PKG00259660-instructions.pdf

Centers for Disease Control and Prevention

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

Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments

CDC-RFA-PS20-2009

Application Due Date: 05/11/2020

Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments

CDC-RFA-PS20-2009

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. Application and Submission Information 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- PS20-2009. 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) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments 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)).

New – Type 1

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS20-2009

E. Assistance Listings (CFDA) Number:

93.270 F. Dates:

1. Due Date for Letter of Intent (LOI): 03/25/2020

2. Due Date for Applications: 05/11/2020, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

Applications due 60 days after publication date.

3. Date for Informational Conference Call:

Call # 1: March 18, 2020 at 1:00 PM (Eastern Standard Time) Call # 2: April 1, 2020 at 1:00 PM (Eastern Standard Time) Local/Regional Bridge Line(s)

(404) 553-8912

(855) 348-8390 Conference ID: 5754594

G. Executive Summary:

1. Summary Paragraph:

This NOFO supports integrated viral hepatitis surveillance and prevention programs in states and large cities in the United States. Key strategies include viral hepatitis outbreak planning and response; and surveillance for acute hepatitis A, B and C, and chronic hepatitis C. Recipients 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 should develop a jurisdictional viral hepatitis elimination plan, increase comprehensive hepatitis B and C reporting, improve HBV and HCV testing and increase healthcare providers trained to treat hepatitis B and C. Contingent on funding, the following activities can be supported:

surveillance for chronic hepatitis B and perinatal hepatitis C; increased hepatitis B and C testing and referral to care in high-impact settings (syringe services programs (SSPs), substance use disorder (SUD) treatment centers, correctional facilities, emergency departments and sexually transmitted disease clinics; and increased access to services preventing viral hepatitis and other infections among persons who inject drugs (PWID). Contingent on funding, an optional component will support improved access to prevention, diagnosis, and treatment of viral, bacterial and fungal infections related to drug use in settings disproportionately affected by drug use. Expected outcomes include improved surveillance for viral hepatitis, increased stakeholder engagement in viral hepatitis elimination planning, and improved access to viral hepatitis prevention, diagnosis, and treatment among populations most at risk.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 58 Component 1: 58 awards Component 2: 58 awards Component 3: 10 awards

d. Total Period of Performance Funding: $341,020,000 Total period of performance funding: Up to $341,020,000

Component 1 (Surveillance): up to $131,600,000 (Component 1 estimated at $11,600,000 in Year One) Component 2 (Prevention): up to $126,670,000 (Component 2 estimated at $6,670,000 in Year One) Component 3 (Special Projects): up to $82,750,000 (Component 3 estimated at $2,750,000 in Year One) 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, CDC can process applications and award funds in a timely manner. In the event that future fiscal year appropriation or other statute fails to authorize this activity, no awards will be made. Final award amounts may be less than requested. Funding availability in subsequent fiscal years is subject to the availability of appropriated funds.

e. Average One Year Award Amount: $315,000 Component 1 (Surveillance): $200,000 Component 2 (Prevention): $115,000 Component 3 (Special Projects): $275,000

These amounts are subject to availability of funds.

f. Total Period of Performance Length: 5

g. Estimated Award Date: 09/01/2020

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview An estimated 2.4 million people are infected with hepatitis C virus in the United States [1], and an estimated 44,000 people are newly infected every year [2]. Hepatitis C is curable, yet only about 56% of adults living with hepatitis C know they are infected [3], and about 1 out of every 14 new cases is reported to public health [4]. An estimated 862,000 people are living with hepatitis B virus in the United States [5], and an estimated 22,000 people are newly infected every year [2]. Hepatitis B is vaccine preventable and treatable, yet only about 32% of adults living with HBV know they are infected [3], and about 1 out of every 7 new cases are reported to public health [4]. The most common risk factor for acute hepatitis B and C is injection drug use [2]. Further, the United States continues to experience an unprecedented multi-state outbreak of acute hepatitis A, with over 30,000 reported cases since 2016 as of January 25, 2020, primarily affecting people who use drugs and people experiencing homelessness [6].

Priorities for this cooperative agreement are: Component 1, improve surveillance for viral hepatitis A, B and C in states and large cities, including outbreak detection, investigation and control; Component 2, facilitate state and large city viral hepatitis elimination planning, and increase access to hepatitis B and C testing and prevention, including hepatitis A and B vaccination, SSPs and medication assisted treatment (MAT) and treatment services. An additional optional Component 3 funds comprehensive, outcome-focused approaches to preventing infections associated with injection drug use, reducing overdose deaths, and linking people to SUD treatment.

National surveillance data has been critical for identifying injection drug use as the primary risk factor for ongoing transmission of hepatitis B and C [2]. For PWID with opioid use disorder (OUD), MAT reduces the risk of hepatitis C acquisition by 50% and the combination of high coverage needle and syringe exchange and MAT reduces hepatitis C acquisition by 74% [7].

PWID can be treated for hepatitis C with sustained viral response about 90% [8]. Despite evidence of effectiveness, state policies may limit access to direct acting antiviral treatment and SSPs [9], and access to MAT remains suboptimal [10]. In addition, hepatitis A and B are vaccine preventable, yet vaccination rates among adults (hepatitis A, 9%, hepatitis B, 24.5%) [11], including adults at increased risk (hepatitis B estimated 17 – 41%) [12, 13], are low.

