oppHRSA-18-048-cfda93.928-cidHRSA-18-048-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

HIV/AIDS Bureau Office of Training and Capacity Development

Special Projects of National Significance

Evidence-Informed Approaches to Improving Health Outcomes for People Living with HIV

Funding Opportunity Number: HRSA-18-048

Funding Opportunity Type: New

Catalog of Federal Domestic Assistance (CFDA) Number: 93.928

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2018

Application Due Date: March 26, 2018

Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

Deadline extensions are not granted for lack of registration.

Registration in all systems, including SAM.gov and Grants.gov, may take up to 1 month to complete.

Issuance Date: January 25, 2018

April Stubbs-Smith, MPH Director, Division of Domestic HIV Programs Office of Training and Capacity Development Telephone: (301) 301-443-7813 Fax: (301) 594-2511 Email: AStubbs-smith@hrsa.gov

Authority: Public Health Service Act, Section 2691 (42 USC § 300ff-101), as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (P.L. 111-87) mailto:AStubbs-smith@hrsa.gov

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EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA), HIV/AIDS Bureau (HAB), Special Projects of National Significance (SPNS) program is accepting applications for fiscal year (FY) 2018 for a new 3-year initiative entitled Evidence-Informed Approaches to Improving Health Outcomes for People Living with HIV (PLWH). The purpose of this program is to support a single organization that will systematically identify, catalog, disseminate, and support the replication of evidence-informed approaches and interventions to engage PLWH who are not receiving HIV health care or who are at risk of not continuing to receive HIV health care. Specifically, the intent of this initiative is to:

1) identify acuity scale tools used to determine if an individual living with HIV is likely to engage or re-engage in health care; 2) identify data utilization interventions to actively identify and intervene with PLWH who are out of care; 3) identify innovative service delivery models/set of services that are responsive to the needs of PLWH who need to be engaged/re-engaged in HIV health care; 4) determine the costs associated with each approach and/or intervention; 5) catalog these approaches and develop an implementation manual to document the implementation components; 6) translate and disseminate these approaches and/or interventions; and 7) support replication by providing technical assistance (TA) to Ryan White HIV/AIDS Program (RWHAP) and other HIV health care service providers. The FY 2018 President’s Budget does not request funding for this program. This notice is a contingency action taken to ensure that, should funds become available for this purpose, applications can be processed, and funds awarded in a timely manner. Applicants should note that this program may be cancelled prior to award recommendations.

Funding Opportunity Title: Evidence-Informed Approaches to

Improving Health Outcomes for People Living with HIV

Funding Opportunity Number: HRSA-18-048 Due Date for Applications: March 26, 2018 Anticipated Total Annual Available FY18 Funding:

$1,700,000

Estimated Number and Type of Award: One (1) cooperative agreement Estimated Award Amount: Up to $1,700,000 per year Cost Sharing/Match Required: No Project Period/Period of Performance: September 1, 2018 through August 31, 2021 (3 years) Eligible Applicants: Entities eligible for funding under Parts A –

D of Title XXVI of the Public Health Service Act as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009, including public health departments and institutions of higher education, state and local governments, nonprofit organizations, faith-based and community-based organizations, tribes and tribal organizations are eligible to apply.

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See Section III-1 of this notice of funding opportunity (NOFO), formerly known as the funding opportunity announcement (FOA), 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. A short video explaining the Application Guide is available at http://www.hrsa.gov/grants/apply/applicationguide/.

Technical Assistance

HRSA strongly encourages all applicants to participate in a webinar for this funding opportunity to ensure the successful submission of the application. The purpose of the webinar is to assist potential applicants in preparing applications that address the requirements of the NOFO.

HRSA has scheduled the following technical assistance webinar:

Day and Date: Wednesday, February 14, 2018 Time: 1 p.m. – 3 p.m.

Call-In Number: 1-888-942-9573 Participant Code: 8381871 Weblink: https://hrsa.connectsolutions.com/hrsa18048-Innovative Approaches

The webinar will be recorded and should be available for viewing by February 28, 2018 at https://careacttarget.org/library/hrsahab-notice-funding-opportunity-nofo-announcements.

