HRSA-24-108(U1S) Syndemic_ETAP 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 – Evaluation and Technical Assistance Provider (ETAP) Opportunity number: HRSA-24-108

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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 – Evaluation and Technical Assistance Provider

(ETAP)

Opportunity number: HRSA-24-108

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. Supported through funding from the Department of Health and Human Services (HHS) 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 communities3, 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 – Evaluation and Technical Assistance Provider (ETAP) project.

The purpose of this program is to support one organization through a cooperative agreement for up to four years to provide technical assistance (TA) to support and conduct a multi-system evaluation for a cohort of 5 demonstration systems funded under a separate announcement number, HRSA-24-107: A System-Level Syndemic Approach to Improve HIV Care and Treatment for People from Racial and Ethnic Minority Groups – Demonstration Systems. The demonstration systems will collaborate with the ETAP 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 and integrated care. Please review this companion announcement for more information.

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 HHS Minority HIV/AIDS Fund | Ryan White HIV/AIDS Program (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

The awarded ETAP organization will provide TA to support each demonstration system and carefully track and measure the TA provided to gauge future replicability in other jurisdictions.

Additionally, the ETAP will develop and implement a multi-system evaluation plan grounded in implementation science frameworks to assess the cost and effectiveness of each demonstration system’s approach, including implementation, service, and client outcomes, as well as implementation strategies. In line with syndemic theory, the evaluation will assess interaction effects on the above outcomes, taking into account the complex interplay of HIV status with co-occurring conditions and social determinants of health.

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?

Go to Contacts & Support.

Key dates Application deadline: July 24, 2024

NOFO issue date: June 24, 2024

Expected award date: September 20, 2024

Expected start date: September 30, 2024

Funding detail Application type: New

Expected total available funding: $ 1,750,000

Expected number and type of awards: 1 cooperative agreement

Funding range per award: up to $1,750,000 for 1 award

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 domestici 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-24-108) 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 – Evaluation and Technical Assistance Provider (ETAP) project administered by the Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB). Funding awarded under this announcement will support one organization for up to four years to lead a multi-system evaluation, conduct a cost analysis, and provide technical assistance (TA) to a cohort of 5 demonstration systems funded under a separate announcement (HRSA-24-107): A System-Level Syndemic Approach to Improve HIV Care and Treatment for People from Racial and Ethnic Minority Groups – Demonstration Systems.

Syndemics are co-occurring epidemics or conditions that interact with one another to disproportionately impact the morbidity and mortality in marginalized communities and contribute to excess burden of disease to a population.4,5 Funding under this announcement will support the design, implementation, and evaluation of syndemic approaches within five (5)

4 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 5 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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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 below). The demonstration systems will work closely with the ETAP to design and implement a syndemic approach to link and retain clients within their jurisdictions in comprehensive and integrated care. Please review the companion announcement noted above (HRSA-24-107) for more information.

The demonstration systems will be supported for up to four years and tasked with designing and implementing 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 and integrated care.6,7 This comprehensive and integrated care will address engagement and retention and include primary HIV care as well as care and treatment for co-occurring and interacting conditions, including behavioral health such as mental and/or substance use disorder and intimate partner violence (IPV). It will prioritize people with HIV from racial and ethnic minority groups that are inequitably impacted when designing interventions, and address the social determinants of health (e.g., income, housing, employment, legal system involved) and barriers to accessing and staying in care (e.g., affordability, transportation, provider bias, stigma, and discrimination ).

The awarded ETAP organization will provide technical assistance (TA) and capacity building to demonstration systems. The ETAP will also lead dissemination of evaluation findings, best practices, and lessons learned to promote replication in other Ryan White HIV/AIDS Program (RWHAP) health care settings and jurisdictions.

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 from racial and ethnic minority groups within their jurisdictions in comprehensive and integrated HIV care and treatment. Develop approaches that are inclusive and welcoming to reduce stigmatizing attitudes, beliefs, and behaviors held in the provision of health care and related services.

