CDC-RFA-PS20-2010.pdf

Centers for Disease Control and Prevention

National Center for HIV-AIDS, Viral Hepatitis, STD, and TB Prevention

Integrated HIV Programs for Health Departments to Support Ending the HIV Epidemic in the

United States

CDC-RFA-PS20-2010

Application Due Date: 04/08/2020

Integrated HIV Programs for Health Departments to Support Ending the HIV Epidemic in the

United States

CDC-RFA-PS20-2010

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Required Registrations E. Review and Selection Process F. Award Administration Information G. Agency Contacts H. Other Information I. Glossary

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- PS20-2010. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) B. Notice of Funding Opportunity (NOFO) Title:

Integrated HIV Programs for Health Departments to Support Ending the HIV Epidemic in the United States C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS20-2010

E. Assistance Listings (CFDA) Number:

93.940 F. Dates:

1. Due Date for Letter of Intent (LOI): N/A Is a LOI: Not Applicable Letters of Intent (LOI) are not requested or required as part of the application for this NOFO.

2. Due Date for Applications: 04/08/2020, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: 02/04/2020 Component A: Tuesday, February 4, 2020 at 2:00 pm (EST) Registration Link: https://globalmeetwebinar.webcasts.com/starthere.jsp?ei=1280904&;tp_key =90383bbac Component B: Wednesday, February 5, 2020 at 2:00 pm (EST) Registration Link: https://globalmeetwebinar.webcasts.com/starthere.jsp?ei=1280906&;tp_key =88f751d0ae Component C: To Be Announced

G. Executive Summary:

1. Summary Paragraph:

The CDC announces the availability of fiscal year 2020 funds for a Notice of Funding Opportunity (NOFO) to support the development and implementation of programs tailored to https://www.grants.gov https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov https://globalmeetwebinar.webcasts.com/starthere.jsp?ei=1280904&tp_key=90383bbac https://globalmeetwebinar.webcasts.com/starthere.jsp?ei=1280904&tp_key=90383bbac https://globalmeetwebinar.webcasts.com/starthere.jsp?ei=1280906&tp_key=88f751d0ae https://globalmeetwebinar.webcasts.com/starthere.jsp?ei=1280906&tp_key=88f751d0ae ending the HIV epidemic in America. Recent scientific advances in HIV prevention and treatment have made ending the HIV epidemic in America a realistic possibility. Under the leadership of President Trump, the Department of Health and Human Services (DHHS) has set an ambitious goal of reducing all new HIV infections by 75% in 5 years and by 90% by 2030.

Reaching this target requires a coordinated national effort that will focus first on the 50 most affected U.S. jurisdictions- 48 counties, Washington DC, and San Juan PR as well as seven states.

With funding from DHHS, this NOFO for the "Ending the HIV Epidemic" (EHE) initiative is intended to build on the on-going activities funded through PS18-1802: Integrated HIV Surveillance and Prevention Programs for Health Departments to strategically advance (i.e., initiate new or expand existing) HIV prevention efforts. The strategies proposed herein embody discrete areas of activity, which, based on the best available scientific evidence and experience, CDC believes will most rapidly accelerate efforts to reduce new HIV infections and merit undertaking. CDC recognizes that local public health must be responsive to local circumstances.

Thus, in response to each strategy, CDC strongly encourages applicants to propose disruptively innovative activities unique to their jurisdiction's local context. Component A is the core component of this NOFO and therefore is required. Funding levels will be determined by formulas reflecting a base funding amount, HIV disease prevalence, number of counties within the health department jurisdiction (if applicable), and program performance (in subsequent years). Funding for Components B and C are contingent upon submission of application for funding under Component A. Applicants should submit one application that is responsive to the requirements outlined under each of the components for which they intend to apply.

Funding is subject to the availability of appropriated funds. Funding availability in subsequent fiscal years will be determined by satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government. The amount available, in addition to the ceiling amounts stated, is based on current projections. Future year ceiling and award amounts may be adjusted to reflect any changes. CDC may require recipients to submit a revised budget and work plan, as necessary, to appropriately reflect the actual funding amounts provided in the Notice of Award(s).

a. Eligible Applicants: Limited

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 48 Component A: 32 Component B: 8 (beginning in Year 2) Component C: 5 - 8

d. Total Period of Performance Funding: $109,000,000

e. Average One Year Award Amount: $0 Component A: Not applicable. Funding will be determined by formulas reflecting a base funding amount, HIV disease prevalence, number of counties within the health department jurisdiction (if applicable), and program performance (in subsequent years). Funding will vary by jurisdiction.

Component B: $450,000 - $725,000; Funding begins in Year 2

Component C: $400,000 - $800,000

f. Number of Years of Award: 5

g. Estimated Award Date: 06/01/2020

h. Cost Sharing and / or Matching Requirements: N

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview For more than 35 years, HIV has affected millions of Americans of whom more than 700,000 have died. In recent years, deaths among persons with HIV have declined, while the number of people with HIV has increased. According to CDC, an estimated 1.1 million persons are living with HIV and approximately 15% are unaware they have HIV. [1, 2] Unless effectively treated to achieve viral suppression, HIV can be transmitted to others and leads to premature death.

