HAB HRSA-22-155 (U1S) MHAF LAI_Final.pdf

U.S. Department of Health and Human Services

HIV/AIDS Bureau

Division of State HIV/AIDS Programs (DSHAP)

Increasing Uptake of Long-Acting Injectable Antiretrovirals Among People with HIV

Funding Opportunity Number: HRSA-22-155

Funding Opportunity Type(s): New

Assistance Listings (AL) Number: 93.899

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2022

Application Due Date: June 21, 2022 Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

HRSA will not approve deadline extensions for lack of registration.

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

Issuance Date: April 21, 2022

Susan Robilotto, D.O.

Director, Division of State HIV/AIDS Programs.

Telephone: (301) 443-6554 Email: srobilotto@hrsa.gov

See Section VII for a complete list of agency contacts.

Authority: Consolidated Appropriations Act, 2022 (P.L. 117-103), Division H, Title II and 42 U.S.C. § 300ff-101 (§ 2691 of the Public Health Service Act).

mailto:srobilotto@hrsa.gov

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508 COMPLIANCE DISCLAIMER

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

Agency Contacts.

EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2022 Increasing Uptake of Long-Acting Injectable Antiretrovirals Among People with HIV. This program is supported with funding from the U.S.

Department of Health and Human Services (HHS) Minority HIV/AIDS Fund (MHAF) and the HRSA HIV/AIDS Bureau (HAB) Special Projects of National Significance (SPNS) Program. The purpose of this program is to develop, implement, and evaluate protocols for successful use of long-acting injectable (LAI) antiretroviral (ARV) medication within clinical practice.

This cooperative agreement will fund one (1) organization that will serve as the Coordination and Evaluation Provider (CEP) to provide technical assistance, capacity development, and evaluation to support ten (10) demonstration sites in the development and pilot implementation of protocols for a novel LAI ARV HIV treatment. The CEP will select and fund organizations that have the capacity and infrastructure to implement novel HIV treatment methods and collect direct patient care data, targeting organizations in jurisdictions funded for the Ending the HIV Epidemic (EHE) initiative.

Funding Opportunity Title: Increasing Uptake of Long-Acting Injectable Antiretrovirals Among People with HIV

Funding Opportunity Number: HRSA-22-155

Due Date for Applications: June 21, 2022

Anticipated Total Annual Available FY 2022 Funding:

$1,500,000

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

Estimated Annual Award Amount:

$1,500,000 in year 1

$2,000,000 in year 2

$2,000,000 in year 3

$1,500,000 in year 4

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Cost Sharing/Match Required: No

Period of Performance: September 1, 2022 through

August 31, 2026 (4 years)

Eligible Applicants: Eligible applicants include entities eligible for funding under Parts A-D of Title XXVI of the Public Health Service (PHS) Act, including public and nonprofit private entities, state and local governments, academic institutions; local health departments; nonprofit hospitals and outpatient clinics; community health centers receiving support under Section 330 of the PHS Act; faith-based and community-based organizations; colleges and universities; and Indian Tribes or Tribal organizations with or without federal recognition. 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 HRSA’s SF-424 Application Guide, available online, except where instructed in this NOFO to do otherwise.

Technical Assistance

HRSA has scheduled the following technical assistance:

Topic: Increasing Uptake of Long-Acting Injectable Antiretrovirals Among People with HIV NOFO TA Webinar Time: Thursday, May 12, 2022 02:00 PM Eastern Time (US and Canada)

Join ZoomGov Meeting https://hrsa-gov.zoomgov.com/j/1609021516?pwd=N2Z2cDJiOHA0VnBlRUVsbEtwdDBEZz09

