RFA-PS-21-001 FINAL 10 16 20.pdf

Centers for Disease Control and Prevention

National Center for HIV-AIDS, Viral Hepatitis, STD, and TB Prevention Extramural Research Program Office

Minority HIV Research Initiative (MARI) to Support Epidemiologic and Implementation Science Research in Racial/Ethnic Minority Communities Disproportionately Affected by HIV and Build Research Capacity Among Historically Underrepresented Researchers

RFA-PS-21-001

Application Due Date: 10/23/2020

Minority HIV Research Initiative (MARI) to Support Epidemiologic and Implementation Science Research in Racial/Ethnic Minority Communities Disproportionately Affected by HIV and Build Research Capacity Among Historically Underrepresented Researchers

RFA-PS-21-001

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Notice of Funding Opportunity (NOFO) Title Minority HIV Research Initiative (MARI) to Support Epidemiologic and Implementation Science Research in Racial/Ethnic Minority Communities Disproportionately Affected by HIV and Build Research Capacity Among Historically Underrepresented Researchers Activity Code U01 - Research Project - Cooperative Agreement

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-PS-21-001

Assistance Listings (CFDA) Number(s) 93.943 93.941 Category of Funding Activity:

Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to support promising epidemiologic and implementation science research in racial/ethnic minority communities disproportionately affected by HIV while strengthening the capacity for conducting such research among investigators working in these communities. The NOFO supports Centers for Disease and Control and Prevention's (CDC's) goals to promote health and reduce disease and disability by funding research that has the potential to result in high public health impact.

The NOFO is aligned with the federal initiative for Ending the HIV Epidemic (EHE) by 2030.

The EHE plan encompasses the following four key strategies: (i) diagnose all individuals with HIV as early as possible; (ii) treat people with HIV rapidly and effectively to reach sustained viral suppression; (iii) prevent new HIV transmissions by using proven interventions, including PrEP and syringe services programs (SSPs); (iv) respond quickly to potential HIV outbreaks to get needed prevention and treatment services to people who need them.

The goals of the NOFO are:

1. To build capacity in epidemiologic and implementation science research related to HIV prevention and services in minority communities by partnering with early-career investigators to address pertinent research questions with potential for accelerating the progress to Ending the HIV Epidemic by 2030.

2. To foster investigator-initiated research by early-career investigators at academic institutions, who serve minority communities disproportionately affected by HIV infections, that complements and extends programmatic activities by the local and state departments of health toward Ending the HIV Epidemic by 2030.

Key Dates Publication Date:

Letter of Intent Due Date:

Application Due Date:

To receive notification of any changes to RFA-PS-21-001, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

09/14/2020

10/23/2020

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S.

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 12/15/2020

Secondary Review:

Estimated Start Date:

Expiration Date:

Due Dates for E.O. 12372:

01/26/2021

05/01/2021

10/24/2020 Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and https://www.grants.gov submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 12 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary

Purpose: The purpose of this Notice of Funding Opportunity (NOFO) is to support promising epidemiologic and implementation science research in racial/ethnic minority communities disproportionately affected by HIV while strengthening the capacity for such research among investigators working in these communities. The NOFO supports CDC's goals to promote health and reduce disease and disability by funding research that has the potential to result in high public health impact.

Mechanism of Support: U01 - Research Project - Cooperative Agreement. This is a teaching/mentored cooperative agreement.

Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire three (3)-year project period is $10,500,000. The number of awards is estimated to be up to ten (10). Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded, and the number of awards, will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) is $3,500,000, with individual awards estimated to be up to $350,000 for the first year. The estimated total funding (direct and indirect) for the entire three (3)-year project period will be $10,500,000. The project period is anticipated to run from 05/01/2021 to 04/30/2024. An indirect cost rate of 8% is not automatic; however, grantee institutions can elect to take an indirect cost rate of 8% should they choose to do so. Setting an indirect cost rate at 8% is not required.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. "Application and Submission Information" of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III. of this announcement are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE:

CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. There will only be one PD/PI (Project Director/Principal Investigator) for each application. Each application must identify 5-10% effort by a local, senior investigator as a mentor who can realistically devote support and mentorship to the PD/PI and the research project based on the proposal and letters of support.

