Supporting Statement A

Goal: Increase the awareness of Zika risks and prevention methods among Hispanics/Latinos, ages 18-44 years, residing in the United States who visit friends and relatives in Latin America, Mexico, and the Caribbean - particularly pregnant women, their partners, and family members.
Intended use of the resulting data: Information collected from focus groups will explore perceptions of the Viajo sin Zika campaign tactics and messages and assess which messages resonated most with the target audience.
Methods to be used: Collect qualitative data through virtual focus groups with community members who were exposed to the Viajo sin Zika campaign.
Subpopulation: Hispanic/Latino adults, 18-44 years old, exposed to the Viajo sin Zika campaign in New York City, Los Angeles, or Orlando. These individuals also should be born in Latin American, Mexico, or the Caribbean or have a parent born in Latin American, Mexico, or the Caribbean have recently traveled to or plan to travel to their family’s country of origin.
How data will be analyzed: Use qualitative data software to facilitate a thematic and content analysis of focus group transcripts.

A.1. Circumstances Making the Collection of Information Necessary

Over 80 million businesspersons, missionaries, students, vacationers, and people visiting friends and relatives (VFRs) traveled abroad in 2015. VFRs are a growing segment of international travelers. A VFR traveler is typically defined as an immigrant, ethnically and racially distinct from the majority population of the country of residence, who returns to his or her country of origin to visit friends or relatives. In 2013, 12 percent of the U.S. population was foreign born. In that same year, 38 percent of travelers from the United States who traveled abroad indicated that visiting friends and relatives was the main purpose for their trip―a total of nearly 12 million travelers.

Traveling abroad might expose travelers to illnesses that are not common in the United States. VFR travelers are at higher risk for some of these diseases. The risk is higher because VFR travelers generally stay longer than tourists, eat local food in people’s homes, and might not take the same precautions (such as preventing insect bites or taking prophylactic medications) as tourists do. In addition, most VFR travelers do not see a doctor for vaccines and advice before they travel, possibly because of cost, cultural or language barriers, or limited time.

With the recent outbreak of Zika virus (Zika) having affected thousands of Hispanics/Latinos across Latin America, the Caribbean, and the United States, the Centers for Disease Control and Prevention (CDC) Travelers’ Health Branch (TH) is developing and implementing an awareness campaign (Viajo sin Zika campaign) aimed at Hispanic/Latino VFRs, as the primary high-risk group, about their Zika risk and prevention behaviors. The campaign seeks to build awareness, cultivate a change of mindset, and reframe the conversation about travel among VFRs going to or coming back from areas at risk for Zika. Campaign messages highlight the steps travelers need to take before, during, and after travel to prevent infection with the Zika virus and address both mosquito bite and sexual transmission, along with the risk of microcephaly and other severe birth defects associated with infection in pregnant women.

Key messages of the campaign were previously cleared by CDC’s Office of the Associate Director of Communications (OADC) and NCEZID/DGMQ as part of the Zika emergency response clearance process. They are:

Pregnant women should not travel to areas with risk of Zika.

Before you go, pack:
- Insect repellent with an active ingredient, such as DEET or picaridin
- Long-sleeved shirts and long pants
- Condoms
During your stay:
- Use insect repellent, day and night, and reapply as directed
- Apply sunscreen first, then insect repellent
- Wear long-sleeved shirts and pants
- Use condoms if you have sex

After you return:

Use insect repellent for 3 weeks to prevent passing Zika to mosquitoes
Use condoms or do not have sex for 2 months (women) or 6 months (men)
Use condoms for the rest of the pregnancy if your partner is pregnant
Talk to your doctor if you develop a fever, rash, headache, joint pain, red eyes, or muscle pain

