GenIC Request - HCP

File Name: 2016021-XXX_Zika_Utah

Request for Approval Under the Generic Clearance for

Emergency Epidemic Investigation Data Collections
(0920-1011)

Instruction: This form should be completed by the primary contact person from the CDC CIO that will be sponsoring the investigation.

Determine if your investigation is appropriate for this Generic mechanism: Instruction: Before completing and submitting this form, determine first if the proposed investigation is appropriate for the EEI Generic ICR mechanism. Complete the checklist below. If you select “yes” to all criteria in Column A, the EEI Generic IR mechanism can be used. If you select “yes” to any criterion in Column B, the EEI Generic ICR mechanism cannot be used.

Column A	Column B
CDC epidemiological assistance is requested by one or more external partners (e.g., local, state, tribal, military, port, other federal agency, or international health authority or other partner organization). Yes No	The Investigation is initiated by CDC, without request from an external partner. Yes No
The investigation is urgent in nature (i.e., timely data are needed to inform rapid public health action to prevent or reduce injury, disease, or death). Yes No	The investigation is not urgent in nature. Yes No
The investigation is characterized by undetermined agent, undetermined source, undetermined mode of transmission, or undetermined risk factors. Yes No	The investigation is conducted for the primary purpose of program evaluation, surveillance, needs assessment, or research to contribute to generalizable knowledge. Yes No
One or more CDC staff (including trainees and fellows) will be deployed to the field. Yes No	CDC staff (including trainees or fellows) are not deployed to the field. Yes No
Data collection will be completed in 90 days or less. Yes No	Data collection expected to require greater than 90 days. Yes No

Did you select “Yes” to all criteria in Column A?

If yes, the EEI Generic ICR may be appropriate for your investigation. → You may proceed with this form.

Did you select “Yes” to any criterion in Column B?

If yes, the EEI Generic ICR is not appropriate for your investigation. → Stop completing this form now.

GenIC #

2016021

-

XXX

Date

07/21/2016

Title of Investigation: Instruction: Provide the title of the investigation in the following format: [Undetermined agent, undetermined source, undetermined mode of transmission, undetermined risk factor] for [disease/problem] among [subpopulation]—[State], [Year]

Undetermined Mode of Transmission_Zika Virus among Utah Health Care Providers, 2016

Location of Investigation: Instruction: Indicate location where investigation will occur. If multiple locations, specify each one.

State:	Utah
City/County (if applicable)	Salt Lake City
Country	USA

Requesting Agency: Instruction: Indicate name of agency requesting epidemiological assistance and the name and position title of the requestor

Agency:	Utah Department of Health
Name and Position Title:	Angela Dunn, Deputy State Epidemiologist

Note: Attach the Letter of Invitation requesting support. The letter should include the following information: 1) background on the outbreak or event; 2) steps already taken toward prevention and control, if any; 3) request for CDC assistance, including objectives of the investigation; and 4) how data will be used to inform prevention and control measures. Sensitive information in the Letter of Invitation not appropriate for public dissemination should be redacted.

Description of Investigation

1. Problem to be Investigated: Instruction: Provide a summary of the outbreak or event. The summary should include all the information you know at this time about the outbreak or event and the investigation that is planned. At a minimum, please provide the following information: 1) background necessary to understand the importance of the outbreak or event, including a justification of the need for an investigation and why this issue requires an urgent response; 2) the objectives of the investigation, including how the information collected will be used to inform prevention and control measures; and 3) a brief overview of the investigation planned, including study design, respondents, mode of data collection. In the description, indicate whether a data collection instrument is attached with the GenIC request (refer to as Appendix 1, etc) and what instruments will be developed in the field. (suggested length: 250-500 words).

On June 25th, 2016, a 73-year-old male died in a Salt Lake City hospital. He had returned from Mexico on June 14 and began feeling unwell on June 17. He initially sought care two days later (June 19) and was admitted on June 22. Following admission, his health rapidly declined and he died 3 days following admission with suspected dengue hemorrhagic shock syndrome. Testing performed after his death identified Zika viral RNA in a blood sample obtained during his hospital admission; the level of viremia in his blood sample, as suggested by the values obtained with the RT-PCR assay, were uncharacteristically high.

On July 1st, an adult male family contact reported developing a subjective fever and then progressed to develop a rash and conjunctivitis. The family contact had no history of travel or sexual contact with someone who traveled, but had been in contact with the index patient during his period of viremia. Testing of urine obtained 7 days after illness onset for the family contact was positive for Zika viral RNA at the Utah State Public Health Laboratory. Because the family contact did not report travel to a Zika-affected area or sexual contact with anyone who had recently traveled to a Zika-affected area, there is concern about local transmission through a potentially unidentified mode of transmission or by local mosquito-borne transmission.

The Utah Department of Health is requesting CDC’s assistance to better define how the second case was infected, given his contact with the index case. CDC will assist with the following investigation objectives:

1. Assess the potential of person-to-person transmission among family contacts and health care providers

2. Evaluate the potential for environmental transmission of Zika virus through vector surveillance and a community survey

3. Assist Utah Department of Heatlh with communication messaging

4. Develop guidelines for healthcare providers to prevent Zika transmission when caring for persons that are Zika positive with underlying chronic conditions, based on the findings of the investigation

The team will perform enhanced surveillance of the Health care providers (HCP) involved in the care of the deceased patient. This surveillance will include a detailed risk assessment questionnaire and, for those determined to have had significant direct contact with the patient, blood draws to test for the presence of Zika IgM antibody.

