PKG00261070-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 – Demonstration Sites

Funding Opportunity Number: HRSA-20-116 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-20-116 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, Improving Care and Treatment Coordination: Focusing on Black Women with HIV

– Demonstration Sites. This funding opportunity announcement will fund up to seven demonstration sites to design, implement, and evaluate bundled interventions, 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.

Funding Opportunity Title: Improving Care and Treatment

Coordination: Focusing on Black Women with HIV – Demonstration Sites

Funding Opportunity Number: HRSA-20-116 Due Date for Applications: June 15, 2020 Anticipated Total Annual Available FY 2020 Funding:

$2,170,000

Estimated Number and Type of Award(s): Up to seven cooperative agreement(s) Estimated Award Amount: Up to $310,000 per year subject to the availability of appropriated funds Cost Sharing/Match Required: No Period of Performance: September 1, 2020, through

August 31, 2023 (3 years)

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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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.

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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: 3:00 p.m. – 4:30 p.m. ET Call-In Number: 1-888-469-3347 Participant Code: 6672543 Weblink: https://hrsa.connectsolutions.com/ta_webinar_hrsa20_116/

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

Playback Number: 1-888-566-0693 Passcode: 2516 http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://hrsa.connectsolutions.com/ta_webinar_hrsa20_116/ https://www.targethiv.org/category/resource-type/training-resources

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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 AND

SYSTEM FOR AWARD MANAGEMENT

4. SUBMISSION DATES AND TIMES

5. INTERGOVERNMENTAL REVIEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

3. ASSESSMENT OF RISK

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

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I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for fiscal year (FY) 2020 funding under the Improving Care and Treatment Coordination: Focusing on Black Women with HIV – Demonstration Sites. Funding awarded under this announcement will support up to seven cooperative agreements for up to three years 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.2 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 is publishing this NOFO in conjunction with Improving Care and Treatment Coordination: Focusing on Black Women with HIV – Evaluation, and Technical Assistance Provider (ETAP). All demonstration sites funded under this announcement will be required to collaborate with the ETAP, (to be funded separately under announcement number HRSA-20-115), which will facilitate technical assistance (TA) and lead a multi-site evaluation to measure the effectiveness of the bundled interventions and impact in the Ryan White HIV/AIDS Program (RWHAP). HRSA encourages you to read the companion announcement number HRSA-20-115, as applicants under both NOFOs are required to work together to ensure the success of the implementation and evaluation/technical assistance initiatives.

Key Definitions

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

2 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 https://hab.hrsa.gov/program-grants-management/policy-notices-and-program-letters

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(PCN) #16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds.3

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.

Additional resources to assist you in determining how to effectively address intimate partner violence in your HRSA-funded programs may be found via the references included in the HRSA Strategy to Address IPV.

2. Background

This Department of Health and Human Services (HHS) Office of the Assistant Secretary for Health Minority HIV/AIDS Fund (MHAF) project, is authorized under Further Consolidated Appropriations Act, 2020 (P.L. 116-94), Division A, Title II, supported, in part, through Special Projects of National Significance (SPNS), and authorized under 42 U.S.C. § 300ff-101 (section 2691 of the Public Health Service (PHS) Act).

Disparity, which is defined as a lack of similarity or equality, inequality or difference4, is a word often used to characterize HIV health outcomes for Black women.5 The CDC shows a decline in new infections among Black women in the United States.6 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.

3 PCN# 16-02 can be viewed at https://hab.hrsa.gov/program-grants-management/policy-notices-and-program-letters

4 Disparity. (n.d.). Available at www.dictionary.com/browse/disparity .Accessed August 14, 2018 5 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.

6 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 https://hab.hrsa.gov/program-grants-management/policy-notices-and-program-letters https://www.hrsa.gov/sites/default/files/hrsa/HRSA-strategy-intimate-partner-violence.pdf https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDMsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMDAxMDguMTUyMTYxOTEiLCJ1cmwiOiJodHRwczovL3d3dy5ocnNhLmdvdi9zaXRlcy9kZWZhdWx0L2ZpbGVzL2hyc2EvSFJTQS1zdHJhdGVneS1pbnRpbWF0ZS1wYXJ0bmVyLXZpb2xlbmNlLnBkZiJ9.5XDYqcDgMZeOEOSLpa1La58JIGP-orrUu2yci7lJLkI/br/73794573613-l https://hab.hrsa.gov/program-grants-management/policy-notices-and-program-letters https://hab.hrsa.gov/program-grants-management/policy-notices-and-program-letters http://www.dictionary.com/browse/disparity https://www.cdc.gov/hiv/group/gender/women/index.html

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Black women with HIV have worse health-related outcomes than women of other racial and ethnic backgrounds7 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, such as unstable housing, lack of transportation, and lack of trust in health care providers.8,9 For Black women with HIV, coping with a new health condition and navigating the health system can be a complex, multi-level process.