However, persons with HIV who use antiretroviral therapy (ART) and reach and maintain an undetectable viral load in their blood can have a nearly normal life expectancy and have effectively no risk of transmitting HIV to others through sex.[3]

The Administration's approach to reducing HIV infections in the United States - or High Impact Prevention (HIP) - focuses on a strategic combination of scientifically proven, cost-effective, and scalable structural, behavioral, and biomedical interventions that target persons both with and without HIV in geographic areas where infections are most concentrated. Reaching and maintaining viral suppression among people with HIV is the most effective way to reduce new infections. Efforts that uniquely target HIV-negative persons, such as behaviors that minimize risk, pre-exposure prophylaxis (PrEP), non-occupational post-exposure prophylaxis (nPEP), and comprehensive syringe service programs (SSPs), are critical supplements to effective treatment.

Behavioral strategies (e.g., use of condoms, reduced number of sexual and injection-sharing partners) are proven effective strategies to reduce risk of HIV transmission in both those with and without HIV.[5] Community partners are uniquely positioned to complement and extend the reach of HIV prevention efforts implemented by state and local health departments. Thus, it is critical that health departments consider the most productive means for reaching out and engaging the community and other partners.

Since the late 1980s, CDC has formally partnered with state and local health departments to conduct HIV surveillance and expand the impact and reach of HIV prevention in affected communities. Additional HIV prevention partners include primary and HIV-specialty care providers, tribal governments and/or tribally designated organizations, community and faith-based organizations, and education agencies, among others. Together with the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Service Administration (SAMHSA), the National Institutes of Health (NIH), Indian Health Service (IHS), and the Office of the Assistant Secretary for Health, CDC seeks to ensure every

American knows their HIV status and is durably linked to and engaged with comprehensive and effective HIV prevention and treatment services.

b. Statutory Authorities Section 318(b-c) of the Public Health Service Act (42 USC § 247c(b-c)), as amended, and the Consolidated Appropriation Act of 2016 (Pub. L. 114-113).

c. Healthy People 2030 This NOFO addresses the Healthy People 2030 focus on HIV: http://www.healthypeople.gov /2020/topicsobjectives2020/overview.aspx?topicid=22

d. Other National Public Health Priorities and Strategies Other National Public Health Priorities Ending the HIV Epidemic: A Plan for America: https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview The HHS Strategic Plan, FY 2018-2022: https://www.hhs.gov/about/strategic-plan/strategic-goal-2/index.html National HIV/AIDS Strategy: Update 2020: https://www.hiv.gov/federal-response/national-hiv-aids-strategy/nhas-update CDC Division of HIV/AIDS Prevention Strategic Plan 2017-2020: https://www.cdc.gov/hiv/pdf /dhap/cdc-hiv-dhap-external-strategic-plan.pdf CDC National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Strategic Plan Through 2020: https://www.cdc.gov/nchhstp/docs/NCHHSTP-Strategic-Plan-through- 2020-508.pdf HIV Care Continuum: https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-conti nuum

e. Relevant Work PS18-1802: Integrated HIV Surveillance and Prevention Programs for Health Departments PS19-1906: Strategic Partnerships and Planning to Support Ending the HIV Epidemic in the United States PS19-1901: Strengthening STD Prevention and Control for Health Departments (STD PCHD)

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=22 http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=22 https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hhs.gov/about/strategic-plan/strategic-goal-2/index.html https://www.hhs.gov/about/strategic-plan/strategic-goal-2/index.html https://www.hiv.gov/federal-response/national-hiv-aids-strategy/nhas-update https://www.hiv.gov/federal-response/national-hiv-aids-strategy/nhas-update https://www.cdc.gov/hiv/pdf/dhap/cdc-hiv-dhap-external-strategic-plan.pdf https://www.cdc.gov/hiv/pdf/dhap/cdc-hiv-dhap-external-strategic-plan.pdf https://www.cdc.gov/nchhstp/docs/NCHHSTP-Strategic-Plan-through-2020-508.pdf https://www.cdc.gov/nchhstp/docs/NCHHSTP-Strategic-Plan-through-2020-508.pdf https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum

i. Purpose The purpose of this NOFO is to implement comprehensive HIV programs, that complement programs, such as the Ryan White program and other HHS programs, designed to support ending the HIV epidemic in America by leveraging powerful data, tools and resources to reduce new HIV infections by 75% in 5 years.

ii. Outcomes The program is expected to demonstrate measurable progress toward addressing the short-term and intermediate outcomes that appear in bold in the NOFO logic model. Indicators that quantify these outcomes are described in the section entitled CDC Evaluation and Performance Measurement Strategy.

