HRSA-24-107 (U1S) Syndemic Approach Demo_final.pdf

Notice of Funding Opportunity

Issuance Date: 06/24/2024 Application Due 07/24/2024

HIV/AIDS Bureau

Division of Policy and Data

A System-Level Syndemic Approach to Improve HIV Care and Treatment for People from Racial and Ethnic Minority Groups – Demonstration Systems Opportunity number: HRSA-24-107

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HRSA-24-107 2

Basic information The key facts

HIV/AIDS Bureau

Division of Policy and Data

Opportunity name: A System-Level Syndemic Approach to Improve HIV Care and Treatment for People from Racial and Ethnic Minority Groups – Demonstration Systems

Opportunity number: HRSA-24-107

Federal Assistance Listing Number: 93.899

Statutory authority: Further Consolidated Appropriations Act, 2024, Pub. L. 118-47, Division D, title II and 42 USC § 300ff-101 (§ 2691 of the Public Health Service Act).

Summary People from racial and ethnic minority groups are disproportionately impacted by HIV1 and are more likely to live at or below 100% of the Federal Poverty Line (FPL) compared to other groups2. Syndemics are co-occurring epidemics or conditions that interact with one another, and often disproportionately impact morbidity and mortality in marginalized communities.3,4

Supported through funding from the Department of Health and Human Services Office of the Assistant Secretary for Health’s Minority HIV/AIDS Fund, which funds projects to prevent HIV and improve health outcomes for racial/ethnic minority communities5, and in part by the Ryan White HIV/AIDS Program Part F Special Projects of National Significance, the Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2024 A System-Level Syndemic Approach to Improve HIV Care and Treatment for People from Racial and Ethnic Minority Groups – Demonstration Systems project.

The purpose of this program is to support up to five demonstration systems through cooperative agreements for up to four years to design, implement, and participate in the evaluation of a syndemic approach to link and retain people with HIV from racial and ethnic minority groups who are out of care, and at greatest risk of being lost to care, in comprehensive

1 National HIV/AIDS Strategy for the United States 2022–2025 (whitehouse.gov) 2 Ryan White HIV/AIDS Program Annual Client-Level Data Report 2021 (hrsa.gov) 3 González-Guarda, R. M., McCabe, B. E., Leblanc, N., De Santis, J. P., & Provencio-Vasquez, E. (2016). The contribution of stress, cultural factors, and sexual identity on the substance abuse, violence, HIV, and depression syndemic among Hispanic men.Cultural Diversity and Ethnic Minority Psychology, 22(4), 563–571 4 Singer, Merrill, Nicola Bulled, and Bayla Ostrach. "Syndemics and human health: implications for prevention and intervention." Annals of Anthropological Practice 36, no. 2 (2012): 205-211 Wilson, Nanin, Amesty, et al. 2014 5 HHS Minority HIV/AIDS Fund | Ryan White HIV/AIDS Program (hrsa.gov) http://www.hrsa.gov/ http://www.hrsa.gov/ https://www.whitehouse.gov/wp-content/uploads/2021/11/National-HIV-AIDS-Strategy.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/rwhap-annual-client-level-data-report-2021.pdf https://ryanwhite.hrsa.gov/about/minority-hiv-aids-fund

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and integrated care.1,2 This includes people who are newly diagnosed within the past 12 months or who have previously been diagnosed with HIV but have missed appointments, are not virally suppressed, or have another high-risk factor (e.g. leaving incarceration). This comprehensive and integrated care will include: 1) engagement and retention in primary HIV care; 2) care and treatment for co-occurring and interacting conditions, including mental health and/or substance use conditions; and 3) addressing social determinants of health, including intimate partner violence (IPV), food insecurity, unstable housing, and others.

This notice is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can process applications and award funds appropriately. You should note that this program may be cancelled before award.

Have questions?

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Key dates Application deadline: July 24, 2024

NOFO issue date: June 24, 2024

Expected award date: September 23, 2024

Expected start date: September 30, 2024

Funding detail Application type: New

Expected total available funding: $2,500,000 in Year 1, and 3,500,000 in Years 2-4.

Expected number and type of awards: 5 cooperative agreements

Funding range per award: up to $500,00 in Year 1, and up to $700,000 per year in Years 2-4.

We plan to fund awards in 4 12-month budget periods for a total 4-year period of performance of September 30, 2024 to September 29, 2028.

To help you find what you need, this NOFO uses internal links. In Adobe Reader, you can return to where you were by pressing Alt + Backspace.

Eligibility Who can apply

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Eligible applicants Only these types of domestic organizations (see note) may apply:

Entities eligible for funding under Parts A-D of the Ryan White HIV/AIDS Program are eligible to apply. These are: public and non-profit private entities, including Tribes and Tribal organizations.

Note: “Domestic” means the fifty States, the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, or the Republic of Palau.

Cost sharing This program has no cost-sharing requirement. If you choose to share in the costs of the project, we will not consider it during merit review. We will hold you accountable for any funds you add, including through reporting.

