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HRSA-23-127 Notice of Funding Opportunity

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U.S. Department of Health and Human Services

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2023

HIV/AIDS Bureau

Division of Metropolitan HIV/AIDS Programs

A Status Neutral Approach to Improve HIV Prevention and Health Outcomes for Racial and Ethnic Minorities – Evaluation and Technical Assistance Provider

(ETAP)

Funding Opportunity Number: HRSA-23-127

Funding Opportunity Type(s): New

Assistance Listings Number: 93.899

Application Due Date: June 12, 2023 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: April 12, 2023

MODIFIED June 6, 2023: The maximum amount you may request in year one has increased from $2,250,000 to $2,650,000.

Chrissy Abrahms Woodland Director, HAB Division of Metropolitan HIV/AIDS Programs Phone: 301-443-1373 Email: CAbrahms@hrsa.gov

See Section VII for a complete list of agency contacts.

Authority: Consolidated Appropriations Act, 2023, Pub. L. 117-328, Division H, title II and 42 USC §§ 300ff-16 and 300ff-101 (§§ 2606 and 2691 of the Public Health Service Act).

mailto:CAbrahms@hrsa.gov

HRSA-23-127 i

508 COMPLIANCE DISCLAIMER

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

EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2023 A Status Neutral Approach to Improve HIV Prevention and Health Outcomes for Racial and Ethnic Minorities – Evaluation and Technical Assistance Provider (ETAP).

The purpose of this program is to support a single organization to develop, implement, and evaluate the status neutral strategies within Ryan White HIV/AIDS Program (RWHAP) Part A jurisdictions for racial and ethnic minority subpopulations who need HIV prevention services funded under separate announcement number HRSA-23-126:

A Status Neutral Approach to Improve HIV Prevention and Health Outcomes for Racial and Ethnic Minorities – Implementation Sites.

The ETAP will provide TA and capacity building to the implementation sites; work collaboratively with the sites to implement a comprehensive multi-site evaluation; and disseminate successful models, findings, best practices, and lessons learned for the RWHAP and the HIV services community.

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.

Funding Opportunity Title: A Status Neutral Approach to Improve HIV Prevention and Health Outcomes for Racial and Ethnic Minorities – Evaluation and Technical Assistance Provider

(ETAP)

Funding Opportunity Number: HRSA-23-127

Due Date for Applications: June 12, 2023

Anticipated FY 2023 Total Available Funding:

$2,650,000 http://www.hrsa.gov/

HRSA-23-127 ii

Estimated Number and Type of Award: One (1) cooperative agreement

Estimated Annual Award Amount:

Up to $2,650,000 for year one and $2,750,000 for years two and three, per award subject to the availability of appropriated funds.

Cost Sharing/Match Required: No

Period of Performance: September 1, 2023 through August 31, 2026 (3 years)

Eligible Applicants: Public and nonprofit private entities, including institutions of higher education and academic health science centers involved in addressing HIV related issues on a national scope. Faith-based and community-based organizations, Tribes and tribal organizations are eligible.

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

Application Guide

You (the applicant organization/agency) are responsible for reading and complying with the instructions included in this NOFO and in HRSA’s SF-424 Application Guide. Visit HRSA’s How to Prepare Your Application page for more information.

Technical Assistance

HRSA has scheduled the following webinar:

Thursday, May 4, 2023 2 p.m. – 4 p.m. ET Weblink: https://hrsa-gov.zoomgov.com/j/1616884295?pwd=MG1FbVFaUFV1T2MxZ2RHcm0wOXFGdz0 Meeting ID: 1616884295 Passcode: SgrX1Fz4

Attendees without computer access or computer audio can use the dial-in information below.

