[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

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0920-26-0026 Clinic Assessment Every 6 Months	Form and Instruction	Modified	Available
Form 0920-26-0026 Clinic Assessment Baseline and Final	Form and Instruction	Modified	Available
Form 0920-22FZ Att 4k_Provider Interview Guide	Form and Instruction	Unchanged	Available
Form 0920-1428 Provider Post-Training Assessment_02OCT2025	Form and Instruction	Unchanged	Available
Form 0920-22FZ Att 4j_Provider Post-Training Assessment	Form and Instruction	Unchanged	Available
Form 0920-1428 Provider Pre-Training Assessment_02OCT2025	Form and Instruction	Unchanged	Available
Att 4i_Provider Pre-Training Assessment	Form and Instruction	Unchanged	Available
Form 0920-22FZ Att 4h_Provider Locator Form	Form and Instruction	Unchanged	Available
Form 0920-22FZ Att 4g_Provider Screener	Form and Instruction	Unchanged	Available
Form 0920-22FZ Att 4f_Patient Interiew Guide Spanish	Form and Instruction	Unchanged	Available
Form 0920-22FZ Att 4f_Patient Interiew Guide English.docx	Form and Instruction	Unchanged	Available
Att 4e_CleverCap App Setup Spanish	Form and Instruction	Unchanged	Available
Att 4e_CleverCap App Setup English	Form and Instruction	Unchanged	Available
Form 0920-26-0026 Quarterly Assessment Spanish	Form and Instruction	Modified	Available
Form 0920-26-0026 Quarterly Assessment English	Form and Instruction	Modified	Available
Form 0920-26-0026 Patient Baseline Assessment Spanish	Form and Instruction	Modified	Available
Form 0920-26-0026 Patient Baseline Assessment English	Form and Instruction	Modified	Available
Form 0920-1428 Patient Locator Form-Spanish_02OCT2025	Form and Instruction	Unchanged	Available
Form 0920-1428 Patient Locator Form-English_02OCT2025	Form and Instruction	Unchanged	Available
Form 0920-22FZ Att 4b_Patient Locator Form Spanish	Form and Instruction	Unchanged	Repair queued
Form 0920-22FZ Patient Locator Form _English	Form and Instruction	Unchanged	Available
Form 0920-1428 Patient Screener-Spanish_02OCT2025	Form and Instruction	Unchanged	Available
Form 0920-1428 Patient Screener-English_02OCT2025	Form and Instruction	Unchanged	Available
Form 0920-25AJ Patient Screener (Spanish)	Form	Unchanged	Available
Form 0920-25AJ Patient Screener (English)	Form	Unchanged	Available
Justification and Summary of Changes.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2026-02-05	Available
Change Request Memo.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2025-10-02	Available
Att 3a_Patient Recruitment Materials English Spanish_CLEAN.docx	Supplementary Document	Uploaded 2025-10-02	Available
mChoice 0920-1428 Justification and Summary of Changes.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2024-11-06	Available
mChoice_summary of changes memo_011024.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2024-02-14	Available
Att 9_Provider Training Summary.docx	Supplementary Document	Uploaded 2024-02-14	Available
Att 8_Privacy Impact Assessment_mChoice.pdf	Supplementary Document	Uploaded 2024-02-14	Available
Att 7_Data Use Plan mChoice.docx	Supplementary Document	Uploaded 2024-02-14	Available
Att 6d_Callen_Lorde IRB reliance agreement.pdf	Supplementary Document	Uploaded 2024-02-14	Available
Att 6b_University of Alabama at Birmingham IRB reliance agreement.pdf	Supplementary Document	Uploaded 2024-02-14	Available
Att 6a_Columbia University IRB approval.pdf	Supplementary Document	Uploaded 2024-02-14	Available
Att 5e_Provider Consent Form.pdf	Supplementary Document	Uploaded 2024-02-14	Available
Att 5d_Provider Consent to Screen.pdf	Supplementary Document	Uploaded 2024-02-14	Available
Att 5c_Patient Interview Consent Form Spanish.pdf	Supplementary Document	Uploaded 2024-02-14	Available
Att 5c_Patient Interview Consent Form English.pdf	Supplementary Document	Uploaded 2024-02-14	Available
Att 5b_Patient Consent Form Spanish_CLEAN.docx	Supplementary Document	Uploaded 2025-10-02	Available
Att 5b_Patient Consent Form English_CLEAN.docx	Supplementary Document	Uploaded 2025-10-02	Repair queued