Expected short-term and intermediate outcomes include the following:

Component A:

Diagnose

Increased routine opt-out HIV screenings in healthcare and other institutional settings Increased local availability of and accessibility to HIV testing services Increased HIV screening and re-screening among persons at elevated risk for HIV Increased knowledge of HIV status (Intermediate Outcome) Reduced new HIV diagnoses (Intermediate Outcome)

Treat

Increased rapid linkage to HIV medical care Increased early initiation of ART Increased immediate re-engagement to HIV prevention and treatment services for PWH who have disengaged from care Increased receipt of HIV medical care among persons with HIV (Intermediate Outcome) Increased viral suppression among PWH (Intermediate Outcome)

Prevent

Increased screening for PrEP indications among HIV-negative clients Increased referral and rapid linkage of persons with indications for PrEP Increased access to SSPs Increased PrEP prescriptions among persons with indications for PrEP (Intermediate

Outcome) Increased knowledge about the evidence-base of SSPs in communities (Intermediate

Outcome) Increased quality of evidence-based SSP service delivery (Intermediate Outcome)

Respond

Increased health department and community engagement for cluster detection and response

Improved surveillance data for real-time cluster detection and response Improved policies and funding mechanisms to respond to and contain HIV clusters and outbreaks Improved response to HIV transmission clusters and outbreaks (Intermediate Outcome)

Component B:

Estimate HIV incidence in selected jurisdictions using a recency-based assay

Component C:

Increased identification of new HIV infections in STD specialty clinics Increased rapid linkage to care for individuals newly diagnosed with HIV infection at

STD specialty clinic Increased identification of virally unsuppressed people in STD specialty clinics Increased re-engagement to care for persons living with HIV infection who are not virally suppressed Increased screening for PrEP/nPEP indication in STD specialty clinics Increased PrEP-eligible individuals in STD specialty clinics who are offered and initiate

PrEP, if indicated

iii. Strategies and Activities Component A: Ending the HIV Epidemic Initiative (EHE) - Required Core Component The strategies and activities included in Component A of this NOFO are designed to be complementary to the strategies and activities funded by PS18-1802: Integrated HIV Surveillance and Prevention Programs for Health Departments. Jurisdictions should carefully evaluate their existing PS18-1802 supported prevention and surveillance portfolio to ensure that activities are being brought to scale and focused on specific populations based upon disease burden, and as outlined by the EHE initiative. If needed, programmatic changes should be made to maximize the impact of available resources in the targeted jurisdictions. Examples included below represent possible activities. However, jurisdictions should consider innovative strategies that better align with the needs of their local jurisdiction. Any proposed new activity should include the rationale for the approach or a brief summary of the evidence that justifies its inclusion. The process of identifying innovative strategies will occur in collaboration with CDC during the first 3 months of the project. When applicable, jurisdictions are encouraged to use and adapt HHS, CDC, HRSA, IHS, or other campaigns to increase knowledge about and promote HIV prevention, including PrEP effectiveness, availability and uptake, and decrease misinformation about PrEP to a broad population. CDC anticipates that jurisdictions may collaborate on the development of communications materials, resources, and other products.

HHS/CDC and funded jurisdictions may find it advantageous to co-brand these materials. In such cases, the funding recipient will work with HHS/CDC to assure that all appropriate permissions are obtained, and materials are appropriately reviewed and approved by

HHS/CDC. All newly developed co-branded materials and/or materials that include the HHS and CDC logos must be prepared with substantial involvement from CDC.

The strategies and activities included in Component A were strategically selected to maximize the ability of all jurisdictions to reach the goals of the EHE initiative and to focus efforts and facilitate transfer of knowledge and best practices from the Phase 1 jurisdictions (see the Eligibility Information section for a list of Phase 1 jurisdictions) to other jurisdictions so that EHE goals can be achieved by 2030. CDC's expectations are that all strategies and activities will be implemented using the principles of High-Impact Prevention (HIP). However, a jurisdiction will have the opportunity to opt-out of some activities (e.g., implementation is not currently feasible due to local or state laws), with the exception of any requirements listed as mandatory. A jurisdiction requesting to opt-out of an activity will be required to provide CDC with a full justification that is included in the application for funding, before a waiver will be approved. Proposed strategies and activities should be consistent with and responsive to EHE plans newly developed or enhanced using funds awarded under PS19-1906: Strategic Partnerships and Planning to Support Ending the HIV Epidemic in the United States.

Additionally, this program allows each jurisdiction to maximize the impact of federal HIV prevention funding, strengthen implementation of HIP, align resources to better match the geographic burden of HIV infections, and improve data collection for public health action. CDC strongly encourages applicants to coordinate with partners such as HRSA HIV/AIDS Bureau and Bureau of Primary Health Care funded recipients, IHS funded recipients, tribal governments and/or tribally designated organizations, STD, viral hepatitis, and TB programs, other surveillance programs, laboratory units, other health agencies, community-based and faith-based organizations, community health centers, lesbian, gay, bisexual and transgender (LGBT) health centers, STD and TB clinics, local education agencies, hospitals, specialty clinics, other non-governmental organizations, and criminal justice and correctional facilities to implement comprehensive HIV programs within the jurisdiction.

