PKG00261065-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

HIV AIDS Bureau Office of Training and Capacity Development

Special Projects of National Significance

Building Capacity to Implement Rapid Antiretroviral Therapy (ART) Start for

Improved Care Engagement in the Ryan White HIV/AIDS Program – Implementation Sites

Funding Opportunity Number: HRSA-20-114

Funding Opportunity Type: New Assistance Listings (CFDA) Number: 93.928

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2020

Application Due Date: June 15, 2020

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, including SAM.gov and Grants.gov, may take up to 1 month to complete.

Issuance Date: April 15, 2020

Adan Cajina, MSc.

Chief, Demonstration and Evaluation Branch Telephone: (301) 443-3180 Fax: (301) 594-2511 Email: ACajina@hrsa.gov

Authority: Further Consolidated Appropriations Act, 2020 (P.L. 116-94), Division A, Title II and 42 U.S.C. § 300ff-101 (section 2691 of the Public Health Service Act).

mailto:ACajina@hrsa.gov

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EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for fiscal year (FY) 2020 Building Capacity to Implement Rapid Antiretroviral Therapy (ART) Start to Improve Care Engagement in the Ryan White HIV/AIDS Program – Implementation Sites. 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.

In support of the Ending the HIV Epidemic (EHE): A Plan for America Initiative,1 this program will fund up to 10 organizations interested in the implementation and evaluation of “rapid start” or the accelerated entry into HIV medical care and rapid initiation of antiretroviral therapy (ART) for people with HIV who are newly diagnosed, new to care, or out of care. This funding opportunity will support organizations that have the capacity and infrastructure to support rapid start implementation but have not yet been able to, with the goal of replicating and expanding successful rapid start models.

Funding Opportunity Title: Building Capacity to Implement Rapid

Antiretroviral Therapy (ART) Start to Improve Care Engagement in the Ryan White HIV/AIDS Program – Implementation Sites

Funding Opportunity Number: HRSA-20-114 Due Date for Applications: June 15, 2020

Anticipated Total Annual Available FY 2020 Funding:

Up to $2,000,000

Estimated Number and Type of Award(s): Up to 10 grants

Estimated Award Amount: Up to $200,000 per year Cost Sharing/Match Required: No Period of Performance: September 1, 2020, through

August 31, 2023 (3 years)

1 U.S. Department of Health and Human Services. Ending the HIV Epidemic: A Plan for America. Available at:

https://www.hhs.gov/blog/2019/02/05/ending-the-hiv-epidemic-a-plan-for-america.html

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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; 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.

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Application Guide

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

Technical Assistance

HRSA has scheduled the following technical assistance:

Webinar

Day and Date: Wednesday, April 29, 2020 Time: 1 p.m. – 2:30 p.m. ET Call-In Number: 1-888-391-7047 Participant Code: 5501604 Weblink: https://hrsa.connectsolutions.com/hrsa-20-114 Playback Number: 1-888-566-0406 Passcode: 2156

The webinar will be recorded and should be available within 10 business days at https://targethiv.org/library/nofos.

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://hrsa.connectsolutions.com/hrsa-20-114 https://targethiv.org/library/nofos

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING/MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Narrative

v. Attachments

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

SYSTEM FOR AWARD MANAGEMENT

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 Building Capacity to Implement Rapid Antiretroviral Therapy (ART) Start to Improve Care Engagement in the Ryan White HIV/AIDS Program – Implementation Sites. In support of the Ending the HIV Epidemic (EHE): A Plan for America Initiative, the purpose of this program is to fund up to 10 organizations interested in the implementation and evaluation of “rapid start” or the accelerated entry into HIV medical care and rapid initiation of antiretroviral therapy (ART) for low income and underserved people with HIV who are newly diagnosed, new to care, or out of care, especially racial and ethnic minorities.

