HAB HRSA-22-037 (H12) Part D DCHAP final mod 1.25.22.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

HIV/AIDS Bureau Division of Community HIV/AIDS Programs

Ryan White HIV/AIDS Program Part D

Coordinated HIV Services and Access to Research for Women, Infants, Children, and Youth (WICY) Existing Geographic Service Areas

Funding Opportunity Number: HRSA-22-037 Funding Opportunity Type(s): New, Competing Continuation, and Competing

Supplemental Assistance Listings (AL/CFDA) Number: 93.153

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2022

Application Due Date: February 4, 2022

Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

HRSA will not approve deadline extensions for lack of registration.

Registration in all systems may take up to 1 month to complete.

Issuance Date: November 1, 2021 Modified on January 25, 2022 to extend the application due date to February 4, 2022

Lillian Bell, MPH Chief, Central Branch Division of Community HIV/AIDS Programs (DCHAP) Email: LBell@hrsa.gov Telephone: (301) 443-5671

See Section VII for a complete list of agency contacts.

Authority: 42 U.S.C. §§ 300ff-71 and 300ff-121 (§§ 2671 and 2693 of the Public Health Service Act).

mailto:LBell@hrsa.gov

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508 Compliance Disclaimer

Note: Persons using assistive technology may not be able to fully access information in this file. For assistance, please email or call one of the HRSA staff in Section VII.

Agency Contacts.

EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2022 – FY 2025 Ryan White HIV/AIDS Program (RWHAP) Part D Coordinated HIV Services and Access to Research for Women, Infants, Children, and Youth (WICY) Existing Geographic Service Areas. In addition, HRSA is accepting proposals for FY 2022 Part D supplemental funding.

The purpose of the RWHAP Part D WICY program is to provide family-centered health care services in an outpatient or ambulatory care setting for low income WICY with HIV.

Under this announcement, applicants must propose to provide family-centered care in outpatient or ambulatory care settings to low income women (25 years and older) with HIV, infants (up to two years of age) exposed to or with HIV, children (ages two to 12) with HIV, and youth (ages 13 to 24) with HIV. RWHAP Part D funding is intended to improve access to family-centered HIV medical care through the provision of coordinated, comprehensive, and culturally and linguistically competent services directly, through contract, or through memoranda of understanding (MOU).

This competition is open to current RWHAP Part D recipients and new organizations proposing to provide RWHAP Part D funded services in the geographic service areas listed in Appendix B. All applicants must demonstrate that they have the capacity to serve all eligible WICY populations with HIV in the proposed service area. New applicants must provide at least the same scope of comprehensive care and treatment services as the current RWHAP Part D recipient for the entire service area. Your application must address the entire service area, as defined in Appendix B. If you are applying for more than one service area listed in Appendix B, you must submit a separate application for each service area.

All applicants who submit an application to provide RWHAP Part D services for one of the published service areas in Appendix B may also apply for up to $150,000 in FY 2022 for RWHAP Part D supplemental funding. The purpose of this one-year supplemental funding is to strengthen organizational infrastructure to respond to the changing health care landscape and to increase capacity to develop, enhance, or expand access to high quality family-centered care services for low income WICY with HIV in the service area.

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Funding Opportunity Title:

Ryan White HIV/AIDS Program Part D Coordinated HIV Services and Access to Research for Women, Infants, Children, and Youth (WICY) Existing Geographic Service Areas

Funding Opportunity Number: HRSA-22-037 Due Date for Applications: February 4, 2022 Anticipated Total Annual Available FY 2022 Funding:

Part D Base: Approximately $75,000,000 Part D Supplemental: $3,500,000

Estimated Number and Type of Award(s): Up to 114 grants, of which approximately 25 grants may receive supplemental funding for FY 2022

Estimated Annual Award Amount: Varies - see Appendix B, subject to the availability of appropriated funds.

Cost Sharing/Match Required: No Period of Performance: Part D Base: August 1, 2022 through

July 31, 2026 (four years) Part D Supplemental: August 1, 2022 through July 31, 2023 (one year)

Eligible Applicants: Public and nonprofit private entities (including a health facility operated by or pursuant to a contract with the Indian Health Service, and faith based and Tribes/Tribal organizations) that provide family-centered care involving outpatient or ambulatory care (directly or through contracts or memoranda of understanding) for WICY with HIV.

See Section III.1 of this notice of funding opportunity (NOFO) for complete eligibility information.

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Application Guide

You (the applicant organization/agency) are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide, available online at http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf, except where instructed in this Notice of Funding Opportunity (NOFO) to do otherwise.

Technical Assistance

HRSA has scheduled the following technical assistance (TA):

Webinar

Day and Date: Tuesday, December 7, 2021 Time: 2 – 4 p.m.

