Supporting Statement A

Information Collection for Evaluation of Education, Communication, and Training Activities for the Division of Global Migration and Quarantine (0920-0932):

Evaluation of Travelers’ Health Zika Prevention Communication Campaign for Hispanics/Latinos Visiting Friends and Family: Word of Mouth Survey

Expiration date: 07/31/2018

December 18, 2017

Supporting Statement A

Contact:

Colleen Brouillette

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, NE

Atlanta, Georgia 30333

Phone: (404) 718-5208

Email: [email protected]

Table of Contents

1. Circumstances Making the Collection of Information Necessary 3

2. Purpose and Use of Information Collection 5

3. Use of Improved Information Technology and Burden Reduction 7

4. Efforts to Identify Duplication and Use of Similar Information 7

5. Impact on Small Businesses or Other Small Entities 8

6. Consequences of Collecting the Information Less Frequently 8

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 8

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

9. Explanation of Any Payment or Gift to Respondents 8

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents 8

11. Institutional Review Board (IRB) and Justification for Sensitive Questions 9

12. Estimates of Annualized Burden Hours and Costs 9

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 10

14. Annualized Cost to the Government 10

15. Explanation for Program Changes or Adjustments 11

16. Plans for Tabulation and Publication and Project Time Schedule 11

17. Reason(s) Display of OMB Expiration Date is Inappropriate 11

18. Exceptions to Certification for Paperwork Reduction Act Submissions 11

Attachments 11

• Goal of the study: To evaluate a Word-of-Mouth (WOM) approach, an interpersonal communication method, with Hispanic/Latinos in New York City, to change community knowledge of Zika and key travel health prevention behaviors.

• Intended use of the resulting data: The resulting data will be used, in part, to evaluate the larger Zika prevention campaign for Hispanic/Latino travelers visiting friends and relatives (VFRs) in the Caribbean and Latin America. The data will also inform program improvements with future health education projects and highlight gaps in knowledge about Zika that subsequent educational efforts can address.

• Methods to be used to collect: The evaluation will use a pre-/post- test community awareness survey administered in both print and online formats.

• The subpopulation to be studied: Hispanics/Latinos in New York City who have traveled abroad in the past 2 to 5 years to visit friends and relatives in the Caribbean or Latin America.

• How data will be analyzed: Descriptive statistics will be performed, comparing frequencies and mean scores from the community surveys.

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 may 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 may 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.

The Zika virus (Zika) is spread to people primarily through the bite of an infected Aedes species mosquito (Ae. aegypti and Ae. albopictus). Zika can also be sexually transmitted from an infected person to his or her partner. Zika infection during pregnancy can cause serious birth defects, including microcephaly and other severe fetal brain defects.

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 education campaign aimed at Hispanic/Latino VFRs, as the primary high-risk group, about their travel health behaviors. Among VFR travelers, different subgroups have been targeted to develop messages and materials relating to that subgroup’s specific travel-related risks and cultural considerations. These subgroups include pregnant women, women trying to get pregnant, male partners, and family members. 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 will highlight the steps travelers need to take before, during, and after travel to prevent infection with the Zika virus and will 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 OADC and NCEZID/DGMQ as part of the Zika emergency response clearance process:

• 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

Most research on health issues associated with VFR travelers has focused on defining and detailing the unique issues related to these travelers. Although this highlights the need for educational interventions for this population, it leaves a distinct knowledge gap in identifying methods to improve their knowledge and attitudes around travel health.

WOM marketing is extremely effective, but there are still large areas of uncertainty. Data show that 92 percent of consumers trust recommendations from people they know; 70 percent of consumers believe that medical information from peers is credible, even if the peers are not experts; and it is estimated that consumers are 50 times more likely to take action from WOM marketing than traditional advertisements.

