HRSA-24-072 RWHAP Implementation for HIV Clinical Quality Improvement.pdf

U.S. Department of Health and Human Services

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2024

HIV/AIDS Bureau

Division of Policy and Data

Ryan White HIV/AIDS Program Implementation for HIV Clinical Quality Improvement

Funding Opportunity Number: HRSA-24-072

Funding Opportunity Type(s): New

Assistance Listings Number: 93.145

Application Due Date: January 23, 2024 Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

We will not approve deadline extensions for lack of registration.

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

Issuance Date: November 21, 2023

Ronald “Chris” Redwood, MBA/HCM, RN Nurse Consultant, Clinical and Quality Branch, Division of Policy and Data HIV/AIDS Bureau Call: (301) 443-2118 Email: rredwood@hrsa.gov

See Section VII for a complete list of agency contacts.

Authority: 42 USC §§ 300ff-16 and 300ff-54(b) (§§ 2606 and 2654(b) of the Public Health Service Act).

mailto:rredwood@hrsa.gov

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508 COMPLIANCE DISCLAIMER

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.

SUMMARY

Funding Opportunity Title: Ryan White HIV/AIDS Program (RWHAP) Implementation for HIV Clinical Quality Improvement

Funding Opportunity Number: HRSA-24-072

Assistance Listing Number: 93.145

Due Date for Applications: January 23, 2024

Purpose: Provide RWHAP Parts A through D recipients training and technical assistance (T/TA) to implement quality improvement principles, methodologies, tools, and techniques

Program Objective(s): 1. Strengthen RWHAP recipients understanding and skills of quality improvement;

2. Develop and disseminate quality improvement resources;

3. Promote and sustain adoption and implementation of quality improvement; and

4. Implement project activities in alignment with RWHAP legislation, Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB) Clinical Quality Management (CQM) Policy Clarification Notice 15-02 (PCN 15-02), and other HRSA HAB policy notices and program letters.

Eligible Applicants: Eligible applicants include public and nonprofit private entities such as institutions of higher education and academic health science centers involved in addressing HIV related issues on a national scope.

https://www.hrsa.gov/ https://www.hrsa.gov/ https://www.hrsa.gov/ https://www.hrsa.gov/ https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-15-02-cqm.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-15-02-cqm.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-15-02-cqm.pdf

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• Native American tribal governments and tribal organizations are eligible.

• Community-based organizations are also eligible.

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

Anticipated FY 2024 Total Available Funding:

$1,750,000

We’re issuing this notice to ensure that, should funds become available for this purpose, we can process applications and award funds appropriately. You should note that we may cancel this program notice before award if funds are not appropriated.

Estimated Number and Type of Award(s):

One (1) new cooperative agreement.

Estimated Annual Award Amount:

Up to $1,750,000 per award, subject to the availability of appropriated funds

Cost Sharing or Matching Required:

No

Period of Performance: July 1, 2024, through June 30, 2028 (4 years)

Agency Contacts: Business, administrative, or fiscal issues:

Nancy Gaines Grants Management Specialist Division of Grants Management Operations, Office of Federal Assistance Management Email: ngaines@hrsa.gov

Program issues or technical assistance:

Ronald “Chris” Redwood Nurse Consultant, Clinical and Quality Branch Division of Policy and Data HIV/AIDS Bureau Email: rredwood@hrsa.gov mailto:ngaines@hrsa.gov

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Application Guide

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

Technical Assistance

We have scheduled the following webinar:

Monday, December 18, 2023 Time: 3 – 4 p.m. ET Weblink: https://hrsa-gov.zoomgov.com/j/1607557310?pwd=TnFKM3ZnOHRMU1FIelpvWkM5cFA3Zz09

Meeting ID: 160 755 7310 Passcode: s69wG2hC

Attendees without computer access or computer audio can use the following dial-in information:

Call-In Number: 833 568 8864 (Toll Free) Meeting ID: 160 755 7310 Passcode: 39625379

We will record the webinar. It will be available on the TargetHIV Center website at https://targethiv.org/library/nofos.