The goal of the Viajo sin Zika campaign is to increase the awareness of Zika risks and prevention methods among Hispanics/Latinos, ages 18-44 years, residing in the United States who visit friends and relatives in Latin America, Mexico, and the Caribbean - particularly pregnant women, their partners, and family members. The campaign uses traditional and social media to share Zika prevention and travel health recommendations with the target audience. The campaign also involves working with Hispanic/Latino focused community-based organizations currently working with the campaign’s target audience to amplify the key messages of the campaign to their constituents. To evaluate how the campaign resonates with the target audience, we will conduct a series of focus groups with individuals who have been exposed to the Viajo sin Zika campaign. The focus groups will explore the influence, if any, of exposure to the Viajo sin Zika campaign on community members’ perceptions related to Zika prevention. The focus groups will also elicit feedback about specific elements of campaign materials like the imagery used in advertisements to inform future communication efforts

To facilitate the collection of data in a timely manner, DGMQ/TH will work with ICF, an approved federal government contractor, to develop data collection instruments, facilitate focus groups, analyze and interpret data, and summarize findings. CDC will oversee and approve all content, materials, and activities related the campaign.

Personal identifiers will be maintained and protected to the extent allowable by law and destroyed at the completion of data collection and once gift cards have been distributed. ICF evaluation staff will have access to collected PII. No PII will be filed or retrievable by CDC; only de-identified data will be shared with CDC. No additional individually identifiable information is being collected.

We will recruit participants through both partner organizations and digital strategies (e.g., social media posts, digital ads), conduct focus groups, and summarize results and findings. Community-based partner organizations will work with ICF to recruit participants from their respective communities into focus groups. An email will be sent to our primary contacts at each partner organizations informing them of the assessment and requesting their assistance in recruiting community members exposed to the campaign and who meet our inclusion criteria above (Attachment A). Partners will share a flyer, electronically and in-print, with potential participants at in-person events or through electronic communications. The flyer (Attachment C) will include a brief description of the project and a link to the online screener (see Appendix D). ICF staff will access results from the screener to then email and/or call individuals who meet eligibility requirements. ICF will contact eligible participants to schedule the date and time of the focus group, and send them a meeting invite that includes the focus group details, time, and call-in number.

ICF will facilitate a maximum of 12 focus groups, up to 4 in each market. Each focus group will include

4-6 people with a maximum of 72 participants. Groups will be segmented by language (English or

Spanish) and gender (e.g. English- speaking women, Spanish-speaking women, English-speaking men,

Spanish-speaking men). The focus groups will be conducted virtually and will be audio-recorded. Each

focus group will last up to one hour. One ICF employee will facilitate the groups, and another ICF

employee will take notes during each focus group session. CDC staff will observe the focus groups and

be available to answer participants’ questions about Zika. Before starting the focus groups, the moderator

will read the informed consent information with the participants (Attachment E). The focus groups will

follow the facilitator’s guide (Attachment E) which contains a series of open-ended questions with follow

up (probing) questions to gather in-depth responses. Participants will receive a $10 Amazon gift card as

thanks for participating in the focus group and will be directed to CDC’s travel health website to learn

more about the risk of Zika and how they can protect themselves and their loved ones. Participants will

also have the opportunity to speak with CDC staff members who observed the focus group discussion

about their specific questions after each discussion is complete. The participant(s) will determine their

preferred method for talking with CDC staff (e.g. remain on the line, email, phone call, etc.).

The information collection for which approval is sought is in accordance with DGMQ’s mission to reduce morbidity and mortality among immigrants, refugees, travelers, expatriates, and other globally mobile populations, and to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States. This mission is supported by delegated legal authorities.

A.2. Purpose and Use of the Information Collection

DGMQ, including the Travelers’ Health Branch, plays a vital role in communicating and educating mobile populations (including travelers, immigrants, expatriates and refugees) in the US about the health risks of Zika to prevent the introduction, transmission and spread of Zika domestically and abroad. Thus far DGMQ has sought to better understand and respond to the health needs and behaviors of priority audiences like clinicians advising travelers and athletes heading to or returning from areas with risk of Zika, travelers to areas with risk of Zika, migrant farmworkers in border communities, and people living in communities with local transmission of Zika. Formative data, message testing, and formative studies helped to shape the design, development, and promotion of multi-lingual communication products. These included electronic travel alert messages in airports, webinars for clinicians and community organizations, and customized messages for pregnant women living in Puerto Rico. The proposed campaign for Hispanic/Latino travelers who visit family and friends in Latin America or the Caribbean, a population at risk for contracting and spreading Zika, is a continuation of those efforts.

