GenIC Clearance for CDC/ATSDR
Formative Research and Tool Development
Focus Groups and In-Depth Interviews with Travelers and Travel Medicine Specialists
OMB Control No. 0920-1154
July 18, 2024
Supporting Statement A
Contact:
Rudith Vice
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention
1600 Clifton Road, NE
Atlanta, Georgia 30333
Phone: (404) 718-7292
Email:[email protected]
1. Circumstances Making the Collection of Information Necessary 3
2. Purpose and Use of Information Collection 4
3. Use of Improved Information Technology and Burden Reduction 4
4. Efforts to Identify Duplication and Use of Similar Information 4
5. Impact on Small Businesses or Other Small Entities 4
6. Consequences of Collecting the Information Less Frequently 4
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 4
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 5
9. Explanation of Any Payment or Gift to Respondents 5
10. Protection of the Privacy and Confidentiality of Information Provided by Respondents 5
11. Institutional Review Board (IRB) and Justification for Sensitive Questions 6
12. Estimates of Annualized Burden Hours and Costs 7
13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 7
14. Annualized Cost to the Government 7
15. Explanation for Program Changes or Adjustments 8
16. Plans for Tabulation and Publication and Project Time Schedule 8
17. Reason(s) Display of OMB Expiration Date is Inappropriate 9
18. Exceptions to the Certification for Paperwork Reduction Act Submissions 9
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The Centers for Disease Control and Prevention (CDC) is requesting approval for a new generic information collection (gen-IC), “Focus Groups and In-Depth Interviews with Travelers and Travel Medicine Specialists.” CDC has recognized the critical need for a formative understanding of the experiences, beliefs, and needs of two key travel health audiences: frequent international travelers visiting friends and relatives (VFRs) in South Asia or Mexico and Central America and travel medicine specialists. Both audiences present unique opportunities for improving CDC’s communication strategy and furthering CDC’s mission of protecting public health.
Travel health risks are serious and well-documented, particularly in countries where diseases like malaria and hepatitis A are prevalent.1 Actions like consulting with a travel medicine specialist, researching the health risks and advisories related to a destination, and receiving recommended pre-travel vaccination or medications can help alleviate these serious health risks. However, previous research has found that many international travelers do not fully appreciate the risks they face abroad and frequently do not take such preventative measures before their trips.2
Research also suggests that VFRs are especially unlikely to seek out travel health information and take preventative measures before traveling. These individuals may feel familiar and comfortable with their intended destination as a result of traveling there previously. Thus, they may not see the need to take any different health precautions prior to, during, and after travel from what they are used to.3 They might also rely more on advice and experiences of their local friends and relatives, who may not emphasize health precautions as much as healthcare professionals would.
While research has been done to understand the scope of the problem, there are opportunities for more in-depth data collections on this topic. Specifically, this project will expand upon existing knowledge by assessing VFRs’ mindsets towards travel health, the role travel medicine specialists play in the process, and the information sources used (or not used) by both groups. Collecting data from these audiences will enable CDC to refine its existing messages and materials, optimize its communication strategies, and ultimately enhance its ability to safeguard traveler health.
The goals of this one-time data collection are to 1) understand VFRs’ health practices and precautions taken prior to, during, and after travel, 2) assess the interactions between healthcare professionals and travelers, 3) and identify trusted messengers and information needs.
In total, six focus groups will be conducted with VFRs. The groups will focus on two regions: South Asia and Mexico and Central America. These were selected due to the high volume of travelers visiting these locations and the elevated travel health risks associated with the regions. Two focus groups will be conducted with those traveling to South Asia and four groups will be conducted with those going to Mexico and Central America. Among the Mexico and Central America groups, two groups will be held in Spanish and two groups will be held in English to ensure the full breadth of experiences are captured. A discussion guide (Attachments 3 and 6) will be used in all focus groups to facilitate a structured conversation around their experiences, attitudes, and behaviors associated with travel health. The discussion guide, screener, and consent form have been translated into Spanish for the Spanish-language groups (Attachments 4, 5, 6).
