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 202602-0920-002 · OMB 0920-1428 · Active

Forms and Documents
DocumentTypeStatusAvailability
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 Repair queued
Form 0920-1428 Provider Post-Training Assessment_02OCT2025 Form and Instruction Unchanged Repair queued
Form 0920-22FZ Att 4j_Provider Post-Training Assessment Form and Instruction Unchanged Repair queued
Form 0920-1428 Provider Pre-Training Assessment_02OCT2025 Form and Instruction Unchanged Repair queued
Att 4i_Provider Pre-Training Assessment Form and Instruction Unchanged Repair queued
Form 0920-22FZ Att 4h_Provider Locator Form Form and Instruction Unchanged Repair queued
Form 0920-22FZ Att 4g_Provider Screener 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
Att 4e_CleverCap App Setup Spanish Form and Instruction Unchanged Available
Att 4e_CleverCap App Setup English Form and Instruction Unchanged Repair queued
Form 0920-26-0026 Quarterly Assessment Spanish Form and Instruction Modified Available
Form 0920-26-0026 Quarterly Assessment English Form and Instruction Modified Repair queued
Form 0920-26-0026 Patient Baseline Assessment Spanish Form and Instruction Modified Repair queued
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 Repair queued
Form 0920-1428 Patient Locator Form-English_02OCT2025 Form and Instruction Unchanged Repair queued
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 Repair queued
Form 0920-1428 Patient Screener-Spanish_02OCT2025 Form and Instruction Unchanged Repair queued
Form 0920-1428 Patient Screener-English_02OCT2025 Form and Instruction Unchanged Repair queued
Form 0920-25AJ Patient Screener (Spanish) Form Unchanged Available
Form 0920-25AJ Patient Screener (English) Form Unchanged Repair queued
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 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 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 Repair queued
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 Repair queued
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 Repair queued
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 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 Available
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 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 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 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
IC IDCollectionTypeStatusForm
263498 Clinic Assessment Every Six Months Form and Instruction ModifiedClinic Assessment Every 6 Months
263498 Clinic Assessment Every Six Months Form and Instruction Modified
263497 Clinical Assesment Baseline & Final Form and Instruction ModifiedClinic Assessment Baseline and Final
263497 Clinical Assesment Baseline & Final Form and Instruction Modified
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 UnchangedProvider Post-Training Assessment_02OCT2025
263495 Provider Post-Training Assessment Form and Instruction UnchangedAtt 4j_Provider Post-Training Assessment
263495 Provider Post-Training Assessment Form and Instruction Unchanged
263494 Provider Pre-Training Assessment Form and Instruction UnchangedProvider Pre-Training Assessment_02OCT2025
263494 Provider Pre-Training Assessment Form and Instruction UnchangedAtt 4i_Provider Pre-Training Assessment
263494 Provider Pre-Training Assessment Form and Instruction Unchanged
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 UnchangedAtt 4e_CleverCap App Setup Spanish
263490 CleverCap App Setup Form and Instruction UnchangedAtt 4e_CleverCap App Setup English
263490 CleverCap App Setup Instruction Unchanged
263489 Patient Quarterly Assessment Form and Instruction ModifiedQuarterly Assessment Spanish
263489 Patient Quarterly Assessment Form and Instruction ModifiedQuarterly Assessment English
263489 Patient Quarterly Assessment Form and Instruction Modified
263488 Patient Baseline Form and Instruction ModifiedPatient Baseline Assessment Spanish
263488 Patient Baseline Form and Instruction ModifiedPatient Baseline Assessment English
263488 Patient Baseline Form and Instruction Modified
263487 Patient Locator Form Form and Instruction UnchangedPatient Locator Form-Spanish_02OCT2025
263487 Patient Locator Form Form and Instruction UnchangedPatient Locator Form-English_02OCT2025
263487 Patient Locator Form Form and Instruction UnchangedAtt 4b_Patient Locator Form Spanish
263487 Patient Locator Form Form and Instruction UnchangedPatient Locator Form _English
263487 Patient Locator Form Form and Instruction Unchanged
263486 Patient Screener (English/Spanish) Form and Instruction UnchangedPatient Screener-Spanish_02OCT2025
263486 Patient Screener (English/Spanish) Form and Instruction UnchangedPatient Screener-English_02OCT2025
263486 Patient Screener (English/Spanish) Form UnchangedPatient Screener (Spanish)
263486 Patient Screener (English/Spanish) Form UnchangedPatient Screener (English)
263486 Patient Screener (English/Spanish) Form Unchanged
ICR Details
0920-1428 202602-0920-002
Active 202510-0920-002
HHS/CDC 0920-26-0026
[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 02/10/2026
Retrieve Notice of Action (NOA) 02/09/2026
  Inventory as of this Action Requested Previously Approved
01/31/2027 01/31/2027 01/31/2027
1,135 0 1,135
551 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. 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
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 0920-26-0026 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
  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
Yes
Miscellaneous Actions
No
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.
$1,112,799
No
    No
    No
No
No
No
No
Odion Clunis 770 488-0045 [email protected]
  Yes
  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.
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.
02/09/2026