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
Clinic Assessment Every Six Months Form and Instruction
Clinical Assesment Baseline & Final Form and Instruction
Provider Interview Form and Instruction
Provider Post-Training Assessment Form and Instruction
Provider Pre-Training Assessment Form and Instruction
Provider Locator Form Form and Instruction
Provider Screening Form and Instruction
Patient Interview Guide Form and Instruction
CleverCap App Setup Form and Instruction
Patient Quarterly Assessment Form and Instruction
Patient Baseline Form and Instruction
Patient Locator Form Form and Instruction
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.