Foa_Content_of_RFA-PS-24-063 (1).pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STDS AND TB PREVENTION

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

RFA-PS-24-063

01/16/2024

Table of Contents 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

Overview Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations 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): Epidemiologic, Behavioral, 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-24-063

Assistance Listings Number(s) 93.943,93.941 Category of Funding Activity HL - Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to support promising epidemiologic, behavioral, and implementation science research addressing the drivers of health inequities in racial and ethnic minority communities disproportionately affected by HIV while strengthening the capacity for conducting such research among underrepresented 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 in the United States (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 pre-exposure prophylaxis (PrEP) and syringe services programs (SSPs);

(iv) respond quickly to potential HIV outbreaks to get vital prevention and treatment services to people who need them.

The goals of the NOFO are:

• To build capacity in epidemiologic, behavioral, and implementation science research related to HIV prevention and treatment services in minority communities by partnering with early-career investigators to address the drivers of health inequities in HIV outcomes in an effort to accelerate the progress to Ending the HIV Epidemic by 2030.

• To foster investigator-initiated research by early-career investigators at academic institutions that serve minority communities disproportionately affected by HIV infections; such research will complement and extend programmatic activities by the local and state departments of health toward Ending the HIV Epidemic by 2030.

Key Dates Publication Date:

To receive notification of any changes to RFA-PS-24-063, 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.

Letter of Intent Due Date:

12/15/2023 12/15/2023

Application Due Date:

01/16/2024 01/16/2024

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 11:59 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

https://www.grants.gov/ http://grants.nih.gov/support/index.html

• E-mail: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552

• Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays

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:

02/22/2024 Secondary Review:

03/22/2024 Estimated Start Date:

06/01/2024 Expiration Date:

01/17/2024 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - 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.

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

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

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, behavioral, and implementation science research addressing the drivers of health inequities in racial and ethnic minority communities disproportionately affected by HIV while strengthening the capacity for such research among early-career investigators from underrepresented groups 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 four (4)-year project period is mailto:commons@od.nih.gov https://grants.nih.gov/grants/how-to-apply-application-guide.html

$7,000,000. The number of awards will be five (5). 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) will be $1,750,000 for five (5) awards with individual awards of $350,000 each. The estimated total funding (direct and indirect) for the entire project period will be $7,000,000 for the NOFO. The project period is anticipated to run from 06/01/2024 to 05/31/2028. An indirect cost rate of 8% in a training award is not automatic nor required; however, recipient institutions can elect to take an indirect cost rate of 8% for this NOFO.

• 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.

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

• Number of PDs/PIs. There will only be one PD/PI for each application.

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

• Application Type. New

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

SF424 (R&R) Form H is to be used when completing the application package. Please see https://grants.nih.gov/grants/how-to-apply-application-guide.html

Section I. Funding Opportunity Description Statutory Authority Sections 301(a), 317(k)(2), and 318(a),(b) of the Public Health Service Act; 42 U.S.C. Sections 241(a), 247b(k)(2), and 247(a), (b).

1. Background and Purpose The purpose of this NOFO is to support promising epidemiologic, behavioral, and implementation science research addressing the drivers of health inequities in racial and ethnic minority communities disproportionately affected by HIV while strengthening the capacity for high-impact research among underrepresented early-career 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 in the United States (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. Social and structural determinants of health such as racism, stigma, access to healthcare, housing, transportation, and poverty are drivers of racial and ethnic disparities in new HIV diagnoses. CDC's HIV surveillance report revealed that, in 2020, Black/African American and Hispanic/Latino persons accounted for 69% of HIV diagnoses but comprised only 31% of the U.S. population. This statistic highlights the urgent need for HIV epidemiologic, behavioral, health services and implementation research in minority communities to effectively intervene on modifiable risk factors and reduce the rates of new HIV infections.

Addressing social and structural determinants of health has the greatest potential to reduce significant barriers to testing and diagnosis of HIV, engagement in prevention services, and linkage to and retention in HIV prevention and treatment services. Healthy People 2030 categorizes social determinants of health into five domains: 1) Economic Stability; 2) Education Access and Quality; 3) Health Care Access and Quality; 4) Neighborhood and Built Environment; and 5) Social and Community Context.