This program will fund organizations that have the capacity (e.g., staff, personnel, workforce trainings) and infrastructure (e.g., clinical system, procedures/workflows) to support rapid start implementation, but have not yet been able to, with the goal of replicating and expanding successful rapid start models. The funding will support sites in leveraging their existing staffing and clinical infrastructure to launch and implement rapid start interventions with the goal of improving engagement in care, including accelerating the period of time from new HIV diagnosis to entry into care, increasing faster linkage and re-engagement into care for those out of care, and achieving and sustaining viral suppression.

The main objective of this initiative is to improve the timeliness and rates of access, linkage, and retention to HIV care, and viral suppression through the implementation of rapid start interventions for individuals newly diagnosed and aware of their HIV status, and people with HIV not currently engaged in HIV care.

In addition to the implementation of rapid start interventions, a main goal of this initiative is to evaluate the effectiveness of rapid start models in improvements in early engagement, retention in care and sustained viral suppression in the RWHAP. Finally, this initiative will facilitate technical assistance (TA) to increase the capacity of health care organizations to implement rapid start interventions and provide high quality, comprehensive care and treatment in the RWHAP setting for people with HIV, especially for racial/ethnic minorities living in areas with the highest HIV burden.

All implementation sites funded under this announcement will be required to collaborate with an evaluation and technical assistance provider (ETAP) (to be funded separately under HRSA-20-113) who will lead a multi-site evaluation to measure the effectiveness of rapid start models and impact in the RWHAP, and provide and facilitate TA through different venues including peer-to-peer learning.

Award recipients under both NOFOs (HRSA-20-113 and HRSA-20-114) will need to work together to be successful. Therefore, HRSA encourages you to read the companion announcement and be familiar with all program expectations within both NOFOs.

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It is anticipated that through implementation and scale-up of rapid start interventions, earlier viral suppression rates will increase and could thereby make an impact to help reduce new HIV infections within the areas of highest HIV burden, especially among low income and racial/ethnic minority populations.

2. Background

This program is funded through the Minority HIV/AIDS Fund, as authorized under the Further Consolidated Appropriations Act, 2020 (P.L. 116-94), Division A, Title II. This initiative is also funded and administered by the HRSA HAB SPNS Program, as authorized by 42 U.S.C. § 300ff-101 (section 2691 of the PHS Act).

Of an estimated more than 1.1 million people with HIV in the United States, approximately 86 percent are aware of their HIV diagnosis. Only about 64 percent of those who are aware of their diagnosis are engaged in medical care.2 Often, there is a delay between patients being notified of their HIV diagnosis and initiation of ART, due to difficulties in referring newly diagnosed individuals to appropriate HIV care providers, lack of availability of appointments, or other individual and structural barriers to care.

Once a patient establishes HIV care, there are often additional delays before the initiation of ART can take place, including completing and filing paperwork for insurance coverage and pharmacy benefits, resulting in the potential of patients to be lost to followup. Thus, some groups have proposed initiation of ART on the same day, next day or within a week of HIV diagnosis for newly diagnosed individuals or re-entry into care for people with HIV who are out of care as a strategy to streamline eligibility processes and improve engagement in care. Clinical studies have shown that reducing the delay between presentation to care and the offer to initiate ART has led to substantially earlier linkage to care, earlier ART initiation, and a shorter time to viral suppression.3

Immediate linkage to care and rapid ART start leads to individual health benefits and can also lead to public health benefits because there is a reduced risk of transmission by individuals with viral suppression. In addition, immediate linkage to care and implementation of novel rapid start strategies, including the promotion of Undetectable = Untransmittable (U=U)4 and reduction in a clinic or structural barriers, may make it more likely individuals stay engaged and retained in the care system. Thus, opportunities exist to accelerate rapid start strategies to increase the timeliness of linkage to care, increase retention in care, maintain sustained viral suppression, and reduce the number of new infections.