This project will gather information about travelers’ awareness of Zika risks and modes of transmission during and after travel, determine their sources of information, and identify best ways to improve prevention messaging and delivery channels. The Moderator’s Guide for Focus Groups with Participants Exposed to the Viajo sin Zika Campaign (Attachment E) was designed to collect data to determine 1) exposure to the campaign messages and materials; 2) attitudes and perceptions about print and digital campaign materials; 3) how campaign message and materials resonated with the target audience; and 4) participants intentions related to Zika prevention behaviors.

Although focus groups provide immediate knowledge of participants’ opinions and understanding on a particular topic, there are limitations in their use. Moderators may deliberately or unconsciously impact the participants’ opinions by introducing their personal opinions, and leading participants into conclusions (Quinn Patton, 2002). Participants can also hide their true opinions for fear of disappointing the moderator (U.S. HHS, 2002). Results from focus groups cannot be generalized the same way as data collection from quantitative techniques because of sample size and selection procedures, therefore data generated from focus groups are less representative of the total universe (U.S. HHS, 2002).

This project will gather information about Hispanic/Latino VFR travelers’ awareness of the risks associated with the Zika virus and the steps travelers need to take before, during, and after travel to prevent infection with the Zika virus. Data collected from this project will explore perceptions of the Viajo sin Zika campaign tactics and messages and assess which messages resonated most with the target audience. Results from this project might also be presented at national or international conferences, reported in a manuscript, and submitted for publication in peer-reviewed journals. Results will be reported in aggregate and will not contain any PII. ICF may be included as co-authors on abstracts or manuscripts.

Any information shared as a result of this collection will be shared in aggregate with personal identifiers removed. Sharing of any information in this way is intended to help improve program activities, help CDC and partners learn about the audiences and their communication, education, and training needs, and guide future efforts in reaching these populations. Some information may be submitted to peer-reviewed journals to help expand knowledge and understanding. All information provided by respondents will be treated in a secure manner and will not be disclosed unless otherwise compelled by law. Respondents will be informed prior to participation that their responses will be treated in a secure manner.

A.3. Use of Improved Information Technology and Burden Reduction

This information request is in compliance with the Government Paperwork Elimination Act (GPEA), Public Law 105-277, title XVII.

Data will be collected through web-based focus groups with respondents in New York City, New York, Orlando, Florida, and Los Angeles, California. After careful consideration and examination of this project’s timeline, resources, and intended audience, these methods present the greatest opportunities for retrieving meaningful data and minimal burden to the pool of respondents.

To further reduce the burden on respondents, questions in the moderator’s guide were held to the minimum required in order to elicit the necessary data. Additionally, the moderator’s guide (Attachment E) includes more questions and probes then those that will actually be used during each 60-minute session. The intent is to allow the moderator the flexibility to use the same guide for participants that may be segmented by gender, if deemed beneficial.

A.4. Efforts to Identify Duplication and Use of Similar Information

Because DGMQ’s public heath mission is supported by regulatory responsibilities, as outlined in Section A1, it is not expected that any of the information collected under this proposed generic clearance is duplicative or is already in the possession of the federal government. The proposed generic clearance will allow DGMQ to significantly improve its ability to develop, refine and evaluate communication, education, and training activities. The results and final products from these activities may be used by multiple government and non-profit agencies.

A review of the scientific and gray literature indicates that no other agency is collecting similar data. There are no similar published data available about travel health knowledge, attitudes, and beliefs and the best strategies to reach these specific audiences (adult Hispanic/Latino VFR travelers, 18-44, visiting Latin America, Mexico, or the Caribbean) regarding the prevention of Zika during and after travel.

A.5. Impact on Small Businesses or Other Small Entities

No small businesses will be involved in this data collection.

