PKG00261066-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

HIV/AIDS Bureau Office of Training and Capacity Development

Improving Care and Treatment Coordination: Focusing on Black Women with HIV – Evaluation and Technical Assistance Provider

Funding Opportunity Number: HRSA-20-115

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

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2020

Application Due Date: June 15, 2020

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

HRSA will not approve deadline extensions for lack of registration.

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

Issuance Date: April 15, 2020

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

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

mailto:ACajina@hrsa.gov

HRSA-20-115 i

EXECUTIVE SUMMARY

Supported through funding from the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Health Minority HIV/AIDS Fund (MHAF), the Health Resources and Services Administration (HRSA), HIV/AIDS Bureau, Special Projects of National Significance (SPNS) Program is accepting applications for fiscal year (FY) 2020 for Improving Care and Treatment Coordination: Focusing on Black Women with HIV – Evaluation and Technical Assistance Provider (ETAP). The purpose of this cooperative agreement is to support a single organization to lead a multi-site evaluation and provide technical assistance (TA) to a cohort of up to seven demonstration sites funded under a separate announcement number, HRSA-20-116: Improving Care and Treatment Coordination: Focusing on Black Women with HIV – Demonstration Sites.

The ETAP will provide TA and capacity building to the demonstration sites; work collaboratively with the sites to implement a comprehensive multi-site evaluation; and disseminate successful models, findings, best practices, and lessons learned for the Ryan White HIV/AIDS Program (RWHAP) community.

Funding Opportunity Title: Improving Care and Treatment Coordination:

Focusing on Black Women with HIV – Evaluation and Technical Assistance Provider

Funding Opportunity Number: HRSA-20-115 Due Date for Applications: June 15, 2020 Anticipated Total Annual Available FY 2020Funding:

$700,000

Estimated Number and Type of Award(s):

1 Cooperative Agreement

Estimated Award Amount: Up to $700,000 per year subject to the availability of appropriated funds

Cost Sharing/Match Required: No Period of Performance: September 1, 2020 through

August 31, 2024 (4 years)

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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; 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 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: Thursday, April 30, 2020 Time: 1:00 p.m. - 2:30 p.m. ET Call-In Number: 1-800-593-8953 Participant Code: 2516127 Weblink: https://hrsa.connectsolutions.com/hrsa-20-115-pre-app-ta/

The webinar will be recorded and should be available at https://www.targethiv.org/category/resource-type/training-resources.

Audio playback will be available as follows:

Playback Number: 1-800-879-4907 Passcode: 2156 http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://hrsa.connectsolutions.com/hrsa-20-115-pre-app-ta/ https://www.targethiv.org/category/resource-type/training-resources

HRSA-20-115 iii

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

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

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

HRSA-20-115 1

I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for fiscal year (FY) 2020 funding under the Improving Care and Treatment Coordination: Focusing on Black Women with HIV – Evaluation and Technical Assistance Provider (ETAP) program. Funding will be provided in the form of a cooperative agreement to support a single organization to lead a multi-site evaluation and provide technical assistance (TA) to a cohort of up to seven demonstration sites funded under a separate announcement number, HRSA-20-116:

Improving Care and Treatment Coordination: Focusing on Black Women with HIV – Demonstration Sites. The awarded ETAP organization will evaluate the implementation of the demonstration sites’ bundled interventions and their outcomes on the HIV care continuum for future replication and scale-up in other Ryan White HIV/AIDS Program (RWHAP) provider organizations. These demonstration sites are supported for up to three years and tasked to design, implement, and evaluate the use of bundled interventions for Black women with HIV. Bundled interventions are a group of evidence-informed practices put together into a package that when implemented together produces better health outcomes than when the practices are delivered separately.1 Bundled interventions will address socio-cultural health determinants, expand the delivery and utilization of comprehensive HIV care and treatment services, support continuous engagement in care, and improve health outcomes for Black women with HIV in a culturally sensitive and responsive manner. HRSA will award grants under this funding announcement to entities in severely underserved areas that contain high populations of Black women with HIV.