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/ https://hrsa.connectsolutions.com/hrsa18048-InnovativeApproaches https://careacttarget.org/library/hrsahab-notice-funding-opportunity-nofo-announcements https://careacttarget.org/library/hrsahab-notice-funding-opportunity-nofo-announcements

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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

i. Budget

ii. Budget Narrative

iii. 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 AND OTHER PRE-AWARD ACTIVITIES

4. ANTICIPATED ANNOUNCEMENT AND AWARD DATES

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

IX. TIPS FOR WRITING A STRONG APPLICATION

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I. Program Funding Opportunity Description

1. Purpose

This notice solicits applications for fiscal year (FY) 2018 for a new 3-year initiative entitled Evidence-Informed Approaches to Improving Health Outcomes for People Living with HIV (PLWH). The purpose of this program is to support a single organization that will systematically identify, catalog, disseminate, and support the replication of evidence-informed approaches and interventions to engage PLWH who are not receiving HIV health care (i.e., individuals who are not currently in care or have never been in care) or are at risk of not continuing to receive HIV health care.

Specifically, the intent of this initiative is to: 1) identify acuity scale tools used to determine if an individual living with HIV is likely to engage or re-engage in health care;

2) identify data utilization interventions to actively identify and intervene with PLWH who are out of care; 3) identify innovative service delivery models/set of services that are responsive to the needs of PLWH who need to be engaged/re-engaged in HIV health care; 4) determine the costs associated with each approach and/or intervention; 5) catalog these approaches and develop an implementation manual to document the implementation components; 6) translate and disseminate these approaches and/or interventions; and 7) support replication by providing technical assistance (TA) to Ryan White HIV/AIDS Program (RWHAP) and other HIV health care service providers.

For the purpose of this notice, evidence-informed approaches and interventions are defined as tools, strategies, or models that have been proven effective or have shown promise as a methodology, practice, or means of improving the care and treatment of

PLWH.

Examples of evidence-informed approaches and interventions may include, but are not limited to:

• Data to care activities, including utilization of surveillance and other data systems, to identify and engage the never in care, out of care, or at risk of not continuing to receive care PLWH populations;

• Streamlined clinic infrastructure or multi-disciplinary team-based approaches to support linkage, re-engagement, and/or retention in health care and HIV treatment services;

• Evidence-informed acuity tools to assess the likelihood of a client’s ability to remain in care and the level of services needed to do so; and

• Innovative models of service delivery, proactive interventions, or bundled sets of services to support and engage PLWH identified as never in care, out of care, or at risk of not continuing to receive care.

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Program Requirements:

The recipient will:

1) Develop a Catalog and Implementation Manual of Evidence-Informed

Approaches and Interventions

• Identify and gather information on evidence-informed approaches and interventions The recipient will identify evidence-informed approaches and collect information on interventions currently being implemented or have been previously implemented in the field by RWHAP and other HIV health care service providers, or that have been identified in the scientific literature. The approaches and interventions should include systems-level, jurisdictional-level (e.g., Eligible Metropolitan Area (EMA), Transitional Grant Area (TGA), and State), and site specific (e.g., clinic or organization) interventions.

The recipient will identify existing evidence-informed approaches and interventions, specifically a) acuity scale tools to determine if an individual living with HIV is likely to engage or re-engage in health care and what level of services are needed for the person to do so; b) data utilization interventions which identify and actively intervene with PLWH who are out of care; and c) innovative service delivery models/set of services that are responsive to the needs of PLWH who need to be engaged/re-engaged or retained in HIV health care.

• Convene a Technical Expert Panel

The recipient will convene an expert panel with HRSA staff, consultants and key stakeholders, to identify existing evidence-informed approaches and interventions aimed at actively engaging and retaining PLWH in medical care who have never been in care, are out of care, or at risk of falling out of care. To support the objectives of this project, the technical expert panel should meet at the start of the initiative to assist in identifying evidence-informed approaches and interventions that have improved health outcomes for PLWH.