6Enhancing 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 7 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 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 and implement a multi-system evaluation grounded in the HAB implementation science approach8 and completed with validated 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.”9 Also use syndemic theory to assess the cost and effectiveness of each demonstration system’s approach.

• 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-24-107 (A System-Level Syndemic Approach to Improve HIV Care and Treatment for People from Racial and Ethnic Minority Groups – Demonstration Systems).

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. Demonstration systems may focus on: 1) development and implementation of a 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

8 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 9 Eccles MP, Mittman BS. Welcome to implementation science. 2006 https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/service-category-pcn-16-02-final.pdf

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Clarification Notice (PCN) #16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds.10

• 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.11

• Intimate partner violence (IPV): any form of physical violence, sexual violence, stalking, or psychological harm by a current or former partner or spouse. 12

• 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.13

• 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)14 at the time of enrollment.

10 PCN# 16-02 can be viewed at https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/service-category-pcn-16-02-final.pdf 11 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.

12 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.

13 Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, 86 FR 7009, at § 2(a) (Jan. 20, 2021), https://www.govinfo.gov/content/pkg/FR-2021-01- 25/pdf/2021-01753.pdf.

14 HRSA HIV/AIDS Bureau Performance Measures: Viral Suppression. Available at: https://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/coremeasures.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 https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/service-category-pcn-16-02-final.pdf https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01753.pdf https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01753.pdf

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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.

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:

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

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• 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).

• 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).15 It 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 disorders in the context of social and structural/institutional factors. 16

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

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

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

Washington, DC.

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 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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multiple coexisting diseases”, social determinants of health, and other risk factors17 such as behavioral health conditions, food insecurity, etc. Syndemic theory underscores the adverse interactions between diseases and social conditions that contribute to an excess burden of disease in a population. Syndemic approaches are interventions that (1) increase the focus on co-occurring and interacting disease and social conditions that exacerbate health inequities18, 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.19

Mental health disorders and substance use disorders, collectively referred to as behavioral health conditions, disproportionally affect people with HIV. Research shows that people with HIV often experience co-occurring behavioral health conditions, including but not limited to depression, anxiety, substance use, and unhealthy alcohol use.20 Co-occurring behavioral health conditions are associated with lower rates of viral suppression and increased rates of hospitalization.21 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.22

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. As part of this MHAF initiative, project outcomes will be monitored to identify emerging or promising practices specific to implementation strategies using syndemic approaches for people from racial and ethnic minority groups.

17 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) 18 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.

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

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

20 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.

21 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.

22 Perry, et al. 2019.

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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, faith-based, community-based, and local organizations;

• Providing information resources, including TA resource centers and other entities of relevance to the project;

• 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 material;

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

• 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; and

• Co-authoring technical manuscripts for publication in scientific journals.

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

• Designing and implementing a multi-system evaluation grounded in implementation science that includes implementation, service, and client outcomes, as well as implementation strategies. In line with syndemic theory, the evaluation will assess interaction effects on the above outcomes, taking into account the complex and potentially complex interplay HIV status with co-occurring conditions and social determinants of health;

• Coordinating the efforts of the demonstration systems to assure the privacy and confidentiality of study participants’ protected health information (PHI);

• Assuring the appropriate review, approval, and renewal of all multi-system evaluation instruments and documents by an identified Institutional Review Board (IRB);

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• Providing and carefully tracking TA to the demonstration systems to support implementation of their system-level syndemic approach;

• Coordinating and leading the logistics for two national multi-jurisdictional meetings with the demonstration systems in each of the four years of the project in the Washington, DC Metropolitan area or a location that is most convenient for all recipients.