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/1607557310?pwd=TnFKM3ZnOHRMU1FIelpvWkM5cFA3Zz09 https://hrsa-gov.zoomgov.com/j/1607557310?pwd=TnFKM3ZnOHRMU1FIelpvWkM5cFA3Zz09 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 OR 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-24-072 RWHAP CQI 1

I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the Ryan White HIV/AIDS Program Implementation for HIV Clinical Quality Improvement.

The Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB) is accepting applications for the fiscal year (FY) 2024 Ryan White HIV/AIDS Program (RWHAP) Implementation for HIV Clinical Quality Improvement program. The purpose of this program is to provide RWHAP Part A through D recipients with training and technical assistance (T/TA) to implement quality improvement methodologies and concepts with an emphasis on skills development and implementing sustainable quality improvement activities for RWHAP Part A through D recipients with little or no experience in quality improvement. The activities outlined in this Notice of Funding Opportunity (NOFO) align with the Ryan White HIV/AIDS Program statute and HRSA HAB Clinical Quality Management (CQM) Policy Clarification Notice 15-02 (PCN 15-02).

Specifically, PCN 15-02 clarifies that CQM programs consist of three components:

infrastructure, performance measurement, and quality improvement. This cooperative agreement will address the quality improvement component.

The RWHAP Implementation for HIV Clinical Quality Improvement program will provide T/TA to RWHAP Part A through D recipients to accomplish the following project objectives:

• Strengthen RWHAP Part A through D recipients’ understanding and skills of quality improvement principles, methodologies, tools, and techniques;

• Develop and disseminate quality improvement resources that help RWHAP Part A through D recipients to design, implement, document, and monitor quality improvement activities;

• Promote the sustainable adoption and implementation of quality improvement methodologies, tools, and techniques; and

• Implement project activities in alignment with RWHAP statute, HRSA HAB CQM Policy Clarification Notice 15-02, and other HRSA HAB policy notices and program letters. This program should aim to address the quality improvement requirements:

o Utilization of a defined approach or methodology (e.g., model for improvement, Lean) to implement quality improvement activities;

o Implementation of quality improvement activities in an organized, systematic fashion;

o Quantification of results showing impact on health outcomes;

o Documentation of all quality improvement activities; and o Inclusion of quality improvement activities within at least one funded service category at any given time.

http://www.hrsa.gov/ https://www.hrsa.gov/about/organization/bureaus/hab https://ryanwhite.hrsa.gov/ https://ryanwhite.hrsa.gov/ https://hab.hrsa.gov/sites/default/files/hab/Global/CQM-PCN-15-02.pdf

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The RWHAP Implementation for HIV Clinical Quality Improvement T/TA should address the needs and structures of RWHAP Part A through D recipients. The activities of this initiative should provide T/TA that addresses the development, implementation, and sustainability of quality improvement activities for recipients with a network of contracted organizations as well as recipients who provide direct services.

The successful implementation of a CQM program, including quality improvement activities, requires an understanding of the RWHAP overall, as well its policy clarification notices (Ryan White HIV/AIDS Program Services: Eligible Individuals & Allowable Uses of Funds PCN 16-02; CQM PCN 15-02); and quality improvement methodologies, tools, and techniques. In designing T/TA, the recipient of this cooperative agreement should consider the challenges faced by RWHAP Part A through D recipients and subrecipients related to health disparities in HIV outcomes for key populations identified in the National HIV/AIDS Strategy (NHAS 2022-2025) and the Ending the HIV Epidemic in the U.S. initiative. Performance measure data guides and informs the development, implementation, monitoring, and sustainability of quality improvement activities. HRSA encourages recipients to use the performance measures developed for the RWHAP at the local level to assess the efficacy of their programs and to analyze and improve the gaps along the HIV care continuum.