Program description

Purpose This notice (HRSA-24-107) announces the opportunity to apply for fiscal year (FY) 2024 funding under A System-Level Syndemic Approach to Improve HIV Care and Treatment for People from Racial and Ethnic Minority Groups – Demonstration Systems project administered by the Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB).

Syndemics are co-occurring epidemics or conditions that interact with one another to disproportionately impact morbidity and mortality in marginalized communities.6,7 Funding awarded under this announcement will support five Health Resources and Services Administration Ryan White HIV/AIDS Program (HRSA RWHAP) Part A and/or B jurisdictions, which will serve as “demonstration systems,” (see Key Definitions section below) to design, implement and participate in the evaluation of syndemic approaches to link and retain people with HIV from racial and ethnic minority groups who are out of care, and at greatest risk of

6 González-Guarda, R. M., McCabe, B. E., Leblanc, N., De Santis, J. P., & Provencio-Vasquez, E. (2016). The contribution of stress, cultural factors, and sexual identity on the substance abuse, violence, HIV, and depression syndemic among Hispanic men.Cultural Diversity and Ethnic Minority Psychology, 22(4), 563–571 7 Singer, Merrill, Nicola Bulled, and Bayla Ostrach. "Syndemics and human health: implications for prevention and intervention." Annals of Anthropological Practice 36, no. 2 (2012): 205-211 Wilson, Nanin, Amesty, et al. 2014

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being lost to care, in comprehensive and integrated care.8,9 This includes people who are newly diagnosed within the past 12 months or who have previously been diagnosed with HIV but have missed appointments, are not virally suppressed, or have another high-risk factor (e.g. leaving incarceration). This comprehensive and integrated care will include: 1) engagement and retention in primary HIV care; 2) treatment for co-occurring and interacting conditions, including mental health and/or substance use conditions; and 3) social determinants of health including intimate partner violence (IPV), food insecurity, unstable housing, and others.

All demonstration systems funded under this announcement are required to collaborate with an evaluation and technical assistance provider to be funded separately under announcement number HRSA-24-108: A System-Level Syndemic Approach to Improve HIV Care and Treatment for People from Racial and Ethnic Minority Groups – Evaluation and Technical Assistance Provider (ETAP). Please review this companion announcement for more information.

Collectively, the demonstration systems and ETAP will collaborate to accomplish the following project objectives:

• Design and implement a syndemic approach to link and retain people with HIV from racial and ethnic groups from their jurisdictions in comprehensive and integrated HIV care and treatment. Develop approaches that are inclusive and welcoming to reduce stigmatizing attitudes, beliefs, and behaviors in the provision of health care and related services.

• Develop and implement a multi-system evaluation grounded in implementation science frameworks, which are models using “methods to promote the systematic uptake of research findings and other evidence-based practices to improve the quality and effectiveness of health services.”10,11

• Assess the cost and effectiveness of each demonstration system’s approach in light of its impact of the syndemic as a whole rather than just individual epidemics or conditions.

8Enhancing Concurrent Capability Toolkit. Comprehensive Interventions. Quick Reference Sheet. Alberta Health Services, June 2020. https://www.albertahealthservices.ca/assets/info/amh/if-amh-ecc-what-are-comprehensive-interventions.pdf 9 Substance Abuse and Mental Health Services Administration. Integrated Treatment for Co-Occurring Disorders:

Building Your Program. DHHS Pub. No. SMA-08-4366, Rockville, MD: Center for Mental Health Services, Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services, 2009.

https://store.samhsa.gov/sites/default/files/d7/priv/ebp-kit-building-your-program-10112019.pdf 10 Eccles MP, Mittman BS. Welcome to implementation science. 2006 11 Psihopaidas D, Cohen SM, West T, Avery L, Dempsey A, Brown K, et al. (2020) Implementation science and the Health Resources and Services Administration’s Ryan White HIV/ AIDS Program’s work towards ending the HIV epidemic in the United States. PLoS Med 17(11):

e1003128. https://doi.org/10.1371/journal.

pmed.1003128 https://www.albertahealthservices.ca/assets/info/amh/if-amh-ecc-what-are-comprehensive-interventions.pdf https://www.albertahealthservices.ca/assets/info/amh/if-amh-ecc-what-are-comprehensive-interventions.pdf https://store.samhsa.gov/sites/default/files/d7/priv/ebp-kit-building-your-program-10112019.pdf

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• Develop practical, user-friendly dissemination resources and tools designed to provide comprehensive and step-by-step guidance to future jurisdictions so that they can successfully replicate the approaches found to be implementable and effective in this project. This includes co-authoring with HRSA HAB and publishing manuscripts describing project design, implementation, and outcomes.

Award recipients under both NOFOs (HRSA-24-108 and HRSA-24-107) will need to work closely together to be successful. HRSA HAB encourages you to read and familiarize yourself with the program expectations of the companion NOFO, HRSA-24-108 (A System-Level Syndemic Approach to Improve HIV Care and Treatment for People from Racial and Ethnic Minority Groups – Evaluation and Technical Assistance Provider).