• Participating in the National Ryan White Conference on HIV Care and Treatment;

• Conducting an annual site visit to each demonstration system for each year of the project;

• Leading and coordinating the publication and dissemination activities for the project, working in collaboration with the demonstration systems and HRSA staff;

• Assisting HRSA with information dissemination to constituencies upon request;

• Establishing and maintaining a webpage on TargetHIV.org for all public facing materials for communication and dissemination;

• Completing all reporting requirements, developing replication resources and tools including step-by-step implementation guidance, developing manuscripts for publication, and communicating about project design and outcomes at various venues throughout the project; and

• Collaborating with assigned HRSA project officers and other HRSA staff as necessary to plan, execute and evaluate project activities.

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.

• 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.

https://targethiv.org/ 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

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• 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.

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.

https://www.ecfr.gov/current/title-45/part-75#p-75.216(b) https://www.hrsa.gov/grants/manage-your-grant https://www.ecfr.gov/current/title-45/section-75.414

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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 direct costs (MTDC). 45 CFR 75.2 defines MTDC. You can use this rate indefinitely or until you negotiate a rate. If you use the de minimis 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.

General recipient expectations The ETAP will lead the following activities:

1) develop and implement TA tracking system and TA data reporting plan;

2) monitor and train demonstration systems for fidelity to their implementation plan and core elements of their selected interventions, as well as compliance with federal regulations;

3) plan and host annual peer-focused Learning Sessions;

4) develop and implement a multi-system evaluation plan grounded in implementation science, as well as a process and platform for collecting and reporting implementation, service, client, cost, and variable-interaction data; and

5) lead the development, review, and distribution of dissemination products including practical guidance to support replication of the approaches implemented by the jurisdictions, manuscripts co-authored with the dissemination system staff and HRSA HAB to describe design and outcomes of the project.

The ETAP and demonstration systems will include collaborations with community members, people of lived experience, and any other stakeholders that will increase the acceptability and feasibility of the approach implemented and the relevance and usefulness of dissemination products in each jurisdiction. Although each jurisdiction’s approach should be tailored for the specific needs of their communities, each approach should be developed with the ultimate goal of replicability in other jurisdictions with similar needs.

The program requirements are described in more detail below:

https://www.ecfr.gov/current/title-45/part-75#p-75.414(f) 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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1) Develop and implement a TA tracking system and TA data reporting plan.

The ETAP will collaborate with HRSA HAB to develop a TA tracking system that will record all identified or requested TA needs and the action taken by the ETAP in response. The ETAP will also develop a TA data reporting plan. The TA data reporting plan will support required quarterly TA data tracking updates to HRSA HAB. The plan should include easy to understand analyses and visualizations of the TA data captured in the preceding quarter. The intentional tracking of TA is essential to HRSA HAB’s efforts to define, track, and measure the TA provided in this project in order to gauge the replicability of the approaches implemented in each jurisdiction.

2) Monitor and train demonstration systems for fidelity to their implementation plan and core elements of their selected interventions, as well as compliance with federal regulations

The ETAP will monitor the demonstration systems to ensure fidelity to the core elements of the syndemic approach, including the core elements of the discrete interventions making up the approach, and their interactions. The ETAP will lead and collaborate with the demonstration systems to develop a logic model for each jurisdiction’s approach that clearly outlines the core elements, implementation strategies, and determinants of each syndemic approach. The logic model will guide ongoing fidelity monitoring and will be adjusted as needed to reflect any necessary mid-implementation adjustments and adaptations. The ETAP will also monitor the demonstration systems to ensure they are staying on track with their implementation plans and remaining in compliance with federal regulations.

Site Visits

The ETAP, in coordination with federal staff, will conduct, at minimum, one annual site visit with each demonstration system throughout the project. The ETAP will develop a site visit protocol to guide the content and focus of the site visits. Generally, the site visits will focus on implementation progress and provision of TA as requested by the demonstration systems or based on the ETAP’s assessment. Site visit protocols should address TA needs in the areas of planning and project implementation, as well as data submission and data quality issues.

