ryan white hiv/aids program - part f pre-application

Ryan White HIV/AIDS Program - Part FPre-Application Technical Assistance Webinar

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)

Competitive Grant Application HRSA-20-113April 29, 20203:00-4:30 PM EST

Son Phan, MD, MPHHealth Scientist HIV/AIDS Bureau (HAB)Health Resources and Services Administration (HRSA)

Chau Nguyen, MPHPublic Health AnalystHIV/AIDS Bureau (HAB)Health Resources and Services Administration (HRSA)

Welcome and Introductions

• April Stubbs-Smith Director, Division of Domestic HIV Programs

• Adan Cajina Chief, Demonstration and Evaluation Branch, SPNS

• Melinda Tinsley HAB SPNS Senior Public Health Analyst

• Son Phan HAB SPNS Health Scientist

• Chau Nguyen HAB SPNS Project Officer

• Beverly Smith HRSA Grants Management Specialist

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Agenda

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• HAB Vision and Mission

• Purpose of Funding Opportunity

• Award Information

• Eligibility

• Application and Submission Information

• Application Review Information

• Application Submission Tips

• Question and Answer

Acronyms

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• CQM – Clinical Quality Management

• DUNS – Data Universal Numbering System

• EHB – Electronic Handbooks• EHR – Electronic Health

Records• HAB – HIV/AIDS Bureau• HHS – Department of Health

and Human Services• GMS – Grants Management

Specialist• MHAF – Minority HIV/AIDS

Fund

• MIS – Management Information System

• NOFO – Notice of Funding Opportunity (formerly FOA)

• PLWH – People Living with HIV

• PO – Project Officer • RWHAP – Ryan White

HIV/AIDS Program• SAM – System for Award

Management• SPNS – Special Projects of

National Significance

HIV/AIDS Bureau Vision and Mission

VisionOptimal HIV/AIDS care and treatment for all

MissionProvide leadership and resources to assure access to and retention in high quality, integrated care,

and treatment services for vulnerable people living with HIV and their families

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Ryan White HIV/AIDS Program Part F – SPNS

• Supports the development of innovative models of HIV care that quickly respond to the emerging needs of clients served by the Ryan White HIV/AIDS Program (RWHAP)

• Evaluates the effectiveness of these models’ design, utilization, cost, and health related outcomes

• Promotes the dissemination and replication of successful models

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Please refer to page 2 of the NOFO

Background

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• Of the ~1.1 million people with HIV in U.S., ~86% are aware of their HIV, and of those, only 64% are engaged in medical care.

• Often there is delay between HIV diagnosis and initiation of antiretroviral therapy (ART) due to individual and structural barriers to care, resulting in potential of patients to be lost to follow-up.

• Thus, rapid ART start, i.e., same day, next day, or within a week of HIV diagnosis/care entry has been suggested as a strategy to improve engagement in care.

• Rapid start strategies have been shown to improve earlier linkage to care, earlier ART initiation, and a shorter time to viral suppression.

Please refer to page 1&2 of the NOFO

Purpose

• HHS MHAF and HRSA HAB SPNS will fund one 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 (being funded under HRSA-20-114).

• Award recipients under both NOFOs (HRSA-20-113 and HRSA-20-114) will need to work together to be successful, you are encouraged to familiarize with the program expectations of HRSA-20-114.


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Specific Expectations:

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

o Outcome measures: include early engagement, retention in care, and sustained viral suppression and/or other outcomes on the HIV care continuum; must include key HAB and MHAF performance measures.

o Process evaluation: assess how the rapid start interventions are adapted and implemented including, but not be limited to, facilitators and barriers to implementation-associated processes.

o Cost analysis: document the related costs, including funding streams and actual costs and expenditures incurred by each implementation site, to inform feasibility for future replication and expansion.

Please refer to pages 7-9 of the NOFO

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Specific Expectations (cont.)

2) Provide and facilitate TA and capacity building assistance (CBA) on the adaptation and implementation of rapid start models

• Facilitate TA and CBA to up to 10 sites based on a review of each site’s needs assessments and determination of readiness including clinical capacity and infrastructure.

• TA through learning collaboratives including peer-to-peer exchange; matching implementation sites with more experienced sites similar in geographic location, size of clinical settings, or available resources.

• Establish and support a rapid start-focused learning collaborative and provide a virtual platform, utilizing available technology facilitating the rapid exchange of information and ideas for participating clinics.