Key Definitions For the purposes of this project, the following definitions will be used:

• Demonstration systems: Demonstrations occurring at the system-level, i.e., within a health system, metro area, state, or other jurisdiction with multiple healthcare delivery sites. Demonstrations systems may focus on: 1) development and implementation of an entirely novel intervention strategy; 2) implementation and evaluation of an emerging, evidence-informed, or evidence-based intervention where significant adaptations are being made to the intervention as originally described. Demonstration systems conduct these practices across the system, rather than at a single site.

• HIV care services: All of the HIV clinical care and treatment services allowable through the RWHAP. For more information regarding RWHAP eligible services, refer to Policy Clarification Notice (PCN) #16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds. 12

• Social determinants of health: conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. Can be grouped into five domains: economic stability; education access and quality; health care access and quality; neighborhood and built environment; and social and community context.13

12 PCN# 16-02 can be viewed at https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/service-category-pcn-16-02-final.pdf 13 Health People 2030. Social Determinants of Health. Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, U.S. Department of Health and Human Services.

https://health.gov/healthypeople/priority-areas/social-determinants-health.

https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/service-category-pcn-16-02-final.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/service-category-pcn-16-02-final.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/service-category-pcn-16-02-final.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/service-category-pcn-16-02-final.pdf

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• Intimate partner violence (IPV): any form of physical violence, sexual violence, stalking, or psychological harm by a current or former partner or spouse14

• Equity: The consistent and systematic fair, just, and impartial treatment of all individuals, including individuals who belong to underserved communities that have been denied such treatment.

• Out of care or risk of being out of care:

o Newly diagnosed within the past 12 months (a ”new positive”); OR o Previously diagnosed with HIV (more than six months ago) but not fully engaged in care, within one or more of the following parameters:

Have one or more gaps in HIV primary care visits which lasted six months or more in the previous two years prior to the date of enrollment (in accordance with HRSA guidelines for retention in care); OR

Be an existing client at risk of falling out of care (including clients who have missed their last two appointments in the last 12 months, or missed their last appointment in the last six months, or clients who are leaving incarceration or have another high-risk factor) OR o Persons who are not virally suppressed (defined as having a viral load >=200 copies/mL)15 at the time of enrollment.

Background

The HHS Secretary’s Minority HIV/AIDS Fund (MHAF)

The HHS Secretary’s Minority HIV/AIDS Fund (MHAF) is a federal program established by the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999 that supports projects that help prevent HIV and improve health outcomes for people from racial and ethnic minority groups. Overall, HIV-related health outcomes have improved over time, however, people from racial and ethnic minority groups continue to be disproportionately impacted by HIV. MHAF supports projects that seek to improve health outcomes for black/African American, Hispanic/Latino, American Indian, Alaska Native, Native Hawaiian, and Asian and Pacific Islander populations at risk for or living with HIV/AIDS.

14 The Office of Women’s Health (OWH) coordinated the development and implementation of the 2017–2020 HRSA Strategy to Address IPV, an effort to address this critical social determinant of health through agency-wide collaborative action.

15 HRSA HIV/AIDS Bureau Performance Measures: Viral Suppression. Available at: https://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/coremeasures.pdf

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The Ryan White HIV/AIDS Program (RWHAP)

The HRSA RWHAP has five statutory funding parts that provide a comprehensive system of medical care, support, and medications for low-income people with HIV.

The HIV care continuum is key to the program. It shows the journey of someone with HIV from diagnosis to effective treatment, leading to viral suppression. Achieving viral suppression enhances the patient’s quality of life and prevents HIV transmission.

This continuum also helps programs and planners measure progress and use resources effectively. We require you to assess your outcomes and work with your community and public health partners to improve outcomes across the HIV care continuum. To assess your program, learn more at HRSA’s Performance Measure Portfolio.

Strategic Frameworks and National Objectives

To address health challenges faced by low-income people with HIV, the use of national objectives and strategic frameworks is crucial. These frameworks include:

• Healthy People 2030

• National HIV/AIDS Strategy (NHAS) (2022–2025)

• Sexually Transmitted Infections National Strategic Plan for the United States (2021– 2025)

• Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination (2021–2025)

These strategies offer guidance on the main principles, priorities, and steps for our national health response. They serve as a blueprint for collective action.

Using Data Effectively: Integrated Data Sharing and Use

HRSA and the Centers for Disease Control and Prevention’s (CDC) Division of HIV Prevention promote integrated data sharing and use for program planning, quality improvement, and public health action. We encourage you to:

• Follow the Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs: Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action

• Create data-sharing agreements between surveillance and HIV programs.

• Progress towards NHAS goals through integrated data sharing, analysis, and use of HIV data by health departments.