Meeting ID: 160 902 1516 Passcode: 3yvewW2g One tap mobile +16692545252,,1609021516#,,,,*75613614# US (San Jose) +16468287666,,1609021516#,,,,*75613614# US (New York) http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fhrsa-gov.zoomgov.com%2Fj%2F1609021516%3Fpwd%3DN2Z2cDJiOHA0VnBlRUVsbEtwdDBEZz09&data=04%7C01%7CSRobilotto%40hrsa.gov%7Ca099b5a4611c4f519a2f08da1d5e98b1%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C637854589364622500%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=pCNWqPNp7bdIVKF3ETyt1AHcYgFGGHyEX4Qk8VvYD%2BQ%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fhrsa-gov.zoomgov.com%2Fj%2F1609021516%3Fpwd%3DN2Z2cDJiOHA0VnBlRUVsbEtwdDBEZz09&data=04%7C01%7CSRobilotto%40hrsa.gov%7Ca099b5a4611c4f519a2f08da1d5e98b1%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C637854589364622500%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=pCNWqPNp7bdIVKF3ETyt1AHcYgFGGHyEX4Qk8VvYD%2BQ%3D&reserved=0

HRSA-22-155 iii

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING/MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Narrative

v. Attachments

3. 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

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I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the Increasing Uptake of Long-Acting Injectable Antiretrovirals Among People with HIV cooperative agreement Increasing viral suppression and client retention in care are critical components of meeting the goals of the National HIV/AIDS Strategy (2022-2025) and ending the HIV epidemic. In order to reach these goals, it is imperative for HIV care communities to address health care inequities. With the advent of FDA-approved long-acting injectable (LAI) antiretroviral (ARV) medication formulations, initiatives that promote, facilitate, and evaluate the uptake and ongoing utilization of LAI ARV medication may improve clinical outcomes for people with HIV, especially for minority populations who continue to face disparate health care inequities and stigma. This project is designed to develop protocols, implement them and modify as needed, to increase uptake of LAI ARV medications among people of color with HIV, since LAI ARV medications may offer benefits in addressing health inequities and achieving viral suppression.

In addition to alleviating challenges associated with oral medications, ongoing utilization of LAI ARV medications in lieu of oral regimens may potentially reduce HIV-related stigma and enhance protection of health privacy. While there are some unique clinical and social benefits to this injectable drug formulation, some aspects of its distribution, administration requirements, and billing have already hindered uptake and utilization within the Ryan White HIV/AIDS Program (RWHAP). As minority populations have historically experienced significant disparities in accessing care and treatment, including the health literacy and access to health care coverage options necessary to engage in care, developing interventions to increase the uptake of LAI ARV medication formulations will help to proactively address and potentially reduce or prevent disparities minority communities may face in accessing this breakthrough therapy.

The main objective of this program is to develop and implement protocols for successful use of LAI ARV medication within clinical practice. This program will fund 1 organization to serve as the Coordination and Evaluation Provider (CEP). The CEP must have the capacity and infrastructure (e.g., staffing/personnel, trainings, clinical systems, data collection and reporting, protocol and implementation evaluation) to support development, implementation, and refinement of LAI ARV medication administration protocols with the goal of replicating and expanding successful protocols. The recipient will solicit and subaward up to 10 demonstration sites (subrecipients) to implement these co-developed protocols and collect data from direct patient care, with priority given to entities located within EHE jurisdictions. HRSA anticipates that through evaluation and scale-up of LAI ARV medication administration protocols, patients with historic difficulty accessing or continuing oral HIV therapy can be bridged to this treatment modality, thus improving viral suppression and retention in care, especially among racial and ethnic minorities.

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2. Background

Increasing Uptake of Long-Acting Injectable Antiretrovirals Among People with HIV is authorized by Consolidated Appropriations Act, 2022(P.L. 117-103), Division H, Title II and 42 U.S.C. § 300ff-54(c)(1)(B) § 2601 of the Public Health Service Act.

Since 2010, the Department of Health and Human Services (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) has implemented national strategies and priorities that focus on reducing HIV-related health inequities among priority populations, with a primary goal of ensuring all persons with HIV have access to high-quality treatment and care that is non-stigmatizing, culturally sensitive, and aligns with evidence-based standards of care.1 However, the HIV epidemic today still disproportionately impacts racial and ethnic minority populations.