2. Background

The RWHAP Implementation for HIV Clinical Quality Improvement is authorized by Sections 2606 (42 U.S.C. § 300ff-16) and 2654(b) (42 U.S.C. § 300ff-54(b)) of the PHS Act. According to the law and PCN 15-02, RWHAP recipients in Parts A through D are required to establish requirements for CQM to:

• Assess the extent to which HIV health services provided to patients under the grant are consistent with the most recent U.S. Department of Health and Human Services (HHS) Clinical Guidelines for the treatment of HIV disease and related opportunistic infections; and

• Develop strategies for ensuring that such services are consistent with the guidelines for improvement in the access to, and quality of HIV services.

The HRSA 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; technical assistance (TA);

clinical training; and the development of innovative interventions and strategies for HIV care and treatment to respond to emerging needs of RWHAP clients.

An important framework in the RWHAP is the HIV care continuum, which is comprised of 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 https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/service-category-pcn-16-02-final.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/service-category-pcn-16-02-final.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-15-02-cqm.pdf https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025/ https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview/ending-epidemic-timeline/ http://ryanwhite.hrsa.gov/deliverhivaidscare/habperformmeasures.html https://clinicalinfo.hiv.gov/en/guidelines https://clinicalinfo.hiv.gov/en/guidelines https://ryanwhite.hrsa.gov/

HRSA-24-072 RWHAP CQI 3

people with HIV to reach viral suppression not only increases their own quality of life and lifespan, but 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 required 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 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 United States

As demonstrated by recent data from the 2021 Ryan White HIV/AIDS Program 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. 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 reach viral suppression.

Using Data Effectively: Integrated Data Sharing and Use

HRSA and the Centers for Disease Control and Prevention’s (CDC) Division of HIV Prevention support integrated data sharing, analysis, and utilization for the purposes of

[1] Health Resources and Services Administration. Ryan White HIV/AIDS Program Annual Client-Level Data Report 2021. https://ryanwhite.hrsa.gov/data/reports. Published December 2022. Accessed December 13, 2022.

http://ryanwhite.hrsa.gov/deliverhivaidscare/habperformmeasures.html https://health.gov/healthypeople https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025 https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025 https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/rwhap-annual-client-level-data-report-2021.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/rwhap-annual-client-level-data-report-2021.pdf https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview/ending-epidemic-timeline https://ryanwhite.hrsa.gov/data/reports

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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 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 secure 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 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.

HRSA’s RWHAP Compass Dashboard is an 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).

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. 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 (for example, 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.

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 http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf https://data.hrsa.gov/topics/hiv-aids/compass-dashboard https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-21-02-determining-eligibility-polr.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-21-02-determining-eligibility-polr.pdf

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RWHAP recipients and subrecipients should first use available data sources to confirm client eligibility before requesting additional information from the client.

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)

• 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)

• AIDS Education Training Center Program – National Coordinating Resource Center

II. Award Information

1. Type of Application and Award

Application type(s): New

We will fund you via a cooperative agreement.

A cooperative agreement is like a grant in that we award money, but we are substantially involved with program activities.

Aside from monitoring and technical assistance (TA), we also get involved in these ways:

• Contributing to, reviewing, and approving documents including conference abstractions and presentations, webinar and training curriculum, publications, and other resources prior to printing, dissemination, or implementation.

https://targethiv.org/help/ta-directory https://targethiv.org/ace https://targethiv.org/bestpractices https://targethiv.org/CIE https://targethiv.org/cqii https://targethiv.org/deii https://targethiv.org/deii https://targethiv.org/e2i https://targethiv.org/e2i https://targethiv.org/escalate https://targethiv.org/elevate https://targethiv.org/elevate https://targethiv.org/ihip https://targethiv.org/ta-org/aetc-ncrc

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• Collaborating in the design, operation, direction, and evaluation of program focus area T/TA activities, including meetings, training activities, guides, tools, or workshops selection of all T/TA participants.

• Aiding and collaborating in the management and technical performance of activities to ensure the identification of organizations in need of assistance.

• Assisting with the coordination of the T/TA efforts in the planning, development, and implementation of the various phases of these projects.

• Anticipating and providing guidance on the changes taking place in the health care environment that will affect the planning process.