Applications for this four (4)-year project should focus on relevant and consequential epidemiological, behavioral, or implementation science research projects that (a) have a potential to advance knowledge and practice in support of EHE, (b) relate to addressing racial and ethnic disparities in HIV and advancing health equity, (c) address and/or investigate social or structural determinants of health and drivers of health inequities in HIV outcomes, (d) inform or extend the programmatic work by the local and state health departments and local non-governmental organizations, and (e) 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 are encouraged and community engagement from the outset of the project is required to maximize the opportunities that the knowledge gained and the effective strategies developed will be incorporated into local programming related to EHE.

Healthy People 2030 and other National Strategic Priorities Research proposed as part of this teaching/mentored award will support the following Healthy People 2030 objectives related to HIV.

• HIV-01, Reduce the number of new HIV infections

• HIV-02, Increase knowledge of HIV status

• HIV-03, Reduce the number of new HIV diagnoses

• HIV-04, Increase linkage to HIV medical care

• HIV-05, Increase viral suppression

• HIV-06, Reduce the rate of mother-to-child HIV transmission

Public Health Impact Since 2003, CDC has sought to build capacity for HIV epidemiologic and prevention research in Black/African American and Hispanic/Latino communities and among Black/African American 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 HIV-related research needs of the nation, especially in racial, ethnic, sexual and gender minority (e.g., gay, bisexual, and other 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 program 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 the Department of Health and Human Services (HHS) will benefit from work conducted under this NOFO because the novel epidemiologic, behavioral 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 innovative strategies and culturally tailored solutions for underserved communities that may have lacked prior in-depth community engagement or may not have been previously prioritized by public health researchers. MARI projects help close the implementation gaps in the adoption and dissemination of high impact HIV prevention programs throughout the nation.

This NOFO advances public health practice and delivery by directly engaging communities in research; by supporting the development and adaptation of interventions informed by persons disproportionately affected by HIV; by addressing the drivers of health inequities; and by diversifying the HIV prevention research and care workforce with trained researchers from historically underrepresented communities. Collaboration with the local health department and staff working on the Ending the HIV Epidemic initiative is encouraged. Direct engagement with community partners, advisory boards, and/or community-based organizations is required as part of early development and throughout implementation to maximize the incorporation of knowledge gained and effective, locally tailored strategies into 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:

https://ajph.aphapublications.org/doi/full/10.2105/AJPH.2013.301345

Applicants may also refer to related NOFOs for programmatic efforts related to Ending the HIV Epidemic 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 https://ajph.aphapublications.org/doi/full/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. 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, behavioral and implementation science research addressing the drivers of health inequities in racial and ethnic minority communities disproportionately affected by HIV while strengthening the capacity for such high-impact research among underrepresented 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 collaborators, relevant Health Departments (HDs) and local mentors to propose and develop epidemiologic, behavioral, and implementation science research projects addressing the drivers of health inequities towards Ending the HIV Epidemic in their communities.

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 Asian/Pacific Islander, and American Indian/Alaska Native communities.

3. Funded investigators will receive training and technical assistance from local and CDC mentors in support of study implementation, data dissemination, writing

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

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

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

2.1. Increased

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

2.2. Increased

number of persons who are tested for HIV and diagnosed

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

2.1. Reduced HIV

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

2.2. Improved

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

2.3. Reduced

HIV-related health disparities.

3. Increased training and career progression opportunities for underrepresented early-career scientific abstracts and manuscripts, and presenting at scientific conferences.

and treatment 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.

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 cluster and outbreak preparedness and response

2.6. Increased

number of effective strategies that address social and structural determinants of health and reduce racial and ethnic HIV-related disparities scientists to create a diverse and more equitable public health scientific workforce.

