PKG00264577-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

HIV/AIDS Bureau Division of Policy and Data

Using Innovative Intervention Strategies to Improve Health Outcomes among

People with HIV - Coordinating Center

Funding Opportunity Number: HRSA-21-076 Funding Opportunity Type: Competing Continuation

Assistance Listings (CFDA) Number: 93.928

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2021

Application Due Date: March 8, 2021

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: December 18, 2020

Demetrios Psihopaidas, PhD, MA Senior Health Scientist, Evaluation, Analysis, and Dissemination Branch Division of Policy and Data, HIV/AIDS Bureau Telephone: (301) 443-1469 Fax: (301) 443-8143 Email: dpsihopaidas@hrsa.gov

Authority: 42 U.S.C. § 300ff-101 (§ 2691 of the Public Health Service Act) mailto:dpsihopaidas@hrsa.gov

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EXECUTIVE SUMMARY

This notice announces the opportunity to apply for fiscal year 2021 (FY21) Health Resources and Services Administration (HRSA) Special Projects of National Significance (SPNS) Program funding for the initiative Using Innovative Intervention Strategies to Improve Health Outcomes among People with HIV – Coordinating Center.

The purpose of this initiative is to use an implementation science framework to identify innovative intervention strategies in four (4) focus areas, pilot test the intervention strategies at subawarded sites and provide technical assistance (TA), and develop replication tools and products. HRSA will provide funding in the form of a cooperative agreement to support one (1) organization for up to four (4) years to serve as the Innovative Intervention Strategies Coordinating Center for Technical Assistance (2iS CCTA). The 2iS CCTA will solicit and subaward up to 20 Ryan White HIV/AIDS Program (RWHAP)-funded recipients/subrecipients (approximately five sites per focus area) to serve as implementation sites where one (1) intervention strategy per site will be piloted. The piloted intervention strategies will be evaluated through the companion funding opportunity announcement titled Using Innovative Intervention Strategies to Improve Health Outcomes among People with HIV – Evaluation Center (2iS EC; HRSA- 21-068). Ultimately, the 2iS EC’s evaluation findings will determine dissemination plans for the replication tools developed by the 2iS CCTA. Please review this companion announcement for more information about the role of the 2iS EC.

Funding Opportunity Title: Using Innovative Intervention Strategies to Improve Health Outcomes among People with HIV – Coordinating Center

Funding Opportunity Number: HRSA-21-076 Due Date for Applications: March 1, 2021 Anticipated Total Annual Available FY 2021 Funding:

$4,825,000

Estimated Number and Type of Award(s): Up to one (1) cooperative agreement Estimated Award Amount: Up to $4,825,000 per year Cost Sharing/Match Required: No Period of Performance: August 1, 2021, through

July 31, 2025 (4 years)

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Eligible Applicants: Eligible applicants include entities eligible for funding under RWHAP Parts A, B, C, and D. These include but are not limited to: public and nonprofit private entities involved in addressing HIV related issues at the regional or national level; state and local governments; academic institutions;

local health departments; nonprofit hospitals and outpatient clinics;

community health centers receiving support under Section 330 of the Public Health Service 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, January 13, 2021 Time: 2 p.m. – 3:30 p.m. ET Call-In Number: 1-800-779-5244 Participant Code: 3606454 Weblink: https://hrsa.connectsolutions.com/hrsa-21webinar/

The webinar will be recorded and should be available within 10 business days at https://targethiv.org/library/nofos. Answers to questions posed during and after the webinar will also be posted there.

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://hrsa.connectsolutions.com/hrsa-21webinar/ https://targethiv.org/library/nofos

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING/MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Narrative

v. Attachments

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

TO THE UNIQUE ENTITY IDENTIFIER (UEI) AND SYSTEM FOR AWARD MANAGEMENT (SAM)

4. SUBMISSION DATES AND TIMES

5. INTERGOVERNMENTAL REVIEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

3. ASSESSMENT OF RISK

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

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I. Program Funding Opportunity Description

1. Purpose

Initiative Overview

This notice announces the opportunity to apply for fiscal year 2021 (FY21) Health Resources and Services Administration (HRSA) Special Projects of National Significance (SPNS) Program funding for the initiative Using Innovative Intervention Strategies to Improve Health Outcomes among People with HIV – Coordinating Center.