• Receiving and triaging all quality improvement TA requests. See TargetHIV for TA request form.

• Coordinating with other RWHAP initiatives to address the training and technical assistance needs as they may relate to new/emerging strategic initiatives.

• Providing the expertise of HRSA personnel and other relevant resources to support the efforts of the initiative activities.

• Facilitating partnership and communication with other federal agencies, HRSA recipients, and community stakeholders to improve coordination efforts.

You must follow all relevant federal regulations and public policy requirements. Your other responsibilities will include:

• Providing RWHAP Part A through D recipients with T/TA to implement quality improvement methodologies and concepts with an emphasis on skills development and implementing sustainable quality improvement activities for RWHAP Part A through D recipients with little or no experience in quality improvement. Modifying activities as necessary in keeping with the changing trends and needs of the RWHAP recipients and clients.

• Ensuring T/TA delivered to RWHAP recipients is designed to promote the sustainable implementation of effective quality improvement methodologies, tools, and techniques.

• Ensuring T/TA delivered to RWHAP recipients is clear and coordinated with other HRSA T/TA resources.

• Collaborating with HRSA and other stakeholders as necessary to plan, execute, and evaluate the activities.

• Disseminating all quality improvement T/TA information, materials and products, findings, best practices, and lessons learned to national and local audiences on the TargetHIV website.

2. Summary of Funding

We estimate $1,750,000 will be available each year to fund one recipient. You may apply for a ceiling amount of up to $1,750,000 annually (reflecting direct and indirect costs).

The period of performance is July 1, 2024 through June 30, 2028 (4 years).

https://targethiv.org/cqm-ta-request https://targethiv.org/searches?search=clinical+quality+management

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This program notice depends on the appropriation of funds. If funds are appropriated for this purpose, we will proceed with the application and award process.

Support beyond the first budget year will depend on:

• Appropriation

• Satisfactory progress in meeting the project’s objectives

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

In addition, HRSA may reduce or take other enforcement actions regarding recipient funding levels beyond the first year if they are unable to fully succeed in achieving the goals listed in application.

45 CFR part 75 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards applies to all HRSA awards.

If you’ve never received a negotiated indirect cost rate, you may elect to charge a de minimis rate of 10 percent of modified total direct costs (MTDC)*. You may use this for the life of the award. If you choose this method, you must use it for all federal awards until you choose to negotiate for a rate. You may apply to do so at any time. See Section 4.1.v. Budget Narrative in the Application Guide.

*Note: One exception is a governmental department or agency unit that receives more than $35 million in direct federal funding.

III. Eligibility Information

1. Eligible Applicants

Eligible applicants include entities eligible for funding under RWHAP Parts A, B, C and D of Title XXVI of the PHS Act. Public and nonprofit private entities involved in addressing HIV/AIDS related issues at the regional or national level; state and local governments;

academic institutions; local health departments; nonprofit hospitals and outpatient clinics; community-based organizations; and Indian Tribes or tribal organizations.

2. Cost Sharing or Matching

Cost sharing or matching is not required for this program.

3. Other

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

• Exceeds the funding ceiling amount

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

Multiple Applications

We will only review your last validated application before the Grants.gov due date.

https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75

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IV. Application and Submission Information

1. Address to Request Application Package

We require you to apply online through Grants.gov. Use the SF-424 workspace application package associated with this notice of funding opportunity (NOFO). Follow these directions: How to Apply for Grants. If you choose to submit using an alternative online method, see Applicant System-to-System.

Note: Grants.gov calls the NOFO “Instructions.”

Select “Subscribe” and enter your email address for HRSA-24-072 to receive emails about changes, clarifications, or instances where we republish the NOFO. You will also be notified by email of documents we place in the RELATED DOCUMENTS tab that may affect the NOFO and your application. You’re responsible for reviewing all information that relates to this NOFO.

2. Content and Form of Application Submission

Application Format Requirements Submit your information as the Application Guide and this program-specific NOFO state. Do so in English and budget figures expressed in U.S. dollars. There’s an Application Completeness Checklist in the Application Guide to help you.