Training

In coordination with HRSA HAB, the ETAP will plan, coordinate, and implement in-person trainings for the site staff in each jurisdiction tailored to the selected interventions, implementation strategies, and other components of their planned syndemic approach. The ETAP will also provide training to demonstration system’s data manager staff in order to meet the requirements of the evaluation.

3) Plan and host annual peer-focused Learning Sessions

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In collaboration with HRSA HAB, the ETAP will plan, coordinate all logistics for, host, and deliver a final report for annual peer-focused Learning Sessions. The demonstration systems will participate in all Learning Sessions, which will be held in person. The Learning Sessions will be multi-day events, and following the last day, the ETAP will host an all-day project planning meeting with only the ETAP and HRSA staff. The ETAP will also report on major activities and outcomes of the learning session to HRSA HAB following the event through submission and presentation of a final report.

4) Develop and implement a multi-system evaluation plan grounded in implementation science, as well as a process and platform for collecting and reporting implementation, service, client, cost and variable-interaction data.

The ETAP will coordinate with HRSA HAB to develop and implement a multi-system evaluation plan grounded in validated implementation science frameworks and Syndemic Theory.

Particular attention will be paid to HAB’s implementation science approach (HAB IS) when developing the evaluation plan (see Psihopaidas 2020). HAB IS is intended to be a scaffolding upon which specific frameworks, measures, and concepts from implementation science are built to develop a robust, tailored evaluation framework. The ETAP will assess the cost and effectiveness of each demonstration system’s approach. The evaluation will include implementation, service, and client outcomes, as well as implementation strategies (see Proctor 2011 and Proctor 2020). In line with syndemic theory, the evaluation will assess interaction effects on the above outcomes, taking into account the complex interplay of HIV status with co-occurring conditions and social determinants of health. The ETAP will provide a secure platform for demonstration systems to report all data to the ETAP, provide training and ongoing support to demonstration system data managers, and conduct ongoing monitoring of data collection and data quality. The ETAP will provide technical input, oversight, and support to the demonstration sites to complete any required institutional review board (IRB) or other approvals needed to collect and report evaluation data to the ETAP.

Data Security

The ETAP will electronically receive, store, manage, and maintain de-identified client-level data to be collected and reported by demonstration systems. The demonstration systems will submit data to the ETAP through a secure data portal that the ETAP will design and maintain. The ETAP will coordinate efforts to assure the privacy and confidentiality of data submitted, collected, and stored under all applicable laws and regulations. The ETAP will be responsible for monitoring data quality and completeness of submissions and interpreting evaluation results.

The ETAP will coordinate the efforts of the demonstration systems to assure the privacy and confidentiality of study participants’ protected health information.

Qualitative and focused evaluation https://pubmed.ncbi.nlm.nih.gov/33156852/ https://pubmed.ncbi.nlm.nih.gov/20957426/ https://pubmed.ncbi.nlm.nih.gov/24289295/

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In addition to developing evaluation components that reflect outcomes that will be consistent across all demonstration systems, the ETAP recipient will be responsible for including in the evaluation plan in-depth qualitative components that are system-specific. These system-specific case studies should support the overall goals of the evaluation, including implementation and service outcomes and the replicability of each approach. In addition, the qualitative and focused components of the evaluation should support a better understanding of how co-occurring conditions and social determinants affect the lived realities of people from racial and ethnic minority groups served in each jurisdiction, as well as how the integrated care plan may improve their health outcomes. The ETAP, in collaboration with the demonstration systems, HRSA staff, and federal partners, will generate the specific topics for these focused studies.

5) Lead the development, review, and distribution of dissemination products

The ETAP will provide to HRSA a workplan and timeline for dissemination of evaluation findings and dissemination productions. Dissemination products will include practical guidance to support replication of the approaches implemented by the jurisdictions, as well as manuscripts co-authored with the dissemination system staff and HRSA to describe the design and outcomes of the project. The ETAP will support all demonstration systems in interpreting and reporting on all evaluation-related data. The ETAP will be responsible for ensuring rigor, quality, and consistency across all dissemination products. The ETAP is expected to review all draft dissemination products prior to submission to HRSA HAB for review. The ETAP will be responsible for managing the completion of all dissemination products through the HRSA clearance process in collaboration with their HRSA Project Officer.