Applications should be investigator-initiated and define one or more research questions the project will address. Each application should clearly specify the following five (5) aspects for the proposed project on the Specific Aim page of the application:

1) Type of research project [choose one]

• Original epidemiologic or behavioral science research (including designing and conducting observational or interventional studies related to HIV prevention or treatment 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 five chapters of Compendium of Evidence-based Interventions and Best Practices for HIV Prevention (PrEP, Structural Interventions, Linkage to, Retention in, and Re-engagement in HIV Care, Medication Adherence, and Risk Reduction):

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 [choose 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 vital prevention and treatment services to people who need them

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

• Racial and ethnic minority gay, bisexual and other men who have sex with men (MSM)

• Racial and ethnic minority cis-gender women

• Racial and ethnic minority transgender women

• Racial and ethnic minority heterosexual men

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

• Black/African American

• Hispanic/Latino

• Asian/Pacific Islander

• American Indian/Alaska Native

5) Social and structural determinants of health priority area(s) that the project will address and/or investigate* [choose all that apply]:

• Economic Stability

• Education Access and Quality

• Health Care Access and Quality

• Neighborhood and Built Environment

• Social and Community Context

• Other emerging social and structural determinants of health as documented in the literature

*Applications can address a known social or structural determinant of health through inclusion in the study design and methods (e.g., providing access to free PrEP or transportation as an aspect of the study to facilitate uptake or participation) and/or investigate the effectiveness of intervening on a social or structural determinant of health (e.g., investigating the effect of housing vouchers on adherence).

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

In developing research proposal suitable for specific population(s) of focus, the application may be guided by some general questions relevant to the four (4) strategies for EHE below. However, please note that this list of questions is not exhaustive. Applications should outline projects related to EHE that are relevant for impact in their selected communities.

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

• 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.

• 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?

• What enhancements to social network testing or partner-services testing approaches are promising for diagnosing HIV in populations of focus?

• What strategies that address social and/or structural determinants of health (e.g., medical mistrust, stigma, etc.) may be effective in reducing the percentage of people with undiagnosed HIV in clinical and non-clinical settings?

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

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

• What types of community-driven or health-services focused interventions could improve antiretroviral adherence and reaching viral suppression in populations of focus?

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

• How do we increase access to and uptake of HIV care among people with diagnosed HIV infection 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).

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

• 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)?

• What approaches can be used to increase the awareness and understanding of HIV treatment as prevention (e.g., the viral suppression is prevention), especially in racial and ethnic minority communities with increased HIV burden?

• What culturally appropriate strategies increase engagement in SSPs and uptake of HIV prevention tools/strategies among people with injection drug use or substance use disorders (e.g., co-location of PrEP services, harm reduction)?

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

• How can local and state health departments engage with communities of color for more effective HIV cluster and outbreak response?

• What are the informational gaps around analysis of molecular data for cluster and outbreak detection and response and how can this information be appropriately disseminated within communities of color with assistance from various public health, clinical, and community partners?

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

• How can local and state health departments identify community-based organizations, providers, and other partners for cluster and outbreak response and more effectively engage with racial and ethnic communities either experiencing or vulnerable to HIV clusters and outbreaks? How do we stimulate and establish effective partnerships in this public health area?

NOTE: CDC will provide technical assistance and guidance in the development of research protocols. All applications should include a 6- to12-month pre-planning period during which formal engagement with the community (e.g., community advisory boards, community-based organizations) will be initiated and formative work can be accomplished. Examples of formative work may include:

• Data analysis of secondary data sources

• Qualitative interviews/focus groups

• Assessing study site readiness

• Identifying potential barriers and facilitators to study implementation and identifying strategies to address identified challenges prior to implementation

Objectives/Outcomes An 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.

• Clearly outline the anticipated short-term and intermediate project-specific outcomes (intended results) to be achieved by the end of the project.

• Present specific, measurable, achievable, realistic and time-phased (SMART) project objectives.

• Clearly indicate if the proposed four (4)-year project will represent original epidemiologic, behavioral, or implementation science research related to an existing evidence-based or informed intervention (please refer to:

https://www.cdc.gov/hiv/effective-interventions/index.html and specify which intervention).

• Clearly describe the social or structural determinants of health that will be addressed and/or investigated as a part of the study.

• Address a known social or structural determinant of health in the study design and methods (e.g., providing access to free PrEP or transportation as an aspect of the study to facilitate uptake or participation) and/or investigate the effectiveness of intervening on a social or structural determinant of health (e.g., investigating the effect of housing vouchers on adherence).