The purpose of this initiative is to use an implementation science framework1 to identify innovative intervention strategies in four (4) focus areas, pilot test the intervention strategies at subawarded sites and provide technical assistance (TA), and develop replication tools and products. HRSA will provide funding in the form of a cooperative agreement to support one (1) organization for up to four (4) years to serve as the Innovative Intervention Strategies Coordinating Center for Technical Assistance (2iS CCTA). The 2iS CCTA will solicit and subaward up to 20 Ryan White HIV/AIDS Program (RWHAP)-funded recipients/subrecipients (approximately five sites per focus area) to serve as implementation sites where one intervention strategy per site will be piloted. The piloted intervention strategies will be evaluated through the companion funding opportunity announcement titled Using Innovative Intervention Strategies to Improve Health Outcomes among People with HIV – Evaluation Center (2iS EC; HRSA- 21-068). Ultimately, the 2iS EC’s evaluation findings will determine dissemination plans for the replication tools developed by the 2iS CCTA. Please review this companion announcement for more information about the role of the 2iS EC. You may also review the previous initiative for which this is a competing continuation (HRSA-17-044; HRSA- 17-049).

2iS Focus Areas

This initiative will focus on three (3) priority populations and one (1) area of opportunity to improve service delivery. Combined, these four (4) focus areas are:

1) Improving HIV health outcomes for people with substance use disorder

2) Improving HIV health outcomes for lesbian, gay, bisexual, transgender, or queer

(LGBTQ+) youth

3) Improving HIV health outcomes for people who are or have been incarcerated

4) Improving HIV health outcomes by using telehealth services

To identify implementation sites to pilot test the intervention strategies identified across the four (4) focus areas, the 2iS CCTA will be responsible for soliciting, selecting, issuing, and monitoring subawards of up to $190,000/year each for up to twenty (20) RWHAP recipients or subrecipients (hereafter referred to as “subawardees”), or up to five (5) per focus area. The 2iS CCTA will select subawardees based on a

1 Psihopaidas D, Cohen SM, West T, et al.; Implementation science and the Health Resources and Services Administration’s Ryan White HIV AIDS Program’s work towards ending the HIV epidemic in the United States. PLoS Med 2020;17(11):e1003128. https://doi.org/10.1371/journal.pmed.1003128 https://doi.org/10.1371/journal.pmed.1003128

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demonstrated need and capacity to implement one intervention strategy from one focus area through a competitive application process. The 2iS CCTA will provide TA to the selected subawardees to support successful uptake of the intervention strategy and engagement of clients. The 2iS CCTA will also develop dissemination products that will support the rapid replication of intervention strategies found to be successfully implemented and effective at improving client outcomes in subawardee sites.

The companion 2iS EC cooperative agreement (HRSA-21-068) will evaluate the uptake, implementation and associated client outcomes of these intervention strategies at the subawarded sites. Please review the related 2iS EC (HRSA-21-068) announcement to understand the collaborative work between the 2iS CCTA and the 2iS EC.

2. Background

The Ryan White HIV/AIDS Program (RWHAP) funds direct health care and support services for over half a million people diagnosed with HIV in the United States. HRSA awards RWHAP funds to cities, states, and local community-based organizations to deliver efficient and effective HIV care, treatment, and support services for low-income people with HIV. Since the program’s inception in 1990, RWHAP has developed a comprehensive system of safety net providers who deliver high quality, innovative HIV health care.

The RWHAP has five statutorily defined Parts (Parts A through D and Part F) that provide funding for core medical and support services, technical assistance, clinical training, and the development of innovative models of care to meet the needs of different communities and populations affected by HIV.