Comprehensive SSPs (https://www.cdc.gov/hiv/pdf/risk/cdc-hiv-syringe-exchange-services.pdf) provide syringe exchange and access to other needed services for PWID.

https://www.cdc.gov/hiv/pdf/risk/cdc-hiv-syringe-exchange-services.pdf

National surveillance data can be leveraged for rapidly detecting outbreaks [6, 14], accurately assessing burden of disease, and monitoring elimination efforts for hepatitis B and C at the jurisdictional level [15, 16]. This cooperative agreement enables states to collect data to evaluate disease burden and trends and analyze and disseminate that data to develop or refine recommendations, policies, and practices that will ultimately reduce the burden of viral hepatitis in the jurisdiction.

This NOFO builds on CDC-RFA PS17-1703 which funded 14 states to build registries of hepatitis B and hepatitis C cases and improve completeness of case reports; and CDC-RFA-PS17- 1702 which funded 50 jurisdictions to identify high burden areas for hepatitis B and/or hepatitis C and improve prevention and treatment in those areas. Both awards have been in place since fiscal year 2017.

b. Statutory Authorities This program is authorized under Section 318 of the Public Health Service Act (42 U.S.C Section 247(c), as amended.

c. Healthy People 2030 This NOFO addresses the following “Healthy People 2020” focus area(s) of Immunization and Infectious Diseases:

IID-1.3 Reduce, eliminate, or maintain elimination of new hepatitis B cases among persons 2 to 18 years;

IID-15 Increase hepatitis B vaccine coverage among high-risk populations;

IID-25 Reduce hepatitis B;

IID-26 Reduce new hepatitis C infections; and, IID-27 Increase the percentage of persons aware they have hepatitis C infection

(http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=23).

d. Other National Public Health Priorities and Strategies This NOFO supports the goals of the 2017-2020 HHS National Viral Hepatitis Action Plan, https ://www.hhs.gov/hepatitis/viral-hepatitis-action-plan/index.html.

This NOFO also supports the Division of Viral Hepatitis (DVH) Strategic plan, https://www.cdc .gov/hepatitis/pdfs/dvh-strategicplan2016-2020.pdf, and the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention strategic plan, https://www.cdc.gov/nchhstp/strategicpriorities Finally, this NOFO supports the goals of enhancing community-based SSPs, as outlined in “Policies & Issues: Syringe Services Programs” at HIV.gov, https://www.hiv.gov/federal-respo nse/policies-issues/syringe-services-programs.

e. Relevant Work This NOFO builds upon previous or current hepatitis B and hepatitis C prevention or surveillance projects, including:

http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=23 https://www.hhs.gov/hepatitis/viral-hepatitis-action-plan/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-action-plan/index.html https://www.cdc.gov/hepatitis/pdfs/dvh-strategicplan2016-2020.pdf https://www.cdc.gov/hepatitis/pdfs/dvh-strategicplan2016-2020.pdf https://www.cdc.gov/nchhstp/strategicpriorities/ https://www.cdc.gov/nchhstp/strategicpriorities/ https://www.hiv.gov/federal-response/policies-issues/syringe-services-programs https://www.hiv.gov/federal-response/policies-issues/syringe-services-programs

CDC-RFA-PS17-1702 - Improving Hepatitis B and C Care Cascades; Focus on Increased Testing and Diagnosis CDC-RFA-PS17-1703 - Strengthening Surveillance in Jurisdictions with High Incidence of Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Infections CDC-RFA-PS19-1909 National Harm Reduction Technical Assistance and Syringe Services Program (SSP) Monitoring and Evaluation Funding Opportunity CDC-RFA-PS19-1904: Capacity Building Assistance (CBA) for High Impact HIV Prevention Program Integration

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities Short-term (Yrs 1-3) and Intermediate (Yrs 4-5) Outcomes

Long-term Outcomes

1. Core Viral Hepatitis Outbreak Response and Surveillance Activities

1.1 Develop, implement, and maintain plan to rapidly detect and respond to outbreaks of:

Hepatitis A Hepatitis B Hepatitis C

Short-term Outcomes:

Established jurisdictional framework for outbreak detection and response Earlier detection and response to viral hepatitis outbreaks Intermediate Outcomes:

Reduced new cases of viral hepatitis

1.2 Systematically collect, analyze, interpret, and disseminate data to characterize trends and implement public health interventions for:

Hepatitis A Acute hepatitis B Acute and chronic hepatitis C

Short-term Outcomes:

Increased public health reporting of chronic and perinatal HCV and chronic HBV infection, and undetectable HCV RNA and HBV DNA laboratory results Improved monitoring of burden of disease and trends in hepatitis A, acute hepatitis B, and acute hepatitis C Improved monitoring of burden of disease and outcomes in chronic hepatitis C Intermediate Outcomes:

Improved monitoring of hepatitis C continuum of cure (CoC)

1. Establishment of comprehensive national viral hepatitis surveillance

2. Reduced new viral hepatitis infections

3. Increased access to care for persons with viral hepatitis

4. Improved health outcomes for people with viral hepatitis

5. Reduced deaths among people with viral

Improved development and utilization of viral hepatitis surveillance data reports

1.3 Systematically collect, analyze, interpret, and disseminate data to characterize trends and implement public health interventions for:

