Information Collection Request

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

ICR 202410-0920-016 · OMB 0920-1428 · Received in OIRA

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0920-1428 can be found here:

2026-02-09 - No material or nonsubstantive change to a currently approved collection
2025-10-02 - No material or nonsubstantive change to a currently approved collection

Forms and Documents

Document	Type	Status	Availability
Form 0920-22FZ Clinic Assessment Every Six Months	Form and Instruction	Unchanged	Repair queued
Form 0920-22FZ Clinical Assesment Baseline & Final	Form and Instruction	Unchanged	Available
Form 0920-22FZ Provider Interview	Form and Instruction	Unchanged	Repair queued
Form 0920-22FZ Provider Post-Training Assessment	Form and Instruction	Unchanged	Repair queued
Provider Pre-Training Assessment	Form and Instruction	Unchanged	Repair queued
Form 0920-22FZ Provider Locator Form	Form and Instruction	Unchanged	Repair queued
Form 0920-22FZ Provider Screening	Form and Instruction	Unchanged	Repair queued
Form 0920-22FZ Patient Interview Guide	Form and Instruction	Unchanged	Repair queued
CleverCap App Setup	Form and Instruction	Unchanged	Repair queued
Patient Quarterly Assessment	Form and Instruction	Unchanged	Repair queued
Patient Baseline	Form and Instruction	Unchanged	Repair queued
Form 0920-22FZ Patient Locator Form	Form and Instruction	Unchanged	Repair queued
Form 0920-25AJ Patient Screener (English/Spanish)	Form	Modified	Repair queued
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	Repair queued
Att 9_Provider Training Summary.docx	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 8_Privacy Impact Assessment_mChoice.pdf	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 7_Data Use Plan mChoice.docx	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 6d_Callen_Lorde IRB reliance agreement.pdf	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 6b_University of Alabama at Birmingham IRB reliance agreement.pdf	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 6a_Columbia University IRB approval.pdf	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 5e_Provider Consent Form.pdf	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 5d_Provider Consent to Screen.pdf	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 5c_Patient Interview Consent Form Spanish.pdf	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 5c_Patient Interview Consent Form English.pdf	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 5b_Patient Consent Form Spanish.pdf	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 5b_Patient Consent Form English.pdf	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 5a_Patient Consent to Screen Spanish.pdf	Supplementary Document	Uploaded 2024-02-14	Repair queued
Att 5a_Patient Consent to Screen_CLEAN.pdf	Supplementary Document	Uploaded 2024-02-14	Repair queued
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	Repair queued
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	Repair queued
SSB mChoice_clean.docx	Supporting Statement B	Uploaded 2024-11-06	Missing upstream
SSA_mChoice_clean.docx	Supporting Statement A	Uploaded 2024-11-06	Missing upstream

IC Document Collections

IC ID	Collection	Type	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

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.

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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

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

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

ICR Summary of Burden

	Total Request	Previously Approved
Annual Number of Responses	1,135	1,135
Annual Time Burden (Hours)	549	549
Annual Cost Burden (Dollars)	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:

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

Agency Contact: Odion Clunis 770 488-0045 [email protected]

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