Key Dates

Related Announcements

• March 10, 2020 - Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional). See NOFO PA-24-201. 

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

The National Institute on Drug Abuse (NIDA) is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for coordinating center infrastructure to support research on opioid overdose —a national public health emergency declared by the Department of Health and Human Services since October 26, 2017— and HIV risk in the context of justice system. NIDA seeks applications to support network and data coordination and dissemination for the recently launched Justice HIV and Overdose Research Network. Key responsibilities include administrative and logistical support; data and analytic support; dissemination and stakeholder engagement support; as well as targeted research projects to support the overall work of the network.

Background

The Ending the HIV Epidemic (EHE) initiative, coordinated by the HHS Office of the Assistant Secretary of Health, focuses on four key strategies (Diagnose, Treat, Prevent, and Respond) that represent key strategies to end the HIV epidemic in the U.S. The EHE initiative addresses inequities in HIV prevention, linkage to care, and optimal uptake of antiretroviral therapy (ART) by prioritizing efforts in U.S. localities.

The US cannot end the overdose and HIV syndemic without attending to the risks and service needs of individuals involved with the criminal legal system. Populations identified in the federal EHE Initiative are over-represented in the criminal legal system, although the initiative does not specifically address justice-related settings. These over-represented populations include people who inject drugs, as well as key populations where drug use often contributes to sexual risks, such as sex workers and members of sexual gender minorities.

In response to this need, NIDA released a set of interrelated Notice of Funding Announcements (RFA-DA-24-015; RFA-DA-24-022), along with the coordinating center infrastructure requested in this notice, to create the Justice HIV and Overdose Research Network. Under this initiative, a set of seven Regional Research Hubs (RRHs) were funded as well as a Patient Engagement Resource Center (PERC). Funded centers can be found here: https://nida.nih.gov/research/nida-research-programs-activities/justice-system-research 

Collectively, this Justice HIV and Overdose Research Network will focus on developing scalable models for delivering HIV diagnostic, prevention and treatment services for individuals with substance use disorders (SUD; not limited to opioid use disorders) who are involved in the criminal legal system, including both adults and juveniles, whether within carceral settings (jails and prisons); under community supervision (probation and parole); or at earlier intercept points (e.g., diversion, deflection, courts). This NOSI seeks to add a component to this network to support data coordination, dissemination, and collaboration across this network as described in detail below.

Research Objectives

Purpose and Scope of Network Support Activities

The proposed supplement(s) will provide support infrastructure to a network of 7 Regional Research Hubs (RRHs). Each funded RRH will conduct a phased research project with the goal of developing effective, replicable, scalable models for delivering integrated HIV/SUD services for criminal legal populations in communities with disproportionate HIV burden and to high-risk populations. The RRH phased awards include an R61 pilot phase and a R33 phase where each Hub will conduct a multi-site hybrid effectiveness implementation study. RRHs will be use common measures across the R33 studies and will also conduct collaborative research projects with other RRHs. The PERC will directly engage persons with lived experience in HIV, SUD, and the criminal legal system and ensure that patient perspectives are broadly represented across the entirety of the network’s activities. 

This NOSI seeks applications, with at least three remaining years of the currently approved project, to support the network activities of the RRHs and PERC by providing either:

a) administrative coordinating infrastructure, communications, and dissemination support; or

b) data infrastructure support; or

c) both coordinating and data infrastructure over a 5-year period.

Specific activities for each functional area include:

Administrative Coordination, Communication, and Dissemination Infrastructure Support:

Applicants who wish to apply to support the network through administrative coordination and communications infrastructure will be responsible for the following activities:

• Providing logistical support and hosting monthly executive committee meetings and an annual in-person executive committee meeting throughout the project period. The executive committee will be composed of research investigators, patient, and stakeholder representatives from each research center; investigators from the PERC; and the providers of administrative coordinating support. These meetings will provide a forum to (1) present research updates; (2) share research resources; and (3) identify opportunities for synergy and collaboration (e.g., data harmonization, protocol modifications).
• Coordinating trans-network working groups that arise to support synergistic activities within this network (e.g., publication policy, data policy, biostatistics, and subject recruitment).
• Establishing internal and external facing communication infrastructure and dissemination strategies for network products, publications, and other research outputs.
• Providing resources and support for coordinated tracking of network-wide projects and progress.