2. Purpose and Use of Information Collection

The overall goal of TH’s Zika VFR project is to increase the awareness of Zika risks and prevention methods among Hispanics/Latinos residing in the United States who visit friends and family in Latin America and the Caribbean through a communications campaign conducted in New York City, Orlando, and Los Angeles. The campaign will use both traditional and social media and will engage partners that are currently working with the campaign’s target audiences. A component of the campaign includes a WOM approach, an interpersonal communications method that will include local community health workers. CDC TH will employ the WOM approach to assist in achieving greater awareness of Hispanic/Latino VFRs living in the New York City area, and using Health Talker, LLC’s resources and connections to a local organization that provides community health services and education.

To help develop and implement the program, CDC TH is working with the firms ICF and HealthTalker, LLC. HealthTalker, LLC will focus on a word-of-mouth (WOM) initiative, which entails sharing CDC TH-produced Zika materials and messages with Hispanic/Latino VFRs in the New York City area. The WOM campaign will rely on volunteers in communities in New York to serve as travel “health talkers” with their social and interpersonal networks. Health talkers are adults who identify as Hispanic/Latino, live in the New York City area, and visit friends and relatives in Latin America and the Caribbean.

More specifically, to evaluate the WOM approach in the Hispanic/Latino population in the NYC metropolitan area, HealthTalker, LLC will conduct a survey, with the assistance of a New York City partner organization and ICF, to assess changes in knowledge among Hispanic/Latino VFRs in NYC before and after receiving WOM health education conversations. The assessment will rely on a convenience sample; therefore, survey respondents may or may not be the same before and after the program. HealthTalker, LLC will use several criteria to determine the selection of the New York City partner organization, including:

• Provides services to Hispanics/Latinos in the NYC metropolitan area with a focus on health

• Located within New York City

• Provides services to English- and Spanish-speaking Hispanics/Latinos of all ages; and if possible, with a bias to those who serve the 18–44 age group and who travel to areas at risk for Zika, particularly pregnant women and their partners

• Maintains an active digital and social media presence with significant followers, engagement, and activity

• Staffed with community outreach workers and holds community health events, conferences, classes, or workshops

HealthTalker, LLC is uniquely skilled and experienced in WOM health campaigns, specifically around the education of VFRs. HealthTalker, LLC will identify an organization in the New York City area to help implement the effort and connect CDC TH to the organization’s community health workers who may elect to volunteer as health talkers or facilitate the recruitment of volunteers from the community to serve as health talkers. Although the NYC partner organization will be instrumental in recruiting, volunteers do not need to be associated with the NYC partner to participate in the campaign. Additionally, employees of ICF or HealthTalker, LLC are not eligible to participate in the campaign.

Once recruited, health talker volunteers will be oriented online or in-person (based on the volunteers’ preference) to CDC’s Zika prevention education materials, messages, and resources for Hispanic/Latino VFR travelers. Equipped with CDC TH-approved education materials and resources, health talkers will share their knowledge via face-to-face conversations, text messages, telephone calls, social media platforms, and emails. These interactions will occur during the health talkers’ normal social interactions and during other community events, like health fairs, at which the New York City partner organization will be represented. They will stress the importance of preventive behaviors that can decrease the incidence of Zika infection when traveling to visit friends and relatives in Latin American destinations.

Using a pre-/post-test method, CDC TH will evaluate changes in community knowledge of Zika and key prevention behaviors highlighted through the WOM approach. The survey will examine the extent to which Hispanic/VFR respondents in NYC know about Zika and the prevention measures they can take before, during, and after they travel to visit family and friends in Latin American and Caribbean destinations to avoid contracting or spreading Zika. The survey will also capture key sources of trusted travel health information and demographics related to the campaign target audiences

The survey instrument (Attachment C, C1 Spanish) was developed to elicit responses that will indicate the participants’ level of knowledge and awareness of Zika that will be addressed in the discussions and CDC materials that will be provided by the community health volunteers.

Data will primarily be collected from the in-person and online surveys in two different phases,

within a time period of 3 to 4 months. Prior to the New York City organization providing information to VFRs in the New York City area through the WOM approach, they will conduct the pre survey to assess the base knowledge of Zika and prevention methods. Following 3 to 4 months of WOM information sharing, the organization will conduct the post survey to assess change in their knowledge.