Health department funding recipients are required to establish a new or expand an existing EHE advisory group or committee, as a standing or ad hoc committee, as allowed by planning group policies, procedures, and/or bylaws, to: 1) advise the health department funding recipient on EHE-related priorities and activities; and 2) ensure ongoing representation from the community throughout the 5-year project period. Additionally, health department funding recipients must adhere to guidance provided in the EHE Planning Program Guidance when establishing criteria for recruiting advisory group or committee members. At a minimum, the composition of the advisory group or committee must be inclusive of representatives from the Phase 1 counties (e.g., health department staff, community members) and members of local communities affected by or living with HIV who may not have been fully heard or may not have felt fully engaged in the past. The proposed structure and role and responsibilities of the group must be described in the EHE plan as well as the PS20-2010 application for funding.

Applicants are eligible to use up to 10%a of the approved total funding amount to:

1. enhance and expand integrated screening activities (e.g., screening for STDs, viral hepatitis, and/or TB), conducted in conjunction with HIV testing, with accompanying referral for prevention and care services; and/or

2. diagnose and treat STDs for uninsured or underinsured people receiving care in not-for-profit or governmental clinics, when conducted in conjunction with HIV testing and provided that these facilities document their ability to provide safety-net STD clinical preventive services as per CDC guidance. At a minimum, clinics receiving assistance should have the capacity to rapidly diagnose and treat bacterial STDs.b

HIV surveillance data are essential for monitoring HIV trends; detecting HIV clusters;

identifying persons in need of critical services, including partner services and linkage to care;

assessment for enhanced support services; and guiding public health action. Moreover, HIV surveillance provides data critical to monitoring the success of efforts to end the HIV epidemic.

In accordance with existing surveillance standards, recipients should strengthen HIV surveillance systems, including developing secure means for timely and accurate reporting of HIV diagnoses and other HIV-related laboratory test results (within two months of the specimen collection date) for assessment of patient needs to maximize real-time linkage to partner services, care, and essential support services. This is a mandatory program requirement and jurisdictions cannot opt out of this program requirement. Failure to implement and maintain comprehensive collection and reporting of HIV laboratory data will result in the restriction of funds.

EHE Health Department Jurisdictions with One or More Phase One Counties Recipients with one or more Phase 1 counties must ensure that at least 70% of the total resources received are directed to the local EHE jurisdiction(s). Recipients may use the remaining funds to support: 1) infrastructure, 2) activities and services, that will be provided by the recipient, and 3) the anticipated support the recipient will provide to the Phase 1 counties within their respective jurisdictions. If a Phase 1 county health department(s) does not have the capacity to manage the funds, the recipient may request to provide less than 70% of funding to ensure adequate oversight and implementation of program activities within the Phase 1 counties. However, the recipient must submit, with the application, a letter of concurrence or agreement (LOC/LOA), obtained from each Phase 1 county in the health department jurisdiction, indicating: 1) the current inability to manage the funds and/or fully implement the required EHE activities, in accordance with the NOFO; and 2) their preference for the recipient to retain full or partial funding until a time in which the necessary capacity is established.

Additionally, the recipient must describe in detail how they will assist with building the capacity of the Phase 1 county over the 5-year project period. Included must be a timeline for the transition of fiscal and/or programmatic management and oversight to the Phase 1 county, if applicable and deemed appropriate. Official approval will be granted via written response from CDC. To ensure that resources are reaching the Phase 1 counties, each funded jurisdiction will be required to report annually to CDC on the amount of funding allocated to these areas.

Additionally, funding should be allocated in a manner that ensures services are targeted to appropriate areas and expand and/or enhance the ability of local areas to increase access to services where challenges currently exist.

Note: The following documents do not count toward the page limit for the Project Narrative.

Applicants must file LOC/LOA with the Phase 1 County(s), as appropriate, name the file(s) LOC," and upload the document(s) as a PDF file under "Other Attachments Forms".

EHE Health Department Jurisdictions without Phase One Counties For the seven states that do not have identified counties, efforts should be made to allocate funding according to the epidemiologic, surveillance, and other available data sources to inform program efforts and assist in program planning, implementation and evaluation. Recipients are encouraged to use the most current epidemiological profile to inform local program efforts and assist in program planning, implementation, and evaluation. Specifically, to ensure resources reach the areas (e.g., county, city, etc.) of greatest need, adequate resources should be allocated to areas that have at least 30% of the state's HIV burden. Recipients should utilize local epidemiologic, surveillance, and other available data as well as locally developed funding formulas to determine the appropriate amount of funding to be allocated to each area. Funded jurisdictions will be required to report annually to CDC the amount of funding allocated to the above-referenced areas. Additionally, funding should be allocated in a manner that ensures services are targeted to appropriate areas and expand and/or enhance the ability of local areas to increase access to services where challenges currently exist, such as rural parts of the state.

