oppHRSA-18-047-cfda93.928-cidHRSA-18-047-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

HIV/AIDS Bureau Office of Training and Capacity Development

Implementation of Evidence-Informed Behavioral Health Models to Improve HIV Health Outcomes for Black Men Who Have Sex with Men - Demonstration Sites

Funding Opportunity Number: HRSA-18-047

Funding Opportunity Type(s): Initial: New Catalog of Federal Domestic Assistance (CFDA) Number: 93.928

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2018

Application Due Date: February 5, 2018

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

Deadline extensions are not granted for lack of registration.

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

Issuance Date: December 5, 2017

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

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

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EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA), HIV/AIDS Bureau is accepting applications for a fiscal year (FY) 2018 Ryan White HIV/AIDS Program (RWHAP) Special Projects of National Significance (SPNS) Program initiative, Implementation of Evidence-Informed Behavioral Health Models to Improve HIV Health Outcomes for Black Men Who Have Sex with Men (BMSM) – Demonstration Sites. The purpose of this initiative is to support the implementation of evidence-informed interventions and/or models of care to engage, link and retain BMSM in HIV medical care and supportive services by addressing their behavioral health needs.

Demonstration site outcomes will inform the development of implementation toolkits and other dissemination products in order to promote replication across the RWHAP and other health care settings.

The FY 2018 President’s Budget does not request funding for this program. This notice is a contingency action taken to ensure that, should funds become available for this purpose, applications can be processed, and funds awarded in a timely manner. Applicants should note that this program may be cancelled prior to award recommendations.

Funding Opportunity Title: Implementation of Evidence-Informed

Behavioral Health Models to Improve HIV Health Outcomes for Black Men Who Have Sex with Men - Demonstration Sites

Funding Opportunity Number: HRSA-18-047 Due Date for Applications: February 5, 2018 Anticipated Total Annual Available FY18 Funding:

$2,100,000

Estimated Number and Type of Award(s): Up to 7 grants Estimated Award Amount: Up to $300,000 per year Cost Sharing/Match Required: No Project Period/Period of Performance: August 1, 2018 through July 31, 2021

(3 years) Eligible Applicants: Entities eligible for funding under Parts A

-D of Title XXVI of the Public Health Service (PHS) Act as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 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; Federally Qualified Health Centers as described in Title XIX, Section 1905 of

HRSA-18-047 ii the Social Security 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), formerly known as the funding opportunity announcement (FOA), for complete eligibility information.

Application Guide

You (the applicant organization/agency) are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide, available online at http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf, except where instructed in this NOFO to do otherwise. A short video explaining the Application Guide is available at http://www.hrsa.gov/grants/apply/applicationguide/.

Technical Assistance

HRSA strongly encourages all applicants to participate in a technical assistance (TA) 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.

Day and Date: Thursday, December 21, 2017 Time: 12 p.m. -1:30 p.m. ET Call-In Number: 1-888-942-9573 Participant Code: 8381871 Weblink: https://hrsa.connectsolutions.com/hrsa18047-Demos

The webinar will be recorded and should be available for viewing by December 31, 2017 at https://careacttarget.org/library/hrsahab-notice-funding-opportunity-nofo-announcements.

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

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING/MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Narrative

v. Attachments (Note: list all required attachments in the order to be submitted. Include all program-specific forms)

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

7. OTHER SUBMISSION REQUIREMENTS, IF APPLICABLE ERROR! BOOKMARK NOT DEFINED.

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

3. ASSESSMENT OF RISK AND OTHER PRE-AWARD ACTIVITIES

4. ANTICIPATED ANNOUNCEMENT AND AWARD DATES

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

IX. TIPS FOR WRITING A STRONG APPLICATION

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I. Program Funding Opportunity Description

1. Purpose

This notice of funding opportunity (NOFO) solicits applications for fiscal year (FY) 2018 for a new, 3-year initiative entitled Implementation of Evidence-Informed Models to Improve HIV Health Outcomes for Black Men Who Have Sex with Men (BMSM) – Demonstration Sites. The Health Resources and Services Administration (HRSA), HIV/AIDS Bureau (HAB) will award up to seven (7) grants of up to $300,000 each per year for 3 years, in order to support the implementation of evidence-informed behavioral health interventions and/or models of care to engage, link and retain BMSM living with HIV in medical care and supportive services. The proposed interventions and/or models of care will include strategies to integrate behavioral health services, including substance use disorder treatment, with HIV care to specifically address the needs of BMSM and improve their health outcomes. Demonstration site outcomes will inform the development of implementation toolkits and other dissemination products in order to promote replication across the Ryan White HIV/AIDS Program (RWHAP) and other health care settings.

