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

ICR 201804-0920-012

OMB: 0920-1209

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Unchanged
Form
Unchanged
Form
Unchanged
Form
Unchanged
Justification for No Material/Nonsubstantive Change
2018-04-23
Supplementary Document
2018-04-23
Supporting Statement A
2018-04-23
Supplementary Document
2017-04-03
Supplementary Document
2017-04-03
Supplementary Document
2017-04-03
Supplementary Document
2017-04-03
Supplementary Document
2017-04-03
Supplementary Document
2017-04-03
Supplementary Document
2017-04-03
Supplementary Document
2017-04-03
Supplementary Document
2017-04-03
Supporting Statement B
2017-04-07
IC Document Collections
IC ID
Document
Title
Status
226274 Unchanged
226273 Unchanged
226272 Unchanged
226271 Unchanged
ICR Details
0920-1209 201804-0920-012
Historical Active 201702-0920-009
HHS/CDC 0920-18KH
Mobile Messaging Intervention to Present New HIV Prevention Options for Men Who have Sex with Men (MSM): Randomized Controlled Trial
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 05/03/2018
Retrieve Notice of Action (NOA) 04/25/2018
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
12/31/2019 12/31/2019 12/31/2019
5,587 0 5,587
3,787 0 3,787
87,980 0 87,980

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.

US Code: 42 USC 241 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  81 FR 73402 10/25/2016
82 FR 16403 04/04/2017
No

  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
No
No
This is a new information collection.

$1,317,692
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
Uncollected
Renita Macaluso 770 488-6458 arp5@cdc.gov

  No

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.
04/25/2018


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