Project Websites

In addition to dissemination products described above, the ETAP will be responsible for collaborating with HRSA and TargetHIV.org to develop and maintain a project-specific website with public access for communication of the project. Upon completion of the project, all dissemination products will be hosted on this website and linked through the HRSA RWHAP Best Practices Compilation. In addition to the public website, a secure, password-protected shared location (e.g., SharePoint) for demonstration systems, ETAP, and HRSA staff will be created and maintained during the project. This private website/shared location will be expected to host key project files, deliverables, presentation slide decks, TA tracking data quarterly reports, Learning Session reports, workplans and timelines, registration information for the national meetings of the project; recent findings of interest from outside the project;

and links to relevant resources, and any other important files.

Publication and Dissemination Committee

The ETAP will form a publication and dissemination committee, consisting of HRSA staff and demonstration systems representatives, to generate study questions, topics for presentations https://targethiv.org/bestpractices https://targethiv.org/bestpractices

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and publications, concept sheets and analyses, and an overall dissemination plan for the project’s products.

National Meetings

The ETAP will plan and coordinate the logistics for presenting with the demonstration systems and HRSA HAB at the National Ryan White HIV/AIDS Conferences (NRWC) in 2026 and 2028. For the NRWC, each demonstration system is responsible for its own travel costs, ground transportation, per diem and hotel accommodations for these meetings. All activities will be conducted in collaboration with HRSA staff, federal partners, and demonstration system project staff.

Promoting Replication

The ETAP will collaborate with HRSA HAB to ensure all replication resources and tools developed in this project are disseminated through the HRSA RWHAP Best Practices Compilation in order to reach MHAF recipients, RWHAP recipients and providers, HIV service delivery staff, and other stakeholders.

The ETAP will also collaborate with national and regional AETC programs to optimize the potential for replication of these comprehensive integrated HIV care interventions. The network of AETC programs is uniquely positioned to help increase the capacity of HIV service providers to implement system-level syndemic approaches for improving health outcomes of people with HIV. The AETC program provides education, training, and capacity-building resources to support its mission to offer timely, high quality, state-of-the-science information to health care professionals working with existing and emerging populations affected by HIV. AETC educational resources and events may be found at https://aidsetc.org.

Additional Communications

The ETAP, in coordination with HRSA staff, will produce and disseminate project reports, documents, and other project materials to key audiences, stakeholders, and the public throughout the duration of the project.

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

• Improve access, engagement, and retention in care;

• Increase medication adherence;

• Reduce stigma;

• Increase health equity;

• Reach and maintain viral suppression.

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 https://aidsetc.org/

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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,23 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 systems to inform feasibility for future replication in RWHAP and other health care settings.

• MHAF-specific performance measures to be captured:

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

The Demonstration Systems

ETAP applicants, in designing your proposed evaluation and TA plans, should become familiar with the requirements for demonstration systems and the comprehensive and integrated HIV care interventions that jurisdictions/demonstration systems may implement under HRSA announcement number HRSA-24-107: A System-Level Syndemic Approach to Improve HIV Care and Treatment for People from Racial and Ethnic Minority Groups – Demonstration Systems.

Five (5) Health Resources and Services Administration Ryan White HIV/AIDS Program (HRSA RWHAP) Part A and/or B jurisdictions, which will serve as “demonstration systems”, to design, implement, and participate in the evaluation of syndemic approaches to link and retain people with HIV from racial and ethnic minority groups that are out of care, and at greatest risk of being lost to care, in comprehensive and integrated care. 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 conditions and/or substance use…