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Request for Sub-collection Under the

Approved Generic ICR: Data Collection Through Web-based Surveys for Evaluating Act Against AIDS (AAA) Social Marketing Campaign Phases Targeting Consumers

OMB No. 0920-0920

Development of Messages for the Let’s Stop HIV Together National Campaign

Supporting Statement A

July 18, 2022

Contact Person:

Stefanie Erskine

1600 Clifton Rd. NE, MS US8-5

Atlanta, GA 30329

Telephone: 404.639.4530

Fax: (404) 639-2007

E-mail: [email protected]

TABLE OF Contents

Section Page

A. Justification 4

A.1 Circumstances Making the Collection of Information Necessary 4

A.2 Purpose and Use of the Information Collection 4

A.3 Use of Improved Information Technology and Burden Reduction 5

A.4 Efforts to Identify Duplication and Use of Similar Information 5

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

A.6 Consequences of Collecting the Information Less Frequently 5

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

A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 5

A.9 Explanation of Any Payment or Gift to Respondents 6

A.10 Protection of the Privacy and Confidentiality of Information Provided by Respondents 6

A.11 Institutional Review Board (IRB) and Justification for Sensitive Questions 8

A.12 Estimates of Annualized Burden Hours and Costs 9

A.12.1 Estimated Annualized Burden Hours 9

A.12.2 Estimated Annualized Burden Costs 9

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

A.14 Annualized Costs to the Federal Government 10

A.15 Explanation for Program Changes or Adjustments 10

A.16 Plans for Tabulation and Publication and Project Time Schedule 10

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

A.18 Exceptions to Certification for Paperwork Reduction Act Submissions 11

REFERENCES 12

Bureau of Labor Statistics (BLS). (2019). May 2019 National Occupational Employment and 12

Wage Estimates United States. [Data table]. Retrieved from https://www.bls.gov/oes/current/oes_nat.htm#00-0000 12

EXHIBITS

Exhibit A.1 Annualized Burden Hours 10

Exhibit A.2 Annualized Cost to Respondents 10

Exhibit A.3 Estimates of Annualized Cost to the Government 11

Exhibit A.4 Project Time Schedule 11

ATTACHMENTS

Attachment 1: Web-based Survey Consent Form

Attachment 2: Web-based Survey Screener

Attachment 3: Web-based Survey Instrument (Microsoft Word)

Attachment 4: Web-Based Screener and Survey Screenshots

Attachment 5: Web-based Survey Reminder E-mail

Attachment 6: Messages

Attachment 7: Concepts

• Goal of the study: The goal of this study is to evaluate the acceptability and potential effectiveness of proposed concepts, messages, and taglines for a component of the Let’s Stop HIV Together campaign focused on HIV prevention that promotes proven, effective prevention strategies, such as pre-exposure prophylaxis (PrEP) and treatment as prevention (TasP), among audiences ages 18 to 64 years old in the United States.

• Intended use of the resulting data: The data obtained will be used to inform CDC, policy makers, prevention practitioners, and researchers about audience receptivity and the potential effects of campaign concepts, messages, and taglines.

• Methods to be used to collect data: The evaluation contractor will conduct a 30-minute web-based survey with 1,000 individuals ages 18-64 across the United States. The evaluation contractor will work with online survey vendors to draw respondents from their proprietary lists of panel members. We do not anticipate challenges related to the COVID-19 pandemic in conducting this survey as all data collection will be completed online.

• The subpopulation to be studied: To achieve our desired sample size, we anticipate screening 1,340 individuals. We will oversample African Americans; Hispanics/Latinos; and gay, bisexual, and other men who have sex with men (MSM) to ensure we obtain a broad cross-section of respondents, particularly those at heightened risk for getting HIV.

• How data will be analyzed: CDC and its contractor will receive data for analysis in aggregate form, and the randomly generated numbers assigned as respondent ID numbers will not link data to individuals. Data from completed surveys will then be compiled into an SPSS (Statistical Package for the Social Sciences) dataset and de-identified by the evaluation contractor with no information in identifiable form (IIF) for analysis.

Development of Messages for the Let’s Stop HIV Together National Campaign

A. Justification

A.1 Circumstances Making the Collection of Information Necessary

The Centers for Disease Control and Prevention (CDC) requests approval for a new data collection called, “Development of Messages for the Let’s Stop HIV Together National Campaign.” This is a genIC request under the OMB approved Generic Clearance #0920-0920; expiration date 5/31/2023, entitled “Data Collection Through Web Based Surveys for Evaluating Act Against AIDS Social Marketing Campaign Phases Targeting Consumers.”