Chronic hepatitis B Perinatal hepatitis C

Short-term Outcomes:

Improved monitoring of burden of disease and trends in perinatal hepatitis C Intermediate Outcomes:

Improved monitoring of burden of disease and outcomes in chronic hepatitis B Improved monitoring of hepatitis B CoC

2. Core Viral Hepatitis Prevention Activities

2.1 Support viral hepatitis

elimination planning and surveillance, and maximize access to testing, treatment, and prevention Increase routine HCV and HBV testing in high volume laboratories and health systems Expand provider capacity to treat hepatitis C and/or hepatitis B Disseminate materials regarding evidence-based best practices for access to HCV treatment and viral hepatitis prevention

Short-term Outcomes:

Increased state engagement with key stakeholders in viral hepatitis elimination planning Increased commercial and hospital-based laboratories conducting HCV RNA reflex testing Increased HCV and/or HBV testing in health care systems Intermediate Outcomes:

Increased healthcare providers trained in prescribing hepatitis C and/or hepatitis B treatment Increased access to HCV treatment Increased access to SSPs for PWID

2.2 Increase access to

HCV and HBV testing and referral to care in high-impact settings Increase routine HCV and HBV testing in high-impact settings Provide post-test counseling and referral to treatment or prevention

Short-term Outcomes:

Increased access to HCV RNA reflex and/or HBV testing among persons receiving services in high-impact settings Increased awareness of infection status among people diagnosed with chronic hepatitis C and/or hepatitis B Increased referral to treatment for people living with hepatitis C and/or hepatitis B Increased referral to treatment and prevention hepatitis

6. Reduced viral hepatitis-related health disparities

7. Decreased overdose deaths among PWID

8. Decreased infections from drug use services for persons who inject drugs (PWID) Intermediate Outcomes:

Increased cure of hepatitis C

2.3 Improve access to

services preventing viral hepatitis and other bloodborne infections among PWID Support SSPs Establish hepatitis A and B vaccine delivery teams

Short-term Outcomes:

Increased utilization of SSPs among PWID Increased referral of PWID to SUD treatment Increased receipt of hepatitis A and hepatitis B vaccination among clients in high-impact settings

3. Special Projects: Prevention, Diagnosis, and Treatment related to the infectious disease consequences of drug use

3.1 Improve access to

services for PWID in settings disproportionately affected by drug use:

Develop and implement PWID service bundle in settings that serve PWID (e.g., SSPs, MAT providers, hospital settings, correctional facilities)

3.2 Implement prevention

services and interventions to address emerging issues related to drug use Education and training to address emerging issues

Short-term Outcomes:

Increased access to high-coverage needle-syringe exchange among PWID Increased linkage to SUD treatment (including MAT among PWID with OUD) Increased HCV, HIV, and HBV testing among PWID Increased linkage to treatment services among people with infectious complications (viral hepatitis, HIV, bacterial, fungal) of

SUD

Increased receipt of hepatitis B and A vaccination among PWID Increased dissemination of evidence-based interventions and guidance to reduce bacterial and fungal complications among PWID Intermediate Outcomes:

Decreased new viral hepatitis, HIV and other infections (e.g., bacterial, fungal) among

PWID

Increased hepatitis C cures among PWID with hepatitis C Decreased unsafe injection practices

i. Purpose The purpose of this NOFO is to establish integrated viral hepatitis programs in health departments to: 1) expand jurisdictional surveillance for acute hepatitis A, B, and C; perinatal hepatitis C; and chronic hepatitis B and C, and 2) facilitate the development and implementation of viral hepatitis elimination plans. An optional component funds increased access to the prevention, diagnosis, and treatment of viral hepatitis B and C, HIV, bacterial and fungal infectious disease consequences of drug use among PWID in settings disproportionately affected by drug use.

ii. Outcomes The recipient is expected to make measurable progress towards 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 1 Core Viral Hepatitis Outbreak Response and Surveillance (Three required sections including one section contingent on funding)

1.1 Develop, implement, and maintain plan to rapidly detect and respond to outbreaks for:

hepatitis A, hepatitis B, and hepatitis C

Outcome 1.1.1 Established jurisdictional framework for outbreak detection and response

1.2 Systematically collect, analyze, interpret, and disseminate data to characterize trends and implement public health interventions for hepatitis A, acute hepatitis B and acute and chronic hepatitis C

Short-term outcomes:

Outcome 1.2.1 Increased public health reporting of chronic and perinatal HCV and chronic HBV infection, and undetectable HCV RNA and HBV DNA laboratory results

Outcome 1.2.2 Improved monitoring of burden of disease and trends in hepatitis A, acute hepatitis B, and acute hepatitis C

Outcome 1.2.3 Improved monitoring of burden of disease and outcomes in chronic hepatitis C

Intermediate outcomes:

Outcome 1.2.4 Improved monitoring of hepatitis C continuum of cure (CoC) Outcome 1.2.5 Improved development and utilization of viral hepatitis surveillance data reports

1.3 Systematically collect, analyze, interpret, and disseminate data to characterize trends and implement public health interventions for chronic hepatitis B, and perinatal hepatitis C (Contingent on available funding)

Short-term outcomes:

Outcome 1.3.1 Improved monitoring of burden of disease and trends in perinatal hepatitis C