Community Engagement Community engagement processes involve the collaboration of key stakeholders and communities who collaboratively identify strategies for increased coordination of HIV programs throughout the state and local health jurisdictions. Ultimately, an effective collaboration should result in a collective vision that assists the jurisdiction in achieving the goals of the EHE Initiative. Furthermore, engaging the community is a key factor in the recipients' ability to successfully implement their EHE programs. Therefore, all recipients must allocate at least 25% of the total funds directed to the local EHE jurisdiction(s) to support planning and implementation of EHE activities by community organizations. Recipients are encouraged to establish new funding relationships with community organizations that have traditionally not received funding and that:

have experience working with communities most affected by HIV, including experience addressing the social determinants that influence populations most severely affected by HIV; and possess the capacity to implement the EHE activities.

Furthermore, recipients may continue funding relationships with community organizations that have proven experience working with communities most affected by HIV, including experience addressing the social determinants that influence populations most severely affected by HIV.

Recipients should also consider funding various community organizations, located in other parts of the jurisdiction, that have the capacity to expand their services to the Phase 1 counties where traditional HIV-focused CBOs do not exist or do not have the capacity to support implementation of EHE activities. For the purposes of this NOFO, community organizations include non-profit public or private organizations, American Indian/Alaska Native tribally designated organizations (e.g., tribal health programs, tribal organizations, urban Indian health programs, etc.), community-based organizations, faith-based organizations, hospitals, and health centers, including federally qualified health centers.

Although not direct recipients of this funding, private sector entities are important partners in achieving success under the EHE initiative. Recipients are encouraged to seek out opportunities to ensure private sector entities are engaged in ways that maximize the impact of the EHE initiative. Examples of engagement, may include, but are not limited to: promoting routine HIV testing as standard of care and building capacity for reimbursement through third party payers, increasing awareness of and capacity to screen for and prescribe PrEP, as well as PEP, or referring patients to substance use disorder treatment and SSPs.

Additionally, recipients are expected to have a robust evaluation plan and should allocate appropriate funds to support evaluation staff and activities. See the Applicant Evaluation and Performance Measurement Plan section for guidance on funding to support evaluation staff and activities.

In anticipation of continued advancements and the availability of new tools and resources, recipients are expected to apply best practices and lessons learned to the implementation of their programs. Thus, jurisdictions should be prepared to revise their programmatic approaches based on advances in science and the dissemination of best practices and lessons learned. In addition, recipients should conduct ongoing reviews of existing data to identify and prioritize social and structural barriers that may be impeding the successful implementation of the NOFO activities, focusing on addressing those with the largest impact as well as the highest likelihood of implementation success.

Strategy 1: Diagnose all people with HIV as early as possible An HIV test is the first step to HIV medical care and treatment for those who test positive and provides a gateway to HIV prevention services such as PrEP for those who test negative but remain at risk for HIV. In 2006, CDC recommended all persons age 13 to 64 be screened for HIV in healthcare settings; however, uptake has been suboptimal. CDC has funded a wide variety of clinical and non-clinical HIV testing activities through other funding mechanisms, including PS18-1802. In order to end the HIV epidemic, health departments are encouraged to propose new and innovative HIV testing strategies, like those described in this section, or improve the reach of existing programs. Impactful programs should be locally tailored to develop a mix of testing options, with the main goals to make HIV testing accessible and routine, and reduce the time from HIV infection to diagnosis. By so doing, those with undiagnosed HIV, as well as those previously testing positive but not engaged in HIV medical care or virally suppressed, can be identified and referred to HIV medical care and treatment services. A negative HIV test should lead to referrals for preventive services, such as PrEP and SSPs. Therefore, proposed Diagnose activities should include a description of how HIV testing encounters will be leveraged to improve the provision of comprehensive HIV medical care and preventive services, and ways in which HIV testing services can be integrated into Response.

Strategy 1A: Expand or implement routine opt-out HIV screening in healthcare and other institutional settings located in high prevalence communities

Identify and select healthcare facilities using criteria developed during the local planning process, such as geographic location and populations served, that have not already implemented routine HIV screening, and automate HIV test orders for eligible patients at key healthcare encounters (e.g. emergency department visits, annual physical exams).

Promote routine opt-out screening as part of medical intake evaluation in jails, particularly in large jails located in high prevalence communities, as well as in prison systems if HIV testing is not yet routinely performed, in accordance with state and local policy.

Identify "champions" or key staff (e.g. nurses/other medical staff performing intake medical examinations) to lead activities to routinize HIV screening at intake.

Modify the electronic medical records to routinize the offer of screening and screen all patients (at least once) for HIV regardless of risk.

