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[OS] CDC/ATSDR Formative Research and Tool Development

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OMB: 0920-1154

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December 22, 2023

GenIC Clearance for CDC/ATSDR

Formative Research and Tool Development



Wastewater Surveillance Communication Evaluation: Assessing Water Surveillance Messages, Knowledge, and Attitudes

OMB Control No. 0920-1154










Supporting Statement A
















Contact: Jena Losch, MPH

Office of the Director

Division of Infectious Disease Readiness & Innovation

Centers for Disease Control and Prevention

1600 Clifton Road, NE

Atlanta, Georgia 30333

Phone: 770.488.3834

Email: [email protected]

TABLE OF CONTENTS

Exhibits



LIST OF ATTACHMENTS

  1. Eligibility Screener

  2. Recruitment Materials

  3. Eligible Participant Screener

  4. Privacy Agreement

  5. Respondent Consent Form for Focus Groups

  6. Standard Invitation for FGs

  7. Participant Confirmation Email

  8. Focus Group Moderator Guide

  9. Messages to be Tested

  10. Human Subjects Determination



A . Justification


1 Circumstances Making the Collection of Information Necessary


CDC’s National Wastewater Surveillance System (NWSS) is the agency’s primary outlet to monitor infectious diseases through wastewater across the country. The system was initially built to coordinate and build the nation’s capacity to track the presence of SARS-CoV-2, the virus that causes COVID-19 in wastewater samples collected across the country but also tracks the presence of other infectious diseases such as mpox. The system serves to educate the public on early detection tools that can help communities prepare for and take action to address increasing cases of infectious diseases. Health departments, community leaders, and individuals can use wastewater monitoring data to make decisions about how best to protect their community. The CDC estimates that more than 1000 sites reported to NWSS in the last two months covering 35% of the U.S. population. CDC is interested in collecting nationally-representative qualitative information to explore and understand the context and rationale behind audience preferences, knowledge, perceptions of wastewater monitoring, and test specific CDC messages and materials with audiences (Attachment 9).


The objectives of this project are to:

  • Obtain information about the suitability (e.g., clarity, applicability) of current messages and materials about the National Wastewater Surveillance System (NWSS), including aspects of the in-development website.

  • Obtain findings on knowledge gaps and communication preferences for viral disease data presentation tools and surveillance messages among those disproportionately affected by diseases that wastewater surveillance can monitor, including caregivers of children under 5, caregivers of elderly individuals, business leaders, individuals at high risk for viral diseases, and rural populations, to promote health equity among these populations.

  • Obtain insights about educational factors that may influence the attitudes, perceptions, and behaviors of individuals who receive health guidance related to viral diseases from CDC.


Data will be used to:

  • Provide updates to wastewater surveillance messages that can help position NWSS as a trusted source of information—along with other CDC resources—for respiratory disease tracking (for example, COVID-19, Flu, and Respiratory Syncytial Virus), management, and best practices for the general public.

  • Inform the development of the new dashboard/website which includes guidance based on national and localized data and the development of a toolkit to guide health departments with decision-making and disseminating information statewide and locally.

  • Provide recommendations on types of communication products that could be created to inform the public (audiences of interest), decision-makers, and public health departments about the NWSS dashboard and motivate them to use and share the resource.


CDC’s contractor, Banyan Communications, will implement qualitative focus groups. The focus group respondents for this project will be a maximum of 60 individuals recruited by Banyan Communications. The project will work with volunteer respondents. Participants must meet a set of criteria to ensure all focus groups will include a maximally diverse group of participants considering age, educational level, and socioeconomic status, gender, and ethnicity and include a mix of geographical areas and urban/rural residents. The focus groups will be conducted between adults (18+) and at least one research staff member. The goal is to obtain feedback to support wastewater surveillance communication initiatives.


Data to be collected include the following: sociodemographics; knowledge, attitudes, beliefs, and perceptions related to wastewater surveillance; and reactions and receptivity to wastewater surveillance messages, content, and wastewater surveillance website. Questions shall assess ways in which participants obtain and/or seek information related to wastewater surveillance, how they interpret this information, message receptivity and whether/how the participants intend to change their behavior based on the message. Participants shall also elaborate on ways in which the presented messages, through text or presentation changes, could be improved so that they are more effective.


The data collection will use

  1. a 5-minute Eligibility Screener before the virtual focus group (Attachment 1)

  2. a 5-minute Eligible participant screener (Attachment 3)

  3. a virtual 60-minute focus group (Attachment 8)


This information collection does not involve websites or website content directed at children less than 13 years of age.


2 Purpose and Use of the Information Collection

The purpose of this project is to conduct focus group discussions with U.S. adults (caregivers of children and elderly individuals), business leaders (with a subgroup identifying as low education; less than high school diploma), adults at high-risk of viral diseases, and adults living in a rural area to improve wastewater surveillance message and web content. Banyan Communications will conduct the focus groups.