A.6. Consequences of Collecting the Information Less Frequently

This is a request for a one-time information collection. There are no legal obstacles to reducing the burden.

A.7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This request fully complies with the regulation 5 CFR 1320.5.

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

A 60-day Federal Register Notice was published in the Federal Register on October 30, 2017, vol. 82, No. 208, pp. 50131. CDC received four non-substantive public comments on this notice. CDC’s standard response was sent.

The following individuals were consulted to obtain their views on availability of data, frequency of collection, clarity of instructions and record keeping, disclosure, or reporting format, and on the data elements to be recorded, disclosed, or reported:

Individual	Contact Information
Maibe Ponet, Chief Communications Officer, New York Health Department	[email protected]
Stella Fogelman, Director, Emergency Preparedness and Response Division, Los Angeles County Department of Public Health	[email protected]
Alvina Chu, Epidemiology, Florida Department of Health Orange County	[email protected]

A.9. Explanation of Any Payment or Gift to Respondents

Participants will be provided a $10 gift card for their 1-hour participation in the web-based focus groups.

The most important aspect of an incentive plan may be its potential for reducing response bias, underreporting bias, and similar sources of error. Findings from the National Survey of Family Growth (a study in which childbearing and family planning patterns are collected from young women) demonstrated that incentives not only had positive effects on response rates, but they also increased the accuracy of reporting (2). Incentives are necessary for testing in order to ensure that those who are willing to participate are as representative as possible of the wider public. Failure to provide a basic incentive is likely to bias samples in the direction of well-educated individuals who are generally predisposed to be helpful.

In the National Adult Literacy Survey by Berlin and colleagues (3), a $20 incentive resulted in not only higher response rates from the sample cohort, but also lower costs per completed case than the comparison group. Importantly, the incentives provided higher response rates from adults with lower-than-average levels of education and basic literacy and numeracy skills.

Empirical evidence suggests that motivation is increased when an incentive is present for research. Krueger (4) cautions that without providing minimal levels of monetary compensation, insufficient numbers of participants will attend and results will not be useful. In addition, there is substantial evidence that monetary incentives increase response rates to surveys. In a meta-analysis of 38 experiments and quasi-experiments, Church (5) found that nonmonetary gifts were significantly less effective than cash in generating survey responses, and noted that offering pre-paid monetary incentives yielded an average increase of 19.1 percentage points over comparison groups.

The gift card amount was determined through discussions with ICF and CDC staff with expertise in conducting focus groups, about Zika and other health topics with similar populations in the United States. The token of appreciation is intended to account for participation in a 60 minute web-based focus group, including dependent or child care arrangements, and productivity losses. These challenges can present a significant burden to participants.

A.10. Protection of Privacy and Confidentiality Information Provided to Respondents

This information collection request has been reviewed by the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), and it has been determined that the Privacy Act does not apply. No personally identifiable information will be filed or retrievable by CDC. No additional individually identifiable information is being collected.

The proposed focus groups pose little risk to the respondents’ privacy. In the event that there are participants in the same focus group who know each other, they will be given the option to leave the group. Further, all participants have the option to use their real or a fictional name during the focus group discussions. The audio recordings of the focus group will be destroyed after the notes are made and checked. Data will always be reported in a de-identified manner. Participants will not be able to be identified either directly or indirectly from the information that appears in the final data set and report. Disclosure of the respondents’ responses outside of the project setting (such as in a journal publication) would not have the potential to place the respondents at risk of criminal or civil liability or be otherwise damaging. The subject matter will not contain sensitive information, and responses will not be traceable to the respondents.

This project will only purposely recruit those who meet the target audience criteria. It will not purposely recruit, but will not exclude, pregnant women.

We will obtain individual verbal or electronic consent during the scheduling process, and will review the key consent points with the entire group prior to beginning the focus group.

Participants will be told that the information obtained from the data collection activity will be combined into a summary report so that details of individual responses cannot be linked to a specific participant. The focus groups will be facilitated in English and Spanish.