2 Centers for Disease Control and Prevention: https://www.cdc.gov/hiv/basics/statistics.html 3 Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents:

http://aidsinfo.nih.gov/guidelines 4 RW Eisinger, CW Dieffenbach, AS Fauci. HIV viral load and transmissibility of HIV infection: undetectable equals untransmittable. Journal of the American Medical Association DOI: 10.1001/jama.2018.21167 (2019).

https://www.cdc.gov/hiv/basics/statistics.html http://aidsinfo.nih.gov/guidelines

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Ending the HIV Epidemic: A Plan for America

In February 2019, the Administration announced a new initiative, Ending the HIV Epidemic: A Plan for America. This 10-year initiative beginning FY 2020 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 first phase of the initiative will focus on 48 counties, Washington, D.C., San Juan, PR, and 7 states that have a substantial rural HIV burden.

By focusing on these jurisdictions in the first phase of the initiative, the U.S. Department of Health and Human Services (HHS) plans to reduce new HIV infections by 75 percent within five years. Across the United States, the initiative will promote and implement the four Pillars to substantially reduce HIV transmissions – Diagnose, Treat, Prevent, and Respond. The initiative is a collaborative effort among key HHS agencies, primarily HRSA, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Indian Health Service (IHS), and the Substance Abuse and Mental Health Services Administration (SAMHSA).

National HIV/AIDS Strategy: Updated to 2020 The National HIV/AIDS Strategy for the United States: Updated to 2020 (NHAS 2020) is a 5-year plan that details principles, priorities, and actions to guide the national response to the HIV epidemic. The RWHAP promotes robust advances and innovations in HIV health care using the National HIV/AIDS Strategy to end the epidemic as its framework. Therefore, to the extent possible, activities funded by RWHAP focus on addressing these four goals:

1) Reduce new HIV infections;

2) Increase access to care and improve health outcomes for people with HIV;

3) Reduce HIV-related health disparities and health inequities; and

4) Achieve a more coordinated national response.

To achieve these shared goals, recipients should align their organization’s efforts, within the parameters of the RWHAP statute and program guidance, to ensure that people with HIV are linked to and retained in care, and have timely access to HIV treatment and the supports needed (e.g., mental health and substance use disorders services) to achieve HIV viral suppression

HIV Care Continuum Diagnosing and linking people with HIV to HIV primary care, and ensuring people with HIV achieve viral suppression are important public health steps toward ending the HIV epidemic in the United States. The HIV care continuum has five main “steps” or stages that include: HIV diagnosis, linkage to care, retention in care, antiretroviral use, and viral suppression. The HIV care continuum provides a framework that depicts the series of stages a person with HIV engages in from initial diagnosis through their successful treatment with HIV medication. It also demonstrates the proportion of individuals with HIV who are engaged at each stage. The HIV care continuum allows recipients and planning groups to measure progress and to direct HIV resources most effectively.

RWHAP recipients are encouraged to assess the outcomes of their programs along this continuum of care. Recipients 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 https://www.hhs.gov/blog/2019/02/05/ending-the-hiv-epidemic-a-plan-for-america.html http://hab.hrsa.gov/deliverhivaidscare/habperformmeasures.html

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

According to recent data from the 2018 Ryan White Services Report (RSR), the RWHAP has made tremendous progress toward ending the HIV epidemic in the United States. From 2014 to 2018, 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 81.4 percent to 87.1 percent;

additionally, racial/ethnic, age-based, and regional disparities have decreased.5 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.6 Scientific advances have shown antiretroviral therapy (ART) preserves the health of people with HIV and prevents sexual HIV transmission. This means that people who take ART daily as prescribed and achieve and maintain an undetectable viral load have effectively no risk of sexually transmitting the virus to an HIV-negative partner. Such findings underscore the importance of supporting effective interventions for linking people with HIV into care, retaining them in care, and helping them adhere to their ART.