As of 2019, the Centers for Disease Control and Prevention (CDC) reported that among people newly diagnosed with HIV in the United States, 44 percent identified as Black, 30 percent as Latinx, and roughly 2 percent identified as Asian, American Indians/Alaska Natives, and/or native Hawaiians and Other Pacific Islanders. However, while representing 76 percent of new HIV diagnoses in the U.S. in 2019, these groups represented only 32.5 percent of the U.S. population (13 percent, 18 percent, and 1.5 percent, respectively), illustrating HIV’s disproportionate impact on communities of color, identified as priority populations for ending the HIV epidemic.2

Furthermore, new HIV infections reported by race between 2015 and 2019 indicate decreases of 17 percent among Whites and 18 percent among Asians, but no decline or change in rates for Black or Latinx populations in the U.S. during that time. 3 While this lack of progress in Black and Latinx communities speaks more directly to prevention efforts and accessibility of prevention measures (e.g., pre-exposure prophylaxis) in minority communities, it also illustrates the continued impact of HIV on populations already experiencing disproportionately unfavorable social determinants of health. In 2019, only 76 percent of all people with HIV received HIV care, only 58 percent were retained in care, and only 66 percent were virally suppressed, compared with 80.8 percent retention and 88.1 percent suppression among clients receiving HIV care through RWHAP funded sites.4,5 When coupled with the data regarding minority populations representing roughly one-third of the total U.S. population, but more than three-fourths of new HIV infections, this disparity further demonstrates the disproportionate burden of viral suppression within minority communities.

1 U.S. Office of Infectious Disease Policy (OIDP). U.S. HIV Statistics. OIDP, June, 2021.

https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics 2 U.S. Centers for Disease Control and Prevention (CDC). HIV in the United States and Dependent Areas. CDC, August, 2021. https://www.cdc.gov/hiv/statistics/overview/ataglance.html 3 ibid 4 ibid 5 Health Resources & Services Administration (HRSA). Ryan White HIV/AIDS Program Annual Client- Level Data Report, 2019. HRSA, October, 2021.

https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/rwhap-annual-client-level-data-report-2019.pdf https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics https://www.cdc.gov/hiv/statistics/overview/ataglance.html https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/rwhap-annual-client-level-data-report-2019.pdf

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The first LAI ARV medication regimen (cabotegravir/rilpivirine) was approved by the U.S. Food and Drug Administration (FDA) in January 2021, with guidelines for monthly injectable use in patients who are virally suppressed at the time of transitioning to the LAI ARV medication from their current regimen of likely oral medications. As the first ARV formulation that does not require daily administration, this LAI ARV medication formulation provides a novel treatment modality for HIV. As of the release date of this NOFO, the current LAI ARV medication is now approved for injection every 2 months, requiring appointment attendance for injection at least 6 times per year versus the typical 4 or less annual visits for patients on daily oral regimens. The importance of increasing the uptake of this injectable is to eliminate the need for daily medication adherence and has significant implications for reducing stigma for patients currently taking oral HIV medications.

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. As HIV providers work to improve outcomes along this continuum, many providers are implementing rapid start protocols for faster patient access to ARVs. These protocols seek to expedite access to and use of ARV medications for clients either new to HIV care or re-engaging in HIV care after any period of time off ARV medications. As LAI ARV medication guidelines evolve, this formulation may also become a useful tool within rapid start protocols to foster engagement in care and accelerate time to viral suppression, which not only increases quality of life and lifespan, but also prevents sexual transmission of HIV to negative partners.

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 U.S.

According to recent data from the 2020 Ryan White Services Report (RSR), the RWHAP has made tremendous progress toward ending the HIV epidemic in the United States. From 2016 to 2020, 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 84.9 percent to 89.4 percent.

Additionally, racial/ethnic, age-based, and regional disparities reflected in viral https://health.gov/healthypeople https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2021-2025 https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2021-2025 https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/rwhap-annual-client-level-data-report-2020.pdf

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suppression rates have significantly decreased.6 For example, the disparities in viral suppression rates between Black/African Americans and white clients have decreased since 2010.7 These improved outcomes mean more people with HIV in the United States will live near normal lifespans and have a reduced risk of transmitting HIV to others through sexual contact.8

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 10-year initiative seeks to achieve the important goal of reducing new HIV infections in the United States to fewer than 3,000 per year by 2030. The initiative promotes and implements four strategies to substantially reduce HIV transmissions – Diagnose, Treat, Prevent, and Respond. The initiative is a collaborative effort among key HHS agencies, primarily HRSA, CDC, the National Institutes of Health (NIH), the Indian Health Service (IHS), and the Substance Abuse and Mental Health Services Administration (SAMHSA).