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application https://hrsa-gov.zoomgov.com/j/1616884295?pwd=MG1FbVFaUFV1T2MxZ2RHcm0wOXFGdz09 https://hrsa-gov.zoomgov.com/j/1616884295?pwd=MG1FbVFaUFV1T2MxZ2RHcm0wOXFGdz09 https://hrsa-gov.zoomgov.com/j/1616884295?pwd=MG1FbVFaUFV1T2MxZ2RHcm0wOXFGdz09

HRSA-23-127 iii

Call-In Number: 1-833-568-8864 Passcode: 42912296

HRSA will record the webinar and will be available at Target HIV.

https://targethiv.org/

HRSA-23-127 iv

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. 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

HRSA-23-127 1

I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the Status Neutral Approach to Improve HIV Prevention and Health Outcomes for Racial and Ethnic Minorities – Evaluation and Technical Assistance Provider (ETAP). Funding will be provided to support a single organization to lead a multi-site evaluation and provide technical assistance (TA), including planning, coordination, mapping services, and infrastructure development/enhancement to a cohort of up to four implementation sites on the development of a status neutral framework, funded under a separate announcement number, HRSA-23-126: A Status Neutral Approach to Improve HIV Prevention and Health Outcomes for Racial and Ethnic Minorities – Implementation Sites.

The ETAP will design an evaluation plan that will monitor the development, implementation, and outcomes of the four implementation sites’ status neutral activities to assess effectiveness and disseminate best practices and lessons learned for replication and expansion in other Ryan White HIV/AIDS Program (RWHAP) Part A programs, Center for Disease Control (CDC) directly-funded health departments and community-based organizations, as well as in the Bureau of Primary Health Care’s Primary Care HIV Prevention Program (PCHP).

The CDC offers a self-paced, eLearning course on Status Neutral hosted on CDC TRAIN (https://www.train.org/cdctrain/welcome), which may be useful to the funding recipient.

For more details, see Program Requirements and Expectations.

2. Background

A Status Neutral Approach to Improve HIV Prevention and Health Outcomes for Racial and Ethnic Minorities – Evaluation and Technical Assistance Provider (ETAP) is authorized by Consolidated Appropriations Act, 2023, Pub. L. 117-328, Division H, title II, and the RWHAP Part F Special Projects of National Significance (SPNS), authorized under 42 USC §§ 300ff-16 and 300ff-101 (§§ 2606 and 2691 of the Public Health Service Act) and supported by the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Health’s Minority HIV/AIDS Fund (MHAF).

The status neutral approach reframes how we think about traditional HIV service models. A status neutral approach centers on the person, not their HIV status. A status neutral approach prioritizes individual needs for services and support that are holistic, comprehensive, continuous, and culturally responsive. The status neutral approach aims to increase access to services and health equity by meeting unmet needs in under-served communities.

https://www.train.org/cdctrain/welcome

HRSA-23-127 2

The status neutral framework is called “status neutral” because the same approach is used to engage and retain people in care, regardless of HIV status. Status neutral HIV health and social services connect community members to the specific resources they need and want. In a status neutral approach, members of the community typically enter the HIV services system through HIV testing services. After HIV testing, people enter one of two pathways. People whose HIV test is non-reactive enter the prevention pathway. They are offered powerful prevention tools, such as pre-exposure prophylaxis (PrEP), condoms, sexual health education, and syringe services, as needed. People whose HIV test is reactive enter the treatment pathway. They are offered effective HIV treatment as well as other tools, such as condoms, sexual health education, and syringe services, as needed. Consistent use of antiretroviral therapy (ART) and maintaining viral suppression improves personal health and well-being. Since people with HIV who take HIV medication as prescribed and reach and maintain viral suppression cannot sexually transmit the virus to their partner.

Regardless of their pathway, community members are offered sexual health education, social and health support services, quality care, and the tools they need to stay healthy and stop HIV. Both pathways share a common goal: preventing HIV transmission and achieving better health outcomes. In addition, a status neutral approach is unique because both pathways (i.e., prevention and treatment) promote continual assessment of each person’s needs, including access to support services, for anyone who could benefit from them. This continuous, high-quality care supports ongoing engagement by providing people with or at risk for HIV with the tools they need to stay healthy and help stop the spread of HIV. Providing effective treatment to maintain an undetectable viral load, and providing PrEP to those at high risk of acquiring HIV, are two such tools.

Status neutral services have four key characteristics that underscore the benefits of adopting a status neutral model. First, the services are whole-person-first. A person-centered approach means seeing each member of the community as a multi-faceted person with a wealth of experiences that influence their health and well-being. Status neutral services are also comprehensive, which means they include and extend beyond HIV prevention and treatment in support of overall health. Status neutral services are also continuous. They engage community members in health and social services as needed over time, with no set endpoint. Finally, the comprehensive and continuous services provided are culturally responsive. The status neutral approach requires understanding that people of different backgrounds have different perspectives on healthcare and wellness, and service provision should be adapted accordingly.

