HIV Outpatient Study (HOPS)

Forms and Documents

Document Name	Status
Form 0920-1080 Informed Consent Form	Modified
Form 0920-1080 Behavioral Survey Form and Instruction	Modified
Att 10 PIA_HOPS-1080.pdf Supplementary Document	2018-08-09
Att 9 Requested Revisions_9_13_2018_final.docx Supplementary Document	2018-09-19
Att 8 List of Study Publications.docx Supplementary Document	2018-08-09
Att 3C Explanation of revisions.docx Supplementary Document	2018-08-09
Att 2_60-Day FRN.pdf Supplementary Document	2015-07-22
Att 7_CDC IRB Approval.docx.pdf Supplementary Document	2018-08-09
Att 2 60 Day FRN.pdf Supplementary Document	2018-08-09
Att 1 Auth Legislation.docx Supplementary Document	2018-08-09
SS B.docx Supporting Statement B	2018-08-09
SSA.080718.docx Supporting Statement A	2018-08-09

IC Document Collections

IC ID	Document Title	Status
216378	Informed Consent Form	Modified
216377	Behavioral Survey Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1080	ICR Reference No: 201808-0920-004
Status: Active	Previous ICR Reference No: 201504-0920-010
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1080
Title: HIV Outpatient Study (HOPS)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/28/2018
	Date Received in OIRA: 08/31/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2021	36 Months From Approved	09/30/2018
Responses	2,950	0	2,950
Time Burden (Hours)	405	0	405
Cost Burden (Dollars)	0	0	0

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Abstract: he HIV Outpatient Study (HOPS) combines medical records data abstraction on HIV-infected adults at 8 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.

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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:
	82 FR 44792	09/26/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 43688	08/27/2018
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Behavioral Survey	0920-1080	Behavioral Survey Instrument
Informed Consent	0920-1080	Consent to Participate in a Research Study

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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	2,950	0	0	0	0
Annual Time Burden (Hours)	405	405	0	0	0	0
Annual Cost Burden (Dollars)	0	0	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:

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Annual Cost to Federal Government: $2,262,205

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.     Yes

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: 08/31/2018

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