Number of Applications. Applicant organizations may submit more than one application, provided that each application is scientifically distinct, has a different PD/PI and a different primary mentor.

Application Type. New.

Application Materials. See Section IV.1 for application materials. Please note that

Forms-F are to be used when completing the application package.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Public Health Service Act Sections 301 [42 USC 241], 317 [42 USC 247b(k)(2)], and 318 [42 USC 247c], as amended.

1. Background and Purpose The purpose of this NOFO is to support promising epidemiologic and implementation science research in racial/ethnic minority communities disproportionately affected by HIV while strengthening the capacity for high-impact research among underrepresented racial/ethnic minority investigators working in these communities. The NOFO supports CDC's goals to promote health and reduce disease and disability by funding research that has the potential to result in high public health impact.

The NOFO is aligned with the federal initiative for Ending the HIV Epidemic (EHE) by 2030.

In particular, the NOFO supports CDC's HIV prevention strategic plan to reduce the number of new HIV infections in the U.S. by focusing on eliminating racial and ethnic disparities in new HIV infections. CDC's HIV surveillance report revealed that, in 2018, blacks/African Americans and Hispanics/Latinos accounted for 69% of HIV diagnoses but comprised only 31% of the U.S. population. This statistic highlights the urgent need for HIV epidemiologic, health services and implementation research in minority communities to effectively intervene on modifiable risk factors and reduce the rates of new HIV infections.

The proposals for this three (3)-year project should focus on relevant and consequential epidemiology or implementation research projects that (a) have a potential to advance knowledge and practice in support of Ending the HIV Epidemic in the United States by 2030,

(b) relate to addressing racial/ethnic disparities in HIV and advancing health equity, (c) inform or extend the programmatic work by the local and state health departments and local non-governmental organizations, and (c) if successful, have a potential to be sustainable, relevant and scalable to communities and populations outside of the study sites. Consultation and collaboration with local and state health department programs and community-based organizations from the outset of the project is encouraged to maximize the opportunities that the knowledge gained, and the effective strategies developed, will be incorporated into local programming related to Ending the HIV Epidemic.

NOTE: Applicants must submit an investigator-initiated proposal and define one or more research questions the project will address. Each application must clearly specify the following four (4) aspects for the proposed project:

1) Type of research project [chose one]

Original epidemiologic research (including designing and conducting observational and interventional studies related to HIV prevention or services) Implementation science research (including using existing evidence-based or evidence-informed HIV-related interventions in new populations or settings and optimizing intervention uptake, effectiveness and efficiency)*

* See: https://www.cdc.gov/hiv/effective-interventions/index.html https://www.cdc.gov/hiv/research/interventionresearch/compendium/index.html

2) The Ending the HIV Epidemic Initiative strategy to which the project relates [chose all that apply]:

Diagnose all individuals with HIV as early as possible Treat people with HIV rapidly and effectively to reach sustained viral suppression Prevent new HIV transmissions by using proven interventions, including PrEP and syringe services programs (SSPs) Respond quickly to potential HIV outbreaks to get needed prevention and treatment services to people who need them

3) The target population for the proposed project, within these priority groups [chose all that apply]:

Racial/ethnic minority gay, bisexual and other men who have sex with men (MSM) Racial/ethnic minority cis-gender women Racial/ethnic minority transgender women Racial/ethnic minority heterosexual men

4) Racial/ethnic minority populations that project will focus on [chose all that apply]:

https://www.cdc.gov/hiv/effective-interventions/index.html https://www.cdc.gov/hiv/research/interventionresearch/compendium/index.html

Black/African American Hispanic/Latino Asian/Pacific Islander American Indian/Alaska Native Multiple races

In developing their own specific research proposal suitable for their target population, the applicants may be guided by some general questions relevant to the four (4) strategies for Ending the HIV Epidemic (EHE) in the United States by 2030, below. However, please note that this list of questions is not exhaustive. Applicants are encouraged to propose projects related to EHE that they believe may have most relevance for and impact in their selected communities.