The RWHAP is a proven model for the provision of services that support engagement in care. RWHAP-funded facilities use a medical home model, offering comprehensive, patient-centered care for people with HIV. The medical home model is a multi-disciplinary approach that integrates care, case management, and support services and emphasizes patient-provider relationships. More than half of people with diagnosed HIV in the United States receive services through the RWHAP each year. Approximately 75 percent of RWHAP-funded facilities provide on-site case management for wrap-around services like assistance for food, housing, and transportation. RWHAP patients are also

HRSA-23-127 3

more likely to have access to on-site mental health and substance use disorder services, thus achieving better health outcomes, with a viral suppression rate of 89.4%.

Since the RWHAP legislation requires grant funds to be used for the care and treatment of people with diagnosed HIV, thus prohibiting the use of RWHAP funds for medical and social support services for people without HIV who are at substantial risk for HIV, people who do not have HIV but have need for HIV prevention services do not always have access to the same medical, behavioral, and social services to support engagement in care.

The 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 priority populations.

The RWHAP has five statutorily defined Parts (Parts A, B, C, D, and F) that provide funding for core medical, support services, and medications; TA; clinical training; and the development of innovative interventions and strategies for HIV care and treatment to quickly respond to emerging needs of RWHAP clients.

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. For those people who do not have HIV, the HIV prevention continuum is an important extension of the care framework. The HIV prevention continuum depicts the support needed to engage and maintain biomedical and social support services, as well as regular testing to ensure the person remains uninfected.

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. HRSA encourages recipients to use the performance measures developed for the RWHAP at their local 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 Healthy People 2030, the National HIV/AIDS Strategy (NHAS) (2022–2025); 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 provide a blueprint for collective action across the Federal Government and other sectors. The RWHAP supports the implementation of these strategies and

HRSA-23-127 4

recipients should align their organization’s efforts, within the parameters of the RWHAP statute and program guidance, with these strategies to the extent possible.

Expanding the Effort: Ending the HIV Epidemic in the U.S.

According to recent data from the 2021 Ryan White Services Report (RSR), the RWHAP has made tremendous progress toward ending the HIV epidemic in the United States. From 2017 to 2021, 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 85.9 percent to 89.7 percent.

Additionally, racial and ethnic, age-based, and regional disparities reflected in viral suppression rates have significantly decreased.[1]

In February 2019, the Ending the HIV Epidemic in the U.S (EHE) initiative was launched to further expand federal efforts to reduce HIV infections. This 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. 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 and in care but not yet virally suppressed, to the essential HIV care, 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 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 NHAS goals and improve outcomes on the HIV care continuum.

HRSA’s RWHAP Compass Dashboard is a user-friendly, interactive data tool to allow users to visualize the reach, impact, and outcomes of the RWHAP and supports data utilization to understand outcomes and inform planning and decision making. The dashboard provides a look at national-, state-, and metro area-level data and allows users to explore RWHAP client characteristics and outcomes, including age, housing status, transmission category, and viral suppression. The RWHAP Compass Dashboard also visualizes information about RWHAP services received and the characteristics of those clients accessing the AIDS Drug Assistance Program (ADAP).

HRSA-23-127 5

As outlined in Policy Clarification Notice 21-02, Determining Client Eligibility & Payor of Last Resort in the Ryan White HIV/AIDS Program, recipients and subrecipients should use electronic data sources (e.g., Medicaid enrollment, state tax filings, enrollment and eligibility information collected from health care marketplaces) to collect and verify client eligibility information, such as income and health care coverage (that includes income limitations), when possible. RWHAP recipients and subrecipients should first use available data sources to confirm client eligibility before requesting additional information from the client.

In addition, RWHAP recipients and subrecipients are encouraged to develop data sharing strategies with other RWHAP recipients and relevant entities to reduce administrative burden across programs. 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 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 U.S. 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.