• Determine effectiveness of approaches and interventions

The recipient will determine the effectiveness of the implementation of the evidence-informed approaches and interventions identified. This may include a literature review, interviews with key informants and staff involved with implementing the approaches or interventions to gather more detailed information about the approaches and interventions, and their impact on specific HIV care continuum outcomes. In collaboration with HRSA, the recipient will utilize, review and examine relevant Ryan White HIV/AIDS Program Services Report (RSR) data, which includes accessing data through a data use agreement with HRSA. Since retrospective analyses of client-level and clinical outcome data will be used, Institutional Review Board (IRB) review will be required.

• Document the interventions

The recipient will document the necessary set of resources and services required to implement each evidence-informed approach and intervention. The recipient

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will develop and implement a methodology to document the relevant set of services required and specialized skills needed to implement these evidence-informed interventions, which can be replicated, adapted and implemented by RWHAP and other HIV health care services providers nationwide. This includes describing the resources needed to translate and support programs in replicating these evidence-informed approaches and interventions, and identifying and documenting any existing and available training, curricula or toolkits that would facilitate the replication.

• Conduct a cost analysis

For each approach and intervention, the recipient will conduct a cost analysis on the service delivery model/set of services needed to improve engagement/re-engagement of PLWH who have never been in care, are out of care, or at risk of falling out of care.

The cost analysis will include documentation of the labor and programmatic costs of each evidence-informed approach and intervention at the sites. Labor costs should be assessed by the costs and hours spent by intervention staff on all intervention activities, and be broken down into direct client contact and non-client contact hours (such as training, record keeping, and other administrative duties).

Programmatic costs will include all other intervention costs, such as facilities (e.g., rent), information technology (IT) and communications, printing, staff, transportation, supplies, and any other non-labor costs. Please note that any staff or IT costs relating to the evaluation of the approach and intervention will not be included in assessing its cost. Cost data should be regionally indexed, based upon each site’s location, to show intervention cost differences across the United States.

• Catalog results

The recipient will catalog the results of the search and create an implementation manual, which will document the methodology, intervention components, and implementation of the evidence-informed approaches. The recipient will develop an outline and timeline to produce a final implementation manual for dissemination and support replication of the evidence-informed approaches and interventions.

The recipient will package the implementation manual as a Portable Document Format (PDF) that documents the methodology and implementation of these evidence-informed approaches and interventions that will be uploaded to the TARGET Center website.1 The implementation manual should include but is not limited to:

o Target population(s)/sub-population(s) of the approach and intervention o Level of care (i.e., clinic, community, jurisdictional, or systems-level) o Specialized skills, resources, and staff needed

1 Technical Assistance Resources, Guidance, Education and Training (TARGET) Center: Tools for the Ryan White Community. Website available at: https://careacttarget.org/ https://careacttarget.org/

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o Summary of the intervention components, including specific RWHAP services utilized (for more information regarding RWHAP eligible services, refer to Policy Clarification Notice #16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds)2 o Target outcome along the HIV care continuum

2) Develop and Implement Dissemination and Replication Support Plans

• Dissemination The purpose of the dissemination plan is to develop the dissemination materials in order to facilitate widespread implementation and support the replication of the evidence-informed approaches and interventions. In consultation with HRSA, the recipient will develop and implement comprehensive dissemination and replication support plans for disseminating and promoting the catalog of evidence-informed approaches and interventions implementation manual to RWHAP and other HIV health care service providers interested in replicating one of these approaches including: Centers for Disease Control and Prevention (CDC) HIV Prevention funded entities, Substance Abuse and Mental Health Services Administration (SAMHSA) funded providers, HRSA’s Health Center Program , state and local health departments, and HIV stakeholders serving

PLWH.

The dissemination plan will include a timeline for distribution, target audience, method, venue (where applicable) and identification of contacts for follow-up strategy.

• Support Replication The purpose of the replication plan is to support the implementation of an evidence-informed approach or intervention by RWHAP and other HIV health care providers. This will require the recipient to directly provide or collaborate with other entities, such as AIDS Education and Training Centers (AETC), to provide TA to RWHAP and other HIV care providers on the implementation of the evidence-informed approaches or interventions; recruiting and mentoring RWHAP recipients and subrecipient providers to implement the evidence-informed approaches and interventions; and supporting overall replication and uptake of these evidence-informed approaches and interventions. This includes developing products, such as resources, webinars and other training products, and providing TA to RWHAP and other HIV health care service providers including: CDC HIV Prevention funded entities, SAMHSA funded providers, HRSA’s Health Center Program recipients, state and local health departments, and HIV stakeholders serving PLWH, and others interested in implementing these evidence-informed approaches and interventions.