• Complete CD4, viral load, and HIV nucleotide sequence reporting to the state and territorial health departments’ HIV surveillance systems. CDC mandates the reporting of all such data to the National HIV Surveillance System (NHSS).

https://ryanwhite.hrsa.gov/about/parts-and-initiatives https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum/ https://ryanwhite.hrsa.gov/grants/performance-measure-portfolio https://health.gov/healthypeople https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025 https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf

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• Use HRSA’s interactive RWHAP Compass Dashboard to visualize the reach, impact, and outcomes of the RWHAP and to inform planning and decision making. The dashboard gives you a look at national, state, and metro area data and displays client demographics, services, outcomes, and viral suppression data. It also includes data about clients using the AIDS Drug Assistance Program (ADAP).

• Use electronic data sources to verify client eligibility when you can. See Policy Clarification Notice 21-02, Determining Client Eligibility & Payor of Last Resort in the Ryan White HIV/AIDS Program.

Program Resources and Innovative Models

HRSA offers multiple projects and resources to help you. A full list is available on TargetHIV. We urge you to learn more about and use them in your project. For some examples, see the helpful website section on Page 45 of this NOFO.

Racial and ethnic HIV health disparities continue to exist in the U.S. and are a priority for HIV prevention, care, and treatment under the National HIV/AIDS Strategy (2022-2025).16 The Strategy calls for the development of new and expanded implementation of effective, evidence-based, or evidence-informed models, and integration of programs to address the syndemic of HIV, substance use, and mental health conditions in the context of social and structural/institutional factors including stigma, discrimination, and violence. 17

Research shows that, especially for people with HIV who are out of care or at greatest risk of being lost to care, HIV providers must “increasingly address the management of individuals with multiple coexisting diseases”18, social determinants of health, and other risk factors19 such as behavioral health conditions, food insecurity, etc. Syndemic approaches are interventions that

(1) increase the focus on co-occurring and interacting disease and social conditions that exacerbate health inequities,20 and (2) advance the evidence base for effective methods to assess, monitor, and intervene with respect to these co-occurring and interacting factors for optimal outcomes in HIV treatment and care.21

Mental health and substance use conditions, collectively referred to as behavioral health conditions, disproportionally affect people with HIV. Research shows that people with HIV often

16 The White House. 2021. National HIV/AIDS Strategy for the United States 2022–2025. Washington, DC.

18 Valderas, Jose M., Barbara Starfield, Bonnie Sibbald, Chris Salisbury, and Martin Roland. "Defining comorbidity:

implications for understanding health and health services." The Annals of Family Medicine 7, no. 4 (2009): 357-363.

(p.357) 19 Valderas, Jose M., Barbara Starfield, Bonnie Sibbald, Chris Salisbury, and Martin Roland. "Defining comorbidity:

implications for understanding health and health services." The Annals of Family Medicine 7, no. 4 (2009): 357-363.

(p.357) 20 Wilson, Patrick A., Jose Nanin, Silvia Amesty, Scyatta Wallace, Emily M. Cherenack, and Robert Fullilove. "Using syndemic theory to understand vulnerability to HIV infection among Black and Latino men in New York City."

Journal of Urban Health 91, no. 5 (2014): 983-998.

21 Singer, Merill, and Scott Clair. "Syndemics and public health: Reconceptualizing disease in bio-social context."

Medical anthropology quarterly 17, no. 4 (2003): 423-441.

https://data.hrsa.gov/topics/hiv-aids/compass-dashboard https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-21-02-determining-eligibility-polr.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-21-02-determining-eligibility-polr.pdf https://targethiv.org/help/ta-directory

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experience co-occurring behavioral health conditions, including but not limited to depression, anxiety, substance use, and unhealthy alcohol use.22 Co-occurring behavioral health conditions are associated with lower rates of viral suppression and increased rates of hospitalization.23 In addition to complex physical and behavioral health needs of people living with HIV, many social determinants of health, such as food and economic insecurity, incarceration, housing instability, and other adverse environmental conditions contribute to poorer health outcomes, lack of engagement, and low retention rates for certain populations with HIV.

The intersection of health and social conditions affecting people with HIV require a coordinated and integrated approach to HIV services and care to achieve the best outcomes, leveraging interventions that are comprehensive, flexible, and tailored to the unique needs of the priority population.24

This project builds upon HRSA’s continued efforts to develop innovative and effective approaches to engage or re-engage people with HIV who are not receiving HIV care or treatment and to support the replication and scaling of effective interventions to end the HIV epidemic in the U.S. Additionally, specific implementation strategies to effectively integrate syndemic approaches for people from racial and ethnic minority groups into routine care will be tested and disseminated.

