Key Dates

Related Announcements

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

RFA-MD-17-003- Research Centers in Minority Institutions (RCMI) (U54)

RFA-MD-17-006- Research Centers in Minority Institutions (RCMI) (U54)

RFA-MD-18-012- Research Centers in Minority Institutions (RCMI) (U54 Clinical Trials Optional)

RFA-MD-20-006- Research Centers in Minority Institutions (RCMI) (U54 Clinical Trials Optional)

Issued by

National Institute on Minority Health and Health Disparities (NIMHD)

Purpose

Background

The objective of the Ending the HIV Epidemic (EHE) in the U.S. is to reduce new HIV infections in the United States by 75% in five years and by 90% by 2030 (https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview). This will be accomplished by implementing proven strategies to prevent new HIV infections – including use of pre-exposure prophylaxis (PrEP) by high-risk HIV-negative individuals and achieving an undetectable viral load through antiretroviral therapy (ART) among individuals living with HIV – in geographic hotspots with disproportionate numbers of new HIV infections. New infections disproportionately occur in young men who have sex with men (MSM) from racial/ethnic minority populations, particularly African Americans and Latinos. However, the subpopulations at the highest risk of acquiring HIV may vary across geographic hotspots and include American Indian/Alaska Native populations, migrants, cisgender and transgender women, persons who use drugs and alcohol, criminal justice-involved populations, and persons who engage in sex work. Challenges in engaging these high-risk populations may also vary depending on local or state HIV-related resources, laws and policies, and social norms and cultural factors.

Research Objectives

NIMHD is soliciting administrative supplements for NIMHD-funded Research Centers in Minority Institutions (RCMI) U54 awardees to conduct collaborative HIV prevention and treatment research in geographic areas with a high rate of new HIV infections.

Research opportunities that warrant exploration include local, accessible implementation of HIV prevention and treatment interventions, including those in non-traditional settings and using unconventional modalities, that engage and address the needs of the highest risk populations.

Supplement projects are expected to develop and pilot HIV prevention and/or treatment interventions in collaboration with community partners in one or more geographic hotspots (see https://files.hiv.gov/s3fs-public/Ending-the-HIV-Epidemic-Counties-and-Territories.pdf for a list of hotspots). Interventions are expected to have the following features:

• Have a primary focus on NIH-designated populations that experience health disparities.
• Promote PrEP awareness,uptake, and other HIV prevention efforts.
• Promote HIV testing in HIV-negative individuals and/or ART initiation and adherence and viral suppression in persons living with HIV. Status neutral approaches that provide both HIV prevention and treatment services are encouraged.
• Includes multi-level approaches as identified in the NIMHD Research Framework and addresses the relevant social determinants using measures available in the Social Determinants of Health Collection of the PhenX Toolkit, as appropriate.
• Interventions to address the challenges that can impact the engagement of these high-risk populations (which may vary depending on local or state HIV-related resources, laws and policies, and social norms and cultural factors) and their adherence to treatment plans.
• Use existing evidence-based HIV-prevention or treatment interventions or practices (including adaptations of effective practices in new contexts), either alone or in combination with new intervention elements. Developing entirely new interventions are not the focus of this NOSI.
• Are conducted in partnership with service providers or organizations responsible for delivering HIV prevention or treatment services or programs at the local, state, or regional level. Partnerships with community-based organizations, HIV advocacy groups, and state/city/local health departments are strongly encouraged.
• Emphasize intervention effectiveness, comparative effectiveness, implementation strategies, or optimization of multi-level and multi-domain interventions. Methodology that is grounded in a guiding implementation model, theory, or framework and measures specific implementation outcomes is strongly encouraged.

Projects are expected to be clinical trials in which participants or settings are prospectively assigned by study investigators to intervention conditions as part of the project. Because of the pilot nature of these projects, it is not expected that interventions will be able to demonstrate impacts on HIV incidence or viral suppression within the supplement period. Interim behavioral outcomes, including HIV testing, HIV prevention behaviors (e.g., PrEP initiation and adherence, condom use, reduction of high-risk sexual behaviors), and HIV treatment behaviors (e.g., engagement in HIV care, initiation and adherence to ART, partner initiation of PrEP) are acceptable for this initiative. However, projects with outcomes that are limited to knowledge or attitudes about HIV prevention or treatment are not a priority for this initiative. In addition, developing entirely new interventions would not be considered a priority in this NOSI.