3 Use of Improved Information Technology and Burden Reduction

We will record each focus group to use for preparing reports. Our data collection requires that we employ qualitative research methods using one-time virtual focus group discussions. We will receive recorded verbal confirmation from participants to record the discussion. Questions within the focus group discussions will be kept to a minimum required for the intended use of the data.



4 Efforts to Identify Duplication and Use of Similar Information

There are no other federal generic collections that duplicate the project types included in this request. Health messages developed by CDC are unique in their mix of intended audience, health behavior, concept, and execution. Therefore, in most cases, there are no similar data available. We have reviewed existing published data and consulted with outside experts to identify information that could facilitate message development prior to conducting any data collection.


5 Impact on Small Businesses or Other Small Entities

This data collection will not involve small businesses or other small entities.


6 Consequences of Collecting the Information Less Frequently

The activities involve a one-time collection of data over a 12-month period.


7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This request fully complies with regulation 5 CFR 1320.5.


8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

For subcollection requests under an approved generic ICR, Federal Register notices are not required, and none were published. A Federal Register notice was published for this generic package on July 22, 2022, Vol. 87, No.140 , pp. 438360. No public comments were received.


Exhibit A.8.1. Outside Consultation

Name

Affiliation

Email

Phone

Sara Bresee

CDC

[email protected]

Office: 404.639.3371

Leslie Wade

CDC

[email protected]

Office: 404.718.4683

Jena Losch

CDC

[email protected]

Office: 770.488.3834

Deanna Amarosa

CDC

[email protected]

Office: 404.639.8805

Nora Kuiper

Banyan Communication

[email protected]

Office:

404.682.3008 x 344

Tola Aina

Banyan Communications

[email protected]

Office: 404.682.3008

Sharanya Thummalapally

Banyan Communications

[email protected]

Office: 404.682.3008

Amanda White

Banyan Communications

[email protected]

Office: 404.682.3008

Bria Berry

Banyan Communications

[email protected]

Office: 404.682.3008


To ensure there is no duplication or redundancy of effort across projects and programs, program staff will consult with a variety of sources on the availability of data, frequency of collection, clarity of instructions, and record keeping, disclosure, and reporting format (if any), and on the data elements to be recorded, disclosed, or reported.


9 Explanation of Any Payment or Gift to Respondents

We will provide a token of appreciation of $75 for each individual who participates in the focus group. Tokens of appreciation were determined based on previous projects and experience with conducting focus groups with individuals. The range of monetary reward is consistent with current rates for participation in formative projects. Tokens of appreciation will take the form of gift cards.


Reviewed literature revealed the payment of incentives can provide significant advantages to the government in terms of direct cost savings and improved data quality (See References). As participants often have competing demands for their time, a token of appreciation for participation in a study is warranted. The use of a token of appreciation treats participants justly and with respect by recognizing and acknowledging the effort participants expend to participate. Numerous empirical studies have also shown that a token of appreciation can significantly increase response rates in cross-sectional studies and reduce attrition in longitudinal studies (e.g., Abreu & Winters, 1999; Castiglioni, Pforr, & Krieger, 2008). It also should be noted that message testing is a marketing technique, and it is standard practice among commercial market researchers to offer incentives as part of respondent recruitment.


We are applying a health equity lens to select our recruitment sample in this project. In the case of wastewater surveillance, a health equity lens would include over-sampling those disproportionately affected by diseases that wastewater surveillance can monitor including rural populations and low education subgroups. Having insufficient representation from these subgroups means their perspectives are not adequately included in message development and results in less effective messaging to support DIDRI’s goals to "prepare for, prevent, and respond to infectious diseases, including outbreaks, bioterrorism, and other public health emergencies''. An appropriate incentive improves the chances for these subgroups to participate, therefore increasing the government's efficiency in data collection and reducing redundancies for future efforts.


These subgroups have been difficult for CDC to reach for several reasons. 

  1. For rural groups, their geographic location makes it harder to participate in similar projects. Additionally, they may not have access to constant wireless services making it harder for them to participate in such projects. An appropriate token of appreciation may address this issue.

  2. Low education subgroups are more likely to be low-income and economically disadvantaged. Low health literacy skills have not only been found to be related to poor health but have also been shown to have a relationship with level of education: People with lower education were found to demonstrate lower health literacy skills in comparison with people with higher education (Lee et al., 2010). Their social economic situation makes it harder for these groups to take off from or miss work to participate in research. Though the groups are virtual, low-income populations are less likely to have jobs where they work from home and may have to miss work or leave work to participate. Offering a higher token of appreciation may address this issue.