The HRSA HAB Implementation Science Approach

The goal of this initiative is to use the HRSA HAB implementation science framework (HAB IS)2 to identify and pilot test proven intervention strategies that could be effective for improving outcomes among people with HIV served by the RWHAP, thereby reducing disparities and moving toward ending the HIV epidemic in the U.S. HAB IS was developed to support the translation of insights from the implementation science literature to real-world settings.

HAB IS includes effectiveness criteria for three (3) categories of intervention strategies for the RWHAP, which include evidence-based interventions, evidence-informed interventions, and emerging strategies. HRSA HAB developed these criteria in collaboration with the Centers for Disease Control and Prevention and the National Institutes of Health (see Fig 1 in Psihopaidas et al. (2020) for detailed descriptions).

This initiative will focus on evidence-informed interventions and emerging strategies (hereafter referred to collectively as “intervention strategies”). By focusing on these two categories, HRSA HAB seeks to identify highly innovative intervention strategies that are most responsive to the current HIV epidemic.

HAB IS involves two core components: the first component is rapid implementation, which includes (1) identifying existing intervention strategies with demonstrated

2 ibid.

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effectiveness at improving outcomes for people with HIV, (2) pilot testing those for success specifically within the RWHAP, and (3) creating accessible dissemination products to promote the replication and scale-up of the intervention strategy. The second component is an implementation science evaluation plan. The details of the evaluation are outlined in the 2iS EC companion announcement (HRSA-21-068).

Health Disparities and Demonstrated Need in the RWHAP

Substance use disorder Compared to other subpopulations of people with HIV, people who inject drugs (PWID) and/or people with substance use disorder (SUD) may face barriers to effective HIV treatment. Co-occurring HIV and SUD have long been stigmatized in the U.S. and are associated with lower health care access, income, educational attainment, and higher rates of unemployment or underemployment.3 Intervention strategies specifically addressing these needs are underutilized.4,5 Additionally, intervention strategies for SUD among people with HIV often specifically focus on injection drug use; however, alcohol, methamphetamine, and other drug use are also prevalent.6 For people with co-occurring HIV and SUD there is a need for intersecting innovative and holistic intervention strategies in addition to understanding how to screen, refer, or treat substance use in a variety of service provision settings.7

LGBTQ+ youth In the US, nearly one-quarter of new HIV diagnoses occur among youth and young adults aged 13-24 years. Lesbian, gay, bisexual, transgender, or queer (LGBTQ+) youth face additional barriers to care compared to youth overall. These barriers contribute to lower rates of viral suppression, lower rates of engagement in care, and lower rates of antiretroviral therapy (ART) adherence for LGBTQ+ youth, and many are unaware of their HIV status.8 The barriers that contribute to poorer HIV-related health outcomes among LGBTQ+ youth may include barriers navigating the health care system, transportation, a lack of youth-oriented care, and ineffective linkage to care.9

3 Conrad C, Bradley HM, Broz D, et al.; Centers for Disease Control and Prevention (CDC). Community outbreak of HIV infection linked to injection drug use of oxymorphone–Indiana, 2015. MMWR Morb Mortal Wkly Rep 2015; 64:443–4. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6416a4.htm 4 Chander G, Himelhoch S, Moore RD. Substance abuse and psychiatric disorders in HIV-positive patients: epidemiology and impact on antiretroviral therapy. Drugs 2006; 66:769–89.

https://link.springer.com/article/10.2165/00003495-200666060-00004 5 Durvasula R, Miller TR. Substance abuse treatment in persons with HIV/AIDS: challenges in managing triple diagnosis. Behav Med 2014; 40:43–52. https://doi.org/10.1080/08964289.2013.866540 6 Haldane V, Cervero-Liceras F, Chuah FL, et al. Integrating HIV and substance use services: a systematic review. J Int AIDS Soc. 2017;20(1):21585.

https://onlinelibrary.wiley.com/doi/full/10.7448/IAS.20.1.21585.