Application Page Limit The total number of pages that count toward the page limit shall be no more than 40 pages when we print them. We 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 do not 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

• Biographical Sketches

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

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

If you use an OMB-approved form that is not in the HRSA-24-072 workspace application package, it may count toward the page limit.

Applications must be complete and validated by Grants.gov under HRSA-24-072 before the deadline.

https://www.grants.gov/ https://www.grants.gov/applicants/grant-applications/how-to-apply-for-grants https://www.grants.gov/system-to-system/applicant-system-to-system/ https://www.hrsa.gov/sites/default/files/hrsa/grants/sf424-application-guide.pdf

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Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

• When you submit your application, you certify that you and your principals1 (for example, program director, principal investigator) can participate in receiving award funds to carry out a proposed project. That is, no federal department or agency has debarred, suspended, proposed for debarment, claimed you ineligible, or you have voluntarily excluded yourself from participating.

• If you fail to make mandatory disclosures, we may take an action like those in 45 CFR § 75.371. This includes suspending or debarring you.2

• If you cannot certify this, you must include an explanation in Attachments 8-15:

Other Relevant Documents.

(See Section 4.1 viii “Certifications” of the Application Guide)

Program Requirements and Expectations The RWHAP Implementation for HIV Clinical Quality Improvement core activities are as follows:

• Offer quality improvement T/TA to RWHAP Part A through D recipients directly related to quality improvement methodologies, tools, and techniques including:

o New and innovative quality improvement training, o Development and dissemination of quality improvement tools and guides, o Targeted, time-limited quality improvement TA, and o Two quality improvement learning collaboratives, one focused on RWHAP

AIDS Drug Assistance Program recipients and one focused on bringing people with HIV who are not in HIV medical care or have never been in HIV medical care, into care.

• Evaluate the use and useability of the T/TA provided to RWHAP Part A through D recipients using scientifically accepted methodologies.

• Assess the efficiency and effectiveness of RWHAP Part A through D recipients and subrecipients in implementing quality improvement activities based on the use of quality improvement methodologies, tools, and techniques learned through T/TA.

• Use HRSA-developed performance measures or HRSA-approved performance measures, ensure alignment with current Department of Health and Human Services Clinical Guidelines; e.g., Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV.

• Ensure that training content is specifically relevant to the RWHAP Part A through D recipient and subrecipients when designing and implementing T/TA.

• Participate in the National Ryan White Conference on HIV Care and Treatment by submitting abstracts for presentations and disseminating information relevant to the target audience.

1 See definitions at eCFR :: 2 CFR 180.995 -- Principal. and eCFR :: 2 CFR 376.995 -- Principal (HHS supplement to government-wide definition at 2 CFR 180.995).

2 See also 2 CFR parts 180 and 376, 31 U.S.C. § 3354, and 45 CFR § 75.113.

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 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 https://targethiv.org/ta/cqm https://ryanwhite.hrsa.gov/grants/performance-measure-portfolio https://clinicalinfo.hiv.gov/en/guidelines https://clinicalinfo.hiv.gov/en/guidelines https://www.ecfr.gov/current/title-2/subtitle-A/chapter-I/part-180/subpart-I/section-180.995 https://www.ecfr.gov/current/title-2/subtitle-B/chapter-III/part-376/subpart-I/section-376.995 https://www.ecfr.gov/current/title-2/subtitle-B/chapter-III/part-376/subpart-I/section-376.995 https://www.ecfr.gov/current/title-2/subtitle-A/chapter-I/part-180 https://www.ecfr.gov/current/title-2/subtitle-B/chapter-III/part-376 https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-chapter33&edition=prelim https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-B/section-75.113

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• Post and disseminate all quality improvement T/TA information, materials and products, findings, best practices, and lessons learned to national and local audiences on the TargetHIV website.

• Provide information related to project activities to HRSA upon request.