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

This project will support EHE initiative efforts by developing protocols that address barriers to LAI ARV medication administration in communities that have shown disparities in HIV health outcomes and prioritizing demonstration sites in EHE jurisdictions.

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.

6 Health Resources and Services Administration. Ryan White HIV/AIDS Program Annual Client-Level Data Report 2020. https://ryanwhite.hrsa.gov/data/reports. Published December 2021. Accessed December 2, 2021.

7 Black/African American clients went from 81.3 percent viral suppression in 2016 to 86.7 percent in 2020, while 89.4 percent of white clients were virally suppressed in 2016 and 92.5 percent in 2020; therefore the gap in viral suppression between these two groups decrease from 8.1 percentage points different to

5.8 percentage points different.

8 National Institute of Allergy and Infectious Diseases (NIAID). Preventing Sexual Transmission of HIV with Anti-HIV Drugs. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US).

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

NCT00074581.

https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview/ending-epidemic-timeline 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 http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf https://ryanwhite.hrsa.gov/data/reports https://clinicaltrials.gov/

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

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

HRSA strongly encourages complete CD4, viral load (VL) and HIV nucleotide sequence reporting to the state and territorial health departments’ HIV surveillance systems to benefit fully from integrated data sharing, analysis, and utilization. State health departments may use CD4, VL, and 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 a number of projects and resources that may assist RWHAP recipients with program implementation. These include a variety of HRSA HAB cooperative agreements, contracts, and grants focused on specific technical assistance (TA), evaluation, and intervention activities. A list of these resources is available on TargetHIV. Recipients should be familiar with these resources and are encouraged to use them as needed to support their program implementation.

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

• E2i: Using Evidence-Informed Interventions to Improve Health Outcomes among People Living with HIV

E2i uses an implementation science approach to evaluate and understand existing and new intervention strategies that can be used in RWHAP provider settings. Once interventions or strategies are demonstrated and evaluated using implementation science, manuals, guides, interactive online tools, publications, and instructional materials are developed and disseminated for replication and integration into RWHAP provider settings.

https://targethiv.org/help/ta-directory 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://targethiv.org/e2i https://targethiv.org/e2i

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• Integrating HIV Innovative Practices (IHIP)

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

• Replication Resources from the SPNS Systems Linkages and Access to Care

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

• Dissemination of Evidence-Informed Interventions

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

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

• Building Futures: Supporting Youth Living with HIV

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

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

• Engage Leadership through Employment, Validation, and Advancing Transformation and Equity (ELEVATE)

• Ending Stigma through Collaboration and Lifting All to Empowerment (ESCALATE)

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.

https://targethiv.org/ihip https://targethiv.org/library/replication-resources-spns-systems-linkages-and-access-care https://targethiv.org/deii https://targethiv.org/library/hrsa-hab-building-futures-supporting-youth-living-hiv https://targethiv.org/cebacc https://targethiv.org/chw https://targethiv.org/elevate https://targethiv.org/elevate https://targethiv.org/escalate

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HRSA program involvement will include:

• Make available experienced HRSA personnel to inform, support, or participate in planning, developing, and/or delivering cooperative agreement activities.

• Ensure cooperative agreement activities build upon past progress, needs assessment and evaluation results, success, and lessons learned by providing access to materials and information from previous work in this area.

• Coordinate communication and develop partnerships with personnel from HRSA, other state and federal agencies, including other TA providers focused on equitable access to LAI ARV medication and other federally funded training and capacity building programs.

• Participate in the design, development, direction, and/or delivery of procedures, strategies, tools, training, TA, and peer learning activities, including the selection of sites to implement and evaluate the protocols.

• Provide ongoing monitoring and review of the design, development, direction, and/or delivery of cooperative agreement activities, including procedures, data collection and evaluation activities, and quality improvement efforts for accomplishing the goals of the cooperative agreement, as stated in Section I.1 of this NOFO.

• Participate, as appropriate, in conference calls, meetings, and learning sessions that are conducted to support cooperative agreement activities.

• Review and provide substantive and stylistic input on cooperative agreement materials and activities.