Program Resources and Innovative Models

HRSA has several projects and resources that may assist RWHAP recipients with program implementation. These include a variety of HRSA HIV/AIDS Bureau (HAB) projects focused on specific TA, evaluation, demonstration, and intervention activities. A full list is available on TargetHIV. Recipients should be familiar with these resources and are encouraged to use them as needed to support their program implementation.

Examples of these resources include:

• Access, Care, and Engagement Technical Assistance Center (ACE TA)

• Best Practices Compilation

• Center for Innovation and Engagement (CIE)

• Center for Quality Improvement and Innovation (CQII)

• Dissemination of Evidence-Informed Interventions (DEII)

• Using Evidence-Informed Interventions to Improve Health Outcomes among People Living with HIV (E2i) https://targethiv.org/ https://targethiv.org/ace https://targethiv.org/blog/rwhap-best-practices-compilation-discover-and-share-innovations https://targethiv.org/CIE https://targethiv.org/cqii https://targethiv.org/deii https://targethiv.org/e2i https://targethiv.org/e2i

HRSA-23-127 6

• Ending Stigma through Collaboration and Lifting All to Empowerment

(ESCALATE)

• Engage Leadership through Employment, Validation, and Advancing Transformation and Equity for persons with HIV (ELEVATE)

• Integrating HIV Innovative Practices (IHIP)

II. Award Information

1. Type of Application and Award

Type of applications sought: New

HRSA will provide funding in the form of a cooperative agreement. A cooperative agreement is a financial assistance mechanism where HRSA anticipates substantial involvement with the recipient during performance of the contemplated project.

In addition to the usual monitoring and TA provided directly to award recipients, HRSA program involvement will include:

• Facilitating the availability and expertise of experienced HRSA HAB personnel as participants in the planning, development, and implementation of the project.

• Coordinating communication and develop partnerships with personnel from HRSA, CDC, other federal agencies, and other federally-funded programs.

• Reviewing and providing substantive and stylistic input on cooperative agreement activities, procedures, measures, and tools to be implemented for accomplishing the program goals.

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

• Ensuring cooperative agreement activities build upon progress, success, and lessons learned by providing access to materials and information from previous work in this area.

• Providing ongoing monitoring and review of the design, development, direction, and/or delivery of cooperative agreement activities, including procedures, evaluation measures, and quality improvement efforts for accomplishing the goals of the cooperative agreement.

In addition to adhering to all applicable federal regulations and public policy requirements, the cooperative agreement recipient’s responsibilities will include:

https://targethiv.org/escalate https://targethiv.org/escalate https://targethiv.org/elevate https://targethiv.org/elevate https://targethiv.org/ihip

HRSA-23-127 7

• Assuring the appropriate review, approval, and renewal of all multi-site evaluation instruments and documents by an identified IRB.

• Leading and coordinating the publication and dissemination activities for the initiative, working in collaboration with the implementation sites and HRSA staff.

• Assisting HRSA with information dissemination to constituencies upon request;

• Developing a final report highlighting the clinical, programmatic, and cost outcomes of the multi-site evaluation to facilitate future replication of successful models.

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

• Collaborating with the four implementation sites, as necessary, to develop and implement a methodology, including proposed metrics, to measure the impact of proposed activities, as well as reporting on outcomes;

• Collaborating with the four implementation sites, as necessary, to ensure proposed activities are based on documented need, a status neutral framework, and designed to reach the identified target population(s);

• Establishing measures and methods for obtaining feedback from implementation sites, evaluating the process and outcome of cooperative agreement activities, and using feedback and evaluation findings to improve future work.

• Responding to feedback from HRSA HAB, and/or implementation sites, by modifying approaches to the content, design, and/or delivery of strategies, tools, and TA to improve their quality, utility, or effectiveness.

• Providing TA, including planning, coordination, mapping services, and infrastructure development/enhancement to the four implementation sites on the development of a status neutral framework.

• Conducting and facilitating site visits to the implementation sites to monitor progress on project goals and provide onsite TA as needed.

2. Summary of Funding

HRSA estimates approximately $2,650,000 to be available annually to fund one recipient.

You may apply for a ceiling amount up to the amounts listed below (reflecting direct and indirect costs) for each year in the three-year period of performance.

• $2,650,000 in FY 2023,

• $2,750,000 in FY 2024, and

• $2,750,000 in FY 2025.