Therefore, women’s adaptation and resiliency are 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 2018.10 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).11 Additionally, percentages of viral suppression among Black women were lower among those in each of the 5-year age groups ranging from 15–34 years (range: 69.6 percent –77.9 percent); for those with perinatal acquired infection (70.8 percent); and those with temporary (80.3 percent) or unstable housing (73.6 percent).12

Women with HIV have various complex needs. Research shows that many women, particularly Black women, struggle with overlapping issues such as physical and sexual violence and trauma or IPV, homelessness, mental health needs, and co-occurring STIs.13,14 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 health care resources.15,16 For some Black women with HIV, balancing care for self and for family, coming to terms with past experiences that increased vulnerability to

7 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.

8 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.

9 Watkin-Hayes et al 10 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 11 Ibid, pg. 7 12 Ibid.

13 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.

14 Sullivan KA, Messer LC, and Quinlivan EB, 2015 15 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.

16 Watkin-Hayes et al 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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infection, and both internalized and external stigma,17 can 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 and overcome health disparities. 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”.18

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.19 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. This initiative 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.

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

17 Ibid 18 Sullivan, Schultz, Ramaiya, et al 2015, pg S52.

19 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.

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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epidemic as its framework. Therefore, to the extent possible, activities funded by RWHAP focus on addressing these four goals:

1) Reduce new HIV infections;

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

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

4) Achieve a more coordinated national response.

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

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

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

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

additionally, racial/ethnic, age-based, and regional disparities have decreased.20 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.21 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

20 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.

21 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://hab.hrsa.gov/data/data-reports https://clinicaltrials.gov/

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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.

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 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 http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf https://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

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• 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:

• 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.

https://targethiv.org/chw https://targethiv.org/help/ta-directory https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://targethiv.org/ihip https://targethiv.org/library/replication-resources-spns-systems-linkages-and-access-care https://targethiv.org/library/replication-resources-spns-systems-linkages-and-access-care https://targethiv.org/library/dissemination-evidence-informed-interventions

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II. Award Information

1. Type of Application and Award

Type of applications sought: New

HRSA will provide funding in the form of a cooperative agreement. A cooperative agreement is a financial assistance mechanism where substantial 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 OWH personnel, as participants in the planning, development, and implementation of the project;

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

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

• Reviewing activities, procedures, measures and tools to be implemented for accomplishing the program goals on an on-going basis;

• 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:

• Completing the proposed initiative work plan activities within the three year project period;

• Collaborating with HRSA on review of activities, procedures, and budget items, including timely communication with project officer;

• Ensuring proposed activities are based on documented need, targeted for maximum impact on HIV care continuum outcomes, and designed to reach, engage, and retain Black women with HIV in care;

• Coordinating the activities with existing RWHAP entities and identified partnering agencies, when applicable;

• Collaborating with the ETAP on the development and implementation of a multi-site evaluation;

• Participating in on-site and remote learning opportunities as coordinated and conducted by the ETAP;

• Developing and implementing a methodology, including proposed metrics, to measure the impact of proposed activities, as well as reporting on outcomes;

• Participating in all aspects of the multi-site evaluation and communicating with the ETAP. Cooperative agreement recipients must comply with requests for data

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and information in accordance with specified timelines of the ETAP. Required multi-site evaluation activities will include, but are not limited to:

o Attending two SPNS multi-site recipient meetings per year. Travel to attend SPNS multi-site recipient meetings is limited to no more than three staff participants. Prior approval from the Project Officer is required for exceptions.

o Collecting and reporting multi-site evaluation data, as specified by the ETAP. Collect and submit data to the ETAP measuring the impact of the bundled interventions for HIV care of Black women with HIV.

o Documenting implementation processes, including action steps taken, lessons learned, and successes and barriers encountered.

o Cooperating with the ETAP to conduct focused evaluation studies of interest to the initiative, such as exploring case studies, cost analysis (including cost-effectiveness, if feasible), impact and/or policy issues pertaining to the goals and objectives of the project.

