Questions and Answers for NIH’s Ending the HIV Epidemic—A Plan for America (EHE) FOAs

NIAID has released three funding opportunity announcements (FOAs) related to the Ending the HIV Epidemic: A Plan for America (EHE) initiative:

  • RFA-AI-21-023, RESPOND: Epidemiology To End the HIV Epidemic (RESPOND: EEE) (R01 Clinical Trial Optional)
  • RFA-AI-21-024, Multidisciplinary Treatment Approaches To End the HIV Epidemic (R01 Clinical Trial Optional)
  • RFA-AI-21-025, Prevention Strategies To End the HIV Epidemic (R01 Clinical Trial Optional)

Updated March 31, 2021. We posted the initial questions and answers shown below.

Table of Contents

General

Will NIAID post additional questions and answers or revise the current ones?

Each time we add new questions or revise, we will replace the dated note shown at the top of this page.

Do these questions and answers modify or add instructions?

No, these questions and answers do not modify or add any instructions. These answers are intended to help you understand and follow the instructions in the RFAs.

What is EHE?

Ending the HIV Epidemic: A Plan for America (EHE) is a plan that aims to end the HIV epidemic in the United States by 2030. EHE is the operational plan developed by agencies across the U.S. Department of Health and Human Services (HHS) to pursue that goal.

Does the applicant organization need to be in one of the 57 EHE priority areas?

No. The applicant institution does not need to be located in one of the geographically defined Priority Jurisdictions. The research being proposed, however, must be targeted to one or more of the priority areas as described in the FOAs.

Are foreign institutions allowed to apply to the EHE FOAs?

No. The sponsoring institution must be a U.S. (domestic) institution.

I will not be able to submit my application on time. May I have permission to submit a late application?

No matter how reasonable the excuse is, we do not have authority to grant advance permission for late submissions. Refer to NIH’s Late Applications policy and NIAID’s Late Applications SOP for additional details.

Also note that as these RFAs have special application due dates, they are not subject to the Continuous Submission Policy.

A system issue is preventing me from submitting my application. How should I get help?

Refer to Dealing With System Issues and contact the eRA Commons Service Desk for assistance.

Scientific Focus and Structure

Where can I find the local EHE plans?

Applicants will need to propose collaborations with local implementing partners such as city, county, and state public health departments, local and regional clinics and health care facilities, clinicians, providers of medication-assisted treatment for opioid use disorder, and community- and faith-based organizations sites funded by CDC, HRSA, IHS and/or SAMHSA. Local EHE plans are specific, dynamic and local, and can be accessed through local implementing partners.

Potential applicants may refer to NASTAD’s Ending the HIV Epidemic Plans website for additional information as it becomes available. 

Are clinical trials required as part of the research plan?

No, clinical trials are optional. Applicants may propose clinical trials as part of their specific aims, depending on the research that is being proposed.

For applications proposing clinical research or clinical trials, does the PHS Human Subjects and Clinical Trials Information Study Record need to be completed?

Yes, for applications that include human subjects research, including clinical trials, the PHS Human Subjects and Clinical Trials Information form must be completed according to the standard SF-424 G.500 Instructions. Note the following points for reference:

  • We expect most applications to these FOAs will not be exempt from Federal Regulations.
  • Human participants would constitute individuals, patients, providers, community members, and/or others who are enrolled in one or more study components after completing a specific study-related informed consent.
  • For the purposes of an implementation clinical trial, the “intervention” may constitute one or more implementation strategies designed to strengthen use of evidence-based/informed health-related interventions or practices. Intervention assignment may occur at the patient, provider, organization, and/or community level.
  • Health-related behavioral and biomedical outcomes are particularly relevant to hybrid implementation-effectiveness designs but may be evaluated alongside implementation outcomes.
  • Many implementation clinical trials may represent Phase IV research for studying or testing the implementation of proven, evidence-based or evidence-informed interventions.
  • When a trial is of minimal risk to participants and involves only a single site or open-label medication, the NIH may determine that the study can be adequately monitored by an Independent Safety Monitor and the IRB of record. Other studies should employ a DSMB or Safety Monitoring Committee. Multisite studies will require a DSMB per NIH policy.

Viral suppression is relevant to both treatment and prevention. Which FOA should we use for an application with an outcome of viral suppression?

An application that has a major focus on prevention of transmission and reducing HIV incidence is appropriate for RFA-AI-21-025, Prevention Strategies to End the HIV Epidemic.

An application that has a major focus on treatment of individuals is appropriate for RFA-AI-21-024, Multidisciplinary Treatment Approaches to End the HIV Epidemic.

The applicant should decide based on the information in the FOAs which is most consistent with the proposed project. Potential applicants are encouraged to email the Scientific/Research Contacts listed in the FOAs with any specific questions.

HIV testing may lead to either treatment or prevention. Does my application need to be limited to only one or the other?

No, the proposed project does not need to focus entirely on prevention or entirely on treatment. However, it is expected that there would be a predominant focus on either prevention or treatment. Applicants should apply to the FOA corresponding to the major area of focus. Potential applicants are encouraged to email the scientific/research contacts listed in Section VII of the FOAs with any specific questions.

Peer Review

To whom should I send the Letter of Intent?

The Letter of Intent should be sent by email to the scientific review officer (SRO) listed under Section IV of the FOA.

Who do I contact for questions about peer review of my application?

Please email the SRO listed under Section VII (Peer Review Contact) of the FOA.

Will I be able to submit additional documents after the application submission deadline?

Applicants are required to follow the instructions for post-submission materials, as described in the Post-Submission Materials Policy and in NOT-OD-20-179. Email the SRO for additional information.

The NIH has Extended Guidance for Applicants Preparing Applications During the COVID-19 Pandemic until further notice. NIH grant applications should not include contingency plans due to COVID-19, and reviewers will not consider the impact of COVID-19 on the proposed work. If and when needed, COVID-19 contingency plans will be requested and carefully considered by NIH staff before funding.

Contact Information

Whom do I contact for more information about these FOAs?

Find NIH scientific/research, peer review, and financial/grants management contacts listed in Section VII of each of the FOAs.

You may submit any general questions about these FOAs to Ann Namkung Lee at anamkung@niaid.nih.gov.

Please include your name, email address, institution, and FOA(s) you are inquiring about.

 

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