Program-Specific Instructions Include application requirements and instructions from Section 4 of the Application Guide (budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract). Also include the following:

i. Project Abstract

Use the Standard OMB-approved Project Abstract Summary Form that you’ll find in the workspace application package. Do not upload the abstract as an attachment or it may count toward the page limit. For information you must include in the Project Abstract Summary Form, see Section 4.1.ix of the Application Guide.

NARRATIVE GUIDANCE

The following table provides a crosswalk between the narrative language and where each section falls within the review criteria. Make sure you’ve addressed everything. We may consider any forms or attachments you reference in a narrative section during the merit review.

Narrative Section Review Criteria

Introduction Criterion 1: NEED

Organizational Information Criterion 5: RESOURCES/CAPABILITIES

Need Criterion 1: NEED

Approach Criterion 2: RESPONSE

Work Plan Criterion 2: RESPONSE Criterion 4: IMPACT

Resolution of Challenges Criterion 2: RESPONSE

Evaluation and Technical Support Capacity

Criterion 3: EVALUATIVE MEASURES

Criterion 5: RESOURCES/CAPABILITIES

Budget Narrative Criterion 6: SUPPORT REQUESTED

ii. Project Narrative

This section must describe all aspects of the proposed project. Make it brief and clear.

Provide the following information in the following order. Please use the section headers.

This ensures reviewers can understand your proposed project.

https://targethiv.org/searches?search=clinical+quality+management

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Introduction -- Corresponds to Section V’s Review Criterion #1 Need Briefly describe the purpose of the proposed project. Describe the overall approach for designing and implementing T/TA to address the needs of RWHAP Part A – D recipients. Include a discussion that show expert understanding of the issues related to the activities included in this NOFO among the applicant’s internal and consulting staff, as well as any partner organizations.

Organizational Information -- Corresponds to Section V’s Review Criterion #5 Resources/Capabilities Describe your organization’s experience with project activities and how this experience would contribute to your capability to implement and meet the goals of this project. Describe your capability and experience in working with RWHAP Part A through D recipients. Describe your resources and capabilities to provide culturally and linguistically competent project activities.

Include a one-page project organizational chart as Attachment 5 depicting the organizational structure of the project (not the entire organization), including contractors (if applicable) and other significant collaborators.

If you will use consultants and/or contractors to provide any of the project activities, describe their roles and responsibilities on the project and the plan for oversight. Include signed letters of agreement, memoranda of understanding, and brief descriptions of proposed and/or existing contracts related to the proposed project in Attachment 4.

Include a proposed staffing plan for project, including staff qualifications, full time equivalent(s) (FTE) for this project, brief job descriptions for all staff included on the budget including the roles, responsibilities, and the management staff overseeing the various project activities. Include the staffing plan as Attachment

2. If a biographical sketch for an individual not yet hired is included, you must attach a letter of commitment signed by the individual. See Section 4.1. of HRSA’s SF-424 Application Guide for additional information.

If project staff, consultants, or contractors serve on other federal awards, please include in the staffing plan a list of the federal awards as well as the FTE for each respective federal award, federal funding agency, and the project title/name in Attachment 2. Project staff cannot bill more than 1.0 FTE across all federal awards.

Include short biographical sketches, each not to exceed two pages in length, of key project staff as Attachment 3. See Section 4.1. of HRSA’s SF-424 Application Guide for information on the content for the sketches. Include staff experience directly related to the project activities.

Need -- Corresponds to Section V’s Review Criterion #1 Need Outline the quality improvement needs specific to RWHAP recipients. Describe how you identified the needs of RWHAP recipients including the information gathering methods used.

HRSA-24-072 RWHAP CQI 12

Use and cite demographic data, including data about the jurisdictions from the Ending the HIV Epidemic in the U.S. initiative whenever possible to support the information provided.

This section will help reviewers understand whom you will serve with the proposed project.