Cooperative agreement terms

Our responsibilities Aside from monitoring and technical assistance, we also get involved in these ways:

• Facilitating the availability and expertise of other appropriate offices within HRSA, Substance Abuse and Mental Health Services Administration (SAMSHA) staff as well as other relevant agencies in the planning, development, and implementation of the project;

• Facilitating effective collaborative relationships with federal and state agencies and community-based and local organizations;

• Reviewing activities, procedures, measures, and tools to be implemented for accomplishing the overall goals and objectives of this project on an on-going basis;

• Participating in the design and implementation of evaluation tools, evaluation plans, and other project materials;

22 Perry NS, Remmert JE, Psaros C, Pinkston M, Safren SA. Learning to address multiple syndemics for people living with HIV through client perspectives on CBT HHS Public Access. Psychother Res. 2019;29(4):492–502.

23 Tolson C, Richey LE, Zhao Y, Korte JE, Brady K, Haynes L, et al. Association of Substance Use with Hospitalization and Virologic Suppression in a Southern Academic HIV Clinic. Am J Med Sci. 2018 24 Perry, et al. 2019.

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• Coordinating activities to address the evaluation-related training and TA needs of the demonstration systems; and

• Reviewing and participating in the dissemination of project activities, products, findings, best practices, evaluation data, and other information developed as part of this project to the broader health care community and RWHAP providers.

Your responsibilities You must follow all relevant laws and policies. Your other responsibilities will include:

• Completing the proposed project work plan activities within the four-year period of performance;

• Collaborating with HRSA on review of activities, procedures, and budget items, including timely communication with project officer;

• Ensuring proposed activities are based on documented need, maximize impact on HIV care continuum outcomes, and designed to reach, engage, and retain in care people with HIV from racial and ethnic groups;

• Coordinating the activities with existing RWHAP entities and identified partnering agencies, when applicable;

• Collaborating with the ETAP on the development and implementation of annual work plans and a multi-system evaluation;

• Participating in multi-system evaluation, TA, and development of project dissemination products such as implementation manual/toolkits, site visits, annual national multi-jurisdictional meetings, multi-system learning sessions, and other activities as coordinated and conducted by the ETAP;

• Developing all required documentation for submission of research protocol to an Institutional Review Board (IRB) and obtaining IRB approval prior to the start of activities involving human subjects. Preparing data use/data sharing agreements and other Memorandum of Understanding (MOU) agreements, if needed, with local and community partners;

• Complying with requests for data and information in accordance with specified timelines of the ETAP. Required multi-system evaluation activities will include, but are not limited to:

o Attending two semi-annual national multi-site meetings in each of the four years of the project in the Washington, DC/Metropolitan area or an area identified by the ETAP. Travel to attend these national multi-site meetings is limited to no more than three staff participants. Prior approval from the Project Officer is required for exceptions.

o Participating in in-person and virtual meetings held by the ETAP or HRSA throughout the course of the period of performance including participation in National Ryan White Conference on HIV Care and Treatment.

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o Hosting annual site visits for each year of the project that is conducted by the

ETAP.

o Collaborating with the ETAP to conduct focused evaluation studies on issues relating to the clinical, administrative financing, or public policy issues pertaining to the goals and objectives of the project.

• Developing a sustainability and integration plan to support successful strategies following the conclusion of the cooperative agreement;

• Modifying system approaches as necessary to ensure relevant outcomes throughout the duration of the project; and

• Participating in the communication and dissemination of project findings, best practices, and lessons learned, including adherence to MHAF and HRSA guidelines pertaining to acknowledgment and disclaimer on all products produced by MHAF and HRSA award funds.

Funding policies & limitations

Policies

• This program depends on the appropriation of funds. If funds are appropriated for this purpose, we will move forward with the review and award process.

• The General Provisions in Division H that reference the Consolidated Appropriations Act, 2023 (P.L. 117-328) apply to this program. Note that these and other restrictions will apply in fiscal years that follow, as the law requires.

• Support beyond the first budget year will depend on:

- Appropriation of funds

- Satisfactory progress in meeting the project’s objectives

- A decision that continued funding is in the government’s best interest

General limitations

• For guidance on some types of costs we do not allow or restrict, see Budget in section 4.1.iv of the Application Guide. You can also see 45 CFR part 75, General Provisions for Selected Items of Cost.

• You cannot earn profit from the federal award. See 45 CFR 75.400(g).

• The salary rate limitation imposed by the current appropriations act applies to this program.

As of January 2024, the salary rate limitation is $221,900. Note this limitation may apply in future years and will be updated.

https://www.hrsa.gov/sites/default/files/hrsa/grants/sf424-application-guide.pdf#page=20 https://www.ecfr.gov/current/title-45/part-75/subject-group-ECFR5d90ba314caea08 https://www.ecfr.gov/current/title-45/part-75/subject-group-ECFR5d90ba314caea08 https://www.ecfr.gov/current/title-45/part-75#p-75.216(b)

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Program-specific limitations

• You cannot use funds under this notice for the following:

• Charges that are billable to third party payers, (e.g., private health insurance, prepaid health plans, Medicaid, Medicare);

• To directly provide medical or support services, (e.g., HIV care, counseling and testing) that supplant existing services;

• Cash payments to intended recipients of RWHAP services;

