Ssa(0920-1169)_03-21-22

Goal of the study: To inform the development of messages, concepts, and materials for CDC’s Let’s Stop HIV Together social marketing campaign for the general public and subpopulations at increased risk for HIV acquisition or transmission. The campaign focuses on reducing stigma and promoting testing, prevention, and treatment across the HIV care continuum.

Intended use of the resulting data: CDC will use findings to develop and/or revise timely, relevant, clear, and engaging messages, concepts, and materials for the Let’s Stop HIV Together campaign in support of the U.S. Department of Health and Human Services’ Ending the HIV Epidemic: A Plan for America.

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

The subpopulations to be studied: 1) General public; 2) gay, bisexual and other men who have sex with men (MSM); 3) Blacks/African Americans; 4) Hispanics/Latinos; 5) Transgender people; 6) people who inject drugs (PWIDs); and 7) people with HIV (PWH).

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

Impact of Covid-19 on Information Collection: We do not anticipate challenges related to the COVID-19 pandemic in conducting these data collections as all data collection can be completed online.

Justification

A.1. Circumstances Making the Collection of Information Necessary

The Centers for Disease Control and Prevention requests approval for a three-year reinstatement with non-substantial change of the information collection request (ICR) entitled “Development of CDC’s Let’s Stop HIV Together Social Marketing Campaigns for Consumers” (OMB 0920-1169, expiration 3/31/20). This information collection package supports information collection (exploratory, message testing, concept testing, and materials testing) using interviews and focus groups with consumer groups in the United States to inform the development and/or revisions of messages, concepts, and materials for the Let’s Stop HIV Together campaign. This is not a generic ICR.

HIV continues to be a serious public health and health care challenge in the U.S. More than 1.1 million people in the U.S. are living with HIV, 1 in 7 of those people are unaware of their infection (CDC, 2019a). Among people with HIV in the U.S. who are aware of their infection, 64% have received some HIV medical care; 49% are retained in care; and 53% are virally suppressed (CDC, 2019a). It is well known that certain populations continue to be disproportionately affected by HIV along the care continuum, including gay, bisexual and other men who have sex with men (collectively referred to as men who have sex with men or MSM), Blacks/African Americans, Hispanics/Latinos (CDC, 2019b), transgender people (Clark et al., 2017), and people who inject drugs (PWID) (CDC, 2019b).

To address the HIV epidemic in the U.S., the Department of Health and Human Services launched Ending the HIV Epidemic: A Plan for America, which is a cross-agency initiative aiming to reduce new HIV infections in the U.S. by 90% by 2030 (CDC, 2019c). CDC’s Let’s Stop HIV Together campaign (formerly known as Act Against AIDS) is part of the national Ending the HIV Epidemic initiative and includes resources aimed at reducing HIV stigma and promoting testing, prevention, and treatment across the HIV care continuum (CDC, 2019d). The information collected under this ICR will be used to develop and/or revise components of the Let’s Stop HIV Together campaign.

A total of 6,189 burden hours were approved for this ICR (OMB No. 0920-1169) in 2017, and since the approval date, 620 burden hours have been used. The information collected from these information collections was used to inform the development/refinement of messages, concepts, and materials for consumer audiences under the Act Against AIDS campaign. We are requesting an additional three years to continue information collections with priority audiences to further develop and refine materials under the Let’s Stop HIV Together campaign in support of the national Ending the HIV Epidemic plan. Through this reinstatement, we plan to use the remaining approved 5,569 burden hours.

The data collection is authorized under the Section 301 of the Public Health Service Act (42 U.S.C. 241) (Attachment 1).

A.2 Purpose and Use of the Information Collection

The purpose of this information collection request is to conduct interviews and focus groups with consumer groups to develop and/or revise messages, concepts, and materials focused on reducing stigma and promoting testing, prevention, and treatment across the HIV care continuum. The research results will be used to develop and/or revise timely, relevant, clear, and engaging messages, concepts, and materials for the Let’s Stop HIV Together campaign. The campaign focuses on consumers aged 18 to 64 years old and includes the following audiences: 1) general public; 2) MSM; 3) Blacks/African Americans; 4) Hispanics/Latinos; 5) Transgender individuals; 6) PWIDs; and 7) people with HIV (PWH). CDC’s contractor will conduct all data collection. The rounds of data collection include exploratory, 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 consumers’ informational needs about HIV testing, prevention, and treatment and pre-test campaign-related messages, concepts, and materials.