Integrated Data Sharing and Use HRSA and CDC’s Division of HIV/AIDS Prevention support integrated data sharing, analysis, and utilization for the purposes of program planning, needs assessments, unmet need estimates, reporting, quality improvement, the development of your HIV care continuum, and public health action. HRSA strongly encourages RWHAP Part F 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 HIV data sharing, analysis, and utilization approaches by state and territorial health departments can help further progress toward reaching the NHAS 2020 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 and 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

5 Health Resources and Services Administration. Ryan White HIV/AIDS Program Annual Client-Level Data Report 2018. http://hab.hrsa.gov/data/data-reports. Published December 2019. Accessed December 2, 2019.

6 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://hab.hrsa.gov/sites/default/files/hab/data/datareports/RWHAP-annual-client-level-data-report-2018.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 http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://hab.hrsa.gov/data/data-reports https://clinicaltrials.gov/

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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 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.

Minority HIV/AIDS Fund from the HHS Secretary’s Office (MHAF), HAB Technical Assistance, and Special Projects of National Significance (SPNS) Program Through the MHAF and through HAB technical assistance (TA) cooperative agreements, HRSA has a number of projects that may be useful for RWHAP recipients to consider. Some select examples are:

• Building Futures: Youth Living with HIV at https://targethiv.org/library/hrsa-hab-building-futures-supporting-youth-living-hiv

• The Center for Engaging Black MSM Across the Care Continuum (CEBACC) at https://targethiv.org/cebacc

• E2i: Using Evidence-Informed Interventions to Improve Health Outcomes among People Living with HIV at https://targethiv.org/e2i

• Using Community Health Workers to Improve Linkage and Retention in Care at https://targethiv.org/chw

Below are additional examples for specific populations, co-morbidities, and program areas: https://targethiv.org/help/ta-directory

Through the SPNS Program, HRSA funds demonstration project initiatives focused on the development of effective interventions to respond quickly to emerging needs of people with HIV receiving assistance under the RWHAP. Through these demonstration projects, SPNS evaluates the design, implementation, utilization, cost, and health related outcomes of innovative treatment models, while promoting dissemination, replication and uptake of successful interventions. SPNS findings have demonstrated promising new approaches to linking and retaining into care underserved and marginalized people with HIV. All RWHAP recipients are encouraged to review and integrate a variety of SPNS evidence-informed 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 as resources permit. SPNS related tools may be found at the following locations:

• Integrating HIV Innovative Practices (IHIP) (https://targethiv.org/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.

https://targethiv.org/library/hrsa-hab-building-futures-supporting-youth-living-hiv https://targethiv.org/library/hrsa-hab-building-futures-supporting-youth-living-hiv https://targethiv.org/cebacc https://targethiv.org/e2i https://targethiv.org/chw https://targethiv.org/help/ta-directory https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://targethiv.org/ihip

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• Replication Resources from the SPNS Systems Linkages and Access to Care (https://targethiv.org/library/replication-resources-spns-systems-linkages-and-access-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 (https://targethiv.org/library/dissemination-evidence-informed-interventions) The Dissemination of Evidence-Informed Interventions initiative runs from 2015- 2020 and disseminates four adapted linkage and retention interventions from prior SPNS and the MHAF initiatives to improve health outcomes along the HIV care continuum. The end goal of the initiative is to produce four evidence-informed care and treatment interventions (CATIs) that are replicable, cost-effective, capable of producing optimal HIV care continuum outcomes, and easily adaptable to the changing healthcare environment. Manuals are currently available at the link provided and will be updated on an ongoing basis.

II. Award Information

1. Type of Application and Award

Type of applications sought: New

HRSA will provide funding in the form of a grant.

2. Summary of Funding

HRSA estimates up to $2,000,000 to be available annually to fund up to 10 recipients.