In addition to adapting and implementing evidence-informed interventions and/or models of care in their own settings, the demonstration sites funded under this initiative will coordinate with the Evaluation and Technical Assistance Provider (ETAP), funded separately, to evaluate programmatic, clinical, and client-level outcomes of the implementation. In addition, the ETAP will assess the costs associated with the implementation of the evidence-informed interventions and/or models of care. In coordination with the ETAP, the demonstration sites will assist in development of implementation toolkits, trainings, and other dissemination products that will promote replication of evidence-informed interventions that were shown to improve health outcomes in other RWHAP and other health care settings.

Because award recipients under both NOFOs (HRSA-18-047 and HRSA-18-053) will need to work together to be successful, HRSA encourages applicants for this NOFO to read the companion announcement and be familiar with all program expectations within both NOFOs.

Key Definitions:

For the purposes of this initiative, HIV care services is defined as all of the HIV care and treatment services allowable through the RWHAP. For more information regarding RWHAP eligible services, refer to Policy Clarification Notice #16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds.1

The term behavioral health refers to mental/emotional well-being and/or actions that affect wellness. Behavioral health problems include substance use disorders; alcohol and drug addiction; and serious psychological distress, suicide, and mental disorders.

Problems that range from unhealthy stress or subclinical conditions to diagnosable and

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

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treatable diseases such as serious mental illnesses and substance use disorders are included. These illnesses and disorders are often chronic in nature but people can and do recover from them with the help of a variety of interventions, including medical and psychosocial treatments, self-help, and mutual aid. The phrase “behavioral health” is also used to describe service systems that encompass prevention and promotion of emotional health; prevention of mental and substance use disorders, substance use, and related problems; treatments and services for mental and substance use disorders;

and recovery support. Behavioral health care includes screening and treatment of substance use disorders; alcohol and drug addiction; and serious psychological distress, suicide, and mental disorders.2

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 living with HIV (PLWH). 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 impact and strength of evidence without meeting AHRQ, CDC, or other criteria for being evidence-based.

Implementation and Adaptation of Evidence-informed interventions

Under a previous HRSA initiative, the National Alliance of State and Territorial AIDS Directors Center for Engaging BMSM across the Care Continuum (CEBACC) created an inventory of evidence-informed interventions for BMSM living with HIV across the care continuum. CEBACC has identified best practices and effective models for HIV clinical care and treatment in order to increase the capacity, quality, and effectiveness of health care providers to screen, diagnose, link, and retain BMSM in HIV clinical care.

Additionally, the National Institute of Mental Health (NIMH) has identified two (2) previous HRSA/SPNS demonstration models as evidence-informed interventions for addressing behavioral health. This new initiative will build upon this work by adapting and implementing interventions such as those identified in the CEBACC and NIMH inventories that specifically address the behavioral health needs of BMSM living with HIV to improve their engagement and retention in care.

Demonstration sites will adapt and implement interventions and/or models of care that incorporate behavioral health treatment to improve health outcomes and address the unique needs of BMSM living with HIV. Specifically, demonstration sites will adapt and implement HIV treatment and service models and approaches that include both medical and behavioral health components that take into consideration social, economic, and cultural factors needed to engage, link and retain BMSM living with HIV in care and behavioral health services. In addition, demonstration sites will be expected to disseminate lessons learned and findings from models that have demonstrated improvements in health outcomes for BMSM to promote uptake and replication of those

2 Substance Abuse and Mental Health Services Administration. National Behavioral Health Quality Framework. Available at: https://www.samhsa.gov/data/national-behavioral-health-quality-framework.

Accessed September 23, 2017 https://www.samhsa.gov/data/national-behavioral-health-quality-framework

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models beyond the original implementing site.

Untreated behavioral health issues are often the root causes of poor retention and engagement in care, antiretroviral therapy (ART) adherence, and viral suppression.3 Demonstration sites are expected to adapt and implement evidence-informed behavioral health interventions and/or models of care, through co-located services or establish networks to improve linkages to behavioral health treatment that specifically addresses the needs of BMSM living with HIV.