Call-In Number: 1-833-568-8864 Meeting ID: 160 404 9527 Passcode: 84126158 Weblink: https://hrsa-gov.zoomgov.com/j/1604049527?pwd=SE9UZUVsdWQ4djMvUzNTZUhnSHMwQT09

This TA webinar will be recorded and made available on the TargetHIV Center website at https://targethiv.org/library/nofos.

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://hrsa-gov.zoomgov.com/j/1604049527?pwd=SE9UZUVsdWQ4djMvUzNTZUhnSHMwQT09 https://hrsa-gov.zoomgov.com/j/1604049527?pwd=SE9UZUVsdWQ4djMvUzNTZUhnSHMwQT09 https://targethiv.org/calendar/2020-Ryan-White-Conference https://targethiv.org/library/nofos

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING/MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Narrative

v. Attachments

3. DUN AND BRADSTREET DATA UNIVERSAL NUMBERING SYSTEM (DUNS) NUMBER TRANSITION

TO THE UNIQUE ENTITY IDENTIFIER (UEI) AND SYSTEM FOR AWARD MANAGEMENT (SAM)

4. SUBMISSION DATES AND TIMES

5. INTERGOVERNMENTAL REVIEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

3. ASSESSMENT OF RISK

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX A: ADDITIONAL AGREEMENTS & ASSURANCES

APPENDIX B: SERVICE AREAS

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I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the Ryan White HIV/AIDS Program (RWHAP) Part D Coordinated HIV Services and Access to Research for Women, Infants, Children, and Youth (WICY) Existing Geographic Service Areas. The purpose of this program is to provide family-centered care in the outpatient or ambulatory care setting to low income WICY with HIV.

Under this announcement, applicants must propose to provide family-centered care in outpatient or ambulatory care settings to low income women (25 years and older) with HIV, infants (up to two years of age) exposed to or with HIV, children (ages 2 to 12) with HIV, and youth (ages 13 to 24) with HIV. RWHAP Part D funding is intended to improve access to family-centered HIV medical care through the provision of coordinated, comprehensive, and culturally and linguistically competent services directly, through contract, or through memoranda of understanding (MOU).

This competition is open to current RWHAP Part D recipients and new organizations proposing to provide RWHAP Part D funded services in the geographic service areas listed in Appendix B. All applicants must demonstrate that they have the capacity to serve all eligible WICY populations with HIV in the proposed service area. New applicants must provide at least the same scope of comprehensive care and treatment services as the current RWHAP Part D recipient for the service area. Your application must address the entire service area, as defined in Appendix B. If you are applying for more than one service area listed in Appendix B, you must submit a separate application for each service area.

All applicants who submit an application to provide RWHAP Part D services for one of the published service areas in Appendix B may also apply for up to $150,000 in FY 2022 for RWHAP Part D supplemental funding. The purpose of this one-year supplemental funding is to strengthen organizational infrastructure to respond to the changing health care landscape and to increase capacity to develop, enhance, or expand access to high quality family-centered care services for low income WICY with HIV in the service area.

For the purpose of implementing programs funded by RWHAP Part D, HIV family-centered care refers to outpatient or ambulatory care, including behavioral health, nutrition, and oral health services. Specialty care refers to specialty HIV care and specialty medical care such as obstetrics and gynecology, hepatology, and neurology.

Support services may include, but are not limited to, the following:

1) Family-centered care services, including case management, that address the health care needs of WICY with HIV in order to achieve optimal health outcomes.

2) Referrals for additional services including:

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a. referrals for inpatient hospital services, substance use disorder treatment, and mental health services; and

b. referrals for other social and support services, as appropriate.

3) Additional services necessary to enable the patient and the family to participate in the established program, including services designed to recruit and retain youth with HIV.

4) The provision of information and education on opportunities to participate in HIV/AIDS-related clinical research.

For additional information, please refer to Policy Clarification Notice (PCN) 16-02 for a list of RWHAP allowable services and use of funds.

For more details, see Program Requirements and Expectations.

2. Background

The Ryan White HIV/AIDS Program (RWHAP) Part D Coordinated HIV Services and Access to Research for Women, Infants, Children, and Youth (WICY) Existing Geographic Service Areas is authorized by 42 U.S.C. §§ 300ff-71 and 300ff-121 (§§ 2671 and 2693 of the Public Health Service Act).

The Ryan White HIV/AIDS Program (RWHAP) provides a comprehensive system of HIV primary medical care, essential support services, and medications for low-income people with HIV. The program funds grants to states, cities, counties, and local community-based organizations to provide care and treatment services to people with HIV to improve health outcomes and reduce HIV transmission among hard-to-reach populations.

The RWHAP has five statutorily defined Parts (Parts A, B, C, D and F) that provide funding for core medical services, support services, and medications; technical assistance; clinical training; and the development of innovative models of care to meet the needs of different communities and populations affected by HIV.

An important framework in the RWHAP is the HIV care continuum, which depicts the series of stages a person with HIV engages in from initial diagnosis through their successful treatment with HIV medication to achieve viral suppression. Supporting people with HIV to reach viral suppression not only increases their own quality of life and lifespan, it also prevents sexual transmission to an HIV-negative partner.