Additionally, eight in-depth interviews will be conducted with travel medicine specialists. This audience has been included because of their pivotal role in preparing travelers for safe and healthy journeys abroad. Alongside gaining insight into traveler-provider interactions, the interviews will be used to evaluate the usability of existing CDC-created resources intended for these healthcare professionals such as the Yellow Book, which compiles the US government's most current travel health guidelines. Formal testing will help ensure these tools are effective and useful. Like the focus groups, a discussion guide (Attachment 9) will be used by interviewers to explore key themes and conduct the usability testing of CDC resources.
The data from this project is expected to provide valuable insights that would inform several divisions within the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID). Findings will be used to develop targeted messaging strategies that deliver desired or needed information and drive behaviors among these audiences. This data collection will also help CDC refine its existing materials, particularly the web resources CDC has already created for healthcare professionals.
KRC Research, a contracted research firm, will conduct all data collection related to the proposed formative research project, under the supervision of NCEZID. KRC’s data collection will include recruiting and screening participants into the project and conducting all six focus groups and eight in-depth interviews.
Data will be collected via online focus groups and interviews through a web-based platform, meaning that participants will not have to download anything to their personal devices (participants need only to have an internet connection). All focus groups and interviews will be conducted by professional moderators from KRC Research, a contracted company. All focus groups and interviews will be audio and video recorded to ensure participant responses are captured accurately and transcribed. Questions included on the moderator guides (Attachments 3, 6, 9) have been limited to only those relevant to the target audience to reduce burden on respondents.
To date, there has been little formative qualitative evaluation exploring the experiences, beliefs, and information needs of these specific travel health audiences, particularly in regard to testing travel health resources.
No small businesses will be involved in this data collection.
The screeners, focus groups, and interviews are all one-time information collections.
There are no special circumstances with this information collection package. This request fully complies with the guidelines in 5 CFR 1320.5 and will be voluntary.
A. This information collection request does not require publication of a 60-day notice in the Federal Register.
B. KRC Research, a contracted research firm, has been consulted in the development of the research plan, sampling parameters, and moderator guides. Under the supervision of NCEZID, KRC will ultimately conduct all data collection related to the proposed evaluation. Data collection will include recruiting and screening participants into the formative research and conducting six 90-minute focus groups and eight 60-minute in-depth interviews.
Participants will receive a monetary incentive of $75 for their participation. Such an incentive is a standard practice in the market research industry and helps to ensure efficient recruitment and ultimate participation among the qualified and scheduled participants. The amount is also standard for an audience participating in a focus group or interview. The incentive is also intended to offset the cost of personal or professional time taken to participate.
NCEZID has determined that the Privacy Act does not apply to this information collection. KRC Research, a contracted firm, will manage recruitment and moderating for this initiative, and PII will not be transmitted to NCEZID or CDC.
The screening instruments for this evaluation are provided in Attachments 1, 4, 7. This screening instrument will be used to evaluate the qualification of potential participants. The screening instruments include information about privacy and confidentiality; only those individuals who agree to these terms will qualify for participation in focus groups or interviews. After an individual agrees to the terms and has qualified, they will be given a separate consent form (Attachments 2, 5, 8) that reiterates privacy and confidentiality policies. The participant will be required to sign the form (electronic submission is allowed) and deliver a copy to the recruiting and moderating team. The participant will be reminded that participation is entirely voluntary.
After the consent form is signed, participants will confirm their focus group or interview slots. During the introduction to each discussion, the trained moderator will review key parts of the privacy and confidentiality agreement:
This discussion is completely voluntary. Participants may choose to leave the focus group or interview and/or not answer a question at any time for any reason.
The evaluation team will take every precaution to protect participant identity and ensure privacy unless otherwise determined by law. This includes keeping names and answers to questions private and keeping contact information separate from any responses.
Results of the focus groups and interviews will be presented in aggregate, and names will not be used in any reports.
Discussions will be audio and video-recorded and notes will be taken during the discussion. All information, notes, and recordings will be locked in a file cabinet or a secure computer file. Only evaluation staff will be able to access the information.