Data collection under this request will contribute to CDC’s efforts under the Ending the HIV Epidemic plan by gathering insights from consumer audiences to inform the development and refinement of campaign materials. Due to the qualitative design, results generated from these information collections cannot be generalized to the overall U.S. population, but the results will provide valuable information to guide CDC in developing/revising campaign materials designed for the general public as well as specific audiences at increased risk for HIV acquisition or transmission. Without these data, CDC would not be able to address the informational 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 are the perceived risks for getting or transmitting HIV?
What is the current level of awareness, knowledge, attitudes, and beliefs about HIV testing, prevention strategies, and treatment, including stigmatizing attitudes and beliefs?
What are the barriers, facilitators, and motivators for getting testing for HIV, using prevention strategies, and getting and staying in treatment?
What is the perceived importance of knowing one’s HIV status, and if HIV-positive, knowing one’s viral load and whether one is virally suppressed?
What are participants’ reported HIV testing, prevention, and treatment behaviors?
How can HIV testing, prevention, and treatment experiences be improved?
What is the awareness of existing HIV testing, prevention, and treatment campaigns, including Let’s Stop HIV Together?
What are consumers’ preferred and trusted sources of information about HIV testing, prevention, and treatment?
What are effective strategies for reaching consumers with HIV-related information?
What are consumers’ perceptions of messages, concepts, and materials, including reactions and receptivity, comprehension, personal relevance, trust, motivational appeal? How can the messages/concepts/materials be improved?

This data collection supports the formative phase for the development of messages, concepts, and materials for the Let’s Stop HIV Together campaign. We have provided a final set of core set of messages in Attachment 7 and core concepts in Attachment 8 that will be shown to participants as part of our data collection activities.

A.3 Use of Improved Information Technology and Burden Reduction

Our data collection requires that we employ qualitative research methods using 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 in-depth interviews and focus groups to capture all information and assist with preparation of reports. If feasible, we may use automated, web-based technologies to collect supplemental survey data from in-depth interviews and focus groups, which may account for up to 212 of the 1,856 annual burden hours (approximately 11%).

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

These are ad hoc data collections (i.e., one-time collections to inform the development/revision of campaign materials for various consumer audiences). There are no legal obstacles to reduce burden. The information collections 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 from 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, prevention, and treatment. 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 was published in the Federal Register on March 12, 2021, Vol. 86, No. 47; pp. 14122-14123 (Attachment 2). We received one non-substantive public comment (Attachment 2a).

The CDC study team collaborated with the contractor on the study design, screening instruments, and data collection instruments. Contract staff are 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. Let’s Stop HIV Together Campaign Evaluation Consultants

Jo Ellen Stryker, PhD, MA

National Center for HIV, 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

gux6@cdc.gov

Euna M. August, PhD, MPH

National Center for HIV, 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

wvj3@cdc.gov

Jennifer D. Uhrig, PhD, MHA

RTI International

Center for Communication Science

3040 Cornwallis Rd.

Research Triangle Park, NC 27709

(919) 316-3311

uhrig@rti.org

Pamela Williams, PhD

RTI International

Center for Communication Science

3040 Cornwallis Rd.

Research Triangle Park, NC 27709

(919) 316-3936pamwilliams@rti.org

A.9 Explanation of Any Payment or Gift to Respondents

Participants will be offered a token of appreciation which is intended to recognize the time burden placed on respondents, encourage their cooperation, and convey appreciation for contributing to this important study. The token of appreciation amount varies by data collection: $40 for in-depth interviews, $75 for focus groups, and $20 for intercept interviews. The amounts were determined in consultation with the contractor; in their experience, smaller amounts are insufficient for recruiting the key audiences required for the information collection.

Numerous empirical studies have shown that tokens of appreciation can significantly increase response rates (Abreu & Winters, 1999; Bentley & Thacker, 2004; Göritz, 2006; Permuth-Wey & Borenstein, 2009; Shettle & Mooney, 1999). Existing theories help to explain why and how tokens of appreciation motivate participation in interviews, focus groups and surveys, such as social exchange theory (Dillman, 1978), the norm of reciprocity (Groves, Cialdini, & Couper, 1992), economic exchange theory (Biner & Kidd, 1994), and leverage-saliency theory (Groves, Singer, & Corning, 2000). In addition to theory, there are psychological factors that underpin participation, including altruism and egoism, drives that balance the desire to be helpful with the need to further one’s own self-interest. In consideration of knowledge gained from similar research and existing theories and psychological factors that underlie participation, we have determined that a token of appreciation is warranted for data collections conducted under this ICR. Based on OMB’s guidance on factors that may justify provision of a token of appreciation (Office of Information and Regulatory Affairs, 2016), we have determined that the following reasons apply:

Improved coverage of specialized respondents, rare groups, or minority populations: 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, 2016). The key audiences prioritized in this data collection include MSM, PWH, racial/ethnic minorities, PWID, and transgender individuals, all of whom are considered members of stigmatized and marginalized groups. To ensure that the campaigns and activities meet the needs of these diverse audiences, it is imperative that sufficient numbers are included in the data collection. Yet, based on the study team’s prior experience conducting data collections with these populations, recruitment can be challenging due to competing basic needs, health issues, and social and emotional vulnerabilities (e.g., concerns about stigma, confidentiality). Provision of a token of appreciation is necessary to ensure adequate cooperation rates from the priority populations.
Data quality: If we are unable to recruit sufficient numbers of individuals to participate in the data collection, we will be unable to collect information to inform the development of new or revisions to existing messages, concepts and materials nor will we be able to adequately test the messages, concepts and materials, which will limit our ability to determine if they are acceptable, understandable, motivating, etc. to the priority audiences, and avoid unintended negative consequences of messages/materials (e.g., perpetuate stigma). This is particularly applicable when we consider that the data collection will include vulnerable/hidden subgroups (see #1).
Reduced data collection costs: We anticipate that without the token of appreciation, recruitment and data collection costs will be higher because we will need to screen more people to achieve the desired cooperation rate (McGrath, 2006) and recruit additional participants to make up for a higher rate of no-shows.

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 prior to indicating their consent. They will be offered a copy of the consent form to take with them if they wish. During the introduction to the interview, the interviewer/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 and/or contractor staff may be watching in person or via a live video stream.

The informed consent includes both the telephone 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 2,165 individuals in order to obtain 852 interview and focus group participants (352 interview and 500 focus group participants) annually; 661 individuals will participate in intercept interviews annually. 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 locations (states, counties, and territories) identified as priorities in the Ending the HIV Epidemic plan.

Participants for in-depth interviews and focus groups 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 component being developed and the priority audience(s), recruiters will screen each potential participant on certain criteria, such as sociodemographics, HIV status, HIV risk, testing, prevention, and/or treatment behaviors (Attachment 3a). 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/focus group 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. Contractor staff will take notes and audio record each interview/focus group for the purpose of analyzing the data and completing the final reports. The entire data collection system will be a one-time in-depth individual interview/focus group and a one-time survey (web-based or paper-and-pencil) per individual.

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 tends to gather such as public events and transit locations, and the contractor will not collect any PII from the participant. The contractor will provide CDC with a report of the results in aggregate.

All data collection will take place through either a 20-minute intercept interview, 661 individuals (Attachment 3t); one-hour individual in-depth interview, 352 individuals (Attachments 3b through 3h); or two-hour focus group, 500 individuals annually (Attachments 3i through 3o); and consist of one of four types of information collection (exploratory research, message testing, concept testing, or 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 message, concept or material being developed (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 (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 661 individuals annually. The intercept interview questions for message, concept and materials testing will be the same for all participants, see Attachment 3t.

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, 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 collected will be used only for the purpose of informing the development/refinement of campaign messages, concepts and materials, 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 the 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.

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 campaign materials aimed at reducing stigma and promoting HIV testing, prevention, and care. Depending on the consumer audience for each campaign material, 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 identity, sexual behavior, and sexual orientation.

A.12 Estimates of Annualized Burden Hours and Costs

The total annualized response burden hours are 1,856. Exhibits A.12.1 and A.12.2 provides detail about how this estimate was calculated. We anticipate screening 2,165 individuals in order to obtain 852 consumer participants for the in-depth interviews and focus groups annually (Attachment 3a). Screening for in-depth interviews and focus groups will take approximately two minutes per individual (72 annual burden hours). There will be 352 respondents for one- hour in-depth interviews of all types (352 annual burden hours) and 500 individuals participating in two-hour focus groups of all types (1,000 annual burden hours). All 852 in-depth interview and focus group participants will take the 15-minute companion survey (213 annual burden hours). Six hundred fifty-seven individuals will participate in intercept interviews (219 annual 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)	2,165	1	2/60	72
	In-depth interviews
	Exploratory- HIV Testing In-depth Interview (Attachment 3b)	50	1	1	50
	Exploratory- HIV Prevention In-depth Interview (Attachment 3c)	52	1	1	52
	Exploratory- HIV Communication and Awareness In-depth Interview (Attachment 3d)	50	1	1	50
	Exploratory- HIV Prevention with Positives In-depth Interview (Attachment 3e)	50	1	1	50
	Message Testing In-depth Interview (Attachment 3f)	50	1	1	50
	Concept Testing In-depth Interview (Attachment 3g)	50	1	1	50
	Materials Testing In-depth Interview (Attachment 3h)	50	1	1	50
	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)	213	1	15/60	53
	HIV Prevention Survey (Attachment 3q)	213	1	15/60	53
	HIV Communication and Awareness Survey (Attachment 3r)	213	1	15/60	53
	HIV Prevention with Positives Survey (Attachment 3s)	213	1	15/60	53
	Intercept Interviews
	Intercept Interview Guide (Attachment 3t)	657	1	20/60	220
	Total				1,856

*Rounded to the nearest hour.