7 Durvasula R, Miller TR. Substance abuse treatment in persons with HIV/AIDS: challenges in managing triple diagnosis. Behav Med 2014; 40:43–52. https://doi.org/10.1080/08964289.2013.866540 8 Kapogiannis BG, Koenig LJ, Xu J, et al. The HIV Continuum of Care for Adolescents and Young Adults Attending 13 Urban US HIV Care Centers of the NICHD-ATN-CDC-HRSA SMILE Collaborative. J Acquir Immune Defic Syndr. 2020;84(1):92-100.

https://journals.lww.com/jaids/Fulltext/2020/05010/The_HIV_Continuum_of_Care_for_Adolescents_and.1 5.aspx.

9 Valencia, R, Wang, LY, Dunville, R, et al. Sexual Risk Behaviors in Adolescent Sexual Minority Males: A Systematic Review and Meta-Analysis. J Primary Prevent 39, 619–645 (2018). https://doi-org.ezproxyhhs.nihlibrary.nih.gov/10.1007/s10935-018-0525-8.

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6416a4.htm https://link.springer.com/article/10.2165/00003495-200666060-00004 https://doi.org/10.1080/08964289.2013.866540 https://onlinelibrary.wiley.com/doi/full/10.7448/IAS.20.1.21585 https://doi.org/10.1080/08964289.2013.866540 https://journals.lww.com/jaids/Fulltext/2020/05010/The_HIV_Continuum_of_Care_for_Adolescents_and.15.aspx https://journals.lww.com/jaids/Fulltext/2020/05010/The_HIV_Continuum_of_Care_for_Adolescents_and.15.aspx https://doi-org.ezproxyhhs.nihlibrary.nih.gov/10.1007/s10935-018-0525-8 https://doi-org.ezproxyhhs.nihlibrary.nih.gov/10.1007/s10935-018-0525-8

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Incarceration For all demographic groups, experiences of incarceration or other justice system involvement can significantly impact engagement in HIV care and treatment. While recent studies have shown improvements in HIV care continuum outcomes for those currently incarcerated, rates of engagement in care, receipt of ART, and virologic suppression have been shown to significantly decrease post-incarceration.10 Intervention strategies to improve linkage to and retention in HIV care and treatment following release from prisons and jails are necessary to improve viral suppression outcomes. Additionally, intervention strategies that expand and destigmatize HIV testing for those currently experiencing incarceration hold promise for improving outcomes, particularly among certain subpopulations including those who identify as transgender, women, and men who have sex with men.11,12,13

Telehealth The COVID-19 public health emergency has demonstrated the need for innovative intervention strategies to engage people with HIV in care and treatment by adopting methods such as telehealth.14 Telehealth has demonstrated effectiveness in addressing barriers to HIV care and treatment such as HIV care provider shortages, transportation, and HIV-related stigma that may be experienced in clinical settings. However, people with HIV who are members of priority populations may face additional barriers to accessing telehealth services.15 For example, among racial/ethnic minorities, people with low income, people living in rural areas, and older people with HIV, barriers to telehealth services may include a lack of (1) access to digital devices and technology infrastructure (i.e., broadband internet), (2) health literacy, (3) privacy when engaging in telehealth visits. Addressing inequities among priority populations with HIV using telehealth will help to expand the benefits of telehealth and improve HIV outcomes along the HIV care continuum.16

To address disparities among people with HIV, the RWHAP needs innovative intervention strategies at all levels of HIV care. By increasing the scale at which

10 Iroh PA, Mayo H, Nijhawan AE. The HIV care cascade before, during, and after incarceration: a systematic review and data synthesis. American journal of public health. 2015 Jul;105(7):e5-16.

https://pubmed.ncbi.nlm.nih.gov/25973818 11 Harawa NT, Brewer R, Buckman V, Ramani S, Khanna A, Fujimoto K, Schneider JA. HIV, Sexually Transmitted Infection, and Substance Use Continuum of Care Interventions Among Criminal Justice– Involved Black Men Who Have Sex With Men: A Systematic Review. American journal of public health.