Specific Areas of Research Interest

Research topics of interest include, but are not limited to:

• Testing of interventions in geographic hotspots that have not had significant EHE research focus to date, including 5 rural EHE states: Arkansas, Kentucky, Missouri, Oklahoma, and South Carolina; and the following EHE counties: Maricopa Co, AZ; Orange, Riverside, Sacramento, San Bernardino Counties, CA; Broward, Hillsborough, Orange, Palm Beach, Pinellas, Duval Counties, FL; Cobb, Gwinnett Counties, GA; Marion County, IN; East Baton Rouge Parish, LA: Montgomery, Prince George’s Counties, MD; Wayne County, MI; Essex, Hudson Counties, NJ; Clark County, NV; Cuyahoga, Franklin, Hamilton Counties, OH; Bexar, Dallas, Tarrant, Travis Counties, TX.
• Multi-level interventions, including those that involve peers, friends, sexual partners, family members, school systems, community members, community- or faith-based organizations, healthcare systems, community clinics, or other relevant service providers.
• Adherence interventions for PrEP and ART that are status neutral, i.e. that include both HIV negative and positive individuals.
• Interventions that include individuals from NIH-designated health disparity populations who also fall into other high-risk groups, including migrants, persons who use drugs and alcohol, criminal justice-involved populations, and persons who engage in sex work.
• Interventions that include clinician- or healthcare setting-level intervention components to enhance cultural competency, reduce health-care related stigma and discrimination, and increase clinician comfort and willingness to prescribe PrEP or ART.
• Projects that involve community members of the target high-risk and NIH-designated populations that experience health disparities or subgroups as investigators, advisors, or peer interventionists.
• Projects that involve collaboration with diverse local stakeholders in addition to HIV-prevention service providers, including school systems, school-based student or parent associations, community-based organizations, consumer organizations, and faith-based organizations, to enhance intervention relevance, feasibility, and sustainability and address relevant social determinants of health.

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-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date(s) – July 31, 2022, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include “NOT-MD-22-021” (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.
• To be eligible, the parent award must be active when the supplement application is submitted (i.e., within five years of the start date of the originally reviewed and approved project period of the existing parent RCMI’s U54 competitive segment; or if applicable, within the originally reviewed and approved project period of a funded competitive revision), and have sufficient time left to complete the studies proposed within this project period at the time of application.
• The supplement proposed must be within the scope of the peer reviewed and approved parent RCMI project, including competitive revisions. Administrative supplement applications may not propose changes to the overall human subjects or clinical trial designation of the award.
• Requests may be for up to one or two years of support (if sufficient time is left to complete the studies proposed within the parent award’s above-referenced project period and the currently approved project period of the parent award).
• Budgets are limited to $500,000 direct costs per year, not including consortium F&A costs.
• The Research Strategy section of the application is limited to 6 pages.
• Only active RCMI U54 awards supported under RFA-MD-17-003, RFA-MD-17-006, RFA-MD-18-012, or RFA-MD-20-006 are eligible to apply.
• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Applications not responsive to this NOSI:

• Projects supplementing awards that are not eligible under this NOSI.

• Projects that are not within the scope of the peer reviewed and approved parent RCMI project, including competitive revisions, e.g., that propose changes to the overall human subjects or clinical trial designation of the award.

• Projects conducting research outside of the U.S. or its territories and possessions, the Commonwealth of Puerto Rico, or the Trust Territory of the Pacific Islands, or requesting foreign components.

Applications nonresponsive to these terms will be withdrawn for this NOSI initiative.

Inquiries

Please direct all inquiries to:

Scientific/Research Contact:

Richard Berzon, DrPH, PA
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8949
Email: [email protected]

Yewande Oladeinde, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-402-1366
Email: [email protected]

Financial/Grants Management Contact:

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]