Ssa_ 2-27

Goal of the study: To develop six social marketing campaigns that target the general public as well as subpopulations at risk (e.g., men who have sex with men, African Americans, persons living with HIV) in order to increase HIV testing rates, increase HIV awareness and knowledge, challenge commonly held misperceptions about HIV, and promote HIV prevention and risk reduction.

Intended use of the resulting data: CDC will use findings to revise and/or develop timely, relevant, clear, and engaging social marketing materials under the umbrella of the larger Act Against AIDS campaign.

Methods to be used to collect data: In-depth interviews, intercept interviews, focus groups, and brief surveys.

The subpopulation to be studied: 1) men who have sex with men (MSM) of all races; 2) Blacks/African Americans; 3) Hispanics/Latinos; 4) Transgender individuals; 5) HIV-positive individuals; and 6) national audience of all races

How data will be analyzed: Descriptive analyses and thematic or grounded theory analysis of qualitative data.

Justification

A.1. Circumstances Making the Collection of Information Necessary

The Centers for Disease Control and Prevention requests a 3-year OMB approval for a new information collection request (ICR) entitled “Development of CDC’s Act Against AIDS Social Marketing Campaigns Targeting Consumers.” The data collection is authorized under the Section 301 of the Public Health Service Act (42 U.S.C. 241) (Attachment 1).The purpose of this study is to conduct interviews and focus groups in four rounds of data collections (exploratory research, message testing, concept testing, materials testing) with consumer groups in the United States aged 18 to 64 years old to develop various social marketing campaigns aimed at increasing HIV testing rates, increasing HIV awareness and knowledge, challenging commonly held misperceptions about HIV, and promoting HIV prevention and risk reduction.

More than 1.2 million people in the United States are living with HIV, and almost 1 in 8 are unaware of their infection (CDC, 2015a); 40% of people living with HIV have received regular HIV medical care; 37% are prescribed HIV medicines; and 30% have an undetectable viral load which is necessary to maintain long-term health and reduce risk of transmission to others (Bradley et al., 2014). It is well known that certain populations are disproportionately impacted by HIV along the care continuum, including Blacks/African Americans (CDC, 2015b), Hispanics/Latinos (CDC, 2015c), gay and bisexual men of all races (collectively referred to as men who have sex with men or MSM) (CDC, 2015d), and transgender individuals (CDC, 2015e).

In response to the continued HIV epidemic in our country, CDC launched Act Against AIDS (AAA) in 2009, a multi-year, multifaceted communication initiative consisting of several campaigns targeting various populations. The overall goal of AAA is to increase HIV/AIDS awareness and reduce HIV incidence in the United States (CDC, 2009). However, special emphasis is placed on populations disproportionately affected by HIV, including MSM, Blacks/African Americans, Hispanics/Latinos, and transgender individuals, as well as people living with HIV. Each campaign under AAA uses mass media and direct-to-consumer channels to deliver HIV prevention, awareness, and testing messages (Attachment 7). The research conducted under this ICR will be part of CDC’s overarching AAA campaign, and the research results will be used to develop materials for specific HIV social marketing campaigns under the umbrella of the larger AAA initiative.

A.2 Purpose and Use of the Information Collection

The purpose of this study is to conduct interviews and focus groups in four rounds of data collections with consumer groups to develop six social marketing campaigns aimed at increasing HIV testing rates, increasing HIV awareness and knowledge, challenging commonly held misperceptions about HIV, and promoting HIV prevention and risk reduction. The research results will be used to develop materials for six specific HIV social marketing campaigns under the umbrella of the larger AAA campaign. The campaigns target consumers aged 18 to 64 years old and include the following audiences:1) men who have sex with men (MSM) of all races; 2) Blacks/African Americans; 3) Hispanics/Latinos; 4) Transgender individuals; 5) HIV-positive individuals; and 6) national audience of all races. CDCs contractor will conduct all data collection. The rounds of data collection include exploratory research, message testing, concept testing, and materials testing. The data collection instruments are provided in Attachments 3b through 3t. Through the interviews and focus groups, we will explore HIV testing and prevention informational needs of consumers and also pre-test campaign related concepts, messages, and materials. All campaign materials will be developed through one-time data collection.