2018 Nov;108(S4):e1-9. https://link.springer.com/article/10.1007/s11524-020-00428-8 12 Erickson M, Shannon K, Sernick A, et al. Women, incarceration and HIV: a systematic review of HIV treatment access, continuity of care and health outcomes across incarceration trajectories. AIDS. 2019 Jan 27;33(1):101-111. https://www.ncbi.nlm.nih.gov/pubmed/30289811 13 Fuge TG, Tsourtos G, Miller ER (2020) A systematic review and meta-analyses on initiation, adherence and outcomes of antiretroviral therapy in incarcerated people. PLoS ONE 15(5):e0233355.

https://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0233355 14 Young JD, Abdel-Massih R, Herchline T, et al. Infectious Diseases Society of America Position Statement on Telehealth and Telemedicine as Applied to the Practice of Infectious Diseases. Clin Infect Dis. 2019;68(9):1437–43. https://pubmed.ncbi.nlm.nih.gov/30851042 15 Dandachi D, Lee C, Morgan RO, et al. Integration of Telehealth Services in the Healthcare System:

With Emphasis on the Experience of Patients Living with HIV. J Investig Med. 2019;67(5): 815–20.

https://pubmed.ncbi.nlm.nih.gov/30826803 16 Mgbako, O, Miller EH, Santoro AF, et al. COVID-19, Telemedicine, and Patient Empowerment in HIV Care and Research. AIDS Behavior 24, 1990–1993 (2020). https://doi.org/10.1007/s10461-020-02926-x https://pubmed.ncbi.nlm.nih.gov/25973818 https://link.springer.com/article/10.1007/s11524-020-00428-8 https://www.ncbi.nlm.nih.gov/pubmed/30289811 https://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0233355 https://pubmed.ncbi.nlm.nih.gov/30851042 https://pubmed.ncbi.nlm.nih.gov/30826803 https://doi.org/10.1007/s10461-020-02926-x

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effective intervention strategies are disseminated and replicated across the RWHAP, this initiative will bring us closer to ending the HIV epidemic.

The Strategic Framework

The RWHAP supports the implementation of the National HIV/AIDS Strategy for the United States: Updated 2020 (NHAS 2020). This strategy is a 5-year plan that details principles, priorities, and actions to guide the national response to the HIV epidemic.

The plan also provides a blueprint for collective action across the federal government and other sectors to help achieve the strategy’s vision.

To ensure that RWHAP aligns with the National HIV/AIDS Strategy, to the extent possible, activities funded by the program focus on addressing the plan’s 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 support services needed (e.g., mental health and substance use disorders services) to achieve HIV viral suppression. The RWHAP also provides technical assistance and training initiatives and promotes the effective use of data to enhance recipients’ capacity to implement programs that support the strategy’s objectives.

Expanding the Effort: Ending the HIV Epidemic: A Plan for America

In February 2019 the Administration launched the Ending the HIV Epidemic: A Plan for America (EHE) initiative to further expand federal efforts to reduce HIV infections. This 10-year initiative which began in 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 is focused 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. The initiative promotes and implements 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).

HIV Care Continuum

Diagnosing and linking people with HIV to 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 stages that include: HIV diagnosis, linkage to care, retention in care, antiretroviral use, and viral 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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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 2019 Ryan White Services Report (RSR) , the RWHAP has made tremendous progress toward ending the HIV epidemic in the United States. From 2015 to 2019, 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 83.4 percent to 88.1 percent.

Additionally, racial/ethnic, age-based, and regional disparities reflected in viral suppression rates have decreased.17 These improved outcomes mean more people with HIV in the United States will live near normal lifespans and have a reduced risk of transmitting HIV to others.18 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.