HRSA-23-127 8

The period of performance is September 1, 2023 through August 31, 2026 (3 years).

Funding beyond the first year is subject to the availability of appropriated funds for A Status Neutral Approach to Improve HIV Prevention and Health Outcomes for Racial and Ethnic Minorities – Evaluation and Technical Assistance Provider (ETAP) in subsequent fiscal years, satisfactory progress, and a decision that continued funding is in the best interest of the Federal Government.

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

Eligible organizations include public and nonprofit private entities, including institutions of higher education and academic health science centers involved in addressing HIV related issues on a national scope. Faith-based and community-based organizations, Tribes, and tribal organizations also are eligible to apply.

Applicants have the option to submit proposals with collaborating organizations if the partnership enhances the approach, capability and reach of the cooperative agreement.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

HRSA may not consider an application for funding if it contains any of the non-responsive criteria below:

• Exceeds the funding ceiling amount

• Fails to satisfy the deadline requirements referenced in Section IV.4

Multiple Applications

Multiple applications from an organization are not allowed. HRSA will only accept and review your last validated electronic submission before the Grants.gov application due date.

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 notice of funding opportunity (NOFO) following the directions provided at Grants.gov: HOW TO APPLY FOR GRANTS. If you use an alternative electronic submission, see Grants.gov:

APPLICANT SYSTEM-TO-SYSTEM.

http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75 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/s2s/applicant-system-to-system.html https://www.grants.gov/web/grants/s2s/applicant-system-to-system.html

HRSA-23-127 9

The NOFO is also known as “Instructions” on Grants.gov. You must select “Subscribe” and provide your email address for HRSA-23-127 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.

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, and certifications. You must submit the information outlined in 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 this NOFO and HRSA’s SF-424 Application Guide. You must submit the application in the English language and budget figures expressed in U.S. dollars (45 CFR § 75.111(a)).

See Section 8.5 of the HRSA SF-424 Application Guide for the Application Completeness Checklist to assist you in completing your application.

Application Page Limit The total number of pages that count toward the page limit shall be no more than 50 pages when we print them. HRSA will not review any pages that exceed the page limit.

Using the pages within the page limit, HRSA will determine eligibility using Section III.

Eligibility Information of the NOFO.

These items don’t count toward the page limit:

• Standard OMB-approved forms you find in the NOFO’s workspace application package

• Abstract (standard form (SF) "Project_Abstract Summary”)

• Indirect Cost Rate Agreement

• Proof of non-profit status (if it applies)

If there are other items that don’t count toward the page limit, we’ll make this clear in Section IV.2.v Attachments.

If you use an OMB-approved form that isn’t in the HRSA-23-127 workspace application package, it may count toward the page limit. We recommend you only use Grants.gov workspace forms related with this NOFO to avoid going over the page limit.

Applications must be complete and validated by Grants.gov under HRSA-23-127 before the deadline.

https://www.grants.gov/web/grants/applicants.html http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

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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. § 3354).

3) If you are unable to attest to the statements in this certification, you must include an explanation in Attachments 7-15: Other Relevant Documents.

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

Temporary Reassignment of State and Local Personnel during a Public Health Emergency Section 319(e) of the Public Health Service (PHS) Act provides the Secretary of the Department of Health and Human Services (HHS) with discretion upon request by a state or tribal organization to authorize the temporary reassignment of state, tribal, and local personnel during a declared federal public health emergency. The temporary reassignment provision is applicable to state, tribal, and local public health department or agency personnel whose positions are funded, in full or part, under PHS programs and allows such personnel to immediately respond to the public health emergency in the affected jurisdiction. Funds provided under the award may be used to support personnel who are temporarily reassigned in accordance with § 319(e), which sunsets / terminates on September 30, 2023. Please reference detailed information available on the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) website.

Program-Specific Instructions In addition to application requirements and instructions in Section 4 of HRSA’s SF-424 Application Guide (including the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract), include the following:

i. Project Abstract Use the Standard OMB-approved Project Abstract Summary Form that is included in the workspace application package. Do not upload the abstract as an attachment or it may count toward the page limit. For information required in the Project Abstract Summary Form, see Section 4.1.ix of HRSA’s SF-424 Application Guide.