A similar communication evaluation project that was conducted in the summer of 2023 proposed and was approved for $75 per person for a 60-minute focus group discussion (OMB No. 0920-1154,Food Safety Communication Evaluation: Assessing Food Safety Messages, Knowledge, and Attitudes ). During this project, the team was very successful and were able to recruit 115 individuals (the goal was to recruit 144).



10 Assurance of Privacy Provided to Respondents

Contractors and anyone listening to the project will be required to sign a privacy agreement prior to the start of the project (Attachment 4). CDC’s contractor, Banyan Communications, will retain notes, audio/video files, and any other project-related documents on secure servers or in locked file cabinets; only project staff members will be able to access the servers via password-protected computers. Focus group findings will be reported in summary form, and participants’ names and identifying information will not be included in the findings. Identifiable information will be kept separate from focus group data, so that participants’ responses cannot be linked with their names. All audio and video files will be destroyed three years after completion of the project. No identifiable information describing individual respondents will be included in the analyzed data and aggregate reports provided to CDC.


In review of this application, it has been determined that the Privacy Act is not applicable.

Banyan Communications will identify, screen, and recruit potential participants through a recruitment firm, using a proprietary recruitment list/database. Banyan Communications will use additional recruitment methods, such as including social media notices and snowball sampling as needed.


Individuals will first be screened to assess if they are eligible to be a part of the focus groups (Attachment 1). Those who meet the screening criteria for the focus groups will then receive a second demographic screener to assess which focus groups they will be put into (Attachment 3). Finally, they will be invited to attend a virtual 60-minute focus group (Attachment 6). Participants will be asked to give verbal consent on a recording prior to the start of the focus group and will also fill out Attachment 5 before starting. They will receive a copy for their records.


The screeners will be stored in an encrypted online file hosted by Banyan Communications throughout the project’s duration. Once the project ends, the screeners will be destroyed. Banyan Communications will retain notes, video files, and any other project-related documents on secure servers for a total of 3 years before destroying; only project staff members will have access to the servers via password-protected computers. Findings will be reported in summary form and participants’ names and identifying information will not be included in the findings. Identifiable information is kept separate from focus group data so that participants’ responses cannot be linked with their names. All video files will be destroyed at the completion of the project.


During the focus group, the moderator will go over key parts of the informed consent during the introduction to the focus group. The moderator will inform participants that the focus group is voluntary, and that they may choose not to answer any question and end participation at any time. The moderator also will inform participants that Banyan Communications will report findings in summary form so that participants cannot be identified and that their identifiable information will be kept secure and separate from the focus group notes and video recordings. The moderator will inform the participant that there is a notetaker listening and taking notes and that members of the CDC may be observing. The informed consent includes the phone numbers for both Banyan Communications, in case participants have questions about their rights as a participant, as well as the principal investigator, in case participants have questions about the project itself.



11 Justification for Sensitive Questions

This data collection was reviewed by CDC’s Human Research Protection Office, and it was not deemed as human subjects’ research and given a non-research determination (Attachment 10).


There is a minimal risk that some questions may make respondents feel uncomfortable. There will be potentially sensitive information collected such as race and income. These questions are critical to the project to ensure a demographically diverse sample. Therefore, the team needs to gather data surrounding race, ethnicity, income etc.


The respondent consent form includes a statement about this risk and informs participants that they may choose not to answer a particular question if they wish and/or end the session at any time without penalty.



12 Estimates of Annualized Burden Hours and Costs

We estimate the total annualized response burden at 83 hours (Exhibit A.12.1). For the focus group discussions, every individual will be pre-screened using a 5-minute eligibility screener and a subsequent 5-minute eligible participant screener. This process will be used to get the final focus group participants not to exceed 60 participants. Those who screen in and agree to participate in the project will participate in a 60-minute focus group including message being tested and consent activities will be included in the 60 minutes. This process will be used to get the final sample not to exceed 60 participants.


Exhibit A.12.1. Estimated Annualized Burden Hours

Type of Respondent

Form Name

No. of Respondents

Responses per Respondent

Average Burden per Response (in hours)

Total Burden Hours

Individual


Eligibility Screener (Focus Group)

Attachment 1

180

1

5/60

15

Eligible Participant Screener for Focus Group Attachment 3

100

1

5/60

8






Focus Group Discussion Attachment 8

Consent form (Attachment 5)

Message being Tested

Attachment 9

60

1

60/60

60

Total

340



83



The estimates of the annualized cost to respondents for the burden hours for the collection of information is derived from the 2022 mean hourly wage of $29.76 across all occupations, per the U.S. Department of Labor (DOL) December 2022 (the most up-to-date non-provisional data) National Occupational Employment and Wage Estimates. The total annualized burden cost is estimated at $2,589.12 per year.