The ETAP will also provide TA and capacity building to demonstration sites by facilitating peer-to-peer collaborative learning on the interventions. In addition, the ETAP will lead dissemination of evaluation findings, best practices and lessons learned, and promote the replication of successful bundled interventions in other Ryan White HIV/AIDS Program (RWHAP) providers and other health care settings.

Because award recipients under both NOFOs (HRSA-20-115 and HRSA-20-116) will need to work together to be successful, HRSA, HIV/AIDS Bureau (HAB) encourages you to read and familiarize yourself with the program expectations of the companion NOFO, HRSA-20-116 (Improving Care and Treatment Coordination: Focusing on Black Women with HIV –Demonstration Sites)

The Department of Health and Human Services (HHS) Office of the Assistant Secretary for Health MHAF project, authorized under Further Consolidated Appropriations Act, 2020 (P.L. 116-94), Division A, Title II, is also supported, in part, through SPNS, authorized under 42 U.S.C. § 300ff-101 (section 2691 of the PHS Act).

1 Huhman M. "Bundled Interventions." Encyclopedia of Health Communication. Ed. Teresa L. Thompson.

Vol. 1. Thousand Oaks: SAGE Publications, Inc., 2014. 140-142. SAGE Knowledge.

http://sk.sagepub.com/reference/download/encyclopedia-of-health-communication/n52.pdf

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Key Definitions:

For purposes of this announcement, HRSA uses “Black women with HIV” to describe the study population for inclusion in the Special Projects of National Significance (SPNS) multi-site evaluation. The actual evaluation project is intended to collect information only concerning Black women with HIV. However, individual programs are required to serve all people regardless of race, ethnicity, or gender. Additionally, in this initiative, a Black woman is described as a cisgender or transgender female who self-identifies as Black or African American or a combination of Black or African American and one or more of the other racial categories. This includes Black - Hispanic and Black - Not Hispanic.

For the purposes of this initiative, evidence-informed interventions are strategies, models, or approaches that have been proven effective or have shown promise as a methodology, practice, or means of improving the care and treatment of people with HIV. Evidence-informed should be understood as distinct from evidence-based.

Evidence-informed interventions with strong evidence bases may meet evidence-based criteria established by the Agency for Healthcare Research and Quality (AHRQ) and the Centers for Disease Control and Prevention (CDC). However, evidence-informed interventions may demonstrate the impact and strength of evidence without meeting AHRQ, CDC, or other criteria for being evidence-based.

For the purposes of this initiative, HIV care services are defined as all of the HIV clinical care and treatment services allowable through the RWHAP. For more information regarding RWHAP eligible services, refer to Policy Clarification Notice (PCN) #16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds.

Social determinants of health (SDOH) are conditions in which people are born, grow, live, work, and age. They include factors like socioeconomic status, education, neighborhood, and physical environment, community violence, employment, and social support networks, as well as access to health care. Intimate partner violence (IPV) is among these factors that can disproportionately affect underserved communities.

According to CDC, National Intimate Partner and Sexual Violence Survey (NISVS), intimate partner violence (IPV) describes physical violence, sexual violence, stalking, or psychological harm by a current or former partner or spouse, and can have direct and indirect effects on individual, family, and community health. In 2017, HRSA launched the HRSA Strategy to Address IPV, an effort to address this critical social determinant of health through agency-wide collaborative action. The Strategy includes four priority areas including (1) Training the nation’s health workforce, (2) Building partnerships to raise awareness, (3) Increasing access to quality care, and (4) Addressing gaps in knowledge about IPV risks, impacts, and interventions. You are strongly encouraged to consider one or more of these priority areas, as relevant, in the development and measurement of your initiative.

https://www.hrsa.gov/sites/default/files/hrsa/HRSA-strategy-intimate-partner-violence.pdf

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2. Background

Disparity, which is defined as a lack of similarity or equality, inequality or difference,2 is a word often used to characterize HIV health outcomes for Black women.3 The CDC shows a decline in new infections among Black women in the United States.4 However, the epidemic’s disproportionate effect on Black people warrants the need to address some of the social and structural issues that hamper HIV prevention strategies in Black communities.

