Information Collection Request

Understanding Decisions and Barriers about PrEP Use and Uptake Among Men Who Have Sex With Men

ICR 201808-0920-015 · OMB 0920-1245 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Behavioral Assessment Form and Instruction New Available
Eligibility Verification Form and Instruction New Available
Focus Group Moderator Guide Form and Instruction New Available
In-Depth Interview Guide Form and Instruction New Repair queued
Contact Form Form and Instruction New Available
Screener Form and Instruction New Available
SSB.docx Supporting Statement B Uploaded 2018-09-07 Available
SSA.docx Supporting Statement A Uploaded 2018-09-07 Available
Att 8 PIA 17AZI.pdf Supplementary Document Uploaded 2018-09-06 Available
Att 7 Data Security Plan.docx Supplementary Document Uploaded 2018-09-06 Available
Att 6 Recruitment materials.pdf Supplementary Document Uploaded 2018-09-06 Available
Att 5b CDC IRB Approval.docx Supplementary Document Uploaded 2018-09-06 Available
Att 5a Emory IRB Decision.pdf Supplementary Document Uploaded 2018-09-06 Available
Att 4c Behavioral Assessment Informed Consent.docx Supplementary Document Uploaded 2018-09-06 Available
Att 4b Focus Group Informed Consent.docx Supplementary Document Uploaded 2018-09-06 Available
Att 4a In-depth Interview Informed Consent.doc.docx Supplementary Document Uploaded 2018-09-06 Available
Att 2 60-Day FRN.pdf Supplementary Document Uploaded 2018-09-06 Available
Att 1 Auth Legislation.docx Supplementary Document Uploaded 2018-09-06 Available
IC Document Collections
IC IDCollectionTypeStatusForm
232944 Behavioral Assessment Form and Instruction New
232943 Eligibility Verification Form and Instruction New
232940 Focus Group Moderator Guide Form and Instruction New
232938 In-Depth Interview Guide Form and Instruction New
232933 Contact Form Form and Instruction New
232929 Screener Form and Instruction New
ICR Details
0920-1245 201808-0920-015
Historical Active
HHS/CDC 0920-17AZI
Understanding Decisions and Barriers about PrEP Use and Uptake Among Men Who Have Sex With Men
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 10/19/2018
Retrieve Notice of Action (NOA) 09/25/2018
  Inventory as of this Action Requested Previously Approved
10/31/2019 12 Months From Approved
1,620 0 0
335 0 0
0 0 0

The purpose of this research is to explore decisions, barriers, and facilitators about pre-exposure prophylaxis (PrEP) use (PrEP is an FDA-approved regimen of Tenofovir/emtricitabine), shown to have greater than 90% efficacy in reducing HIV infections among men who have sex with men (MSM) when taken in accordance with its prescribed daily schedule) among MSM: 1) who were offered PrEP but refused it; 2) who were interested in or started a PrEP regimen but did not follow through; and (3) who are eligible for PrEP per CDC guidelines (report condomless anal sex within last 3 months).

US Code: 42 USC 241 Name of Law: U.S. PHSA
  
None

Not associated with rulemaking

  82 FR 46996 10/10/2017
83 FR 45442 09/07/2018
Yes

  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 1,620 0 0 1,620 0 0
Annual Time Burden (Hours) 335 0 0 335 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Submission of 0920-17AZI - Understanding Decisions and Barriers about PrEP Use and Uptake Among Men Who Have Sex With Men is a New ICR.

$474,083
Yes Part B of Supporting Statement
    Yes
    Yes
No
No
No
Uncollected
Jeffrey Zirger 404 639-7118 [email protected]

  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.
09/25/2018