Assessment of a Comprehensive HIV Clinic-based Intervention to Improve Patients' Health and Reduce Transmission Risk

Forms and Documents

Document Name	Status
Provider Survey (English Only) Form and Instruction	New
Patient Exit Survey (English, Spanish & Creole) Form and Instruction	New
Computer-Based Intervention Assessment Items (English&Spanish) Form and Instruction	New
Patient Behavior Screener (for English, Spanish & Creole) Form and Instruction	New
Supporting Statement B.docx Supporting Statement B	2013-10-31
App 2 60-Day FRN Published.pdf Supplementary Document	2013-10-31
App 15 Project Determination.pdf Supplementary Document	2013-10-31
App 3 Clinical&Dem Variables.docx Supplementary Document	2013-10-31
App 13 IRB approvals from participating sites.docx Supplementary Document	2013-10-31
Supporting Statement A.docx Supporting Statement A	2013-10-31

IC Document Collections

IC ID	Document Title	Status
209259	Provider Survey (English Only) Form and Instruction	New
209258	Patient Exit Survey (English, Spanish & Creole) Form and Instruction	New
209257	Computer-Based Intervention Assessment Items (English&Spanish) Form and Instruction	New
209256	Patient Behavior Screener (for English, Spanish & Creole) Form and Instruction	New
209255	Electronic Transmittal of Clinical Variables Archived in Clinic Databases--Data Manager/no form Other-Records/Data extraction	New

ICR Details

OMB Control No: 0920-1002	ICR Reference No: 201311-0920-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 20821
Title: Assessment of a Comprehensive HIV Clinic-based Intervention to Improve Patients' Health and Reduce Transmission Risk
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/13/2013
	Date Received in OIRA: 11/08/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2016	36 Months From Approved
Responses	33,171	0	0
Time Burden (Hours)	3,378	0	0
Cost Burden (Dollars)	11,667	0	0

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Abstract: The purpose of this project is to increase the percentage of HIV patients who (1) have an undetectable viral load, (2) adhere optimally to antiretroviral therapy (ART), (3) attend clinic regularly for primary care, and (4) practice safer sex. These are objectives of the National HIV/AIDS Strategy and goals of the strategic plan of the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention. The project will be conducted at six HIV clinics in the United States with the following institutions: (1) Baylor College of Medicine, Houston, (2) Boston Medical Center, (3) University of Alabama, Birmingham, (4) University of California at San Diego, (5) University of Miami Medical School, and (6) University of Washington in the state of Washington. The intervention focuses primary on HIV patients who have a detectable viral load, i.e., their viral load is not as low as it can be and is not fully controlled. The intervention includes: (1) brief counseling from medical providers during primary care visits informed by a behavioral screener completed by patients; (2) a computer-based intervention (CBI) in which patients see short audio/visual about the importance of regular clinic attendance, adherence to ART, and safer sex; and (3) opportunity for one-on-one counseling from a prevention specialist if needed.

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Authorizing Statute(s): US Code: 3 USC 301 Name of Law: General Powers and Duties of Public Health Service: Research and Investigations
  

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:
	78 FR 9923	02/12/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 64942	10/30/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Electronic Transmittal of Clinical Variables Archived in Clinic Databases--Data Manager/no form
Patient Behavior Screener (for English, Spanish & Creole)	None, None, None	Appendix 6: Patient Behavior Screener (Creole) ,   Appendix 4: Patient Behavior Screener (English) ,   Appendix 5: Patient Behavior Screener (Spanish)
Computer-Based Intervention Assessment Items (English&Spanish)	None, None	Appendix 7: Computer-Based Intervention Assessment Items (English) ,   Appendix 8: Computer-Based Intervention Assessment Items (Spanish)
Patient Exit Survey (English, Spanish & Creole)	None, None, None	Appendix 10: Patient Exit Survey (Spanish) ,   Appendix 11: Patient Exit Survey (Creole) ,   Appendix 9: Patient Exit Survey (English)
Provider Survey (English Only)	None	Appendix 12: Provider Survey (English Only)

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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	33,171	0	0	33,171	0	0
Annual Time Burden (Hours)	3,378	0	0	3,378	0	0
Annual Cost Burden (Dollars)	11,667	0	0	11,667	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 Information Collection Request.

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Annual Cost to Federal Government: $1,980,609

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 11/08/2013

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