The HIV care continuum framework allows recipients and planning groups to measure progress and to direct HIV resources most effectively. RWHAP recipients are encouraged to assess the outcomes of their programs and should work with their community and public health partners to improve outcomes across the HIV care continuum. The Health Resources and Services Administration (HRSA) encourages recipients to use the performance measures developed for the RWHAP at their local https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf http://hab.hrsa.gov/deliverhivaidscare/habperformmeasures.html

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level to assess the efficacy of their programs and to analyze and improve the gaps along the HIV care continuum.

Strategic Frameworks and National Objectives

National objectives and strategic frameworks like the Healthy People 2030, the HIV National Strategic Plan: A Roadmap to End the HIV Epidemic (2021–2025); the Sexually Transmitted Infections National Strategic Plan for the United States (2021– 2025); and the Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination (2021–2025) are crucial to addressing key public health challenges facing low-income people with HIV. These strategies detail the principles, priorities, and actions to guide the national public health response and provides a blueprint for collective action across the Federal Government and other sectors. The RWHAP supports the implementation of these strategies and recipients should align their organization’s efforts, within the parameters of the RWHAP statute and program guidance, with these strategies to extent possible.

Expanding the Effort: Ending the HIV

Epidemic in the United States

According to recent data from the 2019 Ryan White Services Report (RSR), the RWHAP has made tremendous progress toward ending the HIV epidemic in the United States. From 2015 to 2019, HIV viral suppression among RWHAP patients who have had one or more medical visits during the calendar year and at least one viral load with a result of <200 copies/mL reported, has increased from 83.4 percent to 88.1 percent.

Additionally, racial/ethnic, age-based, and regional disparities reflected in viral suppression rates have significantly decreased.1 For example, the disparities in viral suppression rates between Black/African Americans and White clients have decreased since 2010.2 These improved outcomes mean more people with HIV in the United States will live near normal lifespans and have a reduced risk of transmitting HIV to others.3

In February 2019, the Ending the HIV Epidemic in the United States (EHE) initiative was launched to further expand federal efforts to reduce HIV infections. This 10-year initiative seeks to achieve the important goal of reducing new HIV infections in the United States to fewer than 3,000 per year by 2030. The initiative promotes and implements four strategies to substantially reduce HIV transmissions – Diagnose, Treat, 1 Health Resources and Services Administration. Ryan White HIV/AIDS Program Annual Client-Level Data Report 2019. http://hab.hrsa.gov/data/data-reports. Published December 2020. Accessed December 2, 2020.

2 Black/African American clients went from 79.4 percent viral suppression in 2015 to 85.2 percent in 2019, while 88.3 percent of white clients were virally suppressed in 2015 and 91.8 percent in 2019 3 National Institute of Allergy and Infectious Diseases (NIAID). Preventing Sexual Transmission of HIV with Anti-HIV Drugs. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US).

2000- [cited 2016 Mar 29]. Available from: https://clinicaltrials.gov/ NCT00074581 NLM Identifier:

NCT00074581.

https://health.gov/healthypeople https://www.hiv.gov/federal-response/hiv-national-strategic-plan/hiv-plan-2021-2025 https://www.hiv.gov/federal-response/hiv-national-strategic-plan/hiv-plan-2021-2025 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 https://hab.hrsa.gov/sites/default/files/hab/data/datareports/RWHAP-annual-client-level-data-report-2019.pdf https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview/ending-epidemic-timeline http://hab.hrsa.gov/data/data-reports https://clinicaltrials.gov/

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Prevent, and Respond. The initiative is a collaborative effort among key U.S Department of Health and Human Services (HHS) agencies, primarily HRSA, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Indian Health Service (IHS), and the Substance Abuse and Mental Health Services Administration (SAMHSA).

For the RWHAP, the EHE initiative expands the program’s ability to meet the needs of clients specifically focusing on linking people with HIV who are either newly diagnosed, diagnosed but currently not in care, or are diagnosed in care but not yet virally suppressed to the essential HIV care and treatment and support services needed to help them achieve viral suppression.

Using Data Effectively: Integrated Data Sharing and Use

HRSA and CDC’s Division of HIV/AIDS Prevention support integrated data sharing, analysis, and utilization for the purposes of program planning, conducting needs assessments, determining unmet need estimates, reporting, quality improvement, enhancing the HIV care continuum, and public health action. HRSA strongly encourages RWHAP recipients to:

• Follow the principles and standards in 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.

• Establish data sharing agreements between surveillance and HIV programs to ensure clarity about the process and purpose of the data sharing and utilization.

Integrated data sharing, analysis, and utilization of HIV data by state and territorial health departments can help further progress toward reaching the HIV National Strategic Plan goals and improve outcomes on the HIV care continuum.