• Developing a sustainability and integration plan to support successful strategies following the conclusion of the cooperative agreement;

• Modifying activities as necessary to ensure relevant outcomes for the project;

and

• Participating in the dissemination of project findings, best practices, and lessons learned, including adherence to MHAF and HRSA guidelines pertaining to acknowledgment and disclaimer on all products produced by MHAF and HRSA award funds.

Implementation of Bundled Interventions

HRSA will fund demonstration sites to adopt the delivery of multiple interventions focused on Black women with HIV. When delivered simultaneously, such interventions can produce better health outcomes, (i.e., improved engagement, higher retention, and improved viral suppression), than when these elements are delivered separately.

Applicants must propose a minimum of two evidence-informed interventions to offer a coordinated and comprehensive bundled intervention to be delivered simultaneously.

Interventions should include at least one of the following domains listed below, with the remaining being of the applicant’s choice but related to the goals of the initiative:

1. Enhanced patient navigation, enhanced case management, or peer engagement;

2. Red Carpet Care Experience,22 which provides support and addresses barriers to accessing HIV care including such services as transportation, food/nutrition, housing, employment, mental health, or social support, among others;

3. Stigma reduction intervention that can speak to social determinants of health (e.g., address stigma and the environment, use media to show HIV has a human face, engage the community, help institutions recognize stigma, educate about stigma and HIV);

22 Crider, P and Karpen, C. Red Carpet Care: Breaking Down Barriers to Care. MetroHealth.

https://dsas.cuyahogacounty.us/pdf_dsas/en-US/2017RedCarpetCare.pdf, accessed Feb 19, 2020 https://dsas.cuyahogacounty.us/pdf_dsas/en-US/2017RedCarpetCare.pdf

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4. Use of trauma-informed interventions, provider and/or organizational training on guiding principles to a trauma-informed approach;23

5. Self-efficacy, health literacy or resiliency, and;

6. Interventions for IPV, physical and sexual violence, or other behavioral health needs (e.g. provider and /or organizational training on IPV, physical and sexual violence prevention, or behavioral health and care coordination with other community-based services).

As part of the bundled intervention design, these efforts must focus on Black women who are aware of their HIV status and who have fallen out of care, never entered into care, or are at high risk of falling out of care. Additionally, efforts will focus on Black women who are newly diagnosed or in care and not virally suppressed. Interventions should include coordination with local and partnering agencies that serve Black women, including but not limited to, social, cultural, behavioral, and community-based organizations. Addressing SDOH, such as IPV, is an HRSA objective to improve the health and well-being of individuals and the communities in which they reside.

HRSA HAB developed this initiative in collaboration with staff from HRSA’s Office of Women’s Health (OWH) to ensure the program design supports interventions that are culturally sensitive, inclusive, and empowering while providing care to women who are geographically isolated or economically or medically vulnerable. This project not only furthers HRSA’s Ending the HIV Epidemic: A Plan for America initiative (EHE) goals related to addressing social determinants of health and reducing health disparities, but enhances the OWH’s goals related to improving programs and carrying out initiatives to achieve health equity for underserved women. HRSA will use MHAF resources to foster the development of bundled interventions of comprehensive HIV care and treatment to improve health outcomes particularly for retention in care and the attainment of viral suppression. These efforts will add to the literature and the field of implementation science to address effective care and treatment for Black women with

HIV.

Finally, demonstration sites will be required to participate with the ETAP in the development of an intervention manual to document the implementation methodology of their project for purposes of replication. The manual will include, at minimum, the following: 1) a description of the intervention and key considerations and 2) recommendations for other programs looking to replicate the model.