The risks to participating in the collection of data for this project are minimal. Participants will be asked about their perceptions of the Viajo sin Zika campaign. Participants do not have to respond to any questions they do not want to answer, and they may stop participating at any time. Participants may become distressed talking about Zika, particularly if they are part of an at-risk group; to minimize anxiety, they will be directed to resources (i.e., CDC travel health website) to obtain additional information about the steps they can take to protect themselves and will be urged to contact their healthcare providers with any specific questions related to their personal health and/or risk of Zika.

The benefits of participating in the collection of data are that participants will gain information about Zika while assisting CDC in understanding the impact of the Viajo sin Zika campaign.

The data collected will be retained by ICF during the contract period. After the contract between CDC and ICF expires on November 30, 2018, ICF will transfer de-identified data to CDC and destroy its data files. During the contract period, all audio recordings will be transcribed and shared with CDC. In addition, ICF will provide CDC with notes taken during the focus groups. ICF will store notes, transcripts, and audio-recordings will be in password-protected files. Data transferred to CDC will be stored on a secure password-protected shared drive behind the CDC firewall. Federal records management standards dictate that these data will be maintained by CDC for a minimum of 11 years.

A.11. Institutional Review Board (IRB) and Justification for Sensitive Questions

Institutional Review Board (IRB)

IRB has reviewed Viajo sin Zika Awareness Communication Campaign for Hispanics/Latinos Visiting Friends and Relatives: Focus Groups with Participants Exposed to the Viajo sin Zika Campaign, and has determined this data collection was deemed non-research (Attachment F – IRB Determination Letter of Exemption Protocol 07118KH).

Justification for Sensitive Questions

The majority of questions asked of focus group participants are not sensitive in nature since they primarily focus on exposure to Zika prevention materials and messages and perceptions about the campaign messages and materials. However, some respondents may find discussing Zika virus unpleasant. To minimize discomfort, the moderator will inform participants that they do not have to respond to any questions they do not want to answer and they may stop participating at any time.

A.12. Estimates of Annualized Burden Hours and Costs

A. The information collection requires the use of screening to determine eligibility to participate in focus groups. Standard recruitment procedures estimate that twice the number of respondents must be screened in order to yield the desired number of respondents. The burden in the Table 12.A below is as follow:

Of the 72 potential participants, we expect to recruit 144 participants for a response rate of 50%. The participants will be screened using an online screener (Attachment D) to determine which potential participants meet the eligibility criteria which includes the following: Hispanic/Latino origin, adults between ages 18-44, born in Latin America or the Caribbean or have a parent born in Latin America or the Caribbean, traveled to the family’s country of origin in the past 5 years or have made plans to travel to the family’s country of origin in the next 12 months, live in either New York City, Los Angeles, or Orlando, and recall being exposed to the Viajo sin Zika campaign.
An average of 5 minutes per respondent will be spent for the screening using the online screener for a total of 12 burden hours (144 x 5 = 640 mins.; 640 ÷ 60 mins. = 12 hrs.).
72 Hispanic/Latino VFR travelers will respond to the Moderator’s Guide of Questions for Focus Groups (Attachment E) for approximately 60 minutes per session (72 x 60 mins. = 4320 mins.; 4320 ÷ 60 = 72 hrs.).
The total burden of the information collection is 84 hours.

Table 12.A

Estimated Annualized Burden Hours
Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
Hispanic/Latino traveler between the ages of 18 and 44	Screener	144	1	5/60	12
Hispanic/Latino traveler between the ages of 18 and 44	Moderator’s Guide	72	1	1	72
Total					84

B. Table 12.B presents the calculations for cost of respondents’ time using US hourly mean wage information from the U.S. Department of Labor's (DOL) Bureau of Labor Statistics website (http://www.bls.gov/oes/current/oes_nat.htm), specifically originating from the 2017 National Occupational Employment and Wage Estimates. Based on DOL data for all types of jobs/careers, an average hourly wage of $24.34is estimated for all respondents. The total estimated cost burden is $2044.56.