Intermediate outcomes:

Outcome 1.3.2 Improved monitoring of burden of disease and outcomes in chronic hepatitis B

Outcome 1.3.3 Improved monitoring of hepatitis B CoC

Component 2 Core Viral Hepatitis Prevention (Three required sections including two sections contingent on funding)

2.1 Support viral hepatitis elimination planning and surveillance, and maximize access to testing, treatment, and prevention

Short-term outcomes:

Outcome 2.1.1 Increased state engagement with key stakeholders in viral hepatitis elimination planning

Outcome 2.1.2 Increased commercial and hospital-based laboratories conducting HCV RNA reflex testing

Outcome 2.1.3 Increased HCV and/or HBV testing in health care systems

Intermediate outcomes:

Outcome 2.1.4 Increased healthcare providers trained in prescribing hepatitis C and/or hepatitis B treatment

2.2 Increased access to hepatitis C and hepatitis B testing and referral to care in high-impact settings (Contingent on available funding)

Short-term outcomes:

Outcome 2.2.2 Increased awareness of infection status among people living with chronic hepatitis C and/or hepatitis B

Outcome 2.2.3 Increased referral to treatment for people living with hepatitis C and/or hepatitis B

2.3 Improve access to services preventing viral hepatitis and other bloodborne infections among PWID (Contingent on available funding)

Short-term outcomes:

Outcome 2.3.1 Increased utilization of SSPs among PWID Outcome 2.3.1 Increased referral of PWID to SUD treatment Outcome 2.3.3 Increased receipt of hepatitis A and hepatitis B vaccination among clients in high-impact settings

Component 3 (Optional). Special Projects: Prevention, Diagnosis, and Treatment related to the infectious disease consequences of drug use (Two optional sections contingent on available funding)

3.1 Improve access to services for PWID in settings disproportionately affected by drug use

Short-term outcomes:

Outcome 3.1.1 Increased access to high coverage needle-syringe exchange among PWID Outcome 3.1.2 Increased linkage to substance use disorder treatment (including MAT among PWID with OUD) Outcome 3.1.3 Increased HCV, HIV, and HBV testing among PWID Outcome 3.1.4 Increased linkage to treatment services among people with infectious complications (viral hepatitis, HIV, bacterial, fungal) of SUD Outcome 3.1.5 Increased receipt of hepatitis B and A vaccination among PWID

Intermediate outcomes:

Outcome 3.1.7 Decreased new viral hepatitis, HIV and other infections (e.g., bacterial, fungal) among PWID

Outcome 3.1.8 Increased hepatitis C cures among PWID with hepatitis C

3.2 Prevention services and interventions to address emerging issues related to drug use

(No outcomes specified; based on availability of funding, this sub-component will be considered for funding in years 2-5)

iii. Strategies and Activities Recipients are required to provide an integrated viral hepatitis surveillance and prevention program in the public health jurisdiction. The program consists of six required strategies (three funded and three contingent on funding) and two optional strategies contingent on funding with related activities. Recipients can request to opt out of selected required activities by providing a strong justification, which must be based on program need, resources and/or policies. Approval will be made after review of the application.

Required activities include those related to six strategies: 1.1, develop, implement, and maintain a plan to rapidly detect and respond to outbreaks for: hepatitis A, hepatitis B, and hepatitis C; 1.2, systematically collect, analyze, interpret, and disseminate data to characterize trends, and implement public health interventions for hepatitis A, acute hepatitis B and acute and chronic hepatitis C; 1.3, systematically collect, analyze, interpret, and disseminate data to characterize trends and implement public health interventions for chronic hepatitis B and perinatal hepatitis C;

2.1, support viral hepatitis elimination planning and surveillance, and maximize access to testing, treatment, and prevention; 2.2, increase access to HCV and HBV testing and referral to care in high-impact settings; and 2.3, improve access to services preventing viral hepatitis and other bloodborne infections among PWID.

Component 1: Core Viral Hepatitis Outbreak Response and Surveillance Required Component 1 Strategies and Activities:

1.1. Develop, implement, and maintain a plan to rapidly detect and respond to outbreaks for:

hepatitis A, hepatitis B, hepatitis C virus.

Engage surveillance stakeholders at the state and local levels and collaborate with CDC DVH epidemiologists to develop (a) plan(s) to rapidly detect and respond to outbreaks.

Develop (a) plan(s) to respond to outbreaks of viral hepatitis. It is anticipated that hepatitis outbreak plans may be integrated with other jurisdictional outbreak and emergency response plans. Elements of the plans may vary based on the type of outbreak (e.g., viral hepatitis among PWID and/or persons with other risk factors, healthcare-associated outbreaks of hepatitis B or C, foodborne outbreak of hepatitis A, etc.), and may include, where relevant:

o Routine review of surveillance data (and other data sources) to detect outbreaks o Key departments / personnel to include on the outbreak investigation team o Outbreak response management structure o Laboratory testing o Contact tracing and partner services, as applicable o Prevention and control measures o Linkage to case management and clinical care o Communication plan with key stakeholders, media, and health department leadership o Role of community-based organizations and partners o Debrief, evaluations, and after-action report o Case investigations forms, flowcharts, and other tools to expedite outbreak investigation

1.2. Systematically collect, analyze, interpret, and disseminate data to characterize trends and implement public health interventions for hepatitis A, acute hepatitis B and acute and chronic hepatitis C.