Multi-Site Evaluation Requirements Demonstration sites will be expected to work collaboratively with the ETAP in all aspects of the multi-site evaluation. Sites must have the ability to collect and report quantitative and qualitative data to the ETAP. In order to facilitate adherence to the evaluation protocol, the ETAP will provide TA to all demonstration sites over the course of the entire project. This initiative provides a unique opportunity for HRSA HAB and OWH to examine how bundled interventions promote increased linkage to HIV care, higher retention in care, improved viral suppression, and overall enhanced quality of health for Black women with HIV. By creating an integrated structural intervention that

23 Centers for Disease Control and Prevention, Center for Preparedness and Response. Infographic: 6 Guiding Principles To A Trauma Informed Approach.

https://www.cdc.gov/cpr/infographics/6_principles_trauma_info.htm. Accessed March 4, 2020.

https://www.cdc.gov/cpr/infographics/6_principles_trauma_info.htm

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addresses significant social determinants of health, the federal partners expect to see the following system-level outcomes:

• Improved ability to address socio-cultural determinants of health and unmet needs;

• Enhanced coordinated care models and better tools to help providers build capacity around patient-centered and culturally sensitive and responsive care.

HRSA expects the following health outcomes for Black women with HIV participating in this project:

• Improved engagement, reengagement, and adherence to care

• Stigma reduction

• Achievement and maintenance of viral suppression

Recipients must demonstrate the ability to work among partner organizations.

Additionally, recipients must collect and report data to the ETAP related to HIV health outcomes. Performance measures must include the outcomes of Black women with HIV participants, along the HIV care continuum24 including:

• HAB Core Performance Measures,25 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 o 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,26 as needed

Human Subjects Protection:

Federal regulations (45 CFR part 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. If you anticipate research involving human subjects, you must meet the requirements of the HHS regulations to protect human subjects from research risks. If you anticipate research involving human subjects, please review HRSA’s SF-424 Application Guide to

24 For more information on the HIV Care Continuum go to https://www.aids.gov/federal-resources/policies/care-continuum/ 25 HAB Performance Measures can be viewed at:

https://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/coremeasures.pdf 26 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://www.aids.gov/federal-resources/policies/care-continuum/ https://www.aids.gov/federal-resources/policies/care-continuum/ 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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determine if you are required to hold a Federal Wide Assurance (FWA) of compliance from the Office of Human Research Protections (OHRP) prior to award. You must provide your Human Subject Assurance Number (from the FWA) in the application; if you do not have an assurance, you must indicate in the application that you will obtain one from OHRP prior to award. In addition, you must meet the requirements of the HHS regulations for the protection of human subjects from research risks, including the following:

• develop all required documentation for submission of research protocol to IRB;

• communicate with IRB regarding the research protocol;

• obtain IRB approval prior to the start of activities involving human subjects; and

• communicate about IRB’s decision and any IRB subsequent issues with HRSA.

Client confidentiality requirements apply to all phases of the project. Prior to their IRB approval expiration, recipients must submit documentation from that IRB indicating the project has undergone an annual review and complies with all IRB requirements.

2. Summary of Funding

HRSA anticipates approximately $2,170,000 to be available annually to fund up to seven recipients. You may apply for a ceiling amount of up to $310,000 total cost (includes both direct and indirect, facilities and administrative costs) per year. The period of performance is September 1, 2020 through August 31, 2023 (3 years).

Funding beyond the first year is subject to the availability of appropriated funds for Improving Care and Treatment Coordination: Focusing on Black Women with HIV – Demonstration Sites 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.

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

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2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

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

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

NOTE: Multiple applications from an organization are not allowable.

If for any reason (including submitting to the wrong funding opportunity number or making corrections/updates) an application is submitted more than once prior to the application due date, HRSA will only accept your last validated electronic submission, under the correct funding opportunity number, prior to the Grants.gov application due date as the final and only acceptable application.

IV. Application and Submission Information

1. Address to Request Application Package

HRSA requires you to apply electronically. 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 e-mail 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.

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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2. Content and Form of Application Submission

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

See Section 8.5 of the Application Guide for the Application Completeness Checklist.

Application Page Limit The total size of all uploaded files may not exceed the equivalent of 60 pages when printed by HRSA. The page limit includes the abstract, project and budget narratives, attachments, and letters of commitment and support required in the Application Guide and this NOFO. Standard OMB-approved forms that are included in the workspace application package do not count in the page limit. Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. We strongly urge you to take appropriate measures to ensure your application does not exceed the specified page limit.

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

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

1) You, on behalf of the applicant organization, certify, by submission of your proposal, that neither you nor your principals are presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any federal department or agency.

2) Failure to make required disclosures can result in any of the remedies described in 45 CFR § 75.371, including suspension or debarment. (See also 2 CFR parts 180 and 376, and 31 U.S.C. 3321).

3) Where you are unable to attest to the statements in this certification, an explanation shall be included in Attachment 10: 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,…