PKG00261064-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 – Evaluation and Technical Assistance Provider

Funding Opportunity Number: HRSA-20-113

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 (RWHAP) – Evaluation and Technical Assistance Provider (ETAP). This program is supported by 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 evaluate the implementation of rapid start interventions and their outcomes on the HIV care continuum for future replication and scale-up in other RWHAP provider organizations.

In support of the Ending the HIV Epidemic (EHE): A Plan for America Initiative,1 HRSA will award a cooperative agreement to fund a single organization to conduct a rigorous multi-site evaluation on the implementation of rapid ART start interventions and facilitate technical assistance (TA) to up to 10 implementation sites. The implementation sites are being funded (under a separate announcement (HRSA-20-114)) to promote a “rapid start” connection or accelerated entry into HIV medical care and rapid initiation of ART for people with HIV who are newly diagnosed, new to care, or out of care. The target of the implementation project is to assist 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 – Evaluation and Technical Assistance Provider

(ETAP)

Funding Opportunity Number: HRSA-20-113 Due Date for Applications: June 15, 2020

Anticipated Total Annual Available FY 2020 Funding:

Up to $700,000

Estimated Number and Type of Award(s): Up to 1 cooperative agreement Estimated Award Amount: Up to $700,000 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 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.

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: 3 p.m. – 4:30 p.m. ET Call-In Number: 1-888-391-7047 Participant Code: 5501604 Weblink: https://hrsa.connectsolutions.com/hrsa-20-113 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-20-113 https://hrsa.connectsolutions.com/hrsa-20-113 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

3. 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 – Evaluation and Technical Assistance Provider

(ETAP).

In support of the Ending the HIV Epidemic (EHE): A Plan for America Initiative, the purpose of this program is to support a single organization that provides evaluation and technical assistance (TA) to up to 10 implementation sites (funded separately under announcement number HRSA-20-114). The awarded ETAP organization will evaluate the implementation of rapid start interventions and their outcomes on the HIV care continuum for future replication and scale-up in other Ryan White HIV/AIDS Program (RWHAP) provider organizations. HRSA anticipates that, through the implementation of rapid start and achievement of viral suppression as an effective strategy to prevent HIV transmission, rates of new HIV infections in areas of highest-burden will be reduced.

The ETAP will also provide TA and capacity building to up to 10 implementation sites by facilitating learning collaboratives and peer-to-peer exchanges on rapid start intervention processes and procedures, including sharing innovative and best practices with clinics and organizations that have already successfully implemented rapid start interventions. In addition, the ETAP will lead the dissemination of evaluation findings, best practices and lessons learned, and promote the replication of successful rapid start interventions in other Ryan White HIV/AIDS Program (RWHAP) providers and other health care settings. The expansion of successful rapid start interventions will further the goal of accelerating the period of time from new HIV diagnosis to entry into care, increasing faster linkage and engagement into care for those out of care, and achieving and sustaining viral suppression.

Because award recipients under both NOFOs (HRSA-20-113 and HRSA-20-114) will need to work together to be successful, HRSA, HIV/AIDS Bureau (HAB) encourages you to read and familiarize yourself with the program expectations of the companion NOFO, HRSA-20-114 (Building Capacity to Implement Rapid Antiretroviral Therapy (ART) Start to Improve Care Engagement in the Ryan White HIV/AIDS Program – Implementation Sites).

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 also is funded and administered by the HRSA HIV/AIDS Bureau (HAB) Special Projects of National Significance, as authorized by 42 U.S.C. § 300ff-101 (section 2691 of the PHS Act).

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Of more than 1.1 million people with HIV, approximately 86 percent are aware of their HIV diagnosis, but only 64 percent of those aware 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 follow-up. 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 initiation of 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.

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).