Att 5a_Patient Consent to Screen Spanish_CLEAN.docx	Supplementary Document	Uploaded 2025-10-02	Available
Att 5a_Patient Consent to Screen English_CLEAN.docx	Supplementary Document	Uploaded 2025-10-02	Available
Att 3b_Provider Recruitment Materials.docx	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 3a_Patient Recruitment Materials Spanish.docx	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 3a_Patient Recruitment Materials English.docx	Supplementary Document	Uploaded 2024-02-14	Available
Att 2a_60-day FRN Pub 6_13_2022.pdf	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 1_Auth Legislation.docx	Supplementary Document	Uploaded 2023-11-15	Available
SSB_mChoice_Clean_01.20.26.docx	Supporting Statement B	Uploaded 2026-02-05	Available
SSA_mChoice_Clean_02.04.26.docx	Supporting Statement A	Uploaded 2026-02-05	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
263498	Clinic Assessment Every Six Months	Form and Instruction	Modified	Clinic Assessment Every 6 Months
263498	Clinic Assessment Every Six Months	Form and Instruction	Modified
263497	Clinical Assesment Baseline & Final	Form and Instruction	Modified	Clinic Assessment Baseline and Final
263497	Clinical Assesment Baseline & Final	Form and Instruction	Modified
263496	Provider Interview	Form and Instruction	Unchanged	Att 4k_Provider Interview Guide
263496	Provider Interview	Form and Instruction	Unchanged
263495	Provider Post-Training Assessment	Form and Instruction	Unchanged	Provider Post-Training Assessment_02OCT2025
263495	Provider Post-Training Assessment	Form and Instruction	Unchanged	Att 4j_Provider Post-Training Assessment
263495	Provider Post-Training Assessment	Form and Instruction	Unchanged
263494	Provider Pre-Training Assessment	Form and Instruction	Unchanged	Provider Pre-Training Assessment_02OCT2025
263494	Provider Pre-Training Assessment	Form and Instruction	Unchanged	Att 4i_Provider Pre-Training Assessment
263494	Provider Pre-Training Assessment	Form and Instruction	Unchanged
263493	Provider Locator Form	Form and Instruction	Unchanged	Att 4h_Provider Locator Form
263493	Provider Locator Form	Form and Instruction	Unchanged
263492	Provider Screening	Form and Instruction	Unchanged	Att 4g_Provider Screener
263492	Provider Screening	Form and Instruction	Unchanged
263491	Patient Interview Guide	Form and Instruction	Unchanged	Att 4f_Patient Interiew Guide Spanish
263491	Patient Interview Guide	Form and Instruction	Unchanged	Att 4f_Patient Interiew Guide English.docx
263491	Patient Interview Guide	Form and Instruction	Unchanged
263490	CleverCap App Setup	Form and Instruction	Unchanged	Att 4e_CleverCap App Setup Spanish
263490	CleverCap App Setup	Form and Instruction	Unchanged	Att 4e_CleverCap App Setup English
263490	CleverCap App Setup	Instruction	Unchanged
263489	Patient Quarterly Assessment	Form and Instruction	Modified	Quarterly Assessment Spanish
263489	Patient Quarterly Assessment	Form and Instruction	Modified	Quarterly Assessment English
263489	Patient Quarterly Assessment	Form and Instruction	Modified
263488	Patient Baseline	Form and Instruction	Modified	Patient Baseline Assessment Spanish
263488	Patient Baseline	Form and Instruction	Modified	Patient Baseline Assessment English
263488	Patient Baseline	Form and Instruction	Modified
263487	Patient Locator Form	Form and Instruction	Unchanged	Patient Locator Form-Spanish_02OCT2025
263487	Patient Locator Form	Form and Instruction	Unchanged	Patient Locator Form-English_02OCT2025
263487	Patient Locator Form	Form and Instruction	Unchanged	Att 4b_Patient Locator Form Spanish
263487	Patient Locator Form	Form and Instruction	Unchanged	Patient Locator Form _English
263487	Patient Locator Form	Form and Instruction	Unchanged
263486	Patient Screener (English/Spanish)	Form and Instruction	Unchanged	Patient Screener-Spanish_02OCT2025
263486	Patient Screener (English/Spanish)	Form and Instruction	Unchanged	Patient Screener-English_02OCT2025
263486	Patient Screener (English/Spanish)	Form	Unchanged	Patient Screener (Spanish)
263486	Patient Screener (English/Spanish)	Form	Unchanged	Patient Screener (English)
263486	Patient Screener (English/Spanish)	Form	Unchanged

