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National Center for Injury Prevention and Control (NCIPC) is requesting approval for a new GenIC under OMB Control No. 0920-1154, titled “Message Evaluation for CDC’s Stop Overdose Campaigns” to evaluate the effectiveness of its Stop Overdose campaign messages. Evaluation of drug overdose prevention awareness and behavior change messages is needed to improve existing messages and ensure the use of the most effective, audience-informed messages to help fight the drug overdose epidemic.

Drug overdoses rose by more than 14 percent from 2020 to 2021, setting a new high at nearly 107,000 lives lost that year.¹ The rate of drug overdose involving synthetic opioids such as fentanyl, increased 22 percent.¹ Data also indicates that polysubstance use is a growing issue.² Nearly 50 percent of drug overdoses involved multiple drugs in the first six months of 2019 alone.² Nearly 40 percent of overdoses had a bystander present who could have intervened.² This suggested a need for information about harm reduction strategies, like naloxone, and guided our focus to create tools to help. In 2021, 16.5 percent (or 46.3 million) Americans aged 12 or older, had a substance use disorder.³ Substance use disorders are treatable diseases, not character flaws. Yet stigma about substance use disorders can still be a barrier to treatment and recovery. Understanding addiction, recovery, and treatment is vital.

CDC created four, audience-informed education campaigns to stop overdose and address the evolving drug overdose epidemic. The campaigns address awareness of the dangers of fentanyl, educate about the risks and consequences of polysubstance use, promote the lifesaving power of naloxone, and support recovery to reduce stigma. The intended audience for these campaigns is people who use drugs between the ages of 18-34. Secondary audiences include those who support people who use drugs like friends, family, recovery/treatment specialists, first responders, pharmacists, and healthcare providers.

Health education and media campaigns are a widely used intervention to support behavior change around substance use and illicit drug, and research shows impacts on awareness and information sharing, but more evidence is needed.^4–6 A CDC Community Guide systematic review found campaigns that run up to 6 months garnered the second highest median percentage point change in desired health behavior, after campaigns that ran over 21 months.⁷ Having evidence of campaign effectiveness can further the identification of data-driven messages and communication tools to support overdose prevention and apply what works and what does not work to future campaigns and communication.

A.2 Purpose and Use of the Information Collection

CDC will collect data through a vendor, iHeart/Unified, who uses national survey panels to recruit a non-probability sample from relevant markets for each campaign survey. CDC will use surveys with no more than 50 items to collect quantitative data from individuals ages 18-34. CDC will deploy the surveys prior to campaign implementation in two separate instances, one survey to capture those exposed by radio, and those exposed by digital ads and post-campaign implementation. CDC will capture responses about CDC’s Stop Overdose fentanyl and naloxone campaigns. The surveys will gather audience knowledge, attitudes, and beliefs (KABs), perceptions of campaign asset products, and demographic and drug use-related characteristics.

The purpose of this data collection is to:

Collect data from a sample of audience members who have been exposed to the Stop Overdose campaigns and from a sample who have not been exposed.
Assess the impact of campaign exposure on audiences’ drug overdose prevention knowledge, attitudes, and behaviors.
Assess differences in drug overdose prevention knowledge, attitudes, and behaviors by select demographic characteristics based on key affected populations.

The information collected will be used to

Gain an understanding of the effectiveness of CDC’s Stop Overdose campaign messages and products.
Support the development and improvement of future materials and products for the Stop Overdose campaigns.

The instruments (Attachments 1, 2, 3 and 4) will contain Likert-scale, binary, and open-ended questions. Items were developed by adapting and combining items based on brand image dimensions and constructs from the Theory of Planned Behavior with approved content key messages used in CDC’s Stop Overdose campaigns.^8,9 CDC will measure items related to the fentanyl and naloxone campaign’s messages used in campaign ads, videos, website content, and other materials. See table below.

Domain	Measures	Response Types
Knowledge, Attitudes, and Behaviors related to Stop Overdose Campaign Messages	Items related to knowledge (e.g., naloxone can reverse an overdose), attitudes (e.g., naloxone is easy to carry), and behaviors (e.g. I carry naloxone) from each of the two Stop Overdose campaign messages	Likert, Open-ended, Binary (Yes/No)
Brand Perceptions of Stop Overdose Campaign Products	Items related to brand perceptions: informativeness, likeability (i.e., general perception of favorability), memorability, visual appeal (i.e., perception of visual aspects), and clarity of products	Likert
Demographic	Age, Sex, Gender Identity, Sexual Orientation, Race, Ethnicity, Income, Education, Geographic Location (State)	Likert, Open-ended
Substance use-related items	Personal drug use behaviors: Current use, substance use diagnosis, having a friend or family member who uses substances	Binary (Yes/No)

A.3 Use of Improved Information Technology and Burden Reduction

To reduce burden, technology will be used to collect data using surveys through online survey panels. Questions will be kept to a minimum required for the intended use of the data.