HRSA strongly encourages complete CD4, viral load (VL) and HIV nucleotide sequence reporting to the state and territorial health departments’ HIV surveillance systems to benefit fully from integrated data sharing, analysis, and utilization. State health departments may use CD4, VL, and HIV nucleotide sequence data to identify cases, stage of HIV disease at diagnosis, and monitor disease progression. These data can also be used to evaluate HIV testing and prevention efforts, determine entry into and retention in HIV care, measure viral suppression, monitor prevalence of antiretroviral drug resistance, detect transmission clusters and understand transmission patterns, and assess unmet health care needs. Analyses at the national level to monitor progress toward ending the HIV epidemic in the United States can only occur if all HIV-related CD4, VL, and HIV nucleotide sequence test results are reported by all jurisdictions. CDC requires the reporting to the National HIV Surveillance System (NHSS) all HIV-related CD4 results (counts and percentages), all VL results (undetectable and specific values), and HIV nucleotide sequences.

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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Program Resources and Innovative Models

HRSA has a number of projects and resources that may assist RWHAP recipients with program implementation. These include a variety of HRSA cooperative agreements, contracts, and grants focused on specific technical assistance (TA), evaluation, and intervention activities. A list of these resources is available on TargetHIV. Recipients should be familiar with these resources and are encouraged to use them as needed to support their program implementation.

An important technical assistance resource is the RWHAP Recipient Compilation of Best Practices Intervention Strategies (Best Practices Compilation). The Best Practices Compilationt includes strategies that have been implemented in real world settings and that improve outcomes along the HIV care continuum. The RWHAP Best Practices Compilation is an easily searchable resource to support recipients’ work and the needs of the people served by the RWHAP.

In addition, many RWHAP Special Projects of National Significance (SPNS) projects have demonstrated promising new approaches for linking and retaining priority populations into care. As resources permit, RWHAP recipients are encouraged to review and integrate these tools within their HIV system of care in accordance with the allowable service categories defined in PCN 16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals & Allowable Uses of Funds. Examples of these resources include:

• E2i: Using Evidence-Informed Interventions to Improve Health Outcomes among People Living with HIV E2i uses an implementation science approach to evaluate and understand existing and new intervention strategies that can be used in RWHAP provider settings. Once interventions or strategies are demonstrated and evaluated using implementation science, manuals, guides, interactive online tools, publications, and instructional materials are developed and disseminated for replication and integration into RWHAP provider settings.

• Integrating HIV Innovative Practices (IHIP) Resources on the IHIP website include easy-to-use training manuals, curricula, case studies, pocket guides, monographs, and handbooks, as well as informational handouts and infographics about SPNS generally. IHIP also hosts TA training webinars designed to provide a more interactive experience with experts, and a TA help desk exists for you to submit additional questions and share your own lessons learned.

• Replication Resources from the SPNS Systems Linkages and Access to Care There are intervention manuals for patient navigation, care coordination, state bridge counselors, data to care, and other interventions developed for use at the state and regional levels to address specific HIV care continuum outcomes among hard-to-reach people with HIV.

https://targethiv.org/help/ta-directory https://targethiv.org/bestpractices https://targethiv.org/bestpractices https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://targethiv.org/e2i https://targethiv.org/e2i https://targethiv.org/ihip https://targethiv.org/library/replication-resources-spns-systems-linkages-and-access-care

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• Dissemination of Evidence Informed Interventions The Dissemination of Evidence-Informed Interventions initiative ran from 2015-2020 and disseminated four adapted linkage and retention interventions from prior SPNS and the Minority HIV/AIDS Funds (MHAF) from the HHS Secretary’s Office initiatives to improve health outcomes along the HIV care continuum. The initiative produced four evidence-informed care and treatment interventions (CATIs) that are replicable, cost-effective, capable of producing optimal HIV care continuum outcomes, and easily adaptable to the changing healthcare environment. Manuals are currently available at the link provided and will be updated on an ongoing basis.

HRSA also recognizes the importance of addressing emerging issues, as well as supporting the needs of special populations. To help recipients in responding to these critical issues, HRSA funds projects to provide technical assistance and resources for recipients. Examples of projects include:

• Building Futures: Supporting Youth Living with HIV

• The Center for Engaging Black MSM Across the Care Continuum (CEBACC)

• Using Community Health Workers to Improve Linkage and Retention in Care

Social determinants of health (SDOH) are conditions in which people are born, grow, live, work, and age. They include factors like socioeconomic status, education, neighborhood and physical environment, community violence, employment, and social support networks, as well as access to health care. Intimate partner violence (IPV) is among these factors that can disproportionately affect underserved communities.

