Mobile Messaging Intervention to Present New HIV Prevention Options for Men Who have Sex with Men (MSM): Randomized Controlled Trial

Forms and Documents

Document Name	Status
Assessment Form	Unchanged
Verification of Participant Eligibility Form	Unchanged
Contact Information Form	Unchanged
Initial Participant Screening for Eligibility Form	Unchanged
Justification For Change.docx Justification for No Material/Nonsubstantive Change	2018-04-23
Signed NCHHSTP M3 PIA.pdf 17AX.pdf Supplementary Document	2018-04-23
SSA - for Change.doc Supporting Statement A	2018-04-23
Att 7_Written Messages.docx Supplementary Document	2017-04-03
Att 6d_University of Pennsylvania IAA.pdf Supplementary Document	2017-04-03
Att 6c_University of Michigan IAA.pdf Supplementary Document	2017-04-03
Att 6b_Public Health Solutions IAA.pdf Supplementary Document	2017-04-03
Att 6a_Emory IRB Letter of Approval.pdf Supplementary Document	2017-04-03
Att 5_Consent Form.doc Supplementary Document	2017-04-03
Att 3_Recruitment Materials.docx Supplementary Document	2017-04-03
Att 2 60 Day FRN.pdf Supplementary Document	2017-04-03
Att 1_Auth Legislation.docx Supplementary Document	2017-04-03
SSB_4-07-2017_Word 97-2003.doc Supporting Statement B	2017-04-07

IC Document Collections

IC ID	Document Title	Status
226274	Assessment Form	Unchanged
226273	Verification of Participant Eligibility Form	Unchanged
226272	Contact Information Form	Unchanged
226271	Initial Participant Screening for Eligibility Form	Unchanged

ICR Details

OMB Control No: 0920-1209	ICR Reference No: 201804-0920-012
Status: Historical Active	Previous ICR Reference No: 201702-0920-009
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-18KH
Title: Mobile Messaging Intervention to Present New HIV Prevention Options for Men Who have Sex with Men (MSM): Randomized Controlled Trial
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/03/2018
	Date Received in OIRA: 04/25/2018
Terms of Clearance: Approved consistent with the understanding that CDC will not provide incentives to individuals who are ineligible to participate in the study.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2019	12/31/2019	12/31/2019
Responses	5,587	0	5,587
Time Burden (Hours)	3,787	0	3,787
Cost Burden (Dollars)	87,980	0	87,980

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Abstract: The purpose of this study is to test the efficacy of a smartphone-based HIV prevention intervention, known as M3, through a randomized controlled trial. The information collected through this study will be used to evaluate whether the M3 mobile-messaging intervention is assessing whether exposure to the message-delivery platform results in improvements in participants' self-reported sexual health and HIV prevention behaviors, beliefs and attitudes. The trial will assess whether intervention participants' behaviors significantly change from baseline to post-intervention when compared to participants in a waitlist control arm, and whether these changes are sustained at 6-month and 9-month follow-ups.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

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:
	81 FR 73402	10/25/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 16403	04/04/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Initial Participant Screening for Eligibility	N/A, N/A	Participant Screening ,   Screenshots of the Screening Form
Contact Information	N/A, N/A	Contact Information Form ,   Screenshots of the Contact Information Form
Verification of Participant Eligibility	N/A, N/A	Participant Screening ,   Screenshots of the Screening Form
Assessment	N/A, N/A, N/A	Assessment ,   Example Assessment Screenshots for HIV- Participants ,   Example Assessment Screenshots for HIV+ Participants

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ICR Summary of Burden

	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	5,587	5,587	0	0	0	0
Annual Time Burden (Hours)	3,787	3,787	0	0	0	0
Annual Cost Burden (Dollars)	87,980	87,980	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $1,317,692

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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.     Yes

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? Uncollected

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Common Form ICR:  No

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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: 04/25/2018

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