• Inform methods for evaluating the process and outcomes of cooperative agreement activities, and use evaluation findings to inform future work.

• Participate in the dissemination of cooperative agreement activities, progress and results (e.g., formal or informal presentations to internal and external stakeholders, presentations at national or regional conference), including best practices and lesson learned.

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The cooperative agreement recipient’s responsibilities will include:

• Engage the community in all aspects of the project, including the selection of demonstration sites, identification of populations that will benefit from LAI ARV, and protocol development, implementation and assessment.

• Identify social and structural barriers to administration and sustained use of LAI ART to inform protocol development and implementation.

• Develop protocols for LAI ARV medication administration and client follow-up and retention, as well as engagement in related health care activities (e.g., screenings, tests, assessments) and assess the training and TA needs of CEP and subrecipient staff related to implementing the protocols to build capacity and use of LAI ARV medications among people with HIV, and ensure equitable access to LAI ARV medication for minority populations with HIV.

• Identify and subaward up to 10 demonstration sites (subrecipients) to implement these protocols and collect data from direct patient care, with priority given to entities located within EHE jurisdictions.

• Establish measures and methods for assessing needs and evaluating the process and outcome of cooperative agreement activities, and use findings to improve future work.

• Develop and update culturally appropriate tools (e.g., in multiple languages, with diverse populations represented), training, and/or TA for recipient and subrecipient staff, and people with HIV to implement and maintain LAI ARV medication therapy.

• Identify, assess, and disseminate best practices for implementing and maintaining LAI ARV medication therapy for people with HIV.

• In close collaboration with HRSA HAB, identify or develop strategies and messages for how health equity principles can be used to increase client engagement in care and maintain LAI ARV medication therapy.

• Develop methods and models for peer learning opportunities across recipient and subrecipient staff, building on and leveraging currently available opportunities (e.g., meetings, conferences).

• In response to feedback from HRSA HAB and/or subrecipients, and people with HIV, modify approaches to the content, design, and/or delivery of tools, training, and TA to improve their quality, utility, effectiveness, and impact.

• Disseminate promising or best practices, project accomplishments, results from project evaluation activities, and other pertinent information to key stakeholders and constituents. Dissemination should occur throughout the duration of the project and not only upon conclusion, and should occur using TargetHIV for public-facing documents (e.g., protocols, toolkits, manuscripts).

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• Plan for sustainability of project activities and resources after the period of federal funding ends. NOTE: HRSA expects the recipient and subrecipients to sustain key elements of their project (e.g., strategies, services, interventions, resources), including those that have been effective in improving practices and that have led to improved outcomes for the target populations.

• Ensure meaningful support and collaboration with key stakeholders including people with HIV who may receive LAI ARV medications in design, development, implementation, and evaluation and any potential re-design of all activities and protocols, including the development of this application.

• Develop a multi-year evaluation plan comprised of both quantitative and qualitative data, as well as process and impact outcomes.

• Provide HRSA HAB with a complete, updated, and accessible copy of all federally supported materials, including online content, prepared under this cooperative agreement in an electronic zip file format on a quarterly basis for the duration of the period of performance.

2. Summary of Funding

HRSA estimates $1,500,000 to be available in year 1 to fund 1 recipient. Funding for years 2 and 3 is estimated at up to $2,000,000 each year, and funding for the final project year, year 4, is estimated at up to $1,500,000.

The period of performance is September 1, 2022 through August 31, 2026 (4 years).

Funding beyond the first year is subject to the availability of appropriated funds for Increasing Uptake of Long-Acting Injectable Antiretrovirals Among People with HIV in subsequent fiscal years, satisfactory progress, and a decision that continued funding is in the best interest of the Federal Government. HRSA may reduce funding levels beyond the first year if the recipient is unable to fully succeed in achieving the goals listed in the application.

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 applicants include entities eligible for funding under Parts A-D of Title XXVI of the Public Health Service (PHS) Act, including public and nonprofit private entities, state and local governments, academic institutions; local health departments; nonprofit hospitals and outpatient clinics; colleges and universities; community health centers receiving support under Section 330 of the PHS Act; faith-based and community-based http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75

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organizations; and Indian Tribes or Tribal organizations with or without federal recognition. Proof of applicant status (e.g., proof of non-profit status) may be requested or required.