Collaborate with jurisdictional public health staff and leaders, as appropriate to:

o Identify and clarify gaps in jurisdiction ability to include chronic hepatitis B and

C, perinatal hepatitis C, undetectable HCV RNA and HBV DNA laboratory results as reportable conditions and under public health surveillance.

o Explore and identify options, activities, and stakeholders required to establish surveillance of chronic hepatitis B and C and perinatal hepatitis C, undetectable HCV RNA and HBV DNA laboratory results.

o As appropriate, educate stakeholders about options and proposed surveillance plans. Consult with stakeholders on the best course of action to establish public health reporting of chronic and perinatal hepatitis B and C.

o During years two to five, implement plans to address gaps in establishing public health reporting of chronic and perinatal hepatitis B and C, and reporting of undetectable HCV RNA and HBV DNA.

Inform laboratories that conduct hepatitis testing of reporting requirements and establish a mechanism for reporting to the appropriate health department (local or state).

Develop and implement a plan to improve completeness of case reports for hepatitis A, acute hepatitis B and acute and chronic hepatitis C.

Follow-up with health care providers and/or case patients to improve completeness of risk factor information for all cases of hepatitis A, acute hepatitis B and acute hepatitis C.

Follow-up with health care providers and/or case patients to improve completeness of demographic information for all cases of hepatitis A, acute hepatitis B and acute and chronic hepatitis C.

Jurisdictions without existing registries should create a hepatitis C registry to avoid duplication of cases and to monitor continuum of cure.

Notify CDC of all cases of hepatitis A, acute hepatitis B and acute and chronic hepatitis C that meet the CSTE case definition.

Beginning in year three, produce an annual surveillance report that includes hepatitis A, acute hepatitis B and acute and chronic hepatitis C surveillance data.

Beginning in year three, use jurisdiction-specific data, including undetectable HCV RNA, mortality data, and other data as available to monitor the continuum of care for hepatitis C.

Required Component 1 Strategies and Activities Contingent on Funding:

1.3. Systematically collect, analyze, interpret, and disseminate data to characterize trends and implement public health interventions for chronic hepatitis B and perinatal hepatitis C.

Develop and implement a plan to improve completeness of case reports for chronic hepatitis B and perinatal hepatitis C.

Follow-up with health care providers and/or case patients to improve completeness of demographic information for all cases for chronic hepatitis B and perinatal hepatitis C.

Jurisdictions without existing registries should create a hepatitis B registry to avoid duplication of cases and to monitor continuum of care.

Notify CDC of all cases of chronic hepatitis B and perinatal hepatitis C that meet the CSTE case definition.

Beginning in year three, produce an annual surveillance report that includes chronic hepatitis B, and perinatal hepatitis C surveillance data.

Beginning in year three, use jurisdiction specific data including undetectable HBV DNA, mortality data, and other data as available to monitor the continuum of care for hepatitis B.

CDC federal funds may be used to support CDC’s ability to monitor, control, and prevent viral hepatitis by standardizing the reporting of surveillance data, including:

Implementing new National Notifiable Disease Surveillance System (NNDSS) case notification messages (e.g. hepatitis HL7 Message Mapping Guide, see https://wwwn.cdc .gov/nndss/case-notification/) using the new HL7 case notification structure and onboarding process (https://www.cdc.gov/nmi/ta-trc/index.html); and

Enhance existing information systems(s) y adding or improving functionality.

Component 2 Core Viral Hepatitis Prevention Activities Required Component 2 Strategies and Activities

2.1 Support viral hepatitis elimination planning and surveillance, and maximize access to treatment, and prevention.

The World Health Organization has set worldwide goals for elimination of Hepatitis B and C by 2030 (www.who.int/hepatitis/publications/hep-elimination-by-2030-brief/en/) In the United States, the National Academies of Sciences, Engineering and Medicine has developed a strategy for elimination of hepatitis B and C by 2030. (http://www.nationalacademies .org/hmd/reports/2017/national-strategy-for-the-elimination-of-hepatitis-b-and-c.aspx) and the Department of Health and Human Services has put forward a National Viral Hepatitis Action Plan addressing similar goals. (www.hhs.gov/sites/default/files/National%20Viral%20Hepatitis %20Action%20Plan%202017-2020.pdf) https://wwwn.cdc.gov/nndss/case-notification/ https://wwwn.cdc.gov/nndss/case-notification/ https://www.cdc.gov/nmi/ta-trc/index.html http://www.who.int/hepatitis/publications/hep-elimination-by-2030-brief/en/ http://www.nationalacademies.org/hmd/reports/2017/national-strategy-for-the-elimination-of-hepatitis-b-and-c.aspx http://www.nationalacademies.org/hmd/reports/2017/national-strategy-for-the-elimination-of-hepatitis-b-and-c.aspx http://www.hhs.gov/sites/default/files/National%20Viral%20Hepatitis%20Action%20Plan%202017-2020.pdf http://www.hhs.gov/sites/default/files/National%20Viral%20Hepatitis%20Action%20Plan%202017-2020.pdf

Identify and engage partners as members of a jurisdictional “Viral Hepatitis Elimination Technical Advisory Committee” or create a coalition of appropriate partners and key stakeholders. Document committee membership, governance, meetings, and member roles and responsibilities. See “Collaborations,” in this NOFO.)

