[NCHHSTP] mChoice: Improving PrEP Uptake and Adherence among Minority MSM through Tailored Provider Training and Adherence Assistance in Two High Priority Settings

Forms and Documents

Document Name	Status
Form 0920-22FZ Clinic Assessment Every Six Months Form and Instruction	Unchanged
Form 0920-22FZ Clinical Assesment Baseline & Final Form and Instruction	Unchanged
Form 0920-22FZ Provider Interview Form and Instruction	Unchanged
Form 0920-22FZ Provider Post-Training Assessment Form and Instruction	Unchanged
Provider Pre-Training Assessment Form and Instruction	Unchanged
Form 0920-22FZ Provider Locator Form Form and Instruction	Unchanged
Form 0920-22FZ Provider Screening Form and Instruction	Unchanged
Form 0920-22FZ Patient Interview Guide Form and Instruction	Unchanged
CleverCap App Setup Form and Instruction	Unchanged
Patient Quarterly Assessment Form and Instruction	Unchanged
Patient Baseline Form and Instruction	Unchanged
Form 0920-22FZ Patient Locator Form Form and Instruction	Unchanged
Form 0920-25AJ Patient Screener (English/Spanish) Form	Modified
mChoice 0920-1428 Justification and Summary of Changes.docx Justification for No Material/Nonsubstantive Change	2024-11-06
mChoice_summary of changes memo_011024.docx Justification for No Material/Nonsubstantive Change	2024-02-14
Att 9_Provider Training Summary.docx Supplementary Document	2024-02-14
Att 8_Privacy Impact Assessment_mChoice.pdf Supplementary Document	2024-02-14
Att 7_Data Use Plan mChoice.docx Supplementary Document	2024-02-14
Att 6d_Callen_Lorde IRB reliance agreement.pdf Supplementary Document	2024-02-14
Att 6b_University of Alabama at Birmingham IRB reliance agreement.pdf Supplementary Document	2024-02-14
Att 6a_Columbia University IRB approval.pdf Supplementary Document	2024-02-14
Att 5e_Provider Consent Form.pdf Supplementary Document	2024-02-14
Att 5d_Provider Consent to Screen.pdf Supplementary Document	2024-02-14
Att 5c_Patient Interview Consent Form Spanish.pdf Supplementary Document	2024-02-14
Att 5c_Patient Interview Consent Form English.pdf Supplementary Document	2024-02-14
Att 5b_Patient Consent Form Spanish.pdf Supplementary Document	2024-02-14
Att 5b_Patient Consent Form English.pdf Supplementary Document	2024-02-14
Att 5a_Patient Consent to Screen Spanish.pdf Supplementary Document	2024-02-14
Att 5a_Patient Consent to Screen_CLEAN.pdf Supplementary Document	2024-02-14
Att 3b_Provider Recruitment Materials.docx Supplementary Document	2024-02-14
Att 3a_Patient Recruitment Materials Spanish.docx Supplementary Document	2024-02-14
Att 3a_Patient Recruitment Materials English.docx Supplementary Document	2024-02-14
Att 2a_60-day FRN Pub 6_13_2022.pdf Supplementary Document	2024-02-14
Att 1_Auth Legislation.docx Supplementary Document	2023-11-15
SSB mChoice_clean.docx Supporting Statement B	2024-11-06
SSA_mChoice_clean.docx Supporting Statement A	2024-11-06

IC Document Collections

IC ID	Document Title	Status
263498	Clinic Assessment Every Six Months Form and Instruction	Unchanged
263497	Clinical Assesment Baseline & Final Form and Instruction	Unchanged
263496	Provider Interview Form and Instruction	Unchanged
263495	Provider Post-Training Assessment Form and Instruction	Unchanged
263494	Provider Pre-Training Assessment Form and Instruction	Unchanged
263493	Provider Locator Form Form and Instruction	Unchanged
263492	Provider Screening Form and Instruction	Unchanged
263491	Patient Interview Guide Form and Instruction	Unchanged
263490	CleverCap App Setup Form and Instruction	Unchanged
263489	Patient Quarterly Assessment Form and Instruction	Unchanged
263488	Patient Baseline Form and Instruction	Unchanged
263487	Patient Locator Form Form and Instruction	Unchanged
263486	Patient Screener (English/Spanish) Form	Modified