This study will contribute to CDC’s mission and address NHAS by developing six specific HIV campaigns for consumer audiences aimed at HIV testing, HIV awareness and HIV prevention. Data collection under this request will serve as one component that CDC is implementing to address NHAS and the increasing HIV incidence among consumer audiences. Due to the qualitative study design, results generated from this project cannot be generalized to the general public. Although the results are not meant to be generalized to the entire populations of interest, this valuable information will enable CDC to address HIV testing, prevention and risk reduction more effectively by developing campaigns that are designed for specific campaign audiences at high risk for HIV infection or transmission. Without these data CDC would not be able to address the awareness, testing, prevention and risk reduction needs of specific campaign audiences and make appropriate funding decisions regarding campaign development or campaign direction. Through this data collection, CDC aims to address the key research questions presented in Exhibit A.2.1 below.

Exhibit A.2.1 Key Research Questions

What is the current knowledge of HIV transmission, prevention, and treatment?
What are the perceived level of risk for HIV infection?
What is the current level of knowledge, attitudes, and beliefs about HIV prevention and testing?
What are reasons for wanting and not wanting an HIV test?
What is the perceived importance of knowing ones’ HIV status?
Awareness and perceived access to HIV prevention and testing resources?
What are the reported HIV prevention and testing behaviors?
What are ways to improve the HIV testing experience?
What are motivators for practicing prevention or getting an HIV test?
Are participants aware of existing HIV/AIDS advertisements?
What are the preferred sources of information about HIV?
What are effective strategies for reaching the target audience?
What are the perceptions of the campaign messages, concepts, potential names, logos and materials?

We will disseminate the study results to the public through reports prepared for/by CDC and the contractor. Where appropriate we will also disseminate results through peer-reviewed journal articles and conference presentations. All releases of information will be reviewed and approved by CDC prior to release.

A.3 Use of Improved Information Technology and Burden Reduction

Our data collection requires that we employ qualitative research methods through the use of one-time interviews and focus groups conducted in person or electronically. The responses from the participants are as important as the interviewers’ observation of the participant and the overall data collection. Where possible and upon consent from the participant, we will audio and/or video record the data collection to capture all information and assist with preparation of reports. Only the in-depth interviews and focus groups will be recorded. If feasible, we may use automated, web-based technologies to collect supplemental survey data, which may account for up to 252 of the 2,063 burden hours (approximately 12%). We will not collect survey data from intercept interview participants.

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

In order to identify duplication and use of similar information, we conducted an extensive review of the literature by examining several large periodical journal databases. In addition to reviewing published information, we searched for “gray” literature by exploring the Internet. Searches were performed on several Internet search engines, including Google, Yahoo, AltaVista, Medline, and Science Direct. We were unable to find duplication or the use of similar information. Therefore, we have confirmed the need for the present study.

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 an ad hoc data collection (i.e., a one-time study to develop campaigns for various consumer audiences and does not require periodic collection of data). There are no legal obstacles to reduce burden. The present study will provide the primary data needed to develop final materials. If we did not conduct this formative research, we would not be able to gather information about the various campaign audiences needed to develop and pre-test campaign messages and materials before they are widely distributed. Our formative research process includes gaining an understanding of various attitudes, beliefs, behaviors, perceived needs, perceived benefits sought, and areas of concern regarding HIV testing, HIV prevention and HIV awareness. Subsequently, materials are developed based on these results followed by testing materials with members of the consumer audiences before they are widely disseminated (Slater, 1995).

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

This request fully complies with regulation 5 CRF 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 (attachment 2), was published on 7/1/2016 (Volume 81, No. 127; pages 43204 - 43205). No comments were received.

