Preferences for Longer-Acting Preexposure Prophylaxis (PrEP) Methods Among Persons in US Populations at Highest Need: A Discrete Choice Experiment

Forms and Documents

Document Name	Status
Form 0920 C4P Provider DCE Survey Form and Instruction	New
Form 0920 Provider Screening & Consent Form and Instruction	New
Form 0920 C4P Client DCE Survey Form and Instruction	New
Form 0920 Client Screening & Consent Form and Instruction	New
Att 4 Provider Invitation Email.docx Supplementary Document	2022-09-26
Att 3 Client Invitation Email.docx Supplementary Document	2022-09-26
Att 10 PIA_signed.pdf Supplementary Document	2022-09-26
Att 9 RTI IRB Approval Notice.pdf Supplementary Document	2022-09-26
Att 1 Authorizing Legislation.docx Supplementary Document	2022-09-26
SS Part B_C4P.docx Supporting Statement B	2022-09-26
SS Part A.docx Supporting Statement A	2022-09-26

IC Document Collections

IC ID	Document Title	Status
256139	C4P Provider DCE Survey Form and Instruction	New
256138	Provider Screening & Consent Form and Instruction	New
256137	C4P Client DCE Survey Form and Instruction	New
256136	Client Screening & Consent Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202209-0920-019
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-22CX
Title: Preferences for Longer-Acting Preexposure Prophylaxis (PrEP) Methods Among Persons in US Populations at Highest Need: A Discrete Choice Experiment
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/17/2022

	Requested	Previously Approved
Expiration Date	24 Months From Approved
Responses	11,040	0
Time Burden (Hours)	2,282	0
Cost Burden (Dollars)	0	0

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Abstract: The goal of this study is to understand preferences for long-acting pre-exposure prophylaxis (LA-PrEP) products for HIV prevention among potential users and providers, including product characteristics and other service delivery factors that may facilitate or hinder future update of these products. Data will be collected via two separate self-administered online cross-sectional surveys; one for potential LA-PrEP users and one for clinicians. The study design is comprised of a discrete choice experiment (DCE) and additional questions to directly elicit participant preferences. Results from this experiment will be used to identify key factors for adoption and implementation of LA-PrEP products.

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Authorizing Statute(s): PL: Pub.L. 301 - 241 Research and Investigations Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 11445	03/01/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 61327	10/11/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
C4P Client DCE Survey	0920	C4P Client DCE Survey
C4P Provider DCE Survey	0920	C4P Provider DCE Survey
Client Screening & Consent	0920	Client Screening & Consent
Provider Screening & Consent	0920	Provider Screening & Consent

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	11,040	0	0	11,040	0	0
Annual Time Burden (Hours)	2,282	0	0	2,282	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new data/information collection.

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Annual Cost to Federal Government: $646,424

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 10/17/2022

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