According to Centers for Disease Control and Prevention, National Intimate Partner and Sexual Violence Survey (NISVS), IPV describes physical violence, sexual violence, stalking, or psychological harm by a current or former partner or spouse, and can have both direct and indirect effects on individual, family, and community health. In 2017, HRSA launched its Strategy to Address IPV, an effort to address this critical social determinant of health through agency-wide collaborative action. The Strategy includes four priority areas including (1) Training the nation’s health workforce, (2) Building partnerships to raise awareness, (3) Increasing access to quality care, and (4) Addressing gaps in knowledge about IPV risks, impacts, and interventions. Applicants are encouraged to consider one or more of these priority areas, as relevant, in the development and measurement of their initiative.

Additional resources to assist you in determining how to effectively address intimate partner violence in your HRSA-funded programs may be found in the HRSA Strategy to Address IPV.

II. Award Information

1. Type of Application and Award

Type(s) of applications sought: New, Competing Continuation, and Competing https://targethiv.org/deii https://targethiv.org/library/hrsa-hab-building-futures-supporting-youth-living-hiv https://targethiv.org/cebacc https://targethiv.org/chw https://www.hrsa.gov/sites/default/files/hrsa/HRSA-strategy-intimate-partner-violence.pdf https://www.hrsa.gov/sites/default/files/hrsa/HRSA-strategy-intimate-partner-violence.pdf https://www.hrsa.gov/sites/default/files/hrsa/HRSA-strategy-intimate-partner-violence.pdf

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Supplemental.

HRSA will provide funding in the form of a grant.

2. Summary of Funding

HRSA estimates approximately $75,000,000 to be available annually to fund 114 recipients. You may apply for up to the published ceiling amount in Appendix B per year. The actual amount available will not be determined until enactment of the final FY 2022 federal budget. This program notice is subject to the appropriation of funds, and is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can process applications and award funds appropriately. Applications must be complete, within the specified page limit, and validated by Grants.gov prior to the deadline to be considered under this NOFO.

The period of performance for the RWHAP Part D WICY program is August 1, 2022 through July 31, 2026 (four years). Funding beyond the first year is subject to the availability of appropriated funds for RWHAP Part D Coordinated HIV Services and Access to Research for Women, Infants, Children, and Youth (WICY) Existing Geographic Service Areas in subsequent fiscal years, satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government. In addition, the period of performance for the Part D Supplemental funding is August 1, 2022 – July 31, 2023 (one year). Please review the RWHAP Part D Supplemental Funding section for more information.

New RWHAP Part D Funding Methodology Beginning in 2018, HRSA initiated a 2-year study to understand how to strategically target RWHAP Part D resources to maximize national impact. Activities conducted for this process included analyzing data (Ryan White HIV/AIDS Services Report (RSR), allocation reports, and CDC surveillance, etc.), compiling and reviewing evidence-informed interventions for the WICY population, and receiving feedback from various stakeholders. At the conclusion of the study, HRSA obtained feedback and input regarding potential new actions or directions for the RWHAP Part D WICY to improve linkage, retention, and health outcomes for this population. Based on the results of the study, three priority areas were identified for the next Part D competition: capacity building and training, targeted technical assistance, and a data informed funding methodology. This competition represents the first phase of the gradual implementation of the new funding methodology.

As part of the implementation strategy for the funding methodology, HRSA undertook a systematic revision of how RWHAP Part D funding was previously distributed to ensure that the RWHAP Part D funding awards across service areas are based on the numbers of clients served and presence of additional RWHAP resources.

Similar to the RWHAP Part C funding methodology that was implemented in FY 2018, the new RWHAP Part D funding methodology uses quantitative data to distribute funds

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to grant service areas in a more streamlined and consistent manner to achieve a reasonable and sustainable allocation of resources to improve health outcomes for WICY with HIV. The RWHAP Part D funding methodology includes the following proportions and objective factors:

• Base funding - Each service area receives a minimum baseline award amount of $115,000 to ensure adequate level of funding to support program operations.

• WICY Clients - Base funding amount is augmented by an amount corresponding to the number of eligible RWHAP Part D clients served by the RWHAP Part D recipient as reported through the most recent RSR data, which for this competition is 2019.

Approximately 85% of RWHAP Part D funding is allocated to base funding and WICY clients served.

• Presence of RWHAP Part A resources – The funding amount is increased for RWHAP Part D service areas outside of RWHAP Part A jurisdictions to address areas with limited availability of RWHAP resources, primarily rural areas.

Approximately 15 percent of RWHAP Part D funding is based on the absence of RWHAP Part A resources.

The RWHAP Part D funding methodology seeks to ensure baseline funding for the maintenance of program operations; minimizes disruptions by constraining the maximum decrease and capping maximum increase; and maintains the provision of quality HIV care in existing service areas. HRSA used the funding methodology to determine the funding ceiling amount per service area under this NOFO, which continues to be a competitive, discretionary grant opportunity. Assuming level funding for the RWHAP Part D program in future years, this first phase of the funding methodology ensures that no service area will receive approximately more than a 10 percent decrease or more than a 25 percent increase in funding through this NOFO as compared to FY 2020 funding levels. Future iterations of the RWHAP Part D funding methodology may include new proportions in funding and factors, such as performance in HIV viral suppression, and new guardrails to ensure that the funding allocation across service areas will be responsive to HIV health disparities and the changing demographics of the HIV epidemic, as well as the evolving health care landscape.