Sites will promote how the implementation of these interventions and/or models of care impact improvements in linkage, retention, and health outcomes. Sites will implement intervention plans that are designed so that RWHAP and other public health service providers can adopt and apply the same interventions in their own communities.

For the purposes of this initiative, demonstration sites are to select one (1) organizational intervention and/or model of care from the identified CEBACC and NIMH-identified HRSA/SPNS interventions and/or models of care addressing behavioral health conditions. Sites will modify and implement selected interventions and/or models of care in order to address the structural, provider and individual level barriers that limit engagement and retention in HIV care and viral suppression for BMSM living with HIV.

Eligible demonstration sites will collaborate with the ETAP to adapt and implement the following organizational interventions and/or models of care described below for HIV care and treatment. Applicants must propose to adapt and then implement one of the following identified organizational models to focus on improving health outcomes along the HIV care continuum for BMSM living with HIV. In the redesign, these efforts must focus on BMSM who are aware of their HIV status and who have fallen out of care, never entered into care, or are at risk of falling out of care. The redesigned interventions and/or models of care must integrate behavioral health care with HIV care to improve their health outcomes.4

Organizational Interventions/Models of Care

Summary Website

Keeping them in "STYLE": finding, linking, and retaining young HIV-positive black and Latino men who have sex with men in care.

STYLE (Strength Through Youth Livin’ Empowered) is a novel intervention that utilizes a social marketing campaign aimed to target youth and members of their sexual and social networks, testing and outreach, and a tightly linked medical-social support network to https://www.ncbi.n lm.nih.gov/pubme d/21162690 https://www.cdc.g ov/hiv/pdf/researc h/interventionrese

3 Zuniga JA. The Role of Depression in Retention in Care for Persons Living with HIV. AIDS Patient Care STDS. 2016 Jan 1: 30(1): 34-38.

4 The SAMHSA-HRSA Center for Integrated Health Solutions (CIHS) promotes the development of integrated primary and behavioral health services to better address the needs of individuals with mental health and substance use conditions, whether seen in specialty behavioral health or primary care provider settings. Applicants requiring additional information and technical assistance material on the key components of integration, as well as how to help HIV provider organizations assess where they are on the continuum of integrated care should visit https://www.integration.samhsa.gov/about-us/about-cihs.

https://www.ncbi.nlm.nih.gov/pubmed/21162690 https://www.ncbi.nlm.nih.gov/pubmed/21162690 https://www.ncbi.nlm.nih.gov/pubmed/21162690 https://www.cdc.gov/hiv/pdf/research/interventionresearch/compendium/cdc-hiv-style_ei_retention.pdf https://www.cdc.gov/hiv/pdf/research/interventionresearch/compendium/cdc-hiv-style_ei_retention.pdf https://www.cdc.gov/hiv/pdf/research/interventionresearch/compendium/cdc-hiv-style_ei_retention.pdf https://www.integration.samhsa.gov/about-us/about-cihs

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diagnose, engage, and retain HIV-positive young BMSM in HIV primary care.

arch/compendium /cdc-hiv-style_ei_retention .pdf

A youth-focused case management intervention to engage and retain young gay men of color in HIV care

This intervention seeks to increase rates of engagement and retention in HIV care for HIV-positive Latino and Black/African-American young men who have sex with men (YMSM).

Participants are enrolled into a psychosocial case management intervention administered by Bachelor-level peer case managers. Participants meet weekly with a case manager for the first two months and monthly for the next 22 months. Retention in HIV primary care at 3 and 6 months of follow-up are evaluated as well as factors associated with retention in care.

http://www.tandfo nline.com/doi/abs/ 10.1080/0954012 1.2010.542125

CEBACC: Brothers United/The Damien

Center

Targeted Linkage to Care Program for local Black LGBT communities.

Brothers United and the Damien Center’s joint Linkage to Care (L2C) program connects clients to in-house and off-site medical and social services that help prevent HIV infection and maintain the health of people living with

HIV/AIDS.

https://www.hishe alth.org/models-of-care/brothers-united-damien-center

CEBACC: Project Silk A recreation-based community health center that provides sexual health service delivery for Black LGBT patients. Project Silk’s patient-driven approach engages clients and elicits their advice on program design and service delivery. Providing a stigma-free space is a core component of Project Silk’s successful peer–driven community health model.

https://www.hishe alth.org/models-of-care/project-silk http://projectsilk.o rg/

Strategies and activities funded under this NOFO must comply with Policy Clarification Notice (PCN) #16-02 Ryan White HIV AIDS Program Services: Eligible Individuals & Allowable Uses of Funds (https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf). You are encouraged to review

PCN #16-02.