1. Diagnose all individuals with HIV as early as possible.

a. What HIV testing strategies might be effective for identifying persons with early HIV infections and for reducing the percentage of people with undiagnosed HIV in clinical and non-clinical settings? Consider options including laboratory-based testing, point-of-care and mobile testing and self-testing.

b. How can public health engage effectively with partners (e.g., corrections, social service agencies, homeless shelters, STD clinics) to improve timely diagnosis of HIV and subsequent navigation/linkage to care?

c. What enhancements to social network testing or partner-services testing approaches are promising for diagnosing HIV in hard-to-reach populations?

2. Treat people with HIV rapidly and effectively to reach sustained viral suppression

a. How can initiating ART immediately (or as soon as possible) and other immediate ART programs be scaled up and effectively delivered?

b. What types of community-driven or health-services focused interventions could improve the antiretroviral adherence and reaching viral suppression in a target population?

c. What support systems and multidisciplinary approaches could improve linkage and retention in care for people with HIV who face multiple barriers (including social, structural) to treatment and durable suppression? Consider, for example, integrated case management, data-to-care, or other novel approaches (e.g., telemedicine programs using videoconferencing).

d. How do we increase access to and uptake of HIV care among people who had HIV diagnosed but currently are not in HIV care or accessing any HIV-related services?

3. Prevent new HIV transmissions by using proven interventions, including PrEP and syringe services programs (SSPs).

a. What approaches (at the patient-level or provider/clinic-level) increase awareness of and prescription of PrEP and retention in PrEP services for at-risk persons? Consider navigation to and maintenance of PrEP through various care delivery services (e.g., community health centers, telemedicine combined with pharmacy services).

b. How do we effectively engage communities with high incidence of HIV infection and traditionally low PrEP uptake in PrEP promotion and other HIV prevention strategies that involve families, service providers or community entities (e.g., federally qualified health centers, LGBTQ centers, faith-based settings)?

c. What approaches can be used to increase the awareness and understanding of HIV treatment as prevention and that being undetectable is prevention in racial/ethnic minority populations?

d. What culturally appropriate strategies increase engagement in SSPs and uptake of HIV prevention tools/strategies among people with substance use or injection drug use risk?

4. Respond quickly to potential HIV outbreaks to get needed prevention and treatment services to people who need them.

a. How can local and state health departments engage with communities of color for more effective HIV outbreak response and control?

b. What are the informational gaps around analysis of molecular data for outbreak detection and control and how can this information be appropriately disseminated within the communities with assistance of various public health partners?

c. What barriers experienced by communities of color might impact outbreak response (e.g., mistrust of government and/or medical/public health systems, experiencing disproportionate harms from policing or immigration enforcement, reduced access to care) and how can these barriers be mitigated?

d. How can local and state health departments identify community-based organizations, providers, and other partners for outbreak response and more effectively engage with racial/ethnic communities either experiencing or at risk of experiencing HIV outbreaks?

How do we stimulate and establish effective partnerships in this public health area?

References:

Brown CH, Curran G, Palinkas LA, Aarons GA, Wells KB, et al. An overview of research and evaluation designs for dissemination and implementation. Annu Rev Public Health. 2017.

20;38:1-22.

Centers for Disease Control and Prevention. HIV Surveillance Report, 2017; vol. 29. http ://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published November 2018.

Centers for Disease Control and Prevention. Vital Signs: Status of Human Immunodeficiency Virus Testing, Viral Suppression, and HIV Preexposure Prophylaxis - United States, 2013- 2018. MMWR, December 6, 2019 / 68(48);1117-1123.