All dissemination materials will be made available through the TARGET Center.

The recipient will analyze and provide summary reports of the user analytics gathered from the TARGET Center website in order to gauge the impact and reach of the implementation manual.

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

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Based on the user analytics, the recipient will adjust the implementation manual and replication materials as needed to improve accessibility among RWHAP recipients and subrecipient providers and Health Center Program recipients providing HIV testing and utility across HIV treatment services. Dissemination and replication may also be modified based on feedback following the convening of the technical expert panel.

2. Background

The Special Projects of National Significance (SPNS) program is authorized by Section 2691 of the Public Health Service Act (42 USC 300ff-101), as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (P.L. 111-87). The SPNS Program supports the development of evidence-informed approaches and interventions for HIV care to respond to the emerging needs of clients served by the RWHAP.2 The SPNS Program also evaluates the effectiveness of these approaches’ and interventions’ design, implementation, utilization, cost, and health related outcomes, while promoting the dissemination and successful replication.3

Of the estimated 1.1 million PLWH in the United States, an estimated 85 percent have been diagnosed with HIV, 62 percent linked to HIV care, and 48 percent retained in HIV care.4 Data indicate that some subpopulations continue to demonstrate challenges in accessing care and achieving improved health outcomes.5 Getting people into care through the traditional multi-stages from diagnosis to care entry can often result in individuals not being in or lost to care between each step of the process. Opportunities exist to reduce the time required from diagnosis to entry into care. Early linkage to care and continued engagement in care can lead to individual health benefits resulting from early treatment as well as public health benefits with reduced risk of transmission.

Further systems-level and community-based approaches and client-level interventions at the jurisdiction and clinic site-level are needed to actively identify, link, and retain PLWH who have never been in care, are out of care, or at risk of falling out of care;

critical components to increasing viral suppression. To help accelerate improvements in health outcomes along the HIV care continuum, in some jurisdictions people living with HIV receive enhanced levels of services to help strengthen their engagement and connection to care. 6 These and other innovative approaches and interventions to actively improve engagement, linkage, and retention in care are being used in the United States, and HRSA is looking to identify, catalog, disseminate, and support the replication of the applicability of such evidence-informed approaches and interventions

2 Ryan White HIV/AIDS Program Part F: Special Projects of National Significance (SPNS) Program available at: http://hab.hrsa.gov/abouthab/partfspns.html 3 Publications and products from various SPNS initiatives can be found at:

http://hab.hrsa.gov/abouthab/special/spnsproducts.html AND https://careacttarget.org/library/integrating-hiv-innovative-practices-ihip 4 HIV Continuum of Care, U.S., 2014, Overall and by Age, Race/Ethnicity, Transmission Route and Sex.

Available at: https://www.cdc.gov/nchhstp/newsroom/2017/HIV-Continuum-of-Care.htm 5 Ryan White HIV/AIDS Program, 2015 RSR Annual Client-Level Data Report. Available at:

https://hab.hrsa.gov/sites/default/files/hab/data/datareports/2015rwhapdatareport.pdf 6 Boston Public Health Commission & Massachusetts Department of Public Health. “HIV/AIDS Medical Case Management Acuity System Acuity Toolkit” http://www.bphc.org/whatwedo/infectious-diseases/Ryan-White-Services-Division/Documents/Acuity%20Toolkit.pdf http://hab.hrsa.gov/abouthab/partfspns.html http://hab.hrsa.gov/abouthab/special/spnsproducts.html https://careacttarget.org/library/integrating-hiv-innovative-practices-ihip https://careacttarget.org/library/integrating-hiv-innovative-practices-ihip https://hab.hrsa.gov/sites/default/files/hab/data/datareports/2015rwhapdatareport.pdf http://www.bphc.org/whatwedo/infectious-diseases/Ryan-White-Services-Division/Documents/Acuity%20Toolkit.pdf http://www.bphc.org/whatwedo/infectious-diseases/Ryan-White-Services-Division/Documents/Acuity%20Toolkit.pdf

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among HIV health care providers.