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.hhs.gov/blog/2019/02/05/ending-the-hiv-epidemic-a-plan-for-america.html https://www.hhs.gov/blog/2019/02/05/ending-the-hiv-epidemic-a-plan-for-america.html https://www.cdc.gov/hiv/basics/statistics.html http://aidsinfo.nih.gov/guidelines

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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 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

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.

http://hab.hrsa.gov/deliverhivaidscare/habperformmeasures.html https://hab.hrsa.gov/sites/default/files/hab/data/datareports/RWHAP-annual-client-level-data-report-2018.pdf http://hab.hrsa.gov/data/data-reports

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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 territorial 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 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.

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.

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://clinicaltrials.gov/

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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.

• 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.

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 https://targethiv.org/library/replication-resources-spns-systems-linkages-and-access-care https://targethiv.org/library/replication-resources-spns-systems-linkages-and-access-care

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• 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 cooperative agreement. A cooperative agreement is a financial assistance mechanism where substantial involvement is anticipated between HRSA and the recipient during performance of the contemplated project.

HRSA program involvement will include:

• Providing information and the expertise of HRSA personnel and other relevant resources in the planning, development, management, and technical performance of all phases of the project;

• Facilitating collaborative relationships between the ETAP, funded implementation sites, and other federal agencies and partners as needed;

• Providing an ongoing review of documents, activities, procedures, and tools to be established and implemented for accomplishing the goals of the cooperative agreement, including project information before dissemination to the broader network of RWHAP and other providers serving people with HIV;

• Participating in the design and implementation of evaluation tools, evaluation plans, and other project material; and

• Participating in the dissemination of best practices, lessons learned, and other information developed as part of this project to the broader network of HIV providers.

The cooperative agreement recipient’s responsibilities will include:

• Working closely and concurrently with up to 10 implementation sites (funded separately through HRSA-20-114) to execute this initiative;

• Designing and implementing a rigorous multi-site evaluation that includes outcome, process, and cost measures to assess the effectiveness of rapid start models implemented at the implementation sites in improving early engagement, retention in care, and sustained viral suppression;

https://targethiv.org/library/dissemination-evidence-informed-interventions

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• Facilitating learning collaboratives and peer-to-peer learning on rapid start models including matching funded implementation sites with experienced sites that have already successfully implemented rapid start models to help build and increase the capacity of the implementation sites to implement rapid start approaches in the RWHAP setting for people with HIV;

• Providing TA on the adaptation, implementation, and evaluation of rapid start models to implementation sites through regular teleconferences, webinars, site visits, and in-person meetings if necessary for a range of needs over the course of the initiative;

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

• Assisting HRSA with information dissemination to constituencies upon request;

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

• Developing and maintaining a secure website for the initiative, with both public and private password-protected access to serve as a data portal for the reporting of data by the implementation projects and a communications nexus for the initiative;

• Coordinating the efforts of implementation projects to assure the privacy and confidentiality of study participants in their health-seeking efforts;

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

• Coordinating and leading the logistics for annual national multi-site meetings in each of the 3 years of the initiative with the implementation sites in the Washington, DC/Metropolitan area; and

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

You are encouraged to collaborate with partner organizations, as needed, to conduct the recipient responsibilities and programmatic expectations to achieve the following three (3) goals:

1) Conduct a rigorous multi-site evaluation on the effectiveness of the implementation of rapid start models

The ETAP will work closely with up to 10 implementation sites (funded separately under HRSA announcement HRSA-20-114) to lead and conduct a multi-site evaluation that includes outcome, process, and cost measures to assess the effectiveness of rapid start models and outcomes along the HIV care continuum in the RWHAP setting. The multi-site evaluation seeks to answer, but is not limited to, the following evaluation questions:

• What factors influenced the adaptation and implementation of the selected rapid start interventions?

• How did implementation of the rapid start interventions affect the timing of early entry into care and initiation of ART?

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• How were the implemented rapid start interventions associated with outcomes along the HIV continuum of care, including early linkage to care, rates of engagement, retention in care, and rapid ART initiation?

• Did the adaptation and implementation of the rapid start interventions result in increased viral suppression rates, a shorter period of time to viral suppression, and/or durable viral suppression?