Dissemination Support and Stakeholder Engagement:

Applicants will be expected to lead efforts to translate network findings into resources of interest to external stakeholders. To achieve this goal, they will be responsible for facilitating bidirectional communication and translation between network investigators and external stakeholders. External stakeholder groups include practitioners and policymakers at local, state, and federal levels across a range of criminal legal settings and community-based HIV and SUD services providers that work with justice-involved populations. Responsibilities will include:

• Identifying key audiences for dissemination and engagement and best pathways to communicate with these audiences.
• Developing courses, resources, and other research-based materials to support widespread adoption of science-based practices and interventions. Applicants are expected to work closely with the RRHs and PERC to determine what dissemination support and products would be most beneficial to the projects and the field more broadly. Each year the grant is active, they will collaboratively develop a work plan to provide timely support.
• Track publications, products, and other materials developed by the RRHs and PERC and facilitate the dissemination of these materials, including creating translational products for various audiences.
• Rigorous tracking of metrics to better understand the utilization and uptake of the products created.

Rapid Research Projects:

Policies and practices are rapidly changing and many opportunities for generating insights into the effectiveness of emerging policies and practices go uncaptured. Key research questions may emerge from collaborative discussions across the network. Applicants are expected to provide a flexible structure to be responsive to these emerging needs, including capacity to conduct novel policy, modeling, survey and/or epidemiological research to help support the efforts of the RRHs and broaden the impact of the network. Responsibilities include:

• Proposing one research project to take place during the first year of the network that could provide cross-cutting information on opportunities to make maximal impact in the targeted settings.
• For subsequent years, a research agenda will be set annually with input from the network and subject to approval by NIH. Applicants should outline a process for soliciting input across the network and evaluating emerging research priorities on an annual basis.

Data and Analytic Infrastructure Support:

Applicants who wish to apply to support the network through services related to data and analytic infrastructure support, will be responsible for the following activities:

• Providing NIH with quarterly reports on overall network progress related to participant recruitment, enrollment, findings from the clinical research centers within this network, and other progress metrics.
• Facilitating and supporting efforts by the RRHs to select and implement Common Measures, Data Sharing, and Data Coordination. This may include conducting pilot work to assist in the selection and prioritization of measures. Common Measures will be selected through collaborative discussions among the RRHs and PERC. This work is expected to build upon core measures that have already been developed for related initiatives, such as the Justice Community Opioid Innovation Network (JCOIN). See: https://nida.nih.gov/research/nida-research-programs-activities/justice-system-research.
• Providing resources to support and expand upon economic analyses proposed by RRHs if necessary and/or lead network-wide economic analysis efforts.
• Developing and implementing a plan for data sharing and collaborative analyses across the network, including providing shared infrastructure while the awards are active and taking the lead in planning and coordinating data archiving efforts.
• Providing resources to supplement/support analytic efforts for pilot studies and cross-hub research efforts as needed.

Prospective applicants for either or both functions are strongly encouraged to read the RFAs on RRHs (RFA-DA-24-015) and PERC (RFA-DA-24-022) to better understand the intended purpose and structure of the HIV/Justice Research Network. Applications funded through these RFAs are described here: https://nida.nih.gov/research/nida-research-programs-activities/justice-system-research 

Description of circumstances for which administrative supplements are available.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-24-201 Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-24-201 must be followed, with the following additions:

• NIDA intends to commit $1.5M in FY 2024 to fund up to 2 awards, one per each functional area (coordination infrastructure and data infrastructure).
• Applications must specify whether they propose to provide either a) coordinating infrastructure support; or b) data infrastructure support; or c) both coordinating and data infrastructure support in both the Specific Aims and Research Strategy.
• The Research Strategy section of the application is limited to 6 pages per function:
  • Limited to 6 pages for applications proposing to provide either a) coordinating infrastructure support; or b) data infrastructure support;
  • Limited to 12 pages for applications proposing to provide both coordinating and data infrastructure support.
•  
• Applications that propose to provide coordinating infrastructure support may request up to $650,000 in direct costs per year; applicants that propose to provide data infrastructure support may request up to $350,000 in direct costs per year; applicants that propose to fulfill two functional areas may request up to $1,000,000 in direct costs per year.
• Applications that propose to provide coordinating infrastructure must budget a minimum of $200,000 and a maximum of $250,000 (direct costs) to support the proposed Rapid Research Projects.
• The parent award must be active when the application is submitted. 
• There is no restriction on award mechanisms eligible to apply. All applications should describe relevant expertise in (a) justice, infectious diseases, and/or substance use research; and (b) experiences in coordinating and/or data infrastructure operation.
• Applications will be accepted on a rolling basis through July 12, 2024, by 5:00 PM local time of the applicant organization. 
• IMPORTANT: For funding consideration, all applicants must designate NOT-DA-24-013 (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.
• Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact the Grants Management Specialist on their active award to determine eligibility and the Program Officer on their active award to discuss the proposed project in the context of the parent award.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative. The following applications will be considered non-responsive and will not be reviewed:

• Applications that do not include activities for either coordination infrastructure or data infrastructure;
• Applications that do not have at least three remaining years of the currently approved project. 

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

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions:

Angela Lee-Winn, PhD
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse (NIDA)
Phone: 301-451-7206
Email: [email protected]