OMB.report

Federal forms, ICRs, and supporting documents

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 202510-0920-002 · OMB 0920-1428 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Form 0920-22FZ Att 4m_Clinic Assessment Every 6 Months Form and Instruction Unchanged Available
Form 0920-22FZ Clinic Assessment Every Six Months Form and Instruction Unchanged Repair queued
Form 0920-22FZ Att 4l_Clinic Assessment Baseline and Final Form and Instruction Unchanged Repair queued
Form 0920-22FZ Clinical Assesment Baseline & Final Form and Instruction Unchanged Repair queued
Form 0920-22FZ Att 4k_Provider Interview Guide Form and Instruction Unchanged Available
Form 0920-22FZ Provider Interview Form and Instruction Unchanged Repair queued
Form 0920-1428 Provider Post-Training Assessment_02OCT2025 Form and Instruction Modified Repair queued
Form 0920-22FZ Att 4j_Provider Post-Training Assessment Form and Instruction Modified Available
Form 0920-22FZ Provider Post-Training Assessment Form and Instruction Modified Missing upstream
Form 0920-1428 Provider Pre-Training Assessment_02OCT2025 Form and Instruction Modified Available
Att 4i_Provider Pre-Training Assessment Form and Instruction Modified Available
Provider Pre-Training Assessment Form and Instruction Modified Repair queued
Form 0920-22FZ Att 4h_Provider Locator Form Form and Instruction Unchanged Repair queued
Form 0920-22FZ Provider Locator Form Form and Instruction Unchanged Available
Form 0920-22FZ Att 4g_Provider Screener Form and Instruction Unchanged Repair queued
Form 0920-22FZ Provider Screening Form and Instruction Unchanged Repair queued
Form 0920-22FZ Att 4f_Patient Interiew Guide Spanish Form and Instruction Unchanged Repair queued
Form 0920-22FZ Att 4f_Patient Interiew Guide English.docx Form and Instruction Unchanged Available
Form 0920-22FZ Patient Interview Guide Form and Instruction Unchanged Repair queued
Att 4e_CleverCap App Setup Spanish Form and Instruction Modified Repair queued
Att 4e_CleverCap App Setup English Form and Instruction Modified Repair queued
CleverCap App Setup Form and Instruction Modified Repair queued
Form 0920-1428 Patient Quarterly Assessment-Spanish_02OCT2025 Form and Instruction Modified Repair queued
Form 0920-1428 Patient Quarterly Assessment-English_02OCT2025 Form and Instruction Modified Available
Att 4d_Patient Quarterly Assessment Spanish Form and Instruction Modified Repair queued
Att 4d_Patient Quarterly Assessment English Form and Instruction Modified Repair queued
Patient Quarterly Assessment Form and Instruction Modified Missing upstream
Form 0920-1428 Patient Baseline Assessment-Spanish_02OCT2025 Form and Instruction Modified Available
Form 0920-1428 Patient Baseline Assessment-English_02OCT2025 Form and Instruction Modified Repair queued
Att 4c_Patient Baseline Assessment Spanish Form and Instruction Modified Available
Att 4c_Patient Baseline Assessment English.docx Form and Instruction Modified Available
Patient Baseline Form and Instruction Modified Repair queued
Form 0920-1428 Patient Locator Form-Spanish_02OCT2025 Form and Instruction Modified Available
Form 0920-1428 Patient Locator Form-English_02OCT2025 Form and Instruction Modified Repair queued
Form 0920-22FZ Att 4b_Patient Locator Form Spanish Form and Instruction Modified Repair queued
Form 0920-22FZ Patient Locator Form _English Form and Instruction Modified Available
Form 0920-22FZ Patient Locator Form Form and Instruction Modified Repair queued
Form 0920-1428 Patient Screener-Spanish_02OCT2025 Form and Instruction Modified Repair queued
Form 0920-1428 Patient Screener-English_02OCT2025 Form and Instruction Modified Repair queued
Form 0920-25AJ Patient Screener (Spanish) Form Modified Available
Form 0920-25AJ Patient Screener (English) Form Modified Available
Form 0920-25AJ Patient Screener (English/Spanish) Form Modified Repair queued
Change Request Memo.docx Justification for No Material/Nonsubstantive Change Uploaded 2025-10-02 Repair queued
Change Request Memo.docx Justification for No Material/Nonsubstantive Change Uploaded 2025-10-02 Repair queued