Centers for Disease and Control and Prevention. HIV and transgender communities brief. April 2019. Available at: https://www.cdc.gov/hiv/pdf/policies/cdc-hiv-transgender-brief.pdf Centers for Disease Control and Prevention. HIV injection drug use: Syringe services programs for prevention. December 2016. https://www.cdc.gov/vitalsigns/pdf/2016-12-vitalsigns.pdf Jeffries WL 4th, Henny KD. From epidemiology to action: The case for addressing social determinants of health to end HIV in the Southern United States. AIDS Behav. 2019 Oct;23(Suppl 3):340-346.

Jenness SM, Maloney KM, Smith DK, Hoover KW, Goodreau SM, Rosenberg ES, Weiss KM, Liu AY, Rao DW, Sullivan PS. Addressing gaps in HIV preexposure prophylaxis care to reduce http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html https://www.cdc.gov/hiv/pdf/policies/cdc-hiv-transgender-brief.pdf https://www.cdc.gov/vitalsigns/pdf/2016-12-vitalsigns.pdf racial disparities in HIV incidence in the United States. Am J Epidemiol. 2019;188(4):743-752.

Huang YA, Zhu W, Smith DK, Harris N, Hoover KW. HIV preexposure prophylaxis, by race and ethnicity - United States, 2014-2016. MMWR Morb Mortal Wkly Rep. 2018;67(41):1147- 1150.

Marston HD, Dieffenbach CW, Fauci AS. Ending the HIV Epidemic in the United States:

Closing the Implementation Gaps. Ann Intern Med. 2018 Sep 18;169(6):411-412.

Pinnock, H., Barwick, M., Carpenter, C. R., Eldridge, S., Grandes, G., Griffiths, C. J., . . . Sta, R. I. G. (2017). Standards for Reporting Implementation Studies (StaRI) Statement. BMJ, 356, i6795.

Rabin, B. A. & Brownson, R. C. (2018). Terminology for Dissemination and Implementation Research. In R. C. Brownson, G. A. Colditz, and E. K. Proctor (Eds.), Dissemination and Implementation Research in Health: Translating Science to Practice, Second Edition (Ch. 2).

New York: Oxford University Press.

Rosenberg ES, Millett GA, Sullivan PS, Del Rio C, Curran JW. Understanding the HIV disparities between black and white men who have sex with men in the USA using the HIV care continuum: a modeling study. Lancet HIV. 2014;1(3):e112-e118.

Sheils M, Freedman N, Thomas D, Berrington de Gozalex A. (2018). Trends in U.S. drug overdose deaths in non-Hispanic black, Hispanic, and non-Hispanic white Persons, 2000-2015.

Ann Intern Med. 2018;168: 453-455. doi: 10.7326/M17-1812.

Health Equity:

The program supports efforts to improve the health of populations disproportionately affected by HIV/AIDS, viral hepatitis, sexually transmitted diseases (STDs) and TB by maximizing the health impact of public health services, reducing disease prevalence, and promoting health equity consistent with the National HIV/AIDS Strategy available at http://www.whitehouse.gov /administration/eop/onap/nhas.

Health disparity is a particular type of health difference that is closely linked with social or economic disadvantage based on racial or ethnic group, religion, socioeconomic status, gender, mental health, cognitive, sensory, or physical disability, sexual orientation, geographic location, or other characteristics historically linked to discrimination or exclusion [HP 2020 - http://www .healthypeople.gov/2010/hp2020/advisory/PhaseI/glossary.htm]. Health disparities in HIV, viral Hepatitis, STDs, and TB are inextricably linked to a complex blend of social determinants that influence which populations are most severely affected by these diseases.

Social determinants are the economic and social conditions that influence the health of individuals, communities and jurisdictions and include conditions for early childhood development; education, employment, and work; food security, health services, housing, income, and social exclusion.

Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic disadvantage. It requires:

Continuous efforts focused on elimination of health disparities, including disparities in health and in the living and working conditions that influence health, and

Continuous efforts to maintain a desired state of equity after particular health disparities http://www.whitehouse.gov/administration/eop/onap/nhas http://www.whitehouse.gov/administration/eop/onap/nhas http://www.healthypeople.gov/2010/hp2020/advisory/PhaseI/glossary.htm http://www.healthypeople.gov/2010/hp2020/advisory/PhaseI/glossary.htm are eliminated.

Programs should use data, including social determinants data, to identify communities within their jurisdiction that are disproportionately affected by HIV, viral hepatitis, STDs and TB and related diseases and conditions, and plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, programs should consider social determinants of health in the development, implementation, and evaluation of program specific efforts and use culturally appropriate interventions that are tailored for the communities for which they are intended.

Healthy People 2020 and other National Strategic Priorities Research proposed as part of this teaching/mentored award will support the following Healthy People 2020 objectives related to HIV:

HIV-2, Reduce the number of new infections among adolescents and adults HIV-3, Reduce the rate of HIV transmission among adolescents and adults HIV-9, Reduce the proportion of persons with a diagnosis of Stage 3 HIV (AIDS) within

3 months of diagnosis of HIV infection HIV-13, Increase the proportion of persons living with HIV who know their serostatus HIV-14, Increase the proportion of adolescents and adults who have ever been tested for

HIV

HIV-19, Increase the proportion of persons who are linked to HIV medical care (had a routine HIV medical visit) within 3 months of HIV diagnosis HIV-21, Increase the proportion of persons with an HIV diagnosis in medical care who were prescribed antiretroviral therapy for the treatment of HIV infection at any time in the 12-month measurement period

HIV-22, Increase the proportion of persons with an HIV diagnosis in medical care with a viral load <200 copies/mL at the last test during the 12-month measurement period

The Healthy People 2020 site is available at: https://www.healthypeople.gov/2020/topics-objec tives/topic/hiv.

Other National Public Health Priorities The activities under this NOFO will also support multiple national public health priorities:

Ending the HIV Epidemic: A Plan for America: https://www.hiv.gov/federal-response /ending- the-hiv-epidemic/overview The new initiative seeks to reduce the number of new HIV infections in the United States by 75 percent within five years, and then by at least 90 percent within 10 years, for an estimated 250,000 total HIV infections averted.

The HHS Strategic Plan, FY 2018-2022: https://www.hhs.gov/about/strategic-plan/strat egic- goal-2/index.html

National HIV/AIDS Strategy: Update 2020: https://www.hiv.gov/federal-response/natio nal-hiv- aids-strategy/nhas-update

CDC Division of HIV/AIDS Prevention Strategic Plan 2017-2020: https://www.cdc.gov /hiv/pdf/dhap/cdc-hiv-dhap-external-strategic-plan.pdf

CDC National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) https://www.healthypeople.gov/2020/topics-objectives/topic/hiv https://www.healthypeople.gov/2020/topics-objectives/topic/hiv https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hhs.gov/about/strategic-plan/strategic-goal-2/index.html https://www.hhs.gov/about/strategic-plan/strategic-goal-2/index.html https://www.hhs.gov/about/strategic-plan/strategic-goal-2/index.html https://www.hiv.gov/federal-response/national-hiv-aids-strategy/nhas-update https://www.hiv.gov/federal-response/national-hiv-aids-strategy/nhas-update https://www.hiv.gov/federal-response/national-hiv-aids-strategy/nhas-update https://www.cdc.gov/hiv/pdf/dhap/cdc-hiv-dhap-external-strategic-plan.pdf https://www.cdc.gov/hiv/pdf/dhap/cdc-hiv-dhap-external-strategic-plan.pdf

Strategic Plan Through 2020: https://www.cdc.gov/nchhstp/docs/NCHHSTP-Strategic- Plan-through- 2020-508.pdf

HIV Care Continuum: https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-conti nuum

CDC Winnable Battles goal to reduce new HIV infections in the United States: http ://www.cdc.gov/winnablebattles/HIV/.

