Att 8_IRB Project Determination

Print Date: 11/18/20

Title:

Integrated Viral Hepatitis Surveillance and Prevention Funding for States

Project Id:

0900f3eb81bf3a1a

Accession #:

NCHHSTP-ESB-9/28/20-f3a1a

Project Contact:

Cooley_Laura A (whz3)

Organization:

NCHHSTP/DVH/ESB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

05/01/2021

Estimated Completion Date:

05/01/2026

CDC/ATSDR HRPO/IRB Protocol #:
OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

10/26/20

Dodson_Janella R. (jhd7) CIO HSC

10/26/20

Bonds_Constance (akj8) CTR OMB/PRA Coordinator

45 CFR 46.102(l)(2)

ICRO:
Returned with No Decision

10/26/20

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

08/01/2021

Determination Start Date:

09/28/20

Description:

An estimated 2.4 million people are infected with hepatitis C virus in the United States, and an estimated 50,000 people are newly
infected every year. Hepatitis C is curable, yet only about 56% of adults living with hepatitis C know they are infected, and about 1
out of every 14 new cases is reported to public health. An estimated 862,000 people are living with hepatitis B virus in the United
States, and an estimated 22,000 people are newly infected every year. Hepatitis B is vaccine preventable and treatable, yet only
about 32% of adults living with HBV know they are infected, and about 1 out of every 7 new cases are reported to public health. The
most common risk factor for acute hepatitis B and C is injection drug use. Further, the United States continues to experience an
unprecedented multi-state outbreak of acute hepatitis A, with over 30,000 reported cases between July 2016 and January 2020,
primarily affecting people who use drugs and people experiencing homelessness. National surveillance data has been critical for
identifying injection drug use as the primary risk factor for ongoing transmission of hepatitis B and C. 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%. PWID can be treated for hepatitis C with sustained virologic response
about 90%. Despite evidence of effectiveness, state policies may limit access to direct acting antiviral treatment and SSPs, and
access to MAT remains suboptimal. In addition, hepatitis A and B are vaccine preventable, yet vaccination rates among adults
(hepatitis A, 9%, hepatitis B, 24.5%), including adults at increased risk (hepatitis B estimated 41%), are low. Comprehensive SSPs
provide syringe exchange and access to other needed services for PWID. National surveillance data can be leveraged for rapidly
detecting outbreaks, accurately assessing burden of disease, and monitoring elimination efforts for hepatitis B and C at the
jurisdictional level. This project will enable 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 their jurisdictions.

IMS/CIO/Epi-Aid/Chemical Exposure Submission:

No

IMS Activation Name:

Not selected

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

These activities will support 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. Participants will 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. The following
activities may be supported (contingent on funding): 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). 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.

Objective:

Priorities for this project 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.

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis, Drug Users

CDC's Role:

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided

Method Categories:

Analytic Services (can be data/specimen TA for non-research,research,investigations); Surveillance Support; Technical Assistance

Methods:

Required activities for award recipients 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 (contingent on available funding), 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 (contingent upon
available funding), 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.

Collection of Info, Data or Biospecimen:

A standardized Case Report Form will be used for surveillance data collection submitted to the National Notifiable Diseases
Surveillance System (NNDSS). Program evaluation will include collection and analysis of program performance data submitted by
award recipients which tracks key performance indicators and process indicators and includes required reports. Data collection is
used for program accountability, monitoring, evaluation and performance improvement, those data will include, but are not limited
to, national viral hepatitis surveillance data submitted to CDC, annual performance reports, and quantitative and qualitative data in a
CDC-approved format.

Expected Use of Findings/Results:

This project will enable jurisdictions 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 their
jurisdictions. Data will also be used to produce surveillance reports, reports on project accomplishments, project feedback reports,
fact sheets, and other monitoring and evaluation reports.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

CDC Cooperative Agreement

Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments

PS21-2103

2021

5

HSC Review

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office

No

Estimated number of study participants

Population - Children
Population - Minors
Population - Prisoners
Population - Pregnant Women
Population - Emancipated Minors

Suggested level of risk to subjects Do you anticipate this project will be exempt research or non-exempt research
Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions
Institutions yet to be added .....

Staff
Staff
Member

SIQT Exp.
Date

Danae Bixler

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

Staff Role

Email

Phone

Organization

10/02/2023

Technical
Monitor

nqd0@cdc.
gov

404-7183208

EPIDEMIOLOGY RESEARCH
TEAM

David
Butterworth

09/17/2022

Technical
Monitor

jji7@cdc.
gov

404-7183722

PROGRAM TEAM

Henry
Roberts

03/11/2023

Technical
Monitor

hdr9@cdc.
gov

404-7188659

SURVEILLANCE TEAM

Laurie
Barker

07/23/2022

Technical
Monitor

lub2@cdc.
gov

404-7188059

SURVEILLANCE TEAM

Mona
Doshani

03/25/2022

Technical
Monitor

imf6@cdc.
gov

404-7188854

COMMUNICATIONS AND
PROGRAM TEAM

Data
DMP
Proposed Data Collection Start Date:

8/1/21

CITI Good Clinical Practice
Exp. Date

Proposed Data Collection End Date:

8/1/26

Proposed Public Access Level:

Public

Public Access Justification:

Award recipient surveillance data is submitted to the National Notifiable Diseases Surveillance System (NNDSS) and is made
publically accessible by CSELS through CDC Wonder, etc.

How Access Will Be Provided for Data:

WONDER Weekly Tables of Infectious Diseases (1996 to present), CDC WONDER; DATA.CDC.gov Provisional Weekly Infectious
Disease Data (2014 to present), Data.cdc.gov; MMWR Weekly Tables of Infectious Diseases (through December 2017), MMWR
weekly archive; CDC Stacks Collections of Weekly Infectious Disease Tables (1951 to present), CDC Stacks

Plans for Archival and Long Term Preservation:

Access provided through CDC WONDER, DATA.CDC.gov, MMWR weekly tables, CDC Stacks.

Spatiality
Country

State/Province

County/Region

United States

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date