ICR Details

OMB Control No: 0920-1428	ICR Reference No: 202602-0920-002
Status: Active	Previous ICR Reference No: 202510-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-26-0026
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/10/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/09/2026
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2027	01/31/2027	01/31/2027
Responses	1,135	0	1,135
Time Burden (Hours)	551	0	549
Cost Burden (Dollars)	0	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. In this request, we are proposing adding a new HIV prevention PrEP injectable medication, lenacapavir (also referred to as LEN and Yeztugo), to data collection instruments (elaborating on questions and response options to include lenacapavir). Including lenacapavir as a PrEP option in participant assessments and clinic assessments will help us more accurately capture PrEP uptake and usage. There is a total increase of 2 burden hours

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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

table that charts list of burden

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	0920-26-0026	Clinic Assessment Every 6 Months
Clinical Assesment Baseline & Final	0920-26-0026	Clinic Assessment Baseline and Final
Patient Baseline	0920-26-0026, 0920-26-0026	Patient Baseline Assessment English ,   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	0920-1428, 0920-1428, 0920-22FZ, 0920-22FZ	Patient Locator Form _English ,   Att 4b_Patient Locator Form Spanish ,   Patient Locator Form-English_02OCT2025 ,   Patient Locator Form-Spanish_02OCT2025
Patient Quarterly Assessment	0920-26-0026, 0920-26-0026	Quarterly Assessment English ,   Quarterly Assessment Spanish
Patient Screener (English/Spanish)	0920-1428, 0920-1428, 0920-25AJ, 0920-25AJ	Patient Screener (English) ,   Patient Screener (Spanish) ,   Patient Screener-English_02OCT2025 ,   Patient Screener-Spanish_02OCT2025
Provider Interview	0920-22FZ	Att 4k_Provider Interview Guide
Provider Locator Form	0920-22FZ	Att 4h_Provider Locator Form
Provider Post-Training Assessment	0920-1428, 0920-22FZ	Att 4j_Provider Post-Training Assessment ,   Provider Post-Training Assessment_02OCT2025
Provider Pre-Training Assessment	0920-1428, n/a	Att 4i_Provider Pre-Training Assessment ,   Provider Pre-Training Assessment_02OCT2025
Provider Screening	0920-22FZ	Att 4g_Provider Screener

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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)	551	549	0	2	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 change request seeking to revise instruments, which will add two additional hours of annual burden for a total of 551 hours annually.

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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:  As of January 2026, this Supporting Statement reflects non-substantive changes to the previously approved data collection. The change request adds a new HIV prevention PrEP injectable medication, lenacapavir (also referred to as LEN and Yeztugo), to data collection instruments and elaborates on questions and response options to include lenacapavir. Including lenacapavir as a PrEP option in participant assessments and clinic assessments more accurately captures the current landscape of PrEP uptake and usage.

Approved RCFs using this ICR

table that charts list of RCF

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: 02/09/2026

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