Additional details about previous CDC-funded mentored research to address disparities in HIV are available here: https://www.cdc.gov/hiv/dhap/eb/mari/index.html

Public Health Impact Since 2003, CDC has sought to build capacity for HIV epidemiologic and prevention research in black and Hispanic/Latino communities and among black and Hispanic/Latino investigators working in communities with high prevalence and incidence of HIV by supporting the Minority HIV Research Initiative (MARI) Award program. The MARI program has demonstrated success in preparing qualified early-career scientists for careers that have a significant impact on the HIV-related research needs of the nation, especially in racial/ethnic and sexual minority (e.g., men who have sex with men and transgender) communities. The award provides support for intensive research training and career development under the guidance of an experienced local mentor in HIV prevention research. This leads to promising HIV prevention programs and independent research activities in communities disproportionately affected by HIV. The NOFO supports CDC's overarching goal to promote health and reduce disease and disability.

The CDC and HHS will benefit from work conducted under this NOFO because the novel epidemiologic and implementation science research by minority early-career investigations will be informed, in part, by the priorities of the local and state health department executing Ending the HIV Epidemic plans. The collaborations between early-career investigators working in communities disproportionately affected by HIV and the relevant local and state health departments present new opportunities to address unmet needs and facilitate research-to-program innovation and translation. The resultant MARI research projects are primed to produce "innovatively disruptive" strategies and culturally tailored solutions, for underserved communities that may have been previously outside of the reach of local public health. In that way, MARI projects help close the implementation gaps in the adoption and dissemination of high impact HIV prevention throughout the nation.

This NOFO advances public health practice and delivery by directly engaging communities in research; by supporting development and adaptation of interventions informed by persons at risk of HIV; and by diversifying the HIV prevention research and care workforce with trained researchers from historically underrepresented communities. Collaborations with local health department partners and community-based organizations from the outset of the project are encouraged to maximize the incorporation of knowledge gained and effective strategies into local programming toward Ending the HIV Epidemic.

Relevant Work This research NOFO builds upon previous awards to historically underrepresented researchers working in minority communities with high prevalence and incidence of HIV. An update about the program and relevant publications can be found in the following report: http://ajph.aphap https://www.cdc.gov/nchhstp/docs/NCHHSTP-Strategic-Plan-through-2020-508.pdf https://www.cdc.gov/nchhstp/docs/NCHHSTP-Strategic-Plan-through-2020-508.pdf https://www.cdc.gov/nchhstp/docs/NCHHSTP-Strategic-Plan-through-2020-508.pdf https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-conti https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-conti https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum http://www.cdc.gov/winnablebattles/HIV/ http://www.cdc.gov/winnablebattles/HIV/ https://www.cdc.gov/hiv/dhap/eb/mari/index.html http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2013.301345 ublications.org/doi/abs/10.2105/AJPH.2013.301345 Applicants may also refer to related NOFOs for programmatic efforts related to Ending the HIV in the United States:

PS19-1906: Strategic Partnerships and Planning to Support Ending the HIV Epidemic in the United States: https://www.cdc.gov/hiv/funding/announcements/ps19-1906/index .html

PS20-2010: Integrated HIV Programs for Health Departments to Support Ending the HIV Epidemic in the United States: https://www.cdc.gov/hiv/funding/announcements /ps20-2010/index.html

2. Approach The following logic model summarizes the strategies and outcomes of the NOFO:

LOGIC MODEL: The purpose of this NOFO is to support promising epidemiologic and implementation science research in racial/ethnic minority communities disproportionately affected by HIV while strengthening the capacity for such high-impact research among under represented racial/ethnic minority investigators working in these communities.

Strategies and Activities

Intended Short-Term and Intermediate Outcomes

Intended Long-term Outcomes

Community and human capital development

Research and implementation

1: Funded investigators will engage with community stakeholders, relevant health departments and local mentors to propose and develop epidemiologic and implementation science research projects for Ending the HIV Epidemic in their communities.

1.1. Increased

engagement of historically under-represented minority communities in HIV research and developing or adapting effective interventions.