You may apply for a ceiling amount of up to $200,000 total cost (includes both direct and indirect, facilities and administrative costs) per year. The period of performance is September 1, 2020 through August 31, 2023 (3 years). Funding beyond the first year is subject to the availability of appropriated funds for the Building Capacity to Implement Rapid Antiretroviral Therapy (ART) Start for Improved Care Engagement in the Ryan White HIV/AIDS Program – Implementation Sites Program in subsequent fiscal years, satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government. Also, HRSA may reduce funding levels beyond the first year if recipients are 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.

https://targethiv.org/library/replication-resources-spns-systems-linkages-and-access-care https://targethiv.org/library/replication-resources-spns-systems-linkages-and-access-care https://targethiv.org/library/dissemination-evidence-informed-interventions 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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III. Eligibility Information

1. Eligible Applicants

Eligible applicants include entities eligible for funding under Parts A - D of Title XXVI of the PHS, 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; and Indian Tribes or Tribal organizations with or without federal recognition.

2. Cost Sharing/Matching

Cost-sharing/matching is not required for this program.

3. Other

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

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

NOTE: Multiple applications from an organization are not allowable.

If for any reason (including submitting to the wrong funding opportunity number or making corrections/updates) an application is submitted more than once before the application due date, HRSA will only accept your last validated electronic submission, under the correct funding opportunity number, prior to the Grants.gov application due date as the final and only acceptable application.

IV. Application and Submission Information

1. Address to Request Application Package

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

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

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The NOFO is also known as “Instructions” on Grants.gov. You must provide your email address when reviewing or preparing the workspace application package in order to receive notifications including modifications and/or republications of the NOFO on Grants.gov before its closing date. You will also receive notifications of documents placed in the RELATED DOCUMENTS tab on Grants.gov that may affect the NOFO and your application. Responding to an earlier version of a modified notice may result in a less competitive or ineligible application. Please note you are ultimately responsible for reviewing the For Applicants page for all information relevant to desired opportunities.

2. Content and Form of Application Submission

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

See Section 8.5 of the Application Guide for the Application Completeness Checklist.

Application Page Limit The total size of all uploaded files may not exceed the equivalent of 60 pages when printed by HRSA. The page limit includes the abstract, project and budget narratives, attachments, and letters of commitment and support required in the Application Guide and this NOFO. Standard OMB-approved forms that are included in the workspace application package do not count in the page limit. Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. We strongly urge you to take appropriate measures to ensure your application does not exceed the specified page limit.

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

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

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

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

3) Where you are unable to attest to the statements in this certification, an explanation shall be included in Attachment 7: Other Relevant Documents.

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

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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:

i. Project Abstract See Section 4.1.ix of HRSA’s SF-424 Application Guide.

• List at the top of the page:

o Project Title o Applicant Organization Name o Address o Project Director Name o Contact Phone Numbers and Email Address

• Describe overall project goals and proposed services.

• Include a brief summary description of the proposed project, including how the organization will implement a rapid start intervention into their existing clinical operations and HIV care service delivery.

• Specify the funding amount requested for each year of the three-year period of performance.

The project abstract must be single-spaced and limited to one page in length.

ii. Project Narrative This section provides a comprehensive framework and description of all aspects of the proposed project. It should be succinct, clear, consistent with forms and attachments, and well organized 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. Discuss your organization’s need for funds to improve capacity to initiate rapid start activities. Include a description of your organization’s capacity and infrastructure to provide direct HIV care and treatment services.

Describe how this funding will improve the ability of your organization to initiate a rapid start program as an intervention in response to the goals to improve the timeliness of access, linkage, and retention to quality HIV primary care services for low income, uninsured, and underserved people with HIV, especially racial and ethnic minorities.

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

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

This section will help reviewers understand the community and/or organization that you will serve with the proposed project.

Describe the incidence and/or prevalence rates of HIV infection in your area. Use and cite the most recent available relevant local and/or national data and published research whenever possible to support the information provided.

Describe the existing HIV medical care and support services currently available in your service area, including any relevant gaps or barriers in engaging, linking, and retaining people with HIV into care.

Provide a summary that demonstrates a comprehensive understanding of issues regarding the need for improvement in timeliness of linkage, retention, and viral suppression among people with HIV. Include information specific to the implementation of rapid start that the project hopes to overcome.