CDC proposes to conduct a web-based survey to evaluate the acceptability and potential effectiveness of proposed concepts and messaging for a social marketing campaign focused on promoting HIV prevention among audiences ages 18 to 64 years old in the United States. HIV continues to be a significant public health issue in the United States. Approximately 1.1 million people ages 13 and older are living with HIV in the United States, and about 14% do not know they are infected (CDC, 2016). There are approximately 39,000 new infections each year (CDC, 2019a). The goal of the new Ending the HIV Epidemic: A Plan for America initiative is to reduce new infections in the United States by 90% in the next 10 years (CDC, 2019b). One of the four pillars of the Ending the HIV Epidemic plan is to prevent new HIV infections using proven, comprehensive, effective approaches, such as condoms, PrEP, and TasP. Although PrEP has been shown to be highly effective in preventing HIV infection among people at high risk, it is estimated that less than one quarter of those individuals who could benefit from PrEP are currently using it (CDC, 2019b). As part of the Ending the HIV Epidemic plan, CDC will design, implement, and evaluate concepts, messages, and taglines for a social marketing campaign to prevent new HIV transmission by promoting proven interventions including condoms, PrEP, and TasP. (CDC, 2019b).

The concepts, messages and taglines need to be tested and verified to ensure their acceptability and effectiveness among populations of all ages, genders, races and ethnicities, and sexual orientations (attachments 6 and 7). The study will consist of conducting web-based surveys with a total of 4,500 individuals.

A.2 Purpose and Use of the Information Collection

The purpose of this data collection is to evaluate the acceptability and potential effectiveness of proposed concepts, messages, and taglines for a component of the Let’s Stop HIV Together campaign focused on HIV prevention that incorporates proven, effective prevention strategies, among audiences ages 18 to 64 years old in the United States. The evaluation contractor will conduct a 30-minute web-based survey with 4,500 individuals. We will oversample African Americans; Hispanics/Latinos; gay, bisexual, and other men who have sex with men (MSM); and people with HIV (PWH) to ensure we obtain a broad cross-section of respondents, particularly those at heightened risk.

We will use the findings to determine which messages and concepts to further develop and implement as part of the social marketing campaign. If this data collection is not conducted, CDC will not have data to support whether the proposed messages and concepts reflect the information needs of the priority audiences, which may limit the impact of the social marketing campaign.

We will disseminate findings about audience receptivity and the potential effects of campaign messages and concepts as they are developed within the agency and to policymakers, prevention practitioners, and researchers. CDC and the evaluation contractor will also disseminate the study results to the public through reports prepared for/by CDC and its contractor (RTI International) and through peer-reviewed journal articles where appropriate. All releases of information will be reviewed and approved by CDC.

A.3 Use of Improved Information Technology and Burden Reduction

The data collection will utilize a web-based survey designed to be self-administered on personal computers, tablets or mobile phones. By using web-based technology, we will be able to expose respondents to concepts and messages that may be used in the social marketing campaign and obtain immediate feedback. Other benefits of using a web-based survey include the following: (1) Respondents can complete as much of the survey as desired in one sitting and continue the survey at another time; (2) the possibility of respondent error is reduced by electronically skipping questions that are not applicable to a particular respondent, thus minimizing respondent burden; (3) the potential for interviewer bias is eliminated since the survey is self-administered; (4) the potential for bias related to social desirability is minimized since the data collection is not face-to-face; and (5) because respondents can take the survey in a location of their choosing, they may feel more comfortable revealing information that is intimate, private, and sensitive, improving the validity of the data.

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

The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) has verified that there are no other generic collections that duplicate the study types included in this request. NCHHSTP has a similar ICR, “Development of CDC's Act Against AIDS Social Marketing Campaigns Targeting Consumers” (OMB 0920-1169), which also uses qualitative methodologies, including in-depth interviews, focus groups, and intercept interviews, to inform the development of social marketing campaigns to increase HIV awareness and prevention behaviors among adults ages 18 to 64.

A.5 Impact on Small Businesses or Other Small Entities

This collection request does not involve burden to small businesses or other small entities.

A.6 Consequences of Collecting the Information Less Frequently

The activities involve a one-time collection of data. There are no legal obstacles to reducing the burden.