The funding ceiling amounts in Appendix B reflect the implementation of this methodology.

HRSA encourages current RWHAP Part D recipients to assess their history of expending Part D funds and to examine all resources available, including program income generated as a result of the RWHAP Part D award, when they consider the funding level for which to apply. Appendix B describes the ceiling amount for each service area; applicants can request a funding level that is less than the listed amount in light of their history of expending Part D funds and availability of other resources. HRSA anticipates directing any balance in funds to support technical assistance initiatives for RWHAP Part D service areas, as well as to support the RWHAP Part D Supplemental

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funding. In addition, HRSA reserves the right to fund less than the amount requested based on a history of current RWHAP Part D recipients’ unobligated balances.

RWHAP Part D Supplemental Funding Up to $3,500,000 is expected to be available in FY 2022 to provide one-year supplemental funding to approximately 25 of the 114 recipients. In addition to your application to provide RWHAP Part D services for one of the published service areas in Appendix B, you may also apply for a ceiling amount of up to $150,000 in supplemental funding to implement one HIV Care Innovation activity. The project period for the supplemental funding is August 1, 2022 through July 31, 2023. Both new entities and current RWHAP Part D recipients applying for funding under this announcement (HRSA-22-037) are eligible to apply for supplemental funding. Consideration for this one-year supplemental award is limited to applicants successfully funded under this announcement. Please review instructions in the Program Requirements and Expectations section, Attachment 13, and Section V.1. for additional information.

By law, no more than 10 percent of a federal RWHAP Part D award (including the Part D supplemental award) can be used for administrative expenses. All indirect costs count toward this 10 percent limit. Please see PCN 15-01 Treatment of Costs under the 10% Administrative Cap for Ryan White HIV/AIDS Program Part A, B, C, and D.

All HRSA awards are subject to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements at 45 CFR part 75.

III. Eligibility Information

1. Eligible Applicants

This competition is open to current RWHAP Part D grant recipients and new, eligible applicant organizations proposing to provide RWHAP Part D family-centered care in outpatient or ambulatory care settings to low income WICY with HIV in the entire service area as described in Appendix B.

As identified in section 2671 of the Public Health Service (PHS) Act, eligible applicants include public and nonprofit private entities (including a health facility operated by or pursuant to a contract with the Indian Health Service, and faith-based and Tribes/Tribal organizations) that provide family-centered care involving outpatient or ambulatory care (directly or through contracts or MOUs) for WICY with HIV.

All applicants must meet the basic requirements of a RWHAP Part D Program as outlined in this NOFO and as established in section 2671 of the PHS Act. All applicants must demonstrate need based upon epidemiologic data. All applicants may only submit applications that address the entire RWHAP Part D geographic service area(s) for which they are applying to as published in Appendix B.

https://hab.hrsa.gov/sites/default/files/hab/Global/HRSA-HAB-PCN15-01.pdf https://hab.hrsa.gov/sites/default/files/hab/Global/HRSA-HAB-PCN15-01.pdf http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75

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2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

HRSA will consider any application that exceeds the ceiling amount listed in Appendix B non-responsive and will not consider it for funding under this notice.

Requests for supplemental funding that exceed the ceiling amount of $150,000 will be considered non-responsive and will not be considered for funding under this announcement.

HRSA will consider any application that fails to satisfy the deadline requirements referenced in Section IV.4 non-responsive and will not consider it for funding under this notice.

NOTE: Multiple applications from an organization are allowable. If you are applying for more than one service area listed in Appendix B, you must submit a separate application for each service area. Each application must address the entire service area, as defined in Appendix B.

HRSA will only accept your last validated electronic submission, under the correct funding opportunity number, prior to the Grants.gov application due date as the final and only acceptable application.

IV. Application and Submission Information

1. Address to Request Application Package

HRSA requires you to apply electronically. HRSA encourages you to apply through Grants.gov using the SF-424 workspace application package associated with this NOFO following the directions provided at http://www.grants.gov/applicants/apply-for-grants.html.

The NOFO is also known as “Instructions” on Grants.gov. You must select “Subscribe” and provide your email address for HRSA-22-037 in order to receive notifications including modifications, clarifications, and/or republications of the NOFO on Grants.gov.

You will also receive notifications of documents placed in the RELATED DOCUMENTS tab on Grants.gov that may affect the NOFO and your application. You are ultimately responsible for reviewing the For Applicants page for all information relevant to this NOFO.

https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/web/grants/applicants.html

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2. Content and Form of Application Submission

Application Format Requirements Section 4 of HRSA’s SF-424 Application Guide provides general instructions for the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, etc. You must submit the information outlined in the HRSA SF-424 Application Guide in addition to the program-specific information below. You are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide except where instructed in the NOFO to do otherwise. You must submit the application in the English language and in the terms of U.S. dollars (45 CFR § 75.111(a)).