The CDC study team collaborated with the contractor on the study design, screening instruments, and data collection instruments. Contract staff is trained and experienced in conducting formative research and CDC recognizes the importance of gaining valuable insights from experts with experience working with various consumer audiences. Individuals consulted with and their roles are listed in Exhibit A.8.1. No major problems were identified that could not be resolved.

As needed, CDC will continue to conduct ad hoc consultations with subject-matter experts to obtain broad input from key experts early in the campaign development to identify strengths and areas for improvement; and broadly discuss with experts recommendations for working with potential partners and leveraging pre-existing efforts to complement the campaigns.

Exhibit A.8.1. AAA Campaign Evaluation Consultants

Dr. Seth M. Noar

Department of Communication

University of Kentucky

248 Grehan Building

Lexington, KY 40506-0042

Phone: (859) 257-7809

Fax: (859) 257-4103

E-mail: [email protected]

Dr. Patrick A. Wilson,

Department of Sociomedical Sciences

Mailman School of Public Health

Columbia University

722 W. 168th Street, 5th Floor

New York, NY 10032

Phone: (212) 305-1852

Fax: (212) 305-0315

E-mail: [email protected]

Jo Ellen Stryker, PhD, MA

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Centers for Disease Control and Prevention

1600 Clifton Rd. NE

Mailstop E-49

Atlanta, GA 30329

(404) 639-2071

[email protected]

Euna M. August, PhD, MPH

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Centers for Disease Control and Prevention

1600 Clifton Rd. NE

Mailstop E-49

Atlanta, GA 30329

(404) 639-8297

[email protected]

Jennifer D. Uhrig, PhD, MHA

RTI International

Center for Communication Science

3040 Cornwallis Rd.

Research Triangle Park, NC 27709

(919) 316-3311

[email protected]

Jennie Harris, MPH

RTI International

Center for Communication Science

3040 Cornwallis Rd.

Research Triangle Park, NC 27709

(919) 485-2770

[email protected]

A.9 Explanation of Any Payment or Gift to Respondents

The in-depth interview will take approximately 60 minutes to complete, the focus group will take approximately 2 hours to complete. Participants will be offered a token of appreciation of $40 for their participation in the in-depth interview, $75 for their participation in the focus group, and $10 for the intercept interview, which will last about 20 minutes. For the in-depth interviews and focus groups, the compensation is intended to recognize the time burden placed on participants, including the costs associated with travel to and from the data collection site. For the intercept interviews, the token of appreciation is offered to compensate for the time required to participate, particularly since this activity may be considered intrusive and requires some special effort. Numerous empirical studies have shown that honoraria can significantly increase response rates (Abreu & Winters, 1999; Bentley & Thacker, 2004; Permuth-Wey & Borenstein, 2009; Shettle & Mooney, 1999). A token of appreciation will ensure participation from difficult to reach populations critical for this testing (COPAFS, 1993; OMB, 2006).

The key audiences that are prioritized in this data collection (e.g., gay and bisexual men, transgender individuals, racial/ethnic minorities, etc.) are specialized respondents known to be difficult to identify, locate, and recruit, which warrants the availability of tokens of appreciation as means of improving the cost-effectiveness of recruitment efforts. OMB guidance justifies the use of tokens of appreciation “to improve coverage of specialized respondents, rare groups, or minority populations” and defines specialized respondents as a highly selective group (OMB, 2006). The token of appreciation amounts were determined through discussions with contract staff with expertise in conducting interviews with the study population and interviews about HIV. Removing the token of appreciation would incur significant costs and timeline delays which could threaten the dissemination of the critical messages included in this testing.