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

This data collection 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 for the generic clearance 0920-0920 was published on September 7, 2021 (Volume 86, Number 170, pages 50122-50123). No substantive comments were received from the public.

A.9 Explanation of Any Payment or Gift to Respondents

CDC will not directly provide monetary tokens of appreciation to study respondents. However, online survey panel vendors contracted to provide the sample for the study may provide points of up to $20 (redeemable for merchandise online) as part of their pre-established agreements with their survey panelists. The token of appreciation is intended to recognize the time burden placed on respondents, encourage their cooperation, and convey appreciation for contributing to this important study.

By providing a token of appreciation, we can improve coverage of specialized respondents, rare groups, or minority populations, including MSM, African Americans, Hispanics/Latinos, and PWH. Including these respondents is important to this study to ensure that the campaign materials reflect the information needs and perspectives of those disproportionately affected by HIV. In addition, provision of a token of appreciation will likely reduce survey costs; we anticipate that we will need to screen fewer individuals to obtain our desired sample size by providing a token of appreciation. We believe these justifications are in accordance with OMB’s guidance on this subject (OMB, 2016).

Research into the effects of incentives has demonstrated that providing a token of appreciation is an effective strategy for engaging the types of populations that will be included in this data collection. For example, an often cited, highly regarded study using an online survey targeting gay/bisexual men found that advertisements that indicated tokens of appreciation resulted in more than twice the number of men accessing the Welcome page over a two-week period (Bowen, 2005). Meanwhile, Sullivan et al. (2011) found systematic underrepresentation of gay/bisexual men of color in nearly all the Internet-based HIV prevention studies published from 2004 through 2009, even though this group bears the greatest risk for HIV infection in the US. Given the length of the survey, the specialized minority populations, the past lack of representation in research studies (Yancey et al., 2006), and the sensitive nature of some of the survey questions, the minimum amount the survey vendor (Qualtrics; see Section A.10) has stated that they would need to offer the online panel tokens is one credit per one minute of survey. Further, the evaluation contractor has conducted many successful data collections with targeted populations with great success.

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

Consent will be self-administered electronically through the secure survey website. Individuals who are interested in participating will click on the link for the secure Web site. After viewing a description of the survey, they will be asked to click ‘Yes’ if they wish to be screened. (Attachment 2). Eligible individuals who wish to participate will be presented with the consent form which informs them of the private and voluntary nature of the survey and their rights as participants (Attachment 1). The consent form will cover the following topics:

• The study’s topic and goals;

• The procedures that will be involved, including the sensitive nature of some of the questions that will be asked;

• Potential risks and discomforts associated with participation and the right to refuse or withdraw;

• Benefits to participation;

• Remuneration amount and form;

• The measures that will be taken by CDC and the evaluation contractor to protect privacy as well as the measures respondents can take to protect their information (i.e., take the screener in a private location, such as their own home and/or in a room with a door, and close their browser window when they are finished or if they choose to withdraw); and

• Contact information for the evaluation contractor’s project director if they have questions about the study and the contractor’s Office of Research Protection if they have questions or concerns about their rights as a study participant.

After reading this information, potential participants will be reminded of the voluntary nature of the study and that they can refuse to participate or stop participating without penalty. They will then be asked to select, “I have read this consent form and agree to participate in the survey” or “I have read this consent form and do not want to participate in the survey”. If an individual chooses not to participate, they will be thanked for their time and asked to close their browser window for privacy purposes. No additional contact will be made with individuals who select no. Individuals who do not meet the eligibility criteria for the survey will be told they are ineligible, thanked for their time, and asked to close their browser window for privacy purposes. The consent form as well as other study materials will be at an 8th grade reading level or below.

The evaluation contractor will work with Qualtrics, an online survey panel vendor, to implement this study. Qualtrics maintains the names of and contact information (e.g., addresses, telephone numbers, and email addresses) for panel members who are invited to take part in a survey. Qualtrics will also track survey completion. Qualtrics will use this information to invite participation, remind non-responders to complete the survey, and determine who should receive and to disburse the token of appreciation (see Attachment 5 for invitation and reminder emails). Although CDC will own the data, neither CDC nor the evaluation contractor will have access to respondents’ names and contact information. This information is maintained separately by Qualtrics and is not part of the survey system. Additionally, Qualtrics will not have access to the survey responses. Thus, survey responses cannot be linked to individuals’ names, email addresses, or telephone numbers.