Using Data Effectively: 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, conducting needs assessments, determining unmet need estimates, reporting, quality improvement, enhancing the HIV care continuum, and public health action. HRSA strongly encourages RWHAP recipients to:

• Follow the principles and standards in the Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs: Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action.

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

17 Health Resources and Services Administration. Ryan White HIV/AIDS Program Annual Client-Level Data Report 2019. http://hab.hrsa.gov/data/data-reports. Published December 2020. Accessed December 2, 2020.

18 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://hab.hrsa.gov/deliverhivaidscare/habperformmeasures.html https://hab.hrsa.gov/sites/default/files/hab/data/datareports/RWHAP-annual-client-level-data-report-2019.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://hab.hrsa.gov/data/data-reports https://clinicaltrials.gov/

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Integrated data sharing, analysis, and utilization of HIV data 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 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.

Program Resources and Innovative Models

Through the Minority HIV/AIDS Fund from the HHS Secretary’s Office (MHAF) and HAB technical assistance (TA) cooperative agreements, HRSA has a number of projects that may be useful for RWHAP recipients to assist with program implementation. Some select examples are:

• Building Futures: Supporting 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

Through HAB’s SPNS Program, HRSA funds demonstration projects focused on the development of effective interventions to respond quickly to emerging needs of people with HIV that receive assistance under the RWHAP. Through these demonstration projects, SPNS evaluates the design, implementation, utilization, cost, and health related outcomes of innovative treatment models. Evaluating these models enables HRSA to identify successful interventions that can be replicated and disseminated nationally. SPNS findings have demonstrated promising new approaches for linking and retaining into care underserved and marginalized people with HIV. As resources permit RWHAP recipients are encouraged to review and integrate 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. SPNS related tools may be found at the following locations:

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://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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• 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.

• 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 Minority HIV/AIDS Funds (MHAF) from the HHS Secretary’s Office 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: Competing Continuation

HRSA will provide funding in the form of a cooperative agreement. A cooperative agreement is a financial assistance mechanism where HRSA anticipates substantial involvement with the recipient during performance of the contemplated project.

HRSA program involvement will include:

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

• Facilitating relationships between the 2iS CCTA, the 2iS EC, and other relevant stakeholders.

• Reviewing and concurring with, on an on-going basis, activities, procedures, measures, and tools to be established and implemented for accomplishing the goals of the cooperative agreement, including:

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

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o the process for identifying and assessing intervention strategies and implementation strategies using the HAB IS evidence rubrics, o the process for soliciting and selecting subawards to implementation sites to pilot test the interventions, and o determining dissemination plans for each of the piloted intervention strategies based on the evaluation findings.

• Reviewing and concurring with all information products prior to dissemination.

• Facilitating the dissemination of project findings, best practices, evaluation data, and other information developed as part of this project to the broader network of HIV providers.

The cooperative agreement recipient’s responsibilities will include:

• Leading the identification and selection of intervention strategies and implementation strategies with support from HRSA HAB and the 2iS EC.

• Leading the solicitation and selection of subawardees and preparation for pilot testing with support from HRSA HAB and the 2iS EC.

• Collaborating with intervention strategy developers and training subawardee staff to implement the intervention strategy.

• Monitoring subawardees and providing TA to adapt and implement the intervention strategies and collect evaluation data.

• Developing and hosting learning sessions.

• Supporting the 2iS EC in carrying out their multi-site evaluation.

• Collaborating with the 2iS EC to assess the implemented interventions to inform dissemination plans.

• Developing dissemination materials to support rapid replication of intervention strategies, to describe the project, and to disseminate project findings, including implementation toolkits, manuscripts, and professional conference presentations.

• Anticipating and responding to the changes taking place in the health care environment as they impact or may impact the initiative and/or subawardees.

• Collecting and analyzing data relative to national health issues, unmet needs, marketplace conditions, special populations, and other key health indicators to guide current/future strategic planning, developmental efforts, and work plan activities.