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

The CDC NCHHSTP Privacy and Confidentiality Review Officer has reviewed this ICR and has been determined that the Privacy Act is not applicable. All information collected shall be kept private to the extent allowed by law. All individuals involved in data collection shall be trained concerning procedures and practices to ensure privacy of data and will be required to undergo ethics and protection of human subjects training through an accredited course (e.g., CITI). No personal identifying information, such as names, addresses, or phone numbers, will be collected during the focus groups, in-depth interviews, or intercept interviews or maintained in any data files. However, personally identifiable information (including full name, address, phone, and email), is collected from participants during the screening steps of this collection. Any personally identifiable information (PII) will not be entered into a system of records and will be kept separate from participant responses. Prior to data collection, participants will be given time to read the consent (Attachment 4a, focus group consent form; 4b, in-depth interview consent form; and 3t, intercept interview consent form) and ask questions. They will be given two copies of the informed consent: one to keep and one to sign or indicate consent and return. During the introduction to the interview, the moderator will go over key parts of the informed consent which will include informing participants of the following:

The interview is voluntary; participants may choose not to answer any question and end participation at any time.
The contractor will report findings in summary form so that participants cannot be identified and that their identifiable information will be kept secure and separate from the interview notes and audio recordings.
There may be a note-taker behind a one-way mirror and that CDC staff may be watching in person or via a live video stream.

The informed consent includes both the number for the contractor’s IRB office, in case participants have questions about their rights as a study participant, as well as the project director, should participants have questions about the study itself.

CDC’s contractor will implement all formative research for this study. We anticipate screening 2,338 individuals in order to obtain 1,700 consumer respondents. Seven hundred individuals will participate in intercept interviews. There will be 500 respondents for in-depth interviews and 500 individuals participating in focus groups. Data may be collected in person or electronically (e.g., by phone or through virtual technologies). All data collection for this project will include participants from cities with high HIV/AIDS prevalence and incidence, such as New York, NY; Los Angeles, CA; New Orleans, LA; Washington, DC; Chicago, IL; Atlanta, GA; Miami, FL; Philadelphia, PA; Houston, TX; San Francisco, CA; Baltimore, MD; Dallas, TX, or other cities as appropriate.

Participants will be recruited by contractor staff or through local professional recruitment firms hired by the contractor (hereafter referred to collectively as “recruiters”). Based on the campaign being developed, we will screen each individual participating in the individual interview or focus group on certain criteria, such as age, race/ethnicity, gender, HIV status, HIV prevention, and HIV testing behaviors (Attachment 3a). Screening for the intercept interviews will consist of basic demographic questions such as age, education and race and ethnicity.

Personally identifiable information (PII), including names, email and physical addresses, and telephone numbers, will be maintained by the recruiters and destroyed at the end of each interview. The entire data collection system will be a one-time in-depth individual interview and a one-time survey (web-based or paper-and-pencil) per individual. Contractor staff will take notes and audio tape each interview. All audio files will be destroyed three years after completion of the project.

All data collection will take place through either a 20-minute intercept interview, 700 individuals (Attachment 3t); one-hour individual in-depth interview, 500 individuals (Attachments 3b through 3h); or two-hour focus group, 500 individuals (Attachments 3i through 3o); and will consist of four rounds of research (exploratory research, message testing, concept testing and materials testing). Questions on the data collection guides (Attachments 3b through 3o) will be the same for the individual interviews and focus groups. However, because the focus group will have several people, it is likely that several conversations will be generated requiring more time for the moderator to cover all questions in the guide. The questions for the exploratory round of research will vary and reflect the type of campaign being developed (i.e. HIV testing, prevention, prevention with positives or communication and awareness), see Attachments 3b through 3e and 3i through 3l. Questions on the message, concept and materials testing guides will be the same across all individuals regardless of the type of campaign being developed (Attachments 3f through 3h and 3m through 3o). As with the exploratory guides, more time will be allotted for the focus groups. Based on the results of the message testing, the messages presented in Attachment 7 may be modified and retested to increase overall receptivity among the campaign audiences. Any retesting of messages will take place within the amount of burden hours and number of respondents as detailed for message testing in Exhibit A.12.1 Estimated Annualized Burden Hours.