Given increases in the use of telecommunication technology in public health and because future public health crises can arise (e.g., COVID-19), applicants are 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., internet-based videoconferencing, 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-2020-updated-vol-33.pdf

Applicants are encouraged to use additional data (including social and structural determinants health 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 population of focus 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 community engagement in their HIV prevention research, program implementation or clinical activities to date. The application should provide justification and supporting data for the population of focus 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 population.

Collaboration/Partnerships The Project Director/Principal Investigator (PD/PI) is required to facilitate community engagement and collaborate with partners who are also subject matter experts for their original epidemiologic, behavioral, or implementation science research project. Community engagement fosters community-driven solutions, guides the development and implementation of culturally appropriate interventions, and increases the effectiveness and sustainability of interventions at the community-level. Consultation with local health-department HIV/STD surveillance and prevention programs and with community-based organizations during the preparation of the https://www.cdc.gov/hiv/effective-interventions/index.html https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2020-updated-vol-33.pdf https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2020-updated-vol-33.pdf application is also encouraged so that the proposed research addresses known HIV prevention, treatment, implementation and social 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 should be separated from the local senior mentor who will be supported at the 5-10% effort level in the application budget.

Consultation and partnering with the local health department is encouraged and collaboration with the community is required for the duration of the project 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 four (4)-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.

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, number of persons referred to or prescribed PrEP, and number of persons for whom social and/or structural driver(s) to HIV outcomes were addressed 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 epidemiologic or behavioral science 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 Awardees under this NOFO are supported by mentored cooperative agreements. PD/PIs are supported in their data collection, 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 an initial (kick-off) meeting in Atlanta, GA during the first year and other group meetings (e.g., trainings, conferences) with other MARI-funded Principal Investigators will be an integral part of the program. The meetings will be designed to promote the development of methodologically rigorous epidemiologic, behavioral, and implementation science, research findings dissemination, peer-based learning, and networking among investigators.

3. Funding Strategy N/A

Section II. Award Information Funding Instrument Type:

CA (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:

$7,000,000 Estimated total funding available for first year (first 12 months), including direct and indirect costs: $1,750,000

Estimated total funding available for entire project period, including direct and indirect costs: $7,000,000

Estimated Total Annual Budget Period Funding:

Year 1: $1,750,000 for five (5) awards, $350,000 each award

Year 2: $1,750,000 for five (5) awards, $350,000 each award

Year 3: $1,750,000 for five (5) awards, $350,000 each award

Year 4: $1,750,000 for five (5) awards, $350,000 each award

Anticipated Number of Awards:

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

Award Ceiling:

$350,000 Per Budget Period

Award Floor:

$265,000

Per Budget Period

Total Period of Performance Length:

4 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 (https://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.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

20 (Private institutions of higher education)

22 (For profit organizations other than 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:

https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

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 N/A

4. Justification for Less than Maximum Competition N/A https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true

5. Responsiveness The application must include a Letter of Support from at least one mentor identified in the application.

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 Unique Entity Identifier (UEI) number in order to begin each of the following registrations.

PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission. The UEI replaced the Data Universal Numbering System (DUNS) and is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and Grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov-Finding the UEI.

• (Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: NCAGE Tool / Products / NCS Help Center (nato.int).

• System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, SAM.gov.

• 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 Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal 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 an 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.

https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-update https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons https://www.Grants.gov

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a Unique Entity Identifier (UEI) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The UEI number is a twelve-digit number assigned by SAM.gov. An AOR should be consulted to determine the appropriate number. If the organization does not have a UEI number, an AOR should register through SAM.gov. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a UEI number.

Additionally, organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later.

SAM.gov is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient.

Additional information about registration procedures may be found at SAM.gov and the SAM.gov Knowledge Base.

If an award is granted, the recipient organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its UEI number to the recipient organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Each eligible institution/organization can submit more than one application, but each application must have a different PD/PI and a different senior local mentor as well as a distinctly different title and project. If necessary, co- PI(s) can be listed in the application but only one PD/PI can be https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0 the primary CDC contact for the award, and this must be indicated in the application.

In addition, the PD/PI from the applicant institution should be able to meet and demonstrate the following within the application:

1. Possess a research, health-professional or doctorate-level degree from an accredited school/program;

2. Never have been a primary investigator on an HHS HIV…