Table 12.B:

Estimated Annualized Burden Hours and Costs to Respondents
Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Hispanic/Latino traveler between the ages of 18 and 44	Screener	12	$24.34	$292.08
Hispanic/Latino traveler between the ages of 18 and 44	Moderator’s Guide	72	$24.34	$1,752.48
TOTALS				$2,044.56

A.13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

None.

A.14. Annualized Cost to the Government

This project will span up to 2 months, September 2018 and ending in late October. The total estimated cost to the Federal Government is $20,316.90.

This figure encompasses .05% FTE of one GS-14 and .10% FTE of two GS-12 employees and information collection contract costs. The average annual rate was obtained from the Office of Personnel Management’s website (https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/18Tables/html/ATL.aspx). The annual rate for a GS-14 in metro Atlanta is $108,281 per year and $77,058 for a GS-12 per year. The contractual cost for an information collection (e.g. the development of a screener and instrument, participant recruitment, incentive payments, transcriptions, and final reports) is estimated at $18,500.

The table below details rolled up contract costs rather than presenting contractor rates.

Table 14:

Year	Contractor	Total
2018	$18,500	$18,500

Table 14.1 Estimated Annualized Cost to the Federal Government (CDC)

Estimated Annualized Cost to the Federal Government
Annualized Cost to the Government	No. of Hours per Year	Annualized Cost
Principal Investigator – Health Communication Specialist	10	$520.50
Co-Principal Investigator – Health Scientist	20	$740.80
Assistant Investigator – Health Scientist	15	$555.60
TOTAL	45	$1,816.90

* General Schedule for the locality <Locality pay for Atlanta, GA is 20.70% >

A.15. Explanation for Program Changes or Adjustments

There are no program changes or adjustments at this time.

A.16. Plans for Tabulation and Publication and Project Time Schedule

Under the guidance and direction of the CDC, the contractor will recruit focus group participants, moderate web-based focus groups, analyze findings, and complete a final report summarizing the results and recommendations. The results will evaluate perceptions of the Viajo sin Zika campaign tactics and messages and assess which messages resonated most with the target audience. Results from this project might also be presented at national or international conferences, reported in a manuscript, and submitted for publication in peer-reviewed journals. Once the data is collected, a findings report will be generated to inform future awareness campaigns intended for Hispanic/Latino VFR travelers. The project schedule is as follows:

Project Time Schedule
Activity	Time Schedule
Recruitment of respondents and data collection	August – September 2018
Complete report	November 2018

A.17. Reason(s) Display of OMB Expiration Date is Inappropriate

The display of the OMB expiration date is not inappropriate. No exemption is being requested.

A.18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

REFERENCES

1. U.S. Department of Health and Human Services. Centers for Disease Control and Prevention. Office of the Director, Office of Strategy and Innovation. Introduction to program evaluation for public health programs: A self-study guide. Atlanta: Centers for Disease Control and Prevention; 2005.

2. Mosher WD. Design and operation of the 1995 National Survey of Family Growth. Family Planning Perspectives 1998:30(1).

3. Berlin M, Mohadjer L, Waksberg J, Kolstad A, Kirsch I, Rock D, Yamamoto K. An experiment in monetary incentives. In: American Statistical Association, editor. Proceedings of the American Statistical Association Section on Survey Research Methods. Alexandria (VA): American Statistical Association;1992, p. 393-398.

4. Krueger RA. Focus groups: a practical guide for applied research. 2nd ed. Thousand Oaks, CA: Sage Publications; 1994.

5. Church AH. Estimating the Effect of Incentives on Mail Survey Response Rates: A Meta Analysis. Pub Opin Q 1993:57: 62 79.

ATTACHMENTS

Attachment A – Email Invitation to Partner Organizations

Attachment B – Email Invitation for Partner Organization Members

Attachment C – Recruitment Flyer for Focus Group Participants

Attachment D – Online Focus Group Screener

Attachment E – Focus Group Consent and Moderator’s Guide

Attachment F – IRB Determination Letter

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