the kinds of real-world barriers and enabling factors that determine whether an intervention actually reaches people and continues over time. Examples of the types of coordination needs implied by this definition include harmonizing implementation outcomes and metrics across projects, encouraging consistent reporting and shared methods where appropriate, and supporting approaches that strengthen the likelihood of sustainability, scale-up, and long-term integration into routine HIV care and related services.

The RCCs responsibilities are extensive and operationally oriented. It is expected to organize and run network governance and collaboration structures, including in-person and virtual Network Steering Committee meetings, subcommittee meetings, and working groups. It must actively promote collaboration and communication among investigators and with the broader research community, which implies both internal network coordination and outward-facing dissemination and engagement. The RCC also coordinates network outreach activities and facilitates joint research and capacity-building efforts that span multiple projects, encouraging shared resources, shared training, and coordinated methodological support across regions and institutions.

Another major responsibility is the organization, implementation, and management of a global implementation research Data Safety and Monitoring Board (DSMB). Even though the RCC itself is not running a clinical trial under this U24 announcement, the presence of a DSMB requirement reflects the complexity and potential risk profile of multi-site research involving health interventions and vulnerable populations across diverse settings. The RCC is therefore positioned as the central hub for safety and monitoring oversight processes appropriate for the alliance, ensuring consistent review, standardized procedures, and coordinated communication among projects and oversight bodies.

From an administrative standpoint, the award is issued by the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), as a discretionary cooperative agreement, meaning NIH expects substantial involvement in the projects coordination rather than a hands-off grant mechanism. The announcement listed an expected single award (ExpectedAwards: 1) with an award ceiling of $960,000. Eligibility is broad and includes various levels of government, public and private institutions of higher education, nonprofit organizations with or without 501(c)(3) status, tribal governments and organizations, public housing authorities, for-profit organizations (other than small businesses), small businesses, and other entities as clarified in the FOAs eligibility text. The opportunity was created on October 2, 2019, with an original closing date of December 10, 2019.

Overall, this FOA is best understood as funding the backbone organization for a global implementation research network focused on HLBS comorbidities in PLHIV in LMICs and SIDS. The RCC is not the site conducting the primary implementation studies; instead, it enables those studies to function as a coordinated alliance by providing governance support, communications infrastructure, shared problem-solving mechanisms, capacity building and outreach, and centralized safety and monitoring coordination so that the networks collective work is more coherent, comparable, and impactful across regions.

  • 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) Research Coordinating Center (U24 - Clinical Trial Not Allowed)" 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 $960,000.00 in funding.
  • The number of recipients for this funding is limited to 1 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, 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 (see text field entitled Additional Information on Eligibility for clarification).
Apply for RFA HL 20 026

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Frequently Asked Questions (FAQs)

What is the HLB-SIMPLe Research Coordinating Center (RCC) funding opportunity?

The Heart, Lung, and Blood Co-morbiditieS Implementation Models in People Living with HIV (HLB-SIMPLe) Research Coordinating Center opportunity (RFA HL 20 026) is a National Institutes of Health (NIH) cooperative agreement (U24; clinical trial not allowed) to support a single, centralized Research Coordinating Center (RCC). The RCC is intended to serve as the backbone organization for a linked set of UG3/UH3 phased cooperative agreement projects focused on implementation research in people living with HIV (PLHIV).

What does U24 (cooperative agreement) mean for this award?

This opportunity uses a cooperative agreement mechanism, which means NIH expects substantial involvement in coordinating and guiding aspects of the funded effort rather than a fully hands-off relationship. The RCC is expected to operate as an active hub that supports network governance, collaboration, and oversight functions for the broader alliance of projects.

How many awards are expected under this FOA?

The announcement lists an expected single award (ExpectedAwards: 1), meaning NIH anticipated funding one RCC to coordinate the network.

What is the maximum funding amount (award ceiling) for the RCC?

The award ceiling listed for the opportunity is $960,000.

When was this funding opportunity created and when did it close?

The opportunity was created on October 2, 2019, and had an original closing date of December 10, 2019.

Who is the federal awarding agency?

The award is issued by the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), as a discretionary cooperative agreement.

What is the overall purpose of the RCC?

The RCC is designed to create and operate a centralized coordinating center that supports a linked set of UG3/UH3 implementation research projects. Its purpose is to enable those projects to function as a coherent alliance by providing governance, communications, cross-site coordination, capacity building, outreach, and centralized safety/monitoring coordination.

Is the RCC expected to conduct the primary implementation research studies?

No. The RCC is not the site conducting the primary implementation studies. Instead, it supports and coordinates the UG3/UH3 projects by providing the network infrastructure and operational functions needed for alignment, shared learning, and consistent oversight.

Are clinical trials allowed under this U24 announcement?

No. The opportunity is described as U24 with "clinical trial not allowed."

What is the relationship between the RCC and the UG3/UH3 projects?