All individuals participating in the individual in-depth interviews and focus groups will also take a 15-minute brief survey. The questions on the survey will vary and reflect the type of campaign being developed, see Attachments 3p through 3s. The 20-minute intercept interview guide will only be used to test messages, concepts and materials among a total of 700 individuals. The intercept interview questions for message, concept and materials testing will be the same for all participants regardless of the type of campaign being developed, see Attachment 3t.

CDC’s contractor will recruit participants themselves and/or hire professional recruitment firms (collectively referred to “recruiters” hereafter) to screen and recruit the appropriate consumer audience for the interviews. The recruiters will collect the names, email and physical addresses, phone numbers and emails of the eligible individuals who have agreed to participate and have been given an interview appointment. For the in-depth interviews and focus groups, this personally identifiable information (PII) will be used to provide appointment reminders. All PII will be kept in locked file cabinets or secure online servers and will be destroyed after the in-depth interviews and focus groups are completed. No PII will be sent to CDC.

The in-depth interviews and focus groups will be audio or video recorded for the purpose of completing the final reports. All audio and video recordings will be destroyed after notes have been verified and no links will be maintained to any data collected. For the intercept interviews, the contractor will approach potential participants, introduce the study, and obtain verbal consent from individuals interested in participating. The intercept interviews will be conducted in places where the public tend to gather such as public events and transit locations. The contractor will not collect any PII from the participant and will obtain verbal consent rather than written consent. The contractor will provide CDC with a report of the research results in aggregate.

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

IRB Approval

This project received approval through a Project Determination from the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, which has deemed this activity as program evaluation and not human subject research.

All respondents will be assured that the information will be used only for the purpose of this research and will be kept secure to the extent allowable by law, as detailed in the sample consent form (see Attachments 3t^¹, 4a, and 4b). Respondents will be assured that their answers to screener (see Attachment 3a), and data will not be shared with anyone outside the research team and that their names will not be reported with responses provided. Respondents will be told that the information obtained will be combined into a summary report so that details of individual responses cannot be linked to a specific participant.

CDC’s contractor maintains restricted access to all data preparation areas (i.e., receipt and coding). All data files on multi-user systems will be under the control of a database manager, with access limited to project staff on a “need-to-know” basis only. The online vendor panels take the following security measures to ensure separation between respondents’ identity and their survey data. First, the survey instrument has no personally identifying information (PII) on it. No respondent name, email address, telephone number, or any other kind of PII appears on the survey. The only way a survey is identified is with a digital identification number. Second, although the invitation method (i.e., email) will inherently have PII information included, this will not be combined with survey responses so the responses from the survey are not linked to the PII. Third, screener data will be considered part of the survey data. The vendors will provide the results of the screener questions for all panelists, regardless of whether they qualify for the project. However, they will not retain responses to screening questions for those who are deemed ineligible for any other purpose outside the scope of this project. Fourth, the vendors will retain records for the duration of the project.

Sensitive Questions

The study asks questions of a sensitive nature including questions related to HIV risk. This measurement of sensitive HIV-related questions is necessary to create campaigns aimed at decreasing the number of HIV-positive individuals who are unaware that they are infected, raising awareness and increasing knowledge of HIV and increasing HIV prevention and risk reduction. Depending on the consumer audience for each campaign, the study screener will vary, but some sensitive questions must be asked to identify the intended audience. The study screener, Attachment 3a, will include questions that assess whether individuals have ever tested positive for HIV as well as HIV prevention and testing behaviors. Furthermore, because our campaign materials are targeted to various populations, screening questions may address one or more of the following items: race/ethnicity, gender, sexual behavior, and sexual orientation.