See Section 8.5 of the HRSA SF-424 Application Guide for the Application Completeness Checklist.

Application Page Limitation The total size of all uploaded files included in the page limit may not exceed the equivalent of 80 pages when printed by HRSA. The page limit includes the project and budget narratives, attachments, and letters of commitment and support required in the Application Guide and this NOFO. Hyperlinks to additional documents are not allowed and will not be accessed or reviewed by the ORC reviewers. Standard OMB-approved forms that are included in the workspace application package do not count in the page limit. Please note: If you use an OMB-approved form that is not included in the workspace application package for HRSA-22-037, it may count against the page limit.

Therefore, we strongly recommend you only use Grants.gov workspace forms associated with this NOFO to avoid exceeding the page limit. Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. It is therefore important to take appropriate measures to ensure your application does not exceed the specified page limit.

Applications must be complete, within the specified page limit, and validated by Grants.gov under the correct funding opportunity number prior to the deadline.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

1) You certify on behalf of the applicant organization, by submission of your proposal, that neither you nor your principals are presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any federal department or agency.

2) Failure to make required disclosures can result in any of the remedies described in 45 CFR § 75.371, including suspension or debarment. (See also 2 CFR parts 180 and 376, and 31 U.S.C. § 3321).

3) If you are unable to attest to the statements in this certification, you must include an explanation in Attachment 14 Other Relevant Documents.

See Section 4.1 viii of HRSA’s SF-424 Application Guide for additional information on all certifications.

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

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Program Requirements and Expectations

RWHAP Part D recipients are expected to develop a comprehensive and coordinated system of family-centered care and support services for low income WICY with HIV in their entire service area as listed in Appendix B, especially those populations who are the hardest to reach, have the greatest unmet need, and/or demonstrate the greatest gaps in the HIV care continuum. This system of family-centered HIV care and support services should ensure the progress of the target WICY populations along the HIV care continuum with the goal of optimizing health outcomes demonstrated by testing and linkage to care, retention in medical care, viral suppression, and decreases in new HIV infections in the community.

Evidence-Based and Informed Interventions for Disproportionately Affected WICY The HIV National Strategic Plan for the United States: A Roadmap to End the HIV Epidemic (2021-2025) (HIV National Strategic Plan) identifies priority populations to reduce disparities and improve HIV outcomes. The following target populations that can also identify as WICY were outlined in the plan: gay, bisexual, and other men who have sex with men, in particular Black, Latino, and American Indian/Alaska Native men; Black women; transgender women; youth aged 13-24 years; and people who inject drugs.

Priority sub-populations among WICY for the RWHAP Part D program are Black women; transgender women; youth aged 13-24 years; and people who inject drugs. The HIV National Strategic Plan notes using viral suppression rates as a disparities indicator because increasing and maintaining viral suppression among priority populations will improve health outcomes, reduce HIV-related deaths, and prevent new HIV transmissions. As a result, in seeking to drive health outcome improvements in these disproportionately affected populations, RWHAP Part D recipients are expected to provide evidence-informed interventions.

HAB has a number of program resources and innovative models, described in the Background section of this NOFO, which programs are encouraged to review. The CDC has also compiled a Compendium of Evidence-Based Interventions and Best Practices for HIV Prevention to include interventions with evidence of showing significant effects on HIV related outcomes. RWHAP Part D programs are expected to review the HAB resources and CDC compendium and select an intervention(s) to implement with their WICY and priority WICY populations.

Minority AIDS Initiative (MAI) As established in section 2693 of the PHS Act, the Minority AIDS Initiative (MAI) is intended to address the disproportionate impact that HIV/AIDS has on racial and ethnic minorities and to address the disparities in access, treatment, care, and outcomes for racial and ethnic minorities, including African Americans, Alaska Natives, Hispanic/Latinos, American Indians, Asian Americans, Native Hawaiians, and Pacific Islanders.

https://www.hiv.gov/federal-response/hiv-national-strategic-plan/hiv-plan-2021-2025 https://www.hiv.gov/federal-response/hiv-national-strategic-plan/hiv-plan-2021-2025 https://www.cdc.gov/hiv/research/interventionresearch/compendium/index.html https://www.cdc.gov/hiv/research/interventionresearch/compendium/index.html

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MAI funds are granted to health care organizations that provide culturally and linguistically appropriate care and services to racial and ethnic minorities.

RWHAP Part D WICY recipients will be assigned funds under the MAI by the HAB Division of Community HIV/AIDS Programs (DCHAP), which administers the RWHAP Part D program. This assignment is based on the percentage of the RWHAP Part D WICY populations served from racial/ethnic minority communities as reported in the most recent RSR data and used to determine MAI amounts at the start of the period of performance.