No participants’ personally identifiable information will be shared or made available to NCEZID. No recordings will be shared (audio or video), and shared transcripts will have names and any other identifiable information redacted. All findings will be reported in aggregate only.
Data will be kept private to the extent allowed by law.
Institutional Review Board (IRB)
This project was reviewed by NCEZID’s human subjects advisor and determined to not meet the definition of research under 45 CFR 46. IRB review is not required (Attachment 10).
Justification for Sensitive Questions
All of the questions asked in the focus groups and interviews will be non-sensitive in nature and focus on individuals’ experiences and beliefs related to travel health. All participants will be informed that they need not answer any question that makes them feel uncomfortable or that they simply do not wish to answer.
The total estimated burden is 132 hours. In sum, six focus groups and eight in-depth interviews will be conducted. Table 1 below describes the burden associated with the information collection.
The burden table assumes that 10 respondents will be screened for every one successfully recruited and scheduled for a focus group or interview. It also assumes that 8 individuals will be seated in each focus group. (This one in ten rate is relatively high because sampling is conducted from within a panel of individuals already opted in surveys, focus groups, and interviews. Each individual also has a preexisting demographic profile that makes targeting recruitment much more efficient.) The burden table assumes screening will take 5 minutes per person, and the consent form will take an additional 5 minutes for those individuals who are successfully recruited. Interviews last 60 minutes and focus groups last 90 minutes.
Table 1. Annualized Burden
Type of Respondent |
Form Name |
No. of Respondents |
No. of Responses per Respondent |
Average Burden Per Response (hours) |
Total Burden Hours |
Travelers |
Focus Group Recruitment Screener-English/Spanish
(Attachments 1 & 4) |
480 |
1 |
5/60 |
40 |
Focus Group Consent Form English/Spanish
(Attachments 2 & 5) |
48 |
1 |
5/60 |
4 |
|
Focus Group Guide English/Spanish
(Attachments 3 & 6) |
48 |
1 |
1.5 |
72 |
|
Travel Medicine Specialists |
In-Depth Interview Recruitment Screener
(Attachment 7) |
80 |
1 |
5/60 |
7 |
In-Depth Interview Consent Form
(Attachment 8) |
8 |
1 |
5/60 |
1 |
|
Interview Guide
(Attachment 9) |
8 |
1 |
1 |
8 |
|
Total |
|
132 |
According to the U.S. Bureau of Labor Statistics (BLS) May 2023 National Occupational Employment and Wage Estimates, the average hourly wage for all occupations is $31.48. This amount has been used to calculate cost of participation for the travelers audience. The average hourly wage of physicians ($126.85), physician assistants ($62.74), and nurse practitioners ($61.78) is $83.79 and has been used to calculate the cost burden for travel medicine specialists. The total estimated cost burden is $5,746.43.
Table 2. Cost burden associated with information collection
Type of Respondent |
Form Name |
Total Burden Hours |
Hourly Wage Rate |
Total Respondent Costs |
Travelers |
Focus Group Recruitment Screener-English/Spanish
(Attachments 1 & 4) |
40 |
$31.48 |
$1,259.20 |
Focus Group Consent Form English/Spanish
(Attachments 2 & 5) |
4 |
$31.48 |
$125.92 |
|
Focus Group Guide English/Spanish
(Attachments 3 & 6) |
72 |
$31.48 |
$2,266.56 |
|
Travel Medicine Specialists |
In-Depth Interview Recruitment Screener
(Attachment 7) |
7 |
$83.79 |
$586.53 |
In-Depth Interview Consent Form
(Attachment 8) |
1 |
$83.79 |
$83.79 |
|
Interview Guide
(Attachment 9) |
8 |
$83.79 |
$670.32 |
|
Total |
|
$5,746.43 |
There will be no direct costs to the respondents other than their time to participate in each information collection.
The annualized cost to the Federal Government to collect this information is $101,287.66. Table 3 below describes the cost in more detail.