2. Cost Sharing/Matching

Cost sharing/matching 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 ceiling amount

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

NOTE: Multiple applications from an organization are not allowable.

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

IV. Application and Submission Information

1. Address to Request Application Package

HRSA requires you to apply electronically. HRSA encourages you to apply through Grants.gov using the SF-424 workspace application package associated with this notice of funding opportunity (NOFO) following the directions provided at Grants.gov: HOW TO

APPLY FOR GRANTS.

The NOFO is also known as “Instructions” on Grants.gov. You must select “Subscribe” and provide your email address for HRSA-22-155 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, certifications, etc. You must submit the information outlined in the HRSA SF-424 Application Guide in addition to the program-specific information below. You are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide except where instructed in the NOFO to do otherwise. You must https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/web/grants/applicants.html http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

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submit the application in the English language and in the terms of U.S. dollars (45 CFR § 75.111(a)).

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

Application Page Limitation The total size of all uploaded files may not exceed the equivalent of 60 pages when printed by HRSA. The page limit includes the project and budget narratives, attachments, and letters of commitment and support required in the Application Guide and this NOFO.

Please note: Effective April 22, 2021, the abstract is no longer an attachment that counts in the page limit. The abstract is the standard form (SF) "Project_Abstract Summary.” Standard OMB-approved forms that are included in the workspace application package do not count in the page limit. If you use an OMB-approved form that is not included in the workspace application package for HRSA-22-155 it may count against the page limit. Therefore, we strongly recommend you only use Grants.gov workspace forms associated with this NOFO to avoid exceeding the page limit. Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit.

It is therefore important to take appropriate measures to ensure your application does not exceed the specified page limit. Any application exceeding the page limit of 60 will not be read, evaluated, or considered for funding.

Applications must be complete, within the maximum specified page limit, and validated by Grants.gov under HRSA-22-155 before the deadline.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

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

2) Failure to make required disclosures can result in any of the remedies described in 45 CFR § 75.371, including suspension or debarment. (See also 2 CFR parts 180 and 376, and 31 U.S.C. § 3354).

3) If you are unable to attest to the statements in this certification, you must include an explanation in Attachment 10: Other Relevant Documents.

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

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:

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

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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 limitation. For information required in the Project Abstract Summary Form, see Section 4.1.ix of HRSA’s SF-424 Application Guide.

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

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

Briefly describe the purpose of the proposed project. Include a discussion that exhibits an expert understanding of the issues related to the activities included in this NOFO. Describe how the proposed project will address the goals of this cooperative agreement outlined in Section I.1. Briefly describe the applicant organization and any collaborators.

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

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Describe your understanding of and relevant work related to the NHAS and HIV Care Continuum with close detail to past work on collaborative clinical protocol development and implementation.

Describe the current state of health care access, engagement, treatment, and viral suppression activities for people with HIV nationwide and provide an assessment of any challenges and strategies which may impact your work on this project, specifically addressing identified inequities and disparities among minority populations, including social and structural barriers (e.g., poor health literacy, insufficient health care coverage, staffing or scheduling, geographic access) to administration and sustained use of LAI ARV medications.

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

Discuss the methods and approaches you will use to address the stated purpose and goals in Section I.1., and meet each of the recipient responsibilities listed in Section II.1. of this NOFO. Include innovative strategies, procedures, and activities (including involvement of people with HIV for design, implementation, and evaluation of interventions) for meaningful collaboration with HRSA HAB, other local, state, and federal agencies, and direct care subrecipient organizations to efficiently implement the proposed project and effectively meet the purpose and goals of the cooperative agreement.

Identify why any selected or proposed methodologies are appropriate for this project, and how the chosen methodologies align with the overview provided in the Needs Assessment section and will contribute to the success of the project over the entire period of performance.

Describe how your organization will foster involvement of relevant community partners (e.g. people with lived experience, direct care providers, support service providers, and AIDS Education and Training Center (AETC) staff) through all stages of the project, including development of the criteria for selection of implementation sites and identification of populations that will benefit from LAI ARV medication.