Black women with HIV have worse health-related outcomes than women of other racial and ethnic backgrounds 5 and face significant barriers to accessing, engaging, and staying in medical care. Decreased adherence to antiretrovirals (ART), increased missed medical appointments, and poorer mental health status are all in part impacted by socio-cultural factors like unstable housing, lack of transportation, and lack of trust in healthcare providers.6,7 For Black women with HIV, coping with a new health condition and navigating the health system can be a complex, multi-level process. Therefore, the women’s adaptation and resilience is often based on the social, psychological, and/or cultural context and framing of their life with HIV (i.e., how they view their disease).

As reported in the 2018 Ryan White HIV/AIDS Program Annual Client-Level Data Report, 87.1 percent of clients who received HIV medical care reached viral suppression by 2018.8 The overall percentage of Black women who were retained in care was 82.5 percent and those virally suppressed were 85.7 percent. However, retention in care was lower for Black women ages 20–24 years (76.9 percent), 25–29 years (76.7 percent) and 30–34 years (76.7 percent).9 Additionally, percentages of viral suppression among Black women were lower among those in each of the 5-year age group ranging from 15–34 years (range: 69.6 percent–77.9 percent); for those with

2 Disparity. (n.d.). Available at www.dictionary.com/browse/disparity .Accessed August 14, 2018 3 Bradley ELP, Geter A, Lima AC, Sutton MY, Hubbard McCree D. Effectively Addressing Human Immunodeficiency Virus Disparities Affecting US Black Women. Health Equity. 2018 Nov 16;2(1):329- 333.

4 Centers for Disease Control and Prevention, “New HIV Diagnoses Among Women in the US and Dependent Areas, 2017”, last modified, Jan. 21, 2020, https://www.cdc.gov/hiv/group/gender/women/index.html 5 Sullivan KA, Messer LC, and Quinlivan EB. Substance abuse, violence, and AIDS (SAVA) syndemic effects on viral suppression among HIV positive women of color. AIDS Patient Care STDs 2015; 29 (Suppl 1): S42–S48.

6 Schumann CL, Westergaard RP, Meier AE, et al. Developing a patient navigation program to improve engagement in HIV medical care and viral suppression: A demonstration project protocol. AIDS Behavior.

2019 Jan; 23(Suppl 1):5-13.

7 Watkin-Hayes et al 8 Ryan White HIV/AIDS Program Annual Client-Level Data Report. 2018, pg 6.

https://hab.hrsa.gov/sites/default/files/hab/data/datareports/RWHAP-annual-client-level-data-report- 2018.pdf 9 Ibid, pg. 7 http://www.dictionary.com/browse/disparity https://www.cdc.gov/hiv/group/gender/women/index.html https://hab.hrsa.gov/sites/default/files/hab/data/datareports/RWHAP-annual-client-level-data-report-2018.pdf https://hab.hrsa.gov/sites/default/files/hab/data/datareports/RWHAP-annual-client-level-data-report-2018.pdf

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perinatal acquired infection (70.8 percent); and those with temporary (80.3 percent) or unstable housing (73.6 percent).10

Women with HIV have various complex needs. Research shows that many Black women struggle with overlapping issues, such as physical and sexual violence and trauma or IPV, homelessness, mental health needs, and co-occurring STIs.11,12 Likewise, the intersection of race, gender, social status, and sexuality impacts Black women’s process of coping at varying levels of power and access to institutional and healthcare resources.13,14 For some Black women with HIV, balancing care for self and for family, coming to terms with experiences that increased vulnerability to infection, and both internalized and external stigma,15 provide significant barriers to accessing and remaining in HIV care. Thus innovative interventions to better understand and engage Black women are needed to improve health outcomes. A high prevalence of co-existing health concerns combined with low levels of patient engagement in HIV care shows the need for “comprehensive, multifaceted interventions to promote Black women’s sustained engagement throughout the HIV care continuum.”16

Previous initiatives and interventions for women of color, including Black and Latina women, focused on general HIV health outcomes and disparities. However, gaps in HIV knowledge, education, interventions, cultural sensitivity, and comprehensive care for Black women still exist.17 To promote long-term health and stability for Black women with HIV, this MHAF initiative will support organizations to develop and implement innovative strategies for integrating comprehensive and culturally appropriate HIV care, social and behavioral health services, wellness coaching, and stigma reduction into a bundled intervention. The ETAP will monitor project outcomes to identify progress towards emerging or promising practices and intervention strategies focused on Black women. The initiative will also document challenges and opportunities resulting from these intervention strategies, and share lessons learned with MHAF recipients and the wider HIV, Women’s health, and RWHAP communities.