Some existing programs have implemented approaches and initiatives focused on improving engagement and re-engagement of PLWH who are not in HIV health care or are at risk of not being in care. These programs include immediately linking individuals newly diagnosed with HIV to HIV treatment and care, sometimes within the same or next day.7 Some of these initiatives have been implemented across the country challenging cities, states and localities to accelerate their response to HIV/AIDS.8 Other pilot data utilization initiatives in the United States identified people who were diagnosed with HIV but had never received HIV medical care, including CD4 or viral load results, which could inform data to care strategies.9

There are also various medical case management approaches that have developed and used retention acuity scales to assess the likelihood of a client’s ability to remain connected to care and subsequently receive enhanced level of services to help strengthen their engagement and connection to care.10 The goal of these acuity-based tools is to identify and provide support to clients who may be experiencing challenges in adhering to treatment or staying in care and provide guidance regarding additional medical case management or other comprehensive services needed to support increased engagement in care.

This opportunity will focus on reviewing specific acuity tools, data utilization, and service delivery/set of services approaches to this population. These and other innovative evidence-informed approaches and interventions are being used to actively improve engagement, linkage, and retention in care for PLWH in the United States; and through this effort, HRSA plans to identify, collect, distribute, and replicate their applicability among HIV health care service providers and jurisdictions.

National Goals to End the HIV Epidemic

RWHAP promotes robust advances and innovations in HIV health care using national goals to end the epidemic as its framework. Therefore, activities funded by RWHAP focus on addressing these four goals:

1) Reduce new HIV infections;

2) Increase access to care and optimize health outcomes for PLWH;

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

4) Achieve a more coordinated national response to the HIV epidemic.

7 Red Carpet Program: https://www.whitman-walker.org/service/medical/red-carpet/ and RAPID Program:

http://betablog.org/rapid-program-leads-to-faster-hiv-suppression/ and https://www.gettingtozerosf.org/rapid-committee/ 8 Fast Track Cities: http://www.iapac.org/cities/ and Getting to Zero: http://getting2zerosd.com/the-initiative/ 9 Fagan, et al. “Understanding People Who Have Never Received HIV Medical Care: A Population-Based Approach.” Public Health Reports, 125 (2010): 520-527.

10 Boston Public Health Commission & Massachusetts Department of Public Health. “HIV/AIDS Medical Case Management Acuity System Acuity Toolkit” http://www.bphc.org/whatwedo/infectious-diseases/Ryan-White-Services-Division/Documents/Acuity%20Toolkit.pdf https://www.whitman-walker.org/service/medical/red-carpet/ http://betablog.org/rapid-program-leads-to-faster-hiv-suppression/ https://www.gettingtozerosf.org/rapid-committee/ http://www.iapac.org/cities/ http://getting2zerosd.com/the-initiative/ http://getting2zerosd.com/the-initiative/ http://www.bphc.org/whatwedo/infectious-diseases/Ryan-White-Services-Division/Documents/Acuity%20Toolkit.pdf http://www.bphc.org/whatwedo/infectious-diseases/Ryan-White-Services-Division/Documents/Acuity%20Toolkit.pdf

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

HIV Care Continuum

Diagnosing PLWH, linking PLWH to HIV primary care, and PLWH achieving 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 shows the proportion of individuals living with HIV or individuals diagnosed 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.

According to recent data from the 2016 Ryan White Services Report (RSR), the RWHAP has made tremendous progress toward ending the HIV epidemic in the United States. From 2010 to 2016, 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 69.5 percent to 84.9 percent, and racial/ethnic, age-based, and regional disparities have decreased.11 These improved outcomes mean more PLWH in the United States will live near normal lifespans and have a reduced risk of transmitting HIV to others.12 In a September 27, 2017 Dear Colleague letter, CDC notes that scientific advances have shown that antiretroviral therapy (ART) preserves the health of PLWH. There is also strong evidence of the prevention effectiveness of ART. When ART results in viral suppression, it 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 PLWH into care, retaining them in care, and helping them adhere to their ART.

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 RWHAP performance measures at their local level to assess the efficacy of their programs and to analyze and improve the gaps along the HIV care continuum.