1.1. Experience gained, lessons learned and successful completion of an epidemiologic study or implementation science research project for evidence-based or evidence-informed intervention for priority populations at funded MARI sites.

A. Reduced HIV infections in racial/ethnic minority populations disproportionately affected by HIV.

B. Improved health outcomes for racial/ethnic minority persons living with diagnosed HIV infection.

C. Reduced HIV-related health http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2013.301345 https://www.cdc.gov/hiv/funding/announcements/ps19-1906/index.html https://www.cdc.gov/hiv/funding/announcements/ps19-1906/index.html https://www.cdc.gov/hiv/funding/announcements/ps20-2010/index.html https://www.cdc.gov/hiv/funding/announcements/ps20-2010/index.html

2: Funded investigators will develop and implement protocols to conduct high-impact HIV research in communities disproportionately affected by HIV, especially black/African American, Hispanic/Latino, and MSM communities.

3. Funded investigators will receive training and technical assistance from local and CDC mentors in support of study implementation, data dissemination, writing scientific abstracts and manuscripts, and presenting at scientific conferences.

2.1. Increased funded

research training for historically underrepresented HIV prevention scientists doing community-level research.

2.2. Improved

capacity of minority communities to engage in developing solutions for HIV prevention and services

3.1. Improved skills of

funded investigators for presenting at national and international scientific conferences and publishing research findings in peer-reviewed journals.

3.2. More successful

attempts for larger, federally funded HIV and health disparities research, such as NIH grants.

3.3. Improved ability

of funded investigators to navigate academic and research pathways for career progression.

2.1. Increased portfolio

of promising novel interventions and adapted existing evidence-based or evidence-informed interventions for communities by HIV.

2.2. Increased number

of persons who are tested for HIV and diagnosed earlier with HIV infection.

2.3. Increased number

of persons linked to and accessing HIV care with rapid treatment and achieving sustained viral suppression.

2.4. Increased number

of persons accessing PrEP and SSP services.

2.5. Increased

engagement of communities of color in HIV outbreak preparedness and response disparities.

D. Sustainable HIV prevention research capacity in historically underrepresented minority communities.

E. Improved health equity for a diverse HIV scientific workforce.

Objectives/Outcomes Each application should provide detailed descriptions of research goals and research questions and explain the proposed project's relevance to one or more of the Ending the HIV Epidemic strategies. Each application should clearly outline the anticipated short-term and intermediate project-specific outcomes (intended results) to be achieved by the end of the project. The application should present specific, measurable, achievable, realistic and time-phased (SMART) project objectives. The application should clearly indicate if the proposed three (3)-year project will represent original epidemiologic research or implementation science research related to an existing evidence-based or informed intervention (please refer to: https://www.cdc.gov/hiv/effec tive-interventions/index.html and specify which intervention).

Given public health crises that can arise (i.e., COVID-19), each applicant is encouraged to consider how recruitment and the informed consent process for study participants, administration of surveys, and delivery of potential interventions, could be done by means other than in-person contact, if necessary; for example, by using electronic telecommunications technologies (e.g., videoconferencing, the internet, live streaming, telemedicine, and texting, mobile apps and other e-health interventions) to support proposed project activities.

Target Population This NOFO focuses on populations that are at the highest risk for and disproportionately affected by HIV, consistent with data in the CDC's HIV Surveillance Report: https://www.cdc .gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2018-vol-30.pdf.

Applicants are encouraged to use additional data (including social determinants data) and materials available in the jurisdiction where the work is proposed (e.g., HIV care and prevention council plans, health department's Ending the Epidemic plans) to justify the selection of the target population that can benefit from participating in the project and its anticipated outcomes.

The application should demonstrate that the investigators have been actively working in and with people in the disproportionately affected population as part of their HIV prevention research, program implementation or clinical activities to date. The application should provide justification and supporting data for the target population as being disproportionately affected by HIV in the geographic area for the proposed projects and explain how the proposed research addresses gaps for and needs of the target population in that area.