Multi-site Evaluation Requirements

The initiative’s ETAP will coordinate a multi-site evaluation. Carefully read the https://www.cdc.gov/hiv/pdf/research/interventionresearch/compendium/cdc-hiv-style_ei_retention.pdf https://www.cdc.gov/hiv/pdf/research/interventionresearch/compendium/cdc-hiv-style_ei_retention.pdf https://www.cdc.gov/hiv/pdf/research/interventionresearch/compendium/cdc-hiv-style_ei_retention.pdf https://www.cdc.gov/hiv/pdf/research/interventionresearch/compendium/cdc-hiv-style_ei_retention.pdf http://www.tandfonline.com/doi/abs/10.1080/09540121.2010.542125 http://www.tandfonline.com/doi/abs/10.1080/09540121.2010.542125 http://www.tandfonline.com/doi/abs/10.1080/09540121.2010.542125 http://www.tandfonline.com/doi/abs/10.1080/09540121.2010.542125 http://brothersunitedinc.org/ http://www.damien.org/ http://www.damien.org/ https://www.hishealth.org/models-of-care/brothers-united-damien-center https://www.hishealth.org/models-of-care/brothers-united-damien-center https://www.hishealth.org/models-of-care/brothers-united-damien-center https://www.hishealth.org/models-of-care/brothers-united-damien-center https://www.hishealth.org/models-of-care/brothers-united-damien-center http://www.chscorp.org/project-silk https://www.hishealth.org/models-of-care/project-silk https://www.hishealth.org/models-of-care/project-silk https://www.hishealth.org/models-of-care/project-silk https://www.hishealth.org/models-of-care/project-silk http://projectsilk.org/ http://projectsilk.org/ 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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requirements for the ETAP under Announcement Number HRSA-18-053 to understand the requirements of the national, multi-site evaluation that will be coordinated by the ETAP. Demonstration sites will be expected to collect and report relevant quantitative and qualitative outcome, process and cost measures data for their interventions and/or models of care as part of the national multi-site evaluation. This data may include but is not limited to:

• Client demographic characteristics

• Biomedical and behavioral health indicators

• Utilization of core medical and support services (e.g., substance abuse, mental health, housing assistance)

• Barriers to accessing treatment and services

• Medication adherence measures; and other outcome measures as defined by the ETAP

Demonstration sites will be expected to report biomedical and behavioral health indicators. As such, the demonstration sites must be able to report these indicators, either as a direct clinical provider or through the execution of partnership agreements with a medical clinic for HIV health care services.

The ETAP will also provide technical assistance (TA) to the demonstration sites during regular teleconferences; through its website and webinars; during site visits; and at the twice-a-year national meetings where the ETAP will lead publication and dissemination activities, in collaboration with the demonstration sites and HRSA program staff.

Demonstration sites must collect and report relevant quantitative and qualitative outcome, process, and cost measures data to the ETAP. Because of the data requirements of the project, proposed staffing plans must include at a minimum:

• A 10 percent full-time equivalent Evaluator (.10 FTE) to oversee the implementation of the multi-site evaluation activities conducted by the ETAP, and

• A 25 percent full-time equivalent (.25 FTE) Data Manager to assist in data collection and reporting.

The proposed staff should have demonstrated experience in clinical quality improvement and/or data collection and reporting for the Ryan White HIV/AIDS Program Services Report (RSR). In addition to the multi-site evaluation, the ETAP may also conduct focused studies related to aspects of engagement, linkage, retention, and viral suppression rates of BMSM living with HIV in care and treatment that addresses their behavioral health and HIV care needs. If so, demonstration sites are also expected to participate in these focused studies.

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 RSR treatment and support services data, are reported without disclosure of protected health information (PHI). The Privacy Rule of Health Insurance Portability and Accountability Act (HIPAA) also 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. Demonstration sites will be required to follow all applicable HIPAA and Institutional Review Board (IRB) requirements.

Demonstration sites also must cooperate with the ETAP and HRSA regarding the

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privacy and confidentiality of study participants and their health-seeking efforts.

Demonstration sites will be expected to conform to regulations for human research subjects protection as set forth in Title 45 – Public Welfare, Part 46 – Protection of Human Subjects (45 CFR part 46).

