Heart, Lung, and Blood Co-morbiditieS Implementation Models in People Living with HIV (HLB SIMPLe) (UG3/UH3 - Clinical Trial Optional)

Released Date
Expiration Date
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Frequently Asked Questions for RFA-HL-20-025 Heart, Lung, and Blood Co-morbiditieS Implementation Models in People Living with HIV (HLB SIMPLe) (UG3/UH3)

Q1: Am I required to submit a letter of intent?

A1: Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

Q2: When are applications due?

A2: The receipt date for this funding opportunity announcement (FOA) is Tuesday, December 10, 2019. Applications must be submitted by 5:00 PM local time of applicant organization.

Q3: Are foreign institutions eligible to apply?

A3: Yes, foreign institutions are eligible and encouraged to apply. This FOA is intended to support cooperative agreements in World Bank-designated low- and middle-income countries (LMICs) and Small Island Developing States (SIDS) with LMIC and SIDS institutions as the applicant organization. As stipulated in the HLB SIMPLe (UG3/UH3) FOA, non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply, non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply, and foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Q4: Per the SF424, it states "if you are requesting a budget with $500,000 or more in direct costs for any budget period, contact the awarding component to determine whether you must obtain prior approval before submitting the application." Do I need prior approval?

A4: No. Applicants to this RFA do not need prior approval as budget thresholds are spelled out in the RFA.

Q5: Does the application have a page limit?

A5: Yes. All page limitations are described in the SF424 Application Guide and the Table of Page Limits must be followed.

Q6: How should I submit my application?

A6: All applications must be submitted electronically. Applicants should follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (see RFA-HL-20-025, Section IV. Application and Submission Information for specific information) or in a Notice from NIH Guide for Grants and Contracts.

Q7: Can I be a named researcher on more than one application?

A7: Investigators may be named as personnel on more than one application.

Q8: Can Co-Principal Investigators (Co-PIs) from institutions in two different LMICs apply for the grant with the same activities conducted in both countries?

A8: Yes, multiple PIs are welcomed in the application as well as multiple performance sites within the same country and/or within multiple LMICs. More information about Multiple Principal Investigators can be found at https://grants.nih.gov/grants/multi_pi/.

Q9: Will I lose my early stage investigator (ESI) status for a future R01 submission for myself if I am awarded a grant under the HLB SIMPLe funding opportunity?

A9: An ESI is defined as a Program Director/Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award. Applicants are encouraged to review the information found at this link to learn more about NIH’s ESI policies. A list of NIH grants that a PD/PI can hold and still be considered an ESI can be found here.

Q10: Are there countries that are not permitted to apply to this Funding Opportunity Announcement (FOA)?

A10: This FOA intends to support cooperative agreements from applicant organizations in World Bank-designated low- and middle-income countries (LMICs) and Small Island Developing States (SIDS). The NHLBI recognizes that LMICs that have been reclassified as high-income since January 1, 2011 may continue to have low-resource regions and population sub-groups like those in LMICs. Consequently, the NHLBI also encourages applications from these re-classified countries. Eligible institutions include non-domestic (non-U.S.) entities (Foreign Institutions) in low- or middle-income countries (LMICs), Small Island Developing States (SIDS), and previously designated LMICs re-categorized by the World Bank as high-income on or after January 1, 2011; Non-domestic (non-U.S.) components of U.S. Organizations. Partnerships with institutions in HICs are highly encouraged, however HIC institutions are not eligible applicants as the primary applicant organization.

Q11: Collaboration between institutions in LMICs and HICs is highly encouraged. Who must be the lead?

A11: While Multi-PI (MPI) leadership is allowed and encouraged, including MPIs from HICs, the LMIC institution must be the applicant organization.

Q12: Can I apply if I am from a high-income country?

A12: Partnerships between LMIC and HIC institutions are highly encouraged. You may form a partnership with researchers from any of the LMIC countries in the regions listed in the FOA. Applications submitted by U.S. and other High-Income Countries are not eligible for this Funding Opportunity Announcement and will be deemed non-responsive.

Q13: Is it possible to have multiple PIs, with one of the PIs located in a U.S.-based institution?

A13: Yes, Multi-PI applications can include a U.S.-based PI located at a U.S.-based institution.

Q14: Can an organization submit more than one application?

A14: Yes. Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

Q15: Can I apply to both NHLBI and FIC for this FOA?

A15: Applicants may not apply to more than one NIH Institute or Center with the same project. We strongly recommend that prospective applicants contact the Scientific Contacts for guidance before submitting an application.

Q16: Is there is a limit on the number of collaborating countries?