• Purchase, construction of new facilities or capital improvements to existing facilities;

• Purchase or improvement to land;

• Purchase vehicles;

• Fundraising expenses or lobbying activities and expenses;

• Syringe Services Programs (SSPs) that have not received HRSA’s prior approval or are not in compliance with HHS and HRSA policy. See https://www.aids.gov/federal-resources/policies/syringe-services-programs/;

• To develop materials designed to directly promote or encourage, intravenous drug use or sexual activity;

• Pre-Exposure Prophylaxis (PrEP) or Post-Exposure Prophylaxis (nPEP) medications or related medical services. (Please note that RWHAP recipients and sub-recipient providers may provide prevention counseling and information to eligible clients’ partners – see RWHAP and PrEP Program Letter, November 16, 2021; and/or

• International travel.

• See Manage Your Grant for other information on costs and financial management.

Indirect costs Indirect costs are those incurred for a common or joint purpose across more than one project and that cannot be easily separated by project (like utilities for a building that supports multiple projects). Learn more at 45 CFR 75.414, Indirect Costs.

Indirect costs are determined using one of two methods:

Method 1 – Approved rate. You currently have an indirect cost rate approved by your cognizant federal agency.

Method 2 – De minimis rate. Per 45 CFR 75.414(f), if you have never received a negotiated indirect cost rate, you may elect to charge a de minimis rate. This rate is 10% of modified total https://www/ https://www.hrsa.gov/grants/manage-your-grant https://www.ecfr.gov/current/title-45/section-75.414 https://www.ecfr.gov/current/title-45/part-75#p-75.414(f)

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direct costs (MTDC). See 45 CFR 75.2 defines MTDC. You can use this rate indefinitely or until you negotiate a rate. If you use this rate, you must use it for all federal awards unless you negotiate a rate.

Program income Program income is money earned as a result of your award-supported project activities. You must use any program income you generate from awarded funds for approved project-related activities. Find more about program income at 45 CFR 75.307.

Recipient expectations Develop and Implement System-Level Syndemic Approaches

Interventions must focus on people with HIV from racial and ethnic minorities groups, including adults from 18-39 years old, and are out of care or at greatest risk of being lost to care.

Demonstration systems will implement interventions based on the unique needs of the priority population(s) identified within their communities.

Demonstration systems will collaborate with the ETAP to develop effective and replicable system-level syndemic approaches to link and retain the priority population(s) in comprehensive and integrated care. This comprehensive and integrated care will include: 1) primary HIV care; 2) care and treatment for co-occurring and interacting conditions, including behavioral health conditions such as mental health and/or substance use conditions; 3) social determinants of health including intimate partner violence (IPV), food insecurity, housing instability, and others using validated measures.

Demonstration systems will also participate in the following ETAP-led activities including 1) TA needs reporting and tracking; 2) site monitoring activities; 3) annual multi-system learning sessions; 4) collection and reporting of implementation, service, client, and costing data for the multi-system evaluation; 5) development of dissemination products and other publication and communication activities to support replication of successful approaches; and 6) development of an annual work plan to implement each jurisdiction’s approach and ensure quality and continuity of care of clients engaged in the approach.

Demonstration systems and the ETAP will include collaborations with community members, people of lived experience, intervention developers, and any other collaborations to be able to increase the acceptability and feasibility of the approach for the jurisdiction.

Integration of interventions in a care plan

Applicants must propose an integration of at least three interventions, which may include any of the three categories of interventions identified by HRSA, including emerging, evidence-https://www.ecfr.gov/current/title-45/part-75#p-75.2(Modified%20Total%20Direct%20Cost) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-D/subject-group-ECFR911e5e1a30bfbcb/section-75.307

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informed, and evidence-based interventions.25 The proposed interventions must directly relate to the selected syndemic factors. Successful applicants will propose interventions that fill gaps in services that the applicant jurisdiction does not currently provide sufficiently to eliminate disparities in HIV health outcomes for people from racial and ethnic minority groups in their community.

When identifying interventions, applicants are encouraged to consider interventions listed in HRSA’s Best Practices Compilation, as well as SAMHSA’s Evidence-Based Practices Resource Center and other RWHAP resources (refer to the list of initiatives on TargetHIV). All proposed interventions must be allowable within the RWHAP. Please see Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds Policy Clarification Notice 16-02.

Syndemic Factors

Proposed syndemic approaches should address multiple factors listed in Table 1. Interventions must address HIV (Syndemic Factor 1), at least one co-occurring condition (Syndemic Factor 2), AND at least one social determinant of health. More than one co-occurring condition and/or social determinant of health may be targeted by the approach. Applicants should note that the social determinants of health listed under Syndemic Factor 3 is not exhaustive. Applicants should select a combination of syndemic factors to address based on the unique needs of people from racial and ethnic minority groups within their jurisdiction. Applicants should make a convincing case as to the logic behind the factors selected for their approach, drawing from available demographic, CDC surveillance, RWHAP data, and/or other aggregated client data sources whenever possible.