Demonstration sites are expected to attend two grant recipient meetings per year and host at least one site visit per year that the ETAP will conduct. The ETAP will convene two grant recipient meetings per year during the course of the 3-year period of performance. While the ETAP will coordinate the overall logistics, each demonstration site must cover their travel, lodging per diem and other incidental expenses associated with these meetings. Award recipient meetings will be held in the Washington, DC/Metropolitan area. The ETAP will also provide TA to the demonstration sites during regular teleconferences, through its website and webinars, during site visits, and at the twice-a-year national meetings where the ETAP will lead publication and dissemination activities, in collaboration with the demonstration sites and HRSA program staff.

Dissemination of Findings and Lessons Learned

The ETAP will document successful findings and best practices for purposes of dissemination and replication at the national level. Dissemination of lessons learned and best practices will help to build capacity and readiness of RWHAP recipient organizations and non-RWHAP recipient organizations to successfully engage, link and retain BMSM living with HIV in care and treatment that addresses their behavioral health and supportive service needs to ultimately improve HIV-related outcomes (e.g., viral suppression).

Demonstration sites must participate in the publication and dissemination of program findings and lessons learned in collaboration with the ETAP and HRSA program staff.

Each demonstration site will be expected to designate at least one project staff member to fully participate on the initiative’s publications and disseminations committee.

Demonstration sites must have personnel with the necessary skills to communicate project findings and lessons learned to local communities, state and national conferences, and policymakers, as well as write and publish findings in peer-reviewed journals and making presentations at conferences.

The ETAP, in collaboration with the demonstration sites, will be responsible for producing and disseminating TA toolkits, materials, and products. Audiences for these materials and products include both award receipients under this project, and other RWHAP recipients/subrecipients and HIV providers not funded under this project.

Mechanisms of dissemination may include peer reviewed journals, websites, presentations via webcast, the National Ryan White Conference on HIV Care and Treatment, and other meetings or national forums to inform lessons learned and how to replicate the models. This external dissemination includes tools and materials that can be used by RWHAP recipients not funded under this project to adapt the evidence-informed interventions and/or models of care within their own organizations and assess their impact. The ETAP will work with the TARGET Center (i.e., website for hosting tools, webcasts, trainings, and other resources to assist RWHAP-funded programs) as the web forum to disseminate all information, tools, materials, and products from this project. Accordingly, demonstration sites will be expected to participate in the http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

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development of these dissemination materials and support further replication.

Recipients are strongly encouraged to collaborate with their regional AIDS Education and Training Center (AETC) programs for expert support to disseminate and replicate promising practices, lessons learned and implementation challenges. AETC contact information is available at https://aidsetc.org/aetc-program/regional-offices.

Overall Project Timeline for Demonstration Sites and ETAP

In Year 1, the demonstration sites will work with the ETAP to finalize adaptation and implementation plans. The ETAP will review the adaptation and implementation plans developed by the demonstration sites. Informed by this review, the ETAP will design a TA and capacity building assistance (CBA) plan tailored to each model. During this time, the demonstration sites will conduct start up activities to include any necessary adaptations to the selected evidence informed intervention and/or model of care in collaboration with the ETAP. Also in Year 1, the ETAP will design a multi-site evaluation plan to assess the fidelity, effectiveness and costs of these interventions and/or models of care when implemented in Years 2 and 3. Demonstration sites will contribute to the development of the multi-site evaluation plan. In Years 2 and 3, the demonstration sites will implement their interventions and/or models of care and submit outcome, process and cost data to the ETAP. In year 4, informed by its findings from the multi-site evaluation, the ETAP will produce web-based materials for publication on the TARGET Center website. The ETAP also will engage in publication and dissemination of findings from the initiative, including best practices, lessons learned and cost analyses to foster rapid, efficient replication of these evidence-informed interventions and/or models of care by other RWHAP-funded care and treatment organizations.

Below is a suggested timeline to assist in the preparation of your required project narrative.