Recruiting and data collection will be conducted by KRC Research, a contracted firm. KRC’s work includes recruitment, screening, scheduling, management of consent forms, conducting focus groups and interviews, transcription and data cleaning, reporting, and presentation. Contractor costs cover the work of an existing team working with NCEZID on this and other communications initiatives. and include 99 hours of labor for a KRC Vice President, 231 hours for an Analyst, and 60 hours for a Field Vice President (recruitment management tasks). Hours are tabulated based on existing contractor hourly rates. Contractor expenses are based on competitively bid prices for panel recruitment / screening and transcription, plus cost of incentives.
Oversight and review of all materials and reports will be conducted by one federal government employee (a GS-14 health communication specialist) who is co-leading the project. The work will include providing oversight to KRC Research on the purpose and objectives of the project; guidance and feedback on recruitment, screening, and guide materials; entering the project materials into CDC’s STARS system for project determination; meeting regularly with KRC Research staff to discuss the project’s progress and answer any questions; reviewing the transcripts and reports; and sharing topline findings with NCEZID staff so they can use the findings to strengthen communication messages. The estimate includes 40 hours for a Health Communication Specialist 1.
Estimated federal employee cost is tabulated based on this employee’s current hourly wages (locality-adjusted GS pay table for Atlanta-area workers):
Health Communication Specialist 1: 40 hours @ $76.56/hour = $3,062.40
Table 3. Estimated Annualized Cost to the Government per Activity
Cost Category |
Estimated Annualized Cost |
Contractor personnel costs: costs to oversee recruit, conduct focus groups and interviews |
$36,497.90 |
Contractor personnel costs: costs to report on results |
$18,354.76 |
Contractor expenses: recruitment panel, transcription, incentives |
$46,435.00 |
Federal government personnel costs: oversight, report review |
$3,062.40 |
Total |
$101,287.66 |
This is a new information collection.
This initiative is expected to take seven weeks from start to finish. Four weeks will be spent recruiting and conducting focus groups and interviews, and three weeks will be spent in analysis and reporting. A timeline is in Table 4.
Table 4. Project Time Schedule
Activity |
Time Schedule |
Recruit participants |
2 weeks, beginning immediately after gen-IC approved (August 2024) |
Conduct focus groups and interviews |
2 weeks, overlapping with recruitment (6 focus groups and 8 in-depth interviews total) |
Transcription, data processing, and analysis |
1 week after focus groups and interviews end |
Report development |
2 weeks after analysis is complete |
Disseminate results/reports |
As soon as summary report is complete |
Focus groups and interviews will be audio and video recorded for aid in reporting and analysis. Audio files will be transcribed verbatim in Microsoft Word and used for reporting. (Deidentified transcripts will be delivered to NCEZID.) Results will be used to develop one written report (for travelers and travel medicine specialists combined) with an assessment of findings, recommendations for targeted messaging strategies for CDC communications with these audiences.
The expiration date of OMB approval will be displayed on all information collection instruments.
There are no exceptions to the certification. These activities comply with the requirements in 5 CFR 1320.
List of Attachments
Screener (International Travelers, English)
Consent Form (International Travelers, English)
Focus Group Guide (International Travelers, English)
Screener (International Travelers, Spanish)
Consent Form (International Travelers, Spanish)
Focus Group Guide (International Travelers, Spanish)
Screener (Travel Medicine Specialists)
Consent Form (Travel Medicine Specialists)
IDI Guide (Travel Medicine Specialists)
Human Subjects Determination
1 “Travelers’ Health.” CDC.gov. https://wwwnc.cdc.gov/travel/
2 Hamer, Davidson H., and Bradley A. Connor. “Travel Health Knowledge, Attitudes and Practices among United States Travelers.” Journal of Travel Medicine, vol. 11, no. 1, Jan. 2004, pp. 23–26.
3 Bechini, Angela, et al. “Travelers’ Attitudes, Behaviors, and Practices on the Prevention of Infectious Diseases: A Study for Non-European Destinations.” International Journal of Environmental Research and Public Health, vol. 18, no. 6, Mar. 2021, p. 3110.
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