Overall project phases for 2iS CCTA (HRSA-21-076) and 2iS EC (HRSA-21-068) As a lesson learned from the previous initiative for which this is a competing continuation (HRSA-17-044; HRSA-17-049), this notice outlines anticipated project phases that successful applicants should aim to address across the lifespan of this initiative. This notice also clarifies below the interrelationship between the 2iS CCTA, the 2iS EC, and HRSA HAB on specific project activities.

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Project Phases

2iS CCTA (HRSA-21-076) 2iS EC (HRSA-21-068)

Year 1, first quarter

• Convene with HRSA HAB and 2iS EC to develop joint work plan and timeline

• Lead the identification and assessment of intervention strategies and implementation strategies

• Develop and implement a process for selecting a subset of the identified intervention strategies and implementation strategies to be used for subawardee solicitation

• Convene with HRSA HAB and 2iS EC to develop joint work plan and timeline

• Support the 2iS CCTA in the identification, assessment, and selection of intervention strategies and implementation strategies

• Finalize general approach/goals for the evaluation to inform intervention strategy selection Year 1, second quarter

• Develop and implement a process for solicitation and selection of subawardees

• Lead assessment of TA needs for selected subawardees

• Develop a process for TA tracking and subawardee monitoring

• Develop site visit plans for the implementation phase (years 2-3)

• Support the 2iS CCTA to carry out solicitation and selection of subawardees

• Support 2iS CCTA with assessment of TA needs based on evaluation goals

Year 1, third quarter

• Lead the development of implementation plans for each subawardee

• Develop TA plans for each subawardee

• Develop TA tools to support and monitor the subawardees

• Support 2iS EC with developing data collection tools

• Support the 2iS CCTA to develop implementation plans for each subawardee

• Develop tailored and multi-site evaluation plans

• Develop data collection systems and tools

Year 1, fourth quarter

• Finalize TA plans and tools

• Support subawardees in staff recruitment and preparation for implementation

• Provide TA to prepare for implementation

• Develop dissemination materials

• Lead development and implementation of intervention trainings for subawardees

• Begin baseline data collection

• Lead subawardee data collection systems trainings

• Develop evaluation-related dissemination materials

• Support the 2iS CCTA intervention trainings for subawardees

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Year 2, first quarter

• Initiate subawardee implementation of intervention strategies

• Provide technical assistance

• Monitor subawardees

• Continue baseline data collection

• Continue subawardee data collection systems trainings

• Continue subawardee data support and data monitoring

Years 2-3 • Continue subawardee implementation

• Monitor subawardees

• Provide technical assistance

• Conduct biannual learning sessions (2 per year)

• Support the 2iS EC to determine the feasibility of and implement any mid-implementation adjustments

• Support the 2iS EC with each learning session evaluation

• Develop dissemination materials

• Produce quarterly TA tracking summaries (quantitative and qualitative)

• Collect data

• Continue subawardee data support and data monitoring

• Conduct biannual learning session evaluation

• Lead determining the feasibility of and implementing any mid-implementation adjustments

• Produce biannual preliminary evaluation findings

• Develop evaluation-related dissemination materials

Year 3, fourth quarter

• Closeout subawardee implementation period

• Develop dissemination materials

• Support subawardees to complete final data reporting

• Develop evaluation-related dissemination materials

Year 4, first quarter

• Lead the assessment of dissemination plans for each intervention strategy based on TA tracking, learning sessions, and preliminary evaluation findings

• Conduct learning session

• Develop dissemination materials

• Lead subawardee program integration planning

• Collect data and perform client outcome evaluation

• Support 2iS CCTA to assess dissemination plans for each intervention strategy based on TA tracking, learning sessions, and preliminary evaluation findings

• Present preliminary evaluation findings

• Develop evaluation-related dissemination materials

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Year 4, second-third quarters

• Lead development and assessment of dissemination plans for each intervention strategy based on TA tracking, learning sessions, and preliminary evaluation findings