• Provide other trainings such as team-based provider training on patient screening, baseline laboratory assessments, recommended regimens for immediate ART, and follow-up with a review of contraindications to improve immediate patient linkage and overall retention in care and related activities.

• Work with each site on development and finalization of an implementation protocol specific to the selected rapid start interventions.


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Specific Expectations (cont.)

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

• Identify successful rapid start interventions, promising and best practices, and lessons learned.

• Produce and disseminate TA toolkits, materials, and products including an implementation manual.

• Dissemination via websites (the initiative website and the TargetHIV website), presentations via webcast, conferences, meetings, or national forums.

• Collaborate with national and regional AETC program recipients to optimize the potential for replication of the effective rapid start interventions in RWHAP.


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Specific Expectations: Start Rapid (Cont.)

The cooperative agreement recipient’s responsibilities will include:

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

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

• Facilitating learning collaboratives and peer-to-peer learning on rapid start models including matching funded implementation sites with experienced sites to help build the capacity of the implementation sites;

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

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


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Specific Expectations: Start Rapid (Cont.)

The cooperative agreement recipient’s responsibilities will include:

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

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

• Coordinating and leading the logistics for annual multi-site meetings of the 3 years of the initiative 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.


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Award Information

Summary of Funding:

• Funding will be provided through a cooperative agreement• A cooperative agreement is a mechanism where substantial

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

• Up to $700,000 is available annually to fund one applicant• Requests exceeding this amount will be deemed nonresponsive

and will not be considered.

• Project period: September 1, 2020 – August 31, 2023 (3 years)


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Award Information (cont.)

Summary of Funding:

• 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 – ETAP in subsequent fiscal years, satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government.


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Eligibility Information

• 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

• Foreign entities are not eligible to apply

• Cost sharing/matching is not required

• Maintenance of Effort Information (MOE), if applicable

• Any applications exceeding ceiling amount are not considered for funding

• For multiple submitted applications from the same entity, only the last validated electronic submission under the correct funding opportunity HRSA-20-113 is accepted


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Application and Submission Information

Two Components of the NOFO:1) HRSA-20-113 “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)” focuses on the program-specific content, including goals, expectations, and requirements of the program

2) HRSA’s General Instructions

• SF 424 Application Guide (“Application Guide”)

• Links are found throughout the NOFO

Applicants must use both HRSA-20-113 NOFO and the SF 424 Application Guide to successfully complete and submit an application.

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

Application Package

Applicants must include the following:• SF-424 Application for Federal Assistance

• Project Abstract (uploaded in box 15 of the SF-424)

• Project/Performance Site Location Form

• Project Narrative (uploaded to the Project Narrative Attachment

Form)

• SF-424A Budget

• Budget Narrative (uploaded to the Budget Narrative Attachment Form)

• Attachments (Section IV 2. v. of NOFO)

• Grants.gov Lobbying Form

• SF-424B Assurances

• Key Contacts

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Project Abstract

Include:

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 of the NOFO:

• Brief description of the proposed ETAP structure

• Overall project goals

• Overall multi-site evaluation questions

• Overall TA and CBA approaches

* Note: Abstract must be single-spaced and no more than one page in length.

See pages 13 in the NOFO and 24 in the SF424 Application Guide

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Project Narrative

Sections:

• Introduction

• Needs Assessment

• Methodology

• Work Plan

• Resolution of Challenges

• Evaluation and Technical Support Capacity

• Organizational Information

Please refer to pages 13 to 19 in the NOFO

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Project Narrative - Introduction

• Briefly describe the purpose of the proposed project and how the ETAP will execute the project to respond to 3 goals required by the initiative.

• Briefly describe your organization and any collaborating organizations who will help to meet the goals of the project.

Please refer to pages 13-14 in the NOFO

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Project Narrative - Needs Assessment

• Demonstrate a comprehensive understanding of successful strategies utilized to implement rapid start in similar populations including barriers to 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 challenges and strategies to address.

• Discuss barriers to access of rapid start, adherence, retention in care, and achieving viral suppression for people with HIV, including policy, financial, capacity and structural issues impacting the deployment of rapid start activities.

Please refer to page 14 in the NOFO

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Project Narrative - Methodology

Propose methods that you will use to meet the program expectations in this NOFO.• Multi-site evaluation:

Evaluation plan: approach, methods and tools, data analysis and interpretation, and collaboration to carry out process and outcome evaluation and cost analysis.