A.12 Estimates of Annualized Burden Hours and Costs

The total annualized response burden hours are 2,063. Exhibits A.12.1 and A.12.2 provides detail about how this estimate was calculated. We anticipate screening 2,338 individuals in order to obtain 1,700 consumer respondents (Attachment 3a). Screening for all interview types (in-depth interviews, focus group, and intercepts) will take approximately two minutes per individual (78 burden hours). There will be 500 respondents for one- hour in-depth interviews of all types (500 burden hours) and 500 individuals participating in two hour focus groups of all types (1,000 burden hours). All 1,000 in-depth interview and focus group participants will take the 15-minute companion survey (250 burden hours). Seven hundred individuals will participate in intercept interviews (233 burden hours).

Exhibit A.12.1 Estimated Annualized Burden Hours

Respondents	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in Hours)	Total Burden Hours
Individuals aged 18-64	Study screener (Attachment 3a)	2,338	1	2/60	78
	In-depth interviews
	Exploratory- HIV Testing In-depth Interview (Attachment 3b)	74	1	1	74
	Exploratory- HIV Prevention In-depth Interview (Attachment 3c)	74	1	1	74
	Exploratory- HIV Communication and Awareness In-depth Interview (Attachment 3d)	74	1	1	74
	Exploratory- HIV Prevention with Positives In-depth Interview (Attachment 3e)	74	1	1	74
	Message Testing In-depth Interview (Attachment 3f)	68	1	1	68
	Concept Testing In-depth Interview (Attachment 3g)	68	1	1	68
	Consumer Testing In-depth Interview (Attachment 3h)	68	1	1	68
	Focus Groups
	Exploratory- HIV Testing Focus Group (Attachment 3i)	74	1	2	148
	Exploratory- HIV Prevention Focus Group (Attachment 3j)	74	1	2	148
	Exploratory- HIV Communication and Awareness Focus Group (Attachment 3k)	74	1	2	148
	Exploratory- HIV Prevention with Positives Focus Group (Attachment 3l)	74	1	2	148
	Concept Testing Focus Group (Attachment 3n)	68	1	2	136
	Message Testing Focus Group (Attachment 3m)	68	1	2	136
	Materials Testing Focus Group (Attachment 3o)	68	1	2	136
	Survey
	HIV Testing Survey (Attachment 3p)	250	1	15/60	63
	HIV Prevention Survey (Attachment 3q)	250	1	15/60	63
	HIV Communication and Awareness Survey (Attachment 3r)	250	1	15/60	63
	HIV Prevention with Positives Survey (Attachment 3s)	250	1	15/60	63
	Intercept Interviews
	Intercept Interview Guide (Attachment 3t)	700	1	20/60	233
	Total				2,063

Because we do not know what the wage rate category will be for these selected participants (or even whether they will be employed at all), we used $22.17 per hour as an estimate of mean hourly wage for all occupations across the country (Bureau of Labor Statistics, 2015). The estimated annual cost to participants for the hour burden for collections of information will be $46,850.73.