A16: No limits exist on the number of potential collaborations and/or partnerships.

Q17: Is the UG3 exploratory/developmental phase conceived as a planning phase, where efforts are made to identify the programs and health areas of most importance for implementation strategies, and identification of strategies most appropriate and effective in the setting of interest?

A17: The UG3 phase will support planning activities focused on sustainable uptake of proven-effective interventions throughout the community of interest. This phase should include activities such as the identification of the population in which the strategies to deliver and scale up proven-effective interventions will be tested, establishment of collaborative relationships, identification of the strategies to be tested during the UH3 implementation phase, conduct of a health needs assessment, and preparation of all details required for conducting a clinical trial, such as finalization of the protocol and the informed consent/assent document; the development of the manual of operations and procedures, case report forms and other resources necessary to the performance of the protocol; Data and Safety Monitoring Board (DSMB) review of the protocol; and Institutional Review Board approval of the trial.

Q18: What is required to convert the award from the UG3 developmental phase into the UH3 implementation phase?

A18: Funding for the UH3 phase of the award, which will provide up to three years of support, is contingent on appropriate progress made during the UG3 planning phase of the award. Milestone Accrual Plans (MAPs) will be utilized for both the UG3 and UH3 phases of the award and effective milestone completion during the UG3 phase of the award will determine conversion of the award to the UH3 phase. If progress toward meeting award milestones during the UG3 phase is deemed insufficient, the award will not be converted to the UH3 phase and the award will terminate.

Q19: Is the 12 pages for the Research Plan primarily to provide details about the work to be completed in the UG3 phase of the project?

A19: Applications submitted in response to this FOA must address both the UG3 and UH3 phases and are expected to include plans for project management and performance milestones for each phase within the research plan as outlined in the FOA (See RFA-HL-20-025, Section IV. Application and Submission Information).

Q20: This FOA states that clinical trials are optional. How is this determined?

A20: Applicants proposing to conduct a clinical trial under this FOA should review NHLBI’s requirements for clinical trials research (See https://www.nhlbi.nih.gov/health-topics/clinical-trials). The NIH Definition of a Clinical Trial must be used to determine if a clinical trial is proposed. A decision tool is available to assist with the determination. Applicants are also encouraged to review the NIH policy on clinical trials and case studies for reference.

Q21: I’m proposing a clinical trial. Is a Data and Safety Monitoring Board (DSMB) required?

A21: While DSMBs are required for oversight of NIH clinical trials, the companion HLB SIMPLe Research Coordinating Center (RCC) (U24) (see RFA-HL-20-026 for more information) will administrate a global DSMB for oversight of all associated HLB SIMPLe (UG3/UH3) awards. Funds should be budgeted, however, for appropriate document preparation and local administrative oversight of the proposed clinical trial. Funded HLB SIMPLe (UG3/UH3) programs will be expected to work closely with the HLB SIMPLe RCC (U24) for appropriate DSMB oversight and provide all necessary information for regular DSMB review of the clinical trial.

Q22: Can an applicant submit an application for both the HLB SIMPLe UG3/UH3 and the companion U24 Research Coordinating Center (RCC)?

A22: Please note that the HLB SIMPLe (UG3/UH3) FOA requests applications from foreign institutions as the administrative lead while the HLB SIMPLe RCC (U24) FOA requests applications from domestic institutions (although non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply and foreign components, as defined in the NIH Grants Policy Statement, are allowed).

Q23: How many applications will be funded?

A23: The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Up to seven HLB SIMPLe (UG3/UH3) applications are expected to be supported. One companion HLB SIMPLe RCC (U24) will also be funded under RFA-HL-20-026.

Q24: On what basis are applications selected for funding?

A24: Applications will be selected for funding based on scientific merit, current NIH program research priorities, and availability of funds. Applicants are highly encouraged to discuss potential research aims with program officials to determine fit with programmatic research priorities.

Q25: Where will my application be reviewed?

A25: Applications will be evaluated for scientific and technical merit via a special emphasis panel convened by NHLBI, in accordance with NIH peer review policy and procedures, using the review criteria stated in the HLB SIMPLe (UG3/UH3) FOA (see RFA-HL-20-025, Section V. Application Review Information).

Q26: The HLB SIMPLe program deals specifically with addressing HLBS comorbid conditions in PLHIV; can I propose research with non-HIV populations?