At minimum, the evaluation plan must include: • Elements or domains of process surveys (qualitative and/or

quantitative and/or mixed methods); • Elements or domains of outcome surveys (qualitative and/or

quantitative and/or mixed methods);• Elements or domains of clinical and/or patient outcome surveys

(qualitative and/or quantitative and/or mixed methods); and• Elements of a cost analysis to assess labor, programmatic, and

structural costs associated with implementing the rapid start interventions.


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Project Narrative – Methodology (cont.)

• Multi-site evaluation: The evaluation plan also contains descriptions of following

components:• The analysis and interpretation plan for each data source. The

appropriate data analysis techniques used to answer the proposed evaluation questions.

• The feasibility of collecting data elements based on the capacity of implementation projects operating their rapid start interventions in real-world clinical settings.

• Your approach to working collaboratively with implementation sites as well as other stakeholders in leading data collection and reporting efforts for the multi-site evaluation.

• Your approach to leading and coordinating the annual grantee meeting in the Washington, DC metropolitan area.


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• TA and CBA up to 10 implementation sites:

Customized TA plans and TA level based on degree of readiness and capacity of sites

Facilitate learning collaboratives (e.g., peer-to-peer; matching sites)

Develop and finalize implementation protocol specific to selected rapid start interventions

Please refer to pages 14 -15 of the NOFO

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• Dissemination and replication:

Identify successful rapid start interventions, promising and best practices, and lessons learned

Produce and disseminate TA toolkits and materials

Disseminate thought websites including TargetHIV, presentations via webcast, conferences, meetings or national forums

Please refer to pages 16 of the NOFO

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Project Narrative - Work Plan

• Develop a work plan describing steps used to achieve each of the activities proposed.

• The work plan as Attachment 1 should be presented in a table format and include (1) goals for entire 3-year period of performance; (2) objectives that are specific, time-framed, realistic, and measurable; (3) action steps; (4) staff responsible for each action step; and (5) anticipated dates of completion.

• You must submit a logic model for designing and managing the project as Attachment 7. The logic model should summarize the connections between Goals of the project, assumptions, Inputs, Target population, Activities, Outputs and Outcomes.

Please refer to pages 16&17 of the NOFO

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Project Narrative - Work Plan

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SPECIFIC

MEASURABLE

ACHIEVABLE

REALISTIC &

TIME FRAMED!

Your work plan should include objectives and key action steps that are:

Sample Work Plan – Table

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Project Narrative - Resolution of Challenges

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


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Project Narrative - Evaluation and Technical Support Capacity

• Describe your and your collaborating partner organization’s (if applicable) capacity to conduct a multi-site evaluation.

• Describe how your knowledge of legislative and programmatic requirements of the RWHAP, current reporting protocols for the RWHAP, and the HIV care continuum meet the objectives and expectations of this initiative.

• Describe how the proposed key personnel have the necessary knowledge, experience, training, and skills to successfully carry out the required activities and meet the expectation of the initiative.

• Describe your knowledge of and experience with submission of IRB materials for review and obtaining approvals and renewals.

• Describe the experience of key project staff in collaborative writing and publishing study findings in peer-reviewed journals.

• Describe any potential obstacles for implementing the program performance evaluation and your plan to address those obstacles


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Project Narrative - Organizational Information

• Describe your organization’s mission & structure, scope of current activities, quality & availability of facilities and personnel. Include information on all partnering organizations’ current mission & structure, and scope of current activities.

• Describe your organization’s capacity to conduct the multi-site evaluation, to provide and facilitate TA and CBA activities, and to lead the dissemination.

• Describe the capacity of your organization to build and maintain the project website.

• Provide a one-page figure that depicts the organizational structure of the project, including collaborating organizations, contractors and other significant collaborators as Attachment 5.

• Provide a staffing plan (Attachment 2) that identifies staff credentials and commitments to the proposed project components.

• Describe the roles and responsibilities of any consultants and/or contractors who will carry out aspects of the proposed project. Include any such letters or memoranda as Attachment 4

• Describe the ability of key personnel to successfully publish and disseminate findings about successful rapid start interventions, lessons learned and other findings from multi-site evaluations.


