[NCHHSTP] Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a Transformational Era

Forms and Documents

Document Name	Status
Form 0920-24DF In-Depth Interview Form	Unchanged
Form 0920-24DF Focus Group Consent Form	Modified
STI Sample Collection Form and Instruction	Unchanged
HIV sample collection Form and Instruction	Modified
SMaRT App Install Form and Instruction	Modified
Form 0920-24DF Quarterly Assessment Form	Modified
Form 0920-24DF Registration Contact Information Form Form	Modified
Form 0920-24DF Eligibility Screener Form	Modified
Justification Memo.docx Justification for No Material/Nonsubstantive Change	2025-04-08
MIC-DROP STARS PD_clean.docx Supplementary Document	2025-04-08
MIC DROP burden table.docx Supplementary Document	2024-04-03
Att 5a_Consent to Participate Spanish_clean.docx Supplementary Document	2024-04-03
Att 5a_Consent to Participate English_clean.docx Supplementary Document	2024-04-03
IRB approval for change to the study consent form.pdf Supplementary Document	2024-04-03
IRB approval for change to the screener.pdf Supplementary Document	2024-04-03
IRB approval for change to the in-depth interview consent form.pdf Supplementary Document	2024-04-03
IRB approval for change to the focus group consent form.pdf Supplementary Document	2024-04-03
IRB approval for change to the contact information form.pdf Supplementary Document	2024-04-03
Justification and Summary of Changes 06Mar2024.docx Justification for No Material/Nonsubstantive Change	2024-04-03
Att 8_Privacy Impact Assessment.pdf Supplementary Document	2023-10-04
Att 7_Data Use Agreement.docx Supplementary Document	2023-10-04
Att 6d_San Diego State University IRB reliance agreement.pdf Supplementary Document	2023-10-04
Att 6c_University of Chicago IRB reliance agreement.pdf Supplementary Document	2023-10-04
Att 6b_Emory University IRB reliance agreement.pdf Supplementary Document	2023-10-04
Att 6a_WCG IRB Letter of Approval.pdf Supplementary Document	2023-10-04
Att 5c_In-Depth Interview Consent Spanish.docx Supplementary Document	2023-10-04
Att 5c_In-Depth Interview Consent English.docx Supplementary Document	2023-10-04
Att 5b_Focus Group Consent Spanish.docx Supplementary Document	2023-10-04
Att 5b_Focus Group Consent English.docx Supplementary Document	2023-10-04
Att 5a_Consent to Participate Spanish.docx Supplementary Document	2023-10-04
Att 5a_Consent to Participate English.docx Supplementary Document	2023-10-04
Att 3_Recruitment Materials Spanish.pdf Supplementary Document	2023-10-04
Att 3_Recruitment Materials English.pdf Supplementary Document	2023-10-04
Att 2a_60 Day FRN Pub11-16-2022.pdf Supplementary Document	2023-10-04
Att 1_Auth Legislation.docx Supplementary Document	2023-10-04
SSB MIC DROP_Clean.docx Supporting Statement B	2025-04-08
SSA MIC DROP_Clean.docx Supporting Statement A	2025-04-08

IC Document Collections

IC ID	Document Title	Status
262656	In-Depth Interview Form	Unchanged
262655	Focus Group Consent Form	Modified
262654	STI Sample Collection Form and Instruction	Unchanged
262653	HIV sample collection Form and Instruction	Modified
262652	SMaRT App Install Form and Instruction	Modified
262651	Quarterly Assessment Form	Modified
262650	Registration Contact Information Form Form	Modified
262642	Eligibility Screener Form	Modified

ICR Details

OMB Control No: 0920-1421	ICR Reference No: 202504-0920-010
Status: Received in OIRA	Previous ICR Reference No: 202403-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-25-0073
Title: [NCHHSTP] Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a Transformational Era
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/14/2025

	Requested	Previously Approved
Expiration Date	11/30/2026	11/30/2026
Responses	9,443	9,443
Time Burden (Hours)	4,332	4,332
Cost Burden (Dollars)	0	0

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Abstract: The goal of this study is to understand the use of preexposure prophylaxis (PrEP) and other HIV and sexually transmitted infections (STI) prevention interventions over time among men who have sex with men (MSM). The study will also identify the most effective PrEP messaging and other HIV and STI prevention messaging to increase protective behaviors among MSM.We are requesting changes in order to be more consistent and responsive to participants, and to adhere to the institutional requirements of the awardee of the cooperative grant, Emory University. These changes are consistent with stakeholder input and align with the goals and plans of this project.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: PHSA
  

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 68696	11/16/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 69638	10/06/2023
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Eligibility Screener	0920-24DF, 0920-24DF, 0920-25-0073, 0920-25-0073	Eligibility Screener English ,   Eligibility Screener Spanish ,   Eligibility Screener English ,   Eligibility Screener Spanish
Focus Group Consent	0920-24DF, 0920-24DF	Focus Group Consent English ,   Att 5b_Focus Group Consent Spanish_clean
HIV sample collection	n/a, n/a	HIV Sample Collection ,   HIV Sample Collection (Spanish)
In-Depth Interview	0920-24DF, 0920-24DF	In-Depth Interview Consent English ,   In-Depth Interview Consent Spanish
Quarterly Assessment	0920-24DF, 0920-24DF, 0920-25-0073, 0920-25-0073	Quarterly assessment English ,   Quarterly assessment Spanish ,   Quarterly assessment English ,   Quarterly assessment Spanish
Registration Contact Information Form	0920-24DF, 0920-24DF, 0920-25-0073, 0920-25-0073	Registration Contact Information Form English ,   Registration Contact Information Form Spanish ,   Reg Contact Info Form English ,   Reg Contact Info Form Spanish
SMaRT App Install	n/a, n/a, 0920-25-0073, 0920-25-0073	SMART App Installation ,   SMART App Installation (Spanish) ,   Behavioral_Assessment_HET_Spanish ,   Behavioral_Assessment_HET_English
STI Sample Collection	n/a, n/a	STI Sample Collection ,   STI Sample Collection (Spanish)

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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	9,443	9,443	0	0	0	0
Annual Time Burden (Hours)	4,332	4,332	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $1,583,732

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: 05/14/2025

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