• What were the estimated costs associated with adopting and implementing the selected rapid start interventions in RWHAP settings?

Outcome measures may include early engagement, retention in care, and sustained viral suppression and/or other outcomes on the HIV care continuum. The evaluation should also capture behavioral health indicators, barriers and facilitators to adopting rapid start interventions, and other measures proposed by the ETAP. To show the impact and contribution of rapid start interventions to the overall health of people with HIV, the evaluation plan must include key HAB performance measures7 and the following MHAF performance measures:

• Linkage to HIV Medical Care o Percentage of clients linked to routine HIV medical care within 30 days of

HIV diagnosis.

• Antiretroviral Therapy (ART) Among Persons in HIV Medical Care o Percentage of clients prescribed ART for the treatment of HIV infection in the 12-month measurement period.

• Viral Load Suppression Among Persons in HIV Medical Care o Percentage of clients with a viral load <200 copies/mL during the last test in the 12-month measurement period.

Additional core performance measures may also be proposed, subject to HRSA concurrence (Performance measures can be viewed at http://hab.hrsa.gov/deliverhivaidscare/habperformmeasures.html)

The process evaluation will assess how the rapid start models/interventions are adapted and implemented at the implementation sites. It will include, but not be limited to, facilitators and barriers to implementation-associated processes. The ETAP, in coordination with the funded implementation sites, will develop the final core process evaluation methods.

The ETAP will also employ qualitative methods to better understand how the rapid start interventions are adapted at the implementation sites, and how the interventions affect a diverse set of stakeholders and beneficiaries, including patients and health care staff.

A cost analysis study will document the related costs, including the various funding streams and actual costs and expenditures incurred by each implementation site, to inform feasibility for future replication and expansion in RWHAP and other health care

7 Health Resources and Services Administration, Ryan White HIV/AIDS Program, HIV/AIDS Bureau. Performance Measures Portfolio. Available at: https://hab.hrsa.gov/clinical-quality-management/performance-measure-portfolio http://hab.hrsa.gov/deliverhivaidscare/habperformmeasures.html https://hab.hrsa.gov/clinical-quality-management/performance-measure-portfolio

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settings. Data Portal and Security: The ETAP must demonstrate the capacity of their organizational information technology infrastructure to electronically receive, store, manage, and maintain de-identified client-level data to be collected and reported by implementation sites. The ETAP will coordinate efforts to assure the privacy and confidentiality of data submitted, collected, and stored. The ETAP will be responsible for monitoring data quality and completeness of submissions and interpreting evaluation results. Data use agreements with the funded implementation sites may be necessary to share data with the ETAP to evaluate progress toward meeting outcomes and objectives.

Website: In addition to a secure data portal, the ETAP will be responsible for developing and maintaining an initiative-specific website with both public access for communication of the initiative and private password-protected access for implementation sites, ETAP, HRSA staff, and federal partners. The website will be expected to support TA resources for the multi-site evaluation; registration information for the national meetings of the initiative; recent findings of interest from outside the initiative; and links to relevant resources. This website also serves as a repository of learning collaborative webinars, tools, and resources to share among the implementation sites.

The recipient will deliver interim evaluation results to HRSA HAB for ongoing monitoring and to support performance improvement feedback to funded implementation sites.

2. Provide and facilitate technical and capacity building assistance on the adaptation and implementation of rapid start models

The ETAP will implement and facilitate TA and capacity building assistance (CBA) to up to 10 clinical implementation sites on the adaptation and implementation of their rapid start interventions. The level and scope of TA and CBA provided to each clinic site will be based on a review of each site’s needs assessments and determination of readiness including clinical capacity (e.g., staff, personnel, workforce trainings) and infrastructure (e.g., clinical system, procedures/workflows).