Att 3a_Patient Recruitment Materials English Spanish_CLEAN.docx Supplementary Document Uploaded 2025-10-02 Repair queued
Att 3a_Patient Recruitment Materials English Spanish_CLEAN.docx Supplementary Document Uploaded 2025-10-02 Repair queued
mChoice 0920-1428 Justification and Summary of Changes.docx Justification for No Material/Nonsubstantive Change Uploaded 2024-11-06 Repair queued
mChoice 0920-1428 Justification and Summary of Changes.docx Justification for No Material/Nonsubstantive Change Uploaded 2024-11-06 Repair queued
mChoice_summary of changes memo_011024.docx Justification for No Material/Nonsubstantive Change Uploaded 2024-02-14 Repair queued
mChoice_summary of changes memo_011024.docx Justification for No Material/Nonsubstantive Change Uploaded 2024-02-14 Missing upstream
Att 9_Provider Training Summary.docx Supplementary Document 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 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 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 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 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 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 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 5d_Provider Consent to Screen.pdf Supplementary Document Uploaded 2024-02-14 Missing upstream
Att 5c_Patient Interview Consent Form Spanish.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 5c_Patient Interview Consent Form English.pdf Supplementary Document Uploaded 2024-02-14 Repair queued
Att 5b_Patient Consent Form Spanish_CLEAN.docx Supplementary Document Uploaded 2025-10-02 Repair queued
Att 5b_Patient Consent Form Spanish_CLEAN.docx Supplementary Document Uploaded 2025-10-02 Repair queued
Att 5b_Patient Consent Form English_CLEAN.docx Supplementary Document Uploaded 2025-10-02 Repair queued
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 Repair queued
Att 5a_Patient Consent to Screen Spanish_CLEAN.docx Supplementary Document Uploaded 2025-10-02 Repair queued
Att 5a_Patient Consent to Screen English_CLEAN.docx Supplementary Document Uploaded 2025-10-02 Repair queued
Att 5a_Patient Consent to Screen English_CLEAN.docx Supplementary Document Uploaded 2025-10-02 Repair queued
Att 3b_Provider Recruitment Materials.docx 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 Spanish.docx Supplementary Document Uploaded 2024-02-14 Missing upstream
Att 3a_Patient Recruitment Materials English.docx Supplementary Document Uploaded 2024-02-14 Repair queued
Att 3a_Patient Recruitment Materials English.docx Supplementary Document Uploaded 2024-02-14 Missing upstream
Att 2a_60-day FRN Pub 6_13_2022.pdf 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
Att 1_Auth Legislation.docx Supplementary Document Uploaded 2023-11-15 Available
SSB_Clean.docx Supporting Statement B Uploaded 2025-10-02 Available
SSB_Clean.docx Supporting Statement B Uploaded 2025-10-02 Repair queued
SSA_Clean.docx Supporting Statement A Uploaded 2025-10-02 Available
SSA_Clean.docx Supporting Statement A Uploaded 2025-10-02 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
263498 Clinic Assessment Every Six Months Form and Instruction UnchangedAtt 4m_Clinic Assessment Every 6 Months
263498 Clinic Assessment Every Six Months Form and Instruction Unchanged
263497 Clinical Assesment Baseline & Final Form and Instruction UnchangedAtt 4l_Clinic Assessment Baseline and Final
263497 Clinical Assesment Baseline & Final Form and Instruction Unchanged
263496 Provider Interview Form and Instruction UnchangedAtt 4k_Provider Interview Guide
263496 Provider Interview Form and Instruction Unchanged
263495 Provider Post-Training Assessment Form and Instruction ModifiedProvider Post-Training Assessment_02OCT2025
263495 Provider Post-Training Assessment Form and Instruction ModifiedAtt 4j_Provider Post-Training Assessment
263495 Provider Post-Training Assessment Form and Instruction Modified
263494 Provider Pre-Training Assessment Form and Instruction ModifiedProvider Pre-Training Assessment_02OCT2025