Exhibit A.12.2 Estimated Annualized Burden Costs

Activity

No. of Respondents

No. of Responses per Respondent

Average Burden per Response

(in Hours)

Total Burden Hours

Hourly Wage Rate

Total
Respondent Costs

Eligibility Screener (Focus Group)

Attachment 1

180

1

5/60

15

$29.76

$446.40


Eligible Participant Screener for Focus Group Attachment 3

100

1

5/60

8

$29.76

$238.08

Focus Group Discussion Attachment 8

60

1

60/60

60

$29.76


$1,785.60


Total




83


$2,470.08


13 Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers

There are no costs to respondents other than their time for participation.


14 Annualized Cost to the Federal Government

The contractor’s costs are based on estimates provided by the contractor, who will carry out the data collection activities. With the expected period of performance, the annual cost to the federal government is estimated to be $91,363.25 (Exhibit A.14.1). This is the cost estimated by the contractor, Banyan Communications, and includes the estimated cost of coordination with CDC, data collection, analysis, and reporting.

Exhibit A.14.1. Estimated Cost to the Government

Expense Type

Expense Explanation

Annual Costs (dollars)

Direct cost to the federal government

CDC oversight of contractor and project

CDC Project Officer

$30,726.75


CDC Co-Principal Investigator

$21,866.50

Subtotal, Direct Costs to the Government


Contractor and Other Expenses

Recruitment, data collection, analysis and reporting (contractor)

Labor hours and other direct costs

$38,770.00

Subtotal, contracted services

Total cost to the government

$91,363.25


15 Explanation for Program Changes or Adjustments

No change in burden is requested, as this is a new information collection.


16 Plans for Tabulation and Publication and Project Time Schedule

During qualitative data collection, the Banyan Communications note taker will enter data from the focus group discussion into ATLAS.ti, which will be stored on a password-protected computer. Analysis of the focus group data will start immediately after completion of data collection and will be conducted under the supervision of a senior staff member with extensive experience in qualitative research. Banyan Communications will conduct thematic or ground theory analysis of the data to understand participants’ reactions to the messages in as rigorous and detailed manner as possible. Banyan Communications will summarize results in a final report. The final report will include key data from the online eligibility and demographic screener and report it in descriptive data tables with accompanying narrative in the summary and final reports. Exhibit 16.1 lists the key events and reports.



Exhibit A.16.1. Project Time Schedule

Activity

Time Schedule

Begin recruitment

April 30, 2024

Conduct focus groups

Weeks of 5/13, 5/20, 5/27, 6/3, 6/10 of 2024

Report due

September 18, 2024


17 Reason(s) Display of OMB Expiration Date Is Inappropriate

The display of the OMB expiration date is not inappropriate..


18 Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.


References

Abreu, D.A., & Winters, F. (1999). Using monetary incentives to reduce attrition in the survey of income and program participation. Proceedings of the Survey Research Methods Section of the American Statistical Association.

Bonevski, B., Randell, M., Paul, C., Chapman, K., Twyman, L., Bryant, J., Brozek, I., & Hughes, C. (2014). Reaching the hard-to-reach: a systematic review of strategies for improving health and medical research with socially disadvantaged groups. BMC medical research methodology, 14, 42. https://doi.org/10.1186/1471-2288-14-42

Castiglioni, L., Pforr, K., & Krieger, U. (2008). The effect of incentives on response rates and panel attrition: Results of a controlled experiment. Survey Research Methods, 2(3), 151-158.

Centers for Disease Control and Prevention. About CDC’s National Wastewater Surveillance System (NWSS). Retrieved from https://www.cdc.gov/nwss/about.html, on November 30, 2023

Krueger, R. and Casey, M. (2009) Focus Groups: A Practical Guide for Applied Research. Sage

Publications: Thousand Oaks, CA.

Lee JY, Divaris K, Rozier RG, Baker D, & Vann WF., Jr (2010). Oral health literacy levels among a low income population (abstract). J Dent Res 89(Spec Iss A):1206 [Google Scholar]

Robinson, K.A., Dennison, C.R., Wayman, D.M., Pronovost, P.J., & Needham, D.M. (2007). Systematic

review identifies number of strategies important for retaining study participants. J Clin

Epidemiol; 60(8): 757-765.

Shettle, C., & Mooney, G. (1999). Monetary incentives in U.S. government surveys. Journal of Official Statistics, 15, 231–250.

Singer, E., N. Gelber, J. Van Hoewyk, and J. Brown (1997). Does $10 Equal $10? The Effect of Framing

on the Impact of Incentives. Paper presented at the American Association for Public Opinion;

Norfolk, VA.

Singer, E., Van Hoewyk, J., and Maher, M.P. (2000). Experiments with Incentives in Telephone Surveys.

Public Opinion Quarterly 64(3):171-188.


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