The ETAP will facilitate TA through learning collaboratives that allow groups working toward the same goal to learn from and assist one another during implementation,8 including peer-to-peer exchange. The ETAP will seek experienced organizations that have successfully implemented rapid start programs to work and/or subcontract with to promote peer-to-peer learning with funded implementation sites. This will provide opportunities for engagement with subject matter experts to guide the development and implementation of rapid start approaches. The ETAP will match the implementation sites with experienced sites that are similar in geographic location, size of clinical settings, or available resources.

The ETAP will establish and support a rapid start-focused learning collaborative and provide a virtual platform, utilizing available technology that facilitates the rapid exchange of information and ideas for participating clinics. This will further capacity development, advance the knowledge of existing providers, and expand the provider

8 Planning and Implementing a Successful Learning Collaborative. Available at https://targethiv.org/sites/default/files/file-upload/resources/Plan_Implement-Learning_Collaborative_2008.pdf https://targethiv.org/sites/default/files/file-upload/resources/Plan_Implement-Learning_Collaborative_2008.pdf https://targethiv.org/sites/default/files/file-upload/resources/Plan_Implement-Learning_Collaborative_2008.pdf

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base of personnel skilled in administering rapid start while the recipient focuses on implementation and evaluation of models.

The ETAP will also provide other trainings and CBA to the implementation sites. This may include facilitating team-based provider training on patient screening, baseline laboratory assessments, recommended regimens for immediate ART, and follow-up with a review of contraindications or special considerations to improve immediate patient linkage and overall retention in care and related activities. The ETAP may coordinate training in collaboration with the RWHAP AIDS Education and Training Centers (AETCs) Program or other TA entities in the region to further build capacity around rapid start implementation.

The ETAP will work with each implementation site to support the development and finalization of an implementation protocol specific to the selected rapid start interventions. This will include a step-by-step guide of all aspects of rapid start service delivery, from receipt and intake of new clients, through eligibility and processing, clinical provider visits, follow-up schedule, and any additional services provided by support staff. The protocol may be revised and updated as needed during the implementation period. The ETAP may use the AETC-developed guide titled “Immediate ART Initiation: Guide for Clinicians”9 to facilitate the development of the implementation protocols.

3. Identify and collect best practices and lessons learned of effective rapid start models for the purposes of dissemination and replication

The ETAP will work collaboratively with the implementation sites to identify successful rapid start interventions, promising and best practices, and lessons learned that can be disseminated to the RWHAP community. The ETAP will also work collaboratively with the implementation sites in the development of these dissemination materials to support further replication and expansion.

The ETAP will be responsible for producing and disseminating TA toolkits, materials, and products to include an implementation manual. Mechanisms of dissemination may include websites (the initiative website and the TargetHIV website), presentations via webcasts, conferences, meetings, or national forums. In addition, the ETAP will lead to developing and producing an implementation manual by the end of the period of performance for replication and expansion to the rest of the RWHAP community. The implementation manual should reflect evidence-informed practices for adapting and implementing rapid start services at RWHAP sites describing the different resources and program considerations needed for clinical settings with varying resources.

The ETAP and implementation sites will work with the TargetHIV (https://targethiv.org/) (website for hosting tools, webcasts, trainings, and other resources to assist RWHAP-funded programs) as the web forum to disseminate information, materials, and products. The ETAP shall make all files, including captioning, audio descriptions, videos, tables, graphics/pictures, registration forms, presentations (both audio and video) or other types of proprietary format files – e.g., 9 AETC National Coordinating Resource Center. Immediate ART Initiation: Guide for Clinicians. Available at:

https://aidsetc.org/blog/immediate-art https://targethiv.org/ https://aidsetc.org/blog/immediate-art

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Adobe Portable Document Format (.pdf), Microsoft Office PowerPoint (.ppt) and Microsoft Excel (.xls), fully accessible to members of the public with disabilities.

Technical and functional standards for accessibility are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov.