The RCC is intended to support a linked set of UG3/UH3 phased cooperative agreement projects. Those projects focus on late-stage implementation research in PLHIV related to prevention and treatment interventions for heart, lung, blood, and sleep (HLBS) comorbidities. The RCC coordinates the network so the projects can align where appropriate and learn across sites and regions.

What health focus areas are included in this network?

The network focuses on heart, lung, blood, and sleep (HLBS) comorbidities in people living with HIV. The emphasis is on how to deliver and sustain proven, effective prevention and treatment interventions for these comorbidities in real-world settings.

What is meant by "late-stage implementation research" in this FOA?

The FOA defines late-stage implementation research as research that identifies strategies to achieve sustainable uptake of proven-effective interventions in routine settings and maximize population health impact. In practical terms, this points to real-world implementation challenges such as barriers and facilitators to uptake, durability over time, and integration into routine service delivery.

Is the goal to develop new clinical interventions for HLBS comorbidities?

No. The central idea is not to invent new clinical interventions. The focus is on practical, durable ways to get existing evidence-based HLBS interventions routinely used in clinical care, public health programs, and community-based services, and to keep them working at scale.

What types of settings are emphasized for implementation?

The FOA emphasizes real-world settings such as clinical care environments, public health programs, and community-based services, with a focus on sustained delivery and long-term integration into routine HIV care and related services.

Which countries and regions are emphasized?

A key emphasis is on low- and middle-income countries (LMICs) as designated by the World Bank, and Small Island Developing States (SIDS). The RCC is expected to knit together a global alliance of teams operating across multiple world regions, including East Asia and the Pacific, Europe and Central Asia, Latin America and the Caribbean, the Middle East and North Africa, South Asia, and Sub-Saharan Africa.

What does it mean for the RCC to "knit together a global alliance"?

This means the RCC is responsible for enabling cross-site alignment and shared learning across diverse health systems, resource levels, and HIV care delivery contexts. The RCC is expected to help the network stay focused on improving HLBS-related outcomes for PLHIV through stronger implementation, while coordinating collaboration across different regions and institutions.

What are the main operational responsibilities of the RCC?

The RCC responsibilities are extensive and operationally oriented. They include organizing and running network governance and collaboration structures (such as Network Steering Committee meetings, subcommittee meetings, and working groups), promoting communication and collaboration among investigators, coordinating network outreach, and facilitating joint research and capacity-building efforts that span multiple projects.

What kinds of meetings and working structures is the RCC expected to manage?

The RCC is expected to organize and run in-person and virtual Network Steering Committee meetings, as well as subcommittee meetings and working groups that support governance, coordination, and collaboration across the network.

How does the RCC support collaboration and communication?

The RCC is expected to actively promote collaboration and communication among investigators and with the broader research community. This implies both internal coordination across the network and outward-facing dissemination and engagement activities.

What does the FOA imply about harmonizing outcomes and metrics across projects?

Because the FOA emphasizes late-stage implementation research and cross-site alignment, it implies coordination needs such as harmonizing implementation outcomes and metrics across projects, encouraging consistent reporting and shared methods where appropriate, and supporting approaches that strengthen sustainability, scale-up, and long-term integration.

What is the RCC expected to do regarding outreach and capacity building?

The RCC coordinates network outreach activities and facilitates joint research and capacity-building efforts across multiple projects. This includes encouraging shared resources, shared training, and coordinated methodological support across regions and institutions.

Why is a Data Safety and Monitoring Board (DSMB) included if clinical trials are not allowed?

Even though the RCC itself is not running a clinical trial under this U24 announcement, the FOA requires organization, implementation, and management of a global implementation research DSMB. This reflects the complexity and potential risk profile of multi-site research involving health interventions and vulnerable populations across diverse settings, and it positions the RCC as the central hub for consistent oversight processes.

What is the RCC's role in DSMB organization and oversight?

The RCC is responsible for organizing, implementing, and managing a global implementation research DSMB. This includes enabling consistent review, standardized procedures, and coordinated communication among projects and oversight bodies across the alliance.

What types of organizations are eligible to apply?

Eligibility is broad and includes various levels of government, public and private institutions of higher education, nonprofit organizations with or without 501(c)(3) status, tribal governments and organizations, public housing authorities, for-profit organizations (other than small businesses), small businesses, and other entities as clarified in the FOA's eligibility text.

Is this opportunity limited to U.S.-based institutions?

The provided description emphasizes global coordination across LMICs and SIDS and multiple world regions, and eligibility is described broadly by organization type. The specific geographic eligibility rules are not detailed in the information provided beyond that description.

What makes this RCC a "backbone" organization for the network?

The RCC is funded to provide the infrastructure that makes a multi-region network function effectively: governance support, communications infrastructure, shared problem-solving mechanisms, capacity building and outreach, and centralized safety and monitoring coordination so the collective work is more coherent, comparable, and impactful across regions.

What is the main outcome the network is trying to improve?

The network is focused on improving HLBS-related outcomes for people living with HIV by strengthening the implementation of proven prevention and treatment interventions in routine, real-world service settings, especially in LMICs and SIDS.

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