10 Ibid.

11 Sullivan KA, Schultz K, Ramaiya M, et al. Experiences of women of color with a nurse patient navigation program for linkage and engagement in HIV care. AIDS Patient Care STDs. 2015; 29: Suppl 1, S49-S54.;

12 Sullivan, Messer, and Quinlivan, 2015 13 Ojikutu BO, Stone VE, and Bardeguez A. Women of Color and HIV/AIDS: Epidemiology, Clinical Aspects, and Management. In HIV/AIDS in US Communities of Color. 2009. Valerie Stone, Bisola Ojikutu, M. Keith Rawlings, and Kimberly Y. Smith, eds. Pp. 83–101. New York, NY: Springer.

14 Watkin-Hayes et al 15 Ibid 16 Sullivan, Schultz, Ramaiya, et al 2015, pg S52.

17 Mays, VM., Maas RM, Ricks J, and Cochran SD. HIV and African American Women in the U.S. South:

A Social Determinants Approach to Population-Level HIV Prevention and Intervention Efforts. In Handbook of Health Psychology 2nd ed. 2012. Andrew Baum, Tracey A. Revenson and Jerome Singer, eds. Pp. 771–801. New York: Psychology Press.

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Ending the HIV Epidemic: A Plan for America In February 2019, the Administration announced a new initiative, Ending the HIV Epidemic: A Plan for America. This 10-year initiative beginning FY 2020 seeks to achieve the important goal of reducing new HIV infections in the United States to fewer than 3,000 per year by 2030. The first phase of the initiative will focus on 48 counties, Washington, D.C., San Juan, PR, and 7 states that have a substantial rural HIV burden.

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

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

1) Reduce new HIV infections;

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

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

4) Achieve a more coordinated national response.

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

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

RWHAP recipients are encouraged to assess the outcomes of their programs along this continuum of care. Recipients should work with their community and public health 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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partners to improve outcomes across the HIV care continuum. HRSA encourages recipients to use the performance measures developed for the RWHAP at their local level to assess the efficacy of their programs and to analyze and improve the gaps along the HIV care continuum.

According to recent data from the 2018 Ryan White Services Report (RSR), the RWHAP has made tremendous progress toward ending the HIV epidemic in the United States. From 2014 to 2018, HIV viral suppression among RWHAP patients who have had one or more medical visits during the calendar year and at least one viral load with a result of <200 copies/mL reported, has increased from 81.4 percent to 87.1 percent;

additionally, racial/ethnic, age-based, and regional disparities have decreased.18 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.19 Scientific advances have shown antiretroviral therapy (ART) preserves the health of people with HIV and prevents sexual HIV transmission. This means that people who take ART daily as prescribed and achieve and maintain an undetectable viral load have effectively no risk of sexually transmitting the virus to an HIV-negative partner. Such findings underscore the importance of supporting effective interventions for linking people with HIV into care, retaining them in care, and helping them adhere to their ART.

Integrated Data Sharing and Use HRSA and CDC’s Division of HIV/AIDS Prevention support integrated data sharing, analysis, and utilization for the purposes of program planning, needs assessments, unmet need estimates, reporting, quality improvement, the development of your HIV care continuum, and public health action. HRSA strongly encourages RWHAP recipients to:

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

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

Integrated HIV data sharing, analysis, and utilization approaches by state and territorial health departments can help further progress toward reaching the NHAS 2020 goals and improve outcomes on the HIV care continuum.