11 Health Resources and Services Administration. Ryan White HIV/AIDS Program Annual Client-Level Data Report 2016. http://hab.hrsa.gov/data/data-reports. Published December 2017. Accessed December 1, 2017.

12 National Institute of Allergy and Infectious Disease (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-2016.pdf https://docs.wixstatic.com/ugd/de0404_fab89a3aaeeb406bbd7898d0e90d5dac.pdf http://hab.hrsa.gov/deliverhivaidscare/habperformmeasures.html http://hab.hrsa.gov/data/data-reports https://clinicaltrials.gov/

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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 programmatic involvement is anticipated between HRSA and the recipient during the performance of the contemplated project.

HRSA Program involvement will include:

• Providing the expertise of HRSA personnel and relevant resources to the project.

• Facilitating effective collaborative relationships between the cooperative agreement recipient and other relevant stakeholders.

• Participating in the design and review of activities, procedures, measures, and tools to be established and implemented for accomplishing the program goals and requirements set forth in Section I. 1. of this NOFO.

• Participating in project-related meetings and technical expert panel throughout the project period.

• Analyzing and suggesting modification to activities, as necessary, in keeping with the changing trends and needs of RWHAP providers and the changing health care environment.

• Reviewing all products prior to dissemination, and assisting in the dissemination of findings, and other information developed as part of this project to the broader network of RWHAP and other HIV health care service providers including: CDC HIV Prevention funded entities, SAMHSA funded providers, HRSA’s Health Center Program recipients, state and local health departments, and HIV stakeholders serving PLWH, and others interested in implementing these evidence-informed approaches and interventions.

The cooperative agreement recipient’s responsibilities will include:

• Collaborate with the assigned HRSA Project Officer and other HRSA staff as necessary, to meet the program requirements set forth in Section I.1. of this

NOFO.

• Identify, catalog, disseminate, and support the replication of evidence-informed approaches and interventions to RWHAP and other HIV health care service providers including: CDC HIV Prevention funded entities, SAMHSA funded providers, HRSA’s Health Center Program recipients, state and local health departments, and HIV stakeholders serving PLWH, and others interested in implementing these evidence-informed approaches and interventions.

• Convene a technical expert panel.

• Conduct a cost analysis.

• Develop supporting materials to the implementation manual and TA modules that include procedural materials, as needed, to enable HIV health care service providers to replicate and implement the approach or intervention.

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• Identify RWHAP, HRSA’s Health Center Program recipients providing HIV testing and/or HIV care and treatment services, to replicate the identified approaches and interventions.

2. Summary of Funding

Approximately $1,700,000 is expected to be available annually to fund one (1) cooperative agreement recipient. You may apply for a ceiling amount of up to $1,700,000 total cost (includes both direct and indirect, facilities and administrative costs) per year. The actual amount available will not be determined until enactment of the final FY 2018 federal appropriation. The FY 2018 President’s Budget does not request funding for this program. This program notice is subject to the appropriation of funds, and is a contingency action taken to ensure that, should funds become available for this purpose, applications can be processed, and funds awarded in a timely manner.

The project period is September 1, 2018 through August 31, 2021 (3 years). Funding beyond the first year is dependent on the availability of appropriated funds for this program 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 Public Health Service Act as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009, including public health departments and institutions of higher education, state and local governments, nonprofit organizations, faith-based and community-based organizations, tribes and tribal organizations are eligible to apply.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

Applications that exceed the ceiling amount will be considered non-responsive and will not be considered for funding under this notice.

Any application that fails to satisfy the deadline requirements referenced in Section IV.4 will be considered non-responsive and will not be considered for funding under this notice.

NOTE: Multiple applications from an organization are not allowable.

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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If for any reason (including submitting to the wrong funding opportunity number or making corrections/updates) an application is submitted to Grants.gov more than once prior to 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 through Grants.gov. You must use the SF- 424 application package associated with this NOFO following the directions provided at http://www.grants.gov/applicants/apply-for-grants.html.

Effective December 31, 2017 - You must use the Grants.gov Workspace to complete the workspace forms and submit your application workspace package. After this date, you will no longer be able to use PDF Application Packages.