Approach -- Corresponds to Section V’s Review Criterion #2 Response

1) New and Innovative Training focused on quality improvement methodologies, tools, and techniques. Describe the following for each training.

a) Content: Identify the content, skills to be developed, and level of content (beginner, intermediate, or advanced) to improve patient care, health outcomes, and patient satisfaction with an emphasis for RWHAP Part A through D recipients with little or no experience in quality improvement.

Specifically identify content that is already developed and content that will be newly developed.

b) Quantity: Identify the number of offerings annually, number of training participants, and the target audience.

c) Logistics: Describe the training modality (in-person vs virtual trainings), duration of training, pre and post training support, and the quality and availability of facilities.

d) Recruitment: Describe how you will reach and engage the training participants; describe the application and approval process; identify strategies to assure the participant has adequate knowledge and skills prior to participating in intermediate and advance trainings.

e) Accessibility: Describe how you will ensure the training materials are section 508 compliant, error free, and available on TargetHIV; describe how you will make accommodations for participants who need accommodations to participate.

2) Development and Dissemination of Quality Improvement Tools and

Guides: Develop and disseminate tools and guides related to facilitating and coaching quality improvement teams with a focus aimed at improving patient care, health outcomes, and patient satisfaction with an emphasis on RWHAP Part A through D recipients with little or no experience in quality improvement.

Describe the following for each quality improvement tool or guide to be developed.

a) Content: Describe the purpose and content of tools or guides to be developed, describe the gap in knowledge or skill the guide will address

b) Format: Describe the format of the tool or guide

c) Audience: Ensure content of tools or guides is aimed at RWHAP recipients, subrecipients, and providers, and people with HIV.

https://www.hhs.gov/web/section-508/index.html https://targethiv.org/

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d) Dissemination: Describe the marketing of the tools and guides, describe how the tools and guides will be shared.

e) Usefulness and Sustainability: Describe the strength and usefulness of the proposed tools/products/resources and the extent to which these will be applicable and useable for continued use after the end of this project.

3) Targeted, Time-limited Technical Assistance: TA must be less than six months in duration. TA must focus on the resolution of challenges and specific needs as identified by the recipient (also called TA objectives).

RWHAP Part A-D recipients submit TA requests via TargetHIV. HRSA HAB will triage TA requests focused on quality improvement to the recipient of this cooperative agreement. During the triage, HRSA HAB will host an intake session with the recipient to better understand their needs. The recipient will be invited to the intake sessions at which time the TA objectives and duration of technical assistance will be defined. Describe the following:

a) Format: Describe the communication and interaction methods to deliver TA;

b) Tracking: Describe the mechanism to track receipt of TA, staff assigned to deliver the TA, amount of time spent resolving the TA objectives, key dates associated with the TA, management of TA assigned across staff, and impact of the TA provided;

c) Communication: Describe the method to share updates with staff regarding information from HRSA relevant to TA and describe frequency of updates and trends from TA caseload to HRSA project officer.

4) Learning Collaboratives: Learning collaboratives are a mechanism to create a community of learners among RWHAP Part A through D recipient quality improvement teams to collectively share, learn, and improve on a specific topic. For the purposes of this project, the recipient will develop and implement two quality improvement learning collaboratives, one focused on RWHAP AIDS Drug Assistance Program recipients and one focused on bringing people with HIV who are not in HIV medical care or have never been in HIV medical care, into care. Describe the following for each of the learning collaboratives.

a) Framework and components: Describe how the Institute for Healthcare Improvement (IHI) collaborative model for the learning collaborative framework will be used or adjusted for use in the learning collaborative.

Describe the development, implementation, and monitoring including goals, key milestone, activities, outcomes, and communication with the HRSA project officer. Describe how the use of quality improvement methodologies and concepts lead to improved health outcomes for people with HIV. Describe how the framework and components will promote the sustainability of recipient activities and improvements after the conclusion of the learning collaborative.

http://www.ihi.org/Engage/collaboratives/Pages/default.aspx http://www.ihi.org/Engage/collaboratives/Pages/default.aspx http://www.ihi.org/Engage/collaboratives/Pages/default.aspx http://www.ihi.org/Engage/collaboratives/Pages/default.aspx