Describe how your organization will identify and select subrecipients, including factors that contribute to that decision, and how you will ensure a diverse representation among the subrecipients (geographic, facility type, urban/rural, provider type, model of care, population(s) served, etc.). Also describe how your organization will prioritize subrecipient selection from EHE jurisdictions when possible.

Describe how your organization would support subrecipients in identifying people of color with HIV eligible for LAI ARV medication protocols, any proposed ongoing tracking or support measures to foster continued LAI ARV medication utilization, and any proposed data collection elements or strategies outlined in Section II.1 of this NOFO.

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Describe how your organization will foster involvement of relevant community partners (e.g. people with lived experience, direct care providers, support service providers, and AIDS Education and Training Center (AETC) staff) through all stages of the project, including development of the criteria for selection of implementation sites and identification of populations that will benefit from LAI ARV medication.

Describe how you will assess, in collaboration with HRSA HAB, best practices for protocol implementation to increase uptake and continued utilization of LAI ARV medications, and to engage people with HIV in HIV care utilizing LAI ARV medications, especially communities of color. Use and cite data whenever possible to support the information provided.

Propose a plan addressing how you will design the protocols to support their sustainability after the period of performance. HRSA expects recipients to sustain key elements of their projects (e.g., strategies or services and interventions) which have been effective in improving practices and those that have led to improved outcomes (e.g., viral suppression, appointment attendance, equitable enrollment and access to protocols) and participant (patient and staff) satisfaction (stigma, time spent, attitudes and believes around LAI ARV medications) for the target population. Successful protocols will need to address local social and structural barriers to accessing and engaging in HIV care, so the proposed plan should discuss how barriers will be assessed (e.g., insurance/payment methods, health literacy, physical/geographic, time or staffing) and incorporate approaches to address them throughout the project period.

WORK PLAN -- Corresponds to Section V’s Review Criteria #2 – Response, and #4 – Impact.

The work plan is a tool to actively manage the project. Provide a work plan that clearly delineates your goals for the 4-year period of performance. Describe the action steps you will use over the duration of the 4-year period of performance to implement the methods discussed in the Methodology section, including methods for assessing subrecipient or your own TA needs, updating existing tools and training, developing new tools and training, project implementation, dissemination, training of subrecipients, sustainability, evaluation, and meaningful collaboration.

Be sure all methods discussed in the methodology section are included and appropriately described in the work plan, and identify any appropriate and foreseeable milestones over the period of performance.

Identify proposed staff members (in-kind and cooperative agreement-supported) responsible for each activity in the work plan. The work plan should be presented in a table format and include goals, objectives, action steps, and outcomes that are SMARTIE (specific, measurable, achievable, realistic, timely, inclusive, and equitable), over the entire period of performance broken out by each year of the project.

Consider Year 1 action steps, including, but not limited to:

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• Hiring appropriate staff;

• Developing subrecipient selection and monitoring processes;

• Identifying meaningful support and collaboration with key stakeholders (e.g., people with lived experience, direct care providers, support service providers, AETC staff) in planning, designing, and implementing all activities, including developing the subrecipient selection process;

• Developing selection criteria, including prioritizing subrecipients in EHE jurisdictions, and making awards to subrecipients;

• Developing LAI ARV medication administration protocols in conjunction with selected subrecipients;

• Establishing quality control mechanisms that align with HRSA’s review processes;

• Addressing Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act requirements, as needed;

• In conjunction with subrecipients, identifying relevant data to be collected throughout the period of performance and site-specific means for collecting each measure;

• Establishing a mechanism for the subrecipients to submit evaluation data;

• Establishing the multisite evaluation plan;

• Completing a baseline assessment of each subrecipient to ascertain strengths, weaknesses, opportunities, and threats to successful participation in the project.

Consider Years 2 and 3 action steps, including, but not limited to:

• Implementing site-specific LAI ARV medication protocols for all selected subrecipients, to include relevant enrollment or marketing materials or relevant content for patients and stakeholders;

• On a continual basis (at least quarterly), reviewing and, if needed, revising site-specific LAI ARV medication protocols as desired or as necessary changes are identified;

• Establishing a means of ongoing cooperation and communication, at least…