Establish mechanisms for rapid linkage to HIV medical care and prevention (i.e., PrEP and SSP) services for persons screened for HIV in all healthcare settings.

o Rapid linkage to care for persons newly diagnosed with HIV is defined as, ensuring rapid linkage to care and starting antiretroviral therapy, within 7 days.

Strategy 1B: Develop locally tailored HIV testing programs to reach persons in non-healthcare settings Activities may include, but are not limited to the following:

Normalize HIV testing in non-traditional settings (e.g., pharmacies and retail venues) by advertising broadly and providing residents multiple options to receive HIV tests in venues that do not traditionally promote tests.

o Examples include, but are not limited to a combination of "brick-and-mortar" buildings, mobile units, etc.

Promote rapid HIV self-test distribution programs, mobile testing units, and technology-based partner services and social network recruiting strategies.

Implement testing at health fairs or pop-up testing events where appropriate (including in rural and resource scarce environments), whereby HIV testing is offered as a service bundled with screening for other conditions relevant to the local population (e.g., STD testing, HBV and HCV testing, blood pressure screening, BMI assessment) in order to reduce stigma and normalize HIV testing.

o Incorporate strategies to rapidly link persons to HIV medical care and prevention (i.e., PrEP and SSP) in all non-traditional settings.

Collaborate with laboratories to determine appropriate tests and improve the quality of testing in non-healthcare settings.

Strategy 1C: Increase at least yearly re-screening of persons at elevated risk for HIV per CDC testing guidelines, in healthcare and non-healthcare settings

Establish systems whereby patients with elevated risk are routinely identified and HIV tests are ordered at least yearly. In some settings, annual screening of all patients could be considered.

Identify "champions" (e.g., physicians, nurses, etc.) who can lead all activities in healthcare settings needed to routinize identification of persons at ongoing risk for HIV and conduct at least annual HIV screening for this population

Modify the electronic medical records to routinize the offer of annual screening for those at ongoing risk for HIV.

Promote rapid HIV self-test programs in both healthcare and non-healthcare settings that can offer HIV rapid self-tests to persons at ongoing risk. This could include self-tests that clients can take away for themselves or distribute to others in their network.

Implement novel approaches to make HIV tests widely available in non-healthcare settings where marginalized populations, including people experiencing homelessness and/or those injecting drugs congregate (e.g., homeless shelters, mobile clinics and laboratories, and SSPs).

Strategy 2: Treat people with HIV rapidly and effectively to reach viral suppression HIV treatment has transformed the HIV prevention landscape and dramatically improved the health, quality of life, and life expectancy of people with HIV. In addition, research has shown the profound impact of HIV treatment in preventing the sexual transmission of HIV. Keeping patients in regular, ongoing care can support antiretroviral therapy (ART) adherence, maintain decreased viral load and increased CD4 count, lower rates of progression to AIDS, improve overall health and reduce the risk of HIV transmission. Current treatment guidelines recommend ART for all people with HIV regardless of CD4 count. While ART can reduce HIV-related morbidity and mortality when taken consistently, in the U.S. only 53% of all persons with HIV are virally suppressed.

The Treat strategy is focused on comprehensive strategies to enhance linkage to and engagement in HIV medical care, expand re-engagement and retention in care and improve viral suppression among persons with HIV.

Strategy 2A: Ensure rapid linkage to HIV medical care and antiretroviral therapy (ART) initiation for all persons with newly diagnosed HIV Examples may include, but are not limited to the following:

Develop a robust network (supported by interagency/facility agreements) for rapid linkage (within 7 days) to clinical care and essential support services.

Report all new HIV diagnoses to health departments, as rapidly as possible, in accordance with state and local policy by establishing or expanding secure electronic methods or on-call hotline(s) (including after-hours).

Conduct a rapid needs assessment (housing, transportation etc.) for all persons with new HIV diagnoses and link to a disease intervention specialist and/or case manager as needed.

Develop programs to support and promote rapid linkage (within 7 days) and early ART initiation by HIV medical care and treatment providers in non-Ryan White HIV/AIDS Program facilities.

Strategy 2B: Support re-engagement and retention in HIV medical care and treatment adherence, especially for persons who are not recipients of Ryan White HIV/AIDS Programs Examples may include, but are not limited to the following:

Develop, expand and scale up Data to Care programs using surveillance data and other data sources including Medicaid administrative claims and pharmacy refill data (D2C Rx), to identify patients not in care and develop re-engagement strategies (e.g. utilizing linkage specialists, disease intervention specialists).

Develop electronic based approaches (e.g., text messaging, virtual case management) to support retention in care activities, patient navigation and distribution of strengths-based case management (e.g., ARTAS) via phone.

Create and maintain an easily accessible provider-initiated retention in care support service (e.g., encrypted online reporting system) for providers to request health department support when patients miss appointments or appear to be lost to follow up.

Provide locally informed, evidence-based incentives (non-monetary) to PWH for retention in care and viral suppression.