Project Date Demonstration Sites ETAP Year 1, Months 1-6

• Work with ETAP to finalize adaptation and implementation plans

• Assess TA needs

• Hire intervention/ evaluation staff, as needed

• Assist with intervention and implementation strategy adaptation

• Develop needs assessment tools

• Conduct needs assessment

• Convene initial multi-site meeting

Year 1, Months 7-9 • Assist ETAP with developing multi-site evaluation data collection tools

• Submit evaluation data collection

• Develop evaluation plan

• Develop data collection systems and tools

• Submit instruments to https://aidsetc.org/aetc-program/regional-offices

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instruments to local Institutional Review Boards for approval

IRB for approval

• Develop TA/CBA plans

• Develop TA/CBA tools

Year 1, Months 10-12 • Begin implementation of evidence-informed intervention

• Begin multi-site evaluation data collection and submission to

ETAP

• Begin multi-site evaluation

Year 2 • Submit to IRB for renewal

• Implementation of evidence-informed intervention

• Mid-intervention implementation strategies (if needed)

• Submit to IRB for renewal

• Collect data, conduct interim evaluation

• Conduct annual site visits

• Convene grant recipient meetings

• Continue to provide TA/CBA using tools developed

Year 3, Months 1-6 • Submit to IRB for renewal

• Implementation of

• evidence-informed intervention

• Submit to IRB for renewal

• Collect data, conduct outcome evaluation

Year 3, Months 6-10 • Wrap-up of evidence-informed interventions

• Develop tools for replication of intervention models

• Develop materials for dissemination

• Collect data, conduct outcome evaluation

• Develop materials for dissemination

• Final multi-site meeting

• Work with AETC to help translate these materials into clinical practice

Year 3, Months 11-12 • Dissemination and promotion of materials

• Final data collection activities

Year 4 N/A • Submit for IRB renewal

• Analyze project data

• Develop materials for

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dissemination

• Disseminate findings from project, promote materials and replication

2. Background

The Special Projects of National Significance (SPNS) Program is authorized by Section 2691 of the Public Health Service Act (42 USC 300ff-101), as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (P.L. 111-87). The SPNS Program supports the development of innovative models of HIV care to respond to the emerging needs of clients served by the RWHAP.5 The SPNS Program also evaluates the effectiveness of these models’ design, implementation, utilization, cost, and health related outcomes, while promoting the dissemination and replication of successful models.6

Despite decreasing overall HIV incidence in the United States, Blacks/African Americans have higher HIV incidence rates when compared to other racial/ethnic groups. According to the CDC, Blacks/African Americans accounted for almost half (44.3 percent) of all new HIV diagnoses in 2015, among whom, 38.4 percent were gay and bisexual men.7 Among all subpopulations with new diagnoses, BMSM were the most affected subpopulation. If current HIV diagnoses rates persist, about 1 in 2 BMSM in the United States will be diagnosed with HIV during their lifetime compared with 1 in 11 white MSM.8 In 2014, over 400,000 Blacks/African Americans were living with diagnosed HIV infection (42.4 percent of all people living with diagnosed HIV); in addition, Blacks/African Americans comprised the highest number (6,888) and rate (17.4 per 100,000 population) of HIV-related deaths among all racial/ethnic groups.

Similar disparities also exist within the RWHAP. In 2015, the RWHAP served 533,036 clients, and among them 47.1 percent were Black/African American.9 Among male clients, Blacks/African Americans comprised the largest racial/ethnic group (41.2 percent) of RWHAP clients. African Americans also comprised one-third of MSM clients, but 60.1 percent among MSM aged 13 - 24. Although the percentage of Black/African American men who were retained in care (78.6 percent) was close to the

5 Current SPNS initiatives as well as previously funded projects can be found at:

http://hab.hrsa.gov/abouthab/partfspns.html 6 Publications and products from various SPNS initiatives can be found at:

http://hab.hrsa.gov/abouthab/special/spnsproducts.html AND https://careacttarget.org/library/integrating-hiv-innovative-practices-ihip 7 Centers for Disease Control and Prevention. HIV Surveillance Report, 2015; Volume 27, published November 2016. Accessed 12-1-16 from : https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2015-vol-27.pdf 8 Centers for Disease Control and Prevention. Lifetime Risk of HIV Diagnosis. Conference on Retroviruses and Opportunistic Infection. February 2016. Accessed 0-28-2017 from:

https://www.cdc.gov/nchhstp/newsroom/2016/croi-press-release-risk.html 9 Health Resources and Services Administration. Ryan White HIV/AIDS Program Annual Client-Level Data Report 2015. HIV/AIDS Bureau, HRSA, December 2016. Accessed 8-14-17 from:

http://hab.hrsa.gov/sites/default/files/hab/data/datareports/2015rwhapdatareport.pdf http://hab.hrsa.gov/abouthab/partfspns.html http://hab.hrsa.gov/abouthab/special/spnsproducts.html https://careacttarget.org/library/integrating-hiv-innovative-practices-ihip https://careacttarget.org/library/integrating-hiv-innovative-practices-ihip https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2015-vol-27.pdf https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2015-vol-27.pdf https://www.cdc.gov/nchhstp/newsroom/2016/croi-press-release-risk.html http://hab.hrsa.gov/sites/default/files/hab/data/datareports/2015rwhapdatareport.pdf

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national RWHAP average (80.6 percent), the percentage who achieved viral suppression was slightly lower (78.9 percent) than the national average (83.4 percent).

