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

ICR 202510-0920-002

OMB: 0920-1428

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form
Modified
Justification for No Material/Nonsubstantive Change
2025-10-02
Supplementary Document
2025-10-02
Justification for No Material/Nonsubstantive Change
2024-11-06
Justification for No Material/Nonsubstantive Change
2024-02-14
Supplementary Document
2024-02-14
Supplementary Document
2024-02-14
Supplementary Document
2024-02-14
Supplementary Document
2024-02-14
Supplementary Document
2024-02-14
Supplementary Document
2024-02-14
Supplementary Document
2024-02-14
Supplementary Document
2024-02-14
Supplementary Document
2024-02-14
Supplementary Document
2024-02-14
Supplementary Document
2025-10-02
Supplementary Document
2025-10-02
Supplementary Document
2025-10-02
Supplementary Document
2025-10-02
Supplementary Document
2024-02-14
Supplementary Document
2024-02-14
Supplementary Document
2024-02-14
Supplementary Document
2024-02-14
Supplementary Document
2023-11-15
Supporting Statement B
2025-10-02
Supporting Statement A
2025-10-02
ICR Details
0920-1428 202510-0920-002
Received in OIRA 202410-0920-016
HHS/CDC 0920-25-0178
[NCHHSTP] mChoice: Improving PrEP Uptake and Adherence among Minority MSM through Tailored Provider Training and Adherence Assistance in Two High Priority Settings
No material or nonsubstantive change to a currently approved collection   Yes
Regular 10/02/2025
  Requested Previously Approved
01/31/2027 01/31/2027
1,135 1,135
549 549
0 0

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 is submitted to modify data collection documents for compliance with EO 14168 following Reinstatement. The burden remains the same.

None
None

Not associated with rulemaking

  88 FR 56834 08/21/2023
88 FR 78043 11/14/2023
No

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 0920-1428, 0920-1428, n/a, n/a Att 4c_Patient Baseline Assessment English.docx ,   Att 4c_Patient Baseline Assessment Spanish ,   Patient Baseline Assessment-English_02OCT2025 ,   Patient Baseline Assessment-Spanish_02OCT2025
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 0920-1428, 0920-1428, n/a, n/a Att 4d_Patient Quarterly Assessment English ,   Att 4d_Patient Quarterly Assessment Spanish ,   Patient Quarterly Assessment-English_02OCT2025 ,   Patient Quarterly Assessment-Spanish_02OCT2025
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

  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
No
No

$1,112,799
No
    No
    No
No
No
No
No
Jeffrey Zirger 404 639-7118 wtj5@cdc.gov

  Yes
  No changes made to the Common Forms. Changes made to modify data collection instruments for compliance with EO 14168
Agency/Sub Agency RCF ID RCF Title RCF Status IC Title

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/02/2025


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