Based on data from the Pew Research Center, approximately 4,780,000 Hispanics/Latinos reside in the New York City area (http://www.pewhispanic.org/interactives/hispanic-population-in-select-u-s-metropolitan-areas). CDC estimates that a representative sample for the estimated population of Hispanics/Latinos in the New York City area would equal approximately 384 Hispanic/Latinos. Using this calculation and previous experience with conducting surveys for the WOM method, CDC proposes a sample of 400 respondents each for the pre- and post-intervention surveys, for a total of 800 respondents.

The survey will use a convenience sampling approach that would encompass members of the New York City partner organization who receive emails through its listserv (online survey), as well as individuals who may not be familiar with the organization but are attending a community event at which they will be present. These community members will be given the survey on paper. Prior to completing the community awareness surveys either before or after the program, all respondents will sign and submit documentation of informed consent. Those who receive email invitations to the survey will be prompted to complete an electronic consent (Attachment B, B1 Spanish). The individual will not be allowed to proceed to the survey if they do not complete the consent process. Similarly, those who are invited to complete the survey in-person at community events will be given a hard copy consent form to complete (Attachment A, A1 Spanish) by a representative from the partner organization. The individual will not be allowed to complete the paper survey until they submit a signed consent form.

The pre-program survey will be administered before health talker volunteers are recruited. Likewise, the post-program survey will be conducted after health talkers are instructed to end their activities. Community events may take place in various locations in the NYC area. Ideally, these locations will be accessible to the program’s target audience.

To help staff of the local partner organization who are conducting in-person surveys, ICF and HealthTalker will develop a training to assist staff in identifying and excluding those who have already completed the online survey, administering the consent form, and ensuring participant confidentiality.

ICF will conduct the training virtually with the staff of the local organization. The training will address the following topics:

• Introduction/background of the survey

• Carrying out the survey

• Selection of participants

• Ethical considerations

• Logistics

• Survey questionnaire

The data collection instruments will be translated into Spanish so that the non-English-speaking population of the target audience can participate. The translated survey will be culturally and conceptually relevant to the target audience. Thus, both online and in-person versions of the survey will be offered in English and Spanish. Once the Institutional Review Board (IRB), CDC, and Office of Management and Budget (OMB) approve the instruments, ICF staff trained in the Spanish translation of research instruments will translate the tools.

3. Use of Improved Information Technology and Burden Reduction

The online survey will be administered using an online survey platform. The online survey allows for a greater reach of participants, as it will be distributed through the community partner organization’s listserv to the community. Responses will be automatically compiled into Excel sheets to require less time to enter responses from print surveys, reducing the burden on staff collecting the data.

4. Efforts to Identify Duplication and Use of Similar Information

CDC has consulted with several health department agencies and organizations in the New York City area to confirm that a similar activity is not being undertaken elsewhere.

5. Impact on Small Businesses or Other Small Entities

This data collection will not involve small businesses.

6. Consequences of Collecting the Information Less Frequently

This is a one-time information collection involving a pre- and post-intervention survey.

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

This request fully complies with the regulation 5 CFR 1320.5.

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

A. A 60-day Federal Register notice was published in the Federal Register on 12/17/2014. Vol. 79, p. 75155.  One non-substantive comment was received and CDC’s standard response was sent.

B. Three health departments were consulted with in preparing for this project. They are: New York City Department of Health and Mental Hygiene, Los Angeles County Department of Public Health, and Florida Department of Health – Orange County.

CDC, ICF, and HealthTalker consulted with the New York City Department of Health and Mental Hygiene and with three partner organizations located in New York City. These organizations included Make the Road, Hispanic Federation, and Mount Sinai Hospital. Discussions were held on the background of the local population served by the health department and partner organizations, potential roles and responsibilities, and feasibility of delivering the survey.

9. Explanation of Any Payment or Gift to Respondents

Survey respondents will not receive any payments or gifts for participation.

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

The National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) has reviewed this submission and determined that the Privacy Act does not apply.