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

There are no other known federal generic collections that duplicate the project included in this request. CDC is the leading federal agency for drug overdose prevention communication work. Health messages developed by CDC are unique in their mix of the intended audience, health behavior, concept, and execution. Therefore, in most cases, there is no similar data available. We have scanned search engines, reviewed existing materials for this group (i.e., conducted environmental scans in October 2021 and January 2023), and reviewed existing published data to identify information that could facilitate message development prior to conducting any data collection.^8,10–13

A.5 Impact on Small Businesses or Other Small Entities

This project does not have an impact on small businesses or other small entities.

A.6 Consequences of Collecting the Information Less Frequently

The activities involve a one-time collection of data

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

This request fully complies with regulation 5 CFR 1320.5.

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

This information collection request does not require publication of a 60-day notice in the Federal Register.

CDC consulted with several CDC and outside experts to provide input as listed in the table below.

Exhibit A.8.1. Outside Consultation

Name	Organizational Unit
Everett Long, PhD, Research Lead	Brunet-García (contractor)
Kim Vermillion, Researcher	Brunet-García (contractor)
Chad Villaroel, Account Director	Brunet-García (contractor)

A.9 Explanation of Any Payment or Gift to Respondents

No tokens of appreciation will be provided directly through this project. The surveys will be conducted through survey panels by a vendor, iHeart/Unified. As part of their panel program, they provide respondents with tokens of appreciation in two ways, offering a charity donation or credits toward an Amazon gift card in the amount of $5.

A.10 Assurance of Privacy Provided to Respondents

This submission has been reviewed by the NCIPC's Information Systems Security Officer, who has determined that the Privacy Act does not apply (Attachment 6). CDC will retain survey responses on secure servers or in locked file cabinets; only project staff members will be able to access the servers via password-protected computers. Survey findings will be reported in aggregate form and all data collected separately from participants’ names and identifying information. All survey responses will be destroyed three years after completion of the project. No identifiable information describing individual respondents will be included in the analyzed data and aggregate reports. CDC will identify, screen, and recruit potential participants through vendor iHeart/Unified. Any staff will be required to sign a privacy agreement prior to the start of the project. On the opening page of the survey participants will receive information regarding privacy and confidentiality along with a valid OMB number and contact information in case participants have questions about their rights as a participant.

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

Institutional Review Board (IRB)

This study’s protocol and instruments were reviewed through Sterling Institutional Review Board (IRB) and determined as not constitute human subjects research and therefore does not require IRB approval (Attachment 7).

Justification for Sensitive Questions

There is minimal risk that questions related to drug use, misuse, and/or overdose may make respondents feel uncomfortable or cause some emotional discomfort. It is necessary to get feedback around these sensitive topics, as best practices in health communication show that to develop effective materials, they must be based on audience data. Questions related to gender identity may also be considered sensitive in nature. It is necessary to know the gender identity of the respondents as drug use and overdose differ by gender identity in some cases. When analyzing the data, the contractors from BG will assess differences among the different gender identities. The respondent consent statement includes a statement informing participants that they may choose not to answer a particular question if they wish and/or end the session at any time without penalty.

A.12 Estimates of Annualized Burden Hours and Costs

We estimate the total annualized response burden at 379 hours (Exhibit A.12.1). The burdens for each data collection are described below.

For the survey, each individual will first respond to a 1-minute survey invitation, and if they accept, they will begin the 15-minute online survey. Timing is based on our previous experience conducting research through online survey panels for message testing to determine the overall burden per respondent.

Exhibit A.12.1. Estimated Annualized Burden Hours

BURDEN HOURS

Type of Respondent	Form Name	No. of Respondents	Number of Responses Per Respondent	Average Burden per Response (in hours)	Total Burden (in hours)
Individuals	Recruitment Materials - Broadcast Radio Survey (Attachment 5)	1750	1	1/60	29
	Survey Instrument Broadcast Radio (Attachment 1)	700	1	15/60	175
	Survey Instrument- Digital Ad (Attachment 2)	700	1	15/60	175
Totals					379

According to the U.S. Department of Labor (DOL) December 2022 (the most up-to-date non-provisional data) National Occupational Employment and Wage Estimates, the average hourly wage is $32.82.¹⁴ Because of the scope of this generic clearance and the variety of the types of participants, this average salary was utilized rather than attempting to estimate salaries for groups of audiences. The total annualized burden cost is estimated at $12,448 per year.

Exhibit A.12.2 Estimated Annualized Burden Costs

Activity	No. of Respondents	Average Burden per Respondent	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Recruitment Materials - Broadcast Radio Survey (Attachment 5)	1,750	1/60	29	$32.82	$958
Survey Instrument Broadcast Radio (Attachment 1)	700	15/60	175	$32.82	$5,745
Survey Instrument- Digital Ad (Attachment 2)	700	15/60	175	$32.82	$5,745
TOTAL					$12,448

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

There will be no direct costs to the respondents other than their time to participate in the information collection.