ICR Details

OMB Control No: 0920-1428	ICR Reference No: 202410-0920-016
Status: Received in OIRA	Previous ICR Reference No: 202402-0920-005
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1428-25AJ
Title: [NCHHSTP] mChoice: Improving PrEP Uptake and Adherence among Minority MSM through Tailored Provider Training and Adherence Assistance in Two High Priority Settings
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  Yes
Type of Review Request: Regular	Date Submitted to OIRA: 11/19/2024

	Requested	Previously Approved
Expiration Date	01/31/2027	01/31/2027
Responses	1,135	1,135
Time Burden (Hours)	549	549
Cost Burden (Dollars)	0	0

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Abstract: The purpose of the mChoice project is to rigorously evaluate the use of provider and patient education and support tools in clinical settings to increase PrEP screening, counseling, initiation, adherence, and persistence by MSM. This research project will involve interaction with human participants and intends to collect new individually identifiable data and biospecimens from the participants. This project is considered human subjects research and will be covered by the Paperwork Reduction Act. The mChoice intervention will target healthcare providers and PrEP users. The study will provide training to healthcare providers to improve knowledge of PrEP clinical guidelines and enhance provider communications with their patients. PrEP users will receive CleverCap, an electronic medication monitoring device that is linked to the CleverCap mobile phone application that provides medication dispensing information and reminders to support medication adherence, as well as health information and appointment reminders. This non-substantive change request involves minor edits to instruments and a consent form. The burden remains the same.

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Authorizing Statute(s): None

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:
	88 FR 56834	08/21/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 78043	11/14/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
CleverCap App Setup	n/a, n/a	Att 4e_CleverCap App Setup English ,   Att 4e_CleverCap App Setup Spanish
Clinic Assessment Every Six Months	0920-22FZ	Att 4m_Clinic Assessment Every 6 Months
Clinical Assesment Baseline & Final	0920-22FZ	Att 4l_Clinic Assessment Baseline and Final
Patient Baseline	n/a, n/a	Att 4c_Patient Baseline Assessment English.docx ,   Att 4c_Patient Baseline Assessment Spanish
Patient Interview Guide	0920-22FZ, 0920-22FZ	Att 4f_Patient Interiew Guide English.docx ,   Att 4f_Patient Interiew Guide Spanish
Patient Locator Form	0920-22FZ, 0920-22FZ	Patient Locator Form _English ,   Att 4b_Patient Locator Form Spanish
Patient Quarterly Assessment	n/a, n/a	Att 4d_Patient Quarterly Assessment English ,   Att 4d_Patient Quarterly Assessment Spanish
Patient Screener (English/Spanish)	0920-25AJ, 0920-25AJ	Patient Screener (English) ,   Patient Screener (Spanish)
Provider Interview	0920-22FZ	Att 4k_Provider Interview Guide
Provider Locator Form	0920-22FZ	Att 4h_Provider Locator Form
Provider Post-Training Assessment	0920-22FZ	Att 4j_Provider Post-Training Assessment
Provider Pre-Training Assessment	n/a	Att 4i_Provider Pre-Training Assessment
Provider Screening	0920-22FZ	Att 4g_Provider Screener

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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	1,135	1,135	0	0	0	0
Annual Time Burden (Hours)	549	549	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: $1,112,799

Does this IC contain surveys, censuses, or employ statistical methods? No

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.     No

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:  Yes

Description/Changes for Common Form Usage:  This request includes changes to the inclusion criteria and sexual behavior screening questions. In addition, CDC is also revising the SSA and SSB to reflect changes in CDC staffing on the project. We are also updating the race and ethnicity questions to reflect the new standards announced by the Management and Budget Office on 03/29/2024 (Revisions to OMB's Statistical Policy Directive No. 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, 89 FR 22182).

Approved RCFs using this ICR

Agency/Sub Agency	RCF ID	RCF Title	RCF Status	IC Title

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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: 11/19/2024

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