263494 Provider Pre-Training Assessment Form and Instruction ModifiedAtt 4i_Provider Pre-Training Assessment
263494 Provider Pre-Training Assessment Form and Instruction Modified
263493 Provider Locator Form Form and Instruction UnchangedAtt 4h_Provider Locator Form
263493 Provider Locator Form Form and Instruction Unchanged
263492 Provider Screening Form and Instruction UnchangedAtt 4g_Provider Screener
263492 Provider Screening Form and Instruction Unchanged
263491 Patient Interview Guide Form and Instruction UnchangedAtt 4f_Patient Interiew Guide Spanish
263491 Patient Interview Guide Form and Instruction UnchangedAtt 4f_Patient Interiew Guide English.docx
263491 Patient Interview Guide Form and Instruction Unchanged
263490 CleverCap App Setup Form and Instruction ModifiedAtt 4e_CleverCap App Setup Spanish
263490 CleverCap App Setup Form and Instruction ModifiedAtt 4e_CleverCap App Setup English
263490 CleverCap App Setup Form and Instruction Modified
263490 CleverCap App Setup Instruction Modified
263489 Patient Quarterly Assessment Form and Instruction ModifiedPatient Quarterly Assessment-Spanish_02OCT2025
263489 Patient Quarterly Assessment Form and Instruction ModifiedPatient Quarterly Assessment-English_02OCT2025
263489 Patient Quarterly Assessment Form and Instruction ModifiedAtt 4d_Patient Quarterly Assessment Spanish
263489 Patient Quarterly Assessment Form and Instruction ModifiedAtt 4d_Patient Quarterly Assessment English
263489 Patient Quarterly Assessment Form and Instruction Modified
263488 Patient Baseline Form and Instruction ModifiedPatient Baseline Assessment-Spanish_02OCT2025
263488 Patient Baseline Form and Instruction ModifiedPatient Baseline Assessment-English_02OCT2025
263488 Patient Baseline Form and Instruction ModifiedAtt 4c_Patient Baseline Assessment Spanish
263488 Patient Baseline Form and Instruction ModifiedAtt 4c_Patient Baseline Assessment English.docx
263488 Patient Baseline Form and Instruction Modified
263487 Patient Locator Form Form and Instruction ModifiedPatient Locator Form-Spanish_02OCT2025
263487 Patient Locator Form Form and Instruction ModifiedPatient Locator Form-English_02OCT2025
263487 Patient Locator Form Form and Instruction ModifiedAtt 4b_Patient Locator Form Spanish
263487 Patient Locator Form Form and Instruction ModifiedPatient Locator Form _English
263487 Patient Locator Form Form and Instruction Modified
263486 Patient Screener (English/Spanish) Form and Instruction ModifiedPatient Screener-Spanish_02OCT2025
263486 Patient Screener (English/Spanish) Form and Instruction ModifiedPatient Screener-English_02OCT2025
263486 Patient Screener (English/Spanish) Form ModifiedPatient Screener (Spanish)
263486 Patient Screener (English/Spanish) Form ModifiedPatient Screener (English)
263486 Patient Screener (English/Spanish) Form Modified
ICR Details
0920-1428 202510-0920-002
Historical Active 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
Approved without change 11/13/2025
Retrieve Notice of Action (NOA) 10/02/2025
  Inventory as of this Action Requested Previously Approved
01/31/2027 01/31/2027 01/31/2027
1,135 0 1,135
549 0 549
0 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 0920-22FZ, 0920-22FZ, 0920-1428, 0920-1428 Patient Locator Form _English ,   Att 4b_Patient Locator Form Spanish ,   Patient Locator Form-English_02OCT2025 ,   Patient Locator Form-Spanish_02OCT2025
Patient Quarterly Assessment n/a, 0920-1428, 0920-1428, 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) 0920-25AJ, 0920-25AJ, 0920-1428, 0920-1428 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 0920-22FZ, 0920-1428 Att 4j_Provider Post-Training Assessment ,   Provider Post-Training Assessment_02OCT2025
Provider Pre-Training Assessment n/a, 0920-1428 Att 4i_Provider Pre-Training Assessment ,   Provider Pre-Training Assessment_02OCT2025
Provider Screening 0920-22FZ Att 4g_Provider Screener
  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) 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 [email protected]
  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