HIV Outpatient Study (HOPS)

Forms and Documents

Document Name	Status
Att 2_60-Day FRN.pdf Supplementary Document	2015-07-22
Att 7_CDC IRB Approval.docx Supplementary Document	2015-04-30
Att 2_60-Day FRN.pdf Supplementary Document	2015-07-22
Att 1_Auth Legislation.docx Supplementary Document	2015-04-30
SupSta B.072215.docx Supporting Statement B	2015-07-22
SupSta A.072215.docx Supporting Statement A	2015-07-22

IC Document Collections

IC ID	Document Title	Status
216378	Consent Form	New
216377	Behavioral Survey Other-WORD	New

ICR Details

OMB Control No: 0920-1080	ICR Reference No: 201504-0920-010
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 15JX
Title: HIV Outpatient Study (HOPS)
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: 08/17/2015
	Date Received in OIRA: 05/20/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2018	36 Months From Approved
Responses	2,950	0	0
Time Burden (Hours)	405	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The HIV Outpatient Study (HOPS) combines medical records data abstraction on HIV-infected adults at 9 HIV clinics in the U.S. with a brief behavioral survey for patients who agree to complete the survey annually. The 7-minute survey administered by telephone or through a web interface includes questions on HIV-positive patients' risk behaviors (including sexual, drug use, tobacco use) which can then be linked to diagnoses, treatments and laboratory findings obtained through the abstraction of medical records, in order to inform secondary HIV prevention. The HOPS allows for examining the trends in the epidemiology of chronic HIV disease in this aging U.S. cohort; the identification of interactions between HIV disease, antiretroviral therapy, and other comorbidities; the characterization of the optimal management strategies for HIV-infected patients to reduce morbidity and mortality (e.g., data on drug toxicities, effectiveness of clinical interventions); and monitoring of sexual and drug use behaviors of HIV-infected patients to inform risk-reduction programs. HOPS data can be used to evaluate the progress in achieving the goals of the National HIV/AIDS Strategy (White House, 2010): to increase retention in HIV care, to reduce racial/ethnic disparities in treatment outcomes, and to reduce secondary HIV transmission.

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Authorizing Statute(s): US Code: 30 USC (241)a Name of Law: 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:
	80 FR 506	01/06/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 27313	05/13/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Behavioral Survey
Consent Form

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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	2,950	0	0	2,950	0	0
Annual Time Burden (Hours)	405	0	0	405	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 request for a new OMB Control Number.

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Annual Cost to Federal Government: $2,138,478

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: 05/20/2015

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