Develop robust telemedicine programs that use electronic information and telecommunications technologies (e.g., videoconferencing, the internet, store-and-forward imaging, streaming media) to support and promote long-distance clinical health care and patient health-related education. Please reference the Other Information section for additional resources specific to telemedicine.

Strategy 3: Prevent new HIV transmission by using proven interventions, including pre-exposure prophylaxis (PrEP) and syringe services programs (SSPs) Pre-exposure prophylaxis (PrEP), when used consistently, is a highly effective HIV prevention tool. However, slow uptake has hindered its full potential for reducing new HIV infections in high incidence areas. The intent of the following strategies includes increasing overall PrEP use, while simultaneously focusing on addressing PrEP uptake in communities with the highest need (e.g., African-American men who have sex with men). All activities to expand PrEP care and increase its use should incorporate elements to increase non-occupation post-exposure prophylaxis (nPEP) awareness and access when appropriate, including activities with clinicians, non-clinical CBOs, and persons at risk for HIV acquisition.

HHS supports the implementation of comprehensive SSPs as an effective public health approach to reduce the spread of infectious diseases. SSPs have been associated with a reduced risk of infection with bloodborne diseases such as HIV and viral hepatitis. In addition to improving access to sterile injection equipment, SSPs often provide other services important in supporting persons who inject drugs (PWID). SSPs offer risk reduction counseling and are an important venue for HIV, viral hepatitis, STD, and TB testing; hepatitis A and hepatitis B vaccination; linkage to care and treatment; the provision of naloxone; and referrals to substance use treatment. More information for applicants is provided at the following link: https://www .cdc.gov/ssp/index.html. Refer to the HHS Syringe Services Programs (SSP) Implementation Guidance at https://www.hiv.gov/sites/default/files/hhs-ssp-guidance.pdf. The CDC Program Guidance for Implementing Certain Components of Syringe Services Programs, 2016, provides specific procedures for CDC-funded grantees: https://www.cdc.gov/hiv/pdf/risk/cdc-hiv-syringe -exchange-services.pdf Additionally, the desired outcome for the Prevent strategy's syringe services programs (SSPs) strategy is to develop programs that provide comprehensive service delivery. However, in situations where foundational elements may not exist for developing comprehensive SSP service delivery, applicants may prioritize specific "building block" components that can lead to more robust service delivery.

Strategy 3A: Accelerate efforts to increase PrEP use, particularly for populations with the highest rates of new HIV diagnoses and low PrEP use among those with indications for PrEP.

Examples may include, but are not limited to the following:

Support development and delivery of PrEP services in clinical and nonclinical sites in communities with the highest rates of new HIV diagnoses. Ensure adequate scale-up of PrEP use among MSM of all races, and particularly young African American and Hispanic/Latino gay and bisexual men, transgender persons, and other communities that https://www.cdc.gov/ssp/index.html https://www.cdc.gov/ssp/index.html https://www.hiv.gov/sites/default/files/hhs-ssp-guidance.pdf https://www.cdc.gov/hiv/pdf/risk/cdc-hiv-syringe-exchange-services.pdf https://www.cdc.gov/hiv/pdf/risk/cdc-hiv-syringe-exchange-services.pdf would benefit most from its use. Efforts should also be made to co-locate nPEP with PrEP services to prevent possible HIV infections from recent exposure.

o Examples of clinical and non-clinical sites include, but are not limited to a combination of "brick-and-mortar" buildings (e.g., health centers), and mobile vans.

Increase PrEP training among private and safety-net clinical providers by increasing the number of trained PrEP detailers (i.e., clinical educators) through collaboration with organizations that have demonstrated success in providing ongoing training and support (e.g., AIDS Education Training Centers, The National Resource Center for Academic Detailing), and adapting resources from CDC and others to meet local provider training needs (e.g., materials from the Prescribe HIV Prevention campaign).

Incentivize PrEP provision that is appropriate to locally specific demographics of persons with new HIV diagnoses while maintaining provision of PrEP to all persons with indications for its use. Examples may include, but are not limited to: annual awards or incentives for clinical sites that exceed annual goals for providing PrEP (not already funded by the HRSA Bureau of Primary Health Care) for success in reducing disparities (i.e., matching the provision of PrEP to the local demographics of persons with new HIV diagnoses).

Support the formation of a locally-driven peer network of African American and Hispanic/Latino persons who are PrEP users, to educate on PrEP and support PrEP uptake and continued PrEP use among persons in their social networks.

Develop and implement locally-specific insurance and cost-assistance navigation protocols for PrEP patients.

Support client access to existing traditional PrEP care delivery systems (e.g., community health centers) and non-traditional PrEP care delivery systems. This may include active referral and linkage to: home test kits for some visits, PrEP care in community pharmacies, and use of telemedicine services especially in rural communities.

Disseminate approaches proven effective to support adherence and persistence.

Examples include certified health coaches or nurse educators, certified community health workers, PrEP navigators, use of eHealth technology, and pharmacist- based PrEP services. Priority should be given to services that are fiscally sustainable (e.g., billable).