Among all MSM racial/ethnic groups, viral suppression was lowest for African- Americans (77.7 percent). BMSM aged 13 - 24 years had noticeably lower levels of viral suppression (66.9 percent) compared to BMSM overall, with the lowest viral suppression among those with unstable housing (58.5 percent).

Studies have shown that BMSM experience more frequent and severe consequences of substance use than do White MSM, leading to health disparities such as poorer health outcomes.10 Once HIV-positive, BMSM are at higher risk of having poor health outcomes, and those negative outcomes are further compounded by behavioral health issues such as depression. Among BMSM living with HIV, the stress that accompanies experiences of discrimination based on their race, sexual orientation, and HIV status adds to their cumulative burden of stress and increases their vulnerability for depression. Traumatic life experiences may enhance vulnerability of young BMSM to HIV and increased risk-taking behaviors. Understanding the relative contributions of different traumatic experiences on HIV risk is important in identifying interventions and/or models of care needed to improve the health of young BMSM.

National Goals to End the HIV Epidemic

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

1) Reduce new HIV infections;

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

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

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

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

HIV Care Continuum

Diagnosing PLWH, linking PLWH to HIV primary care, and PLWH achieving viral suppression are important public health steps toward ending the HIV epidemic in the United States. The HIV care continuum has five main “steps” or stages including: HIV diagnosis, linkage to care, retention in care, antiretroviral use, and viral suppression.

The HIV care continuum provides a framework that depicts the series of stages a person with HIV engages in from initial diagnosis through their successful treatment with HIV medication. It shows the proportion of individuals living with HIV or individuals diagnosed with HIV who are engaged at each stage. The HIV care continuum allows recipients and planning groups to measure progress and to direct HIV resources most

10 Buttram ME, Kurtz SP, and Suratt HL. Substance Use and Sexual Risk Mediated by Social Support among Black Men. J Community Health. 2013 Feb; 38(1): 62–69.

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effectively.

According to recent data from the 2016 Ryan White Services Report (RSR), RWHAP has made tremendous progress toward ending the HIV epidemic in the United States.

From 2010 to 2016, HIV viral suppression among RWHAP patients, defined as a patient who had at least one outpatient ambulatory health services visit and at least one viral load test during the measurement year, with the most recent HIV RNA level <200 copies/mL, increased from 69.5 percent to 84.9 percent, and racial/ethnic, age-based, and regional disparities have decreased.11 These improved outcomes mean more PLWH in the United States will live near normal lifespans and have a reduced risk of transmitting HIV to others.12 In a September 27, 2017, Dear Colleague letter, CDC notes that scientific advances have shown that ART preserves the health of PLWH.

There is also strong evidence of the prevention effectiveness of ART. When ART results in viral suppression, it prevents sexual HIV transmission. This means that people who take ART daily as prescribed and achieve and maintain an undetectable viral load have effectively no risk of sexually transmitting the virus to an HIV-negative partner. Such findings underscore the importance of supporting effective interventions for linking PLWH into care, retaining them in care, and helping them adhere to their

ART.

RWHAP recipients are encouraged to assess the outcomes of their programs along this continuum of care. Recipients should work with their community and public health partners to improve outcomes across the HIV care continuum. HRSA encourages recipients to use the 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.

II. Award Information

1. Type of Application and Award

Type of applications sought: New

HRSA will provide funding in the form of a grant.

2. Summary of Funding

HRSA expects to have approximately $2,100,000 available annually to fund up to seven

(7) recipients. You may apply for a ceiling amount of up to $300,000 total cost (includes both direct and indirect facilities and administrative costs) per year. The actual amount available will not be determined until enactment of the final FY 2018 federal appropriation. The FY 2018 President’s Budget does not request funding for this

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

12 National Institute of Allergy and Infectious Disease (NIAID). Preventing Sexual Transmission of HIV with Anti-HIV Drugs. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US).

