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

Forms and Documents

Document Name	Status
Form 0920-22FZ Clinic Assessment Every Six Months Form and Instruction	New
Form 0920-22FZ Clinical Assesment Baseline & Final Form and Instruction	New
Form 0920-22FZ Provider Interview Form and Instruction	New
Form 0920-22FZ Provider Post-Training Assessment Form and Instruction	New
Form 0920-22FZ Provider Pre-Training Assessment Form and Instruction	New
Form 0920-22FZ Provider Locator Form Form and Instruction	New
Form 0920-22FZ Provider Screening Form and Instruction	New
Form 0920-22FZ Patient Interview Guide Form and Instruction	New
Form 0920-22FZ CleverCap App Setup Form and Instruction	New
Form 0920-22FZ Patient Quarterly Assessment Form and Instruction	New
Form 0920-22FZ Patient Baseline Form and Instruction	New
Form 0920-22FZ Patient Locator Form Form and Instruction	New
Form 0920-22FZ Patient Screener (English/Spanish) Form and Instruction	New
Att 9_Provider Training Summary.docx Supplementary Document	2023-11-15
Att 8_Privacy Impact Assessment_mChoice.pdf Supplementary Document	2023-11-15
Att 1_Auth Legislation.docx Supplementary Document	2023-11-15
30_Day FRN_Publication_Request_Worksheet_mChoice.pdf Supplementary Document	2023-11-15
SSB mChoice.docx Supporting Statement B	2023-11-15
SSA_mChoice.docx Supporting Statement A	2023-11-15

IC Document Collections

IC ID	Document Title	Status
263498	Clinic Assessment Every Six Months Form and Instruction	New
263497	Clinical Assesment Baseline & Final Form and Instruction	New
263496	Provider Interview Form and Instruction	New
263495	Provider Post-Training Assessment Form and Instruction	New
263494	Provider Pre-Training Assessment Form and Instruction	New
263493	Provider Locator Form Form and Instruction	New
263492	Provider Screening Form and Instruction	New
263491	Patient Interview Guide Form and Instruction	New
263490	CleverCap App Setup Form and Instruction	New
263489	Patient Quarterly Assessment Form and Instruction	New
263488	Patient Baseline Form and Instruction	New
263487	Patient Locator Form Form and Instruction	New
263486	Patient Screener (English/Spanish) Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202309-0920-010
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-22FZ
Title: [NCHHSTP] mChoice: Improving PrEP Uptake and Adherence among Minority MSM through Tailored Provider Training and Adherence Assistance in Two High Priority Settings
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  Yes
Type of Review Request: Regular	Date Submitted to OIRA: 11/20/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	1,135	0
Time Burden (Hours)	549	0
Cost Burden (Dollars)	0	0

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Abstract: 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.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 56834	08/21/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 78043	11/14/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
CleverCap App Setup	0920-22FZ, 0920-22FZ	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	0920-22FZ, 0920-22FZ	Att 4c_Patient Baseline Assessment English.docx ,   Att 4c_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	0920-22FZ, 0920-22FZ	Patient Locator Form _English ,   Att 4b_Patient Locator Form Spanish
Patient Quarterly Assessment	0920-22FZ, 0920-22FZ	Att 4d_Patient Quarterly Assessment English ,   Att 4d_Patient Quarterly Assessment Spanish
Patient Screener (English/Spanish)	0920-22FZ, 0920-22FZ	Patient Screener (English/Spanish) ,   Att 4a_Patient Screener Spanish
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	Att 4j_Provider Post-Training Assessment
Provider Pre-Training Assessment	0920-22FZ	Att 4i_Provider Pre-Training Assessment
Provider Screening	0920-22FZ	Att 4g_Provider Screener

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ICR Summary of Burden

	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	0	0	1,135	0	0
Annual Time Burden (Hours)	549	0	0	549	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection seeking 3 years of approval and 549 burden hours.

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Annual Cost to Federal Government: $1,112,799

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  Yes

Description/Changes for Common Form Usage: 

Approved RCFs using this ICR

Agency/Sub Agency	RCF ID	RCF Title	RCF Status	IC Title

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 11/20/2023

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