Clearly describe the client populations in your service area who could benefit from a rapid start intervention, including those who are newly identified or recently diagnosed, people with HIV who are engaged in care but were never provided ART, and/or people with HIV who are out of care. Describe the racial and/or ethnic minority population(s) you will serve. Focus populations of interest may include populations with health disparities, including African American and Latino men and women, gay and bisexual men, transgender women, and other populations hardest hit by the HIV epidemic.

Describe your organization’s capacity and specific need for project funding in order to successfully implement a rapid start intervention. Describe how the proposed project builds upon the current standard of care activities and furthers the objectives of your organization in maximizing impact. Post-award, HRSA will share this needs assessment with the ETAP and it will be used to determine the level of TA needed.

METHODOLOGY -- Corresponds to Section V’s Review Criteria #2 (Response), #3 (Evaluative Measures), and #4 (Impact)

Rapid Start Interventions Describe the proposed rapid start intervention that your organization will implement based on your needs assessment. Describe the rationale for your proposed rapid start methodology.

To accelerate and improve the timely linkage to care and rapid initiation of ART, applicants must propose rapid start interventions with the following core components:

• On-site or partnership with, direct referral, or warm handoff from currently established testing programs (e.g., local health departments, HIV testing sites, emergency departments, or primary care centers) to identify newly diagnosed people with HIV;

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• Expedited linkage to HIV care (i.e., same day, next day, or within one week) for individuals newly diagnosed with HIV, new to care or out of care; and

• Rapid initiation of ART, including starter packs of ART administered within the same day, next day or within the week (the time period defined as “rapid start”) Note: Purchase of starter packs of ART can be supported through this funding initiative if alternative mechanisms of payment (including RWHAP or the AIDS Drug Assistance Program (ADAP) is not available).

Since rapid start interventions may be resource-intensive and require coordination and consolidation of multiple steps of testing, counseling, patient transportation, clinical provider evaluation, intake, accelerated insurance coverage, and initiation of ART, you may likely need clinic and other structural changes to improve rapid linkage to care and ART initiation.

Thus, you may propose rapid start activities that can include, but are not limited to:

• Connection with outreach workers or early intervention staff for immediate referral/direct linkage into HIV care, including escorting/transportation into care services or assistance in making appointments

• Improvements to the current capacity and infrastructure of your organization by leveraging existing staff and core medical services (e.g., outreach worker, case manager, or outpatient ambulatory care) to design and implement a rapid start intervention

• Team-based models of care (physician, nurse, counselor, care coordinator, intake staff, social worker, pharmacist, laboratory staff, insurance specialist, peer navigator, etc.) and on-site multi-disciplinary services (including social support, HIV education, mental health counseling, medical evaluation, prescription of ART, pharmacy services, etc.) to support immediate linkage and treatment services

• Streamlined enrollment procedures, e.g., adding priority appointment slots to obtain lab work, or expediting the first provider visit to begin treatment

• Restructuring of staff or clinic workflows to implement rapid start interventions, including consolidating paperwork requirements, counseling, laboratory work, or provider visits into one visit

• Other improvements and modifications to existing clinic infrastructure and logistics to consolidate and facilitate early entry into care (e.g., accelerated intake, paperwork/insurance/benefits support, lab tests, ART supplies, drafting or revising policies and procedures, system enhancements, etc.)

Identification, Rapid Linkage, and Retention in HIV Care Describe how people with HIV who are out of care will be identified and referred to your organization for HIV primary medical care services. Describe your organization’s collaborations, partnerships, or affiliation with sites that provide HIV testing and case finding, and how these and any other relationships will be a source of both newly identified people with HIV and existing people with HIV who are out of care.

Describe the proposed referral and linkage networks to your organization, including referral activities from community stakeholders or collaborations. Include

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information about how you will assist people with HIV who are newly diagnosed and out of care with all proposed rapid ART initiation service components, including engagement/re-engagement into care to help them achieve and sustain viral suppression.