Develop or expand upon an evidence based viral hepatitis B and C elimination plan.

Include strategies to eliminate hepatitis B and C among risk groups (e.g., PWIDs, persons who are incarcerated, persons who are foreign born for hepatitis B) and other target populations with higher prevalence of hepatitis B and hepatitis C. See “Target Populations,” in this NOFO.

Engage with key partners and stakeholders to set goals and objectives, identify target populations, develop a logic model and an action plan.

Understand the program focus and priority areas. Develop program goals and measurable objectives (e.g., SMART objectives).

2.1.a Increase routine HCV and HBV testing in high volume laboratories and health systems.

CDC encourages recipients to build partnerships to encourage adherence to evidence-based guidelines for prevention and treatment of viral hepatitis. Collaborating organizations should be encouraged to provide hepatitis B and hepatitis C testing and care services consistent with CDC, U.S. Preventive Services Task Force (USPSTF), and American Association for the Study of Liver Diseases (AASLD) testing and clinical management recommendations (https://www.hcvguideli nes.org/).

2.1.a.i Increase routine HCV and HBV testing in high volume laboratories.

Testing and reporting practices must be improved in order to accurately detect all persons with current hepatitis B and C infection so that they can be linked to appropriate care and treatment.

For hepatitis C, all persons recommended for HCV screening should initially be tested for HCV antibody. A positive test result for HCV antibody indicates either current (active) HCV infection (acute or chronic), past infection that has resolved, or a false-positive result. Therefore, an HCV nucleic acid test (NAT) to detect viremia is necessary to confirm active hepatitis C infection and guide clinical management, including initiation of hepatitis C treatment. (www.hcvguidelines.org /evaluate/testing-and-linkage).

To ensure complete testing and an efficient patient-centered approach, automatic reflex confirmatory HCV RNA testing is recommended with the same laboratory sample for all patients with a positive antibody test result. If the reflex confirmatory HCV RNA test is positive, a diagnosis of active hepatitis C infection is confirmed, and the individual should be directly referred for hepatitis C care and treatment.

https://www.hcvguidelines.org/ https://www.hcvguidelines.org/ http://www.hcvguidelines.org/evaluate/testing-and-linkage http://www.hcvguidelines.org/evaluate/testing-and-linkage

In year one, collaborate with the viral hepatitis surveillance coordinator to identify the highest volume Clinical Laboratory Improvement Amendments of 1988 (CLIA)-certified laboratories that report 80% or more hepatitis C antibody tests and tests for hepatitis B in the jurisdiction.

In collaboration with the viral hepatitis surveillance coordinator, conduct a needs assessment by the end of year one for these laboratories, to describe their current hepatitis B and C testing practices, determine if they are conducting reflex HCV RNA confirmation and identify the key barriers/challenges and solutions needed to increase reflex HCV RNA testing. Alternatively, in collaboration with the viral hepatitis surveillance coordinator, jurisdictions may conduct a survey of all CLIA-certified laboratories in the jurisdiction to collect the same information.

In collaboration with jurisdictional leadership and stakeholders, summarize assessment (survey) information with recommendations to improve access to reflex HCV RNA testing beginning in year two.

Improve partnerships with the health care and community-based organizations to educate providers, patients, stakeholders and others to implement routine HBV and HCV testing, including reflex HCV RNA confirmation. Assure that routine HBV and HCV testing is addressed in the viral hepatitis elimination plan.

2.1.a.ii Increase routine HCV and HBV testing in health systems.

In collaboration with the jurisdictional viral hepatitis surveillance coordinator and/or stakeholders, identify the five highest volume health systems in the jurisdiction in year one.

By the end of year one, conduct a needs assessment for the identified high-volume health systems to describe their current hepatitis B and C testing practices, prevalence, barriers/challenges, and solutions needed to increase routine HBV and HCV testing; and provide feedback with recommendations to improve access to routine HCV and HBV testing.

Improve partnerships with the health care systems to educate providers, patients, stakeholders, and others to implement routine HBV and HCV testing, beginning in year two.

Assure that routine HCV and HBV testing is addressed in the viral hepatitis elimination plan.

2.1.b Expand provider capacity to treat hepatitis C and/or hepatitis B.

The 2010 Institute of Medicine (IOM) reported that the U.S. health-care system has insufficient capacity to provide the recommended preventive and clinical-care services for the 2.7-3.9 million persons living with hepatitis C (http://www.cdc.gov/hepatitis/PDFs/IOM-HepatitisAndLiverCan cerReport.pdf). Routine hepatitis C antiviral treatment can be safely and effectively delivered in primary-care settings by primary care providers with appropriate training, while persons with advanced liver disease should be referred to specialists for management. (http://www.ncbi.nlm .nih.gov/pubmed?term=(Brew%20IF)%20AND%20Primary%20Care).

The Extension for Community Healthcare Outcomes (Project ECHO) model was developed to enhance primary-care capacity to treat patients with hepatitis C infection and improve access to hepatitis C care in rural settings through case-based learning facilitated by regular video-conferencing with hepatitis C specialists (https://echo.unm.edu/). The program demonstrated the quality of hepatitis C care and treatment provided by primary-care physicians participating in ECHO as being comparable with specialty care in a hepatitis C clinic. Other strategies that might improve rates of initiation and completion of treatment include comprehensive case management (e.g., peer navigation, bridge counseling) and multidisciplinary, integrated care programs.