A.14 Annualized Cost to the Federal Government

The total annualized cost to the government is estimated to be $1,717,631.26 (Exhibit A.14.1). This cost includes salaried labor for contractor staff and other direct costs associated with planning and execution of the collection.

Exhibit A.14.1. Estimated Cost to the Government

Expense Type	Expense Explanation	Annual Costs (dollars)
Direct cost to the federal government
CDC oversight of contractor and project	CDC Project Officer (25%)	$29,875.25
	CDC Co-Principal Investigator (5%)	$5,735.85
Subtotal, Direct Costs to the Government		$35,611.10

Implementation	Media implementation for evaluation, recruitment, data collection	$1,650,000
Labor hours and other direct costs	Analysis and reporting	$84,994.80
Subtotal, contracted services		$1,734,994.80
Total cost to the government		$ $1,770,605.90

A.15 Explanation for Program Changes or Adjustments

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

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

Data will be tabulated, and a report will be developed outlining the findings from this formative research. The project team will use iHeart/Unified data analysis tools to visualize and explore trends among the data. To compare findings across groups or among demographic factors the team will analyze the data using crosstabs for selected variables of interest. Results of this analysis will be used in reports, other dissemination activities, and to inform materials and message development. All findings will be used internally by the CDC to make recommendations to improve communications products and strategies. The project time schedule is provided below.

Exhibit A.16.1. Project Time Schedule

Activity	Due Date
Recruitment	Within 1 week of OMB approval
Data Collection	4 months after OMB approval
Analyze Data and Report	5 to 6 months after OMB approval

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

OMB Expiration Date will be displayed on necessary materials and documents.

A.18 Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

REFERENCES

1. Spencer M, Miniño A, Warner M. Drug Overdose Deaths in the United States, 2001–2021. National Center for Health Statistics (U.S.); 2022. doi:10.15620/cdc:122556

2. O’Donnell J. Vital Signs: Characteristics of Drug Overdose Deaths Involving Opioids and Stimulants — 24 States and the District of Columbia, January–June 2019. MMWR Morb Mortal Wkly Rep. 2020;69. doi:10.15585/mmwr.mm6935a1

3. Key Substance Use and Mental Health Indicators in the United States: Results from the 2021 National Survey on Drug Use and Health. Published online 2021.

4. Allara E, Ferri M, Bo A, Gasparrini A, Faggiano F. Are mass-media campaigns effective in preventing drug use? A Cochrane systematic review and meta-analysis. BMJ Open. 2015;5(9):e007449.

5. Ferri M, Allara E, Bo A, Gasparrini A, Faggiano F. Media campaigns for the prevention of illicit drug use in young people. Cochrane Database Syst Rev. 2013;(6).

6. Rath JM, Perks SN, Vallone DM, et al. Educating Young Adults about Opioid Misuse: Evidence from a Mass Media Intervention. Int J Environ Res Public Health. 2022;19(1):22. doi:10.3390/ijerph19010022

7. Robinson MN, Tansil KA, Elder RW, et al. Mass Media Health Communication Campaigns Combined with Health-Related Product Distribution. Am J Prev Med. 2014;47(3):360-371. doi:10.1016/j.amepre.2014.05.034

8. Low GS, Lamb CW. The measurement and dimensionality of brand associations. J Prod Brand Manag. 2000;9(6):350-370. doi:10.1108/10610420010356966

9. Bandura A. Self-efficacy: Toward a unifying theory of behavioral change. Psychol Rev. 1977;84:191-215. doi:10.1037/0033-295X.84.2.191

10. Zhao X. Health communication campaigns: A brief introduction and call for dialogue. Int J Nurs Sci. 2020;7:S11-S15. doi:10.1016/j.ijnss.2020.04.009

11. Delahanty J, Ganz O, Bernat JK, et al. Awareness of “The Real Cost” campaign among US middle and high school students: National Youth Tobacco Survey, 2017. Public Health Rep. 2020;135(1):82-89.

12. Duke JC, Farrelly MC, Alexander TN, et al. Effect of a national tobacco public education campaign on youth’s risk perceptions and beliefs about smoking. Am J Health Promot. 2018;32(5):1248-1256.

13. MacMonegle AJ, Smith AA, Duke J, et al. Peer Reviewed: Effects of a National Campaign on Youth Beliefs and Perceptions About Electronic Cigarettes and Smoking. Prev Chronic Dis. 2022;19.

14. Summary table B. Establishment data, seasonally adjusted : U.S. Bureau of Labor Statistics. Accessed May 10, 2023. https://www.bls.gov/ces/data/employment-and-earnings/2022/summarytable_202212.htm

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