Table 1: Syndemic Factors for Demonstration Systems

Syndemic Factor 1 – HIV Required

• HIV care and treatment

Syndemic Factor 2 – Co-occurring conditions

At least one required

• Substance use

• Mental health conditions

Syndemic Factor 3 – Social determinants of health

At least one required.

This list is not exhaustive, others may be considered.

• IPV

• Food insecurity

• Housing

• Access to care

• Others

25 Psihopaidas, Demetrios et al. “Implementation science and the Health Resources and Services Administration's Ryan White HIV/AIDS Program's work towards ending the HIV epidemic in the United States.” PLoS medicine vol.

17,11 e1003128. 6 Nov. 2020, doi:10.1371/journal.pmed.1003128 https://targethiv.org/bestpractices https://www.samhsa.gov/resource-search/ebp https://www.samhsa.gov/resource-search/ebp https://targethiv.org/help/ta-directory

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Community Engagement and Partnerships

Demonstration systems must design and implement interventions in partnership with members of the communities within their jurisdictions, including the populations served as well as intervention developers and other stakeholder groups to achieve optimal outcomes. These groups could include, but not be limited to, health departments, public and private health care payers, tribes and tribal organizations, faith-based and community-based organizations, health centers, private sector, academic partners, and the community. Moreover, the groups or entities partnering with the demonstration systems will do so with the goal of advancing health and health equity within their communities.

Implementation Protocols

Demonstration systems will create step-by-step guides of the workflows (e.g., process maps 26, swim lane flowcharts, and written protocols) for review and input by the ETAP and HRSA prior to implementation and throughout the project as mid-implementation adjustments and adaptation needs are identified. Adjustments and adaptations must only be made in consultation with the ETAP and prior approval from HRSA, and should be done iteratively in order to avoid disruption to the ETAP’s TA tracking and evaluation data collection. These implementation protocols will be updated as needed throughout the project in collaboration with the ETAP and HRSA HAB; ultimately they will become one of the key components of the dissemination products distributed to the RWHAP and HIV care providers to support replication of the approach in other jurisdictions.

Multi-System Evaluation

Demonstration systems are expected to work collaboratively with the ETAP in all aspects of the multi-system evaluation to assess the effectiveness of the demonstration systems’ comprehensive and integrated HIV care and treatment models that:

(1) prioritize serving people from racial and ethnic minority groups in jurisdictions who experience significant disparities in HIV outcomes,

(2) address the social determinants of health and unmet needs identified within the priority populations,

(3) integrate HIV care and treatment that can increase the utilization of comprehensive care and treatment to improve linkage and retention for people from racial and ethnic minority groups.

Demonstration systems must have the ability to collect and report quantitative and qualitative data to the ETAP on the frequency and in the format required by the ETAP. To facilitate adherence to the evaluation protocol, the ETAP will provide TA to all demonstration systems

26 Process Flow: Mapping & Analysis | TargetHIV https://targethiv.org/library/process-flow-mapping-analysis

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over the course of the entire project. All ETAP’s TA provision will be systematically tracked and measured to gauge the level and type of support needed to implement, as well as the replicability of the approach. When providing TA, the ETAP will emphasize free, publicly available, and peer-support resources so that those supports may also be available to future jurisdictions seeking to replicate the approach.

The following health outcomes are expected for people with HIV from racial and ethnic minority groups participating in this project:

• Improved access, engagement, and retention in care;

• Increased medication adherence;

• Reduced stigma;

• Increased health equity;

• Reach and maintain viral suppression.

Learning Sessions

The demonstration systems will participate in annual in-person Learning Sessions hosted, planned, and coordinated by the ETAP. In years one through three, the Learning Sessions will emphasize peer learning and create opportunities for the demonstration systems to share implementation activities, outcomes, best practices, and lessons learned. In year four, the final Learning Session will focus on overall lessons learned, plans for sustainment of the approaches implemented in each jurisdiction, and dissemination-related workplan and timeline.

Performance Measures

Key performance measures must include but are not limited to client engagement and retention, antiretroviral therapy adherence, stigma reduction, health equity, and viral suppression. The evaluation should also capture client demographics, biomedical and behavioral health indicators, barriers and facilitators to access and retention in HIV medical care, indicators of health equity, and stigma indicators and other measures proposed by the ETAP. Key performance measures must also include process analysis, cost analysis, HRSA HAB Performance Measures,34 and MHAF-specific performance measures:

• Process analysis, a systematic method of examining how work is done, will assess implementation of the comprehensive and integrated HIV care interventions, including but not limited to facilitators and barriers to implementation. The ETAP, in coordination with the demonstration systems, will develop the final core process methods and implementation strategies.

• A cost analysis study (or cost-effectiveness study, if feasible) will measure the labor and programmatic costs and expenditures incurred by each demonstration system to inform feasibility for future replication in RWHAP and other health care settings.