In addition to the requirements listed in the SF-424 Application Guide, please indicate the project title as “A Status Neutral Approach to Improve HIV Prevention and Health Outcomes for Racial and Ethnic Minorities – Evaluation and Technical Assistance Provider (ETAP)” and include the following information:

https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1371 http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.phe.gov/Preparedness/legal/pahpa/section201/Pages/default.aspx http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

HRSA-23-127 11

• A summary of the proposed activities to support the four implementation sites on the development of a status neutral framework.

• A description of the intended impact of the TA (i.e., planning, coordination, mapping services, and infrastructure development/enhancement) to the implementation sites on the development of a status neutral framework (e.g., how the activities will support the recipients of HRSA-23-126 to meet the goals of the initiative).

• A description of the evaluation plan to monitor the development, implementation, and outcomes of the four implementation sites’ status neutral activities, to include a description of the intended impact of the multi-site evaluation.

NARRATIVE GUIDANCE

To ensure that you fully address the review criteria, the table below provides a crosswalk between the narrative language and where each section falls within the review criteria. Any forms or attachments referenced in a narrative section may be considered during the objective review.

Narrative Section Review Criteria

Introduction (1) Need

Needs Assessment (1) Need

Methodology (2) Response and (4) Impact

Work Plan (2) Response and (4) Impact

Resolution of Challenges (2) Response

Evaluation and Technical Support Capacity

(3) Evaluative Measures and

(5) Resources/Capabilities

Organizational Information (5) Resources/Capabilities

Budget Narrative (6) Support Requested

ii. Project Narrative This section provides a comprehensive description of all aspects of the proposed project. It should be succinct, self-explanatory, consistent with forms and attachments, and organized in alignment with the sections and format below so that reviewers can understand the proposed project.

Successful applications will contain the information below. Please use the following section headers for the narrative:

INTRODUCTION -- Corresponds to Section V’s Review Criterion 1 (Need)

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This section should briefly describe the purpose of the proposed project. Describe your organization, and any collaborating organizations, experience with developing and leading multi-site evaluations, developing TA resources/materials, and providing TA to HIV prevention and treatment stakeholders. Additionally, provide a clear and succinct description of the roles and activities of the ETAP. Specifically, briefly describe how the ETAP will provide TA to the four implementation sites on the development of a status neutral framework as well as evaluate the outcomes of the strategies implemented at the provider organizations within the four jurisdictions.

NEEDS ASSESSMENT -- Corresponds to Section V’s Review Criterion 1 (Need)

Provide a summary that demonstrates a comprehensive understanding of issues regarding status neutral approaches within populations with the greatest need (i.e., Black women; Black, Latino, American Indian/Alaska Native gay, bisexual, and other men who have sex with men; transgender people; and, people who use substances). Discuss the client level, legal, technological, epidemiological, clinical, and systemic challenges that affect wider-scale adoption and/or optimal application of a status neutral approach within RWHAP Part A jurisdictions. Provide a discussion of the challenges associated with the evaluation, dissemination, and replication of evidence-informed strategies implementing a status neutral approach. When appropriate, corroborate your needs assessment narrative with citations of literature and publications.

METHODOLOGY -- Corresponds to Section V’s Review Criteria 2 (Response) and 4 (Impact)

Describe the methods and approaches you will use to address the purpose of this project as outlined in Section I.1. Please include the following in your description.

1. Describe a plan for conducting a rigorous, multi-site evaluation across implementation sites to assess the implementation of a status neutral approach (i.e., HIV testing/linkage to prevention and care services) to engage populations with the greatest need. In your description, include the following:

a. Discuss anticipated evaluation questions for assessing the effectiveness and costs associated with the adaptation and implementation of the status neutral approach.

2. Describe the methodology for collecting, analyzing, and reporting relevant outcome and process measures for the interventions, including a description of the methodology for assessing the effectiveness and impact of the status neutral approach executed at the four implementation sites. Note: the multi-site evaluation plan must include the longitudinal collection and reporting of relevant quantitative and qualitative outcome and process measures.

a. Describe your proposed approach to working collaboratively with the implementation sites in leading data collection and reporting efforts for the multi-site evaluation and additional focused evaluation studies.