Describe your proposed retention strategies to optimize adherence to medication, including use of case management staff and peer navigators to proactively address barriers to increase retention, utilizing clinic resources, and providing workforce training to support long-term retention in care following a rapid start intervention. Retention in care for people with HIV consists of the strategies, services, and efforts used to provide HIV primary medical care and maintain treatment adherence and follow-up HIV primary care services.

Collaboration with the ETAP As mentioned in the Purpose section above, funded implementation sites (recipients) will be required to collaborate with the ETAP (to be funded separately under announcement number HRSA-20-113), which will lead a multi-site evaluation to measure the effectiveness of the implementation of rapid start interventions and provide and facilitate TA to the funded sites.

Multi-Site Evaluation Implementation sites will be expected to collect and report relevant quantitative and qualitative outcomes, and process and cost measures data for their rapid start interventions as part of the national multi-site evaluation. As such, the implementation sites must be able to report these indicators, either as a direct clinical provider or through the execution of partnership and data user agreements with a medical clinic for HIV health care services.

Describe your commitment and plan to participate in all aspects of the national multi-site evaluation led by the ETAP. Your plan should include the process for timely collection and submission of relevant quantitative, cost, and qualitative data related to the performance measures and implementation of the rapid start intervention. HRSA encourages you to read the requirements for the ETAP (funded under announcement number HRSA-20-113) to understand the requirements of the national, multi-site evaluation that the ETAP will coordinate.

Technical Assistance The ETAP will provide technical assistance (TA) to the implementation sites during regular teleconferences; through its website and webinars; during site visits; and at national annual meetings, led by the ETAP in collaboration with the implementation sites and HRSA program staff. Implementation sites are expected to host one site visit per year that the ETAP and relevant partners will conduct.

Learning Collaborative The ETAP will also facilitate TA through learning collaboratives including peer-to-peer exchange. As part of this, the ETAP will seek experienced organizations that have successfully implemented rapid start programs to promote peer-to-peer learning with implementation sites funded through this initiative. This will provide opportunities for engagement with subject matter experts to guide the development and implementation of rapid start interventions. When possible, the

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ETAP will pair funded implementation sites with subject matter experts at other organizations that have successfully implemented rapid ART interventions that are similar in geographic location, size of the clinical setting, or available resources.

This will facilitate learning and exchange of information to further capacity development activities, advance the knowledge of existing providers, and expand the provider base of personnel skilled in administering rapid start interventions.

State your commitment to participate in an ETAP-facilitated learning collaborative.

Describe your plan to ensure participation from key personnel in the scheduled learning sessions, including a presentation on your rapid start intervention to share current methods and promising practices.

Implementation Protocols Post-award and prior to launch and implementation, HRSA will require funded implementation sites to create and finalize an implementation protocol for their proposed rapid start intervention. The ETAP will provide additional TA to develop site-specific protocols as needed.

Describe your plan to develop and finalize a written implementation protocol that details the manner in which your clinical setting will carry out rapid start intervention. This should include a step-by-step guide on all aspects of rapid start service delivery, from receipt and intake of new clients, through eligibility and processing, clinical provider visits, follow-up, and any additional services provided by support staff.

HRSA encourages award recipients to collaborate with their regional AIDS Education and Training Center (AETC) programs and AETC local performance sites for training support needed to successfully implement their protocols.

Specifically, implementation start awardees may use the AETC-developed guide titled “Immediate ART Initiation: Guide for Clinicians”7 to facilitate the development of their implementation protocols.

Dissemination The ETAP will lead the dissemination of successful findings and best practices for purposes of replication at the national level. Funded implementation sites must participate in the development of toolkits, strategies, publications, and dissemination of program findings and lessons learned to support replication in collaboration with the ETAP and HRSA program staff.

Describe your commitment to fully participate in the publication, dissemination and replication efforts for the initiative’s findings and lessons learned, as coordinated by the ETAP and SPNS Program. Describe your plan to participate in the development of an intervention manual, which will document the methodology, implementation, and outcomes of your intervention project, in order to guide potential replication in the future.