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

19 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-2018.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://hab.hrsa.gov/data/data-reports https://clinicaltrials.gov/

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HRSA strongly encourages complete CD4, viral load (VL) and HIV nucleotide sequence reporting to the state and territorial health departments’ HIV surveillance systems to benefit fully from integrated data sharing, analysis, and utilization. State and territorial health departments may use CD4, VL, and nucleotide sequence data to identify cases, stage of HIV disease at diagnosis, and monitor disease progression. These data can also be used to evaluate HIV testing and prevention efforts, determine entry into and retention in HIV care, measure viral suppression, monitor prevalence of antiretroviral drug resistance, detect transmission clusters and understand transmission patterns, and assess unmet health care needs. Analyses at the national level to monitor progress toward ending the HIV epidemic can only occur if all HIV-related CD4, VL, and HIV nucleotide sequence test results are reported by all jurisdictions. CDC requires the reporting to the National HIV Surveillance System (NHSS) all HIV-related CD4 results (counts and percentages), all VL results (undetectable and specific values), and HIV nucleotide sequences.

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

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

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

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

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

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

Through HAB’s SPNS Program, HRSA funds demonstration project initiatives focused on the development of effective interventions to respond quickly to emerging needs of people with HIV receiving assistance under the RWHAP. Through these demonstration projects, SPNS evaluates the design, implementation, utilization, cost, and health related outcomes of innovative treatment models, while promoting dissemination, replication and uptake of successful interventions. SPNS findings have demonstrated promising new approaches to linking and retaining into care underserved and marginalized people with HIV. All RWHAP recipients are encouraged to review and integrate a variety of SPNS evidence-informed tools within their HIV system of care in accordance with the allowable service categories defined in PCN 16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds as resources permit. SPNS related tools may be found at the following locations:

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

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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 MHAF initiatives to improve health outcomes along the HIV care continuum. The end goal of the initiative is to produce four evidence-informed care and treatment interventions (CATIs) that are replicable, cost-effective, capable of producing optimal HIV care continuum outcomes, and easily adaptable to the changing healthcare environment. Manuals are currently available at the link provided and will be updated on an ongoing basis.

II. Award Information

1. Type of Application and Award

Type(s) 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 performance of the contemplated project.

HRSA program involvement will include:

• Facilitating the availability and expertise of experienced HRSA HAB and HRSA OWH personnel as participants in the planning, development, and implementation of the project;

• Facilitating effective collaborative relationships with federal and state agencies, community-based and local organizations;

• Providing information resources, including TA resource centers and other entities of relevance to the initiative;

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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• Reviewing activities, procedures, measures, and tools to be implemented for accomplishing the program goals;

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

• Coordinating activities to address the evaluation-related training and TA needs of the demonstration sites; and

• Reviewing and participating in the dissemination of project activities, products, findings, best practices, evaluation data, and other information developed as part of this initiative to the broader health care, women’s health, and RWHAP providers.

The cooperative agreement recipient’s responsibilities will include:

• Designing and implementing a rigorous multi-site evaluation that includes outcome, process, and cost measures to assess the effectiveness of demonstration sites bundled interventions focused on Black women with HIV to improve their health outcomes along the HIV care continuum;

• Conducting focused evaluation studies on issues relating to the clinical, administrative financing, or public policy aspects of the initiative;

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

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

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

• Providing TA on the adaptation, implementation, and evaluation of evidence-informed interventions to demonstration sites through regular teleconferences, webinars, site visits, and in-person meetings for a range of needs over the course of the initiative;

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

• Conducting an annual site visit to each demonstration site for each year of the initiative;

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

• Assisting HRSA with information dissemination to constituencies upon request;

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

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

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You are encouraged to collaborate with partner organizations, as needed, to conduct the recipient responsibilities and programmatic expectations to achieve the following four (4) goals:

1) Conduct a Rigorous Multi-Site Evaluation

The ETAP will design and implement a multisite evaluation plan to assess the effectiveness of the demonstration sites’ bundled interventions. The evaluation plan proposed by the ETAP must include process and outcome measures, as well as assessing the cost of adapting and implementing the bundled interventions.

Key performance measures must include but are not limited to client retention, access to antiretroviral therapy, and viral suppression. The evaluation should also capture biomedical and behavioral health indicators, barriers and facilitators to retention in HIV medical care, and other measures proposed by the ETAP. Key performance measures must also include process analysis, cost analysis, and HAB Core Performance Measures:

• Process analysis will assess implementation of the bundled evidence-informed interventions, including but not limited to facilitators and barriers to implementation. The ETAP, in coordination with the demonstration sites, will develop the final core process methods.