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Sample Staffing Plan

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NameEducation/

CredentialsTitle Project Role Experience

Mrs. Doe MPHProgram

Coordinator

Oversight of RWHAP

award and project

implementation

5 years as program

coordinator, previously was

Data/CQM Manager for

same entity

Dr. Jones MD Medical Director

Oversight of clinic

staff, SOPS and CQI

projects

15 years providing HIV

primary care

Ms. KonaAssoc

Degree

CQM Coordinator,

Retention Specialist

Oversight of CQM

Activities

4 years working in HIV clinic

scheduling appointments,

making referrals, medical

data entry

Mr. Lewis MSWMedical Case

Manager

Treatment adherence

training3 years providing HIV

medical case management

Budget Requirements

Budget information consists of three parts:

1. SF-424A Budget Information for Non-Construction Programs (included in the application package)

2. Program-specific line item budget: Separate line item budgets for each year of the three (3) year period of performance, using the Section B Budget Categories of the SF-424A and breaking down sub-categorical costs as appropriate (Attachment 6).

3. Budget justification narrative

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See pages 20-21 in the NOFO, and 17-28 in the SF424 Application Guide

Budget Requirements: SF-424A

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Budget and Budget Justification

• Include sufficient narrative to justify the reasonableness of the support requested

• Submit one-year budgets for each of the three project years.

• Include both direct and indirect costs

• Explain each cost element

• Describe how each line item will support proposed project objective

• Identify for all staff the % of FTE allocated, the full salary amount, and other funding sources leveraged to account for the full salary

• Reference the SF-424 Application Guide for directions and writing tips for completing the budget and budget narrative

Please refer to page 21 of the NOFO and pages 28-31 of SF-424 Application Guide

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Salary Limitation

Please note that effective January 27, 2020, the salary rate limitation applicable to RWHAP domestic grants and cooperative agreements increased from $192,300 to $197,300.

• The Consolidated Appropriations Act, 2020 (P.L. 116-94), Division A, § 202 states, “None of the funds appropriated in this title shall be used to pay the salary of an individual, through a grant or other extramural mechanism, at a rate in excess of Executive Level II.”

• As a reminder, RWHAP funds and program income generated by RWHAP awards may not be used to pay salaries in excess of the rate limitation.

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Salary Rate Limitation Example

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• Individual’s full time salary: $255,000.

• Amount that may be claimed on the federal RWHAP award due to the legislative salary limitation:• Individual’s base full time salary adjusted to Executive Level II:

$197,300

Funding Restrictions

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Please refer to pages 24 of the NOFO

In addition to the general restrictions included in Section 4.1.iv of the SF-424 Application Guide, funds may not be used for the following:

1. Any charges that are billable to third party payers (e.g., private health insurance, prepaid health plans, Medicaid, Medicare);

2. To directly provide medical or support services (e.g., HIV care, counseling and testing) that supplant existing services;

3. Cash payments to intended recipients of RWHAP services;

4. Purchase, construction of new facilities or capital improvements to existing facilities;

5. Purchase or improvement to land;

6. Purchase vehicles;

7. Fundraising expenses;

8. Lobbying activities and expenses;

9. Reimbursement of pre-award costs; and/or

10. International travel


Attachments

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List of Attachments can be found in Section IV. 2. v. of the NOFO:• Attachment 1: Work Plan • Attachment 2: Staffing Plan and Job Descriptions for Key

Personnel • Attachment 3: Biographical Sketches of Key Personnel • Attachment 4: Letters of Agreement, Memoranda of

Understanding, and/or Description(s) of Proposed/Existing Contracts, (project-specific)

• Attachment 5: Project Organizational Chart • Attachment 6: Line Item Budgets for Years 1 through 3 • Attachment 7: Logic Model• Attachments 8-12: Other Relevant Documents (if applicable)


Attachments (cont.)