Close cooperation among public health and clinical care professionals (e.g., specialists in hepatitis C care and primary-care providers) involved in the testing, diagnosis, care, and treatment of HCV-infected persons can optimize cure of HCV infection (http://www.ncbi.nlm.nih .gov/pubmed/23811030 https://link.springer.com/content/pdf/10.1007%2Fs40506-018-0177-5.pdf https://www.sciencedirect.com/science/article/pii/S2213076417301045?via%3Dihub ).

Collaborate with the Viral Hepatitis Elimination Technical Advisory Committee, or other coalition of appropriate partners and stakeholders to address provider capacity for treatment of hepatitis B and C. Stakeholders might include state and/or local health departments, specialists in hepatitis B and hepatitis C management and/or continuing medical education, public and private health insurance payors, professional organizations, primary-care providers (e.g., hospital-based, care networks, and community health centers), persons with lived experience (injection drug use and viral hepatitis) and other stakeholders and partners serving the jurisdiction. See “Collaborations” in this NOFO.

In collaboration with the key partners and stakeholders in the workgroup:

o A process for primary-care provider training and consultation with hepatitis C specialists on an ongoing basis in various settings (e.g., based on Project ECHO or other evaluated models of hepatitis C care using telemedicine, e-consultation or video conferencing).

o A repository of existing hepatitis B and hepatitis C training resources, with links to this information on the health department website.

o Guidance to implement appropriate HCV testing among primary-care providers. Appropriate HCV testing means following current CDC and USPSTF recommendations for testing (http://www.cdc.gov/mmwr/preview/mmwrhtml /rr6104a1.htm, https://www.uspreventiveservicestaskforce.org/Page/Document http://www.cdc.gov/hepatitis/PDFs/IOM-HepatitisAndLiverCancerReport.pdf http://www.cdc.gov/hepatitis/PDFs/IOM-HepatitisAndLiverCancerReport.pdf http://www.ncbi.nlm.nih.gov/pubmed?term=(Brew%20IF)%20AND%20Primary%20Care http://www.ncbi.nlm.nih.gov/pubmed?term=(Brew%20IF)%20AND%20Primary%20Care https://echo.unm.edu/ http://www.ncbi.nlm.nih.gov/pubmed/23811030 http://www.ncbi.nlm.nih.gov/pubmed/23811030 https://link.springer.com/content/pdf/10.1007%2Fs40506-018-0177-5.pdf https://www.sciencedirect.com/science/article/pii/S2213076417301045?via%3Dihub http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6104a1.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6104a1.htm https://www.uspreventiveservicestaskforce.org/Page/Document/ClinicalSummaryFinal/hepatitis-c-screening

/ClinicalSummaryFinal/hepatitis-c-screening, or updated recommendations as available) and in accordance with CDC’s guidance for laboratory diagnosis of current hepatitis C (http://www.cdc.gov/hepatitis/HCV/LabTesting.htm), which requires HCV-RNA confirmation to diagnose current HCV infection.

o Training on strategies to reduce or assist with the administrative burden of hepatitis C treatment (e.g., prior authorization, patient assistant programs).

o Training on strategies for case management and patient navigation to facilitate treatment initiation and completion and retention of patients in care.

o Training to support implementation of EMR prompts and reminders in health care settings o Training to expand and improve linkage to care and treatment for persons with chronic hepatitis B and hepatitis C infection, o Recruit and train providers on the viral hepatitis clinical and preventive services guidelines, risk factors and treatment options and provide continuing education credits.

o Ongoing updates and support for providers who have completed basic training.

o A provider resource directory, identifying both private and public provider resources for treatment of hepatitis B and C.

o Protocols for primary-care provider training and consultation for various audiences in culturally sensitive, language appropriate formats. Partner with professional, medical, and other organizations (e.g.: SAMSHA-ATTC, Medicaid) to build a provider workforce skillful at providing viral hepatitis prevention, care, and treatmentDevelopment of worksheets, job aids, and other tools to support implementation.

o Development of worksheets, job aids, and other tools to support implementation.

o Address provider training in the jurisdictional viral hepatitis elimination plan (year one); plans to address provider training might include:

o Address implementation of the plan (year three to five); implementation plans may include:

2.1.c. Disseminate materials regarding evidence-based practices for access to hepatitis C treatment and viral hepatitis prevention.

Evidence-based prevention services for persons at-risk for viral hepatitis include MAT for persons with moderate or severe OUD, SSPs providing sufficient sterile injection materials for all injections, and vaccination against hepatitis A and B. In addition, for persons with hepatitis B and C infection, treatment should be offered in accordance with standard guidelines (https://www .hcvguidelines.org/, https://aasld.org/publications/practice-guidelines). See “Background,” in this

NOFO.