Qualtrics collects IP addresses to reduce the likelihood of ‘ballot box stuffing,’ which is when the same individual attempts to take the same survey more than once for financial gain. Recording IP addresses (which is considered information in identifiable form [IIF]) is a requirement of individuals’ participation in the panel. IP addresses will not be included in the data file that is downloaded by the evaluation contractor. CDC will only have access to the deidentified data file. The consent form will inform individuals that their IP addresses are being collected and why this is necessary. Individuals who do not agree to this condition can decline to take the survey.

It is possible that someone else (e.g., a family member, friend, etc.) could view the survey on the respondent’s computer with or without his/her knowledge, which could create family problems or cause discomfort. The survey instructions will suggest to respondents that they complete the survey in a private location to mitigate this risk and recommend that they close their browser window when they are finished taking the survey or if they wish to withdraw from the study.

Qualtrics takes the following security measures to ensure separation between respondents’ identity and their survey data.

• The survey instrument (which also includes the screener) will not include (or collect) IIF maintained by Qualtrics.

• Although the survey invitation method will inherently include IIF (e.g., email addresses), this information will not be combined with survey responses; thus, there is no link between individuals’ names and contact information and survey responses.

• The evaluation contractor will delete IP addresses when they download the data file. Therefore, the data file maintained by the contractor will not include IIF.

• Qualtrics will provide screener data for all panelists, regardless of whether they qualify for the study. However, they will not retain screener data for those who are deemed ineligible for any other purpose outside the scope of this project.

• Qualtrics will retain study records for the duration of the study. Upon final delivery of data files to the evaluation contractor and completion of the project, they will destroy all study records, including data files, upon request.

The evaluation contractor will maintain restricted access to all project data. Data are kept on a network drive behind the contractor’s firewall that requires multi-factor authentication to access. Within the contractor’s firewall, access to the folder with data are restricted to only select users who need access to carryout project work.

Screener and survey data will be encrypted end-to-end in both transmission and at rest. Data are transmitted from the user’s device by SSL to the survey platform. Qualtrics will initially store the data on a hard drive, and the data will be encrypted. This means individuals who are not authorized to access the data will be unable to do so, even if they have physical access to the hard drive. For the evaluation contractor to retrieve the data, they will need to use their master key to decrypt and then download the data by SSL. Only the evaluation contractor can decrypt and download the data. No more than two contractor staff have access to the master key which reduces the risk that IIF will be exposed. Qualtrics has no logical access to the data or a master key to decrypt the data. With the data encrypted at rest, even in the event of a physical breach at the Qualtrics’ location, the data would not be readable by any party.

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

IRB Approval

It has been determined that the data collection is not research involving human subjects; thus, IRB approval is not required.

Sensitive Questions

The study asks questions of a sensitive nature that are critical to achieving the campaign’s goal of increasing HIV prevention behaviors among the general public. Asking questions related to HIV is necessary to adequately assess the topic area. Further, the questions are necessary to assess message content and delivery preferences which will enable CDC to develop new campaign materials and ways of reaching our priority audiences. Specifically, the web survey includes sensitive questions related to HIV communication and information seeking behaviors, risk perceptions and behaviors, and prevention strategies (see survey in Attachment 3).

To identify the intended audience and for the purposes of oversampling African Americans, Hispanics/Latinos, MSM, and PWH, the screener includes sensitive questions related to race/ethnicity, sexual orientation, HIV testing history and HIV status (see screener in Attachment 2). Additionally, the screener includes questions about risk behaviors to ensure that we are able to include an adequate number of respondents who are at increased risk for getting HIV and therefore appropriate candidates for PrEP.

A.12 Estimates of Annualized Burden Hours and Costs

A.12.1 Estimated Annualized Burden Hours

The total annualized response burden is estimated at 545 hours. Exhibit A.1 provides details about how this estimate was calculated. The screener (Attachment 2) for the web-based survey is expected to be given to 1,340 individuals and is estimated to take about 2 minutes to complete for a total of 45 burden hours. The web-based survey (Attachment 3) is expected to be completed by 1,000 respondents and to take 30 minutes for an estimated 500 burden hours.

Exhibit A.1 Annualized Burden Hours

Type of Respondent	Form Name	No. of Respondents			No. of Responses per Respondent		Average Burden Per Response (in Hours)	Total Response Burden Hours*
General public	Screener (Att. 2)	6000			1		2/60	200
	Web-based Survey (Att. 3)	4500			1		30/60	2,250
Total									2,450

*Rounded to the nearest whole number

A.12.2 Estimated Annualized Burden Costs

Because we do not know what the wage rate category will be for these selected respondents (or even whether they will be employed at all), we used $25.72 per hour as an estimate of average hourly wage across the country (Bureau of Labor Statistics, 2019). The estimated annual cost to respondents for the collection of information will be $14,017 (Exhibit A.2).