HRSA-24-072 RWHAP CQI 14

b) Metrics: Describe the performance measures used to track engagement of participants, progress to improvements in patient care, health outcomes, and patient satisfaction. Describe the method and frequency of performance measure data collection, analysis, and dissemination.

c) Format: Describe the methods for sharing information and convening learning collaborative meetings and activities.

d) Engagement and retention of participants: Describe the methods used to promote and sustain engagement of the quality improvement team in learning collaborative activities.

e) Engagement and participation of HRSA Project Officers: Describe the proposed methods to engage the HRSA project officer and designated staff in the development, initiation, and management of learning collaboratives to include the identification of the need for the learning collaboratives, determination of the focus, identification and resolution of challenges, and ability of staff to manage learning collaboratives.

f) Development and dissemination of resources: Describe how resources (e.g., tools and manuals) will be developed and shared to audiences beyond the participants of each collaborative to showcase the impact of implemented quality improvement activities.

Work Plan -- Corresponds to Section V’s Review Criteria #2 Response and #4 Impact A work plan is a concise easy-to-read overview of your goals, strategies, objectives, activities, timeline, and staff responsible for implementing the project.

You must submit a detailed work plan for the four-year period of performance.

Your work plan activities should correspond to your proposed budget for each year of the four-year period of performance. Be certain to include key activities, including the proposal to deliver T/TA, plans to improve the impact of T/TA, dissemination of project findings, impact of tools and resources, and replicability of project activities.

Describe the activities that you will implement during the entire period of performance. For each activity, include a description of the activity, targeted date for completion, staff (in-kind and cooperative agreement-supported) responsible for completing the activity, and measures to evaluate success (as relevant). As appropriate, identify meaningful support and collaboration with key partners in planning, designing, and implementing all activities. The work plan should be presented in a table format and include:

1) goals;

2) objectives that are specific, time-framed, and measurable;

3) action steps with corresponding due dates;

4) staff responsible for each action step; and

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5) anticipated dates of completion of goals.

Write objectives and key action steps in time-framed and measurable terms, providing numbers for targeted outcomes where applicable, not just percentages.

All work plan goals, objectives and activities must directly relate to the methods described in the Need section of this NOFO. You must submit the detailed work plan for each 12-month period of the four-year period of performance. The work plan should be included 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, implementing, and evaluating the activities described in the work plan and describe realistic and appropriate 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

Evaluation: Describe your organization’s plan for evaluating the activities described in the work plan. The evaluation should focus on assessing:

• whether the implemented T/TA achieved the stated goals and objectives;

• use and usability of the T/TA by RWHAP Part A – D recipients; and

• effectiveness of the T/TA to improve patient care, health outcomes, and patient satisfaction.

Describe the data collection strategy and the scientifically accepted methodologies that will be used to collect, analyze, and track the evaluation activities. Propose a plan that can assess the extent to which the project has met its objectives and if the results can be attributed to the project activities. Explain how the evaluation results will be used to improve the impact of T/TA and for the development of quality improvement tools and interventions.

Describe your organization’s capacity and expertise in coordinating, facilitating and implementing at least two learning collaboratives using the IHI Framework

Technical support capacity: Describe the proposed staff’s (including consultants’ and contractors’, if applicable) ability, experience, and expertise in:

• Developing and implementing clinical quality management programs, especially quality improvement, and corresponding activities.

• Developing, implementing, and monitoring quality improvement T/TA.

• Understanding of RWHAP statute, RWHAP Parts A through D structures, and HRSA HAB Policy Clarification Notice 15-02.

• Applying clinical knowledge (e.g., medical provider, HIV specialists) and quality improvement expertise as it relates to this cooperative agreement

HRSA-24-072 RWHAP CQI 16

including verifying that proposed activities align across RWHAP Part A through D recipient workflows and provider level staffing scope of practice.

• Administering fiscal and programmatic knowledge of, expertise of, and authority to manage the program and to serve as the contact person for HRSA staff.

• Exercising knowledge and expertise…