HealthTalker, LLC and the New York City organizations (to be determined) will facilitate and manage recruitment of all program participants. Contact information or documents that include personal identification information (PII), will be kept in a secure, locked file cabinet when not in use and will only be handled by trained staff. Electronic consent forms will be kept in a secure password-protected electronic file. Personal identifiers will be maintained and protected to the extent allowable by law and destroyed at the completion of data collection. 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.

The data collected will be retained by HealthTalker, LLC and the New York City partner during the contract period. During the contract, ICF and Health Talker, LLC will provide CDC with de-identified raw data, from the survey. Data transferred to and from CDC will be stored on a secure password-protected share drive behind the CDC firewall.

Outreach conducted on behalf of the campaign through the WOM approach by the local partner organization may capture personal identifiers such as email addresses to distribute Zika information, but that information will not be collected and provided to HealthTalker, LLC, ICF, or CDC. The information will be kept in a password-secure account managed by the organization.

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

Institutional Review Board (IRB)

This project has been determined by ICF IRB (FWA00002349) to be in compliance with the Code of Federal Regulations, Title 45: Public Welfare Department of Health and Human Services, Part 46: Protection of Human Subjects.

CDC NCEZID determined that this program does not meet the definition of research under 45 CFR 46.102(d).  IRB review is not required. 

See Attachment D for the CDC human subjects determination documentation.

Justification for Sensitive Questions

There are no planned sensitive questions. There are survey questions that gather information on the knowledge of prevention measures, specifically on condom use. However, the questions do not ask personal sexual behaviors related to prevention measures.

12. Estimates of Annualized Burden Hours and Costs

A. Estimated Annualized Burden Hours

A total of 800 respondents who fit the selection criteria will complete the survey, with 400 completing the survey before the WOM intervention and 400 completing the survey after the intervention. The surveys were timed at 10 minutes, resulting in 66 burden hours for each phase of survey implementation and a total of 132 burden hours for the entire project.

Type of Respondent	Form Name	No. of Respondents	No. Responses per Respondent	Avg. Burden per response (in hrs.)	Total Burden (in hrs.)
General Public	Community awareness pre-test	400	1	10/60	66
General Public	Community awareness post-test	400	1	10/60	66
Total		800			132

B. Estimated Annualized Burden Costs

The estimated annualized burden costs for the total burden hours of 132 is $3,054.08, based on the BLS estimate for the general public (https://www.bls.gov/oes/current/oes_nat.htm#00-0000).

Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
General Public	Community awareness pre-test	66	$23.86	$1,574.76
General Public	Community awareness post-test	66	$23.86	$1,574.76
Total		132		$3,149.52

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

There are no costs to respondents other than their time to participate.

14. Annualized Cost to the Government

There are no equipment or overhead costs; however, contractors are being used to support the development of the instruments, data collection, and data analysis. The only cost to the federal government would be the salary of CDC staff and contractors. ICF costs ($3,113), Health Talker costs ($16,536), and costs for the local organization in New York City ($2,000) total to $21,650. The total estimated cost to the federal government is $1,906.47.

Estimated Annualized Cost to the Federal Government
Annualized Cost to the Government	No. of Hours per Year	Average Annualized Cost
Principal investigator – Health Communications Specialist	15	$971.70
Co-Principal Investigator – Health Communications Specialist	15	$600.45
Assistant Investigator – Health Scientist	5	$218.40
Assistant Investigator - Epidemiologist	2	$115.92
TOTAL	37	$1906.47

15. Explanation for Program Changes or Adjustments

This is a new information collection.

16. Plans for Tabulation and Publication and Project Time Schedule

There are no planned publications related to this project.

Project Time Schedule
Activity	Time Schedule
Pre-survey administered in NYC communities	After getting OMB clearance
Program implementation (includes recruitment of volunteer health talkers)	January–April 2018
Post-program survey administered in NYC communities	May 2018
data analysis and final report	June 2018

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.

Attachments

A - Word of Mouth Informed Consent Statement for Print Survey (English and A1 Spanish)

B - Word of Mouth Informed Consent Statement for Online Survey (English and B1 Spanish)

C - Word of Mouth Pre- and Post-test Survey (English and C1 Spanish)

D – CDC Human Subjects Determination Documentation

10