CDC funds may be used to support limited personnel costs related to the provision of PrEP medication if coupled with other supportive PrEP services, e.g., eligibility assessments, risk reduction education, referral/navigation support to other essential services, etc. These activities must be a well-defined set of duties that are in addition to writing prescriptions and provision of clinical care. The funded percentage for these duties may not exceed 75% of the FTE. Other sources of funding are needed to support any duties specifically related to clinical care.

CDC funds may be used for laboratory costs for screening or monitoring PrEP per CDC Guidelines for uninsured or underinsured people receiving PrEP in not-for-profit or governmental clinics.

CDC funds may be used for mobile units and other novel engagement strategies.

CDC funds cannot be used to cover the costs of antiretroviral medication, including

PrEP.

CDC funds may not be used for clinical care except as allowed by law.c

Strategy 3B: Increase availability, use, and access to and quality of comprehensive Syringe Services Programs (SSPs) Use of funds to support proposed SSPs must be in accordance with federal law and CDC guidance. Additionally, resources awarded as part of this NOFO may be used to support efforts to build or expand SSPs, but only when certain conditions are met. In consultation with CDC, state and local health departments must first demonstrate that the jurisdiction or area they are serving is at risk for, or experiencing, a significant increase in hepatitis infections or an HIV outbreak due to injection drug use. Recipients can initiate the Determination of Need (DON) request at any time during the project period. However, funds cannot be allocated to support SSPs until concurrence with the DON has been received. More information can be found at https://www.aids.gov/pdf/hhs-ssp-guidance.pdf.

Examples may include, but are not limited to the following:

Ensure that SSPs provide clients with the following standard services: needs-based access to sterile needles and syringes and other injection equipment (e.g., sterile water, cookers), condoms, syringe disposal, HIV and HCV testing, linkage to HIV and HCV care, linkage to PrEP, naloxone distribution, and linkage to medication-assisted treatment.

o Condom distribution efforts, including the promotion of and provision of condoms, within communities, venues, and other settings, should be included as a component of the SSPs.

Ensure that SSPs have the following additional services provided directly to clients or available through formal, active referral arrangements facilitated by patient navigators:

o Infectious disease prevention, detection, care, and treatment; including HIV, viral hepatitis (HAV, HBV, and HCV), sexually transmitted infections (syphilis, gonorrhea, and chlamydia) and wound care.

o Substance use disorder care and treatment; including low threshold medication-assisted treatment and evidence-based psychological and behavioral treatments (e.g., talk therapies).

o Essential support services, including housing, transportation; mental health/substance use counseling.

Promote and establish SSPs strategically distributed across communities with the highest number of new HIV diagnoses attributed to injection drug use, highest number of new HCV diagnoses, and/or highest rates of drug overdose.

o Examples include, but are not limited to a combination of "brick-and-mortar" buildings, mobile vans, vending machines, and peer-delivery systems.

o For jurisdictions that do not currently have laws in place to support SSPs, educate stakeholders about the evidence which has shown that SSPs reduce the transmission and spread of infectious diseases.

Increase access to sterile needles and syringes for persons who inject drugs (PWID) through non-prescription syringe sales in community pharmacies, where allowed by law.

Educate the community about the availability and evidence-base of SSP services, including through the use of evidence-based consumer materials and content.

https://www.aids.gov/pdf/hhs-ssp-guidance.pdf

Develop and implement a quality management program to continuously evaluate and improve SSP service delivery according to evidence-based practices defined by HHS.

Strategy 4: Respond quickly to potential HIV outbreaks to get needed prevention and treatment services to people who need them Cluster and outbreak detection and response are relatively new activities in 2019 that have not yet been widely implemented. Therefore, the benefit has not been fully realized. Responding quickly to clusters and outbreaks in which HIV is spreading quickly offers an opportunity to interrupt that spread. The presence of a cluster indicates gaps in prevention services, which must be addressed to improve access to services such as HIV testing, ART, and PrEP in order to stop transmission. In this way, response is closely related to other strategies described here, as cluster response uses traditional HIV prevention approaches in a more focused way.

Successful cluster response depends on strong partnerships, processes, data systems, and policies. The activities included in the first strategy (4A) focus on these fundamental building blocks to help ensure successful response; for this reason, it is critically important that recipients prioritize and complete these activities to promote success in cluster response.

Strategy 4A: Develop partnerships, processes, data systems, and policies to facilitate robust, real-time cluster detection and response

Establish new or expand an existing standing committee that meets routinely to guide cluster response. Include health department leadership and staff with diverse areas of expertise and authority to implement change; routinely review cluster data, prioritize clusters, guide cluster response, review response data, and modify and improve responses as needed.

Actively involve members of local communities in planning, implementation, and evaluation. Include people with or at risk for HIV, local HIV services providers, Ryan White HIV/AIDS Program facility…