The ETAP will also collaborate with national and regional AETC program recipients to optimize the potential for replication of the effective rapid start interventions in the RWHAP. The RWHAP AETC Program is uniquely positioned to help increase the capacity of HIV service providers and supports the uptake and replication of evidence-informed strategies for improving the health outcomes of people with HIV. The AETC Program provides education, training and capacity-building resources to support its mission to offer timely, high quality, state-of-the-science information to health care professionals working with existing and emerging populations affected by HIV. AETC educational resources and events may be found at www.aidsetc.org.

The ETAP, in coordination with HRSA staff, will lead the dissemination of evaluation results, findings, and lessons learned from rapid start implementation to improve early engagement, retention in care and sustained viral suppression.

3. Summary of Funding

HRSA estimates approximately up to $700,000 to be available annually to fund one ETAP recipient. You may apply for a ceiling amount of up to $700,000 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 Building Capacity to Implement Rapid Antiretroviral Therapy (ART) Start for Improved Care Engagement in the Ryan White HIV/AIDS Program – Evaluation and Technical Assistance Provider (ETAP) in subsequent fiscal years, satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government.

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

III. Eligibility Information

1. Eligible Applicants

Entities eligible for funding under Parts A – D of Title XXVI of the 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, Indian Tribes or Tribal organizations with or without federal recognition.

http://www.access-board.gov/ http://www.access-board.gov/ http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75

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2. Cost Sharing/Matching

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

3. Other

HRSA will consider any application that exceeds the ceiling amount 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 NOFO following the directions provided at http://www.grants.gov/applicants/apply-for-grants.html.

The NOFO is also known as “Instructions” on Grants.gov. You must provide your email address when reviewing or preparing the workspace application package 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.

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

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2. Content and Form of Application Submission

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 8 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:

i. Project Abstract See Section 4.1.ix of HRSA’s SF-424 Application Guide. In addition to the requirements listed in the SF424 Application Guide, the abstract must include the following information:

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

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• Brief description of the proposed ETAP structure

• Overall project goals

• Overall multi-site evaluation questions

• Overall TA and CBA approaches

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)

This section should briefly describe the purpose of the proposed project and how the ETAP will execute the project to respond to the three (3) goals required by the initiative. Briefly describe your organization and any collaborating organizations that will help to meet the goals of the project.

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

Provide a brief summary of the literature that demonstrates a comprehensive understanding of successful strategies that have been utilized to implement rapid start in similar populations. Describe the existing barriers regarding the access to rapid start and timely linkage to HIV care of the target population.

Discuss technical, programmatic, clinical capacity, and infrastructure issues in the implementation of rapid start administration, identifying salient challenges and possible strategies to address those challenges. Discuss barriers to access to rapid start, adherence, retention in care, and achieving viral suppression for people with HIV, including policy, financial, capacity, and structural issues that impact the deployment of rapid start activities.

METHODOLOGY -- Corresponds to Section V’s Review Criteria #2 (Response),

(3) Evaluative Measures, and (4) Impact Propose methods that you will use to meet the program expectations in this

NOFO.

For the multi-site evaluation:

Describe a plan for conducting a rigorous multi-site evaluation of the effectiveness of implementation of rapid start models at the implementation sites. Take into consideration the following items in the development of the plan:

Discuss the evaluation approach you will use to gather information to answer the evaluation questions stated under Section II, Goal 1 of this NOFO. Note that you may add additional elements to your evaluation. The evaluation approach must

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include the theoretical framework that you will use to design the multi-site evaluation. Provide the rationale for its selection.

Describe your methodology, tools, and instruments that you will use to collect evaluation data and how these data collection methods align with evaluation questions as well as steps taken to ensure that the measurements of outcomes are reliable and valid.

The multi-site evaluation plan must include the collection and reporting of relevant quantitative and qualitative outcomes and process measures as well as costs associated with the implementation of the rapid start interventions to measure their effectiveness. At a minimum, the evaluation plan must include the following descriptions:

o Elements or domains of process surveys (qualitative and/or quantitative and/or mixed methods) and their analyses to assess factors, including barriers and facilitators…