Key Dates

Related Announcements

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

Issued by

National Institute on Minority Health and Health Disparities (NIMHD)

Purpose

Background

The objective of the Ending the HIV Epidemic 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 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, 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. Local, accessible implementation of HIV prevention and treatment interventions, including in non-traditional settings and using unconventional modalities, that engage and address the needs of the highest risk populations are necessary if EHE efforts are to succeed.

Research Objectives

NIMHD and the Office of Infectious Disease and HIV/AIDS Policy (OIDP), US Department of Health and Human Services, are collaborating to solicit administrative supplements for NIMHD 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.

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 populations that experience health disparities. NIH-designated health disparity populations include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities.
• Promote PrEP awareness and uptake, condom use, and 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.
• Address relevant social determinants of health that serve as barriers to or facilitators of HIV prevention and treatment among the target populations. Examples of determinants that may be relevant include but are not limited to poverty, unemployment, limited health literacy, limited English proficiency, housing instability, food insecurity, criminal justice involvement, lack of social support, intimate partner violence, community violence, stigma and discrimination, and lack of access to culturally competent HIV care or pharmacy services. See the NIMHD Research Framework (https://www.nimhd.nih.gov/about/overview/research-framework.html) for additional examples of determinants across different domains and levels of influence and the Social Determinants of Health Collection of the PhenX Toolkit for potential measures (www.phenxtoolkit.org).
• 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. 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-component 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.

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, 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 health disparity populations 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.
   

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– July 30, 2021, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include “NOT-MD-21-023” (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 competitive segment; or if applicable, within the originally reviewed and approved project period of a competitive revision).
• 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 one or two years of support (if sufficient time is left to complete the studies proposed within the parent award’s current project period). The supplement project period must be within 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 Research Centers in Minority Institutions (RCMI) U54 awards supported under RFA-MD-17-003, RFA-MD-17-006, RFA-MD-18-012, or RFA-MD-20-006 are eligible
• Applicants are strongly encouraged to notify the NIMHD scientific contact that a request has been submitted in response to this FOA 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:

Nathan Stinson, Jr, PhD, MD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8704
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]