• MHAF-specific performance measures to be captured:

https://ryanwhite.hrsa.gov/grants/performance-measure-portfolio https://ryanwhite.hrsa.gov/grants/performance-measure-portfolio

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o HIV viral suppression o Linkage to care o HIV-related disparities o Health inequities

Step 2:

Get Ready to Apply

In this step

Get registered

Find the application package

Application writing help

HRSA-24-107 20

Get registered

SAM.gov You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI). SAM.gov registration can take several weeks. Begin that process today.

To register, go to SAM.gov Entity Registration and click Get Started. From the same page, you can also click on the Entity Registration Checklist for the information you will need to register.

Grants.gov You must also have an active account with Grants.gov. You can see step-by step instructions at the Grants.gov Quick Start Guide for Applicants.

Find the application package The application package has all the forms you need to apply. You can find it online. Go to Grants Search at Grants.gov and search for opportunity number HRSA-24-107.

After you select the opportunity, we recommend that you click the Subscribe button to get updates.

Application writing help Visit HHS Tips for Preparing Grant Proposals.

Visit HRSA’s How to Prepare Your Application page for more guidance.

See Apply for a Grant for other help and resources.

Join the webinar For more information about this opportunity, join the webinar on July 16, 2024 at 01:00 PM ET.

You can join at https://hrsa-gov.zoomgov.com/j/1614145081?pwd=NXRLWmU3Rk90NEdUcHFGR0g2VEdSUT09

Meeting ID: 161 414 5081

Passcode: 95BG0BSi

If you are not able to join through your computer, you can call in at 1-833-568-8864 with the following:

Meeting ID: 161 414 5081

Passcode: 71473324 https://sam.gov/content/entity-registration https://grants.gov/applicants/applicant-registration http://www.grants.gov/quick-start-guide/applicants https://www.grants.gov/web/grants/search-grants.html https://www.grants.gov/web/grants/search-grants.html https://www.hhs.gov/grants-contracts/grants/get-ready-for-grants-management/tips-for-preparing-grant-proposals/index.html https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application https://www.hrsa.gov/grants/apply-for-a-grant https://hrsa-gov.zoomgov.com/j/1614145081?pwd=NXRLWmU3Rk90NEdUcHFGR0g2VEdSUT09 https://hrsa-gov.zoomgov.com/j/1614145081?pwd=NXRLWmU3Rk90NEdUcHFGR0g2VEdSUT09

HRSA-24-107 21

We will record the webinar. If you are not able to join live, you can replay it at https://targethiv.org/.

Need Help? See Contacts & Support.

https://targethiv.org/

Step 3:

Write Your Application

In this step

Application contents & format

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Application contents & format Applications include 4 main components. This section includes guidance on each.

There is a 60-page limit for the overall application.

Submit your information in English and express budget figures using U.S. dollars.

Make sure you include each of these:

Components Submission Format

Project abstract Use the Project Abstract Summary form

Project narrative Use the Project Narrative Attachment form

Budget narrative Use the Budget Narrative Attachment form

Attachments Insert each in the Other Attachments form.

Other required Forms

Upload using each required form.

Required format You must format your narratives and attachments using our required formats for fonts, size, margins, etc. See the formatting guidelines in section 4.2 of the Application Guide.

Project abstract Complete the information in the Project Abstract Summary Form. Include a short description of your proposed project. Include the needs you plan to address, the proposed services, and the population groups you plan to serve. For more information, see section 4.1.ix of the Application Guide.

Include the following within the project abstract:

o Goals and Objectives: Describe overall project goals and proposed services.

o Summary of project: Provide a brief description of the proposed project, including the proposed innovative comprehensive intervention to be implemented, specific sites where the activities will take place, and collaborating entities.

o Priority population(s): Provide a brief description of the geographic area(s) and demographic characteristics of the priority population(s) to be served by the proposed project.

o Summary of Funding: Specify the funding amount requested for each year of the four-year period of performance.

https://www.hrsa.gov/sites/default/files/hrsa/grants/sf424-application-guide.pdf#page=37 https://www.hrsa.gov/sites/default/files/hrsa/grants/sf424-application-guide.pdf#page=36 https://www.hrsa.gov/sites/default/files/hrsa/grants/sf424-application-guide.pdf#page=36

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Project narrative In this section, you will describe all aspects of your project. Project activities must comply with the nondiscrimination requirements.

Use the section headers and the order below.

Introduction See merit review criterion 1: Need

Briefly describe the purpose of your project. Provide a clear and succinct description of how the proposed project addresses the goal and objectives listed in the “Purpose” section of this

NOFO.

Describe the overall plan to conduct the project activities to include:

• Identifying and implementing innovative comprehensive interventions of the effective and replicable system’s syndemic approach.

• Creating an implementation protocol.

• Engaging and partnering with other community organizations and providers to implement and provide services to clients within the first year of the award.

• Collaborating with the ETAP.

• Participating in sharing and disseminating effective and replicable services and interventions.

• Sustaining and…