2000- [cited 2016 Mar 29]. Available from: https://clinicaltrials.gov/ NLM Identifier: NCT00074581.

https://hab.hrsa.gov/sites/default/files/hab/data/datareports/RWHAP-annual-client-level-data-report-2016.pdf https://docs.wixstatic.com/ugd/de0404_fab89a3aaeeb406bbd7898d0e90d5dac.pdf http://hab.hrsa.gov/deliverhivaidscare/habperformmeasures.html http://hab.hrsa.gov/data/data-reports https://clinicaltrials.gov/

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program. This program notice is subject to the appropriation of funds, and is a contingency action taken to ensure that, should funds become available for this purpose, applications can be processed, and funds awarded in a timely manner. The period of performance is August 1, 2018 through July 31, 2021 (3 years). Funding beyond the first year is dependent on the availability of appropriated funds for this program in subsequent fiscal years, satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government.

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

III. Eligibility Information

1. Eligible Applicants

Eligible applicants include entities eligible for funding under Parts A - D of Title XXVI of the Public Health Service (PHS) Act as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 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; Federally Qualified Health Centers as described in Title XIX, Section 1905 of the Social Security 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 through Grants.gov. You must use the SF- 424 application package associated with this NOFO following the directions provided at http://www.grants.gov/applicants/apply-for-grants.html.

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

HRSA recommends that you supply an email address to Grants.gov on the grant opportunity synopsis page when accessing the NOFO (also known as “Instructions” on Grants.gov) or application package. This allows Grants.gov to email organizations that supply an email address in the event the NOFO is changed and/or republished on Grants.gov before its closing date. Responding to an earlier version of a modified notice may result in a less competitive or ineligible application. Please note you are ultimately responsible for reviewing the Find Grant Opportunities page for all information relevant to desired opportunities.

2. Content and Form of Application Submission

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

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

Application Page Limit The total size of all uploaded files may not exceed the equivalent of 80 pages when printed by HRSA. The page limit includes the abstract, project and budget narratives, attachments, and letters of commitment and support required in the Application Guide and this NOFO. Standard OMB-approved forms that are included in the application package do not count in the page limitation. Indirect Cost Rate 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) The prospective recipient certifies, by submission of this proposal, that neither it http://www.grants.gov/applicants/apply-for-grants.html http://www.grants.gov/web/grants/applicants/workspace-overview.html http://apply07.grants.gov/search/spoExit.jsp?p=search-grants.html

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nor its principals is presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any federal department or agency.

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

3) Where the prospective recipient is unable to attest to the statements in this certification, an explanation shall be included in Attachment 12: Other Relevant Documents.

See Section 4.1 viii of HRSA’s SF-424 Application Guide for additional information on all certifications.

Program-Specific Instructions In addition to application requirements and instructions in Section 4 of HRSA’s SF-424 Application Guide (including the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract), please include the following:

i. Project Abstract See Section 4.1.ix of HRSA’s SF-424 Application Guide. In addition to the content required in the SF-424 Application Guide, the abstract must include the following:

• selected model that will be adapted/replicated;

• brief summary of the project goals, specific target population, service area setting;

• identify other sources of RWHAP funds by Part, if applicable; and

• overall methodology.

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

Successful applications will contain the information below. Please use the following section headers for the narrative:

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

This section should briefly describe the purpose of the proposed project. Briefly describe your organization and any collaborating organizations. Identify the CEBACC or NIMH-identified HRSA/SPNS intervention and/or model of care you propose to adapt and/or implement. Provide a clear rationale for selecting the specific organizational intervention and/or model of care. Provide a succinct description of the proposed strategies that you will use to adapt the intervention and/or model of care, with collaboration from the ETAP, to link and retain BMSM living with HIV in care that addresses their behavioral health and supportive service needs to help them achieve and maintain viral suppression. Include a brief description of the proposed plan to ascertain and disseminate findings, lessons learned, and best practices.

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NEEDS ASSESSMENT -- Corresponds to Section V’s Review Criterion #1 Need

Provide a summary that demonstrates a comprehensive understanding of issues regarding the improvement of linkage, retention and viral suppression among BMSM living with HIV. Include in the summary a demonstration of your understanding of the behavioral health needs of BMSM living with HIV. Describe the need to integrate behavioral health services with HIV care and treatment.

Describe the racial and/or ethnic…