7 AETC National Coordinating Resource Center. Immediate ART Initiation: Guide for Clinicians. Available at: https://aidsetc.org/blog/immediate-art https://aidsetc.org/blog/immediate-art

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Recipients are also strongly encouraged to collaborate with their regional AETCs and local performance sites for expert support to disseminate key findings, implementation challenges, and lessons learned to replicate promising practices of rapid start models. AETC contact information is available at https://aidsetc.org/aetc-program/regional-offices.

Describe your commitment and plan to collaborate with the ETAP and SPNS program in the publication, dissemination, and replication efforts for the initiative’s findings and lessons learned. Describe your plan to develop an intervention manual, which will document the methodology, implementation and outcomes of your rapid start model, in order to guide potential replication in the future.

Implementation sites must have personnel with the necessary skills to communicate project findings and lessons learned to local communities, state and national conference attendees, and policymakers, as well as write and publish findings in peer-reviewed journals and presentations at conferences.

Sustainability and Program Integration HRSA expects recipients to sustain key elements of their interventions, e.g., strategies or services, which have been effective in improving practices and those that have led to improved outcomes for the target population. The funded implementation sites will be required to demonstrate the capacity to sustain a rapid start intervention during the period of performance and after the funding for the project ends.

Thus, you must also propose a plan for project sustainability after the period of federal funding ends. Describe a detailed plan for the sustainability of the proposed rapid start intervention, including the incorporation of your rapid start service delivery into your standard of care beyond the 3-year funded period of performance.

Collaborations Describe the proposed collaborations with needed partners to successfully implement the proposed rapid start activities. Clearly describe each proposed partner and explain how their services and/or resources can augment and support the implementation activities you propose. Identify the tasks that each partner proposes to perform. Include letters of agreement from each partner and/or collaborating entity as Attachment 4.

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, and timeline, and includes those responsible for making the program successful.

Describe the activities or steps that you will use to achieve each of the objectives proposed to implement rapid start services during the entire period of performance. Use a timeline that includes each activity, targeted date for completion, and identifies responsible staff. As relevant, identify the measures you will use to evaluate success. As appropriate, identify meaningful support and https://aidsetc.org/aetc-program/regional-offices

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collaboration with key partners in planning, designing, and implementing all activities.

Identify proposed staff members (in-kind and cooperative agreement-supported) responsible for each activity. 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; (4) staff responsible for each action step, and; (5) anticipated dates of completion. Key activities to address in the timeline include, but are not limited to, start-up activities, assessments, implementation of clinic or system components, training activities, and documentation of the comprehensive rapid start strategy.

Submit the work plan as Attachment 1. You must submit the detailed work plan for each 12-month period of the three-year period of performance of September 1, 2020 through August 31, 2023. The first 12-month budget period will address activities from September 1, 2020 to August 31, 2021, with ensuing work plans covering years two and three.

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

Discuss challenges you are likely to encounter in the planning and implementation of your proposed rapid start project. Describe the specific activities or strategies you will use to mitigate or resolve such challenges.

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

Implementation sites must work with the ETAP to participate in and submit data as part of a national multi-site evaluation. HRSA requires implementation sites to collect and report relevant quantitative and qualitative outcomes, process, and cost measures data for their rapid start interventions. To show the impact of the implementation of a rapid start intervention as it relates to linkage to care and ART provision, as well as long term effectiveness on retention in care and sustained viral suppression, this initiative will collect and utilize RSR data8 and client-level outcomes, among other sources.

Describe your plan to participate and cooperate in all aspects of a national, multi-site evaluation led by the ETAP, who will provide evaluation-related TA to the sites in order to collect data and measure the impact of the implementation of effective models for rapid start. Your plan should include the process for obtaining patient consent if needed, and the timely collection and submission of relevant qualitative and quantitative client-level data related to the following performance measures:

the timeliness of linkage to care, retention in HIV care, and viral suppression of people with HIV.