Collaboration/Partnerships The Project Director/Principal Investigator (PD/PI) may choose to collaborate with partners who are also subject matter experts for their original epidemiologic research or implementation science research proposal. Consultation with local health department HIV/STD surveillance and prevention programs and with community-based organizations during the preparation of the proposal is encouraged so that the proposed research addresses known HIV prevention, implementation and services gaps. The application should include letters of support that indicate a Memorandum of Understanding (MOU) will be developed with each proposed partner after receiving the award. The letters of support should include: 1) specific roles and responsibilities of each partner, 2) names and titles of individuals who will be committed to this project, 3) a description of how progress will be measured, and 4) whether any funding will go to the proposed partner. These collaborations may be separate from the local senior mentor who will be supported at the 5-10% effort level in the proposal budget.

Consultation and partnering with the local health department for the duration of the project is encouraged to maximize opportunities that knowledge gained, and effective strategies developed, will be incorporated sustainably into further local programming toward Ending the HIV Epidemic in the jurisdiction.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a three (3)-year research project period. The application should describe specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the application's project plan and describe the development and implementation of project performance measures based on specific programmatic objectives.

https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2018-vol-30.pdf https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2018-vol-30.pdf

Ascertaining and reporting the number of persons who were engaged and served as part of research project screening, interventions and service provision is expected in the annual progress report. This includes reporting the number of persons tested for HIV, number of persons linked to HIV care, number of persons who achieved viral suppression, and number of persons referred to or prescribed PrEP, as a result of the project, whenever applicable. Please refer to the logic model for intended short-term, mid-term and long-term outcomes. Proposed type and scale of evaluation and monitoring activities as well as staffing or resources should be specified.

All applications should include a detailed study plan, and implementation science projects should include implementation science design, monitoring and evaluation framework. If the proposed implementation research project aims to evaluate implementation strategies for improving the integration of a proven intervention, the application should also specify the implementation logic model and which implementation outcomes will be measured in the project.

Translation Plan In this mentored award/cooperative agreement, MARI PD/PIs are supported in their data analyses, abstract/manuscript writing, and data dissemination efforts by their local mentors and by CDC. Dissemination plans should be well thought out and include efforts with local communities, presentations to the local and state health departments, presentations at national and international scientific meetings, and publication of results in peer-reviewed journals.

Attendance and presentations at CDC seminars, group site visits, and symposia, online or in person, to share interim findings is also encouraged. Attending initial (kick-off) and annual group meetings with other MARI-funded Principal Investigators to promote the development of methodologically rigorous epidemiologic research and implementation science, research findings dissemination, peer-based learning, and networking among investigators should be budgeted by investigators in the application in years 1-3 to attend these meetings in Atlanta, Georgia.

Section II. Award Information Funding Instrument Type: Cooperative Agreement

A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $10,500,000 Estimated total funding available for the first year (first 12 months), including direct and indirect costs: $3,500,000 Estimated total funding available for the entire period of performance, including direct and indirect costs: $10,500,000

Anticipated Number of Awards: 10

Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award ceiling and floor are for the first 12-month budget period only.

Award Ceiling: $350,000 Per Budget Period Award Floor: $0 Per Budget Period Total Period of Performance Length: 3 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf education Private institutions of higher education For profit organizations other than small businesses Small businesses

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions

Nonprofits (Other than Institutions of Higher Education):

Nonprofits (Other than Institutions of Higher Education)

Governments:

Eligible Agencies of the Federal Government U.S. Territory or Possession

Other:

Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms."

Federally Funded Research and Development Centers (FFRDCs):

FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://gov.ecfr.io/cgi-bin/searchECFR

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Additional Information on Eligibility

4. Justification for Less than Maximum Competition N/A

5. Responsiveness N/A

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https:// eportal.nspa.nato. int/ AC135Public/ Docs/ US%20Instructions%2 0for%20NSPA%20NCAGE.pdf

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principle Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process. During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements.