Ssa_kap_peh_9.28.2022

60-day FRN
Project Information Sheet
Knowledge, Attitudes, and Practices (KAP) about body lice- and flea-borne diseases: Survey for Shelter Workers
Knowledge, Attitudes, and Practices (KAP) about body lice- and flea-borne diseases: Survey for Street/Outreach Workers
Site Assessment Form for Homeless Service Sites
Site Assessment Form for Street/Outreach Workers
Human Subjects Approval Letter

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Goal of the Project: Several bacterial vector-borne diseases that are spread by body lice and fleas disproportionately affect people experiencing homelessness. Given the potential severity of louse- and flea-borne diseases, as well as their disproportionate impact this population, understanding current knowledge and resource gaps of urban homeless service providers will allow for targeted education and resource allocation to reduce the risk of flea- and louse-borne disease among persons experiencing homelessness.
Intended use of the resulting data: The collected data will be used to gain insight about gaps in current understanding and prevention efforts to inform tailored educational campaigns and intervention efforts to reduce risk of infestation with body lice and fleas and their associated diseases among persons experiencing homelessness.
Methods to be used to collect: Local and state public health partners will be invited to participate in this effort. Each participating local or state public health partner will recruit up to 10 homeless service sites or outreach organization. At each participating service site or outreach organization, 3–5 participants will be recruited to participate, with a goal of 30–50 participants recruited by each local or state public health partner. A total of 240-500 participants will complete a survey instrument. In addition, one participant from each homeless service site or outreach organization will complete a separate site assessment form regarding policies and services to better understand structural barriers to vector-borne disease prevention, diagnosis, and treatment.
Subpopulation to be studied: Homeless service providers who work or volunteer in shelters serving persons experiencing homelessness and homeless service providers who work on outreach teams serving unhoused persons living on the street or in encampments.
How data will be analyzed: The survey data will be analyzed using descriptive and comparative statistical methods. We are primarily interested in identifying knowledge gaps, differences in practice, and how these knowledge gaps or differences in practice

Supporting Statement A

OMB approval is being sought for an three-year EXTENSION request for “Homeless service providers knowledge, attitudes, and practices regarding body lice, fleas and associated diseases surveys.” Approval of this information collection will continue to facilitate implementation of data collection projects that allow us to better understand the knowledge, attitudes, and practices (KAP) regarding fleas, lice, fleaborne diseases, louseborne diseases, and their prevention among homeless service providers in specific regions of the United States. The activities will be conducted by the staff of DVBD and partners. These activities involve the development and administration of surveys related to flea- and louse-borne diseases knowledge, risk factors, risk perception, prevention practices, and availability of prevention practices for homeless service providers. The results of these surveys will inform future educational outreach for prevention of flea- and louse-borne disease prevention among people experiencing homelessness. Information gathered under this OMB clearance will not be used for the purpose of substantially informing influential policy decisions.

A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

Clusters of Bartonella quintana, a louseborne disease, have been recently detected among people experiencing homelessness (PMID 35895412; 34239947). Clusters or outbreaks of flea-borne Rickettsia typhi in this population have also been described (PMID 18697325; 22093517). However, homeless service providers’ knowledge and practices to prevent body lice and fleas and diseases they transmit - is not known. To address this knowledge gap, the Centers for Disease Control and Prevention (CDC) Division of Vector-Borne Diseases (DVBD) is requesting a three-year approval to conduct KAP surveys regarding vector-borne diseases among people experiencing homelessness (PEH). We propose a multi-site survey among urban homeless service providers and street/encampment outreach workers to gain insight about gaps in understanding, prevention, and intervention to inform tailored educational campaigns and intervention efforts to reduce risk of infestation with body lice and fleas and their associated diseases among PEH.

This proposed data collection fits into CDC’s broader research agenda to prevent disease incidence and morbidity in populations at disproportionate risk and to advance health equity in populations experiencing systemic bias and discrimination. This project has been identified as the Health Equity priority project for CDC’s Bacterial Diseases Branch in DVBD. An EMERGENCY (0920-1372) clearance was sought and approved by OMB on September 21, 2022, due to funding issues. Per the Terms of clearance: Approval of this emergency ICR is with the understand that CDC will quickly publish the 30-day notice and submit for regular PRA approval.

Section 301 of the Public Health Service (PHS) Act (42 USC 241) (Attachment 1) authorizes the Secretary of Health and Human Services (HHS) to conduct studies relating to the control and prevention of physical diseases of man, such as VBDs, and to collect and make available through publications and other appropriate means, information as to, and the practical application of, such research and other activities. These regulations are codified in 42 Code of Federal Regulations (CFR) Part A.

Items of Information to be Collected

Data collection will be limited to homeless service providers in specific geographic areas in the United States (CA, CO, GA, MD, MN, NY, TX, WA)

Data collection will be performed using 4 survey instruments. Each participant will complete one Knowledge, Attitudes, and Practices (KAP) survey, either as a person who works at a homeless shelter or as a person who works as part of an outreach team who provides services to people experiencing unsheltered homelessness. In addition, one participant (the site supervisor) at each homeless shelter or outreach team will complete a Site Assessment to describe shelter or team infrastructure, staff, resources, and policies.

Knowledge, Attitudes, and Practices (KAP) about body lice- and flea-borne diseases: Survey for Shelter Workers (Attachment 4)
Knowledge, Attitudes, and Practices (KAP) about body lice- and flea-borne diseases: Survey for Street/Outreach Workers (Attachment 5)
Site Assessment Form for Homeless Service Sites (Attachment 6)
Site Assessment Form for Street/Outreach Workers (Attachment 7)

2. Purpose and Use of Information Collection

Collaborating local or state public health professionals will identify homeless service sites that are interested to participate and will confirm the optimal time and date for a site visit for data collection. During the site visit, survey administrators will verbally invite homeless service providers to participate in the survey. Surveys will be administered one time to interested homeless service providers at participating homeless service sites in 8 states (CA, CO, GA, MD, MN, NY, TX, WA). The data collected will help to identify knowledge gaps and best practices to prevent body lice and fleas and associated diseases in people experiencing sheltered or unsheltered homelessness. The information collected will be used by CDC, state and local public health practitioners, and academicians to inform development of new educational resources and tools for homeless service providers to recognize and prevent body lice and fleas and associated diseases among PEH. These new educational tools will be shared with homeless service providers and outreach workers nation-wide.

3. Use of Improved Information Technology and Burden Reduction

Per the Government Paperwork Elimination Act (GPEA), Public Law 105-277, title XVII, information collection will be conducted using the most current modes of survey data collection. The nature of some of the proposed activities requires direct interaction between respondents and project staff. As such, survey staff will administer questionnaires either in-person or via videoconference; data entry can take place electronically via mobile device. Staff will then complete all data entry forms and enter data into an electronic database; each participant will only be asked to answer questions verbally.

The number of questions posed will be held to the minimum required in all information collections in order to elicit the necessary data.

4. Efforts to Identify Duplication and Use of Similar Information

No similar data are currently available; that is, other institutions collecting information on human VBDs are not collecting this information as it relates to KAP surveys for homeless service providers or for persons experiencing homelessness. DVBD has verified through RegInfo.gov that there are no other federal collections that duplicate information collection for VBD research included in this request. We used the following search terms to identify other ICRs that may involve a duplication of efforts: tick-borne disease, tickborne disease, louse-borne disease, louseborne disease, bartonellosis, Bartonella quintana, murine typhus, Rickettsia typhi, epidemic typhus, and typhus. We have conducted extensive literature searches using online databases (such as PubMed) to verify that similar data collections are not being conducted by other institutions, whether federal, academic, industry, or otherwise.

We are planning to conduct these data collections in conjunction with the Public Health and Homelessness Centers of Excellence.

5. Impact on Small Businesses and Other Small Entities

This activity will not involve data collection from small businesses or other small entities.

6. Consequences of Collecting the Information Less Frequently

We will be only collecting data once at each participating site. The 8 states (CA, CO, GA, MD, MN, NY, TX, WA) where data will be collected were selected to provide broad representation across regions. If data were collected at fewer sites, the data might not represent the knowledge or experiences of homeless service providers in non-participating regions.

7. Special Circumstances Relating to Guidelines of 5 CFR 1320.5

This request fully complies with regulation 5 CFR 1320.5.

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

A. A 60-Day Federal Register Notice was published in the Federal Register on February 22, 2022, Vol. 87, No. 35, pg. 9624 (Attachment 2). No public comments were received.

B. The following agencies and organizations outside of CDC have been consulted on the need for data collection with the audiences, and for the purposes, described in this clearance package:

Public Health – Seattle and King County

BreeAnna Dell (2022)

Project/Program Manager of One Health Investigations

206.477.5477, [email protected]

Colorado Department of Public Health and Environment

Christopher Grano (2022)

Communicable Disease Branch Administrator

720.248.8069, [email protected]

9. Explanation of Any Payment or Gift to Respondents

CDC understands that the default for these types of collections is not to offer incentives. For the proposed information collections, we will provide respondents with a gift card of $25 to a local grocery store. This amount and type of gift card was chosen in consultation with local partners to ensure that this would be appropriate and non-coercive.

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

NCEZID’s Information Systems Security Officer reviewed this submission and determined that the Privacy Act does not apply. This data collection will not collect personally identifiable information; a formal Privacy Impact Assessment is not required.

All CDC staff, as well as local partners receive appropriate annual privacy and confidentiality training.

Electronic data will be kept on the project-specific network on a secure server, which is accessible only to users granted rights by the project director and in a secure location with restricted physical access to staff working on the project only.

Participation in formative research information collection activities is strictly voluntary. All human subjects regulations will be followed.

Participants will be informed that their data will be maintained in a secure manner and that the data will only be used for purposes stated in the consent form. Personally identifiable information will not be collected during the survey. Only authorized project staff will be allowed to have access to study information (whether identifiable or not) and all information stored in hard copy will be kept in a locked cabinet and/or locked office with limited access.

Information in Identifiable Form

Activities do not involve the collection of individually identifiable information.

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

IRB Approval

This survey has been reviewed by the CDC Human Subjects Research Office and was determined to be a non-research activity (Attachment 8)

Sensitive Questions

No sensitive questions are anticipated for this information collection request. The possibility exists that respondents may find certain questions from the surveys to be sensitive in nature. However, questions covering such topics as demographics, activity locations, and health history are typical components of medical examinations. These questions are necessary to develop appropriate and tailored information on vector-borne disease prevention. During the enrollment process, respondents will be told that they may choose to skip any question they wish, for any reason. They will also be told that they may terminate participation at any time. If a subject asks to be withdrawn from the study, they will still be eligible to receive the grocery store gift card as a token of appreciation for their time.

12.A Estimates of Annualized Burden Hours and Costs:

Based on the length of the survey instruments, we estimate that the annualized burden for survey respondents will be 320 hours. We conducted a pilot of 6 respondents who completed each KAB survey instruments and Site Assessments (Attachments 4 -7); the average burden per response is included in the table below on which the burden estimate was derived.

Estimated Annualized Burden Table

Type of Respondent	Attachment Number	Form Name	Number of Respondents*	Number of Responses per Respondent*	Average Burden per Response (in hours)*	Total Burden Hours
Homeless Service Providers	4	Knowledge, Attitudes, and Practices (KAP) about body lice- and flea-borne diseases: Survey for Shelter Workers	200	1	45/60	150
Homeless Service Providers	5	Knowledge, Attitudes, and Practices (KAP) about body lice- and flea-borne diseases: Survey for Street/Outreach Workers	200	1	45/60	150
Site Supervisor	6	Site Assessment Form for Homeless Service Sites	40	1	15/60	10
Site Supervisor	7	Site Assessment Form for Street/Outreach Workers	40	1	15/60	10
Total						320

*This estimate of annualized burden is based on the largest projected sample size.

12.B Estimated Annualized Burden Costs.

The average annual response burden cost is estimated to be $8,963.20. The mean hourly wage estimate is based on the Bureau of Labor Statistics May 2021 National Occupational Employment and Wage Estimates (http://www.bls.gov/oes/current/oes_nat.htm).

Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate		Total Respondent Costs
General public, individuals or households	Knowledge, Attitudes, and Practices (KAP) about body lice- and flea-borne diseases: Survey for Shelter Workers	150	$28.01		$4,201.50
	Knowledge, Attitudes, and Practices (KAP) about body lice- and flea-borne diseases: Survey for Street/Outreach Workers	150	$28.01		$4,201.50
	Site Assessment Form for Homeless Service Sites	10	$28.01		$280.10
	Site Assessment Form for Street/Outreach Workers	10	$28.01		$280.10
Total				$8,963.20

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

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

14. Annualized Costs to the Federal Government

This information collection will involve participation of two CDC project officers, who will jointly be responsible for the project design, obtaining IRB approvals, providing project oversight, and analysis and dissemination of the results. These two positions will provide remote and onsite technical assistance to the local areas implementing the data collection. Travel may be required to provide this technical assistance. It is estimated that the annual cost to the Federal Government is $81,000.

Governmental Costs

		Total ($)
Federal Government Personnel Costs	CDC Project Officer (GS-13/14 at 0.2 FTE)	$20,500
	CDC Project Officer (GS-13/14 at 0.2 FTE)	$20,500
	CDC Travel (8 trips)	$30,000
	Tokens of Appreciation	$10,000
Subtotal, Federal Direct Costs		$81,000
Total Annualized Cost to Government		$81,000

15. Explanation for Program Changes or Adjustments

This is a EXTENSION data collection. Based on the Terms of Clearance for the currently approved EXERGENCY is with the understand that CDC will quickly publish the 30-day notice and submit for regular PRA approval.

16. Plans for Tabulation and Publication and Project Time Schedule

An estimated project time schedule for is outlined below. Individual project time schedules will be submitted for individual data collection requests.

A.16 - 1 Project Time Schedule
Activity	Time Schedule
Identification of participating local partners and sites	1 month after OMB approval
Enrollment and survey administration	1-4 months after OMB approval
Final survey administered	4-6 months after OMB approval
Data cleaning and validation	6-9 months after OMB approval
Analyses	9-15 months after OMB approval
Development of Improved Guidance	12-36 months after OMB approval

A.16 - 1 Project Time Schedule

Activity

Time Schedule

Identification of participating local partners and sites

1 month after OMB approval

Enrollment and survey administration

1-4 months after OMB approval

Final survey administered

4-6 months after OMB approval

Data cleaning and validation

6-9 months after OMB approval

Analyses

9-15 months after OMB approval

Development of Improved Guidance

12-36 months after OMB approval

Individual data collection will be conducted only once. Data collection activities will take less than six months to complete.

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

The display of the OMB expiration date is not inappropriate.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

Attachments

1. Authorizing Legislation

2. 60-day FRN

3. Project Information Sheet

4. Knowledge, Attitudes, and Practices (KAP) about body lice- and flea-borne diseases: Survey for Shelter Workers

5. Knowledge, Attitudes, and Practices (KAP) about body lice- and flea-borne diseases: Survey for Street/Outreach Workers

6. Site Assessment Form for Homeless Service Sites

7. Site Assessment Form for Street/Outreach Workers

8. Human Subjects Approval Letter

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
File Modified	0000-00-00
File Created	2022-09-30

Ssa_kap_peh_9.28.2022