• Develop tools for replication of intervention models

• Develop implementation-related materials for dissemination

• Conduct a final learning session

• Support 2iS CCTA to develop and assess dissemination plans for each intervention strategy based on TA tracking, learning sessions, and preliminary evaluation findings

• Conduct analyses of project data for implementation and client outcome evaluation

• Develop evaluation-related materials for dissemination

• Develop evaluation tools for replicat ion products

• Conduct final learning session evaluation

Year 4, fourth quarter

• Disseminate replication products and promote materials

• Disseminate evaluation findings and promote materials

At least annually, the successful 2iS EC applicant should plan to collaborate with HRSA HAB to update existing work plans and, as needed, integrate new priorities during the funding period (i.e., through monthly strategy discussion calls, or other communication as needed).

2. Summary of Funding

HRSA estimates approximately $4,825,000 to be available annually to fund one (1) recipient. You may apply for a ceiling amount of up to $4,825,000 total cost (includes both direct and indirect, facilities and administrative costs) per year. You should note that the award amount includes approximately $3,800,000 to fund up to 20 subawardees at a ceiling amount of up to $190,000 each. The actual amount available for this program will not be determined until the enactment of the final FY 2021 federal appropriation. 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, HRSA can process applications and award funds appropriately. Funding beyond the first year is subject to the availability of appropriated funds for the Using Innovative Intervention Strategies to Improve Health Outcomes among People with HIV

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

The period of performance is August 1, 2021, through July 31, 2025 (4 years).

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If you are applying for funding under this announcement (HRSA-21-076) and under the companion Evaluation Center announcement (HRSA-21-068), you must be able to demonstrate the ability to administer multiple federal awards and to ensure adequate quality controls, staffing, and impartiality.

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

III. Eligibility Information

1. Eligible Applicants

Eligible applicants include entities eligible for funding under RWHAP Parts A, B, C, and D. These include but are not limited to any domestic organizations of the following category: public and nonprofit private entities involved in addressing HIV-related issues at the regional or national level; 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.

Foreign entities are not eligible for these HRSA awards.

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.

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.

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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IV. Application and Submission Information

1. Address to Request Application Package

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

The NOFO is also known as “Instructions” on Grants.gov. You must select “Subscribe” and provide your email address for each NOFO you are reviewing or preparing in the workspace application package in order to receive notifications including modifications, clarifications, and/or republications of the NOFO on Grants.gov. You will also receive notifications of documents placed in the RELATED DOCUMENTS tab on Grants.gov that may affect the NOFO and your application. You are ultimately responsible for reviewing the For Applicants page for all information relevant to this NOFO.

2. Content and Form of Application Submission

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 included in the page limit 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 workspace application package do not count in the page limit.

Please note: If you use an OMB-approved form that is not included in the workspace application package for HRSA-21-076, it may count against the page limit. Therefore, we strongly recommend you only use Grants.gov workspace forms associated with this NOFO to avoid exceeding the page limit. Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. It is therefore important to take appropriate measures to ensure your application does not exceed the specified page limit.

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

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

1) You certify on behalf of the applicant organization, by submission of your proposal, that neither you nor your principals are presently debarred, suspended, https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/web/grants/applicants.html

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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 Attachments # 7-15: 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.

ii. Project Narrative This section provides a comprehensive framework and description of all aspects of the proposed project. It should be succinct, self-explanatory, 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

Briefly describe the purpose of the proposed project as it responds to the purpose set forth in this NOFO.

Provide a clear and succinct description of the roles and activities of the 2iS CCTA. Describe the 2iS CCTA’s overall approach to how it will select and monitor up to 20 subawardees, as well as conduct the TA activities to support the subawardees’ implementation of innovative intervention strategies in the three (3) priority populations and one (1) area of opportunity to improve service delivery;

together these make up the four (4) focus areas:

1) Improving HIV health outcomes for people…