Exhibit A.12.2 Cost to Respondents

Respondents	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in Hours)	Hourly Wage Rate	Total Burden Hours*	Total Respondent Costs**
Individuals aged 18-64: Study screener	2,338	1	2/60	$22.71	78	$1,771
Individuals aged 18-64: Exploratory- HIV Testing In-depth Interview	74	1	1	$22.71	74	$1,681
Individuals aged 18-64: Exploratory- HIV Prevention In-depth Interview	74	1	1	$22.71	74	$1,681
Individuals aged 18-64: Exploratory- HIV Communication and Awareness In-depth Interview	74	1	1	$22.71	74	$1,681
Individuals aged 18-64: Exploratory- HIV Prevention with Positives In-depth Interview	74	1	1	$22.71	74	$1,681
Individuals aged 18-64: Consumer Message Testing In-depth Interview	68	1	1	$22.71	68	$1,544
Individuals aged 18-64: Consumer Concept Testing In-depth Interview	68	1	1	$22.71	68	$1,544
Individuals aged 18-64: Consumer Materials Testing In-depth Interview	68	1	1	$22.71	68	$1,544
Individuals aged 18-64: Exploratory- HIV Testing Focus Group	74	1	2	$22.71	148	$3,361
Individuals aged 18-64: Exploratory- HIV Prevention Focus Group	74	1	2	$22.71	148	$3,361
Individuals aged 18-64: Exploratory- HIV Communication and Awareness Focus Group	74	1	2	$22.71	148	$3,361
Individuals aged 18-64: Exploratory- HIV Prevention with Positives Focus Group	74	1	2	$22.71	148	$3,361
Individuals aged 18-64: Consumer Message Testing Focus Group	68	1	2	$22.71	136	$3,089
Individuals aged 18-64: Consumer Concept Testing Focus Group	68	1	2	$22.71	136	$3,089
Individuals aged 18-64: Consumer Materials Testing Focus Group	68	1	2	$22.71	136	$3,089
Individuals (males and females) aged 18-64 - HIV Testing Survey	250	1	15/60	$22.71	63	$1,431
Individuals aged 18-64: HIV Prevention Survey	250	1	15/60	$22.71	63	$1,431
Individuals aged 18-64: HIV Communication and Awareness Survey	250	1	15/60	$22.71	63	$1,431
Individuals aged 18-64: HIV Prevention with Positives Survey	250	1	15/60	$22.71	63	$1,431
Individuals aged 18-64: Intercept Interview Guide	700	1	20/60	$22.71	233	$5,291
Total $46,851

*Rounded to the nearest hour.

**Rounded to the nearest dollar.

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

There are no other costs to respondents or record keepers.

A.14 Annualized Cost to the Federal Government

The annualized cost to the federal government is $519, 298. The contractor’s costs are based on estimates provided by the contractor who will carry out the data collection activities. This is the cost estimated by the contractor and includes the estimated cost of coordination with CDC, data collection, analysis, and reporting.

Exhibit A.14.1 Government Costs

Item/Activity	Details	$ Amount
CDC oversight of contractor and project	60% of FTE: GS-13 Behavioral Scientist and 15% of FTE GS-13 Health Communication Specialist	$84,033
Recruitment, data collection including honorarium costs, analysis and reporting (contractor)	Labor hours and ODCs	$435,265
Total		$519,298

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

A.15 Explanation for Program Changes or Adjustments

This is a new information collection.

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

Data from the interviews and focus groups will be entered into an electronic data matrix by the contractor’s note taker during the data collection and stored on a password protected computer. The contract will conduct thematic or ground theory analysis of the data to understand participants’ reactions to the campaign messages in as rigorous and detailed manner as possible. The contractor and CDC will review the preliminary data within one week after data collection is completed via a debriefing conference call. Contract analysts will further analyze the data in the matrices and summarize results in a topline report by round (exploratory, concept, message and materials testing) for each campaign. One final report will be developed for each campaign developed once all data collection for that specific campaign has been completed. The key events and reports to be prepared are listed in Exhibit A.16.1.

Exhibit A.16.1 Project Time Schedule

Activity	Time Schedule
Identify and reserve professional recruitment firms	1 month after OMB approval
Begin recruitment	1 month after OMB approval
Conduct first round of interviews specific consumer group	2 months after OMB approval
Topline report due	4 months after OMB approval
Summary report due	6 months after OMB approval

We anticipate the first data collection taking place within one month of receiving OMB approval. Data collection for all other campaigns under this Generic ICR will follow a similar time schedule.

For this study, we expect the findings to be disseminated to a number of audiences. The reporting and dissemination mechanism will consist of three primary components: (1) final formative research reports for each campaign, (2) peer-reviewed journal articles, and (3) conference presentations. The final reports will be written in clear language that is understandable by a wide range of audiences (the target audience, practitioners, policy makers, and researchers). The final reports will include the following information: an executive summary; overview of background literature to provide contextual information about the purpose of the research; a detailed summary of the formative research results; a discussion of findings; strengths and limitations of the research; and recommendations.