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 $25.72 per hour as an estimate of mean hourly wage for all occupations across the country (Bureau of Labor Statistics, 2019). The estimated annual cost to participants for the hour burden for collections of information will be $47,741.

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	2,165	1	2/60	$25.72	72	$1,856
Individuals aged 18-64: Exploratory- HIV Testing In-depth Interview	50	1	1	$25.72	50	$1,286
Individuals aged 18-64: Exploratory- HIV Prevention In-depth Interview	52	1	1	$25.72	52	$1,337
Individuals aged 18-64: Exploratory- HIV Communication and Awareness In-depth Interview	50	1	1	$25.72	50	$1,286
Individuals aged 18-64: Exploratory- HIV Prevention with Positives In-depth Interview	50	1	1	$25.72	50	$1,286
Individuals aged 18-64: Consumer Message Testing In-depth Interview	50	1	1	$25.72	50	$1,286
Individuals aged 18-64: Consumer Concept Testing In-depth Interview	50	1	1	$25.72	50	$1,286
Individuals aged 18-64: Consumer Materials Testing In-depth Interview	50	1	1	$25.72	50	$1,286
Individuals aged 18-64: Exploratory- HIV Testing Focus Group	74	1	2	$25.72	148	$3,807
Individuals aged 18-64: Exploratory- HIV Prevention Focus Group	74	1	2	$25.72	148	$3,807
Individuals aged 18-64: Exploratory- HIV Communication and Awareness Focus Group	74	1	2	$25.72	148	$3,807
Individuals aged 18-64: Exploratory- HIV Prevention with Positives Focus Group	74	1	2	$25.72	148	$3,807
Individuals aged 18-64: Consumer Message Testing Focus Group	68	1	2	$25.72	136	$3,498
Individuals aged 18-64: Consumer Concept Testing Focus Group	68	1	2	$25.72	136	$3,498
Individuals aged 18-64: Consumer Materials Testing Focus Group	68	1	2	$25.72	136	$3,498
Individuals (males and females) aged 18-64 - HIV Testing Survey	213	1	15/60	$25.72	53	$1,370
Individuals aged 18-64: HIV Prevention Survey	213	1	15/60	$25.72	53	$1,370
Individuals aged 18-64: HIV Communication and Awareness Survey	213	1	15/60	$25.72	53	$1,370
Individuals aged 18-64: HIV Prevention with Positives Survey	213	1	15/60	$25.72	53	$1,370
Individuals aged 18-64: Intercept Interview Guide	657	1	20/60	$25.72	220	$5,633
Total $47,741

*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 and 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 reinstatement request for ICR 0920-1169. There are no program changes or adjustments. We are requesting additional time to use the remaining approved burden hours.

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

Data from the in-depth interviews, focus groups and intercept interviews will be stored on a password-protected computer, cleaned, coded, and analyzed to identify themes, patterns, and unique insights offered by participants in as rigorous and detailed manner as possible. The contractor will conduct descriptive analyses of the data from the screener and brief survey, develop results tables, and summarize results in narrative form. When possible, analysts will triangulate results from the qualitative interviews and focus groups with the results from the brief survey and highlight notable differences by key audience segments (e.g., MSM, racial/ethnic minorities, transgender people, PWID, PWH). Results from each round of data collection will be summarized in a topline report and/or PowerPoint slide deck. 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 identifying and reserving recruitment firms
Conduct first round of data collection	1 month after recruitment begins
Draft topline report due	1 month after data collection ends
Final topline report and/or PowerPoint Slide Deck	1 month after receiving comments on draft topline report

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

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 topline reports and/or PowerPoint slide decks for each round of data collection, (2) peer-reviewed journal articles, and (3) conference presentations. The final topline reports will be written in clear language that is understandable by a wide range of audiences (the priority audience, practitioners, policymakers, and researchers). The final topline reports will include the following sections: an executive summary; overview of background literature to provide contextual information about the purpose of the data collection; summary of the results; a discussion of findings; limitations; 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.

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

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File Title	Supporting Statement A
Author	snaauw
File Modified	0000-00-00
File Created	2022-06-27