Collaborate with stakeholders and partners, e.g., viral hepatitis elimination technical advisory committee, to develop a plan to disseminate materials regarding evidence-based practices for access to hepatitis C treatment and harm reduction (year one); elements of the plan might include:

https://www.uspreventiveservicestaskforce.org/Page/Document/ClinicalSummaryFinal/hepatitis-c-screening http://www.cdc.gov/hepatitis/HCV/LabTesting.htm https://www.hcvguidelines.org/ https://www.hcvguidelines.org/ https://aasld.org/publications/practice-guidelines o Information on hepatitis C treatment recommendations for public and private insurance payors o Information on harm reduction for law enforcement and other emergency responders o Information on recommended viral hepatitis prevention and treatment services for PWID, their family and friends o Information on recommended viral hepatitis prevention and treatment services for high-impact settings.

o Prioritized materials matched to target audiences; for example:

o Plans for developing, adapting or identifying materials regarding evidence-based practices o Plans for dissemination of materials.

During years two to five:

o Disseminate materials regarding evidence-based practices for access to hepatitis C treatment and harm reduction programs; update as needed o Evaluate impact.

Required Component 2 Strategies and Activities Contingent on Funding

2.2. Increase access to HCV and HBV testing and referral to care in high-impact settings.

For the purpose of this section of the NOFO the following apply:

“High-impact” settings are venues serving persons with a high prevalence of injection drug use or hepatitis B, hepatitis C or HIV (e.g. SSPs, SUD treatment centers, correctional facilities, emergency departments and sexually transmitted disease clinics). Recipients must focus activities in one or more high-impact settings working in collaboration with relevant organizations to provide viral hepatitis testing and referral to care.

Recognizing the importance of tailoring local approaches, this award supports local partnerships to implement the activities in high-impact settings in the jurisdiction through the collaboration of organizations that, together, demonstrate:

Specialized experience and capacity for reaching PWID Ability to perform screening and diagnostic testing for hepatitis B and hepatitis C infections Established partnerships to refer PWID diagnosed with hepatitis B and hepatitis C infection to appropriate care Established partnerships to refer PWID to appropriate prevention services Use of data systems to track testing, test results, and referrals, and to report cases of hepatitis B and hepatitis C infection to the appropriate health department in accordance with applicable requirements

Example program partnerships for increasing access to HCV and HBV testing and referral to care in high-impact settings:

1. SSPs. Viral hepatitis testing and referral services are incorporated into an existing SSP in this example. The SSP conducts outreach/education for their PWID clientele about viral hepatitis infections and offers testing for hepatitis B and hepatitis C to all SSP clients. For those who test positive for current infection, SSP staff make referrals and patient or peer navigators link clients to an identified partner primary care clinic or hospital system for HCV RNA testing (if needed) and evaluation, treatment, and care for hepatitis B or hepatitis C infection.

2. SUD Treatment Facilities and MAT providers. In this example, a SUD treatment facility or MAT provider conducts hepatitis B and hepatitis C testing on all clients. Patient or peer navigators link those who test positive for current infection, facility staff make referrals to an identified partner primary care clinic or hospital system for evaluation, treatment, and care.

3. Emergency Department/Hospital Systems. In this example, an emergency department of a local hospital conducts hepatitis B testing and hepatitis C testing for patients presenting with an illness associated with injection drug use (e.g., invasive bacterial or fungal infections, wound infections), an illicit drug overdose, or who have injection drug use history documented in the medical chart. For those who test positive for current infection, ED staff make referrals to appropriate primary care clinic or specialty care clinic affiliated with the hospital. ED staff also connect the patient to a patient or peer navigator who helps ensure the patient makes the first visit (e.g., helps with transportation assistance, appointment reminders)

4. Correctional facilities. In this example, correctional facilities (e.g., local jail, state prison) test new inmates on arrival for hepatitis B and hepatitis C. Those who test positive for current infection are referred for medical care within the correctional facility.

Applicants may propose to build state laboratory capacity for hepatitis C and hepatitis B testing.

This may include purchase of necessary equipment and performance of validation testing and quality assurance. The applicant must describe the need for the additional laboratory capacity and how it will facilitate this project and enhance overall capacity at the state lab. Recipients may purchase hepatitis B and C test kits (including HCV RNA tests) for this component.

Patient navigators (or peer navigators) may be clinic- or hospital-based and work in partnership with one or more high-impact settings in the community (e.g., SSP, SUD treatment facility, MAT provider). Alternatively, patient or peer navigators may be community-based and affiliated with the organization that has a high-impact setting (e.g., SSP, SUD treatment facility, MAT provider) and link patients to one or more clinics or hospitals in the community for evaluation and care.

Patient navigator and referral services can include scheduling hepatitis B or hepatitis C-related medical appointments, preparing clients for medical appointments, and coordinating efforts with the client’s care team to ensure the first visit is scheduled and occurs. Patient navigation services can also include linkage or referral to treatment for those diagnosed with hepatitis B or hepatitis C, and prevention services for PWID (e.g., patient navigators (or other staff for the project) may provide to all clients educational materials and referrals for viral hepatitis prevention services recommended for PWID such as SSPs, SUD treatment, hepatitis A and hepatitis B vaccination, and family planning).

2.2.a Increase routine HCV and HBV testing in high-impact settings.

Collaborate with key stakeholders and partners to establish partnerships, to select one or more high priority high-impact settings, and develop a plan to increase HBV and HCV testing.

Conduct a needs assessment with clients and staff in high-impact settings on HBV and HCV screening and testing practices and referral or linkage to treatment.

Support high-impact settings to:

o Opt-out initial and annual HCV antibody test…