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

The display of the OMB expiration date is not inappropriate.

A.18 Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

References

Abreu, D. A., & Winters, F. (1999). Using monetary incentives to reduce attrition in the survey of income and program participation. Proceedings of the Survey Research Methods Section of the American Statistical Association.

Bentley, J. P. & Thacker, P. G. (2004). The influence of risk and monetary payment on the research participation decision making process. J Med Ethics, 30(3):293-298.

Bradley, H. H., Hall, I., Wilitski, R.J. Van Hendel, M.M., Stone, A.E., LaFlam, M., Skarbinski, J., Higa, D.H., Prejean, J., Frazier, E.L., Patel, R., Huang, P., Ruinguang, Q.A., Tang, T., Valleroy, L.A. (2014). Vital Signs: HIV Diagnosis, Care, and Treatment Among Persons Living with HIV — United States, 2011. Morbidity and Mortality Weekly Report (MMWR), 63(47); 1113-1117.

Bureau of Labor Statistics (2015). National Compensation Survey. U.S. Department of Labor. Retrieved November 10, 2015, from http://www.bls.gov/ncs/.

Centers for Disease Control and Prevention (CDC). (2009). Act Against AIDS refocusing national attention on the HIV crisis in the United States. Retrieved June 1, 2009, from http://www.cdc.gov/nchhstp/Newsroom/docs/AAABackgrounder-3-31-09-508Compliant.pdf.

Centers for Disease Control and Prevention (CDC). (2010). National HIV/AIDS Strategy. Retrieved May 1, 2011, from http://www.cdc.gov/Features/HIVAIDSstrategy.

Centers for Disease Control and Prevention (CDC). (2015a). Prevalence of Diagnosed and Undiagnosed HIV Infection — United States, 2008–2012. MMWR; 64:657-662

Centers for Disease Control and Prevention (CDC). (2015b). HIV Among African Americans.

http://www.cdc.gov/hiv/group/racialethnic/africanamericans/index.html. Accessed on October 7, 2015.

Centers for Disease Control and Prevention (CDC). (2015c). HIV Among Latinos. http://www.cdc.gov/hiv/pdf/risk_latino2.pdf. Accessed on October 7, 2015.

Centers for Disease Control and Prevention (CDC). (2015d). HIV Among Gay and Bisexual Men. http://www.cdc.gov/hiv/risk/gender/msm/facts/index.html. Accessed on October 7, 2015.

Centers for Disease Control and Prevention (CDC). (2015e). HIV Among Transgender People. http://www.cdc.gov/hiv/risk/transgender/index.html. Accessed on October 7, 2015.

The Council of Professional Associations on Federal Statistics. (1993). Providing Incentives to Survey Respondents. Retrieved from http://www.copafs.org/reports/providing_incentives_to_survey_respondents.aspx.

Gallagher, K. M., Sullivan, P. S., Lansky, A., & Onorato, I. M. (2007). Behavioral surveillance among people at risk for HIV infection in the U.S.: The national HIV Behavioral Surveillance System. Public Health Report, 122(Suppl 1), 32–38. Office of Management and Budget (2006). Questions and Answers When Designing Surveys for Information Collections. Retrieved from http://www.whitehouse.gov/sites/default/files/omb/inforeg/pmc_survey_guidance_2006.pdf.

Permuth-Wey, J. & Borenstein, A.R. (2009). Financial remuneration for clinical and behavioral research participation: ethical and practical considerations. Ann Epidemiol, 19(4):280-285.

Shettle, C., & Mooney, G. (1999). Monetary incentives in U.S. government surveys. Journal of Official Statistics, 15, 231–250.

1 Note that the consent script for the intercept interviews is embedded in the interview guide.

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
File Title	Supporting Statement A
Author	snaauw
File Modified	0000-00-00
File Created	2021-01-23