• A cost analysis study (or cost-effectiveness study, if feasible) will measure the labor and programmatic costs and expenditures incurred by each demonstration site, to inform feasibility for future replication in RWHAP and other health care settings.

• HAB Core Performance Measures,20 specifically:

o Retention in HIV Medical Care Percentage of patients, regardless of age, with a diagnosis of HIV who had at least two (2) encounters within the 12-month measurement year.

o Antiretroviral Therapy (ART) Among Persons in HIV Medical Care Percentage of clients prescribed ART for the treatment of HIV infection in the 12-month measurement period Viral Suppression Among Persons in HIV Medical Care Percentage of clients with a viral load <200 copies/mL during the last test in the 12-month measurement period

• Additional HAB Core Performance Measures,21 as needed

• Measurement of clients newly diagnosed

20 HAB Performance Measures can be viewed at: https://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/coremeasures.pdf 21 HAB Performance Measures can be viewed at: https://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/coremeasures.pdf https://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/coremeasures.pdf https://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/coremeasures.pdf https://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/coremeasures.pdf https://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/coremeasures.pdf https://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/coremeasures.pdf https://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/coremeasures.pdf

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• Measurement of individuals never in care o People identified with HIV but have never entered care

Data Portal and Security: The ETAP will electronically receive, store, manage, and maintain de-identified client-level data to be collected and reported by demonstration sites. The demonstration sites will submit data to the ETAP through a secure data portal that the ETAP will design and maintain. The ETAP will coordinate efforts to assure the privacy and confidentiality of data submitted, collected, and stored. The ETAP will be responsible for monitoring data quality and completeness of submissions and interpreting evaluation results.

Website: In addition to a secure data portal, the ETAP will be responsible for developing and maintaining a project-specific website with both public access for communication of the initiative and private password-protected access for demonstration sites, ETAP, HRSA staff, and federal partners. The website will be expected to support TA resources for the multi-site evaluation; registration information for the national meetings of the initiative; recent findings of interest from outside the initiative; and links to relevant resources.

Institutional Review Board (IRB): Data to be collected and used in this initiative are classified as either public health data or client-level data. Public health data, such as HIV surveillance data and the Ryan White HIV/AIDS Program Services Report (RSR) treatment and support services data, are reported without disclosure of protected health information (PHI). The Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) grants exemptions to covered entities that collect and report PHI for the purposes of communicable disease surveillance in public health activities and quality improvement in health care operations.22 IRB review will be required to determine where the Privacy Rule applies. Data that are PHI may not be submitted to HRSA/HAB, pursuant to section 2685 of the PHS Act.

Focused evaluation studies: In addition to the multi-site evaluation, the ETAP recipient will be responsible for conducting focused evaluation studies including but not limited to case studies or qualitative studies that focus on addressing issues and barriers specific to Black women with HIV that facilitate or impede access to, engagement, and retention in HIV clinical care and treatment. The ETAP, in collaboration with the demonstration sites, HRSA staff, and federal partners, will generate the specific topics for these focused studies.

2) Provide Evaluation and Implementation Technical Assistance

The ETAP will conduct an evaluation and provide TA to demonstration sites to support the implementation of the bundled interventions, designed to focus on Black women with HIV to improve their health outcomes. The ETAP will provide TA to the

22 See Summary of the HIPAA Privacy Rule at:

http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html

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demonstration projects in areas of intervention adaptation, implementation, and maintenance.

ETAP applicants, in designing their proposed evaluation and TA plans, should become familiar with the requirements for demonstration sites and the bundle of evidence-informed interventions that sites may implement under HRSA announcement number HRSA-20-116: Improving Care and Treatment Coordination: Focusing on Black Women with HIV – Demonstration Sites. For example, the demonstration sites will be funded to implement a minimum of three evidence-informed practices to offer a coordinated and comprehensive bundled intervention. The list of domains is provided in the companion NOFO, HRSA-20-116. The ETAP will provide training and other resources specifically tailored to the selected evidence-informed interventions for purposes of creating intervention manuals and tools for replication. The ETAP will assess demonstration sites' TA needs and will be responsible for the provision of evaluation-related TA to the demonstration sites. These overall TA goals will be achieved through regular face-to-face meetings, site visits, website resources, webinars, and teleconferences with the demonstration sites and designated HRSA program staff over the course of the project.