Exhibit A.2 Annualized Cost to Respondents

Activity	Total Burden Hours	Hourly Wage Rate	Total Respondent Cost*
Screener (Att. 2)	200	$25.72	$5,144
Web-based Survey (Att. 3)	2250	$25.72	$57,870
Total			$63,014

*Rounded to the nearest dollar.

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

There are no costs to respondents or record keepers.

A.14 Annualized Costs to the Federal Government

The annualized cost to the federal government is estimated to be $347,767 (Exhibit A.3). This is the cost estimated by the contractor, RTI International, and includes the estimated cost of coordination with CDC, data collection, analysis, and reporting. One CDC Contracting Officers’ Representative (COR) will be responsible for obtaining CDC approvals, providing project oversight, and participating in analysis and dissemination of the results. The contractor’s costs are based on estimates provided by the contractor who will carry out the data collection activities.

Exhibit A.3 Estimates of Annualized Cost to the Government

Expense Type	Expense Explanation	Annual Costs
CDC oversight of contractor and project	20% of FTE: GS-13 Health Communication Specialist	$17,100
Recruitment, data collection, analysis, and reporting (Contractor – RTI International)	Labor hours and ODCs	$330,667
Total		$347,767

CDC = Centers for Disease Control and Prevention; FTE = full-time equivalent; ODC = other direct cost

A.15 Explanation for Program Changes or Adjustments

Not applicable: This request is for a sub-collection under a generic approval.

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

Data analysis will be conducted to evaluate acceptability and potential effectiveness of newly developed concepts and messaging for a social marketing campaign focused on HIV prevention that incorporates proven, effective prevention strategies among adult audiences. Data will be analyzed overall, as well as by important sociodemographic characteristics (e.g., age, gender identity, race/ethnicity, sexual orientation). Response rates for individual questions will be calculated. Data analysis will include basic summary statistics for the purposes of describing the sample and examining the distribution of the primary outcome variables (e.g., message comprehension, clarity, word choice, satisfaction, personal relevance, credibility, and motivational appeal).

A final report of less than 50 pages will provide background, methods, results, and recommendations based on the study’s findings, and relevant appendices.

The key events and reports to be prepared for this study are listed in Exhibit A.4.

Exhibit A.4 Project Time Schedule

Activity	Time Schedule
Begin recruitment	Upon OMB approval
Conduct web-based surveys	2 months after OMB approval
Data analysis	4 months after OMB approval
Submit report	6 months after completion of data collection

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

The OMB expiration date will be displayed.

A.18 Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

REFERENCES

Bowen, A.M. (2005). Internet sexuality research with rural men who have sex with men. Journal of Sex Research, 42(4):317-23.

Bureau of Labor Statistics (BLS). (2019). May 2019 National Occupational Employment and Wage Estimates United States. [Data table]. Retrieved from https://www.bls.gov/oes/current/oes_nat.htm#00-0000

Centers for Disease Control and Prevention. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data—United States and 6 dependent areas, 2014. HIV Surveillance Supplemental Report 2016;21(No. 4). Published July 2016.

Centers for Disease Control and Prevention. (2019a). Estimated HIV incidence and prevalence in the United States, 2010–2016. HIV Surveillance Supplemental Report 2019;24(No. 1). http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published February 2019. Accessed September 26, 2019.

Centers for Disease Control and Prevention. (2019b). Ending the HIV Epidemic: Prevent. https://www.cdc.gov/endhiv/prevent.html. Published June 24, 2019. Accessed October 16, 2019.

Office of Management and Budget (2016). Questions and Answers When Designing Surveys for Information Collections. Retrieved from https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/assets/OMB/inforeg/pmc_survey_guidance_2006.pdf.

Sullivan, P.S., Khosropour, C.M., Luisi, N., Amsden, M., Coggia, T., Wingwood, G.M., DiClemente, RJ (2011). Bias in online recruitment and retention of racial and ethnic minority men who have sex with men. Journal of Medical Internet Research, 13(2): e38.

Yancey, A.K., Ortega, A.N., Kumanyika, S.K. (2006). Effective Recruitment and Retention of Minority Research Respondents. Annual Review of Public Health.27:1-28.

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