Key Dates

Related Announcements

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

RFA AI-21-020 - Early-Stage Development of Data Science Technologies for Infectious and Immune-mediated Diseases (U01 Clinical Trial Not Allowed)

RFA AI-21-021 - Enhancement or Sustainment of Data Science Tools for Infectious and Immune-Mediated diseases (U24 Clinical Trial Not Allowed)

RFA AI-21-035 - Exploratory Data Science Methods and Algorithm Development in Infectious and Immune-mediated Diseases (R21 Clinical Trial Not Allowed)

PA 20-265 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

PA-20-260 - PHS 2020 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute on Drug Abuse (NIDA)

Purpose

This Notice of Special Interest (NOSI) is to inform potential applicants of NIAID’s interest in the development and optimization of next generation methodologies for HIV-1 drug resistance (DR) mutation detection and reporting. This is needed to improve the guidance available to treatment and prevention programs for both individuals and populations. Research responsive to this NOSI could include the development of: (i) highly sensitive mutation detection technologies that can be integrated into multiplex assay systems capable of simultaneous assessment of large numbers of potential mutations (ii) point of care (POC) DR assays, or (iii) strategies for rapid acquisition, curation and analysis of these HIV DR data and timely dissemination to healthcare providers and public health decision makers. Strategies applicable to low and middle income countries as defined by the World Bank are especially encouraged.

HIV DR has been identified as an increasing barrier to effective antiretroviral therapy (ART) and is expected to have a growing impact on pre-exposure prophylaxis (PrEP). This is critical, given that ART and PrEP are core components of the HIV response. Users and providers need to know as early as possible when DR emerges, and public health authorities need clade, region, and population-specific DR information to evaluate the effectiveness of current ART and PrEP practices and policies. Similar data regarding mutations conferring resistance to broadly neutralizing antibodies (bnAbs) used for HIV treatment and prevention may be considered for inclusion in future HIV multiplex assays.

Recent technological advances offer new options for generating, analyzing, and reporting these much-needed data. For example, diagnostic platforms that use CRISPR-based technology and microfluidic chips make it possible to perform a large number of HIV DR mutation tests simultaneously. Despite the challenges, it appears that these new platforms can also be developed for POC use.

There is also a need to develop tools to capture, analyze, and report the large datasets these platforms produce. These tools must be rapid and the reports generated easily interpretable by local providers, and national and regional authorities. Examples might include real-time HIV DR dashboards, algorithms to predict emerging hot spots, and similar tools.

NIDA Statement of Interest

The development of technology and strategies to promote use of ART and PrEP and to determine HIV DR as soon as possible is critical among people who use and/or inject drugs and are likely to experience HIV DR, and/or gaps in HIV testing and care. This will likely require adaptations in technology, testing, and dissemination of results to engage this population and non-health care settings including homeless shelters, justice settings, substance abuse treatment and behavioral health facilities, and syringe service programs.

NIDA is interested in the following areas:

• Feasibility of self-administered, cost effective, and potential for mail-in testing and follow up through mobile technologies targeting substance-using populations living with HIV
• Development of technologies that allow sensitive and rapid read out of drug resistance
• Plans for post-administering surveys to assess rates of access, acceptability (stigma and ethical concerns), accuracy, and treatment outcomes
• Technologies that are easily adaptable for implementation in homeless shelters, community clinics, criminal justice, and emergency department settings

Application and Submission Information

Applicants must select the IC and associated FOA to use for submission of an application in response to this NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative. In addition, applicants using NIH Parent Announcements (listed below) will be assigned to those ICs on this NOSI that have indicated those FOAs are acceptable and based on usual application-IC assignment practices.

This notice applies to due dates on or after September 5, 2021 and subsequent receipt dates through May 7, 2024.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.
 

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-AI-21-056” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Usha Sharma, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (240) 292-4809
Email: usharma@niaid.nih.gov

Raul N. Mandler, MD; FAAN; FANA
National Institute on Drug Abuse (NIDA)
Telephone: (301) 480-2541
Email: mandlerr@nida.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2899
Email: adevine@niaid.nih.gov

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301- 480-1159
Email: pfleming@mail.nih.gov