Intervention Manuals and Materials: The ETAP will coordinate with sites to adapt implementation tools and resources to provide competent and high-quality care for Black women with HIV, including bi-directional patient-provider education to establish better communication and coordination between HIV and ancillary and support service providers. These manuals and materials will be used by AIDS Education and Training Center (AETC) Programs to support uptake and replication of the successful models.

Site Visits: The ETAP will conduct, at minimum, one annual site visit with each demonstration site throughout the initiative, in coordination with federal staff, if available.

The ETAP will develop a site visit protocol to guide the content and focus of these visits.

Generally, the site visits will focus on the provision of TA as requested by the demonstration site or based on the ETAP’s assessment. Site visit protocols should address TA needs in the areas of planning and project implementation, as well as data submission and data quality issues.

Grant Recipient Meetings: The ETAP will coordinate the logistics for two meetings with the demonstration sites during each year of the demonstration sites’ 3-year period of performance. This activity includes but is not limited to meeting venue selection, logistics coordination, participant registration, development of meeting agendas, and meeting facilitation. While the ETAP is responsible for overall logistics and meeting costs, each demonstration site is responsible for its own travel costs, ground transportation, per diem and hotel accommodations for these meetings. All activities will be conducted in collaboration with HRSA staff, federal partners, and demonstration project staff. The meetings will take place in the Washington, DC metropolitan area.

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3) Lead and Coordinate Dissemination of Findings

Dissemination: The ETAP, in coordination with HRSA staff, will lead the dissemination of findings and lessons learned from the bundled interventions designed to address the needs of Black women with HIV and improve their health outcomes along the HIV care continuum. The ETAP will be responsible for producing and disseminating TA toolkits, materials, and products to include intervention manuals. In collaboration with the demonstration sites, the ETAP will disseminate findings, including best practices and lessons learned to foster replication of these bundled interventions by other organizations that include patients who are Black women with HIV. This dissemination will include but is not limited to, intervention manuals that can be used by RWHAP and other organizations not funded under this project to adapt the bundled interventions within their organizations.

The ETAP will form a publication and disseminations committee, consisting of HRSA staff and demonstration site representatives, to generate research questions; topics for presentations and publications; concept sheets and analyses; and an overall dissemination plan for the initiative’s products.

4) Promote Replication of Evidence-informed Interventions

The ETAP will develop intervention manuals and toolkits describing how to replicate bundled interventions proven effective in improving outcomes as well as best practices for implementation.

The ETAP will document challenges and opportunities of emerging intervention strategies and will share lessons learned with the demonstration sites and the wider HIV community. All materials will be disseminated to RWHAP and community health center programs.

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

2. Summary of Funding

HRSA estimates approximately $700,000 will be available annually to fund one (1) recipient. You may apply for a ceiling amount of up to $700,000 total cost (includes both direct and indirect, facilities and administrative costs) per year. The period of performance is September 1, 2020 through August 31, 2024 (4 years). Funding beyond http://www.aidsetc.org/

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the first year is subject to the availability of appropriated funds for Improving Care and Treatment Coordination: Focusing on Black Women with HIV – Evaluation, and Technical Assistance Provider (ETAP) in subsequent fiscal years, satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government. In addition, HRSA may reduce recipient funding levels beyond the first year if recipients are unable to fully succeed in achieving the goals listed in the application.

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

III. Eligibility Information

1. Eligible Applicants

Entities eligible for funding under Parts A – D of Title XXVI of the Public Health Service Act, including public and nonprofit private entities, state and local governments;

academic institutions; local health departments; nonprofit hospitals and outpatient clinics; community health centers receiving support under Section 330 of the PHS Act;

faith-based and community-based organizations; and Indian Tribes or Tribal organizations with or without federal recognition.

2. Cost Sharing/Matching

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

3. Other

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

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

NOTE: Multiple applications from an organization are not allowable. If for any reason (including submitting to the wrong funding opportunity number or making corrections/updates) an application is submitted more than once 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.

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

2. Content and Form of Application Submission

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

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