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3. Describe a plan for the provision of TA to the implementation sites over the course of the project, to include a routine TA needs assessment. Describe what kinds of TA needs are anticipated and how they will be addressed. In your discussion, include the following:

a. Describe your plan to conduct, at minimum, one site visit per year with each implementation site to assess their intervention implementation and to deliver TA as needed. Describe the elements of a site visit protocol, including timely documentation of all findings.

4. Describe your plan for developing a (or utilizing/modifying an existing) web portal and data repository system where information, multi-site data, and TA tools will be housed and available to the implementation sites during the project.

Provide a detailed plan for constructing and maintaining a (or utilizing/modifying an existing) secure website for the project to serve as a data portal for implementation projects to report multi-site evaluation data. The website should also serve as a communications nexus for the project and have both public access for promotion of the project and private password-protected access for the implementation project, ETAP, and HRSA staff. Additionally, the website will be expected to support TA resources for the multi-site evaluation;

ongoing documentation of presentation, publication, and dissemination efforts for the initiative; and a calendar of upcoming project events and national conferences with abstract submission deadlines. The website may also be used to disseminate recent findings of interest from outside the project, and links for relevant resources.

5. Describe your approach in coordinating the publication and dissemination efforts for the project’s findings and lessons learned in conjunction with HRSA staff. Include a plan to disseminate reports, products, and/or project outputs to key target audiences.

WORK PLAN -- Corresponds to Section V’s Review Criteria 2 (Response) and 4

(Impact)

Provide a work plan that delineates the ETAP’s goals for the three-year period of performance. The work plan is a tool to manage the project by measuring progress, identifying necessary changes, and quantifying project accomplishments. The work plan should directly relate to your Methodology section and the program requirements of this announcement. Include all aspects of TA planning and provision; design and implementation of the multi-site evaluation; and publication and dissemination activities. The work plan should include:

1. Goals for the entire proposed three-year period of performance;

2. Objectives that are specific, time-framed, and measurable;

3. Activities or action steps to achieve the stated objectives;

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4. Staff responsible for each action step (including consultants); and

5. Anticipated start and completion dates.

Please note that goals for the work plan are to be written for the entire proposed three-year period of performance, but objectives and action steps are required only for the goals set for year one. First-year objectives should describe key action steps or activities that you will undertake to identify TA needs and implement the multi-site evaluation. Include the project’s work plan as Attachment 1.

RESOLUTION OF CHALLENGES -- Corresponds to Section V’s Review Criterion 2 (Response)

Discuss challenges that you are likely to encounter in designing and implementing the activities described in the work plan and the proposed methods described in the Methodology section. Identify and describe the approaches that you will use to resolve such challenges.

EVALUATION AND TECHNICAL SUPPORT CAPACITY -- Corresponds to Section V’s Review Criteria 3 (Evaluative Measures) and 5 (Resources/Capabilities)

Describe your organization’s (and your collaborating partner organizations’, if applicable) capacity to conduct a comprehensive multi-site evaluation to assess the implementation and outcomes of the status neutral approach across the four implementation sites. Include evidence of experience, skills, training, and knowledge of proposed key project staff (including any consultants, sub-recipients, and contractors, if applicable) in achieving evaluation integrity in conducting a multi-site evaluation of national scope that will have maximum impact on prevention and care stakeholder organizations.

Describe how the proposed key personnel (including any consultants, sub-recipients, and contractors, if applicable) have the necessary knowledge, experience, training, and skills in designing and implementing public health program evaluations, specifically quantitative and qualitative outcome and process evaluations and cost studies needed to support adoption of a status neutral framework.

Describe the systems and processes that will support your organization's multi-site evaluation requirements through effective tracking of performance outcomes, including a description of how the organization will collect and manage data (e.g., assigned skilled staff, data management software) in a way that allows for accurate and timely reporting of performance outcomes. Describe current experience, skills, and knowledge, including individuals on staff, materials published, and previous work of a similar nature. As appropriate, describe the data collection strategy to collect, analyze, and track data to measure process and impact/outcomes, and explain how the data will be used to inform program development and service delivery across the four implementation sites. You must

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describe any potential obstacles for implementing the program performance evaluation and your plan to address those obstacles.