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List of Attachments can be found in Section IV. 2. v. of the NOFO

• Upload attachments in the order specified to the Attachments Form in the application package

• Label each attachment clearly

• Unless otherwise noted, attachments counttoward the page limit


Application Review Information

• HRSA’s Division of Independent Review (DIR) is responsible for managing the objective and independent application review performed by a committee of qualified experts

• Applications will be reviewed and rated based on the review criteria in Section V of the NOFO if they

o are submitted by the published deadline

o do not exceed the page limit

o do not request more than the ceiling amount, and

o pass the initial HRSA eligibility and completeness screening

• The competitive objective review process is based solely on the merits of your application. It is critical that you paint a clear picture of your proposed project and the capabilities that your organization brings to the work

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Application Review Information

• Review Criteria are used to review and rank applications. For this opportunity, there are 6 review criteria:

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Criteria Points

Criterion 1: Need 10

Criterion 2: Response 30

Criterion 3: Evaluative Measures 20

Criterion 4: Impact 10

Criterion 5: Resources/Capabilities 20

Criterion 6: Support Requested 10

Total Points 100


Application Review Crosswalk

• Review Criteria correspond to the applicant’s written response to the Project Narrative and required attachments:

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Project Narrative Section Review Criteria

Introduction (1) Need

Needs Assessment (1) Need

Methodology(2) Response, (3) Evaluative

Measures, and (4) Impact

Work Plan (2) Response and (4) Impact

Resolution of Challenges (2) Response


Application Review Crosswalk - Continued

• Review Criteria correspond to the applicant’s written response to the Project Narrative and required attachments:

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Project Narrative Section Review Criteria

Evaluation and Technical

Support Capacity(3) Evaluative Measures

Organizational Information (5) Resources/Capabilities

Budget and Budget Narrative (6) Support Requested


Application Package: Where is it?

• At www.grants.gov• Search by opportunity number, or• CFDA

• The Application Guide is available at https://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf or click the links in the NOFO

• Grants.gov “Workspace” instructional information and videos are available online at https://www.grants.gov/web/grants/applicants/workspace-overview.html

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http://www.grants.gov/

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

https://www.grants.gov/web/grants/applicants/workspace-overview.html

Application Submission Tips

• Read the NOFO and the SF-424 Application Guide carefully and follow instructions.

• Include your agency name and the name of this program on all pages (RWHAP 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)).

• Refer to section 4.7 of the Application Guide for additional Tips for Writing a Strong Application.

• Apply early; do not wait until the last minute in case you run into challenges!

• Make sure the person who can submit for your organization will be available.

• Ensure SAM.gov and Grants.gov registration and passwords are current immediately!

Have all your PIN numbers and passwords handy!

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Grants.gov Contact Information

• When to contact Grants.gov Helpdesk

• Error messages

• Other technical issues

• Application did NOT transmit to HRSA

• If you have any submission problems, please contact Grants.gov immediately!

• Grants.gov Contact Center (24/7 except Federal holidays): • 1-800-518-4726, or

• [email protected], or

• https://grants-portal.psc.gov/Welcome.aspx?pt=Grants

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mailto:[email protected]

https://grants-portal.psc.gov/Welcome.aspx?pt=Grants

Tracking Grants.gov Submissions

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SF424 Application Guide, section 8.2.5

Grants.gov Message upon Application Upload

• Thank you for submitting your grant application package via Grants.gov. Your application is currently being processed by the Grants.gov system. Once your submission has been processed, Grants.gov will send email messages to advise you of the progress of your application through the system. Over the next 24 to 48 hours, you should receive two emails. The first will confirm receipt of your application by the Grants.gov system, and the second will indicate that the application has either been successfully validated by the system prior to transmission to the grantor agency or has been rejected due to errors.”

• “IMPORTANT NOTICE: If you do not receive a receipt confirmation and either a validation confirmation or a rejection email message within 48 hours, please contact us. The Grants.gov Contact Center can be reached by email at [email protected], or by telephone at 1-800-518-4726. Always include your Grants.gov tracking number in all correspondence. The tracking numbers issued by Grants.gov look like GRANTXXXXXXXXX.”

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Reminders

• Your application must be electronically submitted through and successfully validated by Grants.gov no later than June 15, 2020,11:59 pm ET.

• We recommend submission of the application at least four business days before the due date.

• Applicants should check back on Grants.gov. In case there are any changes to the NOFO, it will be posted.

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Applicants should check back on Grants.gov. as any changes to the NOFO will be posted there.

Applicants should check back on Grants.gov. In case there are any changes to the NOFO, it will be posted there.

HRSA Contacts

Applicants who need additional information may contact:

Program Contact Grants Contact

Adan Cajina Beverly Smith

Chief, Demonstration Grants Management Specialist and Evaluation Branch HRSA Office of Federal

HRSA HIV/AIDS Bureau Assistance Management

[email protected] [email protected]

(301) 443-3180 (301) 443-7065

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Q&A - Your Questions are Welcome!

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