OMB control number

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

OMB 0920-1428 · HHS/CDC.

OMB 0920-1428

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

The latest form for [NCHHSTP] mChoice: Improving PrEP Uptake and Adherence among Minority MSM through Tailored Provider Training and Adherence Assistance in Two High Priority Settings expires 2027-01-31 and can be found here.

Latest Forms, Documents, and Supporting Material

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

All Historical Document Collections

202602-0920-002 Approved without change	No material or nonsubstantive change to a currently approved collection	2026-02-09
202510-0920-002	No material or nonsubstantive change to a currently approved collection	2025-10-02
202410-0920-016 Approved without change	No material or nonsubstantive change to a currently approved collection	2024-11-19
202402-0920-005 Approved with change	No material or nonsubstantive change to a currently approved collection	2024-02-14
202309-0920-010 Approved without change	New collection (Request for a new OMB Control Number)	2023-11-20

OMB Details

Patient Screener (English/Spanish)

Federal Enterprise Architecture: Health - Public Health Monitoring

Form 0920-1428	Patient Screener-English_02OCT2025	N/A	Form and instruction
Form 0920-25AJ	Patient Screener (Spanish)	Fillable Fileable	Form
Form 0920-25AJ	Patient Screener (English)	Fillable Fileable	Form
Form 0920-1428	Patient Screener-Spanish_02OCT2025	N/A	Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.