ORGANIZATIONAL INFORMATION -- Corresponds to Section V’s Review Criterion 5 (Resources/Capabilities)

Provide a staffing plan and job descriptions for key personnel and submit as Attachment 2. In the staffing plan, describe how the grant funds will be administered in the jurisdiction with reference to the staff positions, including program and fiscal staff, described in the budget narrative and the program organizational chart. The narrative should describe the organization responsible for the cooperative agreement and, as applicable, identify the entity responsible for administering it, including the department, unit, staffing levels (full-time equivalent staff [FTE], including any vacancies), fiscal agents, and in-kind support staff. As Attachment 3, include biographical sketches for persons occupying the key positions, not to exceed two pages in length per person. If a biographical sketch is included for an identified individual not yet hired, include a letter of commitment from that person with the biographical sketch. Include a project organizational chart as Attachment 4. The chart should be a one-page figure that depicts the project structure, not the entire organization. It should include sub-recipients, contractors, and other significant collaborators, if applicable. Include signed letters of agreement, memoranda of understanding, and descriptions of proposed and/or existing contracts related to the proposed project as Attachment 5.

iii. Budget The directions offered in the SF-424 Application Guide may differ from those offered by Grants.gov. Follow the instructions in Section 4.1.iv of HRSA’s SF-424 Application Guide and the additional budget instructions provided below. A budget that follows the Application Guide will ensure that, if HRSA selects your application for funding, you will have a well-organized plan and, by carefully following the approved plan, may avoid audit issues during the implementation phase.

Submit the SF-424A Budget Information – Non-Construction Programs per the instructions in Section 4.1.iv of HRSA’s SF-424 Application Guide.

Reminder: The Total Project or Program Costs are the total allowable costs (inclusive of direct and indirect costs) you incur to carry out a HRSA-supported project or activity.

Total project or program costs include costs charged to the award and costs borne by you to satisfy a matching or cost-sharing requirement, as applicable

As required by the Consolidated Appropriations Act, 2023 (P.L. 117-328), Division H, § 202, “None of the funds appropriated in this title shall be used to pay the salary of an individual, through a grant or other extramural mechanism, at a rate in excess of Executive Level II.” Effective January 2023, the salary rate limitation is $212,100. Note that these or other salary rate limitations may apply in the following fiscal years, as required by law.

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://www.congress.gov/bill/117th-congress/house-bill/2617/text

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iv. Budget Narrative See Section 4.1.v. of HRSA’s SF-424 Application Guide.

In addition, HAB requires the following:

Provide a narrative that explains the amounts requested for each line in the budget. The budget narrative should specifically describe how each item will support the achievement of proposed objectives. The budget period is for one year; however, you must submit projected one-year budgets for each of the subsequent budget periods within the requested period of performance (three years) at the time of application. The budget narrative must clearly and concisely describe each cost element and explain how each cost contributes to meeting the project’s objectives/goals.

For all staff listed on the budget identify what percentage of the FTE you will allocate to this award, the full salary amount and all other funding sources leveraged to account for the full salary.

For subsequent budget years, the budget narrative should support training and TA to implementation sites, a final evaluation data analysis, and development of TA products and manuals. Do not repeat the same information across years in the budget narrative.

If indirect costs are included in the budget, please attach a copy of the organization’s indirect cost rate agreement as Attachment 6. Indirect cost rate agreements will not count toward the page limit.

v. Attachments Provide the following items in the order specified below to complete the content of the application. Unless otherwise noted, attachments count toward the application page limit. Your indirect cost rate agreement and proof of non-profit status (if applicable) will not count toward the page limit. Clearly label each attachment. You must upload attachments into the application. HRSA and the objective review -committee will not open/review any hyperlinked attachments.

Attachment 1: Work Plan (required) Attach the work plan for the project that includes all information detailed in Section IV.2.ii. Project Narrative. If you will make subawards or expend funds on contracts, describe how your organization will ensure proper documentation of funds. The workplan should include timelines, key activities, personnel responsible, and outcome measures.

Attachment 2: Staffing Plan and Job Descriptions for Key Personnel (see Section 4.1. of HRSA’s SF-424 Application Guide) (required)

Keep each job description to one page in length as much as is possible. Include the role, responsibilities, and qualifications of proposed project staff.

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