2. Characteristics of Outbreak or Event (Check all that Apply):

Undetermined agent

Undetermined source

Undetermined mode of transmission

Undetermined risk factor

3. Respondents: Instruction: Select all that apply. For each respondent type selected, provide a brief description. Be sure to include a description of control respondents, if applicable. Use as much space as necessary for each description.

General public (describe):

Healthcare staff (describe):

Cases: healthcare personnel who had substantial contact with the patient and/or patient’s bodily fluids; Controls: health personnel who did not have contact with patient and/or patient’s bodily fluids

Laboratory staff (describe):

Patients (describe):

Restaurant staff (describe):

Other (describe):

4. Selection of Respondents: Instruction: Provide a brief description of how respondents will be identified and selected. Use as much space as necessary for the description.

Healthcare personnel to include nurses, physicians, pharmacists, phlebotomists, radiology technicians, nursing assistants, laboratorians, and environmental services staff.

5. Study Design: Instruction: Select all that apply. For each study design planned, provide a brief description. Use as much space as necessary for the description.

Epidemiologic Study (indicate which type(s) below)

Descriptive Study (describe):

Cross-sectional Study (describe):

Cohort Study (describe):

Case-Control Study (describe):

Other (describe):

seroprevalence survey with matched cohort

Environmental Assessment (describe):

Laboratory Testing (describe):

Other (describe):

6. Data Collection Mode: Instruction: Select all that apply. For each data collection mode planned, provide a brief description. Use as much space as necessary for the description.

Survey Mode (indicate which mode(s) below):

Face-to-face Interview (describe):

Investigators will administer a detailed questionnaire to determine the level of contact each identified healthcare worker had with the deceased patient. Information to be collected will include type of contact, type of care provided, exposure to blood or body fluids, and use of PPE during care. We will also collect relevant information on the employee's history, including recent travel, vaccinations, and pregnancy status.

Telephone Interview (describe):

Self-administered Paper-and-Pencil Questionnaire (describe):

Self-administered Internet Questionnaire (describe):

Other (describe):

Medical Record Abstraction (describe):

Biological Specimen Sample

Serum Sample

Environmental Sample:

Other (describe):

7. Type of Information to be Collected: Instruction: Select all that apply. For each type of information to be collected, provide a brief description. Use as much space as necessary for the description.

Behaviors (describe):

Level of contact each identified healthcare worker had with the deceased patient and use of PPE

Clinical information/symptoms (describe):

Contact information (describe):

Name, address and DOB

Demographic information (describe):

Gender

Environmental factors (describe):

Exposures (describe):

Exposure to index case

Medical history (describe):

Symptoms related to Zika

Pregnancy status and vaccination history

Risk factors (describe):

Specimen/lab information (describe):

Travel history (describe):

Recent travel

Other (describe):

8. Duration of Data Collection (number of weeks):

4 weeks

Research Determination: Instruction: Indicate the research determination decision. If the decision is research, provide the research determination letter and IRB approval, if required.

Research

Not Research

CDC Investigation Lead: Instruction: Indicate the name, title, and affiliation of the person who will serve as the CDC lead for this investigation.

Name:	Bryan Christensen
Title:	Infection Control Specialist
Affiliation:	CDC/ DHQP/OD

CDC Sponsoring Program and Primary Contact Person: Instruction: Indicate the sponsoring CIO/Division/Branch for this investigation. Indicate the name, title, and contact information of the CDC Primary Contact Person for this investigation. Indicate the preferred method of contact during the OMB approval process. Note, contact person or a designee must be available during the OMB approval process in case questions arise.

CIO/Division/Branch:	OPHPR/DEO
Name:	Maleeka Glover, [email protected]
Title:	Medical Investigations Team Lead/ CERT Lead

Certification: Please read the certification carefully. Type your name to validate that you are providing certification. Note: If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved. Certification should be signed by the CDC Primary Contact Person for this Investigation.

I, [Maleeka Glover], certify the following to be true:

1. The collection is voluntary.

2. Respondents will not be personally identified in any published reports of the study.

3. Information gathered will be primarily used to inform effective prevention and control measures.

CDC Sponsoring Program Primary Contact Name:	Maleeka Glover
Date of Certification:	7/21/2016

Requested Approval Date (mm/dd/yyyy): Instruction: Indicate the date by which approval is needed.

07/22/2016

E-mail the completed form to the Information Collection Request Liaison (ICRL) or EIS program ICRL designee.

EEI Information Collection Request Liaison:

Danice Eaton, PhD, MPH

EIS Program Staff Epidemiologist

EWB/DSEPD/CDC

2400 Century Center, MS E-92

Office: 404.498.6389
[email protected]

For internal use. Do not complete.

Date/Time initial GenIC received by ICRL
Date/Time final GenIC received by ICRL
Date/Time submitted to OMB
Date/Time approved

Date Form Revised: GenIC 6.16.14 5