A26: No. All applications should propose to conduct research in populations living with HIV/AIDS, as stipulated in NIH HIV/AIDS policy (see https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities/hiv-aids/applications-faqs)

Q27: Is it a requirement for the proposed research project to cover all four areas of Heart, Lung, Blood, and Sleep (HLBS)-related diseases and disorders? Or is a focus on a specific comorbid HLBS disease or disorder in PLHIV sufficient?

A27: Research can be proposed related to any or all HLBS-related comorbid diseases and disorders in PLHIV; there is no requirement to propose research focused on a specific number of comorbid conditions in PLHIV.

Q28: Multidisciplinary teams are encouraged in the HLB SIMPLe (UG3/UH3) FOA; who needs to be included as a part of the team?

A28: Project team composition will be determined in large part by the research question and proposed approach. It is anticipated that each multidisciplinary research team will, at minimum, include members with the appropriate level of expertise in behavioral and social science, implementation science, chronic disease research in LMICs, HIV/AIDS, NCD/HIV integrated care, economics, epidemiology, and/or policy.

Q29: Who qualifies as a Program Director/Principal Investigator for this FOA?

A29: Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support under this FOA.

Q30: What type of research designs, frameworks, outcomes, and measures might you expect to see in a responsive grant application to RFA-HL-20-025?

A30: This FOA is intended to support applications that propose to: (1) employ validated theoretical or conceptual implementation research frameworks (e.g., Consolidated Framework for Implementation Research (CFIR); Promoting Action on Research Implementation in Health Services (PARiHS); Pragmatic-explanatory continuum indicator summary (PRECIS); Reach Effectiveness Adoption Implementation Maintenance (RE-AIM); PRECEDE-PROCEED, K2A, etc.); (2) include implementation research study designs (e.g., experimental, quasi-experimental, observational, modeling, cluster randomization, stepped-wedge, Type III hybrid effectiveness, etc.); (3) include implementation measures as primary research outcomes (e.g., acceptability, adoption, appropriateness, affordability, costs, feasibility, fidelity, penetrance, and sustainability etc.; and (4) inform understanding of key mediators and mechanisms of action of the implementation.

Q31: Must applications address implementation research delivery strategies aimed at a target population within a specific age range?

A31: No age range is specified in this FOA. Please note, however, that research should be relevant to populations living with HIV/AIDS.

Q32: As the HLB SIMPLe global research network is developed, will individual awardees of the different grants be required to work together?

A32: Per the FOA Cooperative Agreement Terms and Condition of Award (see Section VI. Award Administration Information), PD(s)/PI(s) agree to participate in the cooperative research program, including serving on the Steering Committee, participating in Steering Committee meetings and teleconferences, adhering to Steering Committee policies and decisions, attending annual meetings or workshops, and accepting the close coordination, cooperation, participation and assistance of NIH staff. The Steering Committee (SC) will serve as the governing board for awardees. All participants in the program are bound by the policies and procedures developed by the SC; adoption of such policies and procedures requires a majority vote. Awardees under this FOA will be required to accept and implement policies approved by the SC. Steering Committee responsibilities will include:

  • Evaluating, reviewing, and recommending new collaborations and resource allocations for projects across awardees
  • Coordinating data sharing and collaborative research efforts among awardees (e.g., measures, consultations with staff across awardees), as appropriate
  • Developing and conducting shared protocols, when appropriate
  • Jointly developing appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data
  • Cooperating to ensure the timely and broad dissemination of lessons learned to inform researchers and health care systems engaged in scaling up evidence-based interventions at the population level for integrated HLBS/HIV care in LMICs.

Q33: What is NIH’s role in the activities of the research I’m proposing?

A33: The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined in this FOA under Section VI. Award Administration Information.

Q34: How often will the HLB SIMPLe global research network (HLB SIMPLe (UG3/UH3) awardees and the HLB SIMPLe RCC (U24) awardee) meet over the course of the proposed 5 year period of performance?

A34: It is anticipated that representatives from the HLB SIMPLe UG3/UH3 and U24 awardees will meet at least one time per year. Applicants must budget for annual costs of having a PD/PI and two additional team members participate in an annual three-day face-to-face meeting of the global implementation research alliance (international meeting location to vary annually; for budgeting purposes, assume Zurich, Switzerland). Attendance at this meeting is required for the PD/PI and two additional individuals from each awardee team, with participants from the LMIC preferred. Teams are also encouraged to include a junior team member in each annual meeting. In Year 1, it is expected that a start-up meeting will take place in the Washington, DC area, and representatives from each funded UG3/UH3 and U24 program are expected to attend.

For any questions related to the HLB SIMPLe (UG3/UH3) FOA, please send your inquiries to:
Brad Newsome, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8170
Email: brad.newsome@nih.gov