The amount of MAI funds awarded will be noted under the grant-specific program terms section (if applicable) of the Notice of Award (NOA) which establishes the final funding for each budget period.

Clinical Requirements:

• Prevention of HIV Transmission Programs are encouraged to incorporate HHS Guidelines on Antiretroviral Therapy to Prevent Sexual Transmission of HIV (Treatment as Prevention) and the Centers for Disease Control’s Recommendations for HIV prevention with adults and adolescents with HIV in the United States, 2014: Summary for clinical providers.

These guidelines include new and longstanding federal guidance on biomedical, behavioral, and structural interventions that can decrease HIV transmission from persons with HIV by promoting adherence to antiretroviral therapy (ART) and reducing their HIV viral load. These include:

o Treatment as prevention (TasP) preventing sexual transmission of HIV through prescription of and adherence to ART to achieve and sustain viral load suppression (<200 copies/mL).

o Screening patients for behavioral risk through interviews or questionnaires regarding sexual and needle-sharing behaviors and screening for sexually transmitted infections (STIs) and pregnancy.

o Offering behavioral interventions to change knowledge, attitudes, and behaviors to reduce personal risk of transmitting or acquiring other STIs.

Interventions should include information about TasP, viral suppression, pre-exposure prophylaxis (PrEP), and non-occupational post exposure prophylaxis (nPEP).

o Providing partner counseling and referral services (PCRS) which includes partner notification and suggests offering services, including PrEP, which can help the sex and needle-sharing partners of people with

HIV.

Providers should ensure that the information they provide reflects recent advances in HIV prevention, including TasP, viral suppression, PrEP (see US Public Health Service Pre-exposure Prophylaxis for the Prevention of HIV Infection in the United States), and nPEP (see Updated guidelines for antiretroviral post-exposure prophylaxis after sexual, injection drug use, or other non-occupational exposure to https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/antiretroviral-therapy-prevent-sexual-transmission-hiv?view=full https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/antiretroviral-therapy-prevent-sexual-transmission-hiv?view=full https://stacks.cdc.gov/view/cdc/44065 https://stacks.cdc.gov/view/cdc/44065 https://clinicalinfo.hiv.gov/themes/custom/aidsinfo/documents/cdc-hiv-prep-guidelines-2017.pdf https://clinicalinfo.hiv.gov/themes/custom/aidsinfo/documents/cdc-hiv-prep-guidelines-2017.pdf https://clinicalinfo.hiv.gov/themes/custom/aidsinfo/documents/cdc-hiv-prep-guidelines-2017.pdf https://stacks.cdc.gov/view/cdc/38856 https://stacks.cdc.gov/view/cdc/38856

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HIV). Note that the RWHAP prohibits the use of RWHAP funds for PrEP medications and the related medical services such as clinician visits and laboratory costs. While RWHAP legislation prohibits the use of RWHAP funds for PrEP services, RWHAP grant recipients are expected to link persons who could benefit from PrEP to appropriate HIV prevention service providers in their area.

For more information see the Ryan White HIV/AIDS Program and Pre-Exposure Prophylaxis (PrEP) Letter.

• Medical Care Evaluation and Clinical Care – RWHAP Part D programs must develop a comprehensive and coordinated system of family-centered care and support services in an outpatient or ambulatory care setting either directly or through contracts or MOUs throughout their entire designated service area (see Appendix B).

• Clinical Guidelines – All clinical care must be provided in accordance with HHS Clinical Guidelines. You are strongly encouraged to require, at least yearly, continuing education opportunities for RWHAP Part D program staff to ensure they remain knowledgeable of clinical advances in the treatment of HIV and are familiar with the most recent HHS Clinical Guidelines.

• Referral Systems - A process must be in place for referring patients to needed health care and support services such as oral health, specialty care, medical case management, etc. The referral system should include the tracking and monitoring of those referrals, including the documentation of the referral’s outcome in the medical record so that follow-up may occur.

• Linkage to Clinical Trials – A plan must be in place for referring appropriate patients to biomedical research facilities or community-based organizations that conduct HIV-related clinical trials. For information on these protocols, visit the NIH HIV Clinical Trials Network website.

• Clinical Quality Management (CQM) – Section 2671 of the PHS Act requires

RWHAP Part D recipients to: (1) assess the extent to which HIV health services provided to patients under the grant are consistent with HHS Guidelines for the treatment of HIV and related opportunistic infections, and (2) develop strategies for ensuring such services are consistent with the guidelines for improvement in the access to and quality of HIV health services. Please see HAB PCN 15-02 Clinical Quality Management and related Frequently Asked Questions for PCN 15-02 for information on CQM program requirements.

• Coordination/Linkages to Other Programs – Coordination must occur with all available and accessible community resources, such as federally-funded and non-federally-funded programs (e.g., substance use disorder treatment, mental health treatment, homelessness, housing, other support service programs) and with other providers of health care services under this act and Title V of the Social Security Act, including…