HRSA recommends that you supply an email address to Grants.gov on the grant opportunity synopsis page when accessing the notice of funding opportunity (NOFO) (also known as “Instructions” on Grants.gov) or application package. This allows Grants.gov to email organizations that supply an email address in the event the NOFO is changed and/or republished on Grants.gov before its closing date. 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 https://www.grants.gov/ 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. Applications must be submitted in the English language and must be 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 80 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 application package do not count in the page limitation. Indirect Cost Rate Agreements and proof of non-profit status (if applicable) will not be counted in the page limit. We strongly urge you to take appropriate measures to ensure your application does not exceed the specified page limit.

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

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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) The prospective recipient certifies, by submission of this proposal, that neither it nor its principals is 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 the prospective recipient is 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), please include the following:

i. Project Abstract See Section 4.1.ix of HRSA’s SF-424 Application Guide. In addition, the project abstract must also include a brief statement indicating the project structure and goals.

ii. Project Narrative

This section provides a comprehensive framework and description of all aspects of the proposed project. It should be succinct, self-explanatory and well organized so that reviewers can understand the proposed project.

Please use the following section headers for the narrative:

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

Detail your understanding of the challenges of engaging and retaining PLWH who have never been in care, are out of care, or at risk of falling out of care. Use and cite demographic and/or other epidemiologic data whenever possible to support your assessment of the information provided. Include the data information gathering methods when applicable.

Detail your understanding of the RWHAP, RHWAP services, and the HIV care continuum. Provide a clear understanding of the purpose of the project, clear descriptions of the roles and activities as well as describe the overall approach of how you will conduct the technical expert panel to identify evidence-informed approaches and interventions to engage PLWH.

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)

Describe the need to identify evidence-informed approaches and interventions for reaching PLWH who have never been in care, are out of care, or at risk of falling out of care. Describe the potential benefit of identifying these approaches and interventions, cataloging them, and conducting a cost analysis of their implementation.

Describe the need for supporting their replication and disseminating an implementation manual for use by RWHAP and other HIV health care service providers including: CDC HIV Prevention funded entities, SAMHSA funded providers, HRSA’s Health Center Program recipients, state and local health departments, HIV stakeholders serving PLWH, and others interested in implementing these evidence-informed approaches and interventions.

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

Propose methods that will be used to meet each of the following program requirements and expectations in this cooperative agreement. Discuss why your selected methodology is appropriate for this project. Describe the degree to which intervention site staff, stakeholders, and PLWH will be involved. Use the following headings to outline your response:

• Identify approaches and interventions

• Determine the effectiveness of the identified approaches and interventions

• Convene a technical expert panel

• Develop the catalog and implementation manual of evidence-informed approaches and interventions

• Disseminate the catalog and implementation manual of evidence-informed approaches and interventions

• Support replication of the evidence-informed approaches and interventions

Identify approaches and interventions:

Briefly describe the purpose of the proposed project as it responds to the purpose set forth in this NOFO. Provide a clear description of the roles and activities of your organization and any partners, if applicable.

Describe the process for identifying the evidence-informed approaches and interventions including a literature scan and communicating with existing HIV and related health service providers, as well as federal, state and/or local stakeholders.

Describe the methodology for systematically identifying and collecting information on a wide variety of approaches and interventions currently or previously implemented in the field by RWHAP and other HIV health care service providers, or identified in the scientific literature.

Determine the effectiveness of the identified approach and intervention:

Describe the methodology of determining effectiveness of the identified

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approaches and interventions. This may include interviews with key informants and staff involved with implementing the approaches and/or interventions to gather more detailed information about the approach and/or intervention and its impact on specific HIV care continuum outcomes. The methodologies proposed should be relevant and able to identify effective approaches and interventions.

Describe the proposed methodology for utilizing retrospective analyses of client-level and clinical outcome data, including review and evaluation of relevant RSR data. Describe the plan to submit documentation for IRB review. Should your IRB determine that such data is not needed for IRB approval, state your agreement to provide HRSA a copy of the exemption or waiver. Discuss process elements and expected outcomes.

Convene a technical expert panel Describe the overall approach of how you will conduct the technical expert panel to identify evidence-informed approaches and interventions to engage PLWH.

Conduct a cost analysis:

Propose a methodology to document the labor and programmatic costs of each intervention at the sites, including how the cost analysis will be conducted. If applicable, include a methodology to conduct a cost-effectiveness study to implement these interventions.

Develop a catalog and implementation manual of evidence-informed approaches and interventions:

Briefly describe the applicant organization and your ability to identify, catalog, disseminate, and support the replication of evidence-informed approaches and interventions to engage PLWH who are not receiving HIV health care or who are at risk of not continuing to receive HIV care.

Describe how the approaches and interventions will be documented. Describe how the implementation manual will be packaged.

Disseminate the catalog and implementation manual of evidence-informed approaches and interventions:

Describe your plan for the rapid deployment of the implementation manual.

Provide an outline of your dissemination plan identifying appropriate venues and target audiences, including but not limited to, HIV and related health care service providers, program administrators, and policy makers. Include the process you will utilize and incorporate findings and lessons learned from training, outreach, collaboration, communication, and information dissemination.

Support replication of the evidence-informed approaches and interventions:

Describe how you will work collaboratively with national stakeholders and TA providers, including AETCs, to identify, solicit programs and support replicating an approach or intervention.

Describe how you will transfer knowledge to clinical providers and community-based organizations serving PLWH.

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Describe methods of information dissemination. These may include but are not limited to webinars, training, workbooks, curricula and tool kits that are printed and or available in electronic form and designed to promote replication and implementation of approaches and interventions appropriate for the target group.

Describe anticipated TA needs of HIV providers interested in implementing evidence-informed approaches and interventions, and how they will be addressed across the following domains: program development, implementation, sustainability and program integration.

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

Describe the activities or steps that you will use to achieve each of the objectives proposed during the entire project period in the Methodology section. Use a time line that includes each activity and identifies responsible staff. As appropriate, identify meaningful support and collaboration with key stakeholders in planning, designing and implementing all activities, including development of the application.

Provide a work plan that delineates goals for the 3-year project period. The work plan is to be used as a tool to manage the initiative by measuring progress, identifying necessary changes, and quantifying project accomplishments. The work plan should directly relate to your Methodology and the program requirements of this announcement.

Include all aspects of planning and design, implementation and dissemination.

The work plan should include clearly written (1) goals; (2) objectives that are specific, time-framed, and measurable; (3) action steps; (4) staff responsible for each action step (including consultants); and (5) anticipated dates of completion.

Goals should be included in the work plan for the entire proposed 3-year project period. Objectives and action steps are required in the work plan only in relation to goals set for year one. First year objectives should describe key action steps or activities that you will undertake. Include the project’s work plan as Attachment 6, and provide a succinct complementary description and explanation of the work plan in the application narrative.

Include in Attachment 6 an accompanying logic model for designing and managing the project. A logic model is a one-page diagram that presents the conceptual framework for a proposed project and explains the links among program elements. While there are many versions of logic models, for the purposes of this notice, the logic model should summarize the connections between the:

• Goals of the project (e.g., objectives, reasons for proposing the approach and intervention, if applicable);

• Assumptions (e.g., beliefs about how the program will work and support resources; base assumptions on research, best practices, and experience);

• Inputs (e.g., organizational profile, collaborative partners, key staff, budget, HRSA-18-048 15 other resources);

• Target population (e.g., the individuals to be served);

• Activities (e.g., approach, listing key approach and intervention, if applicable);

• Outputs (i.e., the direct products or deliverables of program activities); and

• Outcomes (i.e., the results of a program, typically describing a change in people or systems).

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

Discuss challenges that you are likely to encounter in designing and implementing the activities described in the work plan, and approaches that you will use to resolve such challenges.

Discuss the strength of your methodology in identifying and responding to these challenges.

Discuss approaches that will be used to resolve such challenges. Also, discuss relevant challenges encountered in implementing similar work plans, and how these were resolved.

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

Describe how you plan to monitor the goals and objectives of the project outlined in the proposal.

Describe your methods to gather data and explain how the data will be used to determine the approaches and interventions with the highest likelihood of improving outcomes for engaging and retaining PLWH who have never been in care, are out of care, or at risk of falling out of care.

Describe your plan for analyzing the cost analysis for the evidence-informed approaches and interventions selected to be included…